Sub- LAW AND MEDICINE, SEM - 6, Mum. Univ.

New Syllabus – 2025

LAW AND MEDICINE

COURSE OBJECTIVES
The course is designed to impart the students an understanding of the areas of health law and
various kinds of Alternative Medicine law in India. It will help in analyzing lacunae within the
professional obligations of doctors and understand the doctor-patient relationship. The students
will be taught to synthesize various related provisions under Constitution, Tort Law, Indian Penal
Code and the Consumer Laws. The students‘ knowledge on law and medicine with special
emphasis on the legal and ethical issues surrounding the administration of treatment of medical
procedures in the backdrop of advancement of science and technology is covered. This syllabus is
designed to enable the students to be legally armed for skilful advocacy as practicing lawyers and
jurists in future. Overall, this course aspires to provide in-depth understanding of working of the
medical profession, and equip students accordingly with the requisite knowledge to protect the
interests of people, prevent wrongs and remedy wrongs.

COURSE OUTCOMES
After completing this course the students will be able to-
1. Understand the relationship between the law and medicines, medical professionals and all
allied alternative medical professions
2. Analyze the international legal framework for the law and medicine, and identify situations
that frequently present legal issues in the healthcare industry.
3. Understand the legal, social, and economic risks of potential legal claims.
4. Acquire detailed knowledge of regulation of traditional medicines and essential medicines
through the AYUSH ministry.
5. Interpret the policy of the government regarding medicine e.g. pricing of medicines,
spurious drugs, and advertisements.
6. Understand the specific legislations pertaining to law and practice on clinical trial, organ
transplantation, Pre conception and pre-natal diagnostics techniques law and the Magic
Remedies.

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MODULE 1: Right to Health and Different Provisions having bearing on Right to health in
the Indian Constitution
1.1 Health care Delivery System in India
1.1.1 Primary Health Centre‘s, Dispensaries, District level Hospitals, Hospitals with affiliated
Medical colleges, Advanced Centre’s aided by private sector which run corporate hospitals,
small multi-specialty hospitals and nursing homes.
1.1 Health Care Delivery System in India
India’s health care delivery system is a three-tier structure aimed at ensuring access to
medical facilities for all, especially in rural and underserved areas. The system is divided into
Primary Health Centers (PHCs), Secondary Health Care, and Tertiary Health Care.

1.1.1 Primary Health Centers (PHCs)

Introduction to PHCs
• Primary Health Centers (PHCs) form the cornerstone of India’s rural health care system.
• Established under the recommendations of the Bhore Committee in 1946, PHCs serve as
the first point of contact between the rural population and the formal health care system.
• They are designed to provide comprehensive primary health care services to
communities, ensuring accessibility and affordability.
Structure and Organization
• Population Coverage:
o A PHC typically caters to a population of 20,000–30,000 in rural areas and around
50,000–75,000 in tribal or difficult terrains.
• Staffing:
o Each PHC is staffed by a medical officer, nurses, pharmacists, laboratory technicians,
and other support personnel.
• Facilities:
o Infrastructure includes an outpatient department (OPD), inpatient beds (usually 4–
6), basic laboratory services, and minor surgical capabilities.
Services Offered
PHCs are expected to deliver the following services:
1. Maternal and Child Health (MCH) Services:
o Antenatal care, postnatal care, and immunizations.
2. Family Planning:
o Counseling, distribution of contraceptives, and sterilization services.
3. Preventive and Promotive Health Care:
o Immunization drives, sanitation, and health education.
4. Curative Services:
o Treatment for minor illnesses and first-level referral services for more serious
cases.
5. Control of Epidemics:
o Monitoring, reporting, and containment of outbreaks of diseases such as malaria,
dengue, and tuberculosis.
Significance of PHCs in India’s Health Care System
1. Accessibility:
o PHCs bridge the gap between the rural population and health care services.

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2. Preventive Health Care:

o Focus on immunization and sanitation helps prevent diseases.
3. Community Participation:
o Involves local population through village health workers like ASHAs (Accredited
Social Health Activists).

Challenges Faced by PHCs

1. Inadequate Infrastructure
• Many PHCs lack essential facilities such as clean water supply, electricity, and adequate
space for medical services.
2. Shortage of Staff
• PHCs often face shortages of medical officers and trained paramedical staff.
3. Insufficient Funding
• Budgetary constraints hinder the ability to upgrade facilities, purchase medicines, and
maintain equipment.
4. Lack of Community Awareness
• Many rural communities remain unaware of the services offered by PHCs, leading to
underutilization.
5. High Patient Load
• Overburdened with a high number of patients, PHCs may struggle to provide quality care.

Government Initiatives to Strengthen PHCs

1. National Health Mission (NHM):
o Launched in 2013, NHM provides financial and technical support to improve PHCs.
o Focus areas include infrastructure development, recruitment of staff, and ensuring
availability of medicines.
2. Ayushman Bharat - Health and Wellness Centers (HWCs):
o Under Ayushman Bharat, existing PHCs are being upgraded to HWCs to provide
comprehensive health care services, including preventive, promotive, and curative
care.
3. Digital Health Initiatives:
o Telemedicine and mobile health apps are being integrated to bridge the gap
between PHCs and tertiary care facilities.
4. Training and Capacity Building:
o Continuous medical education and training programs are conducted for PHC staff to
improve their skills.

Right to Health in the Indian Constitution

While the Right to Health is not explicitly recognized as a fundamental right in the Indian
Constitution, several provisions indirectly support it:
1. Article 21 (Right to Life):
o The Supreme Court has interpreted the Right to Life to include the Right to Health in
several judgments.

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o Case law: Bandhua Mukti Morcha v. Union of India (1984): Recognized health as a
part of the Right to Life.
2. Article 39(e) and (f):
o Directs the state to protect the health and strength of workers and children.
3. Article 41:
o Mandates the state to provide public assistance in cases of sickness and disability.
4. Article 42:
o Provides for just and humane conditions of work and maternity relief.
5. Article 47:
o Imposes a duty on the state to raise the level of nutrition and improve public health.
6. Directive Principles of State Policy:
o Envisions a welfare state committed to the health and well-being of its citizens.

Judicial Recognition of the Right to Health

1. Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996):
o The Supreme Court emphasized that the state has a constitutional obligation to
provide adequate medical facilities.
2. State of Punjab v. Mohinder Singh Chawla (1997):
o Held that the Right to Health is an integral part of the Right to Life under Article 21.
3. Consumer Education and Research Centre v. Union of India (1995):
o Expanded the scope of Article 21 to include the right to health and medical care.

Dispensaries
Introduction to Dispensaries
Dispensaries play a crucial role in India’s health care system, particularly in providing basic
outpatient services, minor treatments, and preventive health care. They cater to patients with
minor ailments and serve as the first point of contact for individuals requiring medical
assistance, especially in semi-urban and rural areas.

Nature and Purpose of Dispensaries

• Definition: A dispensary is a health care facility where medical advice, diagnosis, and
treatment are provided, along with basic medications and preventive services.
• Target Audience: Focused on individuals requiring non-emergency outpatient care.
• Scope of Services:
o Dispensing medicines prescribed by doctors.
o Providing minor medical care and first aid.
o Offering preventive health services, including immunizations and health awareness
programs.

Structure and Organization

1. Infrastructure
• Typically smaller than hospitals and primary health centers (PHCs).
• Basic setup includes consultation rooms, a waiting area, a pharmacy, and limited diagnostic
facilities.

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2. Staffing
• Staff usually includes:
o A general physician or medical officer.
o A pharmacist responsible for dispensing medicines.
o Nursing staff and paramedics for administering injections, vaccinations, or minor
treatments.
o Health assistants or community health workers in rural areas.
3. Location and Coverage
• Found in both urban and rural areas.
• Rural dispensaries often cater to populations of 5,000–10,000, while urban dispensaries
manage larger outpatient loads.

Functions of Dispensaries
1. Outpatient Services
o Provides basic medical consultations for minor illnesses like fevers, colds,
infections, and minor injuries.
2. Preventive Care
o Vaccination drives, health check-ups, and awareness campaigns on diseases such as
malaria, dengue, and tuberculosis.
3. Medication Distribution
o Dispenses essential medicines prescribed by doctors.
4. Family Planning Services
o Counseling on contraceptive methods and distribution of contraceptives.
5. Referrals to Higher Centers
o Refers patients requiring advanced or specialized treatment to PHCs, secondary
care hospitals, or tertiary institutions.

Significance of Dispensaries in Health Care Delivery

1. Accessibility:
o Provides localized health care access, reducing the need to travel long distances for
minor medical issues.
2. Cost-Effective Services:
o Offers affordable or free treatment for minor ailments, benefiting economically
weaker sections of society.
3. Health Monitoring:
o Acts as an interface for government health schemes and data collection for disease
surveillance.
4. Community Health Focus:
o Promotes hygiene, sanitation, and preventive measures within the community.

Challenges Faced by Dispensaries

1. Infrastructure Constraints
• Many dispensaries lack proper equipment, diagnostic tools, and storage for medicines.

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2. Shortage of Qualified Personnel

• Rural dispensaries often face shortages of doctors and pharmacists, relying on paramedical
staff.
3. Limited Scope of Services
• The absence of diagnostic or emergency care facilities reduces their effectiveness in
addressing more significant medical needs.
4. Poor Awareness
• Many people, especially in rural areas, remain unaware of the dispensaries’ services,
leading to underutilization.
5. Funding and Resource Allocation
• Budgetary constraints limit the dispensary’s ability to expand its services or maintain
adequate medicine stocks.

Government Initiatives for Dispensaries

1. National Health Mission (NHM)
o Focus on strengthening dispensaries as part of rural and urban health care systems.
o Funding for equipment, medicines, and staffing.
2. Ayushman Bharat – Health and Wellness Centers (HWCs)
o Transforming dispensaries into HWCs to provide comprehensive health care
services, including diagnostic and telemedicine facilities.
3. Integration with Public Health Programs
o Dispensaries are central to government immunization programs, family planning
initiatives, and health awareness drives.
4. Mobile Health Units
o Mobile dispensaries are deployed in remote and inaccessible areas to provide basic
health care services.

Constitutional and Legal Framework Supporting Dispensaries

1. Article 21 (Right to Life)
o Interpreted by the judiciary to include the right to health and access to basic
medical care.
2. Article 47
o Obliges the state to improve public health and raise the standard of living.
3. Judicial Recognition:
o In State of Punjab v. Mohinder Singh Chawla (1997), the Supreme Court emphasized
the importance of affordable and accessible health care as part of the right to health.

District Level Hospitals

Introduction
District-level hospitals serve as the primary referral centers in India’s public health care
system. Located at the district headquarters, these hospitals play a crucial role in providing
secondary health care services to the population of the district. They function as an
intermediary between primary health centers (PHCs) and tertiary hospitals.

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Key Features of District Hospitals

1. Definition
o A district hospital is a secondary-tier health care facility catering to the health care
needs of an entire district.
2. Capacity
o The bed strength varies depending on the district's population, typically ranging
from 100 to 500 beds.
3. Role in Health Care System
o Acts as a referral center for PHCs and community health centers (CHCs).
o Provides specialized health care services not available at lower-level facilities.

Structure and Organization

1. Infrastructure
• Equipped with wards, outpatient departments (OPDs), emergency rooms, operation
theaters, intensive care units (ICUs), diagnostic labs, and pharmacies.
• Separate sections for maternity care, pediatrics, general medicine, surgery, orthopedics,
and other specialties.
2. Staffing
• Multidisciplinary staff including:
o Specialist doctors (e.g., surgeons, pediatricians, gynecologists).
o General physicians.
o Nurses and paramedics.
o Administrative and support staff.
3. Technology and Equipment
• Equipped with advanced diagnostic tools such as X-ray machines, CT scanners, and
laboratories for blood tests and pathology.
• Facilities for dialysis, ultrasound, and other specialized treatments are often available.

Functions of District Hospitals

1. Referral Services
o Acts as a bridge between PHCs/CHCs and tertiary hospitals for specialized
treatments.
2. Curative Services
o Provides secondary medical care, including inpatient and outpatient services for a
range of medical conditions.
3. Emergency Care
o Handles trauma cases, accidents, and medical emergencies.
o Equipped with ambulances for emergency response.
4. Maternal and Child Health Services
o Comprehensive care for mothers and children, including maternity wards and
neonatal units.
5. Specialist Services
o Offers specialized care in fields like surgery, orthopedics, cardiology, pediatrics,
gynecology, and psychiatry.

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6. Preventive and Public Health Services

o Immunization programs, disease surveillance, and health education initiatives.
7. Training and Capacity Building
o Serves as a training center for medical and paramedical staff.
o Conducts workshops and continuous education for health care workers.

Significance of District Hospitals in Health Care Delivery

1. Accessibility
o Makes specialized health care services available at the district level, reducing the
need for patients to travel to urban centers.
2. Cost-Effectiveness
o Provides affordable care compared to private hospitals, making health services
accessible to economically weaker sections.
3. Comprehensive Care
o Combines curative, preventive, and rehabilitative services under one roof.
4. Health Data Collection
o Functions as a nodal point for collecting health statistics, vital for policy planning
and disease surveillance.
5. Public Health Outreach
o Facilitates the implementation of national health programs, such as TB eradication,
HIV/AIDS prevention, and vaccination campaigns.

Challenges Faced by District Hospitals

1. Inadequate Infrastructure
o Overcrowding and limited space due to the increasing patient load.
2. Shortage of Specialist Doctors and Staff
o Many district hospitals face a shortage of skilled specialists, leading to delayed
treatments.
3. Resource Constraints
o Insufficient funding for purchasing modern equipment and maintaining facilities.
4. Limited Awareness
o Rural populations often lack awareness about the services offered, leading to
underutilization.
5. Referral Bottlenecks
o Inefficient referral systems can delay critical care for patients requiring tertiary
services.

Government Initiatives to Strengthen District Hospitals

1. National Health Mission (NHM)
o Focus on upgrading district hospitals with additional infrastructure, staff, and
equipment.
2. Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PMJAY)
o Empaneling district hospitals to provide cashless treatment to beneficiaries under
this health insurance scheme.

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3. Health and Wellness Centers

o Linking district hospitals with primary and community health centers to create a
seamless health care delivery chain.
4. Telemedicine Services
o Use of telemedicine to connect district hospitals with tertiary hospitals for
specialized consultations.
5. Kayakalp Awards
o Incentivizing district hospitals for maintaining high standards of sanitation, hygiene,
and patient satisfaction.

Constitutional and Legal Support

1. Article 21 (Right to Life)
o Encompasses the right to health care, with district hospitals playing a pivotal role in
ensuring this right.
2. Article 47
o Directs the state to improve public health as a primary duty.
3. Judicial Precedents:
o In Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996), the Supreme
Court emphasized that adequate health care facilities, including district hospitals,
are essential for the realization of the right to life.

Hospitals with Affiliated Medical Colleges in India

Introduction
Hospitals affiliated with medical colleges play a pivotal role in the healthcare system of India.
These hospitals not only provide healthcare services to the public but also serve as training
grounds for future medical professionals. They offer students a practical learning experience
in diagnosing, treating, and caring for patients under the guidance of experienced medical
professionals. This dual role of patient care and education has made these hospitals an
integral part of the healthcare ecosystem.

Key Features of Hospitals with Affiliated Medical Colleges

1. Education and Training
o Hospitals affiliated with medical colleges are primary centers for training medical
students, nurses, and other health professionals. They offer students hands-on
training in clinical settings, which is essential for acquiring practical knowledge.
o The curriculum for medical students includes practical training in various
departments such as surgery, medicine, pediatrics, obstetrics, gynecology, and other
specialized fields, facilitated through the hospital's patient care services.
2. Specialized Services
o These hospitals provide specialized medical services that are often unavailable at
smaller, non-affiliated hospitals. This includes advanced diagnostics, surgeries, and
complex treatments.
o They typically have specialized departments, such as cardiology, neurology,
oncology, and orthopedics, where both students and patients benefit from the high
level of care and expertise.
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3. Research and Development

o Medical colleges often engage in medical research, and the affiliated hospitals serve
as the fieldwork location for many of these research projects. This enables students
to participate in clinical research, learn about new treatments, and contribute to
advancements in the medical field.
o These hospitals often serve as testing grounds for medical innovations, clinical
trials, and new treatments, thus contributing to the overall medical knowledge and
practice.
4. Quality of Care
o As teaching hospitals, these facilities tend to have highly skilled staff and cutting-
edge equipment, which are essential for training medical professionals and
providing quality patient care.
o Supervision by experienced doctors ensures that patient care meets high standards,
although medical students may be involved in the care process under supervision.
5. Patient Care Services
o In addition to providing advanced medical care, these hospitals offer low-cost or
subsidized services, making healthcare more accessible to a broader section of
society, particularly in the public health sector.
o They generally have a higher bed capacity and offer emergency, outpatient, and
inpatient services across various specialties.

Structure and Organization

1. Affiliated Medical College
o A medical college affiliated with a hospital offers undergraduate (MBBS),
postgraduate (MD, MS), and sometimes doctoral programs (Ph.D.) in various
medical fields. The college is responsible for the academic and theoretical training
of students, while the hospital provides practical, clinical exposure.
2. Hospital Departments
o These hospitals have multiple departments that provide comprehensive services,
including:
 Emergency Services: For trauma cases, accidents, and life-threatening
conditions.
 Outpatient Department (OPD): For general consultations and follow-up
treatments.
 Inpatient Services: For patients requiring hospitalization, including
specialized care units like ICU and NICU.
 Surgical Units: Offering routine and specialized surgeries.
 Laboratories: For diagnostic tests like blood tests, imaging, etc.
3. Staffing
o Medical Faculty: These hospitals employ faculty from medical colleges, who serve
as professors, consultants, and department heads. These doctors train students and
supervise them in practical situations.
o Junior Residents: Postgraduate students are usually placed in these hospitals to
gain hands-on experience under the supervision of senior doctors.

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o Nursing and Paramedical Staff: In addition to doctors, these hospitals also employ
nurses, lab technicians, physiotherapists, and other healthcare professionals to
support the overall patient care system.

Examples of Hospitals Affiliated with Medical Colleges in India

1. All India Institute of Medical Sciences (AIIMS), New Delhi
o Affiliated Hospital: AIIMS Hospital
o AIIMS is one of India’s leading medical institutions, known for its world-class
facilities, research, and education. It has a hospital that serves as a teaching and
research center, providing high-quality medical care to patients and offering hands-
on training for medical students.
2. King Edward Memorial (KEM) Hospital, Mumbai
o Affiliated College: Seth G.S. Medical College
o KEM is one of the most renowned hospitals in Mumbai, affiliated with Seth G.S.
Medical College. It offers comprehensive health services and is a key teaching
hospital for MBBS and postgraduate medical students.
3. Christian Medical College (CMC), Vellore
o Affiliated Hospital: Christian Medical College & Hospital, Vellore
o CMC Vellore is both a medical college and a hospital that provides a wide range of
health services and is also known for its high-quality medical education and
research.
4. Madras Medical College, Chennai
o Affiliated Hospital: Rajiv Gandhi Government General Hospital
o Madras Medical College, one of the oldest medical colleges in India, is affiliated with
the Rajiv Gandhi Government General Hospital. The hospital provides specialized
medical services and serves as a training ground for medical students.
5. Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
o Affiliated Hospital: PGIMER Hospital
o PGIMER is a leading medical institution in Chandigarh, offering advanced medical
care, research, and training for medical professionals. Its hospital provides a wide
array of services, including emergency care, surgical treatments, and specialty care.
6. All India Institute of Medical Sciences (AIIMS), Bhubaneswar
o Affiliated Hospital: AIIMS Bhubaneswar Hospital
o AIIMS Bhubaneswar is another branch of AIIMS, and its hospital provides
comprehensive health services along with serving as a teaching hospital for medical
students.

Advantages of Hospitals with Affiliated Medical Colleges

1. Advanced Medical Training
o Medical colleges affiliated with hospitals provide the best learning environment for
future healthcare professionals. Students get access to clinical exposure and hands-
on training under the supervision of experienced doctors.

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2. Availability of Specialized Care

o These hospitals offer a wider range of specialized services compared to general
hospitals, giving patients access to cutting-edge medical care. Medical students gain
experience in various specializations, ensuring they are well-prepared for their
careers.
3. Research and Innovation
o These institutions are hubs of medical research and often conduct studies that
improve health care delivery. They may also be involved in the development of new
treatments and medical technologies.
4. Affordable Healthcare
o Since these hospitals are often publicly funded, they provide healthcare services at
much lower costs compared to private institutions, making healthcare accessible to
people from all economic backgrounds.
5. Quality of Care and Infrastructure
o As part of their educational mandate, these hospitals are typically equipped with the
latest medical technologies and staffed with highly trained professionals, ensuring
high-quality patient care.

Challenges Faced by Hospitals with Affiliated Medical Colleges

1. Overcrowding
o These hospitals tend to have a high patient load, leading to overcrowding in
outpatient departments and wards. This can affect the quality of care and delay
treatment times.
2. Balancing Education and Patient Care
o Since these hospitals also function as educational institutions, balancing the
educational needs of students with the patient care demands can sometimes create
a conflict, especially in terms of the level of responsibility entrusted to students.
3. Limited Resources
o Despite having advanced facilities, the resource availability in government-affiliated
hospitals can sometimes be limited, particularly in terms of funding, leading to
equipment shortages or delays in patient care.
4. Long Waiting Times
o Due to the large number of patients, waiting times for consultations and procedures
in these hospitals can be long, which can be a significant challenge in delivering
timely care.
Advanced Centers Aided by the Private Sector Running Corporate Hospitals
Introduction
The private sector plays a significant role in India’s healthcare system, complementing public
healthcare facilities. Advanced centers, often funded or aided by private entities, are
established to deliver specialized and high-quality medical care. These centers frequently
operate as corporate hospitals, providing state-of-the-art healthcare services, contributing to
medical advancements, and addressing gaps in public health infrastructure.

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Characteristics of Corporate Hospitals

1. High-Quality Infrastructure
o These hospitals are equipped with advanced medical technology and infrastructure,
such as robotic surgery systems, high-precision diagnostic tools, and modular
operating rooms.
o Private funding ensures continuous upgrades to technology, which keeps these
hospitals at the forefront of medical innovation.
2. Specialized Services
o They offer a range of specialized treatments in areas like cardiology, oncology,
neurology, orthopedics, and organ transplantation.
o Multispecialty and superspecialty departments ensure comprehensive healthcare
under one roof.
3. Professional Management
o Corporate hospitals are professionally managed, with a focus on efficiency, patient
satisfaction, and profitability.
o They adopt corporate strategies, such as branding, marketing, and customer service,
to attract patients, including those from international markets.
4. Patient-Centric Approach
o Emphasis is placed on patient comfort, privacy, and service quality. Hospitals often
have luxurious patient rooms, concierge services, and dedicated customer care.
5. Research and Innovation
o Many advanced centers are involved in clinical trials, drug development, and the
testing of new medical devices.
o Collaborations with pharmaceutical companies and research institutions enable
cutting-edge research.

Role in India’s Healthcare System

1. Bridging the Public Healthcare Gap
o Advanced centers address the inadequacies of the public healthcare system, such as
long wait times, outdated infrastructure, and limited specialized care.
o These hospitals are often the first choice for complex and critical treatments.
2. Medical Tourism
o Corporate hospitals are key players in promoting India as a medical tourism hub.
They attract international patients by offering high-quality care at comparatively
lower costs.
o Services like multilingual support, travel assistance, and postoperative care
packages enhance the appeal for foreign patients.
3. Employment Generation
o These hospitals create job opportunities for healthcare professionals, including
doctors, nurses, paramedics, and administrative staff.
o They also attract Indian medical professionals who have trained or worked abroad,
contributing to reversing the brain drain in the medical field.

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4. Partnerships and Investments

o Collaborations between private entities and foreign investors have brought global
expertise and resources to Indian healthcare.
o Joint ventures with academic institutions and research organizations foster medical
education and innovation.

Examples of Corporate Hospitals in India

1. Apollo Hospitals
o Overview: Founded in 1983, Apollo Hospitals is one of the largest private
healthcare providers in Asia.
o Specializations: Cardiology, oncology, neurology, organ transplants, and robotic
surgeries.
o Innovation: The chain has pioneered telemedicine in India and implemented
advanced healthcare IT systems.
2. Fortis Healthcare
o Overview: Fortis is a leading integrated healthcare service provider with a network
of hospitals across India.
o Specializations: Multispecialty care, including advanced cardiac surgeries, cancer
care, and orthopedics.
o Focus: Offers a patient-first approach with international quality standards.
3. Max Healthcare
o Overview: Known for its high-end healthcare services and luxurious infrastructure.
o Specializations: Oncology, fertility treatments, and minimally invasive surgeries.
o Global Reach: Attracts international patients for medical tourism.
4. Manipal Hospitals
o Overview: With a strong focus on education and healthcare, Manipal Hospitals is a
trusted name in the industry.
o Specializations: Organ transplants, gynecology, urology, and gastroenterology.
o Research: Engages in clinical trials and medical research.
5. Narayana Health
o Overview: Founded by Dr. Devi Shetty, Narayana Health focuses on providing
affordable cardiac care and high-quality healthcare.
o Specializations: Pediatric and adult cardiac surgery, organ transplantation, and
critical care.
o Accessibility: Combines affordability with quality care to cater to a wider
demographic.

Strengths of Corporate Hospitals

1. Access to Modern Technology
o Investments in advanced medical devices and technology improve diagnostic
accuracy and treatment outcomes.

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2. World-Class Healthcare
o Corporate hospitals follow international standards in healthcare delivery, often
obtaining accreditations like JCI (Joint Commission International) and NABH
(National Accreditation Board for Hospitals & Healthcare Providers).
3. Efficiency and Speed
o These hospitals are known for their quick and efficient handling of patient cases,
significantly reducing wait times for diagnosis and treatment.
4. Innovative Healthcare Models
o Adoption of health insurance partnerships, preventive health checkup packages,
and telemedicine services caters to evolving patient needs.

Challenges Faced by Corporate Hospitals

1. High Cost of Care
o The advanced infrastructure and specialized services come at a premium, making
these hospitals inaccessible to lower-income groups.
2. Profit-Driven Model
o Critics argue that the profit-centric approach may sometimes lead to unnecessary
procedures or tests to increase revenue.
3. Urban-Centric Facilities
o Most corporate hospitals are located in urban areas, limiting access for rural
populations who might need specialized care.
4. Shortage of Skilled Professionals
o Despite high demand, there is a shortage of skilled doctors and nurses, leading to
high workloads and potential burnout.

Government and Private Sector Collaborations

To address the accessibility and affordability issues of corporate hospitals, several Public-
Private Partnerships (PPPs) have been initiated. These collaborations aim to:
• Provide subsidized healthcare services to economically weaker sections.
• Set up advanced centers in semi-urban and rural areas.
• Foster skill development in healthcare through training programs and workshops.
Small Multi-Specialty Hospitals and Nursing Homes
Introduction
Small multi-specialty hospitals and nursing homes form an essential part of the healthcare
delivery system in India. They serve as intermediate healthcare providers, bridging the gap
between primary healthcare centers and large tertiary hospitals. These facilities are often
found in urban neighborhoods and semi-urban or rural areas, providing accessible and
affordable healthcare services to the community.

Characteristics of Small Multi-Specialty Hospitals and Nursing Homes

1. Limited Capacity
o Typically, these facilities have fewer than 50-100 beds.
o They focus on providing care in key specialties like general medicine, pediatrics,
gynecology, orthopedics, and minor surgical interventions.

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2. Community-Oriented Services
o These hospitals are usually owned and managed by local healthcare professionals,
offering personalized care to patients.
o They are trusted by the community for quick and convenient access to medical
services.
3. Cost-Effective Care
o Small hospitals and nursing homes provide affordable healthcare compared to large
corporate hospitals.
o They cater to middle- and lower-income groups, often offering flexible payment
options.
4. Basic Infrastructure
o These facilities are equipped with essential medical equipment and diagnostic tools.
o Advanced diagnostic and treatment procedures may be limited, with referrals made
to larger hospitals for specialized care.
5. Round-the-Clock Services
o Many nursing homes offer 24/7 emergency services, maternity care, and minor
surgical treatments, making them a vital part of the healthcare system.

Role in the Healthcare System

1. Primary and Secondary Care
o They act as the first point of contact for patients needing medical assistance.
o Offer outpatient and inpatient services for common illnesses, injuries, and elective
procedures.
2. Accessible Healthcare
o Located close to residential areas, they are easily accessible to patients in
emergencies.
o They reduce the burden on larger hospitals by handling less complex cases locally.
3. Maternity and Childcare Services
o Many nursing homes specialize in obstetrics and gynecology, providing antenatal
care, deliveries, and neonatal care.
4. Preventive Healthcare
o Provide regular health checkups, vaccination drives, and preventive care measures
within the community.
5. Referral System
o Serve as a link in the referral system, directing patients requiring advanced care to
larger, specialized hospitals.

Advantages of Small Multi-Specialty Hospitals and Nursing Homes

1. Personalized Care
o Due to their smaller size, healthcare providers can build stronger doctor-patient
relationships, leading to more personalized treatment plans.
2. Affordable Treatment
o Their cost structure is lower than that of corporate hospitals, making healthcare
services more accessible to economically weaker sections.

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3. Local Employment
o Generate jobs for medical and paramedical staff, including nurses, technicians, and
administrative personnel.
4. Ease of Access
o Located within residential areas, they are convenient for patients who may face
difficulties traveling to large hospitals.
5. Quick Service
o With fewer patients, these facilities often provide faster treatment and reduced
waiting times compared to larger hospitals.

Challenges Faced by Small Multi-Specialty Hospitals and Nursing Homes

1. Limited Resources
o Lack of advanced medical equipment and facilities for complex surgeries or
treatments.
o Dependency on larger hospitals for specialized services.
2. Workforce Shortages
o Difficulty in attracting and retaining skilled doctors and nurses, particularly in rural
areas.
3. Financial Constraints
o Limited budgets for infrastructure upgrades and compliance with stringent
healthcare regulations.
4. Competition from Larger Hospitals
o Face stiff competition from corporate hospitals offering comprehensive services
under one roof.
5. Regulatory Challenges
o Compliance with multiple legal and regulatory requirements, including licensing
and accreditation, can be burdensome.

1.1.2. Limitations of smaller setups, Procedure and Requirements while starting a new
Setup
Limitations of Smaller Setups in Healthcare
Small multi-specialty hospitals and nursing homes, while integral to the healthcare system,
face several limitations due to their size, resources, and operational scope. Understanding
these limitations is crucial for identifying areas of improvement and designing supportive
policies for these facilities.

1. Resource Constraints
1.1 Financial Limitations
• Restricted Funding: Smaller setups often operate with limited financial resources, which
affects their ability to invest in advanced medical equipment and technology.
• Dependence on Revenue: Many small hospitals rely heavily on patient revenue, leaving
little room for expansion or upgrades.
1.2 Infrastructure Challenges
• Basic Facilities: The infrastructure in smaller hospitals may not meet the standards
required for complex medical procedures.
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• Limited Diagnostic Tools: Lack of advanced diagnostic equipment like MRI and CT
scanners forces patients to seek care elsewhere.
• Space Constraints: Smaller hospitals often face space shortages, restricting the addition of
specialized wards or new services.
1.3 Workforce Shortages
• Limited Staff: These setups may struggle to hire and retain highly skilled doctors, nurses,
and paramedical professionals due to budget constraints or location disadvantages.
• Overburdened Personnel: A small workforce can result in overworked staff, leading to
burnout and reduced efficiency.

2. Restricted Range of Services

2.1 Specialization Deficit
• Basic Care Only: Small setups primarily focus on general medical care and lack specialized
departments like cardiology, oncology, or neurology.
• Surgical Limitations: Many cannot perform complex surgeries, requiring patients to be
referred to larger hospitals.
2.2 Emergency Services
• Inadequate Emergency Care: They may lack dedicated emergency departments, trauma
care units, or intensive care units (ICUs).
• Referral Dependency: Emergency cases often need immediate transfer to tertiary care
centers, leading to delays in critical care.

3. Technological Limitations
3.1 Outdated Equipment
• Smaller hospitals may use older medical equipment, impacting diagnostic accuracy and
treatment quality.
• The cost of upgrading technology is often prohibitive for these setups.
3.2 Limited Digital Integration
• Lack of access to electronic medical records (EMRs) or telemedicine facilities can hinder
efficient patient management and follow-up care.

4. Challenges in Quality Standards and Compliance

4.1 Accreditation and Licensing
• Compliance with national and international healthcare standards (like NABH or JCI
accreditation) can be expensive and complex for smaller setups.
• Lack of accreditation may reduce patient trust and credibility.
4.2 Infection Control
• Smaller setups may face challenges in maintaining stringent infection control protocols due
to space and resource limitations.
4.3 Legal and Regulatory Burdens
• The need to comply with various legal and regulatory frameworks, including building
safety codes, waste management, and labor laws, adds operational complexity.

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5. Patient Perception and Competition

5.1 Trust Deficit
• Patients often perceive smaller hospitals as less equipped or reliable compared to
corporate hospitals and tertiary care centers.
5.2 Competition from Larger Hospitals
• Larger hospitals offering comprehensive services and advanced care attract patients,
leaving smaller setups at a competitive disadvantage.

6. Geographic and Demographic Challenges

6.1 Urban Focus
• Many smaller setups are concentrated in urban areas, leaving rural and remote regions
underserved.
• Lack of adequate healthcare access in rural areas results in disparities in healthcare
delivery.
6.2 Population Overload
• In densely populated areas, smaller hospitals may become overcrowded, leading to longer
wait times and reduced quality of care.

7. Financial Sustainability
7.1 Insurance and Reimbursement Issues
• Delays in insurance claim processing and low reimbursement rates affect the financial
viability of smaller hospitals.
• Many patients in lower economic strata are unable to afford even the basic charges at these
facilities.
7.2 High Operational Costs
• Rising costs of medical supplies, utilities, and staff salaries further strain the finances of
smaller setups.

8. Emergency Preparedness
8.1 Limited Disaster Management
• Small hospitals are often ill-equipped to handle large-scale emergencies or pandemics, as
seen during the COVID-19 crisis.
8.2 Lack of Specialized Training
• Staff may lack training for managing emergencies, disasters, or public health crises.

9. Referral and Networking Gaps

9.1 Weak Referral Networks
• Poor integration with larger hospitals and specialty centers can lead to delays in patient
transfers and continuity of care.
9.2 Coordination Challenges
• Communication gaps between small setups and higher-tier facilities hinder seamless
patient care.

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Procedure and Requirements for Starting a New Healthcare Setup in India

Setting up a new healthcare facility, whether it's a hospital, clinic, or nursing home, involves
navigating through legal, infrastructural, and operational requirements. Here is a detailed
guide outlining the step-by-step procedure and essential requirements for starting a
healthcare setup in India.

I. Initial Planning and Feasibility Study

1. Determine Type and Scale of Setup
• Decide the type (clinic, hospital, nursing home, diagnostic center) and scale (primary,
secondary, or tertiary care) of the healthcare facility.
• Define the specialties to be offered (e.g., general medicine, pediatrics, cardiology).
2. Conduct a Feasibility Study
• Assess the demand for healthcare services in the chosen location.
• Identify the target population and their healthcare needs.
• Estimate capital investment, operating costs, and revenue potential.
3. Location Selection
• Choose a location easily accessible to the target demographic.
• Ensure compliance with zoning regulations and environmental norms.

II. Legal and Regulatory Approvals

1. Registration and Licensing
• Registration under the Clinical Establishments Act, 2010 (if applicable in the state):
Ensure your facility complies with minimum standards for infrastructure, staff, and
services.
• Trade License: Obtain from the local municipal authority to operate the business.
• Biomedical Waste Management Authorization: Mandatory under the Biomedical Waste
Management Rules, 2016.
• Fire Safety Clearance: Obtain approval from the Fire Department after ensuring adequate
fire safety measures.
• Pollution Control Board Clearance: For waste disposal and environmental compliance.
• Electrical Safety Clearance: Obtain approval for electrical installations.
2. Healthcare-Specific Licenses
• Pharmacy License: If the facility includes a pharmacy, register under the Drugs and
Cosmetics Act, 1940.
• Blood Bank License: Required if the facility plans to operate a blood bank.
• X-ray/Imaging License: Obtain permissions for diagnostic equipment under the Atomic
Energy Regulatory Board (AERB).
3. PAN and GST Registration
• Register for a Permanent Account Number (PAN) and Goods and Services Tax (GST) to
comply with taxation laws.
4. Compliance with Labour Laws
• Adhere to labour laws such as the Employees’ Provident Fund Act, Minimum Wages Act,
and Employees' State Insurance Act for staff welfare.

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III. Infrastructure Development

1. Building Construction and Design
• Follow guidelines under the National Building Code (NBC) of India.
• Design infrastructure to accommodate services like outpatient departments, inpatient
wards, operation theaters, diagnostic labs, and emergency units.
2. Equipment Procurement
• Source medical equipment based on the facility’s specialties and services (e.g., ECG
machines, X-rays, ventilators).
• Ensure all equipment is certified and meets safety standards.
3. Utilities and Amenities
• Install adequate power backup systems, water supply, and waste disposal systems.
• Provide patient-friendly amenities such as waiting areas, restrooms, and cafeteria services.

IV. Staff Recruitment and Training

1. Hiring Medical Professionals
• Recruit qualified doctors, nurses, paramedical staff, and technicians based on service
requirements.
• Verify their credentials and register them with relevant state medical councils.
2. Support Staff
• Hire administrative and support staff for roles like reception, billing, housekeeping, and
security.
3. Training
• Conduct regular training for all staff on healthcare protocols, emergency management, and
patient care.

V. Operational Setup
1. Establish Standard Operating Procedures (SOPs)
• Develop SOPs for patient admission, discharge, billing, and emergency care.
• Ensure compliance with medical ethics and patient safety standards.
2. Biomedical Waste Management
• Set up a system for segregating, storing, and disposing of biomedical waste as per
guidelines.
3. Information Management System
• Implement a hospital management system (HMS) for maintaining patient records, billing,
and appointments.
4. Insurance Empanelment
• Partner with health insurance companies to offer cashless treatment options.

VI. Marketing and Outreach

1. Branding
• Create a brand identity with a unique name, logo, and mission statement.
2. Marketing
• Use traditional and digital platforms to promote the facility and its services.
• Partner with local communities for health awareness campaigns.

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VII. Key Considerations

1. Legal Compliance
• Regularly update licenses and certifications.
• Maintain compliance with changes in healthcare laws and regulations.
2. Quality Assurance
• Strive for accreditation from bodies like the National Accreditation Board for Hospitals &
Healthcare Providers (NABH) to enhance credibility.
3. Financial Management
• Set up systems for revenue management, including patient billing and insurance claims.
• Explore financing options for initial capital, such as loans or private investments.
4. Risk Management
• Implement robust policies for handling medical errors, legal claims, and emergencies.

Checklist of Key Documents

1. Ownership or lease documents for the facility.
2. Building plan approval from local authorities.
3. Trade license from the municipal corporation.
4. Registration certificate under the Clinical Establishments Act.
5. Biomedical waste disposal agreement.
6. Tax registrations (PAN, GST).
7. Licenses for pharmacy, radiology, and blood bank (if applicable).
8. Labour law compliance documents.

1.1.3. Importance of Standards, Certifications and Accreditation‘s – International

Organisation for Standardization, National Accreditation Board for Hospitals
Standards in healthcare are critical for ensuring quality, safety, efficiency, and equity in the
delivery of medical services. They provide a benchmark for healthcare providers to achieve
optimal care outcomes while maintaining ethical and legal compliance. The importance of
healthcare standards can be analyzed under the following headings:

1. Ensuring Quality of Care

1. Consistency in Services:
o Standards ensure that patients receive uniform quality care, irrespective of the
location or provider.
o For example, adherence to infection control protocols reduces hospital-acquired
infections (HAIs).
2. Evidence-Based Practices:
o Standards encourage the use of proven and effective medical practices.
o Guidelines from the National Accreditation Board for Hospitals and Healthcare
Providers (NABH) promote consistent clinical practices.

2. Enhancing Patient Safety

1. Error Reduction:
o Following procedural standards reduces the likelihood of medical errors, such as
incorrect diagnoses or drug administration errors.
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o For instance, the WHO Surgical Safety Checklist standard minimizes surgical
complications.
2. Safe Environment:
o Standards mandate safety measures in healthcare facilities, such as fire safety,
biomedical waste disposal, and patient privacy.

3. Legal and Regulatory Compliance

1. Avoiding Legal Liability:
o Compliance with healthcare standards protects facilities and professionals from
malpractice lawsuits.
o For example, adherence to the Clinical Establishments (Registration and
Regulation) Act ensures minimum service quality standards.
2. Regulatory Approvals:
o Standards are prerequisites for obtaining licenses and accreditations from
regulatory authorities.

4. Facilitating Accreditation
1. National and International Recognition:
o Standards are the foundation for obtaining accreditations, such as NABH in India or
Joint Commission International (JCI) globally.
o Accredited facilities gain patient trust and credibility.
2. Improved Outcomes:
o Accreditation-driven adherence to standards ensures better clinical outcomes,
patient satisfaction, and organizational efficiency.

5. Promoting Efficient Resource Utilization

1. Optimal Use of Resources:
o Standards guide efficient use of medical equipment, medicines, and human
resources.
o For example, the guidelines for diagnostic imaging ensure appropriate use of X-ray
and MRI technology.
2. Cost Reduction:
o By reducing wastage and errors, adherence to standards minimizes unnecessary
costs.

6. Supporting Training and Education

1. Uniform Curriculum:
o Standards help establish consistent training protocols for medical and paramedical
staff.
o For example, the Indian Nursing Council (INC) prescribes standards for nursing
education and practice.
2. Skill Enhancement:
o Continuous professional development based on updated standards ensures that
healthcare professionals remain competent.

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7. Strengthening Patient Rights and Ethics

1. Informed Consent:
o Standards mandate processes to ensure that patients are well-informed before
undergoing procedures.
2. Patient Privacy:
o Adherence to data protection standards, such as those outlined by the Health Data
Management Policy under the National Digital Health Mission, safeguards patient
confidentiality.

8. Facilitating International Collaboration

1. Global Standards for Health Tourism:
o Facilities adhering to international standards attract medical tourists, enhancing the
facility's reputation and revenue.
2. Uniformity Across Borders:
o International standards, such as those by the World Health Organization (WHO),
ensure global consistency in health outcomes.

9. Continuous Improvement
1. Benchmarking and Performance Monitoring:
o Standards serve as benchmarks for healthcare organizations to measure their
performance and identify improvement areas.
2. Feedback Mechanism:
o Patient feedback, based on standards, allows facilities to improve their services
continually.

10. Examples of Key Standards in India

1. National Accreditation Board for Hospitals (NABH) Standards:
o Address patient safety, infection control, and quality improvement.
2. ISO Standards for Healthcare:
o Focus on service quality (ISO 9001), information security (ISO 27001), and medical
devices (ISO 13485).
3. Biomedical Waste Management Rules, 2016:
o Govern the segregation, treatment, and disposal of biomedical waste.
4. National Health Policy, 2017:
o Emphasizes quality assurance and patient safety as core components of the
healthcare system.
Certifications and Accreditations in Healthcare
Certifications and accreditations are critical mechanisms for maintaining quality, safety, and
efficiency in healthcare services. One of the most widely recognized organizations in this field
is the International Organization for Standardization (ISO). Below is a comprehensive
overview of ISO certifications and their significance in the healthcare sector.

1. What is ISO (International Organization for Standardization)?

• ISO is an independent, non-governmental international organization that develops and
publishes standards for a wide range of industries, including healthcare.
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• It establishes globally recognized frameworks for processes, services, and systems to

ensure quality, safety, and efficiency.

2. Importance of ISO Certifications in Healthcare

ISO certifications in healthcare help organizations achieve:
1. Improved Quality of Care:
o Ensures that processes and practices meet international benchmarks.
2. Enhanced Patient Safety:
o Reduces risks and errors by standardizing procedures.
3. Regulatory Compliance:
o Helps healthcare facilities meet legal and regulatory requirements in various
jurisdictions.
4. Operational Efficiency:
o Optimizes resource utilization, reducing waste and costs.
5. Global Recognition:
o Establishes credibility and fosters trust among international patients and
collaborators.

3. Key ISO Standards in Healthcare

3.1. ISO 9001: Quality Management Systems (QMS)
• Scope: Ensures quality management in healthcare organizations.
• Benefits:
o Streamlines patient care delivery.
o Promotes continuous quality improvement.
o Focuses on patient satisfaction.
3.2. ISO 13485: Medical Devices Quality Management
• Scope: Specifies requirements for a quality management system for the design and
manufacturing of medical devices.
• Benefits:
o Ensures safety and effectiveness of medical devices.
o Facilitates compliance with global regulations.
3.3. ISO 14001: Environmental Management Systems (EMS)
• Scope: Provides guidelines for managing environmental responsibilities.
• Benefits:
o Ensures proper disposal of biomedical waste.
o Reduces environmental impact of healthcare operations.
3.4. ISO 45001: Occupational Health and Safety Management
• Scope: Focuses on the safety of healthcare workers and other employees.
• Benefits:
o Minimizes workplace hazards.
o Promotes a safe and healthy work environment.
3.5. ISO 27001: Information Security Management Systems (ISMS)
• Scope: Protects sensitive patient information and healthcare data.

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• Benefits:
o Prevents data breaches.
o Ensures compliance with privacy regulations such as the GDPR.
3.6. ISO 15189: Medical Laboratories
• Scope: Provides specific requirements for the competence of medical laboratories.
• Benefits:
o Ensures accuracy and reliability of laboratory test results.
o Promotes better diagnostics and treatment outcomes.

4. Accreditation Bodies Associated with ISO Standards

4.1. National Accreditation Board for Hospitals & Healthcare Providers (NABH):
• NABH in India often aligns with ISO standards to certify healthcare facilities.
4.2. Joint Commission International (JCI):
• While distinct from ISO, JCI often uses ISO principles in its global accreditation programs.
4.3. International Laboratory Accreditation Cooperation (ILAC):
• Collaborates with ISO for laboratory accreditation.
4.4. World Health Organization (WHO):
• Collaborates with ISO on standards for global health initiatives.

5. Certification Process
1. Gap Analysis:
o Identify gaps between existing processes and ISO requirements.
2. Training and Documentation:
o Train staff and prepare necessary documentation.
3. Implementation:
o Implement new procedures and practices.
4. Internal Audit:
o Conduct an internal review to ensure compliance.
5. Certification Audit:
o Accredited certification bodies audit the facility for compliance.
6. Certification Issuance:
o Upon successful completion, the healthcare organization is awarded an ISO
certification.

6. Challenges in Implementing ISO Standards in Healthcare

1. High Costs:
o Certification and compliance can be expensive.
2. Resistance to Change:
o Staff may resist new processes.
3. Resource-Intensive Process:
o Requires significant time and effort.
4. Continuous Updates:
o Organizations must regularly update practices to remain compliant.

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7. Advantages of ISO Accreditation

1. Enhanced Credibility and Trust:
o ISO certification boosts patient confidence in healthcare services.
2. International Collaboration:
o Facilitates partnerships with global healthcare organizations.
3. Efficiency Gains:
o Streamlines operations and reduces redundancy.
4. Competitive Advantage:
o Certified organizations gain a competitive edge in the healthcare market.
National Accreditation Board for Hospitals & Healthcare Providers (NABH)
The National Accreditation Board for Hospitals & Healthcare Providers (NABH) is an
important body in India that provides accreditation to healthcare organizations and hospitals.
NABH ensures that healthcare services meet specific standards of quality and safety, thereby
enhancing the delivery of healthcare and patient satisfaction.

1. Introduction to NABH
NABH is a constituent board of the Quality Council of India (QCI), which is an autonomous
body set up by the Government of India. NABH was established in 2006 with the aim to
establish and operate accreditation programs for healthcare organizations. The board works
closely with hospitals, medical facilities, and healthcare providers to assess the quality of
services provided and guide them towards continuous improvement.
The primary objective of NABH is to ensure that healthcare providers deliver the highest
standards of care while adhering to best practices in medical ethics, patient safety, and patient
care.

2. Objectives of NABH
The key objectives of NABH include:
1. Ensuring High Quality Healthcare:
NABH ensures that hospitals and healthcare providers comply with quality standards that
promote effective healthcare delivery.
2. Improving Patient Safety:
The accreditation process promotes a safe environment for patients by enforcing strict
protocols to avoid medical errors, improve treatment processes, and safeguard patient
rights.
3. Enhancing Patient Satisfaction:
NABH emphasizes patient-centered care, focusing on comfort, satisfaction, and the overall
experience of patients throughout their treatment journey.
4. Facilitating International Recognition:
NABH-accredited hospitals can achieve international recognition, ensuring that Indian
healthcare standards align with global benchmarks.
5. Promoting Continuous Quality Improvement:
It encourages healthcare organizations to adopt continuous quality improvement practices
to stay updated with the latest medical standards and practices.

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3. NABH Accreditation Process

The process of NABH accreditation involves several stages to ensure that healthcare providers
meet the necessary standards. Here's a typical process:
3.1. Pre-Assessment and Self-Assessment
• Pre-Assessment: This is an initial evaluation where the healthcare organization assesses
itself against the NABH standards and determines areas of improvement.
• Self-Assessment: The healthcare organization conducts a thorough self-assessment to
identify gaps between existing practices and NABH standards.
3.2. Submission of Application
• The healthcare organization submits an application for accreditation to NABH along with
supporting documents, policies, and procedures for review.
3.3. Assessment by NABH Assessors
• NABH appoints a team of assessors to visit the healthcare facility. The assessors evaluate
the organization's adherence to NABH standards and norms.
• They conduct a detailed audit, reviewing policies, medical practices, facilities,
infrastructure, and patient care systems.
3.4. Review of Findings
• After the assessment, the assessors submit their findings to NABH. The organization then
has the opportunity to rectify any non-compliance issues before proceeding to the next
step.
3.5. Issuance of Accreditation
• If the healthcare facility meets the prescribed standards, NABH grants accreditation for a
period of 3 years. The accredited facility is then required to maintain and continually
improve its quality management practices.
3.6. Surveillance and Re-assessment
• NABH conducts periodic surveillance audits during the accreditation period to ensure
continuous compliance. At the end of the 3-year term, the organization undergoes a re-
assessment to renew the accreditation.

4. NABH Accreditation Standards

NABH provides a set of standards that hospitals and healthcare providers must follow for
accreditation. These standards are comprehensive and cover various aspects of healthcare
delivery, including but not limited to:
4.1. Patient Care and Safety
• The organization must implement policies and systems to ensure patient safety and high-
quality care.
• It includes protocols for infection control, patient rights, informed consent, and privacy.
4.2. Infrastructure and Environment
• Hospitals must ensure that the physical environment meets safety and infection control
standards. This includes cleanliness, proper equipment, and maintenance.
4.3. Quality Management Systems
• Hospitals should implement a quality management system, such as ISO 9001, for
continuous improvement in their processes.

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4.4. Medical Records

• Accurate and complete medical records must be maintained for each patient to ensure
continuity of care and compliance with healthcare regulations.
4.5. Staff Competence and Training
• Medical professionals and support staff should be adequately trained and competent to
perform their duties, ensuring patient safety and quality care.
4.6. Risk Management
• A structured approach to risk management is essential, covering potential clinical,
financial, operational, and safety risks.
4.7. Patient Education and Rights
• Hospitals must provide patients with information about their medical conditions,
treatment options, and their rights as patients.
4.8. Communication and Feedback Mechanisms
• Clear communication channels for patients, families, and staff must be established, along
with a mechanism for receiving and acting on feedback.

5. NABH Accreditation Categories

NABH offers accreditation for different types of healthcare facilities, such as:
5.1. NABH for Hospitals
• This is for general hospitals and multi-specialty hospitals providing a range of services.
5.2. NABH for Primary Health Centres (PHC)
• Accreditation for smaller healthcare facilities, focusing on primary care services in rural or
underserved areas.
5.3. NABH for Specialty Hospitals
• Accreditation for healthcare organizations specializing in specific medical fields, such as
cardiology, oncology, or pediatrics.
5.4. NABH for Diagnostic Centres
• Accreditation for facilities offering diagnostic services, such as pathology labs, imaging
centers, and radiology clinics.

6. Benefits of NABH Accreditation

6.1. For Healthcare Organizations:
1. Improved Quality of Care:
NABH accreditation drives hospitals to maintain and improve the quality of their
healthcare services, leading to enhanced patient care.
2. Increased Credibility:
Accreditation provides an official recognition that the hospital meets national and
international quality standards, boosting its reputation.
3. Better Operational Efficiency:
Accreditation pushes healthcare providers to streamline their processes, reducing errors
and wastage, leading to better operational efficiency.
4. Patient Satisfaction:
The focus on quality and patient care ensures high patient satisfaction, enhancing the
overall experience.

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6.2. For Patients:

1. Assured Quality Care:
Patients can trust accredited facilities to provide care that meets the highest standards of
safety and effectiveness.
2. Increased Trust in Healthcare Providers:
Accreditation builds trust among patients, knowing that healthcare providers have met
rigorous criteria for quality and patient safety.

7. Challenges of NABH Accreditation

1. High Costs of Accreditation:
The process of obtaining and maintaining NABH accreditation can be expensive, especially
for small or newly established healthcare providers.
2. Resistance to Change:
Some healthcare organizations may face internal resistance in adopting the new standards
or modifying existing practices to meet NABH requirements.
3. Continuous Monitoring:
Maintaining NABH accreditation requires ongoing monitoring and improvement, which can
be resource-intensive.
4. Time-Consuming Process:
The preparation and implementation required to meet NABH standards can take
significant time, depending on the organization's current state.

1.2. Control of Medical Profession - Functions of the Commission/Councils under the

following Acts
1.2.1. National Medical Commission Act, 2019
The National Medical Commission Act, 2019 is a landmark piece of legislation aimed
at transforming medical education and improving healthcare in India. It replaces the
previous Medical Council of India (MCI), which was criticized for its inefficiency,
corruption, and failure to ensure the quality of medical education and professional
standards. The new law established the National Medical Commission (NMC) to regulate
the medical profession, education, and healthcare delivery in India with a view to
promoting quality medical education, ensuring better healthcare delivery, and reforming
the regulatory framework.

1. Background and Objective of the National Medical Commission Act, 2019

The National Medical Commission Act was introduced to overcome the challenges faced by the
healthcare and medical education system in India, such as:
• Lack of regulation: The medical profession was not regulated adequately, leading to
inconsistent quality in medical education and practice.
• Inefficient governance of medical education and health institutions: The Medical
Council of India (MCI) was often seen as ineffective in its role, which led to delays in
decision-making and poor enforcement of regulations.
• Over-regulation: The previous system led to over-regulation, hindering the growth of
medical education and causing inefficiency.
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• Unequal distribution of doctors: There were concerns about the availability of qualified
doctors in rural and underserved regions.
The National Medical Commission Act, 2019 was designed to ensure that medical education is
of a high standard and that the medical profession is adequately regulated to maintain public
health and safety.

2. Structure and Functions of the National Medical Commission

The National Medical Commission (NMC) comprises various bodies, each responsible for
different aspects of medical education, professional conduct, and regulation of the healthcare
system. The NMC Act established four major committees under its framework:
2.1. National Medical Commission (NMC)
The National Medical Commission is the apex body responsible for formulating policies,
establishing standards for medical education, overseeing medical practice, and ensuring
healthcare delivery. The NMC is tasked with the responsibility of regulating medical education
and practice in India.
Functions of NMC:
• Setting Standards for Medical Education and Practice: The NMC establishes guidelines
for medical education, including undergraduate and postgraduate programs, as well as
continuing medical education for professionals.
• Regulation of Medical Colleges: It determines the criteria for the establishment and
functioning of medical colleges, medical schools, and hospitals.
• Granting Licenses: The NMC is responsible for granting licenses to medical professionals
to practice in India, ensuring that only qualified individuals are allowed to provide medical
services.
• Inspection of Medical Institutions: The NMC conducts inspections of medical colleges,
hospitals, and institutions to ensure compliance with standards set for medical education
and clinical practice.
• Promoting Medical Research and Innovation: It promotes research and innovation in
the medical field, encouraging medical institutions to participate in clinical and medical
research.

2.2. Medical Advisory Board

The Medical Advisory Board under the NMC is a consultative body that advises the
commission on matters related to the medical profession, education, and health policy.
Functions of the Medical Advisory Board:
• It advises the NMC on the implementation of the National Medical Commission's objectives
and the enhancement of medical education quality.
• It acts as a guiding body for medical reforms, including ensuring accessibility to medical
education and healthcare across the country.
• The Medical Advisory Board also provides input on public health initiatives and helps in
strengthening the healthcare delivery system.

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2.3. Undergraduate Medical Education Board (UGMEB)

The Undergraduate Medical Education Board is responsible for regulating the
undergraduate medical education system. This body plays a crucial role in shaping the future
of medical education by laying down the curriculum, examination systems, and criteria for
medical colleges offering undergraduate programs.
Functions of the UGMEB:
• Curriculum Development: It is responsible for designing the curriculum for
undergraduate medical programs and ensuring that it meets international standards.
• Conducting Examinations: The board is tasked with organizing and regulating the final
examinations for undergraduate medical courses.
• Accreditation of Institutions: The UGMEB assesses the quality of undergraduate medical
programs and grants recognition to medical institutions.

2.4. Postgraduate Medical Education Board (PGMEB)

The Postgraduate Medical Education Board deals with matters related to postgraduate
medical education, including courses and training programs for specialization in various
medical fields. This board is crucial in ensuring that postgraduate medical students receive the
necessary expertise to become skilled specialists.
Functions of the PGMEB:
• Curriculum and Training: It designs and updates the curriculum for postgraduate
medical education.
• Accreditation of Postgraduate Institutions: The PGMEB is responsible for accrediting
postgraduate medical education programs and institutions to ensure quality training and
development of specialized medical professionals.
• Examinations: It regulates the conduct of postgraduate medical examinations, ensuring
that standards of competency are met.

2.5. Ethics and Medical Registration Board

The Ethics and Medical Registration Board is tasked with establishing ethical standards for
the medical profession. It also maintains a central registry of medical practitioners to ensure
that only qualified individuals are practicing medicine.
Functions of the Ethics and Medical Registration Board:
• Maintaining Medical Registers: It maintains a national register of qualified medical
practitioners and ensures that doctors are registered to practice medicine.
• Enforcement of Ethical Standards: The board ensures that doctors follow ethical codes of
conduct in their practice, including guidelines related to professional behavior,
confidentiality, and patient welfare.
• Disciplinary Action: The board has the authority to take disciplinary action against
practitioners who breach ethical standards, such as suspending or revoking medical
licenses for malpractice or unethical practices.

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3. Key Features and Reforms of the National Medical Commission Act, 2019
The National Medical Commission Act, 2019 brings several key reforms aimed at improving
the quality of medical education, regulating the medical profession, and enhancing access to
healthcare. Some notable features of the Act include:
3.1. Replacing MCI with NMC
The National Medical Commission replaces the Medical Council of India (MCI), which was
widely criticized for inefficiencies, corruption, and failure to meet global standards. The NMC
aims to be more efficient and transparent in regulating medical education and practice.
3.2. Bridge Course for AYUSH Practitioners
A key reform is the introduction of the Bridge Course for AYUSH (Ayurveda, Yoga, Unani,
Siddha, and Homeopathy) practitioners. This course enables these practitioners to legally
prescribe modern medicine, which could address the shortage of healthcare professionals in
rural areas and ensure that people in remote locations have access to essential healthcare
services.
3.3. National Exit Test (NEXT)
The National Exit Test (NEXT) is introduced as a common final examination for medical
graduates. It will serve as a licensure exam to practice medicine and will also function as the
entrance examination for postgraduate medical courses. This move aims to standardize
medical education and streamline the process for new practitioners entering the workforce.
3.4. Regulation of Fees and Seat Availability
The Act mandates that the NMC regulate the fees for private medical colleges and determine
the number of seats available for students. This helps make medical education more
affordable and equitable.
3.5. National Medical Register
The NMC establishes a National Medical Register, which will track medical practitioners'
qualifications, training, and licenses. It ensures that only registered professionals are allowed
to practice medicine.

1.2.2. The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation
2002
The Indian Medical Council (Professional Conduct, Etiquette and Ethics)
Regulation, 2002 was introduced by the Medical Council of India (MCI), and it governs
the professional conduct, etiquette, and ethical practices that medical professionals in India
must adhere to. The regulation provides a comprehensive framework to ensure that
medical practitioners maintain the highest standards of professional integrity and ethical
behavior in their practice. The regulation is important as it aims to protect the interests of
patients and the medical profession, ensuring that medical practitioners perform their
duties responsibly, ethically, and in a manner that upholds public trust.
While the Medical Council of India has been replaced by the National Medical Commission
(NMC) in 2019 under the National Medical Commission Act, 2019, the Professional Conduct,
Etiquette, and Ethics Regulation of 2002 continues to guide the ethical behavior of medical
professionals. These guidelines have been instrumental in ensuring ethical practice across
various spheres of medical services, including patient care, medical education, and the
relationship between medical practitioners and their patients, peers, and the public.

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1. Key Provisions of the Indian Medical Council (Professional Conduct, Etiquette and
Ethics) Regulation, 2002
The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulation,
2002 addresses several crucial areas of medical practice. Some of the key provisions include:
1.1. General Principles of Professional Conduct
The regulation lays down a set of core values and professional ethics that every doctor in India
must follow to maintain the dignity of the medical profession and to ensure the well-being of
patients. These include:
• Honesty and Integrity: Doctors are required to be honest in their professional dealings
and provide truthful and accurate information to their patients.
• Patient Care and Safety: The doctor’s primary concern must be the health, safety, and
well-being of the patient. The regulation emphasizes providing competent and
compassionate care.
• Confidentiality: Medical practitioners must respect the confidentiality of patient
information and avoid disclosing any information about a patient without the patient’s
consent, except in cases where disclosure is required by law or for the patient's welfare.
• Patient Consent: Before administering any treatment, doctors are expected to obtain
informed consent from their patients, ensuring they understand the risks, benefits, and
alternatives.
1.2. Etiquette and Behavior
The regulation outlines the expected conduct of medical professionals, emphasizing courteous
and respectful behavior towards patients, peers, and the public. It highlights that:
• Respect for Dignity: Doctors must respect the dignity and rights of the patients,
acknowledging their autonomy and right to make decisions regarding their treatment.
• Professional Appearance: Medical professionals should maintain a high standard of
personal hygiene and dress appropriately, projecting professionalism.
• Proper Communication: Effective communication with patients, families, and colleagues
is essential. Doctors must avoid using technical jargon that may confuse patients and
should strive to communicate clearly and empathetically.
1.3. Professional Relations and Referrals
The regulation provides guidelines on maintaining professional relationships with colleagues,
healthcare providers, and patients:
• Respect for Peers: Doctors should maintain cordial relationships with their colleagues,
respecting their opinions and working collaboratively to achieve optimal patient outcomes.
• Referral and Transfer of Patients: If a doctor is not equipped to handle a particular
medical case, the regulation mandates that the doctor should refer the patient to a
specialist or appropriate facility for further treatment.
• Avoiding Conflicts of Interest: Doctors must avoid any actions that could lead to conflicts
of interest, including situations where their professional judgment could be influenced by
personal interests or financial gains.
1.4. Ethical Issues in Medical Practice
The regulation discusses ethical issues that may arise in the course of medical practice,
including:

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• Misleading Advertising and Promotion: Doctors are prohibited from engaging in

misleading advertising or promotion of medical services. Any advertisement or publicity
by a medical professional should not misrepresent the nature of the services or the
practitioner’s qualifications.
• Unprofessional Conduct: The regulation prohibits unethical practices such as accepting
commissions or kickbacks for referring patients to specific healthcare facilities, or
indulging in fraudulent practices to acquire medical records or credentials.
• Commercialization of Medicine: Doctors are encouraged to refrain from commercializing
medicine to the extent that it compromises patient care or leads to exploitation. The focus
should always be on delivering quality care rather than prioritizing financial gain.
1.5. Duty of Care
The regulation also emphasizes that doctors have an ongoing duty to care for their patients.
This includes:
• Continuous Professional Development: Doctors should keep themselves updated on the
latest developments in medical science and practice, ensuring that they provide evidence-
based care.
• Duty to Provide Medical Services: Doctors should provide medical services promptly,
especially in emergencies. They should not abandon patients without reasonable cause and
should ensure continuity of care when required.
• Quality of Service: Doctors must always ensure that they deliver medical services to the
best of their ability, based on established standards and protocols.
1.6. Discouragement of Malpractice and Negligence
The regulation provides a framework for identifying and addressing medical malpractice and
negligence:
• Medical Negligence: Doctors must ensure that they follow the prescribed protocols and
standards of care while treating patients. In cases where a doctor fails to provide adequate
care leading to harm, it may be considered negligence or malpractice.
• Professional Misconduct: The regulation defines the types of misconduct that may lead to
disciplinary action by the Medical Council or National Medical Commission. Misconduct
includes dishonesty, incompetence, and unethical behavior in professional practice.

2. Ethical Obligations towards Patients

The regulation highlights the ethical obligations that medical professionals must fulfill in
relation to patients. Some of these obligations include:
2.1. Duty of Care and Compassion
Doctors are expected to act with empathy and compassion towards their patients. They must
listen to their patients, understand their concerns, and provide care that is aligned with the
patient’s needs and values.
2.2. Informed Consent
Before any procedure, surgery, or significant treatment, the regulation mandates that doctors
must inform the patient about the nature of the treatment, its risks, and the possible
outcomes. Informed consent is a crucial ethical practice in medical care, and failure to obtain it
can lead to legal consequences.

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2.3. Confidentiality
Confidentiality is one of the core ethical principles in medical practice. Doctors must keep all
patient information confidential and only share it when authorized by the patient or when
required by law. This includes patient history, medical records, and any other private
information obtained during the course of treatment.
2.4. No Discrimination
The regulation emphasizes that doctors should treat all patients equally, without any
discrimination based on factors such as gender, age, caste, religion, economic status, or
disability. Every patient deserves equal attention and care.

3. Disciplinary Provisions and Penalties for Unethical Conduct

The regulation specifies the disciplinary actions that may be taken against medical
professionals who violate the established ethical guidelines. Some of the possible penalties
include:
• Suspension or Removal from Medical Register: A doctor may be suspended or
permanently removed from the medical register for serious professional misconduct or
repeated violations of ethical standards.
• Fines and Warnings: Doctors may be penalized with fines or issued warnings for less
severe violations of ethical conduct.
• Legal Action: In cases of serious malpractice, negligence, or criminal behavior, legal action
may be taken against the medical practitioner, leading to lawsuits or criminal charges.

1.2.3 The Indian Medicine Central Council Act, 1970

The Indian Medicine Central Council Act, 1970 was enacted to regulate the practice of
Indian medicine, including Ayurvedic, Siddha, and Unani systems of medicine, in India. The
primary purpose of this legislation was to establish a uniform system of medical education
and professional standards within the Indian medical community, specifically for practitioners
of these traditional Indian systems. The Act provides for the establishment of a central council,
the Central Council of Indian Medicine (CCIM), which is responsible for the regulation,
promotion, and development of Indian medicine in the country.
1. Key Features of the Indian Medicine Central Council Act, 1970
The Act is aimed at ensuring the quality of education and practice in the Indian systems of
medicine, such as Ayurveda, Siddha, and Unani, by establishing a regulatory framework. The
key provisions under the Act include:
1.1. Establishment of the Central Council of Indian Medicine (CCIM)
The Central Council of Indian Medicine (CCIM) is the apex body that regulates the
education and practice of Indian systems of medicine. The CCIM is responsible for maintaining
a national register of practitioners and ensuring that medical education institutions offering
courses in these fields adhere to the standards set by the council.
• Composition of CCIM: The CCIM comprises a variety of members, including government
representatives, practitioners, and scholars from the fields of Ayurveda, Siddha, and Unani.
These members help in formulating policies and setting guidelines for the medical
community.
• Functions of CCIM: The Council is responsible for:
o Maintaining a national register of practitioners of Indian medicine.
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o Recognizing medical qualifications granted by universities and institutions in India

and abroad.
o Regulating the standards of medical education in Indian medicine and ensuring
their uniformity across the country.
o Formulating regulations to ensure proper professional conduct, ethics, and
discipline.
1.2. Regulation of Medical Education and Qualifications
The Act authorizes the CCIM to regulate the standards of medical education for Ayurveda,
Siddha, and Unani medicine. The regulations made by the council are binding on all medical
institutions offering courses in these fields. The Act provides a legal framework to:
• Recognize Medical Institutions and Degrees: The CCIM is authorized to recognize
institutions and medical degrees for Ayurveda, Siddha, and Unani, ensuring that only
accredited institutions are allowed to award valid degrees in these fields. The council also
determines the curriculum and duration of courses for medical education in Indian
systems of medicine.
• Standards of Education: It prescribes minimum standards of education for teaching
institutions and ensures that the curricula for undergraduate and postgraduate courses in
these systems of medicine are up to date with modern developments while preserving the
traditional elements of the disciplines.
1.3. National Register of Indian Medicine Practitioners
The Act mandates the establishment of a National Register of Indian Medicine, where
practitioners of Ayurvedic, Siddha, and Unani medicine must register in order to be legally
recognized as practitioners. The CCIM maintains this register and ensures that only qualified
professionals with recognized degrees are allowed to practice.
• Eligibility for Registration: Practitioners can only register if they have obtained a
recognized medical degree or diploma in the relevant system of medicine from a
government-recognized institution.
• Removal from the Register: The CCIM has the authority to remove practitioners from the
register if they are found guilty of professional misconduct, negligence, or breach of ethical
standards.
1.4. Regulation of Professional Conduct and Ethics
The CCIM is responsible for setting ethical standards for the practice of Indian medicine. This
includes setting guidelines for the professional conduct of practitioners, promoting continuing
medical education, and ensuring that ethical considerations are at the forefront of practice in
Ayurvedic, Siddha, and Unani medicine. These ethical standards align with general medical
ethics but focus on the traditional systems of Indian medicine.
1.5. Powers of the Central Government
The Central Government has the authority to take action in cases where the functions of the
CCIM are not being carried out effectively. The government can intervene if the CCIM fails to
fulfill its duties and responsibilities or if its actions are contrary to public interest. The
government can:
• Dissolve the CCIM: In extreme cases, the central government can dissolve the CCIM and
take over the regulation of the Indian medicine sector, though this power is rarely invoked.

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• Make Regulations: The Central Government can also make rules or amend regulations as
needed, in consultation with the CCIM, to ensure the effective functioning of the Act.
1.6. Recognition of Medical Qualifications
The Act allows for the recognition of medical qualifications in Ayurveda, Siddha, and Unani
medicine. In cases where practitioners have received their qualifications from foreign
institutions, the CCIM has the authority to determine whether these qualifications are
equivalent to Indian qualifications and if the foreign qualifications meet the required
standards for practice in India.
• Foreign Qualifications: If a practitioner has a degree in Ayurvedic, Siddha, or Unani
medicine from a foreign institution, they must have their qualifications recognized by the
CCIM before being allowed to practice in India.
• Issuance of Certificates: The CCIM can issue certificates of registration to practitioners
whose qualifications are recognized under the Act.
1.7. Disciplinary Action
The CCIM is empowered to take disciplinary action against practitioners who violate the
regulations or engage in unprofessional or unethical practices. Disciplinary action may
include:
• Censure or Warning: A formal reprimand or warning for minor violations.
• Suspension or Removal from Practice: Serious misconduct may lead to suspension or
permanent removal from the register.
• Penalties and Fines: Practitioners found guilty of violations may be penalized with fines
or other punitive measures.
1.8. Research and Development in Indian Medicine
The Indian Medicine Central Council Act encourages research and development in the field of
traditional Indian medicine, including Ayurveda, Siddha, and Unani medicine. The CCIM
promotes research aimed at improving the effectiveness and safety of treatments, and the
government provides support for scientific advancements in these fields.
• Research Guidelines: The Act provides for guidelines on conducting ethical research in
Indian medicine, including clinical trials and the development of new drugs or therapies.
• Collaboration with International Bodies: The CCIM also promotes collaboration
between Indian institutions and international research bodies, ensuring that Indian
medicine remains relevant and up-to-date in the global medical community.

2. Impact and Importance of the Act

The Indian Medicine Central Council Act, 1970 has played a significant role in the
development and regulation of the traditional systems of medicine in India. It has helped
standardize medical education in Ayurveda, Siddha, and Unani medicine, ensuring that
practitioners are well-trained and adhere to ethical practices. The establishment of the CCIM
has also created a regulatory body that is responsible for maintaining high standards in
education and practice, ensuring that patients receive quality care from qualified
professionals.
The Act also aims to protect patients' interests by ensuring that only those who meet
established educational and ethical standards are allowed to practice. By regulating the

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qualifications of medical practitioners and maintaining a national register, the Act ensures
that only competent and responsible practitioners serve the public.
In addition, the Act has contributed to the recognition of Indian traditional medicine on the
global stage, facilitating collaboration and research in these fields. It has supported the
advancement of Ayurveda, Siddha, and Unani medicine while preserving their cultural and
historical significance.

3. Challenges and the Need for Reforms

While the Indian Medicine Central Council Act, 1970 has contributed to the growth of
traditional medicine, there are challenges that remain:
• Regulation and Oversight: The enforcement of standards across the vast number of
medical institutions in India remains a challenge, and there are concerns about the varying
quality of education and practice in different regions.
• Lack of Modernization: There is a need to modernize the curriculum to include
contemporary scientific knowledge and align traditional practices with modern
advancements in healthcare.
• Overseeing Unregulated Practice: In some regions, there are reports of unqualified
practitioners engaging in Indian medicine, leading to unsafe practices and patient harm.
To address these issues, ongoing reforms are necessary, including updating educational
standards, improving oversight, and creating awareness about the importance of regulation to
protect patients and the integrity of traditional systems of medicine.

1.2.4 Homeopathy Central Council Act.1973

The Homeopathy Central Council Act, 1973 is a legislation enacted by the Parliament of
India to regulate the education and practice of homeopathy in India. It is intended to ensure
that the practice of homeopathy adheres to prescribed standards and that those practicing
homeopathy possess the requisite qualifications and skills. The Act facilitates the
establishment of a regulatory body, Central Council of Homeopathy (CCH), and provides for
the registration of homeopathic practitioners in India.
1. Key Features of the Homeopathy Central Council Act, 1973
The Homeopathy Central Council Act, 1973 has several important provisions designed to
regulate homeopathic practice and education in India. Some of the key provisions include:
1.1 Establishment of the Central Council of Homeopathy (CCH)
The Central Council of Homeopathy (CCH) is the apex body for regulating the education and
practice of homeopathy in India. The Council oversees homeopathic education standards and
ensures that homeopathic practitioners comply with professional ethics.
• Composition of CCH: The Council is composed of 29 members, which include
professionals from the homeopathic field, government representatives, and nominees from
various state councils.
• Functions of CCH: The key functions of the Central Council of Homeopathy include:
o Maintaining a national register of practitioners of homeopathy.
o Setting and regulating the standards of education for homeopathy.
o Recognizing homeopathic institutions and courses that meet the standards set by
the Council.
o Developing and promoting ethical guidelines for practitioners of homeopathy.
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o Investigating complaints of professional misconduct against homeopathic

practitioners.
1.2 Recognition of Medical Qualifications in Homeopathy
Under the Act, the CCH has the authority to recognize medical qualifications in homeopathy.
This includes determining the validity and equivalence of degrees, diplomas, and certificates
in homeopathy from educational institutions in India and abroad.
• Recognition of Indian Qualifications: Homeopathic qualifications granted by recognized
Indian medical institutions are registered by the CCH, and practitioners can register their
names with the State Homeopathic Medical Councils after obtaining these qualifications.
• Recognition of Foreign Qualifications: The Act empowers the CCH to determine whether
a foreign qualification is equivalent to a recognized Indian qualification. Practitioners with
foreign qualifications must have their qualifications recognized by the CCH before they can
practice in India.
1.3 Homeopathic Medical Education and Standards
The Act mandates that the Central Council of Homeopathy establishes uniform standards for
homeopathic medical education across the country. This ensures that all homeopathic
institutions in India follow similar curricula and meet educational standards.
• Curriculum and Duration: The CCH prescribes the syllabus, course duration, and
requirements for granting degrees in homeopathy, which must be followed by
homeopathic colleges and universities in India.
• Regulation of Teaching Institutions: The Act enables the CCH to inspect and approve
institutions offering homeopathic courses. It also has the authority to de-recognize
institutions that do not adhere to prescribed standards.
1.4 National Register of Homeopathic Practitioners
The Act provides for the establishment of a National Register of Homeopathic
Practitioners to ensure that only qualified practitioners are allowed to practice homeopathy
in India. This register is maintained by the CCH, and it is compulsory for practitioners to be
registered with the relevant State Homeopathic Medical Council.
• Registration Process: Homeopathic practitioners who possess recognized qualifications
are eligible to register with the appropriate State Council, which in turn maintains a record
of registered practitioners.
• Removal from the Register: The CCH has the authority to remove practitioners from the
register if they are found guilty of professional misconduct, negligence, or unethical
practices.
1.5 Powers of the State Homeopathic Medical Councils
In addition to the Central Council, each state in India is required to establish its own State
Homeopathic Medical Council. These councils are responsible for maintaining a register of
homeopathic practitioners within the state and ensuring that practitioners adhere to
professional standards and ethics.
• Functions of State Councils: The State Homeopathic Medical Councils are responsible for:
o Maintaining the register of homeopathic practitioners in the state.
o Ensuring that practitioners adhere to professional ethics and standards set by the
Central Council.

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o Taking disciplinary action against practitioners found guilty of professional

misconduct.
1.6 Professional Conduct, Ethics, and Disciplinary Actions
The Central Council of Homeopathy is responsible for setting ethical standards for the
practice of homeopathy. The Act ensures that practitioners follow professional conduct and
adhere to the ethical guidelines provided by the Council.
• Professional Misconduct: The Act empowers the CCH to investigate cases of professional
misconduct, including issues related to negligence, malpractice, or unethical behavior by
registered practitioners. The Council can take action against erring practitioners, including
suspension, removal from the register, and other penalties.
• Ethical Guidelines: The CCH issues guidelines for practitioners to follow in their practice,
including matters relating to patient care, treatment methods, and professional
interactions.
1.7 Health and Safety Regulations for Homeopathic Practitioners
In addition to ethical conduct, the Act also includes provisions that govern the health and
safety standards for homeopathic practice. Homeopaths are required to adhere to certain
standards of practice to ensure the safety and well-being of their patients.
• Regulation of Homeopathic Drugs: The Act provides for the regulation of homeopathic
medicines, ensuring that they are manufactured, labeled, and sold in compliance with
safety standards. The Drugs and Cosmetics Act, 1940 also plays a role in regulating
homeopathic drugs.
• Protection for Patients: The regulatory framework ensures that homeopaths practice in a
manner that does not harm patients and that treatments are safe, effective, and consistent
with established homeopathic principles.
1.8 Continuing Professional Education
The Act encourages homeopathic practitioners to engage in continuing professional education
(CPE). This helps ensure that homeopaths are up-to-date with new research, clinical practices,
and ethical standards in the field of homeopathy.
• Mandatory Training: The CCH may establish requirements for practitioners to undergo
periodic training and educational courses to maintain their professional competence and
ensure they remain current with modern practices.
1.9 Regulation of Homeopathic Practice in Rural and Remote Areas
One of the objectives of the Homeopathy Central Council Act is to improve access to
homeopathic care, especially in rural and underserved areas. The Act encourages the practice
of homeopathy in such areas by facilitating the registration of practitioners and the
availability of homeopathic treatments.
• Rural Health Initiatives: The central government, in collaboration with state
governments, has made efforts to promote homeopathic practices in rural areas by setting
up dispensaries and clinics and offering incentives to practitioners willing to work in
remote areas.

2. Challenges and Need for Reform

While the Homeopathy Central Council Act, 1973 has successfully regulated homeopathic
education and practice, there are several challenges that need to be addressed:

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• Over Regulation: There is a growing concern that excessive regulation by the central and
state councils can stifle innovation and research in homeopathy. Striking a balance
between regulation and the need for professional freedom is essential.
• Quality of Education: While the Act provides for the regulation of medical education,
there are concerns regarding the quality of education in some institutions. Ensuring that all
homeopathic institutions meet the prescribed standards remains an ongoing challenge.
• Integration with Modern Medicine: Homeopathy, like other traditional systems of
medicine, faces challenges in integrating with modern allopathic medicine. There is a need
for better integration of scientific methods and evidence-based practices with homeopathy
to make it more effective and acceptable in mainstream healthcare.
• Unregistered Practitioners: Despite the regulatory framework, there are still many
unregistered or unqualified individuals practicing homeopathy. There is a need for better
enforcement of registration requirements and increased awareness among the public
regarding the importance of consulting qualified practitioners.

1.2.5 Importance of Registration (Different Courses, Recognition schedule 1 of MCI Act)

The importance of registration in medical professions, particularly under the Medical
Council of India (MCI) Act, is paramount in maintaining the standards of medical education
and ensuring the delivery of quality healthcare in India. Registration serves as a mechanism to
guarantee that medical practitioners, including homeopaths, allopathic doctors, and other
healthcare professionals, have received appropriate training and qualifications to practice
medicine. The Medical Council of India (MCI), established under the Indian Medical
Council Act, 1956, played a crucial role in regulating medical education in India until it was
replaced by the National Medical Commission (NMC) in 2020. Despite the shift, the
framework for the recognition of medical qualifications and the registration of professionals
remains critical.
In the context of the MCI Act, and its successor institutions such as the National Medical
Commission (NMC), the registration process ensures that only qualified and competent
individuals are allowed to practice medicine in India. The Recognition Schedule I of the MCI
Act contains detailed provisions for the recognition of medical qualifications granted by
various institutions and universities in India and abroad.
1. Key Aspects of Registration and Recognition under Schedule I of the MCI Act
1.1 Medical Courses and Recognition under Schedule I
Schedule I of the Indian Medical Council Act, 1956, provides the list of medical
qualifications that are recognized by the Indian Medical Council (or the NMC, after the Act's
amendment). It contains a comprehensive list of degrees, diplomas, and other educational
qualifications in medicine that are considered valid for registration as a medical practitioner
in India.
Types of Medical Qualifications Recognized under Schedule I:
• Undergraduate Medical Degrees: These include MBBS degrees or equivalent, which are
granted by recognized medical colleges. The MBBS is the basic medical degree that
qualifies a candidate to practice as a doctor in India.
• Postgraduate Medical Degrees: Specializations in various fields of medicine (e.g., MD,
MS) are recognized as advanced qualifications, which allow a medical professional to
specialize in a particular field of medicine.
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• Diplomas: The Act also recognizes various medical diplomas, including diplomas in
specific areas such as radiology, obstetrics and gynecology, and pathology.
• Foreign Qualifications: Medical qualifications obtained from foreign universities or
medical schools must also be recognized by the MCI/NMC. These foreign qualifications are
evaluated to ensure they are equivalent to Indian medical degrees and meet the required
standards for practice in India.
Recognition by the MCI or NMC is crucial because only those with recognized qualifications
are eligible to register with the State Medical Councils and are allowed to practice as
licensed medical professionals. Without proper recognition, a doctor’s ability to practice in
India is restricted.
1.2 Role of Registration in Quality Control of Medical Practice
The registration process serves as a quality control mechanism in the medical profession,
ensuring that only those individuals who meet specific academic, professional, and ethical
standards are allowed to practice medicine. State Medical Councils maintain a registry of
medical practitioners, which is continuously updated. They ensure that:
1. Competence: Only individuals with proper qualifications and training are allowed to treat
patients. This ensures a high standard of medical care and patient safety.
2. Ethical Standards: Registered practitioners are expected to adhere to ethical guidelines
set forth by the MCI, NMC, or other relevant professional bodies. These guidelines
encompass professional conduct, medical ethics, and treatment protocols.
3. Accountability: Medical professionals are held accountable for their actions through
registration. If a registered practitioner violates medical ethics or is found guilty of
malpractice, they can face disciplinary actions such as suspension or removal from the
register.
1.3 Importance of Registration for Medical Institutions
The registration and recognition of courses under Schedule I of the MCI Act is not only
crucial for individual practitioners but also for medical institutions. Only medical colleges
and universities that meet the standards set by the MCI/NMC and provide recognized degrees
are allowed to operate legally. This ensures that medical education in India maintains a
consistent and recognized level of quality.
Institutional Recognition under the MCI Act:
• Medical institutions (colleges and universities) must obtain recognition from the MCI/NMC
for their courses and degrees. This recognition confirms that their curriculum, faculty,
infrastructure, and overall education system adhere to the national standards for medical
education.
• For an institution to award degrees (e.g., MBBS, MD, MS), it must be recognized by the
MCI/NMC, ensuring that the degrees granted are valid and that graduates of these
institutions are eligible for registration and practice in India.
1.4 Ensuring Standardization of Medical Education
The Schedule I list of recognized qualifications is vital for ensuring that the medical education
system in India is standardized across the country. Whether a student attends a medical
college in Delhi, Tamil Nadu, or Uttar Pradesh, the qualifications they receive must meet
national standards to ensure uniformity in medical practice.

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• Curriculum and Training: The MCI/NMC sets guidelines for the curriculum and training
provided by medical institutions in India. The courses listed in Schedule I are required to
meet these standards, ensuring that graduates are adequately prepared to provide medical
care.
• Accreditation: Medical colleges and institutions must undergo a rigorous accreditation
process to maintain their recognition under the MCI/NMC framework. This helps eliminate
substandard institutions that could compromise the quality of education and the
healthcare system.
1.5 The Link between Registration and Public Health
Public Health Protection is one of the primary reasons for the mandatory registration of
medical practitioners. Only registered doctors with recognized qualifications can legally treat
patients and provide medical services. This helps protect public health by ensuring that all
medical practitioners are qualified and competent, which in turn minimizes the risk of
malpractice and negligence.
• Patient Trust: Registration reassures the public that the doctor they are consulting is
qualified, competent, and legally allowed to practice. This fosters trust in the healthcare
system.
• Professional Liability: Registered practitioners are subject to professional liability for
their actions. This includes the responsibility to provide adequate care and treatment. In
the case of negligence or misconduct, registered practitioners can be held accountable.
1.6 International Recognition and Practice
Medical professionals registered under the MCI/NMC have the opportunity to practice
internationally, depending on the equivalence of their qualifications. Recognition of medical
degrees through Schedule I allows Indian doctors to gain international recognition, which is
crucial for those looking to practice medicine in foreign countries.
• Medical Licensing Exams Abroad: Many countries require foreign-trained doctors to pass
licensing exams or meet specific qualifications before they are allowed to practice
medicine. Indian qualifications recognized by the MCI and NMC are accepted by several
countries for this purpose, enabling doctors to practice abroad.
1.7 Regulatory Mechanism for Continuing Education
The registration system also serves as a regulatory mechanism for continuing medical
education (CME). Medical practitioners are encouraged to engage in professional
development programs, courses, and workshops to maintain and enhance their skills. The
MCI/NMC mandates that doctors regularly participate in CME programs to maintain their
registration and ensure they remain up-to-date with medical advancements.
1.8 Consequences of Non-Registration
Failure to register with the State Medical Council or the National Medical Commission
(NMC) means that an individual cannot legally practice medicine. Additionally, medical
professionals practicing without valid registration face legal consequences, including:
• Legal Prosecution: Unauthorized practice of medicine is considered an offense under the
Indian Penal Code and could result in fines, imprisonment, or both.
• Malpractice Claims: Unregistered practitioners cannot defend themselves legally if they
are sued for malpractice, as they are not considered licensed professionals.

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1.2.6 Self-Regulation through Codes of conduct, Rights and duties of Registered Medical
Practitioner, Unethical Acts and Misconduct
Self-regulation within the medical profession is a critical mechanism that allows
professionals to maintain high standards of practice, ensure ethical behavior, and provide
quality care while remaining accountable to both society and the law. In India, the codes of
conduct and ethical guidelines set by medical councils, professional organizations, and
regulatory bodies form the foundation of self-regulation. These codes serve as guidelines for
the professional conduct of doctors and other healthcare practitioners, ensuring that they
maintain an appropriate standard of practice in their clinical and professional activities.
Self-regulation is necessary because medicine involves complex decision-making, which often
deals with patients' lives, health, and well-being. By establishing ethical norms, medical
professionals can provide the highest quality care while remaining accountable for their
actions.
1. The Role of Self-Regulation in the Medical Profession
Self-regulation refers to the ability of professionals to manage and oversee their conduct
without outside interference. In the case of the medical profession, this principle is embodied
in various codes of conduct, ethics, and guidelines that set standards for medical practice. This
allows medical professionals to have a framework for making ethical decisions in the best
interest of patients while upholding the values of the profession.
The Indian Medical Council Act, 1956 (repealed by the National Medical Commission Act,
2019) and subsequent regulatory frameworks provided the basis for medical ethics and self-
regulation. Self-regulation helps in areas such as maintaining professional standards,
addressing complaints, imposing disciplinary actions, and resolving disputes among medical
professionals or between doctors and patients.
2. Key Codes of Conduct for Medical Professionals
There are various codes of conduct established by medical councils, regulatory bodies, and
professional organizations. These guidelines outline the ethical and professional
responsibilities of medical practitioners. Some of the most important and widely recognized
codes of conduct include:
2.1 The Indian Medical Council (Professional Conduct, Etiquette and Ethics)
Regulations, 2002
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations,
2002 were framed by the Indian Medical Council (MCI) to promote ethical practice among
doctors. Even after the transition to the National Medical Commission (NMC) in 2020, these
ethical regulations remain influential.
• Professional Conduct: This regulation defines the ethical standards of behavior expected
from doctors. It includes rules about how doctors should interact with patients, the
importance of maintaining patient confidentiality, and the need for honesty and
transparency in medical practice.
• Etiquette: The regulations also include etiquette guidelines, emphasizing the importance
of respectful communication between doctors and patients. This includes aspects such as a
doctor’s attitude toward patients, maintaining dignity in medical practice, and treating
patients with kindness and empathy.
• Medical Ethics: The code emphasizes core ethical principles like beneficence (acting in the
best interest of patients), non-maleficence (do no harm), justice (fairness), and respect for
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autonomy (honoring patients' rights to make informed decisions about their treatment).
The Indian Medical Council’s ethical guidelines provide a comprehensive framework to
help practitioners navigate complex ethical dilemmas in their practice.
2.2 Code of Ethics by the National Medical Commission (NMC)
Following the enactment of the National Medical Commission (NMC) Act, 2019, the
National Medical Commission (NMC) assumed the responsibility of regulating the medical
profession and ensuring the adherence to ethical standards. The NMC continues to uphold and
enforce the Code of Ethics Regulations, 2023 (previously the Indian Medical Council Ethics
Regulations).
• Patient-Centered Care: The code advocates for the well-being of patients, emphasizing
that doctors must always prioritize the health and interests of their patients, ensuring that
their treatment is appropriate and ethical.
• Transparency and Informed Consent: One of the key components of the NMC code is
ensuring that patients are well-informed about their condition and treatment options. The
regulation stresses the importance of obtaining informed consent from patients for any
treatment or procedure.
• Professional Integrity: The NMC enforces a strict code of conduct that upholds the
reputation of the medical profession. Doctors must maintain high levels of professionalism,
competence, and moral integrity in all aspects of their practice.
2.3 Ethical Guidelines for Specialized Practices
In addition to the broader codes of conduct, there are more specific ethical guidelines for
specialized fields of medicine. For example:
• Ethical Guidelines for Medical Practitioners in the Field of Surgery
• Guidelines for Medical Practitioners in Obstetrics and Gynecology
• Ethical Guidelines for Psychiatry
These specialized codes ensure that medical professionals working in niche fields maintain
the highest levels of ethical conduct and practice, taking into account the specific needs and
considerations of their patients.
3. Functions and Importance of Self-Regulation through Codes of Conduct
3.1 Maintaining Professionalism
Self-regulation through codes of conduct ensures that medical professionals adhere to the
highest levels of professionalism. This is important because a doctor's professional behavior
directly impacts the quality of care they provide, their relationship with patients, and their
ability to maintain the trust of society. Codes of conduct help doctors balance personal
interests with their professional obligations.
• Guidelines for Treatment and Interaction: By adhering to codes of conduct, doctors
know how to interact with patients, what treatment options are ethically acceptable, and
when to seek second opinions or refer cases to specialists. It ensures that decisions are
made with the best interests of the patients in mind.
3.2 Patient Safety and Quality of Care
Ethical guidelines ensure that doctors prioritize patient safety and deliver the best care
possible. By following standards set forth in the code of conduct, medical professionals
prevent errors, ensure the safety of medical procedures, and reduce the likelihood of
malpractice or negligence.

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• Informed Consent: By emphasizing the need for informed consent, doctors ensure that
patients understand the risks and benefits of medical procedures, leading to more
transparent and trusted relationships with patients.
3.3 Accountability and Discipline
Self-regulation allows the medical profession to maintain accountability. The ethical codes
provide a framework for disciplinary action when doctors fail to adhere to established
professional standards. If a doctor violates these codes (such as through medical negligence,
misconduct, or unethical practices), their actions can be reviewed and sanctioned by
professional bodies.
• Disciplinary Action: Violations of the ethical code can result in actions such as warnings,
suspension, or even revocation of a doctor's medical license. This ensures that the medical
profession is held to high standards and that patients can trust in the competence and
integrity of their healthcare providers.
3.4 Preventing Malpractice and Medical Negligence
Codes of conduct offer a preventive mechanism for potential malpractice and negligence. By
following ethical guidelines, doctors are more likely to avoid making unethical decisions that
could harm patients or the reputation of the medical profession.
• Best Practices: Codes of conduct advocate for best practices in medical care. They provide
detailed guidance on how to approach treatment decisions and patient interactions in a
manner that minimizes risk to the patient and the doctor.
3.5 Ethical Standards for Medical Research
Medical research is another domain where self-regulation through codes of conduct plays a
critical role. The ethical guidelines ensure that research involving human subjects is
conducted responsibly, with full consent, and in compliance with international ethical
standards, such as the Declaration of Helsinki.
• Ethical Review Boards: Research projects typically undergo scrutiny by ethical review
boards, ensuring that research is conducted without exploitation of vulnerable populations
and that scientific integrity is upheld.
3.6 Building Trust in Healthcare
The medical profession’s credibility depends on the trust that patients and the general public
place in doctors. By adhering to ethical codes of conduct, doctors help to build and maintain
this trust, which is essential for effective patient care. Self-regulation via these codes
demonstrates a commitment to professional integrity and patient well-being.
4. Challenges to Self-Regulation
Despite its benefits, self-regulation through codes of conduct faces several challenges:
• Inconsistent Enforcement: One of the significant challenges is the inconsistent
enforcement of ethical standards across various states or institutions. Medical
professionals may face different levels of scrutiny depending on where they practice.
• Corruption and Malpractice: While codes of conduct help maintain professionalism, cases
of corruption or malpractice still occur. Some doctors may exploit their position for
personal gain or may be reluctant to report unethical behavior by their peers.
• Public Awareness: There may be a lack of awareness among the public about the ethical
standards governing medical practice. This can sometimes lead to patients unknowingly
accepting substandard care or unethical practices.

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Rights and Duties of Registered Medical Practitioners

A Registered Medical Practitioner (RMP) refers to a medical professional who has been
duly recognized and registered with the appropriate regulatory authority, such as the
National Medical Commission (NMC) or state medical councils, in accordance with the
provisions of the relevant medical laws. In India, the primary body responsible for the
regulation and registration of medical practitioners is the National Medical Commission
(NMC), which replaced the Indian Medical Council (IMC) Act of 1956 with the National
Medical Commission Act, 2019.
The rights and duties of a Registered Medical Practitioner are rooted in medical ethics,
professional conduct, legal norms, and the responsibilities they bear toward patients, society,
and the medical community. These rights and duties ensure that medical practitioners
perform their work with diligence, uphold ethical standards, and maintain trust in the
healthcare system.

Rights of a Registered Medical Practitioner

The rights of a Registered Medical Practitioner enable them to practice medicine with dignity,
autonomy, and professional respect. These rights are essential for the effective discharge of
their duties and responsibilities.
1. Right to Practice Medicine
A Registered Medical Practitioner has the legal right to practice medicine in India, provided
they are registered with a medical council (State or National). This right allows them to offer
medical services, whether as an independent practitioner, as part of a healthcare institution,
or in a government setup.
• Right to Use Medical Title: Registered practitioners are entitled to use medical titles such
as “Dr.” or other relevant professional titles in accordance with their qualifications.
• Right to Work in Healthcare Institutions: They have the right to be employed in public
or private hospitals, clinics, and other healthcare settings.
2. Right to Confidentiality
A Registered Medical Practitioner has the right to confidentiality regarding the medical
history, diagnoses, and treatment of their patients. Confidentiality is a fundamental ethical
duty, and breach of it can lead to legal consequences. The right to confidentiality is enshrined
in various medical ethical codes, including the Indian Medical Council (Professional
Conduct, Etiquette, and Ethics) Regulations, 2002.
• Patient Consent: Any disclosure of patient information requires the patient’s consent
unless disclosure is necessary for legal purposes or in the case of certain public health
situations.
3. Right to Practice Without Unlawful Interference
Medical practitioners have the right to practice medicine without undue interference from
non-medical entities. This ensures the autonomy of medical professionals in making clinical
decisions based on their expertise and ethical guidelines.
• Professional Autonomy: A doctor has the right to exercise their professional judgment
when diagnosing and treating patients, as long as they do so in accordance with the law
and medical ethics.

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4. Right to Protection from Harassment and Violence

Given the increasing instances of violence against healthcare professionals, RMPs are granted
the right to protection against harassment and physical violence during the course of their
duties. In some states, laws such as the The Maharashtra Medicare Service Persons and
Medicare Service Institutions (Prevention of Violence) Act, 2010 provide legal
protections to medical practitioners from violence.
5. Right to Continuing Education and Professional Development
Medical practitioners have the right to pursue continuing education and training in their field.
This ensures that they stay updated with the latest advancements in medical science and
practice. They may also participate in seminars, conferences, and workshops, which are
essential for maintaining their medical registration and practicing competently.
6. Right to Work in a Safe and Supportive Environment
Medical professionals have the right to work in a safe environment, including the provision of
adequate medical supplies, hygiene standards, and protections against health risks, especially
when working with infectious diseases.
7. Right to Participate in Medical Research
Registered medical practitioners also have the right to participate in clinical research, subject
to ethics and approval from relevant institutional review boards. This gives them the
opportunity to contribute to medical advancements and improve patient care practices.

Duties of a Registered Medical Practitioner

Along with the rights, a Registered Medical Practitioner is entrusted with several duties and
responsibilities. These are essential for ensuring that the medical profession is practiced
ethically, responsibly, and in a manner that serves the well-being of patients and society.
1. Duty to Provide Competent Care
A Registered Medical Practitioner has the primary duty to provide competent and effective
medical care to their patients. This means offering appropriate treatment, diagnosis, and
management based on the medical condition presented.
• Duty to Maintain Professional Competence: RMPs must ensure their skills and
knowledge are up to date. They should keep abreast of medical advancements and
integrate the latest scientific research into their practice.
• Duty to Refer Patients: If the medical practitioner lacks expertise in certain cases, they
have a duty to refer patients to appropriate specialists.
2. Duty to Act in the Best Interests of the Patient
A Registered Medical Practitioner must always act in the best interest of the patient. This
means prioritizing the patient’s health and well-being over personal gain, and refraining from
unethical practices such as over-treatment or under-treatment for personal or financial
motives.
• Duty of Non-Maleficence (Do No Harm): A core ethical principle of medicine is to avoid
harm to the patient. This includes ensuring the safety of medical procedures, medications,
and treatments.
• Duty of Beneficence: RMPs must act to benefit the patient, making decisions that enhance
the health and quality of life of their patients.

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3. Duty of Confidentiality
As mentioned earlier, the duty to maintain patient confidentiality is one of the most crucial
responsibilities of a medical practitioner. RMPs are obligated to safeguard patient information
and only disclose it when required by law or with the patient's consent.
• Duty to Respect Privacy: RMPs must also respect the privacy of their patients, ensuring
that their personal and medical information is not disclosed without proper authorization.
4. Duty to Provide Informed Consent
A Registered Medical Practitioner is obligated to ensure that the patient is provided with all
relevant information regarding their treatment options and the associated risks, so they can
make an informed decision. This includes:
• Informed Consent for Procedures and Treatment: Before performing any medical
procedure, RMPs must explain the benefits, risks, and alternatives to the patient, ensuring
they understand and voluntarily agree to the procedure.
• Duty to Document Consent: Medical practitioners must properly document the patient’s
consent in writing, especially for surgeries or high-risk procedures.
5. Duty to Maintain Professional Ethics
A Registered Medical Practitioner is bound by professional codes of conduct, ethics, and
etiquette. They must not engage in any activities that compromise their integrity or the
reputation of the profession.
• Prohibition of Malpractice: RMPs must not engage in any forms of malpractice, including
falsifying medical records, providing unnecessary treatments, or indulging in fraudulent
activities.
• Prohibition of Unethical Advertising: The medical profession has strict guidelines
regarding the promotion of services. A doctor should not advertise their practice in a
misleading or unethical manner. They should avoid making exaggerated claims regarding
the outcomes of treatments.
6. Duty to Collaborate with Other Medical Professionals
Doctors have a duty to collaborate with other healthcare providers, including specialists,
nurses, and support staff. Working as part of a healthcare team ensures the best possible care
for the patient.
• Duty to Provide Guidance and Support: Senior medical practitioners must guide and
mentor junior medical staff, ensuring they follow ethical practices and continue to learn
and develop professionally.
7. Duty to Comply with Legal and Regulatory Requirements
Registered Medical Practitioners must comply with the relevant laws and regulations
governing the practice of medicine. This includes adhering to:
• The Medical Council’s Rules and Guidelines: Compliance with rules laid out by the
National Medical Commission (NMC) or State Medical Councils is mandatory.
• Reporting Obligations: In certain cases, such as in the case of epidemics, communicable
diseases, or criminal activities like medical negligence or malpractice, doctors have a duty
to report these matters to the relevant authorities.
8. Duty to Respect Human Rights
RMPs must uphold the fundamental human rights of their patients. This includes respecting
patients’ autonomy, dignity, and rights to make their own decisions about their healthcare.

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• Non-Discrimination: Doctors must treat all patients fairly and without any form of
discrimination based on caste, gender, race, religion, or socio-economic status.
Unethical Acts and Misconduct in the Medical Profession
The medical profession is one that carries significant responsibility, trust, and authority.
Registered Medical Practitioners (RMPs) are entrusted with the health and well-being of
individuals, and the public expects them to perform their duties with the highest level of
professionalism, integrity, and ethical conduct. However, when medical practitioners engage
in unethical acts or misconduct, it undermines the trust placed in the healthcare system,
endangers patients, and damages the reputation of the medical profession. Unethical acts in
the medical field can range from minor lapses in conduct to serious violations of medical
ethics and laws.
The National Medical Commission (NMC), along with other medical councils, has set forth a
comprehensive framework of ethical standards that doctors must adhere to. The Indian
Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 and the
National Medical Commission (NMC) Act, 2019 outline the obligations and responsibilities
of medical practitioners. Any deviation from these norms constitutes misconduct and can lead
to disciplinary actions, legal consequences, and loss of professional credentials.
This article highlights common unethical acts and misconduct in the medical field, their
implications, and the consequences for medical practitioners involved in such activities.

1. Malpractice and Medical Negligence

Medical malpractice and negligence are among the most serious unethical acts a medical
professional can commit. These occur when a doctor fails to meet the accepted standards of
care, resulting in harm or injury to a patient. Medical malpractice refers to professional
negligence, while medical negligence is the failure to exercise reasonable care in performing
medical duties.
Examples of Malpractice and Negligence:
• Misdiagnosis or delayed diagnosis: Incorrectly diagnosing a patient or failing to
diagnose a condition can lead to improper treatment and worsening of the patient’s
condition.
• Errors during surgery or treatment: Mistakes such as performing the wrong surgery,
leaving instruments inside a patient’s body, or administering incorrect medications.
• Failure to inform the patient of risks: Not providing full information about the risks and
benefits of a treatment or procedure can lead to the patient making uninformed decisions.
Consequences:
• Loss of License: Medical practitioners found guilty of serious negligence may face
suspension or permanent revocation of their medical license.
• Legal Action: Patients or their families may file lawsuits for medical malpractice, which
could result in compensation claims and punitive damages.
• Criminal Liability: In cases of gross negligence, doctors can face criminal charges,
including imprisonment.

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2. Breach of Patient Confidentiality

One of the core ethical principles in medicine is the duty to maintain patient confidentiality.
When a medical professional discloses patient information without consent or fails to protect
sensitive patient data, they breach this fundamental principle.
Examples of Breach of Confidentiality:
• Sharing medical records: Disclosing patient information to unauthorized individuals or
organizations without proper consent.
• Discussing patient cases in public forums: Discussing a patient’s condition or treatment
in non-confidential settings, such as in social media or public spaces.
• Failure to secure medical records: Not maintaining adequate safeguards to prevent
unauthorized access to patient records.
Consequences:
• Disciplinary Action: The medical council may take action against the practitioner,
including suspension, a warning, or mandatory retraining on ethical standards.
• Civil and Criminal Liability: In certain cases, breach of confidentiality can lead to lawsuits
and penalties, particularly if the disclosure results in harm to the patient or violates data
protection laws.

3. Fraudulent Activities and Misrepresentation

Fraudulent activities and misrepresentation are clear violations of ethical medical practice.
This includes providing false information about qualifications, medical treatments, or the
outcomes of procedures. Misrepresentation can also involve inflating bills or falsifying
medical records.
Examples of Fraudulent Activities:
• Falsifying Medical Records: Altering or fabricating patient records to mislead or defraud
insurance companies, courts, or other entities.
• Providing False Credentials: Claiming qualifications or certifications that the doctor does
not possess.
• Overcharging and Billing Fraud: Charging patients for services that were not rendered or
inflating the cost of treatment.
Consequences:
• Criminal Charges: Fraudulent behavior can result in criminal prosecution, including
imprisonment and fines.
• Loss of Medical License: Misrepresentation of qualifications or fraudulent activities can
lead to permanent removal from the medical register.
• Damaged Reputation: The doctor may suffer irreparable harm to their professional
standing, making it difficult to practice in the future.

4. Exploitation and Abuse of Patients

Exploitation and abuse of patients, particularly vulnerable individuals, are severe ethical
violations. This includes any form of physical, emotional, or sexual abuse, as well as exploiting
the patient for financial gain.

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Examples of Exploitation and Abuse:

• Sexual Harassment: A medical practitioner using their position of power to exploit
patients sexually is a serious form of misconduct.
• Financial Exploitation: Forcing patients to undergo unnecessary treatments or tests for
personal financial gain.
• Verbal Abuse and Coercion: Using a threatening or coercive approach to pressure
patients into consenting to a procedure or treatment.
Consequences:
• Criminal Liability: Sexual abuse or exploitation is punishable under the Indian Penal Code
(IPC) and can lead to imprisonment and fines.
• Revocation of License: A medical professional found guilty of abuse or exploitation will
likely have their medical license revoked permanently.
• Civil Lawsuits: Victims may file lawsuits for emotional distress, compensation, and other
damages.

5. Unnecessary Medical Procedures and Over-Treatment

Over-treatment and performing unnecessary medical procedures for profit is another
unethical act in medicine. This occurs when a medical practitioner recommends treatments,
procedures, or tests that are not medically justified.
Examples of Unnecessary Procedures:
• Unnecessary Surgeries: Performing surgeries that are not medically needed, often
motivated by financial gain or personal benefit.
• Excessive Diagnostic Testing: Recommending unnecessary tests and procedures to
generate income from patients or insurance companies.
Consequences:
• Criminal Charges: Over-treatment and unnecessary procedures can lead to criminal
charges, particularly if the patient suffers harm.
• Disciplinary Action: The medical council may impose penalties, including suspension or
revocation of the doctor’s license.
• Loss of Trust: Such acts result in a loss of trust, both from patients and peers, and can lead
to a damaged reputation.

6. Substance Abuse and Impairment

Substance abuse by medical professionals is not only a personal issue but also a serious
professional misconduct. A medical practitioner under the influence of alcohol or drugs can
make impaired judgments that put patient safety at risk.
Examples of Substance Abuse and Impairment:
• Working Under the Influence: A doctor practicing while intoxicated or under the
influence of drugs, impairing their ability to make sound clinical decisions.
• Prescription Abuse: Prescribing drugs for personal use or selling medications illegally.
Consequences:
• Suspension or Revocation of License: Medical councils may suspend or permanently
revoke a doctor’s license if they are found to be practicing while impaired.

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• Treatment and Rehabilitation: Doctors caught in substance abuse cases may be required
to undergo rehabilitation and counseling before they can resume practice.
• Criminal Charges: Prescription abuse can lead to criminal prosecution under laws related
to drug trafficking and illegal substance abuse.

7. Conflict of Interest and Commercialization

Doctors are expected to provide unbiased medical advice based solely on their professional
judgment and the patient’s health needs. Engaging in practices that involve conflicts of
interest or commercialization of healthcare services is unethical.
Examples of Conflict of Interest:
• Referral Kickbacks: Receiving money or gifts for referring patients to a particular
hospital, pharmacy, or specialist.
• Promotion of Unverified Treatments: Recommending certain treatments or products
due to financial arrangements with pharmaceutical companies or healthcare providers.
Consequences:
• Disciplinary Action: Medical councils may take action against doctors involved in
unethical practices or financial misconduct.
• Loss of Reputation: Commercialized practices can tarnish the doctor’s reputation and
trustworthiness, leading to a loss of patients.

1.3 Varieties of Medical Profession

1.3.1 Ayush Ministry, Purpose
The AYUSH Ministry (Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and
Homoeopathy) is a specialized government body in India dedicated to promoting and
developing traditional Indian systems of medicine. Established with the aim to integrate and
regulate various forms of traditional medical practices, the AYUSH Ministry plays a crucial
role in strengthening the healthcare system by offering alternative healthcare options
alongside allopathic medicine.
1. What is AYUSH?
AYUSH is an acronym that represents the following systems of traditional medicine:
• Ayurveda: An ancient system of medicine that focuses on balancing the body’s energies
(doshas) through diet, herbs, yoga, and lifestyle practices.
• Yoga: A spiritual and physical discipline that aims to harmonize the body and mind through
practices like physical postures (asanas), breathing exercises (pranayama), and meditation.
• Unani: A system of medicine with roots in Greek, Persian, and Arabic traditions, focusing
on the balance of bodily humors (blood, phlegm, yellow bile, and black bile).
• Siddha: An ancient South Indian system of medicine that focuses on achieving a balance
between the physical, mental, and spiritual aspects of health.
• Homoeopathy: A system of alternative medicine based on the principle of "like cures like,"
where a substance that causes symptoms in a healthy person is used to treat similar
symptoms in a sick person.
The Ministry of AYUSH was established in 2014 to ensure proper growth and regulation of
these indigenous systems of medicine, preserving their authenticity while facilitating their
integration into India’s broader healthcare framework. It serves as the coordinating agency
for policies, regulations, education, research, and development related to traditional Indian
medical practices.

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2. Purpose of the AYUSH Ministry

The primary objectives and purpose of the AYUSH Ministry can be broken down into
several key areas:
a. Promoting Traditional Medicine Systems
The Ministry’s central aim is to promote and standardize the various traditional medical
systems (Ayurveda, Yoga, Unani, Siddha, and Homoeopathy) and ensure they are accessible to
the public. By integrating these medical systems into the national healthcare framework, the
government intends to offer alternative healing methods alongside allopathic medicine,
providing people with more holistic and diversified healthcare choices.
b. Policy Formulation and Regulation
The Ministry plays a vital role in the formulation of policies for the effective regulation of
these traditional medical systems. It aims to ensure that these systems are practiced in a
standardized and scientific manner, keeping in line with modern health regulations. The
Ministry establishes guidelines for training, certification, and licensure, ensuring that
practitioners of Ayurveda, Yoga, Unani, Siddha, and Homoeopathy adhere to ethical and
medical standards.
c. Education and Training
One of the significant functions of the Ministry is to promote and regulate education and
training programs in the AYUSH systems. It works to establish recognized institutions offering
courses in these fields and ensures the availability of well-trained and qualified professionals.
This ensures that there is an adequate supply of skilled practitioners for each of the AYUSH
systems.
• Central Council of Indian Medicine (CCIM) regulates the education and practice of
Ayurveda, Siddha, and Unani medicine.
• Central Council of Homoeopathy (CCH) regulates the education and practice of
Homeopathy.
• The National Commission for Indian Systems of Medicine (NCISM) was set up under
the National Commission for Indian Systems of Medicine Act, 2020 to oversee education
and practice in the Indian systems of medicine.
d. Research and Development
The Ministry supports research in AYUSH systems by funding and encouraging scientific
studies, clinical trials, and evidence-based research that evaluate the efficacy and safety of
treatments in Ayurveda, Unani, Siddha, Yoga, and Homeopathy. The Ministry also collaborates
with national and international organizations to promote scientific research into the
effectiveness of these systems in managing various health conditions.
• It promotes the establishment of research institutes such as Central Council for Research
in Ayurvedic Sciences (CCRAS), Central Council for Research in Homoeopathy
(CCRH), and Central Council for Research in Unani Medicine (CCRUM) to conduct
research on traditional medicines.
• The Ministry also encourages collaborations between AYUSH systems and modern
medical research.
e. Integration with Mainstream Healthcare
One of the overarching goals of the Ministry is to promote the integration of traditional
medicine with allopathic practices, where appropriate. For instance, the National AYUSH
Mission (NAM) was launched to promote the development of AYUSH systems in healthcare
delivery at various levels, especially in rural and remote areas. It seeks to integrate these
traditional systems into the national healthcare delivery system through health centers,
hospitals, and medical colleges.
• The AYUSH Health & Wellness Centers (HWCs) are part of an effort to promote the
accessibility of traditional medicine alongside modern healthcare practices.

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• AYUSH hospitals are also integrated into the National Health Mission (NHM) to ensure
comprehensive healthcare.
f. Promoting Public Health and Preventive Healthcare
The Ministry also promotes preventive health and wellness through the practice of Yoga and
Ayurveda, which focus on maintaining physical and mental well-being. Programs like the
National Yoga Day (celebrated on June 21) are promoted by the Ministry to spread
awareness about the benefits of Yoga for health.
Additionally, the Ministry focuses on preventive healthcare through Ayurveda and Unani
therapies, which include natural remedies, dietary guidelines, and lifestyle changes.
g. International Promotion of AYUSH
The Ministry is tasked with promoting traditional Indian medicine systems abroad, fostering
collaborations with other countries and international organizations. The global interest in
natural and alternative healthcare has led to greater acceptance and incorporation of AYUSH
systems in international healthcare.
The Ministry has been instrumental in promoting AYUSH through diplomatic channels,
international forums, and conventions. For example, it has worked closely with the World
Health Organization (WHO) to promote the integration of traditional medicine into national
healthcare systems worldwide.

3. Functions of the AYUSH Ministry

The functions of the AYUSH Ministry are multifaceted and encompass several important
areas related to policy formulation, education, research, and international outreach:
a. Regulatory Functions
• Establishing guidelines and regulations for practitioners and educational institutions
related to AYUSH.
• Licensing and accrediting healthcare professionals, institutions, and medical colleges
offering courses in traditional medicine.
• Ensuring the quality control of Ayurvedic, Siddha, Unani, and Homeopathic medicines and
products.
b. Research and Scientific Development
• Encouraging research in the field of traditional medicine and publishing scientific studies
and findings.
• Providing funding and grants for research projects in collaboration with Indian and
international research bodies.
c. Training and Education
• Overseeing the creation and administration of educational programs for AYUSH
practitioners and students.
• Facilitating the opening of AYUSH colleges and the certification of programs.
d. Public Health and Wellness Promotion
• Developing and promoting programs for the prevention of diseases and promotion of
wellness using AYUSH methods.
• Promoting Yoga and Ayurveda as part of holistic health programs across the country.
e. International Collaborations
• Promoting AYUSH systems internationally and strengthening diplomatic ties with other
countries in the area of traditional medicine.
• Encouraging the adoption of Yoga and natural healing practices on a global scale.

4. Challenges Faced by AYUSH Ministry

While the AYUSH Ministry plays a critical role in promoting and regulating traditional medical
systems, several challenges remain:

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• Lack of standardization and scientific evidence: There is often skepticism about the
efficacy of traditional medicines. The Ministry faces challenges in conducting research and
standardizing the treatments, especially in comparison to evidence-based allopathic
practices.
• Integration with Modern Medicine: The integration of AYUSH systems with conventional
allopathic medicine remains a challenge due to differences in training, approaches, and
perceptions of the effectiveness of treatments.
• Limited Infrastructure: In some regions, especially rural areas, there is a lack of proper
healthcare infrastructure and trained practitioners for AYUSH systems, leading to limited
accessibility for the general population.
• Awareness and Acceptance: While traditional medicine is deeply rooted in Indian culture,
there is still a lack of awareness in many parts of the country regarding the various AYUSH
systems and their benefits.

1.3.2 Ayurveda, Siddha, Unani, Homeopathy and Allopathy —Recognized Courses, Yoga
and Naturopathy
Ayurveda: Overview and Significance
Ayurveda is one of the oldest and most profound systems of traditional medicine that
originated in India more than 5,000 years ago. The term "Ayurveda" is derived from two
Sanskrit words: "Ayur" meaning "life" and "Veda" meaning "knowledge" or "science," together
translating to "The Science of Life." Ayurveda is a holistic system of medicine that aims to
promote health by maintaining a balance between the body, mind, and spirit. It is based on the
belief that good health results from a balance between the three doshas (vata, pitta, and
kapha), and disease is caused when these doshas are out of balance.
Ayurveda is not just about treating diseases, but rather about promoting general well-being,
longevity, and a healthy lifestyle. It emphasizes prevention, balance, and the use of natural
therapies, including herbs, dietary changes, yoga, meditation, and lifestyle adjustments.

1. The Principles of Ayurveda

Ayurveda is based on several key principles that form the foundation of its healing approach:
a. The Concept of Five Elements (Pancha Mahabhutas)
Ayurveda believes that the human body is made up of five elements (pancha mahabhutas):
1. Prithvi (Earth) - Represents stability and structure.
2. Ap (Water) - Represents liquid or fluid functions in the body.
3. Tejas (Fire) - Represents energy, metabolism, and transformation.
4. Vayu (Air) - Represents movement and life force.
5. Akasha (Ether) - Represents space and consciousness.
These five elements combine in the human body to form the three doshas (vata, pitta, and
kapha), which regulate various physiological functions.
b. The Three Doshas (Vata, Pitta, and Kapha)
In Ayurveda, health is maintained when the three doshas are in balance. Each individual has a
unique constitution, or Prakriti, which is a combination of these doshas in varying
proportions. When the doshas are in balance, the body functions optimally, but when they are
imbalanced, disease can occur.
1. Vata (Air and Ether): Responsible for movement in the body, such as breathing,
circulation, and the nervous system. When imbalanced, it can lead to anxiety, dryness,
digestive issues, and irregularity.
2. Pitta (Fire and Water): Responsible for metabolism, digestion, and transformation. It
governs digestion, energy production, and temperature regulation. Imbalance can lead to
inflammation, irritability, digestive problems, and heat-related conditions.

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3. Kapha (Water and Earth): Responsible for structure, lubrication, and immunity. It
maintains strength, stability, and smooth functioning of tissues. When imbalanced, it can
lead to weight gain, sluggishness, congestion, and excess mucus production.
c. The Concept of Agni (Digestive Fire)
Ayurveda emphasizes the importance of Agni or digestive fire, which is believed to be the
cornerstone of health. Proper digestion is essential for the body to absorb nutrients and
eliminate waste. Poor Agni (weak digestion) can lead to the accumulation of toxins (Ama),
which are believed to be the root cause of many diseases in Ayurveda.
d. The Role of Ojas, Tejas, and Prana
• Ojas: Represents vitality and immunity. It is considered the essence of life and is
responsible for the body’s overall strength and resistance to disease.
• Tejas: Represents the mental and intellectual strength. It is associated with clarity, focus,
and enthusiasm.
• Prana: Represents life force or energy. It governs the functioning of the body and mind and
is essential for maintaining vitality.

2. Ayurvedic Treatments and Therapies

Ayurveda employs a variety of therapies to restore balance and health in the body. These
treatments are individualized and depend on the patient’s dosha constitution, age, and the
nature of the illness.
a. Herbal Medicine
One of the mainstays of Ayurvedic treatment is the use of herbs and plants to restore health.
Ayurvedic practitioners use medicinal plants, herbs, and their combinations to create
remedies for various conditions. Some well-known Ayurvedic herbs include:
• Ashwagandha: Known for reducing stress and enhancing energy.
• Tulsi: Used for its antibacterial and anti-inflammatory properties.
• Turmeric: Known for its anti-inflammatory and antioxidant effects.
• Neem: Used for skin disorders and detoxification.
• Triphala: A combination of three fruits used to promote digestion and detoxification.
b. Panchakarma (Detoxification Therapy)
Panchakarma is a system of five therapeutic treatments used to detoxify and rejuvenate the
body. The therapies involve purification of the body’s internal systems, eliminating toxins
(Ama), and restoring balance. The five treatments are:
1. Vamana (Emesis or vomiting therapy) - Used for expelling excess kapha from the body.
2. Virechana (Purgation) - Used for eliminating excess pitta.
3. Basti (Enema therapy) - Used for cleansing the colon and balancing vata.
4. Nasya (Nasal therapy) - Involves the administration of herbal oils or powders through the
nose to clear the sinuses and improve mental clarity.
5. Raktamokshana (Bloodletting) - Used for purifying the blood and eliminating toxins.
c. Abhyanga (Oil Massage)
Abhyanga is a traditional Ayurvedic massage involving the application of warm herbal oils to
the body. The oils are chosen based on the patient’s dosha and are used to promote relaxation,
improve circulation, and nourish the skin. It is also believed to help balance the doshas and
relieve stress.
d. Shirodhara
Shirodhara is a therapy in which a steady stream of warm herbal oil is poured over the
forehead, usually over the third eye area. This treatment is known for its relaxing and calming
effects and is often used to treat conditions related to stress, anxiety, insomnia, and mental
clarity.

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e. Yoga and Meditation

Yoga is considered an integral part of Ayurveda as it helps to promote physical and mental
well-being. Certain asanas (postures), pranayama (breathing exercises), and meditation
techniques are recommended based on an individual’s dosha and health condition. Yoga and
meditation help in balancing the body’s energies and improving mental clarity, which is
essential for good health.

3. Ayurvedic Diet and Lifestyle

Ayurveda places great emphasis on a balanced and healthy lifestyle to maintain good health. It
encourages individuals to make choices that harmonize with their nature and the seasons.
a. Ayurvedic Diet
Ayurvedic diets are customized based on the individual’s dosha and their current state of
health. The food one consumes should support the body’s natural constitution and maintain
the balance of doshas. For example:
• Vata individuals may benefit from warm, moist, and grounding foods.
• Pitta individuals are advised to consume cooling and refreshing foods.
• Kapha individuals should focus on light, dry, and stimulating foods.
Ayurveda recommends eating meals at regular times, avoiding overeating, and eating in
moderation. It also suggests drinking plenty of water and consuming fresh, seasonal foods to
align with the natural rhythms of the body.
b. Daily Routine (Dinacharya)
Ayurveda advocates a daily routine (Dinacharya) to maintain health and harmony. This
includes practices like:
• Waking up early and practicing yoga and meditation.
• Oil massage (Abhyanga) to nourish the skin and calm the mind.
• Cleansing: Practices like oil pulling, tongue scraping, and washing the eyes are suggested.
• Proper Sleep: Ensuring adequate and restful sleep is crucial for health.
• Regular Exercise: Moderate physical activity, including walking and yoga, is
recommended.

4. Benefits and Effectiveness of Ayurveda

Ayurveda offers a range of benefits, including:
• Holistic Healing: Ayurveda treats the person as a whole, addressing the root causes of
illness rather than merely managing symptoms.
• Prevention: It focuses on maintaining health and preventing diseases through proper
lifestyle, diet, and self-care practices.
• Natural Therapies: It uses natural remedies, including herbs, oils, and therapies that are
gentle on the body and have fewer side effects.
• Personalized Treatment: Ayurveda recognizes that every individual is unique and tailors
treatments to suit individual needs, improving effectiveness.

5. Challenges and Limitations of Ayurveda

While Ayurveda has a long history and offers many benefits, there are certain challenges and
limitations:
• Lack of Scientific Validation: Some aspects of Ayurveda lack modern scientific validation,
leading to skepticism about its effectiveness.
• Standardization of Practices: Given the variety of treatments and approaches, there is a
need for standardization in Ayurvedic practices to ensure safety and efficacy.
• Access and Affordability: High-quality Ayurvedic treatments and products can be
expensive and may not be easily accessible to all populations.

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6. Ayurveda in Modern Medicine

In recent years, there has been growing recognition of the potential of Ayurveda in the global
healthcare system. Many modern medical practitioners are exploring the integration of
Ayurvedic principles and treatments alongside conventional medicine. This has led to
increased collaboration between modern medicine and traditional healing practices, offering
patients a more holistic approach to health and well-being.

Siddha: Overview and Significance

Siddha medicine is one of the oldest traditional medical systems in India, with its roots in the
Tamil culture of Southern India. It is often grouped alongside Ayurveda and other indigenous
healing systems, but Siddha medicine has a distinct approach and philosophy of health and
healing. The word “Siddha” is derived from the Tamil word "Siddhi," which means
perfection or success. The Siddha system is believed to have been founded by the Siddhars,
a group of ancient Tamil saints, who are considered to have attained spiritual enlightenment
through their deep meditation and practice. These Siddhars are credited with developing the
Siddha system of medicine, which aims to restore balance in the body and mind, promoting
health and longevity.
Siddha is primarily practiced in Tamil Nadu and other parts of South India, but its influence
extends to Sri Lanka and other countries in the region. Like other traditional medical systems,
Siddha is based on the concept of balance in the body’s internal energies and its relationship
with the environment.

1. The Principles of Siddha Medicine

a. The Concept of the Five Elements (Pancha Mahabhutas)
Similar to Ayurveda, the Siddha system is based on the understanding that the body is
composed of five basic elements, known as Pancha Mahabhutas:
1. Prithvi (Earth) – Represents the solid structure of the body, including bones and tissues.
2. Appu (Water) – Represents bodily fluids such as blood, lymph, and other liquids.
3. Tejas (Fire) – Represents energy, metabolism, and heat.
4. Vayu (Air) – Represents movement and functions like respiration and circulation.
5. Akasha (Ether) – Represents space or the void within the body.
These five elements combine in varying proportions to form the three humors (or doshas) in
Siddha medicine, known as Vata, Pitta, and Kapha, which are responsible for regulating
various bodily functions. Maintaining balance between these elements and humors is crucial
for good health.
b. The Three Humors (Vata, Pitta, and Kapha)
The concept of the three humors (known as Vata, Pitta, and Kapha) is central to Siddha
medicine, similar to Ayurveda. These humors represent the dynamic forces that govern the
physiological and psychological aspects of the body:
1. Vata – Represents the principle of movement, which governs the activities of the nervous
system, circulation, breathing, and elimination. An imbalance of Vata can lead to conditions
such as dryness, anxiety, and constipation.
2. Pitta – Represents the principle of transformation and heat, governing metabolism,
digestion, and energy. An imbalance in Pitta can result in inflammation, anger, acidity, and
digestive disorders.
3. Kapha – Represents the principle of structure and stability, maintaining body fluids,
immunity, and lubrication. An imbalance in Kapha can lead to conditions like obesity,
congestion, and lethargy.
Siddha medicine maintains that these three humors must be in harmony with each other to
ensure overall health, and illness occurs when these humors become imbalanced.

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c. The Concept of Soul and Spirit

In Siddha medicine, health is not only seen as a physical condition but also involves the
harmony between the body, mind, and spirit. According to the Siddha system, each individual
has a spiritual essence or soul, known as "Atma", which is the source of life and vitality. The
health of the soul is considered essential for overall health. Imbalance in the spirit or soul can
manifest as emotional and psychological disturbances, which can lead to physical illness.

2. Siddha Treatments and Therapies

Siddha medicine is a comprehensive system that emphasizes the use of natural ingredients
and techniques to restore balance in the body. Some of the core treatments and therapeutic
practices in Siddha medicine include:
a. Herbal Medicine
Herbal remedies form the cornerstone of Siddha medicine. The system uses a vast array of
plants, minerals, and animal products to formulate remedies. Some of the well-known Siddha
herbs include:
• Amla (Indian Gooseberry) – Used for improving immunity and digestion.
• Turmeric – Known for its anti-inflammatory and antioxidant properties.
• Ashwagandha – Used for reducing stress and promoting vitality.
• Tulsi – Considered sacred, it is used for its purifying properties.
• Chandana (Sandalwood) – Known for its cooling properties, it is used for skin conditions
and inflammation.
These herbs are used in different forms like powders, tablets, oils, and decoctions. Siddha
medicine also utilizes metallic and mineral substances in certain treatments, but they must
be prepared with great care to avoid toxicity.
b. Therapeutic Practices
1. Marma Therapy: Marma therapy involves the manipulation of specific points on the body,
similar to acupressure. These points are believed to be vital energy centers, and treating
them helps in restoring balance and relieving pain.
2. Nadi Pariksha (Pulse Diagnosis): Nadi Pariksha is a unique diagnostic method in Siddha
medicine. The practitioner assesses the pulse to determine the individual’s dosha balance
and any imbalances in the body. The pulse is believed to contain valuable information
about the health of the person.
3. Panchakarma: Similar to Ayurveda, Siddha also employs Panchakarma therapies for
detoxification and rejuvenation, such as Virechana (purification), Basti (enemas), and
Abhyanga (oil massage).
c. Internal and External Remedies
1. Internal Medicines: These include herbal concoctions, medicated oils, tablets, and
decoctions designed to balance the humors and treat specific conditions.
2. External Applications: These involve ointments, poultices, compresses, and plasters
applied to the body to treat external injuries, skin diseases, and inflammation.
d. Dietary Guidelines
Like other traditional systems, Siddha places significant importance on diet as part of the
healing process. Each person is advised to follow a dietary regimen based on their prakriti
(individual constitution), and it is recommended that the foods consumed should align with
the natural rhythms of the body.
The dietary guidelines in Siddha medicine encourage the consumption of fresh, nutritious
foods and avoidance of foods that may aggravate the body’s doshas. Foods that are spicy, sour,
oily, and heavy are typically avoided, while cooling, light, and easily digestible foods are
encouraged.

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3. Specializations in Siddha Medicine

Siddha practitioners specialize in various branches of treatment, addressing specific health
concerns:
• Vatha (Pain Relief): Treating pain, inflammation, and physical stress.
• Karna (Ear Diseases): Focused on ear-related ailments.
• Thalaka (Head Diseases): Addressing head-related issues like headaches, neurological
conditions, and mental health.
• Visha (Toxicology): Treatment of poisoning and toxic conditions, including snake bites.
• Rogam (General Diseases): General health and preventive care.

4. Importance of Registration in Siddha Medicine

In India, practitioners of Siddha medicine are required to be registered with the Central
Council of Indian Medicine (CCIM) under the Indian Medicine Central Council Act, 1970.
The registration ensures that practitioners meet the prescribed educational qualifications and
standards. In the context of Siddha, the Siddha Medical College offers training and education
in the Siddha system, and only registered practitioners are allowed to diagnose and prescribe
Siddha treatments.

5. Siddha Medicine in the Modern World

Siddha medicine, like Ayurveda, is experiencing a revival in recent years, with increasing
global recognition of its holistic approach to health. Research into the scientific validation of
Siddha remedies and techniques is growing, and more people are turning to Siddha
treatments for conditions where modern medicine has limited options, such as chronic
diseases and stress-related disorders.
While Siddha medicine shares similarities with Ayurveda, it remains an indigenous system
with its unique practices and philosophies. Siddha has integrated well with modern wellness
practices, and many individuals now incorporate its teachings on diet, lifestyle, and spiritual
health into their daily lives.

6. Challenges and Limitations of Siddha Medicine

While Siddha has many advantages, it faces several challenges:
• Lack of Scientific Validation: Some aspects of Siddha treatments have not been
sufficiently researched in the context of modern scientific standards.
• Standardization of Practices: Siddha treatments vary widely across different
practitioners and regions, making it difficult to maintain consistency in treatment
outcomes.
• Limited Access: Siddha practitioners and medicines are mostly concentrated in specific
regions, limiting access for people in other parts of India or the world.
• Misuse and Lack of Regulation: In some cases, there are unqualified practitioners
offering unverified treatments, leading to safety concerns.

Unani Medicine: Overview and Significance

Unani Medicine is one of the traditional systems of medicine that originated in ancient
Greece but has evolved and flourished in the Indian subcontinent. It is a holistic system of
healthcare that focuses on the balance of the body's humors (fluids), the principles of health
and disease, and the prevention and treatment of illnesses. The word “Unani” is derived from
the Arabic word “Yunani,” meaning Greek, as the system has its roots in Greek medicine,
particularly the works of Hippocrates and Galen. Over time, Unani medicine was influenced
by various cultures, including Persian, Arab, and Indian, and became well-established in India
during the Mughal era.

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Unani medicine is officially recognized as a system of alternative medicine in India, regulated

under the Ministry of AYUSH (Ayurveda, Yoga, Unani, Siddha, and Homeopathy), and is
practiced primarily in countries like India, Pakistan, and parts of the Middle East and
Southeast Asia. It is based on the understanding that health depends on the balance of four
bodily humors and their interaction with the environment.

2. The Basic Principles of Unani Medicine

a. The Four Humors (Akhlat)
Unani medicine revolves around the concept of four humors (also known as Akhlat in
Arabic), which are bodily fluids responsible for maintaining health. These humors are:
1. Damm (Blood) – Considered the most important humor, responsible for vitality, energy,
and nourishment. Its balance ensures the proper functioning of the body.
2. Balgham (Phlegm) – Associated with coolness and moisture, phlegm governs the
respiratory and digestive systems. Its imbalance can cause respiratory and digestive issues.
3. Safra (Yellow Bile) – Linked with the digestive system, yellow bile is believed to govern
warmth, metabolism, and digestive juices.
4. Sauda (Black Bile) – Related to the spleen and liver, black bile is associated with the
body’s dryness and coldness. Its imbalance can lead to disorders like depression,
gastrointestinal issues, and liver dysfunction.
The health of an individual depends on the harmony between these humors. Imbalances in the
humors are believed to lead to disease, and the Unani system focuses on restoring this balance
through diet, herbal treatments, and lifestyle modifications.
b. Temperaments (Mizaj)
Unani medicine also categorizes individuals based on their temperament or Mizaj, which
reflects the balance of the humors in a person’s body and mind. There are four basic types of
temperaments:
1. Damvi (Sanguine) – Dominated by blood, individuals with a sanguine temperament are
typically warm, active, and social.
2. Balghami (Phlegmatic) – Dominated by phlegm, individuals with a phlegmatic
temperament tend to be calm, patient, and prone to lethargy.
3. Safrawi (Choleric) – Dominated by yellow bile, individuals with a choleric temperament
are energetic, ambitious, and prone to irritability.
4. Saudawi (Melancholic) – Dominated by black bile, individuals with a melancholic
temperament are introverted, thoughtful, and prone to sadness or depression.
The temperament type helps the practitioner of Unani medicine determine the best approach
for treating the patient, including their dietary requirements, treatments, and lifestyle
changes.
c. The Five Natural Elements (Arkan)
Unani medicine also incorporates the concept of the Five Natural Elements (Arkan) that
form the basis of the human body. These elements are:
1. Air (Hawa) – Governs breathing and circulation in the body.
2. Water (Maa) – Regulates body fluids and is essential for digestion and hydration.
3. Fire (Naar) – Associated with heat and energy, it controls the body’s metabolism and
digestion.
4. Earth (Ard) – Represents the solid structures of the body, such as bones and tissues.
5. Ether (Ruh) – Represents the vital spirit or the life force within the body.
These elements interact with the four humors to maintain health and harmony within the
body. A disturbance in the balance of these elements or humors is believed to lead to illness.

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3. Diagnosis in Unani Medicine

Unani practitioners use various diagnostic methods to assess a patient’s condition. The key
techniques include:
a. Pulse Diagnosis (Nabz)
Pulse diagnosis, or Nabz, is an important diagnostic method in Unani medicine. The
practitioner feels the pulse at different points on the body, particularly on the wrist, to
determine the balance of the humors and the state of the body’s internal organs. The pulse can
reveal vital information about a person’s overall health, energy levels, and temperament.
b. Urine Analysis (Boul)
Urine analysis is another essential diagnostic tool in Unani medicine. The color, consistency,
and odor of urine are carefully studied to gain insight into the body’s internal balance. Unani
practitioners believe that changes in the urine can indicate imbalances in the humors or the
presence of disease.
c. Observation and Interview (Shahada and Istishhad)
Unani practitioners also rely heavily on the patient’s physical appearance, behavior, and
complaints. They conduct detailed interviews to understand the patient’s symptoms, medical
history, and lifestyle habits. Observing the skin, tongue, and other visible indicators helps in
making a diagnosis.

4. Treatment Modalities in Unani Medicine

Unani medicine offers a wide range of treatments to restore balance and address various
health conditions. The therapies include:
a. Herbal Medicine
Herbal remedies are the cornerstone of Unani treatment. Plants, herbs, minerals, and even
animal products are used to create medicinal formulations. Some common herbs used in
Unani medicine include:
• Amla (Indian Gooseberry) – Known for its antioxidant properties and used in
strengthening the immune system.
• Tulsi (Holy Basil) – A powerful herb used for treating respiratory infections, reducing
stress, and enhancing immunity.
• Zingiber (Ginger) – Used for treating digestive issues, nausea, and inflammation.
• Saffron (Zafran) – Known for its calming properties, used for anxiety and skin conditions.
Herbal concoctions, oils, syrups, and tablets are made from these ingredients and are tailored
to individual needs.
b. Regimen and Diet (Nuskha)
Diet plays a crucial role in Unani medicine. Patients are encouraged to follow a prescribed diet
based on their temperaments and the nature of their illness. Unani physicians suggest
specific foods that balance the humors and promote health. For example:
• Hot foods are recommended for those with excess coldness (associated with phlegm or
black bile).
• Cold foods are recommended for those suffering from excess heat (due to yellow bile or
blood).
A regulated lifestyle, including proper sleep, exercise, and hygiene, is also emphasized in
Unani medicine.
c. Cupping Therapy (Hijama)
One of the most well-known treatments in Unani medicine is Hijama, or cupping therapy,
which involves creating suction on specific areas of the body to draw out harmful substances
and toxins from the body. Hijama is believed to help improve circulation, relieve pain, and
detoxify the body.

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d. Leech Therapy (Radd al-Mi’ah)

Leech therapy is another unique treatment in Unani medicine, used to draw out blood and
toxins from the body. It is used for conditions such as high blood pressure, skin diseases, and
varicose veins.
e. Massage and Oil Therapy (Dalk)
Oil therapy, or Dalk, involves the application of warm oils to the body to relieve muscle
stiffness, improve circulation, and reduce pain. This is often combined with massages to
improve the overall functioning of the body and mind.

5. Modern Relevance of Unani Medicine

Unani medicine has gained recognition in the modern world for its holistic approach to health.
It is increasingly being incorporated into integrative health systems, combining conventional
treatments with traditional remedies. In India, Unani medicine is supported by the Ministry
of AYUSH, which promotes research and development in this field.
Unani medicine is particularly beneficial for the treatment of chronic conditions, such as
arthritis, respiratory issues, digestive problems, and neurological disorders. Many individuals
seek Unani treatments when they experience side effects from modern pharmacological
treatments.

6. Challenges and Limitations of Unani Medicine

Despite its potential, Unani medicine faces several challenges:
• Lack of Scientific Validation: Like other traditional systems, the efficacy of many Unani
treatments has not been fully validated by modern scientific methods.
• Limited Access: Unani practitioners are primarily concentrated in specific regions, making
it difficult for people in other parts of the country to access treatments.
• Quality Control Issues: There is a lack of standardization and regulation in the
preparation of Unani medicines, leading to concerns about quality and safety.

Homeopathy and Allopathy — Recognized Courses in India

In India, healthcare systems such as Homeopathy and Allopathy are well-recognized and
regulated by respective regulatory bodies. These systems offer a variety of courses to train
professionals, with specific educational programs available to students aspiring to become
medical practitioners. Let's delve into the recognized courses for both Homeopathy and
Allopathy in India.

1. Allopathy (Modern Medicine)

Allopathy refers to the conventional system of medicine, commonly practiced worldwide. It is
based on the use of pharmaceuticals and surgery to treat diseases. The educational system in
Allopathic medicine is regulated by the Medical Council of India (MCI), which has now
been replaced by the National Medical Commission (NMC) under the National Medical
Commission Act, 2019.
1.1 Recognized Allopathy Courses
1. Bachelor of Medicine and Bachelor of Surgery (MBBS)
o Duration: 5.5 years (including a 1-year internship)
o Overview: This is the primary medical qualification required to practice as an
allopathic doctor in India. The course includes both theoretical education and
clinical training in various medical fields such as internal medicine, surgery,
obstetrics, pediatrics, and psychiatry.
o Regulation: The MBBS degree is recognized by the NMC (formerly MCI). To practice
after completing the MBBS, one must obtain registration with a State Medical
Council or the National Medical Council (NMC).

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2. Postgraduate (PG) Medical Courses

o Duration: 3 years
o Overview: After obtaining the MBBS degree, doctors can pursue postgraduate
courses in specific medical fields. These include specialties like General Surgery,
Obstetrics and Gynecology, Pediatrics, Dermatology, Psychiatry, Orthopedics,
Cardiology, Neurology, etc.
o Types of Postgraduate Courses:
 Doctor of Medicine (MD): A postgraduate degree in various specialties such
as Internal Medicine, Pediatrics, Anesthesiology, Psychiatry, etc.
 Master of Surgery (MS): A postgraduate degree in Surgical Specialties
such as General Surgery, Orthopedics, Obstetrics and Gynecology, etc.
 Diplomate of National Board (DNB): Equivalent to MD/MS, awarded by the
National Board of Examinations (NBE).
3. Diploma Courses
o Duration: 2 years
o Overview: There are various diploma courses available for medical practitioners in
specialized fields like Anesthesia, Radiology, Gynecology, Dermatology, and
others. These diplomas allow doctors to specialize in specific areas without
committing to a full MD/MS course.
4. Super Specialty Courses
o Duration: 3 years
o Overview: These courses are pursued after completing a postgraduate degree
(MD/MS) and are aimed at doctors who wish to specialize further in advanced
medical areas. Some examples of super specialty courses include Cardiology,
Neurology, Nephrology, Oncology, and Gastroenterology.

2. Homeopathy (Traditional System of Medicine)

Homeopathy is a system of alternative medicine that treats diseases based on the principle of
“like cures like.” It involves the use of highly diluted substances to stimulate the body’s
healing processes. The education and practice of Homeopathy are regulated by the Central
Council of Homoeopathy (CCH) under the Homeopathy Central Council Act, 1973.
Homeopathic education in India is standardized and regulated by the government, ensuring
that practitioners are well-trained and certified.
2.1 Recognized Homeopathy Courses
1. Bachelor of Homeopathic Medicine and Surgery (BHMS)
o Duration: 5.5 years (including internship)
o Overview: The BHMS is the foundational degree for practicing Homeopathy in
India. This course combines theoretical knowledge with practical clinical training in
Homeopathic principles, Materia Medica (the study of homeopathic medicines),
repertory, pathology, anatomy, physiology, and surgery. It also includes subjects
specific to Homeopathy, such as Philosophy of Homeopathy, Homeopathic
Pharmacy, and Clinical Medicine.
o Regulation: The BHMS degree is recognized by the Central Council of
Homoeopathy (CCH), and homeopaths must register with a State Homoeopathic
Council to practice legally.
2. Postgraduate (PG) Homeopathy Courses
o Duration: 3 years
o Overview: After completing the BHMS degree, practitioners can pursue a
Postgraduate (MD in Homeopathy) degree in various specialties such as
Homeopathic Materia Medica, Homeopathic Philosophy, Organon of Medicine,

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and clinical subjects like Homeopathic Pediatrics, Homeopathic Psychiatry, and

Homeopathic Dermatology.
o Types of Postgraduate Courses:
 MD in Homeopathy: A highly specialized course focusing on different
aspects of Homeopathic treatments.
 MSc in Homeopathic Medicine: A postgraduate degree offered by certain
institutions, focusing on medical and scientific research in the field of
Homeopathy.
3. Diploma Courses in Homeopathy
o Duration: 1-2 years
o Overview: There are various diploma courses offered for those who wish to pursue
specialized knowledge in certain aspects of Homeopathy or for practitioners who
are looking to expand their skills. Some common diplomas include:
 Diploma in Homeopathic Pharmacy (DHP): A specialized course focused
on the preparation and dispensation of homeopathic medicines.
 Diploma in Homeopathic Medicine and Surgery (DHMS): A more
condensed version of the BHMS, allowing students to practice homeopathy
after a shorter period of study.
4. Certificate Courses in Homeopathy
o Duration: A few months to a year
o Overview: Short-term certificate courses are available for students and
practitioners wishing to gain practical knowledge in specific areas of Homeopathy,
such as Homeopathic Treatment for Skin Diseases, Homeopathic Pediatrics,
and Homeopathic Nutrition.

3. Regulation and Recognition of Medical Courses in India

1. Allopathy (Modern Medicine)
o The National Medical Commission (NMC) regulates medical education and
ensures the quality and standardization of medical courses in India, including MBBS,
MD, MS, and DNB.
o Students must pass the National Eligibility cum Entrance Test (NEET) to gain
admission to MBBS and Postgraduate courses.
o Medical Registration: After completing an MBBS degree, graduates must register
with the State Medical Council to practice legally in India. They are also required
to renew their registration periodically.
2. Homeopathy
o The Central Council of Homoeopathy (CCH) regulates the education and practice
of Homeopathy in India, ensuring the standardization of courses like BHMS and MD
in Homeopathy.
o Homeopathy practitioners must register with the State Homoeopathic Council to
practice legally.
o National Eligibility cum Entrance Test for Homeopathy (NEET-Homoeopathy)
is the exam for admission into Homeopathic undergraduate courses (BHMS).

4. Career Opportunities and Scope

1. Career Scope in Allopathy
o Medical Practitioners (Doctors): After completing MBBS, one can practice in
hospitals, clinics, and private settings as a general physician or specialize in a
chosen field.
o Public Health: Opportunities in public health organizations, government health
schemes, or NGOs.

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o Teaching and Research: Postgraduate and super-specialty doctors can teach at

medical colleges or work in medical research institutions.
o Hospital Administration: Medical graduates can pursue degrees in hospital
management for roles in hospital administration.
2. Career Scope in Homeopathy
o Homeopathic Practitioners: After completing BHMS, one can start a clinic or join a
hospital as a homeopathic physician.
o Research: Graduates can pursue research in Homeopathic medicine and
pharmaceutical development.
o Teaching: Homeopathic physicians can teach at colleges or schools of Homeopathy.
o Pharmacy and Manufacturing: Involved in the production and sale of
homeopathic medicines.

Yoga and Naturopathy: Overview, Courses, and Recognition

Yoga and Naturopathy are two ancient systems of health and wellness that have gained
significant recognition worldwide, particularly in India. Both are rooted in holistic
approaches, focusing on prevention, treatment, and overall well-being. These fields have
distinct practices but share similar philosophical foundations, emphasizing the body’s natural
ability to heal through lifestyle adjustments, natural therapies, and mental discipline. In India,
these systems are recognized and regulated by the government through various educational
and regulatory frameworks.

1. Yoga: Philosophy, Practices, and Recognition

Yoga is a physical, mental, and spiritual discipline that originated in ancient India. It aims to
unite the mind, body, and spirit, fostering a balanced state of well-being. Yoga is practiced
through various techniques such as asanas (physical postures), pranayama (breathing
exercises), meditation, and ethical guidelines (Yamas and Niyamas).
1.1 Yoga Courses and Educational Programs in India
The practice of Yoga has gained immense popularity in modern times, and it has been
institutionalized in many educational and healthcare systems across the globe. India offers a
variety of courses to train individuals to become professional yoga instructors, therapists, and
practitioners.
1. Certificate and Diploma Courses in Yoga
o Duration: 6 months to 1 year
o Overview: Certificate and diploma courses are offered by several universities, yoga
institutions, and wellness centers. These courses cover the basics of yoga practice,
meditation techniques, and breathing exercises, and they often incorporate basic
anatomy and physiology to understand the effects of yoga on the body.
o Eligibility: High school (10+2) education or equivalent. Some institutions may have
a specific age requirement and physical fitness criteria.
2. Bachelor of Science in Yoga (B.Sc. Yoga)
o Duration: 3 years
o Overview: This undergraduate program focuses on theoretical and practical
aspects of yoga, including its various styles and techniques, philosophy, and the
therapeutic application of yoga.
o Eligibility: Candidates must have completed high school (10+2) with a science
background.
3. Master of Science in Yoga (M.Sc. Yoga)
o Duration: 2 years

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o Overview: The postgraduate course is more advanced and covers topics such as
yoga therapy, psychological aspects of yoga, and the integration of yoga with
modern medicine.
o Eligibility: A Bachelor’s degree in Yoga or related fields (such as B.Sc. in Yoga or
B.A. in Yoga).
4. Doctor of Philosophy in Yoga (Ph.D. in Yoga)
o Duration: 3-5 years
o Overview: A research-oriented course aimed at advancing the field of yoga through
academic study and investigation. It involves in-depth research on various aspects
of yoga, its therapeutic applications, and its global impact.
o Eligibility: A Master's degree in Yoga or related fields with a strong academic
background.
1.2 Yoga Therapy
Yoga Therapy refers to the use of yoga techniques to address specific health issues, physical
disabilities, or chronic illnesses. Some specialized programs teach how to integrate yoga
practice with medical treatments for diseases such as diabetes, hypertension, anxiety, and
chronic pain.
• Duration: 6 months to 1 year
• Eligibility: For those with prior knowledge of yoga or a medical background.
1.3 Recognized Institutions and Regulatory Bodies
• Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and
Homoeopathy): The Ministry of AYUSH plays a key role in promoting traditional systems
of healthcare in India, including Yoga. It provides guidelines and standards for yoga
education and practice in India.
• The Quality Council of India (QCI): Provides accreditation for yoga training institutions
to ensure quality and consistency in yoga education.
• National Institute of Yoga (NIFY): An autonomous body under the Ministry of AYUSH, it
offers various training programs and certification courses in yoga education and therapy.
• Indian Yoga Association (IYA): A national organization that represents a network of yoga
teachers, schools, and organizations that promote the standards and practices of yoga.

2. Naturopathy: Philosophy, Practices, and Recognition

Naturopathy is a system of alternative medicine that focuses on using natural remedies to
promote healing and well-being. It is based on the belief that the body has an inherent ability
to heal itself through lifestyle modifications, proper nutrition, physical therapies, and natural
substances. Naturopathy incorporates various techniques like hydrotherapy, aromatherapy,
massage, detoxification, and herbal medicine.
2.1 Naturopathy Courses and Educational Programs in India
India offers a wide range of programs in Naturopathy through recognized educational
institutions. These programs are designed to train individuals to become naturopaths, who
can treat patients using non-invasive, natural methods.
1. Bachelor of Naturopathy and Yogic Sciences (BNYS)
o Duration: 5.5 years (including internship)
o Overview: This is an undergraduate course that combines the practices of
Naturopathy and Yoga. The curriculum includes various therapeutic techniques
like detoxification, nutrition therapy, herbal medicine, and hydrotherapy. The
course prepares students to work in hospitals, wellness centers, and independent
practice.
o Eligibility: Candidates must have completed high school (10+2) with a science
background.

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2. Postgraduate Courses in Naturopathy

o Duration: 2 years
o Overview: After completing a BNYS degree, students can pursue postgraduate
studies in specialized areas of Naturopathy such as Naturopathic Medicine,
Clinical Nutrition, and Naturopathic Therapy.
o Eligibility: A Bachelor’s degree in Naturopathy or related fields.
3. Diploma and Certificate Courses in Naturopathy
o Duration: 1-2 years
o Overview: These short-term courses focus on specific aspects of Naturopathy like
Hydrotherapy, Aromatherapy, Herbal Medicine, or Detoxification. They are
ideal for individuals looking to specialize in particular naturopathic treatments.
o Eligibility: High school education (10+2) or a Bachelor’s degree in a related field.
2.2 Recognized Institutions and Regulatory Bodies
• Ministry of AYUSH: Similar to Yoga, Naturopathy is recognized and regulated by the
Ministry of AYUSH, which also provides recognition to institutions offering Naturopathy
education and certifications.
• National Institute of Naturopathy: This institution provides training, certification, and
research in the field of Naturopathy.
• Central Council of Indian Medicine (CCIM): CCIM is responsible for setting the standards
of education and practice in various traditional systems of medicine in India, including
Naturopathy and Yoga.
• National Board of Naturopathy and Yoga: This board is responsible for ensuring the
quality of education and certification in Naturopathy and Yoga practices in India.

3. Yoga and Naturopathy: Career Prospects and Scope

3.1 Career Opportunities in Yoga
1. Yoga Instructor: Teaching yoga classes in wellness centers, gyms, schools, and community
centers.
2. Yoga Therapist: Working in hospitals, rehabilitation centers, and wellness clinics, using
yoga as a therapy for specific diseases and health conditions.
3. Research and Teaching: Engaging in academic research or teaching at universities, yoga
institutes, and schools.
4. Yoga Consultant: Offering specialized advice on using yoga to promote overall health or
address specific issues like mental health, fitness, or chronic diseases.
3.2 Career Opportunities in Naturopathy
1. Naturopathic Practitioner: Offering consultations and treatments using natural remedies
like herbs, massage, and detox programs.
2. Health and Wellness Consultant: Working in wellness centers, spas, and holistic health
organizations to promote natural therapies.
3. Research and Education: Working as a researcher in Naturopathy-related areas or
teaching at naturopathy schools and institutes.
4. Corporate Wellness Consultant: Providing corporate wellness programs focusing on
stress management, detoxification, and lifestyle improvement.

1.3.3. Different Degrees Conferred, Doctors getting Degrees from Abroad, Crosspathy
Practice and Mixopathy
In India, the medical field is vast, with multiple systems of medicine and health care. Each
system has its own structure of degrees and educational qualifications conferred by
recognized institutions. Below is an overview of the degrees awarded in Ayurveda, Siddha,
Unani, Homeopathy, Allopathy, Yoga, and Naturopathy.

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1. Ayurveda
Ayurveda is one of the oldest systems of medicine, originating in India thousands of years ago.
It is based on the belief that health is governed by the balance of three fundamental energies:
Vata, Pitta, and Kapha. Ayurveda focuses on holistic healing through natural methods like
herbal medicines, dietary changes, and lifestyle adjustments.
Degrees Conferred in Ayurveda
1. Bachelor of Ayurvedic Medicine and Surgery (BAMS)
o Duration: 5.5 years (including internship)
o Eligibility: Completion of 10+2 with science (Physics, Chemistry, Biology)
o Overview: This undergraduate degree trains students in the principles, practices,
and therapeutic techniques of Ayurveda. BAMS graduates can practice as Ayurvedic
doctors and prescribe Ayurvedic treatments.
2. Master of Surgery (Ayurveda) [MS (Ayu)]
o Duration: 3 years
o Eligibility: BAMS degree
o Overview: A postgraduate degree focusing on advanced surgery and therapeutic
procedures based on Ayurvedic principles. Specializations include areas such as
Shalya Tantra (surgery), Shalakya Tantra (diseases of the eye, ear, nose, and
throat), and Roga Vijnana (disease diagnosis).
3. Master of Ayurvedic Medicine (MD in Ayurveda)
o Duration: 3 years
o Eligibility: BAMS degree
o Overview: A postgraduate degree that focuses on the deeper aspects of Ayurvedic
medicine. The MD offers specialization in areas like Kayachikitsa (internal
medicine), Panchakarma (detoxification), and Dravyaguna (medicinal plants).
4. Doctor of Philosophy (Ph.D.) in Ayurveda
o Duration: 3-5 years
o Eligibility: MD in Ayurveda
o Overview: A research-oriented degree aimed at furthering knowledge in Ayurvedic
treatments, practices, and therapies.

2. Siddha
Siddha medicine is a traditional system of medicine that originated in South India. It is based
on the concept of mooligai (herbs), metals, and minerals. Siddha is known for its therapeutic
uses of natural substances, particularly plant-based and metallic medicines.
Degrees Conferred in Siddha
1. Bachelor of Siddha Medicine and Surgery (BSMS)
o Duration: 5.5 years (including internship)
o Eligibility: Completion of 10+2 with science (Physics, Chemistry, Biology)
o Overview: This undergraduate degree focuses on the principles of Siddha medicine,
including Nadi Pariksha (pulse diagnosis), herbal and mineral therapy, and Marma
Shastra (healing points).
2. Master of Surgery (Siddha) [MS (Siddha)]
o Duration: 3 years
o Eligibility: BSMS degree
o Overview: A postgraduate program offering specialized knowledge in the surgical
techniques and treatments practiced within the Siddha system.
3. Master of Siddha Medicine [MD (Siddha)]
o Duration: 3 years
o Eligibility: BSMS degree

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o Overview: A postgraduate degree that provides advanced training in specialized

areas such as Kayachikitsa (internal medicine), Panchakarma (detoxification),
and Vaidya Vijnana (philosophy and principles).
4. Doctor of Philosophy (Ph.D.) in Siddha
o Duration: 3-5 years
o Eligibility: MD in Siddha
o Overview: A research degree aimed at exploring new methods and systems in
Siddha medicine.

3. Unani
Unani medicine is a traditional system of medicine that originated in Greece but became
popular in India. It is based on the teachings of Hippocrates and Galen, and later developed
in Persia and the Arab world. It uses herbal medicines, dietary management, and physical
therapies to maintain health.
Degrees Conferred in Unani
1. Bachelor of Unani Medicine and Surgery (BUMS)
o Duration: 5.5 years (including internship)
o Eligibility: Completion of 10+2 with science (Physics, Chemistry, Biology)
o Overview: This undergraduate degree offers a foundational education in Unani
medicine, focusing on Ilaj bit Tabi (treatment through natural therapies), Ilaj bit
Dawa (medicine), and surgical practices.
2. Master of Unani Medicine [MD (Unani)]
o Duration: 3 years
o Eligibility: BUMS degree
o Overview: The postgraduate program in Unani medicine provides advanced
knowledge in fields like Tibb (medicine), Ilaj bit Dawa (medications), and Unani
surgery.
3. Doctor of Philosophy (Ph.D.) in Unani
o Duration: 3-5 years
o Eligibility: MD in Unani
o Overview: A research degree to delve deeper into the principles, treatments, and
pharmacology of Unani medicine.

4. Homeopathy
Homeopathy is a system of alternative medicine founded on the principle of treating "like with
like." Homeopathic remedies are made from natural substances and aim to stimulate the
body’s healing process.
Degrees Conferred in Homeopathy
1. Bachelor of Homeopathic Medicine and Surgery (BHMS)
o Duration: 5.5 years (including internship)
o Eligibility: Completion of 10+2 with science (Physics, Chemistry, Biology)
o Overview: This undergraduate degree trains students in the theory and practice of
Homeopathy, focusing on homeopathic medicines and their effects on the body.
2. Master of Homeopathic Medicine (MD (Homeopathy))
o Duration: 3 years
o Eligibility: BHMS degree
o Overview: The MD program offers deeper insight into homeopathic therapeutics,
clinical research, and specialized homeopathic remedies for specific diseases.
3. Doctor of Philosophy (Ph.D.) in Homeopathy
o Duration: 3-5 years
o Eligibility: MD in Homeopathy

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o Overview: A research degree that explores advanced aspects of homeopathic

treatment and its applications in modern medical science.

5. Allopathy (Modern Medicine)

Allopathy is the most widely practiced form of medicine in the world. It focuses on the use of
drugs, surgery, and other medical treatments to combat disease. Allopathic medicine is
governed by rigorous scientific research and evidence-based practices.
Degrees Conferred in Allopathy
1. Bachelor of Medicine, Bachelor of Surgery (MBBS)
o Duration: 5.5 years (including internship)
o Eligibility: Completion of 10+2 with science (Physics, Chemistry, Biology)
o Overview: The MBBS is the primary qualification for allopathic doctors in India. It
covers the basics of medical sciences, clinical skills, and surgical procedures.
2. Doctor of Medicine (MD)
o Duration: 3 years
o Eligibility: MBBS degree
o Overview: The MD degree offers specialization in various medical fields, including
internal medicine, paediatrics, obstetrics and gynecology, and psychiatry.
3. Master of Surgery (MS)
o Duration: 3 years
o Eligibility: MBBS degree
o Overview: MS degrees offer specialized training in surgery, with specializations
such as general surgery, orthopaedics, ophthalmology, and ENT.
4. Doctor of Philosophy (Ph.D.) in Medicine
o Duration: 3-5 years
o Eligibility: MD or MS in Medicine
o Overview: A research degree that aims to push the boundaries of medical
knowledge, focusing on clinical research, medical advancements, and new treatment
methodologies.

6. Yoga
Yoga is a physical, mental, and spiritual discipline that originated in India. It aims to unite the
body, mind, and spirit through physical postures, breathing techniques, and meditation.
Degrees Conferred in Yoga
1. Bachelor of Science in Yoga (B.Sc. Yoga)
o Duration: 3 years
o Overview: An undergraduate program focusing on yoga as a therapeutic and
fitness-based practice.
2. Master of Science in Yoga (M.Sc. Yoga)
o Duration: 2 years
o Overview: A postgraduate program focusing on advanced yoga techniques, therapy,
and research.
3. Diploma and Certificate Courses in Yoga Therapy
o Duration: 6 months to 1 year
o Overview: Specialization in using yoga as a therapeutic tool for physical and mental
health issues.

7. Naturopathy
Naturopathy emphasizes the use of natural remedies and a holistic approach to healing,
combining various therapies such as herbal medicine, massage, and hydrotherapy.
Degrees Conferred in Naturopathy

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1. Bachelor of Naturopathy and Yogic Sciences (BNYS)

o Duration: 5.5 years (including internship)
o Overview: This degree trains students in naturopathy and yoga therapy,
preparing them for a career in natural healing.
2. Master of Naturopathy
o Duration: 2 years
o Overview: A postgraduate degree offering specialized training in various
naturopathic therapies.

Doctors Getting Degrees from Abroad: An Overview

In today’s globalized world, obtaining a medical degree from abroad has become a common
practice for many aspiring doctors, particularly in India. A medical degree from a foreign country
can provide numerous advantages, including exposure to advanced medical systems, diverse
clinical practices, and opportunities for specialization in fields that may not be as readily available
in one's home country. However, it also raises several important issues related to recognition,
eligibility, and the ability to practice in India. Below is an in-depth look into the process,
advantages, and challenges for Indian students pursuing medical degrees abroad.

1. Medical Degrees from Abroad: Common Countries and Programs

Indian students commonly pursue medical degrees in countries such as Russia, China, the
Philippines, Ukraine, and the United States. Each of these countries offers different medical
programs with varying structures, durations, and educational approaches.
Popular Countries for Medical Degrees

1. Russia: Medical education in Russia is recognized for its affordability and quality.
Universities like the Moscow State University of Medicine and Pirogov Russian
National Research Medical University offer MBBS and MD degrees in English. The
duration is typically 6 years.

2. China: With many medical universities offering courses in English, such as Beijing
University of Chinese Medicine and Shanghai Medical University, China has become a
popular destination for Indian medical students. Chinese medical degrees are affordable
and recognized by the Medical Council of India (MCI), but the quality varies depending
on the institution.

3. Ukraine: Known for its relatively low tuition fees and European-standard medical
education, Ukraine offers a variety of English-medium MBBS courses in universities such as
Kyiv Medical University and Bogomolets National Medical University. Ukrainian
degrees are also recognized in India after fulfilling certain requirements.

4. The Philippines: The Philippines has a large number of English-speaking medical

universities, including University of Santo Tomas and University of the East. The
country is known for its affordable medical education. The Philippines offers a 4-year MD
program after a pre-medical undergraduate course, and it is considered comparable to the
MBBS in India.
5. United States: The United States is home to some of the world’s top medical universities,
such as Harvard Medical School, Johns Hopkins School of Medicine, and Stanford
School of Medicine. While highly competitive, the United States offers the MD (Doctor of
Medicine) degree, which is not the same as MBBS but is recognized globally. The duration
of the program is usually 4 years, with additional years for residency.
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6. United Kingdom: The MBBS or MBChB (Bachelor of Medicine, Bachelor of Surgery)

degree is awarded by many prestigious UK universities, such as Oxford, Cambridge, and
Imperial College London. The degree is recognized in India, though students must pass
screening tests to practice in India.
2. Recognition of Foreign Medical Degrees in India

For Indian students returning after completing their medical studies abroad, the Medical Council
of India (MCI), now replaced by the National Medical Commission (NMC), plays a crucial role in
determining the eligibility of their degrees to practice medicine in India. The degree must be
recognized by the NMC to ensure that the graduate is eligible to sit for the Foreign Medical
Graduate Examination (FMGE) and practice in India.
Steps for Recognizing Foreign Medical Degrees in India

1. Eligibility for the FMGE: Graduates from foreign medical colleges must appear for the
Foreign Medical Graduate Examination (FMGE), which is conducted by the National
Board of Examinations (NBE). The FMGE is a licensing exam that tests the candidate's
knowledge of medical principles, clinical practices, and skills necessary for practicing in
India. Passing the FMGE is mandatory for obtaining the license to practice.
2. Screening Test: The FMGE, which is a qualifying examination, tests the competency of
foreign-trained doctors to ensure they meet the standards required to practice in India.
The exam consists of a written test that covers topics in clinical medicine, surgery,
obstetrics and gynecology, and other medical fields.

3. NMC's Role: The NMC maintains a list of approved medical universities and institutes
whose degrees are recognized for the FMGE. The degree and the university from which a
student has graduated must appear on this list for the graduate to be eligible to sit for the
FMGE.

4. Time Frame for Medical Studies: In addition to the university’s recognition, the NMC also
evaluates whether the medical program abroad meets the required standards. For
instance, most recognized medical universities abroad offer a program duration that is
comparable to the MBBS program in India (5 to 6 years). If the duration is shorter or if the
university does not meet prescribed standards, the degree may not be recognized.

5. Additional Requirements: Some countries or universities may require students to take

additional steps, such as completing internships in India, or taking bridge courses before
appearing for the FMGE. For instance, graduates from the Philippines must complete their
internship in India to become eligible for the FMGE.

3. Challenges Faced by Indian Graduates with Foreign Medical Degrees

While a foreign medical degree can open doors to international practice, returning to India and
practicing medicine presents several challenges for graduates.

Challenges

1. FMGE Difficulty: One of the primary challenges is passing the FMGE. The exam has a low
pass percentage, which means that many foreign-trained doctors are unable to clear the
test on their first attempt. As a result, they cannot practice medicine in India unless they
clear this examination.

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2. Recognition of the Institution: Not all foreign medical universities are recognized by the
NMC. If a graduate has completed their degree from an unrecognized institution, they will
not be allowed to sit for the FMGE, thus preventing them from practicing in India.

3. Clinical Training Gaps: Medical education abroad may not always match the standards or
practical exposure available in India. The differences in clinical exposure, training methods,
and patient demographics can create a gap between what is taught abroad and the skills
required in Indian healthcare systems. This is one of the reasons why the FMGE is
mandatory.
4. Language Barriers: Some foreign universities offer programs in non-English languages.
This can create communication issues in both the academic environment and during
clinical practice. Even universities offering courses in English may have different
educational methods, making it hard for Indian students to adjust to medical systems back
home.

5. Cultural and Systemic Differences: Medicine in different countries follows different

protocols, systems, and cultural practices. Medical graduates from abroad may face
challenges in adapting to the Indian healthcare system, especially when it comes to dealing
with cultural nuances, patient behavior, and ethical issues.
4. Advantages of Getting a Degree from Abroad

Despite these challenges, pursuing a medical degree from abroad offers several benefits:
Advantages

1. Cost-Effective: Medical education in countries like Russia, Ukraine, China, and the
Philippines is much more affordable than in India or Western countries. Tuition fees and
living expenses are generally lower, making medical education accessible to many students
from different economic backgrounds.
2. Access to Advanced Medical Practices: Some countries, particularly in Europe and North
America, provide exposure to advanced medical practices, cutting-edge technology, and
state-of-the-art hospitals. This experience can significantly broaden a doctor's perspective
and skillset.

3. Global Recognition: Graduating from a well-known university abroad can open doors for
international practice. Many foreign universities have collaborations with renowned
medical centers worldwide, providing opportunities for further specialization and
research.

4. Quality of Education: Many foreign medical universities offer highly competitive and
comprehensive programs that are recognized for their quality of education. Some
universities offer specialized courses and research opportunities that may not be available
in India.

5. Diverse Cultural Experience: Studying medicine abroad provides exposure to diverse

patient populations, medical practices, and cultural contexts, which can help broaden a
doctor’s understanding of global health challenges.
Introduction to Crosspathy and Mixopathy

The terms crosspathy and mixopathy have gained significant attention in the healthcare
community, particularly in the context of Indian medicine. These terms refer to the practice of
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using different systems of medicine simultaneously or interchangeably, which is considered

unethical and unprofessional by many regulatory bodies.

• Crosspathy refers to the practice where a practitioner trained in one system of medicine
(such as Allopathy, Ayurveda, Homeopathy, etc.) practices or prescribes treatments from
another system.

• Mixopathy, on the other hand, refers to the practice of mixing or combining treatments
from different medical systems without proper integration, resulting in the use of remedies
or drugs from various streams of medicine without the required understanding of how
they interact.

Both these practices are a point of contention in modern medicine, and regulatory bodies have
taken a strong stance against them.

2. Legal and Ethical Implications

2.1 Medical Ethics

The primary concern with crosspathy and mixopathy is the potential harm they could cause to
patients. Both practices contravene the ethical principles that govern the medical profession,
particularly those of patient safety, competence, and professional integrity.

• Patient Safety: Mixing treatments from different systems of medicine without a clear
understanding of their interactions can lead to harmful side effects, especially when there
is no clear evidence supporting their combined use. For example, an Ayurvedic herbal
remedy might interact negatively with a pharmaceutical drug prescribed by an allopathic
doctor.

• Competence: Medical professionals are trained in specific systems of medicine, and they
are licensed to practice only within their domain. By practicing outside of their area of
competence, they may provide treatments that they are not equipped to handle, potentially
leading to misdiagnoses or suboptimal care.

• Professional Integrity: Practitioners engaging in crosspathy or mixopathy undermine

the credibility of their respective medical systems. Mixing therapies without scientific
evidence can cause confusion among patients and the medical community, leading to a lack
of trust in both traditional and modern systems of medicine.
2.2 Regulatory Framework in India

In India, medical practice is regulated by various acts, including the Indian Medical Council Act,
1956, National Medical Commission Act, 2019, Ayurvedic, Siddha, Unani, and
Homoeopathic practitioners (Amendment) Act, and other state-level regulations. These laws
clearly delineate the scope of practice for each system of medicine. Engaging in crosspathy or
mixopathy is strictly prohibited under these laws. Some important points are:

• The Indian Medical Council Act (1956): This act governs the practice of Allopathy
(modern medicine) in India. It mandates that only those who have graduated from
recognized medical colleges and hold a valid medical degree (MBBS, MD, etc.) are allowed
to practice modern medicine. The Act does not permit Allopathic doctors to practice any
form of alternative medicine unless they hold separate qualifications in that system.

• National Medical Commission Act (2019): The NMC Act established the National
Medical Commission (NMC), which regulates medical education and practice in India.
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According to the NMC guidelines, only those qualified in specific fields such as Ayurveda,
Homeopathy, Unani, or Allopathy are authorized to practice their respective systems.

• The Central Council of Indian Medicine (CCIM) and Central Council of Homoeopathy
(CCH): These statutory bodies regulate the education and practice of Ayurveda, Siddha,
and Homeopathy in India. Practitioners in these fields are prohibited from prescribing or
practicing Allopathy or any other systems without the appropriate qualifications.

Any violation of these regulations is treated as professional misconduct and can lead to the
suspension or cancellation of the practitioner’s license.

2.3 The Stance of Medical Councils

Both the Medical Council of India (MCI), now replaced by the National Medical Commission
(NMC), and various state councils, are clear in their opposition to mixopathy or crosspathy.
These bodies maintain that each medical system, such as Allopathy, Ayurveda, Homeopathy,
Unani, and others, is based on a specific philosophy, diagnostic techniques, treatment modalities,
and patient management practices.

• MCI’s Guidelines on Mixing Treatments: The Medical Council of India, in its ethical
guidelines, has made it clear that medical practitioners must not combine treatments from
different medical systems unless they are specifically qualified in both. For example, an
Allopathic doctor cannot prescribe Ayurvedic medicines or Homeopathic remedies unless
they are licensed to practice in those fields.

• National Medical Commission (NMC): The NMC Act emphasizes that doctors are allowed
to practice only in their respective domains, and mixopathy violates this restriction. As per
the NMC guidelines, there are no provisions allowing practitioners of one stream to
prescribe treatments from another unless they are duly qualified.

• Ayurvedic and Homeopathic Medical Councils: These councils also prohibit their
registered practitioners from indulging in crosspathy. Ayurvedic or Homeopathic
practitioners are allowed to practice only in their specialized areas of treatment. Any
attempt to prescribe modern allopathic drugs or treatments is considered a breach of the
ethical guidelines set by their respective councils.

3. Health Risks and Concerns

3.1 Adverse Drug Reactions (ADR)

One of the main health risks of mixopathy and crosspathy is the possibility of adverse drug
reactions (ADRs). The combination of treatments from different systems of medicine can lead to
unpredictable effects on the patient’s body. For instance:

• Drug Interactions: Allopathic medications are often formulated with specific dosages and
active ingredients. Mixing them with herbal or alternative remedies can lead to dangerous
interactions, reducing the efficacy of one or both treatments or causing harmful side
effects.
• Toxicity: Certain herbal remedies, if not used in the proper dosage or with other
medications, can cause toxicity. For example, an Ayurvedic herb may interact with an
allopathic drug and increase its toxicity or reduce its effectiveness.

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• Delay in Diagnosis and Treatment: Mixing treatments can delay the diagnosis of an
illness or lead to inappropriate treatments. For instance, if an Ayurvedic practitioner treats
a serious infection with herbs instead of antibiotics, the infection may worsen, leading to
more severe complications.
3.2 Undermining Evidence-Based Medicine

Medical practice, particularly in Allopathy, is based on evidence-based medicine (EBM), which

relies on scientific research, clinical trials, and empirical data to determine the safety and
effectiveness of treatments. Crosspathy and mixopathy undermine this approach as treatments
from different systems may not be supported by the same scientific evidence or may not have
undergone rigorous testing.
The use of alternative treatments without scientific backing can result in the use of ineffective or
harmful interventions. This erodes trust in the medical system and complicates the patient's care.

4. Public Awareness and Education

4.1 Need for Awareness

The growing trend of crosspathy and mixopathy calls for greater public awareness. Patients
must be informed about the risks associated with using treatments from multiple medical systems
simultaneously.
• Education Campaigns: Public health education campaigns must emphasize the
importance of seeking treatment from qualified professionals within a single system of
medicine. This would help ensure that patients receive treatments based on scientific
evidence and avoid harmful practices.

• Legal and Ethical Counseling: Doctors and healthcare providers must be educated about
the legal implications of practicing outside their scope of training. Encouraging compliance
with ethical standards and legal guidelines will help preserve the integrity of each system
of medicine.

4.2 Role of Government and Medical Bodies

The government, along with regulatory bodies like the National Medical Commission (NMC) and
the Central Council of Indian Medicine (CCIM), must enforce stricter regulations to curb the
practice of mixopathy and crosspathy. This could include:
• More stringent monitoring and auditing of medical practitioners.

• Raising awareness about the importance of registering with the correct medical council.

• Promoting professional development programs to train doctors in evidence-based

practices within their field.

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MODULE 2: Doctor Patient Relationship

2.1. Medico legal Implications of Consent, Different types of consent, Informed Refusal
and Therapeutic Privilege.

Medico-Legal Implications of Consent

The concept of consent in the context of the doctor-patient relationship is a critical aspect
of medical practice, as it directly impacts the legality and ethics of medical treatment. Consent
is a fundamental principle of medical law, reflecting the patient’s autonomy and right to make
informed decisions about their own healthcare. In the absence of valid consent, a medical
practitioner may be legally liable for battery, negligence, or medical misconduct.
Consent in healthcare can be categorized into several types, including express consent,
implied consent, and informed consent, each with its own legal significance. Understanding
the medico-legal implications of consent is essential for both patients and healthcare
professionals to navigate the often complex dynamics of medical treatment.

1. The Legal Concept of Consent

In law, consent is defined as the voluntary, informed, and unequivocal agreement of a person
to a particular act. In the context of medical treatment, consent is essential to ensure that the
patient has given their approval for the healthcare provider to proceed with a given procedure
or treatment.
1.1 Types of Consent
• Express Consent: Express consent occurs when a patient explicitly agrees to a proposed
medical intervention. This is typically given verbally or in writing, and it is the clearest
form of consent. An example is when a patient signs a consent form before undergoing
surgery or a complex medical procedure.
• Implied Consent: Implied consent occurs when a patient’s actions indicate agreement to a
medical procedure. This may be inferred from the patient's conduct or behavior, such as
when a patient voluntarily visits a doctor, allows them to examine them, or permits a
minor treatment. For example, when a patient presents themselves to an emergency room
for treatment, implied consent is assumed for necessary life-saving procedures.
• Informed Consent: Informed consent is the most significant form of consent in medical
law. It involves not only agreeing to treatment but also understanding the nature, risks,
benefits, and alternatives of the proposed treatment. The healthcare provider must inform
the patient comprehensively and in a language they understand, allowing the patient to
make an educated decision.

2. Medico-Legal Implications of Informed Consent

Informed consent is central to the relationship between a doctor and a patient, as it ensures
that the patient’s autonomy is respected and protects healthcare professionals from legal
liability. It is grounded in the legal principles of autonomy, self-determination, and the right
to privacy.
2.1 Key Elements of Informed Consent
For consent to be valid in a medico-legal context, it must meet the following criteria:
1. Voluntariness: The patient must freely choose to undergo the proposed treatment or
procedure without coercion, manipulation, or undue pressure from the doctor or other
parties.
2. Competence: The patient must have the mental capacity to make an informed decision
about their treatment. This means the patient must be of legal age (in most jurisdictions, 18
years or older) and mentally sound to understand the nature of the procedure, the risks
involved, and the consequences of not undergoing the treatment.

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3. Understanding: The patient must understand the information provided to them about the
procedure, its risks, and its benefits. The healthcare provider is required to disclose all
relevant information, including potential side effects, complications, and any alternative
treatment options.
4. Disclosure: The healthcare provider must disclose all pertinent information related to the
treatment or procedure. This includes:
o The nature of the treatment or procedure.
o Potential risks and complications.
o Available alternatives.
o The possible outcomes and consequences of refusing the treatment.
5. Consent in Writing: While consent may be verbal or implied in some cases, certain
procedures, especially those that are high-risk or invasive (like surgery), require written
consent. The written consent serves as evidence that the patient was properly informed
and voluntarily agreed to the procedure.
2.2 Failure to Obtain Informed Consent
If a healthcare provider proceeds with a treatment or procedure without obtaining informed
consent from the patient, several legal implications can arise:
• Battery: If a doctor performs a procedure without the patient's consent, it can be
considered battery in the legal sense. In medical law, battery refers to any unauthorized
physical contact or intervention, including non-consensual treatment. Even if the treatment
was beneficial, the absence of consent can still lead to legal consequences.
• Negligence: Failure to provide adequate information regarding the risks and benefits of a
procedure may result in a claim of medical negligence. A patient may argue that the
healthcare provider failed to meet the standard of care expected in the medical community
by not ensuring that the patient understood the treatment.
• Medical Malpractice: If a doctor performs a procedure that leads to harm, without proper
consent or proper disclosure of risks, the patient can sue for medical malpractice. This
could be based on the premise that the doctor failed to meet the required legal and ethical
standards for informed consent.
• Breach of Duty: The duty to obtain informed consent is part of the professional obligation
of a healthcare provider. A breach of this duty may lead to civil liability, disciplinary action
by medical boards, and loss of licensure.
2.3 Special Cases of Informed Consent
• Minors: In the case of minors (individuals under the age of 18 in most jurisdictions), the
ability to provide informed consent is limited. The law typically requires that a parent or
guardian give consent on behalf of the child. However, in emergencies or when a minor is
deemed mature enough (mature minor doctrine), the minor may give consent to medical
treatment.
• Incompetent Patients: Patients who are mentally incapacitated due to illness, injury, or
other reasons may be unable to provide informed consent. In such cases, a legal guardian
or an appointed representative (often through a Power of Attorney) must provide
consent. In some cases, if there is an immediate medical emergency, implied consent may
apply.
• Emergency Situations: In emergencies where the patient is unable to give consent (such
as in cases of unconsciousness or severe trauma), healthcare providers may proceed with
necessary life-saving treatments under the legal doctrine of implied consent. This ensures
that urgent medical care can be administered without waiting for formal consent.

3. Consent and Medical Research

In the context of medical research, informed consent plays a significant role. Medical
professionals conducting clinical trials or experimental procedures must obtain explicit
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informed consent from participants. This includes providing detailed information about the
research, its potential risks, and the voluntary nature of participation. Ethical guidelines, such
as those set out in the Declaration of Helsinki, regulate the conduct of clinical trials, ensuring
that the rights of participants are safeguarded.

4. The Role of Medical Ethics Committees

In institutions like hospitals and research centers, Ethics Committees play a crucial role in
reviewing and ensuring that informed consent is obtained before medical procedures or
research. These committees oversee:
• The adequacy of information provided to patients.
• Ensuring that the consent is voluntary and not influenced by external pressures.
• Reviewing consent forms to ensure they comply with legal and ethical standards.

5. Challenges in the Doctor-Patient Relationship

5.1 Language and Communication Barriers
A significant challenge in obtaining informed consent is the language barrier or
communication issues. Medical terminology can be complex, and patients may not always
fully understand the risks or procedures being explained to them. This is especially relevant in
a multi-lingual country like India, where a patient’s ability to comprehend the information
provided by a doctor may be impaired due to language differences.
5.2 Cultural Factors
Cultural differences can also impact the consent process. For instance, in some cultures,
patients may place greater trust in the doctor’s authority and may not ask questions or
express concerns about the proposed treatment. In such cases, it becomes the responsibility of
the healthcare provider to ensure that the patient fully understands and voluntarily consents
to the procedure.
5.3 Patient Coercion or Pressure
Patients may sometimes feel coerced into consenting to a treatment due to the doctor’s
perceived authority or pressure from family members. This can undermine the validity of
consent and potentially expose healthcare providers to legal claims.

Different Types of Consent in Medical Law

Consent is a cornerstone of the doctor-patient relationship, reflecting the autonomy of the
patient and protecting healthcare providers from legal liability. In medical practice, consent
can be broadly classified into various types, each of which carries different legal and ethical
implications. These types of consent are critical for ensuring that patients have a full
understanding of the medical procedures or treatments they are consenting to and that their
rights are respected in the process.
1. Express Consent
Express consent occurs when a patient explicitly agrees to a medical procedure or treatment
after being informed about its nature, risks, benefits, and alternatives. This consent can be
verbal or written, with written consent typically being required for more invasive or high-
risk procedures.
Key Features:
• Verbal or Written: Express consent is typically given in a clear and unequivocal manner,
either by speaking or through signing a consent form.
• Used for High-Risk Procedures: Express consent is often required for complex or
invasive procedures such as surgeries, organ transplants, or experimental treatments.
Example:
• A patient signs a written consent form before undergoing surgery. The form outlines the
procedure, potential risks, and alternatives.

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2. Implied Consent
Implied consent is the form of consent that can be inferred from a patient's actions, conduct,
or the circumstances surrounding the medical treatment. It occurs when a patient’s behavior
indicates agreement, even without a formal verbal or written acknowledgment.
Key Features:
• Implied through Behavior: A patient may not verbally express consent, but their actions
imply that they agree to the treatment.
• Common in Routine or Minor Procedures: This is often applicable to routine or minor
medical procedures like taking vital signs, administering a simple injection, or performing
a basic examination.
Example:
• A patient visits a doctor for an examination, rolls up their sleeve when asked to have their
blood pressure taken, and follows the doctor’s instructions without protest. This action
implies consent.
3. Informed Consent
Informed consent is the most comprehensive form of consent, where the patient is fully
informed about the procedure, its risks, benefits, and alternatives. It is the patient’s right to
understand the information, make a voluntary decision, and give consent based on that
understanding.
Key Features:
• Comprehensive Disclosure: The healthcare provider must provide all necessary details,
including potential risks, benefits, alternatives, and the likely outcomes of treatment or
non-treatment.
• Voluntary Decision: The patient must not be under any pressure or coercion to give
consent.
• Competence of the Patient: The patient must have the mental and legal capacity to
understand the information and make an informed decision. For minors or patients who
are mentally incapacitated, consent may need to come from a guardian or legal
representative.
Example:
• A doctor explains to a patient the risks of a surgery, the possible complications, and
alternative treatment options. The patient then signs a detailed consent form after fully
understanding the information.
4. Consent in Emergency Situations (Implied Consent)
In medical emergencies where a patient is unconscious or unable to communicate their
consent, implied consent may be assumed. In such cases, healthcare providers may proceed
with necessary treatment to save the patient’s life or prevent serious harm, as the law
recognizes the need for timely intervention in emergencies.
Key Features:
• Urgency of Treatment: Consent is implied because delaying treatment could lead to harm
or death.
• No Need for Explicit Consent: In urgent situations, implied consent is inferred from the
necessity of treatment.
Example:
• A patient is involved in a car accident and is unconscious. The attending doctor performs a
life-saving surgery without explicit consent, as it is assumed that the patient would consent
if they were able to.
5. Consent for Research/Clinical Trials
When a patient participates in a clinical trial or experimental treatment, they must provide
informed consent specific to the research or trial. This involves understanding the
experimental nature of the treatment, its risks, the possibility of side effects, and the voluntary
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nature of participation. Informed consent for research is more detailed, often documented
with specific forms and agreements.
Key Features:
• Specific to Research: The patient must be informed about the purpose of the research, the
methodology, the risks, and the potential benefits of participation.
• Right to Withdraw: The patient must be informed that they can withdraw from the trial at
any time without affecting their treatment outside the trial.
Example:
• A patient agrees to participate in a clinical trial for a new drug after being informed of the
potential risks, the nature of the trial, and their ability to withdraw at any time without
penalty.
6. Parental/Guardian Consent (for Minors)
Minors (individuals under the legal age of adulthood, typically 18) generally cannot provide
legal consent to medical treatment on their own. In such cases, parental or guardian consent
is required, unless the minor is deemed a “mature minor” capable of making their own
informed decisions, depending on the jurisdiction.
Key Features:
• Guardian’s Role: Parents or legal guardians provide consent on behalf of the minor.
• Mature Minor Doctrine: In some jurisdictions, minors who are mature enough to
understand the nature of medical procedures can provide their own consent.
Example:
• A child under the age of 18 needs to undergo surgery. The consent form is signed by the
child’s parent or legal guardian, indicating that the minor’s best interests are being
considered.
7. Consent in Mental Health Treatment
For individuals with mental illness or cognitive impairments, obtaining informed consent
can be complicated. In such cases, mental competence is a key factor. If a person is unable to
understand the treatment options or their implications, a legal guardian or an appointed
representative may need to provide consent.
Key Features:
• Mental Competence: The patient must be able to understand the information related to
their treatment and make an informed decision.
• Involvement of Guardians or Court Orders: If the patient is mentally incompetent, their
legal guardian or a court-appointed representative may give consent.
Example:
• An individual with severe depression is prescribed medication. If they are not able to
understand the effects of the medication, their guardian or caregiver may provide the
necessary consent.
8. Refused or Withdrawn Consent
Patients have the right to refuse or withdraw their consent at any time, even if they have
initially agreed to a procedure or treatment. This right is an essential aspect of patient
autonomy. If a patient withdraws consent after treatment has begun, the healthcare provider
must stop the treatment, unless the situation involves a life-threatening emergency.
Key Features:
• Right to Refuse: Patients can change their minds at any time before or during treatment.
• Documentation: The refusal or withdrawal of consent should be documented to avoid
legal complications.
Example:
• A patient who initially consented to undergo surgery decides to withdraw consent just
before the operation begins. The healthcare provider halts the procedure, and the patient’s
decision is documented.
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Informed Refusal and Therapeutic Privilege in Medical Law

Informed refusal and therapeutic privilege are two crucial concepts in the field of medical law
that relate to patient autonomy, the patient's right to make decisions about their own
healthcare, and the boundaries of the doctor's duty to disclose information. Both principles
emphasize the balance between ensuring that patients have the information they need to
make decisions and the potential ethical and practical limitations on how much information
should be shared.
1. Informed Refusal
Informed refusal refers to the situation where a patient decides to refuse medical treatment
after being fully informed of the consequences of that refusal, including the potential risks and
benefits of not undergoing the recommended treatment. In the same way that a patient has
the right to accept medical treatment (informed consent), they also have the right to refuse
treatment, provided that they are informed about the potential consequences of their
decision.
Informed refusal is a critical aspect of patient autonomy and bodily integrity. It underscores
the principle that individuals have the right to control their own bodies, including the right to
refuse interventions, even if such refusal may lead to harm or deterioration of health.
Key Features of Informed Refusal:
• Full Disclosure: The healthcare provider must fully inform the patient about the risks of
refusing treatment, as well as the potential consequences, including death or disability if
applicable.
• Voluntary Decision: The patient must make the decision to refuse treatment voluntarily,
without any coercion or undue pressure.
• Competence: The patient must have the mental capacity to understand the information
provided and to make an informed decision regarding their health.
• Documentation: Medical practitioners are encouraged to document the patient’s refusal in
writing, especially when refusing critical medical interventions.
Example of Informed Refusal:
• A patient diagnosed with a life-threatening illness is informed by the doctor that they need
immediate surgery. The doctor explains the potential benefits and risks of the surgery, as
well as the likely outcomes of not having the surgery. Despite this information, the patient
decides to refuse the surgery, understanding that it may lead to death or significant health
complications. The refusal is documented in the medical record.
2. Therapeutic Privilege
Therapeutic privilege is a medical doctrine that allows healthcare providers to withhold
certain information from a patient when the doctor believes that disclosing such information
could harm the patient's well-being or mental health. In essence, it allows for non-disclosure
of information when the doctor believes that telling the patient the truth may cause them
significant emotional distress or undermine their ability to make a rational decision.
While the concept of therapeutic privilege may seem to conflict with the principle of informed
consent, it is sometimes invoked in situations where the physician feels that providing certain
details could worsen the patient’s condition or cause unnecessary panic. However, therapeutic
privilege must be used judiciously and ethically, as withholding information can be seen as a
violation of the patient's right to autonomy and informed decision-making.
Key Features of Therapeutic Privilege:
• Physician's Discretion: Therapeutic privilege gives the physician the discretion to
withhold certain information if they believe that disclosure would cause harm to the
patient.
• Limited Use: Therapeutic privilege should be used only in exceptional cases, typically
when the doctor believes that full disclosure would cause immediate harm to the patient’s
health, either psychologically or physically.
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• Risk of Abuse: If abused, therapeutic privilege could infringe on the patient’s right to make
informed decisions about their own healthcare. It is, therefore, a controversial practice and
should be used sparingly.
• Not a Blanket Exception: Therapeutic privilege does not provide carte blanche authority
to withhold any information at the physician’s discretion. The decision to withhold must be
justified, and the risks of non-disclosure should be carefully considered.
Example of Therapeutic Privilege:
• A terminally ill patient is diagnosed with a condition where death is imminent. The
physician, understanding that telling the patient the full prognosis (i.e., that the patient has
only a short time to live) would cause them extreme distress, may decide to withhold the
full details of the prognosis, instead offering a more optimistic outlook. This is done with
the intention of preserving the patient's emotional stability and quality of life.
Comparison of Informed Refusal and Therapeutic Privilege
Aspect Informed Refusal Therapeutic Privilege

The patient refuses medical The physician withholds

Definition treatment after being fully information from the patient to
informed of the consequences. prevent harm or distress.

Respects the patient’s autonomy May limit the patient's

by allowing them to make autonomy by withholding
Autonomy
decisions regarding their own critical information.
care.
Involves non-disclosure of
Requires full disclosure of information, based on the
Disclosure of
information so that the patient physician's judgment of
Information
can make an informed decision. potential harm.

The patient is the one who The physician decides what

Patient’s information is best withheld
decides whether to accept or
Decision from the patient.
refuse the treatment.
May be documented in the
Written documentation of the patient’s record as a
Documentation patient’s refusal is often justification for withholding
required. information.

Ethically contentious and

Fully ethical when the patient is should be used sparingly to
Ethical
informed and voluntarily refuses prevent potential harm from
Considerations
treatment. non-disclosure.

A doctor withholds the truth

A patient refuses surgery after about a terminal diagnosis to
Examples being informed of all risks and spare the patient emotional
benefits. distress.

Legal and Ethical Considerations of Informed Refusal and Therapeutic Privilege

Both informed refusal and therapeutic privilege have important legal and ethical implications.
Informed Refusal:

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• Legally, patients have the right to refuse medical treatment. This is grounded in the
constitutional principle of autonomy, which is protected by Article 21 of the Indian
Constitution, which guarantees the right to life and personal liberty.
• Medically, refusal must be carefully documented. Failure to obtain informed refusal,
particularly in high-risk situations, can result in liability for battery or medical
negligence, even if the doctor acted in the patient's best interest.
Therapeutic Privilege:
• Ethically, therapeutic privilege is controversial because it undermines the patient’s right to
make informed decisions. Withholding information can lead to legal consequences if the
patient suffers harm due to not knowing all the facts.
• Legally, withholding information may be justified in specific circumstances (e.g., in
emergencies or cases where disclosure could cause immediate harm). However, if
therapeutic privilege is used inappropriately, it can result in liability for malpractice and
may be seen as a violation of the principle of informed consent.
• Case law: In the case of Samira Kohli v. Dr. Prabha Manchanda (2008), the Supreme
Court of India held that a doctor cannot withhold information from a patient without
justifiable reasons, emphasizing the importance of informed consent in medical treatment.

2.2. Importance of Documentation, Certificates in Medical practice, Medical Record

Importance of Documentation in the Doctor-Patient Relationship
Documentation plays a critical role in the healthcare profession. It serves as a formal record of
medical decisions, treatments, patient consent, and the entire care process. For doctors and
healthcare providers, proper documentation is not only a legal and ethical necessity but also
ensures continuity of care, protects against malpractice claims, and helps in regulatory
compliance. This section explores the importance of documentation in the doctor-patient
relationship from a legal, medical, and practical standpoint.
1. Legal Significance of Documentation
In the context of the doctor-patient relationship, documentation holds immense legal
significance. In the event of disputes, malpractice claims, or investigations into the quality of
care provided, medical records act as critical evidence in the courtroom. Properly documented
interactions between doctors and patients can serve as a defense against allegations of
negligence, misconduct, or breach of trust.
Key Legal Aspects:
• Evidence in Legal Proceedings: If a patient files a legal case (e.g., for medical malpractice,
negligence, or breach of duty), the medical records are often the most significant piece of
evidence. In India, Section 113 of the Indian Evidence Act, 1872 provides that hospital
records can be used as evidence in court, provided they are authentic and properly
maintained.
• Proof of Informed Consent and Refusal: Documentation of the informed consent process
is critical. It acts as proof that the doctor fully explained the risks, benefits, and alternatives
of the treatment and that the patient voluntarily consented to the medical intervention.
Similarly, if the patient refuses treatment, it should be documented to protect the doctor
against claims of battery or negligence.
• Protection Against Malpractice Claims: In medical malpractice claims, the
documentation can be a defense. If a doctor follows established protocols, records
discussions with the patient, and documents their observations and decisions, this can
shield them from allegations of substandard care. Failure to document may be viewed as a
sign of negligence, and in many legal systems, including India, a lack of documentation may
lead to an assumption of error.
• Legal Compliance: Doctors are legally required to maintain medical records according to
standards set by the medical boards or councils in their respective regions. The National
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Medical Commission (NMC) in India, for instance, mandates that hospitals and doctors
maintain proper patient records for a minimum of three years from the date of the last
treatment.
2. Ethical Importance of Documentation
Medical ethics emphasize the right of patients to be informed about their treatment and to
have access to their medical records. Ethical medical practice is grounded in the principle of
autonomy, which includes providing the patient with sufficient information and respecting
their right to make informed decisions about their healthcare.
Key Ethical Aspects:
• Respect for Patient Autonomy: Proper documentation ensures that patients' decisions
regarding their healthcare are made freely and with full knowledge. This includes the
informed consent process where the doctor explains the treatment options, risks, benefits,
and any alternatives. By documenting the consent process, doctors demonstrate respect for
the patient's autonomy and decision-making rights.
• Confidentiality and Privacy: Maintaining accurate medical records upholds the ethical
principle of patient confidentiality. Patient information, including diagnosis, treatment, and
personal details, should be kept private. Breaching confidentiality, either by sharing
information without consent or by failing to maintain secure records, is an ethical violation
and may result in legal consequences.
• Accountability: Ethical medical practice requires accountability for the treatment
provided to patients. By maintaining comprehensive documentation, healthcare
professionals ensure that there is a record of what was done, when it was done, and why it
was done, ensuring accountability in case of future inquiries or complications.
3. Practical Benefits of Documentation
In addition to its legal and ethical significance, documentation has several practical
advantages for both healthcare providers and patients.
Key Practical Aspects:
• Continuity of Care: Documentation ensures continuity of care, especially when multiple
healthcare providers are involved in the treatment of the same patient. Detailed records
allow for better coordination between different departments, specialists, and medical staff.
This is particularly crucial in complex cases or when patients are referred to specialists.
• Medical Decision-Making: Medical records provide a basis for clinical decision-making.
When a healthcare provider refers to previous records, they can better assess the patient’s
medical history, track progress, and make informed decisions based on past treatments,
medications, allergies, and other relevant information.
• Quality Control and Improvement: Proper documentation allows for monitoring the
quality of care provided. It enables healthcare facilities to review treatment outcomes,
identify patterns, and assess whether protocols are being followed. This can lead to
improvements in patient care practices and treatment protocols.
• Billing and Insurance: For hospitals and medical practitioners, medical records are
essential for accurate billing and insurance purposes. Insurance companies often require
documentation to verify treatment and care before reimbursing medical expenses. Proper
records ensure that patients are billed accurately and that insurance claims are processed
smoothly.
• Audits and Compliance: Many healthcare systems require regular audits to ensure
compliance with laws, regulations, and accreditation standards. Well-maintained
documentation facilitates these audits, ensuring that the healthcare provider meets
regulatory standards and avoids penalties.
4. Documentation in Different Contexts
a) Informed Consent Documentation: Informed consent is one of the most critical aspects of
medical practice. It documents that the patient has been made aware of the nature of the
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treatment, including the potential risks, benefits, and alternatives. This documentation is not
limited to a signature on a consent form but should be comprehensive, including:
• The explanation provided to the patient about the diagnosis and treatment plan.
• The risks and potential complications of the procedure.
• Any alternatives to the proposed treatment.
• The patient’s decision to consent or refuse treatment.
b) Refusal of Treatment: When a patient refuses treatment, documentation becomes just as
important as when a patient gives consent. Doctors must document:
• The patient’s refusal of the proposed treatment.
• The reasons for refusal (if known).
• Any consequences of refusal explained to the patient.
• The patient's understanding and acknowledgment of the risks of refusing treatment.
c) Surgical Documentation: In the case of surgeries, detailed documentation is necessary to
explain the:
• Type of surgery being performed.
• Consent obtained before the procedure.
• Anesthesia used, including the patient's medical history and any allergies.
• Postoperative instructions and follow-up care.
d) Medical Notes: Daily or periodic medical notes are essential for tracking the patient’s
condition and progress. These notes should record:
• The patient’s current condition.
• Any changes or complications observed.
• The treatments provided.
• The response to treatments and medications.
e) Emergency Situations: In emergency medical situations, quick but thorough
documentation is essential. This documentation can explain:
• The emergency medical condition and interventions.
• Consent given for immediate life-saving treatments, especially if the patient is
incapacitated.
• The rationale for any emergency procedures performed.
5. Challenges in Documentation
While documentation is essential, several challenges may arise in the process:
• Time Constraints: Busy healthcare environments may not provide adequate time for
detailed documentation, leading to incomplete or rushed records.
• Incomplete Records: Sometimes, due to oversight, records may not contain all the
relevant details of a patient's care. This can be problematic in case of future complications
or disputes.
• Privacy Concerns: Ensuring that patient information is kept confidential and securely
stored is a constant concern, especially with the rise of digital medical records.
• Legal Implications: Inadequate or improper documentation can lead to legal
consequences, including negligence claims. Failure to document informed consent, patient
refusals, or treatments can leave a healthcare provider vulnerable to litigation.

Certificates in Medical Practice

Certificates in the context of medical practice are official documents that recognize a specific
medical professional's qualifications, competencies, or status in a given medical field. These
certificates are essential for various purposes, including legal, professional, and educational
requirements. They serve as a validation of a healthcare provider's skills, compliance with
regulations, and authorization to practice medicine. This section outlines the different types of
certificates, their importance, and their legal, ethical, and professional implications in the
medical field.
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1. Types of Certificates in Medical Practice

Medical practitioners must obtain several types of certificates during their careers. These
certificates cover different aspects of professional qualifications, recognition, and compliance
with statutory requirements. Below are some of the essential certificates in medical practice:
1.1 Medical Degree Certificate
• Definition: The medical degree certificate is a formal document awarded by a recognized
medical college or university upon the successful completion of medical education. It
signifies that the individual has received formal training in medicine and is eligible to
practice as a doctor in their designated field.
• Examples:
o MBBS (Bachelor of Medicine, Bachelor of Surgery) for general practice.
o MD (Doctor of Medicine), MS (Master of Surgery) for specialists.
o BDS (Bachelor of Dental Surgery) for dentists.
• Importance: The degree certificate is the foundational document required for entry into
the medical profession. It is crucial for registering with the appropriate medical council
(e.g., Medical Council of India - MCI, State Medical Councils).
1.2 Registration Certificate
• Definition: The registration certificate is issued by a medical council (either the State
Medical Council or National Medical Commission) to a doctor who has completed the
requisite medical education and training. It serves as the official permission for the
individual to practice medicine in India.
• Examples:
o Permanent Registration Certificate: Issued after completion of required training
and examinations.
o Provisional Registration Certificate: Issued to students who have completed their
MBBS degree and are waiting for a permanent registration after completing their
internship.
• Importance: Without a registration certificate, a medical practitioner cannot legally
practice medicine. It ensures that the practitioner adheres to the ethical and professional
standards of the medical profession.
1.3 Postgraduate Medical Certificates
• Definition: These certificates are awarded after the completion of postgraduate studies in
specialized fields of medicine. A medical practitioner may pursue further education to
specialize in fields such as cardiology, neurology, orthopedics, etc.
• Examples:
o Diplomate of National Board (DNB): A postgraduate qualification recognized by
the National Board of Examinations (NBE) in India.
o MD/MS in specific specialties (e.g., MD in Dermatology, MS in Orthopedics).
• Importance: These certificates allow doctors to practice in a specialized area of medicine.
Postgraduate certifications are often necessary for those aiming for higher positions in
hospitals or for those looking to provide more specialized care.
1.4 Medical Licensure Certificate
• Definition: In some countries, obtaining a medical license is a requirement before
practicing medicine. In India, the Medical Council of India (MCI) or the National Medical
Commission (NMC) licenses medical practitioners by issuing licensure certificates.
• Importance: This certification acts as proof that the doctor has met all the legal and
regulatory requirements to practice medicine in a given region. Licensure is also crucial for
compliance with healthcare regulations and standards.
1.5 Continuing Medical Education (CME) Certificates
• Definition: Continuing Medical Education (CME) refers to educational programs that
doctors are required to participate in after obtaining their medical degrees. CME helps
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medical practitioners stay updated with the latest developments in medicine and
healthcare practices.
• Importance: Many medical councils and professional bodies require doctors to earn CME
credits regularly to maintain their medical registration and licensure. This ensures that
practitioners remain knowledgeable about advancements in medical science, new
treatments, and technologies.
1.6 Good Standing Certificate
• Definition: A Good Standing Certificate is issued by the medical council to confirm that a
medical practitioner is in good standing and has not been subject to any disciplinary
actions. It may be required when a doctor seeks to practice medicine in a different state or
country.
• Importance: This certificate is essential when applying for licenses in other jurisdictions
or when seeking employment at medical institutions. It provides proof that the doctor is fit
to practice without any legal encumbrances.
1.7 Fitness to Practice Certificate
• Definition: A Fitness to Practice certificate is typically required in cases where a
healthcare provider may be transitioning back to practice after a health-related break or if
concerns have been raised about their competency to practice. This certificate is often
issued by an authorized body or medical board after evaluating the practitioner's physical
and mental health.
• Importance: This certificate is particularly important for medical practitioners who have
been absent from the profession due to illness or have undergone treatment that affects
their ability to perform medical duties effectively. It ensures that the doctor can safely
return to work without endangering patients.
1.8 Medical Certification for Specific Purposes
• Definition: Doctors may be required to issue specific certifications depending on the
patient’s medical condition or the situation. Some examples of these include:
o Disability Certificates: Issued to individuals with physical or mental disabilities for
purposes such as government benefits or legal purposes.
o Fitness Certificates: Certifying that a patient is fit to resume work, travel, or
participate in specific activities (e.g., sports or school).
o Death Certificate: A formal statement issued by a doctor confirming the death of an
individual and the cause of death, if known.
o Medical Leave Certificates: Issued for employees or students to justify an absence
from work or studies due to illness.
• Importance: These certifications are crucial for legal, insurance, and employment
purposes, and they must be issued by a registered and qualified medical professional.
1.9 Medical Specialist Certifications
• Definition: In some cases, medical specialists or consultants in specific areas of medicine,
such as cardiology, oncology, or pediatrics, may receive certifications recognizing their
expertise in the field.
• Examples:
o Certified Diabetes Educator (CDE)
o Fellowships from medical societies like the Indian Heart Association (IHA) or
Indian Cancer Society.
• Importance: These certificates add to the professional credibility of the medical
practitioner and demonstrate their expertise in a specific medical domain.
2. Regulatory Bodies and their Role in Issuing Certificates
In India, several regulatory bodies oversee the issuance of certificates related to medical
practice. Their role is pivotal in ensuring that only qualified and competent professionals
practice medicine.
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2.1 National Medical Commission (NMC)

The National Medical Commission (NMC) is responsible for overseeing medical education
and practice in India. It is tasked with maintaining the standards of medical education,
ensuring ethical practices, and providing recognition to medical degrees. It issues registration
certificates, guidelines for medical ethics, and conducts regular assessments of medical
colleges.
2.2 State Medical Councils
Each state in India has its own medical council that is responsible for registering doctors,
ensuring adherence to professional ethics, and providing local certifications. State councils
often have their own requirements for continuing education and certification.
2.3 Indian Medical Association (IMA)
The Indian Medical Association (IMA), although not a regulatory body, provides various
certifications for medical professionals. It offers recognition of certain specialties, conducts
training programs, and issues CME certificates.
2.4 Central Council of Indian Medicine (CCIM)
The Central Council of Indian Medicine (CCIM) governs traditional Indian medicine systems
like Ayurveda, Siddha, and Unani. It sets standards for education, training, and certifications
in these fields.
2.5 Central Council of Homeopathy (CCH)
Similar to the CCIM, the Central Council of Homeopathy (CCH) oversees medical practice
and education in Homeopathy. It ensures that homeopathic practitioners adhere to
recognized standards and maintains the register of certified homeopathic practitioners.
3. Importance of Medical Certificates in Practice
3.1 Ensuring Professional Competency
Certificates are crucial in confirming a doctor’s education, qualifications, and competency to
practice. They are evidence of professional credibility and are necessary for healthcare
providers to gain the trust of patients and employers.
3.2 Legal Protection
Certificates, especially those related to registration, licensure, and good standing, provide
legal protection for both the practitioner and the patient. They ensure that the doctor has met
the legal requirements for practicing medicine and can defend against accusations of
malpractice or negligence.
3.3 Ethical Compliance
The possession of relevant medical certificates indicates that a practitioner adheres to ethical
standards and has received training in line with medical ethics. Informed consent,
confidentiality, and non-maleficence are essential aspects of medical practice that require
certification and documentation.
3.4 Ensuring Patient Safety
Medical certificates are also vital in ensuring that doctors possess the necessary expertise and
knowledge to deliver safe and effective care. They protect patients by ensuring that those
involved in their care are adequately qualified and trained.
3.5 Facilitating Healthcare Access
For patients seeking medical treatment abroad or across different states, having certified and
recognized medical credentials can facilitate access to healthcare, as international and
interstate health bodies often require proof of qualifications.

Medical Record
A medical record is a comprehensive documentation of a patient’s medical history,
treatments, procedures, and health conditions that are maintained by healthcare providers
such as doctors, hospitals, clinics, and medical institutions. It serves as both a historical record
and a vital communication tool within the healthcare system. Medical records are critical for
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providing ongoing care, facilitating informed decision-making, ensuring the quality of

treatment, and complying with legal, ethical, and regulatory requirements.
1. Types of Medical Records
There are different types of medical records, each serving a distinct purpose in healthcare:
1.1 Patient’s Medical History
• Definition: The patient’s medical history refers to a detailed account of their health
condition, including past illnesses, surgeries, family medical history, and lifestyle factors
that may affect their health.
• Contents:
o Personal details: Name, age, sex, address, contact information.
o Chief Complaint: The reason for seeking medical care.
o Past Medical History: Includes major illnesses, surgeries, injuries, and treatments
received.
o Family History: Details of any hereditary conditions that may influence the
patient's health.
o Social History: Lifestyle factors such as smoking, alcohol use, diet, and exercise.
o Medications: Any current or past medications, including dosage and duration.
• Importance: The medical history helps doctors understand the patient’s health risks and
provides a comprehensive context for diagnosis and treatment.
1.2 Clinical Notes
• Definition: Clinical notes are written observations made by healthcare providers during
patient consultations. They document the patient’s symptoms, physical exam findings,
diagnosis, and treatment plan.
• Contents:
o Subjective Information: The patient’s description of their condition, including
symptoms and complaints.
o Objective Information: The healthcare provider’s observations, such as physical
examination results and diagnostic test results.
o Assessment: The healthcare provider’s analysis of the patient’s condition based on
the subjective and objective information.
o Plan: The treatment plan, including medication, lifestyle modifications, and follow-
up appointments.
• Importance: Clinical notes are essential for tracking a patient’s progress, guiding future
treatments, and communicating with other healthcare professionals.
1.3 Laboratory and Diagnostic Test Results
• Definition: These records include the results of laboratory tests, radiological images,
biopsies, and other diagnostic procedures.
• Contents:
o Blood Tests: Results of tests like CBC, blood glucose, cholesterol levels, liver
function tests, etc.
o Imaging: X-rays, MRIs, CT scans, and other imaging studies.
o Biopsy and Histopathology Reports: Examination of tissue samples to diagnose
diseases like cancer.
o Microbiological Reports: Results of cultures to detect infections.
• Importance: Diagnostic test results are crucial for accurate diagnosis, treatment planning,
and ongoing monitoring of conditions.
1.4 Treatment and Medication Records
• Definition: This category includes records of medications prescribed, treatments
administered, and any surgical procedures performed.

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• Contents:
o Medications: The names, dosages, and administration schedules of medications
prescribed to the patient.
o Treatment Plans: Documentation of any non-pharmacological treatments,
including physical therapy or psychological counseling.
o Surgical Procedures: Details of any surgeries, including the type of surgery, date,
outcome, and recovery plan.
• Importance: Treatment records ensure that healthcare providers have accurate
information regarding the care provided, reducing the risk of errors and ensuring
continuity of care.
1.5 Progress Notes
• Definition: Progress notes are records of the patient’s condition over time, written by
healthcare providers during follow-up visits. They track the patient's recovery, response to
treatment, and any changes in the clinical status.
• Contents:
o Updates on symptoms, improvements, or complications.
o Reassessments of the treatment plan.
o Follow-up instructions or additional tests ordered.
• Importance: Progress notes help healthcare providers evaluate whether the treatment
plan is effective and make necessary adjustments.
1.6 Consent Forms
• Definition: Consent forms are documents that the patient signs, giving explicit permission
for medical procedures or treatments. Consent is a vital legal requirement in medical
practice.
• Contents:
o Informed Consent: The patient’s understanding of the procedure, including risks
and benefits.
o Procedure Details: Information about the nature of the medical intervention or
surgery.
• Importance: Consent forms protect healthcare providers from liability and ensure that
patients understand their rights and the potential risks involved in their care.

2. Legal and Ethical Aspects of Medical Records

2.1 Legal Importance of Medical Records
• Evidence in Legal Cases: Medical records are often used as evidence in legal proceedings,
including malpractice suits, personal injury cases, or insurance claims. In these cases,
medical records must be accurate, comprehensive, and timely.
• Record Keeping Requirements: Laws and regulations, such as the Indian Medical
Council Act, 1956, and the Indian Evidence Act, 1872, require that medical records be
maintained for specific periods (typically 5 to 7 years in India) and are accessible for legal
scrutiny.
• Confidentiality and Privacy: Medical records are confidential documents, protected
under laws such as The Right to Information Act, 2005 and the Information
Technology (Reasonable Security Practices and Procedures and Sensitive Personal
Data or Information) Rules, 2011. Unauthorized access or disclosure of medical records
can result in legal action.
2.2 Ethical Considerations
• Confidentiality: Healthcare providers are ethically and legally bound to maintain the
confidentiality of medical records. Disclosure of patient information without consent,
except in specific circumstances (e.g., to protect public health), is unethical and illegal.

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• Accuracy and Completeness: Doctors and healthcare institutions have an ethical duty to
ensure that medical records are accurate, complete, and up-to-date. Inaccurate records can
lead to misdiagnosis, incorrect treatment, or negligence.
• Patient Rights: Patients have the right to access their medical records and request
corrections if there are errors. This empowers patients and ensures transparency in the
medical process.
2.3 Role in Informed Consent
Medical records document the process of informed consent. Consent should be properly
recorded, indicating that the patient has been informed of the procedure, its risks, and
alternatives. In legal cases, medical records can prove that informed consent was obtained,
protecting healthcare providers from potential liability.

3. Protection and Security of Medical Records

3.1 Data Protection Laws
In India, The Personal Data Protection Bill, 2019, addresses the protection of personal data,
including medical records. It establishes guidelines for the collection, storage, and processing
of personal data to safeguard individual privacy. Medical institutions are required to adhere to
these laws to ensure that patient data is not misused.
3.2 Electronic Health Records (EHR)
With advancements in technology, many healthcare providers now use Electronic Health
Records (EHRs) to maintain medical records. EHR systems offer several advantages:
• Efficiency: EHRs allow healthcare providers to quickly access patient information,
facilitating timely and informed decision-making.
• Interoperability: EHR systems allow different healthcare providers to share patient data
securely, improving coordination of care.
• Data Security: EHRs have built-in encryption and security measures to protect patient
privacy.
• Patient Access: Patients can also access their medical records electronically, promoting
transparency and patient autonomy.
3.3 Physical Security
For physical medical records, healthcare institutions must implement adequate physical
security measures to protect records from unauthorized access, theft, or damage. This
includes locked filing cabinets, restricted access areas, and safeguards against environmental
damage (e.g., fireproof storage).

4. Challenges in Managing Medical Records

4.1 Data Breaches and Cybersecurity Risks
As medical records increasingly move to digital platforms, the risk of data breaches has
escalated. Cyberattacks, hacking, and unauthorized access are significant threats to patient
privacy. Healthcare organizations must invest in robust cybersecurity measures to protect
digital records.
4.2 Maintaining Accuracy and Consistency
Maintaining accurate and consistent records is essential for patient safety. Incomplete or
inconsistent documentation can lead to medical errors, especially when multiple healthcare
providers are involved. Implementing standardized record-keeping protocols is crucial to
minimizing errors.
4.3 Storage and Archiving
Medical records need to be stored for several years, and proper archiving procedures must be
in place to ensure that records are preserved in a way that allows easy retrieval. However,
storing large amounts of medical data can be costly and requires efficient systems to manage
and archive records.
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2.3 Confidentiality and Privileged Communication between Doctor and Patient

The relationship between a doctor and a patient is one that is built on trust and mutual
respect. At the core of this relationship lies the fundamental principle of confidentiality—the
obligation of the doctor to keep information shared by the patient private, and not disclose it
without the patient's consent. This is considered one of the most important ethical and legal
duties of a healthcare provider.
1. Concept of Confidentiality in Healthcare
Confidentiality in healthcare refers to the duty of the doctor to protect the privacy of the
patient's medical information. This includes all details about the patient’s condition,
treatment, and any other personal information revealed during consultations. This legal and
ethical obligation ensures that patients feel safe and secure when seeking medical care,
knowing that their personal health information will not be shared without their consent,
except under specific and justified circumstances.
2. Legal Framework Governing Confidentiality
In India, confidentiality is protected under both statutory laws and common law principles.
Various laws, including the Indian Medical Council (Professional Conduct, Etiquette and
Ethics) Regulations, 2002, and the Indian Evidence Act, 1872, provide a framework for
confidentiality.
• Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations,
2002: Regulation 1.3.3 states that a doctor should not disclose a patient’s personal
information unless required by law or authorized by the patient. Doctors must maintain
the highest standards of confidentiality in their practice.
• Indian Evidence Act, 1872: Sections 122 and 126 of the Indian Evidence Act provide a
legal framework for confidentiality in the context of doctor-patient relationships. Section
122 protects communication between the doctor and patient as privileged
communication (to be discussed below). Section 126 protects communication between
legal professionals and their clients, which can be applied analogously to doctor-patient
relationships in certain contexts.
• Constitutional Right to Privacy: The Right to Privacy, recognized as a fundamental right
by the Supreme Court in K.S. Puttaswamy v. Union of India (2017), provides a broad
legal basis for maintaining confidentiality. It implies that medical information falls under
the domain of privacy, which must be respected.
3. Nature of Confidential Information
Confidential information includes but is not limited to:
• Personal identification details such as name, address, phone number, etc.
• Medical history, including past illnesses, surgeries, and treatment records.
• Current health conditions, including diagnoses and test results.
• Psychological assessments, counseling, or therapy records.
• Treatment plans, including medications prescribed, surgical procedures, and follow-up
care instructions.
• Any information voluntarily provided by the patient about their lifestyle choices (e.g.,
smoking, alcohol use).
All this information must be protected, as unauthorized disclosure could harm the patient's
health, reputation, or lead to discrimination.
4. Circumstances When Confidentiality Can Be Breached
While confidentiality is a cornerstone of medical practice, there are certain situations where a
doctor is allowed or even required to breach confidentiality. These exceptions typically
revolve around the protection of public health, safety, or the interests of justice. These include:
• With the patient’s consent: The most straightforward scenario where confidentiality can
be breached is when the patient provides explicit consent for the sharing of their

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information. This consent must be informed, meaning the patient understands the nature
of the disclosure and its consequences.
• In case of public health emergencies: If a patient is suffering from a contagious disease
(e.g., tuberculosis, HIV/AIDS) or a serious public health risk (e.g., an outbreak of infectious
diseases), the doctor may be required to report the condition to health authorities. This is
done to prevent further spread of disease and protect the general public.
• When disclosure is required by law: Certain laws require doctors to disclose information
in specific cases. For example, in cases of criminal offenses, doctors may be compelled to
share relevant medical records if subpoenaed. A doctor may also be required to report
instances of child abuse or domestic violence as per the laws of the respective state.
• For medical research and educational purposes: In some cases, patient information can
be used for medical research or teaching, but it must be anonymized to protect the
patient’s identity. Ethical guidelines and institutional review boards govern these practices.
• Court Orders: If a court orders the disclosure of medical information, such as in cases
involving medical malpractice or personal injury claims, the doctor may be required to
comply, provided that the information is directly related to the case.
• Risk of Harm to Others: In rare instances, a doctor may disclose confidential information
to protect third parties from harm. For example, if a patient reveals that they are infected
with a sexually transmitted disease and refuses treatment, the doctor may notify the
patient's partner to prevent the transmission of the disease.
5. Privileged Communication
In addition to confidentiality, privileged communication is a legal doctrine that grants
certain communications between a doctor and a patient (or between the patient and their
legal representatives) immunity from being used as evidence in court.
• Section 122 of the Indian Evidence Act, 1872: This section grants privilege to
communications between a doctor and a patient in the course of medical treatment. The
communication cannot be disclosed unless there is an exception, such as the consent of the
patient or a court order.
• Common Law Privilege: Under common law, a doctor-patient communication is
considered privileged, meaning the doctor cannot be compelled to reveal it in legal
proceedings without the patient’s consent.
However, the privilege does not apply in certain circumstances. For example, communications
related to the commission of a crime may not be protected by privilege if the doctor is
subpoenaed to provide such information in a criminal investigation or court case.
6. Ethical Dilemmas and Challenges in Maintaining Confidentiality
• Genetic Information: One of the growing areas of concern is the handling of genetic
information. As genetic testing becomes more widespread, doctors are faced with difficult
questions about how to maintain confidentiality while addressing potential risks to family
members.
• Mental Health and Substance Abuse: Doctors treating patients with mental health
conditions or substance abuse issues may encounter conflicts between patient
confidentiality and the need to disclose information in the interest of public safety.
Balancing the duty of confidentiality with the protection of others’ rights can be
particularly challenging.
• Confidentiality in the Digital Age: The increasing use of electronic medical records
(EMRs) presents new challenges to confidentiality. With the rise of hacking, data breaches,
and cyberattacks, healthcare organizations must adopt stringent measures to ensure the
protection of electronic health data. Both legal and ethical guidelines need to adapt to
ensure the confidentiality of digital health records.
7. Violations of Confidentiality
Breaches of confidentiality can have serious legal, ethical, and professional consequences:
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• Professional Consequences: A doctor who discloses a patient’s confidential information

without authorization may face disciplinary action from medical boards, suspension, or
revocation of their medical license.
• Legal Consequences: Unauthorized disclosure of patient information can also lead to legal
actions against the doctor, including claims for damages under civil law or even criminal
charges in cases of gross negligence or willful misconduct.
• Loss of Trust: Violating patient confidentiality can erode the trust between the doctor and
the patient, undermining the therapeutic relationship and the patient’s willingness to seek
care in the future.

2.4. Patients Right to self Determination and Euthanasia- Legal Position in India
The concept of self-determination refers to a patient's right to make decisions about their
own medical treatment and the ability to choose or refuse treatment, including decisions that
might end their life. The notion of euthanasia, or the practice of intentionally ending a life to
relieve pain and suffering, is closely linked to the principle of self-determination. In India,
these issues intersect with complex ethical, legal, and medical concerns.
This section examines the legal and ethical aspects of a patient's right to self-determination,
particularly in the context of euthanasia, under Indian law. The legal framework and judicial
pronouncements on euthanasia highlight the balance between individual autonomy and the
protection of human life.

1. Right to Self-Determination
The right to self-determination is an extension of an individual's right to autonomy in
matters of personal choices, including health and medical treatment. It emphasizes that a
competent individual has the right to make decisions about their own body and health,
including the refusal or acceptance of medical interventions.
Key Principles:
• Autonomy: The principle that individuals have the right to make decisions regarding their
own lives and bodies.
• Informed Consent: The cornerstone of medical ethics, it asserts that patients must be
provided with all necessary information regarding the risks and benefits of treatment
options before they can give valid consent.
• Right to Refuse Treatment: Even if a particular medical treatment is necessary to sustain
life, a competent patient has the legal right to refuse it. This right extends to refusing life-
sustaining treatments like ventilators or feeding tubes.
The Indian Constitution guarantees the Right to Life under Article 21, which is interpreted
broadly by the courts to include a right to health, access to medical treatment, and the right to
make decisions about one's body.

2. Euthanasia: Meaning and Types

Euthanasia refers to the intentional act of ending the life of a person suffering from an
incurable and painful condition, usually through the administration of lethal substances.
There are two primary types of euthanasia:
1. Active Euthanasia: Involves taking deliberate action to cause the death of a patient, such
as administering a lethal dose of drugs. Active euthanasia is illegal in most jurisdictions,
including India.
2. Passive Euthanasia: Involves withholding or withdrawing life-sustaining treatment,
allowing the patient to die naturally. This could involve stopping medication, turning off a
ventilator, or withholding food and water.
• Voluntary Euthanasia: The person who is euthanized gives consent to end their life.

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• Involuntary Euthanasia: The person is euthanized without their consent, typically in

cases where the person is unconscious or incapable of making decisions.
In India, the legality of euthanasia is heavily debated, and passive euthanasia is distinguished
from active euthanasia, which remains illegal.

3. Legal Position of Euthanasia in India

The legal position of euthanasia in India was initially unclear, but over time, the Supreme
Court has delivered landmark judgments that have shaped the legal framework surrounding
euthanasia.
3.1. Aruna Shanbaug Case (2011) – Passive Euthanasia
The first significant case involving euthanasia in India was Aruna Shanbaug v. Union of
India (2011). Aruna Shanbaug was a nurse who was in a persistent vegetative state (PVS) for
nearly 40 years after being sexually assaulted. Her condition was irreversible, and her request
for euthanasia was made by her close friends and family, based on her presumed wish to die
peacefully.
• Supreme Court Judgment: The Supreme Court ruled that passive euthanasia could be
permitted in India under certain conditions. It allowed the withdrawal of life support in
certain situations, recognizing that a patient’s right to die with dignity is encompassed
under Article 21 (Right to Life and Personal Liberty) of the Indian Constitution.
• The Court laid down strict guidelines for the process, requiring the approval of a medical
board and a High Court. The High Court would have to decide whether the patient, like
Aruna Shanbaug, is in a "persistent vegetative state" and whether their condition is
irreversible.
This case set the legal precedent for passive euthanasia, recognizing the patient’s right to die
with dignity. However, it explicitly stated that active euthanasia remains illegal in India.
3.2. Common Cause Case (2018) – Right to Die with Dignity and Living Will
In 2018, the Supreme Court of India delivered a landmark judgment in the Common Cause v.
Union of India case, which further refined the legal understanding of euthanasia in India.
• Supreme Court Judgment: The Court ruled that “right to die with dignity” is a
fundamental right under Article 21 of the Constitution. The Court legalized passive
euthanasia and recognized the concept of a living will, which allows an individual to
make a written advance directive for end-of-life treatment.
o Living Will: A living will is a document that allows a person to express their wish to
discontinue medical treatment or not receive life-sustaining interventions if they
become terminally ill or are in a vegetative state.
o The Court set strict guidelines for executing a living will, requiring that the
document be signed by the person in sound mental health, witnessed by two
persons, and kept under the custody of a close family member.
o The Court also established a process for verifying the authenticity of the living will,
which includes scrutiny by a medical board and approval from the High Court. This
ensured that the decision to withdraw life support was made following due process
of law.
The Common Cause case marked a significant advancement in the legal position on
euthanasia, recognizing the importance of respecting a patient’s right to self-determination
and their decision to end their life in dignity.

4. The Constitutional Right to Die with Dignity

In the Common Cause case, the Supreme Court further emphasized that the right to die
with dignity is a fundamental part of the right to life under Article 21 of the Indian
Constitution. This is a significant shift in India’s constitutional interpretation, expanding the
right to life beyond mere existence to include the right to live with dignity.

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The Court acknowledged that forced medical treatments, particularly for terminally ill
patients or those in a persistent vegetative state, may infringe upon a person’s right to dignity.
The judgment reflects a recognition that the right to self-determination, particularly in
matters related to health and life, is an essential part of a person's dignity.

5. Ethical Considerations and Challenges

• Moral and Religious Opposition: In India, euthanasia has been met with strong
opposition from various religious and ethical groups who argue that it goes against the
sanctity of life. Religious beliefs that life is sacred, and that only God has the authority to
end it, have played a significant role in shaping the societal view on euthanasia.
• Slippery Slope Argument: Critics argue that permitting euthanasia could set a dangerous
precedent, leading to non-voluntary or involuntary euthanasia. There is a fear that
vulnerable individuals, such as the elderly or disabled, could be coerced into ending their
lives, even if they don’t wish to die.
• Medical Ethics: Euthanasia raises significant ethical concerns within the medical
profession, where the Hippocratic Oath traditionally calls for doctors to "do no harm." The
medical community is divided, with some supporting the right to die with dignity, while
others oppose euthanasia on the grounds of patient protection and ethical integrity.

2.5. Concept of living Will and Request for DNR- Do Not resuscitate
The concepts of Living Will and DNR (Do Not Resuscitate) orders are deeply intertwined in
the context of a patient's right to self-determination and the legal and ethical dimensions of
end-of-life care. Both these concepts relate to a patient's autonomy in making healthcare
decisions, particularly when they are unable to make such decisions due to incapacity.

1. Living Will:
A Living Will is a legal document that allows individuals to outline their preferences for
medical treatment in situations where they are incapacitated or unable to communicate their
wishes. It is primarily used in scenarios where the patient is terminally ill, in a persistent
vegetative state, or has an irreversible condition, and they no longer wish to undergo certain
medical interventions.
Key Aspects of a Living Will:
1. Advance Directive: The living will serves as an advance directive, which helps guide
medical professionals and family members about the patient's preferences for medical
treatment in specific circumstances.
2. End-of-life Care: The living will typically includes directives regarding life-sustaining
treatments such as mechanical ventilation, artificial feeding, or resuscitation efforts. It may
request that certain procedures be withheld or stopped if the individual is in an
irreversible or terminal state.
3. Legal Standing: In some jurisdictions, living wills are legally binding, meaning healthcare
providers are required to follow the directives as long as they are legally valid. However,
the extent to which a living will is enforceable varies depending on the legal framework of
a country or state.
4. Health Care Proxy: Many living wills also involve the designation of a healthcare proxy or
agent who is authorized to make healthcare decisions on behalf of the individual if they are
incapacitated and unable to make decisions themselves.
Legal Position in India:
The legal status of living wills in India has been a subject of significant debate. In 2018, the
Supreme Court of India, in the case of Common Cause v. Union of India (2018), recognized the
validity of "living wills" or advance directives to withdraw medical treatment for patients in a
terminal condition or a vegetative state, under strict guidelines.

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• Guidelines: The court laid down the following guidelines for the implementation of living
wills:
1. Mental Competence: The individual must be mentally competent when making the
living will.
2. No Immediate Family Dispute: There must be no dispute among family members
about the patient's condition and their wishes.
3. Independent Medical Opinion: An independent medical board must certify the
patient's condition as terminal or irreversible.
4. Judicial Approval: In the event that a living will is presented for withdrawal of
treatment, a bench of at least two doctors should verify that it is consistent with the
patient's wishes.
5. Respecting Autonomy: The recognition of a living will reflects the principle of
respecting a person's autonomy to make decisions regarding their own body and
medical care.
However, living wills in India are not a common practice, and the guidelines set by the
Supreme Court provide a cautious and regulated approach.

2. Do Not Resuscitate (DNR):

A DNR order is a medical directive that requests healthcare providers to withhold
resuscitation efforts in the event that the patient's heart stops beating or they stop breathing.
The primary intent behind a DNR order is to avoid aggressive measures like CPR
(cardiopulmonary resuscitation) that may not be in line with the patient's wishes or could
cause unnecessary suffering.
Key Aspects of a DNR Order:
1. Application in Specific Situations: DNR orders are typically applied when a patient is
terminally ill, has no realistic chance of recovery, and may otherwise experience pain and
distress from resuscitative efforts.
2. Patient Autonomy: A DNR order is a way for patients to exercise their right to refuse
unwanted medical treatment, particularly when they are near the end of life and want to
die peacefully without invasive interventions.
3. Procedure: A DNR order can be placed in the patient’s medical record and must be
communicated clearly to the healthcare team, particularly emergency personnel who may
be called in to provide assistance in a medical crisis.
4. Family Involvement: In many cases, family members or legal guardians must be involved
in making the decision to place a DNR order, particularly if the patient is unable to
communicate their wishes due to their medical condition.
Legal Position in India:
The concept of DNR in India has not been clearly defined or regulated by law, though the
general principles of autonomy and patient rights are applicable under the Indian
Constitution. However, DNR orders have become a part of the discussion on end-of-life care,
especially after the Supreme Court's landmark judgment in the Common Cause v. Union of
India case (2018), where the Court recognized the right of terminally ill patients to refuse life-
sustaining treatment.
• Guidelines for Withdrawal of Medical Treatment: The court’s guidelines for the
withdrawal of medical treatment can be applied to cases involving a DNR order. For
instance, the patient’s wishes must be respected, and a medical board must verify the
patient’s condition and ensure that the refusal of treatment aligns with the patient’s earlier
expressed wishes.
• Challenges and Debate: The issue of DNR orders and end-of-life decisions is sensitive in
the Indian context, where medical professionals and families may feel conflicted due to
cultural, ethical, and religious reasons. DNR orders are still rare, and there is a lack of clear
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legislative and regulatory frameworks that can guide doctors and families in these
decisions.

Relationship Between Living Will and DNR Orders:

The concepts of living wills and DNR orders are related, as they both involve the right of a
patient to control their medical treatment when they are incapacitated. The living will often
includes a request for a DNR order in cases where resuscitation would be futile or unwanted.
• A living will can include directives related to the refusal of life-sustaining treatments,
including a DNR order, in the case of a terminal illness or irreversible condition.
• A DNR order is a specific type of instruction, often found within a living will, to withhold
resuscitative measures in the event of a cardiac arrest or respiratory failure.
In both cases, the fundamental idea is the patient’s right to decide what happens to their body
and to refuse medical interventions that they deem unnecessary or against their wishes.

Ethical and Legal Considerations:

1. Respecting Autonomy: Both living wills and DNR orders highlight the ethical principle of
respecting patient autonomy—the right to make decisions about one's own medical care.
2. Reluctance in Implementation: Despite the recognition of these rights in legal
frameworks, there is still significant reluctance among healthcare providers and family
members to implement living wills and DNR orders due to ethical concerns, cultural beliefs,
and fear of legal repercussions.
3. Medical Ethics and Professional Responsibility: Doctors are bound by ethical standards
to ensure that patient wishes are respected, but they must also balance these with their
professional responsibility to preserve life. When dealing with terminally ill patients,
doctors often face challenges in determining whether to honor a living will or a DNR order,
especially when family members disagree.
4. Regulation and Clarity: While there is progress in India towards respecting patient
autonomy in end-of-life decisions, there is still a need for clearer legislation and guidelines
that regulate living wills, DNR orders, and other aspects of end-of-life care.

2.6 Professional Obligations of Medical Professionals

Medical professionals, including doctors, have ethical and legal duties towards their
patients, society, and the medical profession. These obligations are meant to ensure that
healthcare is delivered with the highest standards of care, respect for human dignity, and
adherence to ethical principles. Professional obligations stem from both legal mandates
and ethical guidelines that govern the practice of medicine. Below are some key aspects of
these professional obligations:
1. Duty of Care
A medical professional has a legal and ethical obligation to provide a standard of care that
meets or exceeds the expectations of medical practice. This is commonly referred to as the
duty of care. The physician must:
• Take appropriate steps to diagnose and treat the patient.
• Ensure that the patient receives the best possible care according to accepted medical
practices.
• Protect the patient from harm and minimize risks during treatment or procedures.
• Continuously update their medical knowledge to keep pace with developments in medical
science.
Failure to fulfill this duty can result in medical negligence or malpractice claims, which could
lead to legal and professional consequences, including lawsuits and revocation of medical
licenses.

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2. Confidentiality
One of the core principles of medical ethics is confidentiality. Medical professionals are
bound by confidentiality rules that ensure that any personal and sensitive information shared
by a patient is kept private. This obligation extends beyond the doctor-patient relationship to
include all healthcare providers involved in the patient's care. This confidentiality is crucial
for:
• Building trust between patients and healthcare providers.
• Allowing patients to freely disclose important health information.
• Protecting patients' privacy rights under the Indian Medical Council (Professional
Conduct, Etiquette and Ethics) Regulations, 2002.
There are exceptions to this confidentiality when disclosure is required by law, such as in
cases of public health risks, where non-disclosure might lead to harm to others, or when
ordered by a court of law.
3. Informed Consent
Before administering any treatment or performing any procedure, medical professionals must
ensure that they obtain informed consent from the patient. This is an essential obligation
that involves:
• Explaining the proposed treatment, its risks, benefits, and alternatives.
• Allowing the patient to ask questions and ensuring they understand the information
provided.
• Ensuring that the patient voluntarily agrees to the procedure without any coercion or
undue influence.
Informed consent ensures that patients have control over their medical decisions and are not
subjected to unwanted procedures or treatments. For minors or individuals who cannot make
decisions independently, the consent of a legal guardian or representative is necessary.
4. Professional Competence
Doctors have a professional obligation to maintain competence in their field. This means:
• Continuously engaging in professional development and continuing medical education
(CME) to keep up-to-date with new medical research, technologies, and treatment options.
• Participating in regular skills assessments to ensure that they can provide the best
possible care to their patients.
• Seeking help from specialists or consulting colleagues when faced with unfamiliar
conditions or complex cases.
Competence also includes being aware of one’s limitations and referring patients to
specialists when appropriate.
5. Non-Discrimination and Equity in Care
Medical professionals are required to provide care to all patients without discrimination on
the grounds of:
• Race, gender, age, sexual orientation, religion, socio-economic status, or disability.
• Every patient deserves to be treated with dignity, respect, and fairness.
This obligation is also enshrined in Article 14 of the Indian Constitution, which guarantees
equality before the law, and further supports the principle of non-discriminatory
healthcare.
6. Providing Emergency Care
Medical professionals have an obligation to provide emergency care when required,
regardless of the patient's ability to pay or their social status. In the case of an emergency,
healthcare providers must not:
• Delay treatment or refuse care on grounds of non-payment or non-insurance.
• Act in a way that harms the patient due to negligence in an emergency situation.
This ethical obligation aligns with the provisions under Section 304-A of the Indian Penal
Code (IPC) dealing with causing death by negligence in emergency situations.
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7. End-of-Life Care and Palliative Care

Doctors are required to respect patients' decisions at the end of life and provide palliative
care for those with terminal conditions. This includes:
• Respecting the wishes of the patient, particularly in relation to end-of-life decisions such as
euthanasia or living wills.
• Providing comfort and pain relief for patients with terminal illnesses, ensuring their quality
of life is maintained.
The Indian Penal Code allows passive euthanasia in cases where a patient has given a written
directive (living will) or if the patient is in a terminal state with no chance of recovery.
8. Respect for Patient Autonomy
Medical professionals must respect patient autonomy, which means the right of patients to
make decisions about their own healthcare. This is closely related to the principles of
informed consent and respect for individual rights.
• Patients have the right to refuse treatment, even if that decision may result in harm.
• Medical professionals should support patients in making decisions, providing guidance but
also respecting the choices they make.
9. Avoiding Conflicts of Interest
Doctors must avoid any conflicts of interest that may affect their professional judgment or
the care of their patients. This includes:
• Not receiving undue financial incentives from pharmaceutical companies or healthcare
suppliers that may influence the prescribing or use of certain treatments or medicines.
• Being transparent and clear about any potential conflicts when advising patients, ensuring
that their personal or financial interests do not compromise patient care.
10. Reporting and Addressing Misconduct
Doctors have a responsibility to report any form of misconduct or unethical behavior by
their colleagues. This includes:
• Reporting instances of medical negligence, fraud, or corruption.
• Ensuring that patients' rights are protected by reporting any breach of ethical or legal
guidelines within the medical practice.
Ethical obligations in medicine are enforced by regulatory bodies such as the Medical Council
of India (MCI) and, more recently, the National Medical Commission (NMC), which issue
guidelines and codes of conduct for doctors. In case of violations, these bodies have the
authority to take disciplinary action, including suspension or revocation of the doctor's
license.

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MODULE 3: Medical Negligence and Different remedies

3.1 Negligence in Medical Practice, Contributory Negligence and Different Remedies
Negligence in medical practice refers to a breach of the duty of care owed by a healthcare
professional to a patient. It occurs when a medical professional fails to provide the standard
level of care that is expected in their field, leading to harm or injury to the patient. The law of
negligence is critical in healthcare as it ensures that medical professionals are held
accountable for their actions and omissions, promoting patient safety and ethical practices.
Legal Framework for Medical Negligence
The concept of medical negligence is well recognized in legal systems across the world,
including India. It is a subcategory of tort law, which focuses on civil wrongs causing harm to
an individual due to the failure to act with reasonable care.
In India, medical negligence is governed under:
1. Indian Penal Code, 1860 (IPC): Sections 269, 270, 304A, and 338 of the IPC deal with
negligent acts likely to spread infection, causing death by negligence, and causing grievous
hurt by a negligent act, respectively.
2. Consumer Protection Act, 2019: Under this Act, a patient can file a complaint against a
healthcare provider for medical negligence. The Act defines the healthcare services
provided to a patient as “services,” and any deficiency in those services can result in legal
liability.
3. The Medical Council of India (MCI) Guidelines: The MCI provides ethical guidelines for
medical professionals. Breaching these standards of care can lead to disciplinary action by
the respective medical council.
Elements of Medical Negligence
For an act to be considered as medical negligence, the following elements must generally be
proven:
1. Duty of Care: The medical professional must owe a duty to the patient. In doctor-patient
relationships, this duty is inherent, as the doctor must provide care that meets the accepted
standard of practice.
2. Breach of Duty: There must be a failure to meet the standard of care expected from a
reasonable and competent medical professional under similar circumstances. This breach
could occur through actions or omissions, such as misdiagnosis, improper treatment, or
failure to inform the patient adequately about risks.
3. Causation: The breach of duty must directly cause harm or injury to the patient. It must be
proven that the damage was a result of the negligent action or inaction of the medical
professional. If the injury would have occurred despite the professional's care, no
negligence is established.
4. Damage or Harm: The patient must have suffered damage or injury due to the breach of
duty. The harm could be physical, emotional, or financial, and it must be significant enough
to warrant a claim for compensation.
Types of Medical Negligence
Medical negligence can manifest in various forms, including:
1. Diagnostic Errors: Failing to diagnose or misdiagnosing a medical condition, such as
failing to identify cancer or heart disease. An incorrect diagnosis can result in a delay in
treatment, which may worsen the patient's condition.
2. Surgical Negligence: Errors during surgery, including performing the wrong procedure,
damaging organs, or leaving surgical instruments inside a patient’s body.
3. Medication Errors: Prescribing the wrong medication, incorrect dosage, or failure to warn
the patient of potential drug interactions can cause significant harm.
4. Failure to Obtain Informed Consent: A patient must be fully informed about the risks
and benefits of a medical procedure or treatment. Failing to obtain the patient's consent

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before performing a medical procedure, or not disclosing significant risks, can be

considered negligence.
5. Delay in Treatment: A delay in diagnosing a medical condition or providing treatment can
be a form of medical negligence, especially when the delay results in preventable harm.
Defenses to Medical Negligence Claims
In response to a claim of medical negligence, a healthcare professional or facility can raise
several defenses:
1. Standard of Care: The defendant may argue that the care provided was within the
accepted medical standards, and that any alleged failure was an unfortunate but inevitable
consequence of the patient's condition.
2. No Causation: The defendant may argue that there was no direct link between the alleged
breach and the injury or harm suffered by the patient.
3. Contributory Negligence: The healthcare professional may argue that the patient's own
actions (e.g., refusal of treatment or failure to follow medical advice) contributed to the
harm or injury.
4. Error of Judgment: In some cases, the defendant may argue that an error in judgment
occurred, but it was a reasonable mistake given the available information at the time, and
does not amount to negligence.
5. Assumption of Risk: If the patient was informed of the risks and voluntarily accepted
them, the medical professional may argue that the patient assumed the risk of any
potential harm, which negates the claim of negligence.
Landmark Cases in Medical Negligence in India
Several landmark cases have shaped the law of medical negligence in India:
1. Indian Medical Association v. V.P. Shanta (1995): The Supreme Court of India clarified
that medical services fall under the definition of "services" under the Consumer Protection
Act, 1986. This landmark judgment made it easier for patients to file complaints against
healthcare providers under consumer law.
2. Bolam v. Friern Hospital Management Committee (1957, UK): Though a UK case,
Bolam has had a significant influence on Indian law regarding medical negligence. The case
established the “Bolam Test,” which states that a doctor is not negligent if they acted in
accordance with a practice accepted by a responsible body of medical opinion, even if other
professionals disagree.
3. Dr. Laxman Balkrishna Joshi v. Dr. Trimbak Bapu Godbole (1969): This case involved
a surgeon’s failure to recognize a life-threatening condition and remove a tumor during
surgery. The court ruled that failure to diagnose and act appropriately, given the
circumstances, amounted to negligence.
4. Suresh Gupta v. Government of NCT of Delhi (2004): This case involved a claim of
negligence against a doctor for a fatal error during surgery. The court laid down the
principle that a mere error in judgment does not amount to negligence, and a doctor should
be judged based on the standard of care expected from a reasonably competent
professional in similar circumstances.
Liability and Compensation
Medical professionals and institutions can be held liable for medical negligence. The patient
may seek compensation for the harm suffered. The compensation can cover:
1. Medical Expenses: The cost incurred due to negligent treatment or misdiagnosis.
2. Pain and Suffering: Compensation for the physical and emotional distress caused by the
negligent act.
3. Loss of Earning Capacity: In cases of permanent disability or incapacity due to negligence.
4. Loss of Consortium: Compensation to the family members for loss of companionship if the
negligence leads to death or permanent disability.

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Negligence in Medical Practice, Contributory Negligence, and Different Remedies

1. Medical Negligence
Medical negligence refers to the failure of a healthcare professional or institution to
provide the standard care that is reasonably expected under the given circumstances. It
involves a breach of the duty of care owed to the patient, resulting in harm or injury. Medical
negligence is a significant area of concern, both in terms of civil liability and criminal
responsibility.
1.1 Duty of Care
In medical practice, the duty of care refers to the responsibility a doctor or healthcare
provider has to ensure the well-being and safety of their patients. This duty arises from the
doctor-patient relationship, where the doctor is expected to act with the same level of skill,
care, and diligence that a reasonably competent doctor in the same field would apply.
The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations,
2002 govern this aspect and impose an ethical obligation on doctors to maintain a standard of
care.
1.2 Breach of Duty
A breach of duty occurs when a doctor fails to meet the expected standard of care. For
example, if a doctor makes an error in diagnosis, treatment, or procedure, leading to harm or
injury to the patient, they have breached their duty.
1.3 Causation and Injury
To establish negligence, it must be proven that the breach of duty directly caused harm or
injury to the patient. Causation involves linking the doctor's actions (or inactions) to the
injury suffered by the patient. If no injury is caused, there is no negligence, even if the doctor
breached their duty.
1.4 Types of Medical Negligence
• Diagnostic Negligence: Incorrect diagnosis, delayed diagnosis, or failure to diagnose a
condition that leads to adverse outcomes for the patient.
• Treatment Negligence: Incorrect or improper treatment administered to the patient, such
as prescribing the wrong medication, dosage, or procedure.
• Surgical Negligence: Errors during surgery, such as performing the wrong procedure,
damaging healthy tissue, or leaving foreign objects inside the patient’s body.
• Pharmaceutical Negligence: Incorrect dispensation of medications, either through wrong
prescriptions, errors in drug administration, or lack of monitoring the effects of prescribed
drugs.
2. Contributory Negligence in Medical Practice
Contributory negligence refers to a situation where the patient’s actions or failure to act
contribute to the harm they suffered. In medical negligence cases, if a patient fails to follow
the doctor’s advice, does not comply with prescribed treatments, or engages in behavior that
exacerbates their condition, it may be deemed contributory negligence.
2.1 Legal Implications of Contributory Negligence
Under Indian law, the Law of Torts recognizes contributory negligence. If a patient is found to
have contributed to the harm, it may reduce or entirely negate the liability of the healthcare
provider. Courts take into account the patient’s responsibility in maintaining their health and
following medical advice when determining liability.
For instance, if a patient does not take prescribed medication or fails to attend follow-up
appointments and their condition worsens, the court may find that the patient’s actions
contributed to the injury.
However, contributory negligence does not always absolve the doctor of liability. The key
factor in medical negligence is whether the doctor’s actions were the primary cause of the
harm. In some cases, contributory negligence may only reduce the amount of damages
awarded to the patient, rather than eliminate the healthcare provider's liability entirely.
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3. Remedies for Medical Negligence

When a patient suffers harm as a result of medical negligence, they are entitled to seek
remedies under various legal frameworks in India.
3.1 Civil Remedies: Compensation
In civil law, the primary remedy available to the victim of medical negligence is compensation,
which is typically sought through a civil suit or consumer protection forums (the
Consumer Protection Act, 2019). The patient can file a suit for damages in the civil court or
approach a consumer forum for redressal of grievances, where the complaint is filed as a
consumer dispute.

The compensation is calculated based on the following factors:

• Economic loss: The loss of earnings, medical expenses, or other direct financial losses.
• Non-economic loss: Pain, suffering, and emotional distress caused by the injury.
• Loss of life expectancy: If the patient suffers permanent disability or loss of life
expectancy, compensation can be awarded.
• Medical costs: Additional treatment costs or lifelong treatment required due to the
negligence.
3.2 Criminal Liability
In certain extreme cases, medical negligence may lead to criminal liability under the Indian
Penal Code (IPC). Sections that may be invoked in cases of medical negligence include:
• Section 304A (Causing death by negligence): This section holds a person criminally liable
if they cause the death of another through negligence.
• Section 337 (Causing hurt by act endangering life or personal safety of others): If a patient
suffers injuries due to a doctor’s negligent act, criminal action may be initiated.
• Section 338 (Causing grievous hurt by act endangering life or personal safety of others):
For serious injury or permanent harm.
Criminal prosecution is rarely pursued in medical negligence cases unless there is clear
evidence of gross negligence or recklessness. However, if a doctor’s actions result in a
patient’s death or significant harm, criminal proceedings may follow.
3.3 Professional Disciplinary Action
The Medical Council of India (MCI) and various State Medical Councils are authorized to
take disciplinary action against medical professionals found guilty of professional misconduct.
Such actions include:
• Suspension or cancellation of medical license.
• Imposition of fines or other penalties.
• Public reprimand.
Disciplinary proceedings are initiated based on complaints filed by patients or their families,
or by other professionals. However, disciplinary action is separate from the civil or criminal
remedy and does not substitute for compensation or criminal punishment.
3.4 Defenses to Medical Negligence Claims
A healthcare provider may raise several defenses against allegations of medical negligence,
including:
• No breach of duty: Arguing that the standard of care was met and no negligence occurred.
• Causation: Arguing that the alleged harm was not caused by the doctor’s actions but by
other factors, such as the patient’s pre-existing condition or contributory negligence.
• Informed consent: The doctor can argue that the patient had been adequately informed
about the risks and gave consent to the treatment or procedure.
3.5 Statutory Defenses
Certain statutory defenses available to healthcare professionals include:
• Emergency situations: If a medical professional acted in good faith during an emergency,
they may not be held liable for negligence.
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• Standard medical practice: A doctor may defend their actions by proving that the
treatment or procedure followed was in line with the accepted medical standards.

3.2. Errors in Medical Practice, Medical Accidents

Medical errors are unfortunately a part of healthcare systems globally, with significant
implications for patients' health and the medical professionals involved. These errors can
range from a misdiagnosis or improper treatment to surgical mistakes or medication
mishaps. While medical professionals and institutions strive to provide the best care
possible, human error, systemic issues, and a variety of other factors contribute to medical
errors.
Understanding Medical Errors: Medical errors are broadly categorized into the following
types:
1. Diagnostic Errors: Occurs when a healthcare provider fails to diagnose a condition or
makes an incorrect diagnosis. These errors can be caused by the misinterpretation of lab
results, failure to order necessary tests, or failure to consider a correct diagnosis. This can
lead to the wrong treatment being administered.
o Example: A patient with chest pain being misdiagnosed with acid reflux instead of a
heart attack.
2. Treatment Errors: Occur when the healthcare provider makes an error in administering
the right treatment. This includes prescribing the wrong medication, administering
incorrect dosages, or using the wrong medical procedure or therapy.
o Example: A nurse administering the wrong drug or dose to a patient, resulting in an
allergic reaction or overdose.
3. Surgical Errors: These are mistakes made during surgical procedures, such as performing
the wrong surgery, leaving foreign objects inside a patient, or damaging surrounding
tissues.
o Example: A surgeon removing the wrong organ or leaving surgical tools inside the
body after a procedure.
4. Medication Errors: These involve mistakes in prescribing, dispensing, or administering
medications. This can be a result of miscommunication between healthcare providers,
patients, or pharmacists.
o Example: A doctor prescribing a medication that is contraindicated due to the
patient's existing medical conditions.
5. Systemic Errors: Sometimes errors happen due to systemic problems, such as
communication failures within a medical team, inadequate staffing, or errors in the
electronic medical record system. These errors are often the result of organizational or
process failures rather than an individual’s fault.
o Example: A patient receiving the wrong test results due to a data entry error in the
hospital system.

Medical Accidents:
Medical accidents, as distinguished from errors, involve unexpected, usually unavoidable,
adverse events during medical treatment or procedures. These incidents typically do not
result from negligence, but they still cause harm to the patient.
• Example: A patient suffering from complications after surgery, which were unforeseen and
could not have been predicted despite careful planning.
While medical accidents may not always result in negligence, healthcare professionals and
institutions are still expected to explain the situation clearly to the patient and take necessary
corrective actions to prevent future occurrences. The key difference between an error and an
accident is that an error can often be prevented through proper care and attention, whereas
accidents can occur despite the best efforts.
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Legal Implications and Liability for Medical Errors:

In India, medical errors can give rise to legal consequences, ranging from civil liability for
negligence to criminal charges in cases of gross negligence or malpractice.
Civil Liability for Medical Negligence:
Under Indian law, medical negligence is a form of tort law where a doctor or medical
practitioner may be sued for damages if it is proven that their negligent actions led to harm.
Medical negligence, according to the Indian Penal Code (IPC), is primarily dealt with under the
law of torts and consumer protection.
• Standard of Care: The standard of care required of a medical professional is that of a
reasonable practitioner in the field. If a healthcare provider fails to meet this standard and
it results in injury or damage to the patient, they may be held liable.
o Case Example: Jacob Mathew v. State of Punjab (2005): In this landmark case, the
Supreme Court of India stated that the standard of care in medical negligence cases
is that of a reasonable practitioner in the field, and the doctor must not be judged
with the benefit of hindsight.
• Negligence and Proof: To successfully prove medical negligence, the plaintiff (patient)
must show that there was a clear duty of care owed by the doctor, that the duty was
breached, and that the breach directly resulted in harm to the patient.
• Consumer Protection Act: Under the Consumer Protection Act, 1986, patients can file
complaints against healthcare providers for medical negligence. The District Consumer
Forum, State Consumer Forum, and the National Consumer Disputes Redressal
Commission (NCDRC) are authorized to handle such cases.
Criminal Liability for Medical Errors:
In cases of gross medical negligence or criminal negligence, a healthcare professional can be
prosecuted under the Indian Penal Code (IPC). Criminal negligence may involve a higher
degree of recklessness or disregard for the safety of others, such as operating on the wrong
patient or performing a procedure without proper consent.
• Section 304A of IPC (Causing death by negligence): This section deals with causing
death by a rash or negligent act. If a medical error leads to the death of a patient, the doctor
may face charges under this provision.
• Section 337 (Causing hurt by act endangering life or personal safety): A healthcare
provider can be charged under this section if their actions cause harm to the patient’s
safety, even if death does not occur.
• Case Example: Dr. Laxman Balkrishna Joshi v. The State of Maharashtra (1969): The
court ruled that doctors could be held liable for criminal negligence if they failed to adhere
to the standard of care expected of them and their actions caused harm.
Contributory Negligence:
In medical cases, contributory negligence refers to a situation where the patient’s own
negligence or actions contribute to the injury they suffer. For example, if a patient fails to
follow medical advice, such as skipping prescribed treatments or ignoring follow-up
appointments, and this leads to worsening of their condition, it may reduce the liability of the
medical professional.
• Case Example: Tameshwar Lal Sharma v. The State of Punjab (2014): In this case, the
court ruled that if the patient does not follow the prescribed instructions and neglects their
part of the treatment, it could be considered contributory negligence, reducing the doctor's
liability.
Remedies for Medical Errors:
Patients who suffer from medical errors have a variety of legal remedies available, depending
on the nature of the error and its consequences.

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1. Compensation: If a medical error causes harm, patients can seek financial compensation
through civil suits. In cases involving serious errors leading to permanent injury or death,
substantial compensation may be awarded.
o Example: A patient who suffered a permanent disability due to a surgical error may
be entitled to compensation for medical expenses, loss of earnings, pain and
suffering, and emotional distress.
2. Apology and Explanation: Many jurisdictions, including India, require that healthcare
providers offer an explanation or apology to the patient when an error has occurred. While
an apology does not necessarily absolve legal liability, it can help ease the patient's
emotional distress.
3. Disciplinary Actions: Medical professionals found guilty of negligence may face
disciplinary actions, including suspension, revocation of licenses, or professional sanctions,
by medical boards or councils.
4. Criminal Penalties: In cases of gross negligence that lead to serious injury or death,
criminal penalties may apply. Medical professionals can face jail time and fines if convicted.
Preventing Medical Errors:
To prevent medical errors, healthcare institutions and practitioners must focus on continuous
improvement, education, and safety practices, including:
• Regular Training and Education: Keeping healthcare professionals updated on the latest
medical practices and technologies.
• Implementing Checklists: For surgeries and medical procedures, using checklists can
minimize human error and ensure all steps are followed.
• Patient Communication: Ensuring clear and accurate communication with patients about
their conditions, treatment options, and expected outcomes.
• Technology Integration: Utilizing electronic health records (EHR) and other technologies
to minimize errors related to miscommunication or prescription mistakes.

Errors in Medical Practice and Medical Accidents

Medical practice is a highly specialized and technical field where the well-being of patients
depends on the knowledge, skills, and judgment of healthcare professionals. However, medical
errors and accidents can sometimes occur, despite the best efforts of medical practitioners.
These errors can result in significant harm to patients, leading to legal consequences,
professional liability, and ethical dilemmas.
1. Medical Errors: Definition and Types
Medical errors can be defined as a failure to perform a medical task as expected, resulting in
harm or injury to the patient. Errors in medical practice are often categorized based on the
stage at which they occur, and their impact on patient care. Some common types of medical
errors include:
1. Diagnostic Errors: These occur when a healthcare provider fails to accurately diagnose a
patient's condition, either through misinterpretation of test results, overlooking symptoms,
or providing an incorrect diagnosis. Misdiagnoses can lead to improper treatment and
severe consequences for patients. For example, failing to diagnose cancer early could delay
necessary treatment, worsening the patient's condition.
2. Treatment Errors: These occur when a healthcare provider administers the wrong
treatment, medication, or dosage. Such errors can also happen if a healthcare provider
prescribes the wrong treatment for a particular diagnosis, leading to an adverse outcome.
An example is prescribing an antibiotic that a patient is allergic to, causing anaphylactic
shock.
3. Surgical Errors: Surgical errors involve mistakes during a medical procedure, including
wrong-site surgery, leaving surgical instruments inside the patient, or making incisions in

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the wrong location. These types of errors can be life-threatening and result in permanent
disabilities.
4. Medication Errors: Medication errors occur when a patient receives the wrong
medication, the wrong dosage, or is given medication in the wrong manner. This can
happen due to miscommunication, prescription mistakes, or a failure in understanding the
patient's medical history. For instance, a nurse may administer the wrong dosage of insulin
to a diabetic patient, leading to a diabetic crisis.
5. Anesthesia Errors: Anesthesia errors can occur during surgery or other medical
procedures involving sedation. If too much or too little anesthesia is administered, or if it is
administered at the wrong time, it can lead to complications such as respiratory failure,
brain damage, or even death.
6. Errors in Monitoring: Medical errors can occur due to a failure to monitor a patient's
condition adequately, particularly in intensive care settings. Failing to recognize signs of
distress, infection, or complications can result in preventable harm. For example, not
recognizing that a patient's oxygen levels are dropping can lead to serious consequences.
7. Communication Failures: Poor communication between healthcare providers, such as
between doctors, nurses, and other medical staff, can lead to errors in patient care.
Misunderstandings, incomplete patient records, or failure to convey critical information
about a patient's condition can cause delays in treatment and worsen the patient's
condition.
2. Medical Accidents
Medical accidents refer to incidents where harm is caused to a patient despite all reasonable
precautions being taken by medical professionals. Unlike errors, medical accidents may not
always be the result of negligence or malpractice. Medical accidents often occur due to
unforeseen circumstances or complications that arise during medical procedures or
treatment. Some examples of medical accidents include:
• Adverse Reactions to Treatment: Even with the best medical care, patients may
experience unexpected adverse reactions to medications or treatments. For example, a
patient may experience severe side effects from a chemotherapy drug that was
administered correctly, which was not anticipated by the medical team.
• Unexpected Surgical Complications: In some surgeries, complications such as excessive
bleeding, infection, or organ damage may occur despite the medical team taking all
necessary precautions. These accidents may not be the result of negligence but could still
lead to significant harm to the patient.
• Infections: Healthcare-associated infections (HAIs) can sometimes occur despite the use of
proper hygiene practices and infection control measures. These infections can have serious
consequences for patients, particularly those with weakened immune systems.
3. Legal Implications of Medical Errors and Accidents
When errors or accidents occur, there may be significant legal and professional implications
for the healthcare providers involved. The legal consequences often depend on whether the
incident was caused by negligence or whether it was an unavoidable medical accident.
1. Negligence: In the context of medical practice, negligence refers to the failure of a medical
professional to provide the standard of care expected from them, resulting in harm to the
patient. To prove medical negligence, the following elements must typically be established:
o Duty of Care: The healthcare provider owed a duty of care to the patient.
o Breach of Duty: The healthcare provider breached that duty by failing to meet the
standard of care.
o Causation: The breach of duty directly caused harm or injury to the patient.
o Damages: The patient suffered actual harm, damage, or loss as a result.

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If a medical error or accident is caused by negligence, the affected patient may be entitled to
compensation for their injury or loss. This could include payment for medical bills, lost wages,
pain and suffering, and other related damages.
2. Medical Malpractice Claims: In India, medical malpractice claims can be filed against a
doctor or healthcare facility under the Consumer Protection Act, 1986 or Indian Penal
Code (IPC), depending on the nature and severity of the incident. Under the Consumer
Protection Act, a patient may file a complaint for medical negligence against a healthcare
provider, and the court may order compensation if the claim is proven.
3. Criminal Liability: In cases of severe medical negligence or gross errors, the healthcare
provider may face criminal liability under Section 304A of the IPC, which deals with
causing death by negligence. For less severe cases, Section 338 of the IPC may be
applicable, which covers causing grievous hurt by act endangering life or personal safety of
others.
4. Defenses to Medical Errors and Accidents: Healthcare providers may argue various
defenses to defend themselves against medical malpractice claims. Common defenses
include:
o No Breach of Duty: The healthcare provider may argue that the standard of care
was met and that the error was unavoidable or outside their control.
o Informed Consent: In some cases, patients may have been informed of the
potential risks of a procedure or treatment and consented to it.
o Accident: If the error was due to an unforeseen medical accident and not the result
of negligence, the healthcare provider may argue that they are not liable for the
outcome.
5. Medical Insurance: Many healthcare providers carry medical malpractice insurance to
protect themselves from the financial consequences of lawsuits. This insurance typically
covers the costs of defending against claims and any compensation awarded in the event of
a successful claim.
4. Remedies and Recourse
For patients who suffer harm due to medical errors or accidents, there are several potential
remedies:
1. Compensation: Patients may be entitled to monetary compensation for their injuries,
including hospital bills, medical expenses, loss of income, and pain and suffering.
Compensation may also cover the cost of future medical treatment and rehabilitation if
necessary.
2. Reparative Treatment: If a medical error or accident leads to physical injury or damage,
the healthcare provider or facility may be required to provide corrective or reparative
treatment at no additional cost to the patient.
3. Punitive Damages: In some cases, courts may award punitive damages in addition to
compensatory damages if the healthcare provider's actions were particularly egregious or
if gross negligence is proven.
4. Medical Board Review: In cases of medical negligence, the healthcare provider may be
subject to an investigation by the relevant medical board or council. If found guilty of
misconduct or professional negligence, they may face disciplinary action, including
suspension or revocation of their medical license.
5. Prevention and Mitigation
To minimize the occurrence of medical errors and accidents, healthcare providers and
facilities must adhere to best practices, including:
1. Continuous Education and Training: Medical professionals should undergo continuous
education and training to stay updated on the latest medical advancements and ensure that
they are following established protocols and guidelines.

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2. Clear Communication: Effective communication between doctors, nurses, patients, and

their families is essential in preventing errors. This includes proper documentation, clear
instructions, and ensuring that all parties are informed of potential risks.
3. Standard Operating Procedures (SOPs): Hospitals and medical facilities should
implement standard operating procedures and checklists for common medical practices,
surgeries, and treatments to reduce the risk of errors.
4. Patient Safety Initiatives: Healthcare organizations should invest in initiatives aimed at
improving patient safety, such as infection control protocols, fall prevention programs, and
the use of electronic medical records to reduce the chance of mistakes.

3.3. Consumer Protection Act, 2019 and Medical Profession

The Consumer Protection Act, 2019 (CPA 2019), represents a significant overhaul of the
previous Consumer Protection Act, 1986, introducing various changes to ensure more
effective consumer protection in India. One of the important aspects of this legislation is its
application to medical professionals and healthcare services. This chapter discusses the
relationship between the medical profession and the Consumer Protection Act, 2019,
including the scope of liability for medical professionals, the consumer grievance redressal
mechanisms available, and key provisions that safeguard patients’ rights.
1. Consumer as a Patient
The definition of a consumer under the CPA 2019 has been expanded to include patients, as
medical services provided by healthcare professionals are considered to be "services" under
the Act. Section 2(7) of the CPA 2019 defines "consumer" as any person who avails of a service
for a consideration, and in this case, a patient availing of medical services is classified as a
consumer.
Thus, a patient who receives medical services in exchange for a fee is entitled to the rights
and protections guaranteed to a consumer under the Act. The rights include access to quality
service, protection against exploitation, and redressal of grievances in case of deficiency or
negligence in service.
2. Liability of Medical Professionals under the CPA 2019
a. Deficiency in Service
Medical professionals, including doctors, hospitals, and clinics, are regarded as service
providers under the CPA 2019. If a medical professional fails to meet the standard of care
expected, the patient can file a complaint alleging deficiency in service.
The concept of "deficiency" refers to any fault, imperfection, shortcoming, or inadequacy
in the quality, nature, or manner of the medical service provided. Medical professionals are
expected to follow established standards of care and provide treatment that aligns with these
standards. If they fail to do so, they can be held liable under the Act.
b. Negligence
The doctrine of medical negligence is at the core of many cases filed by patients against
healthcare professionals. In a medical negligence case, the complainant (patient or their
family) must prove that the doctor or hospital was negligent in providing the medical service.
Negligence occurs when the medical professional fails to exercise the standard level of skill,
care, and diligence expected in the medical profession.
However, it is important to note that mere error in judgment or an unsuccessful outcome
does not automatically constitute negligence. The complainant must prove that the
professional’s conduct was below the accepted standard and that it led to harm or injury.
c. Medical Malpractice
Medical malpractice is another form of negligence where the healthcare provider acts in a
manner that deviates from established medical practices, causing harm to the patient. For
example, prescribing an incorrect drug, performing unnecessary surgeries, or failing to
diagnose a condition properly can lead to malpractice claims under the CPA 2019.
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Medical professionals are not automatically held responsible for complications or side
effects that occur during treatment, provided that the risks were disclosed to the patient
beforehand. Malpractice can only be proven if the standard of care was violated and it led to
avoidable harm.
d. Standard of Care
The standard of care expected from a medical professional is that which a reasonable and
competent professional in the same field would provide under similar circumstances. This
includes proper diagnosis, treatment, and referral if necessary.
3. Consumer Redressal Mechanism under CPA 2019
Under the Consumer Protection Act, 2019, the redressal mechanism is designed to provide an
expeditious and cost-effective way for consumers (patients) to seek remedies against
deficiencies in service.
a. District Forum, State Commission, and National Commission
The three-tiered structure under the CPA 2019 consists of:
1. District Consumer Disputes Redressal Forum – This is the first level of the grievance
redressal mechanism, where complaints involving amounts up to ₹1 crore can be filed.
2. State Consumer Disputes Redressal Commission – This forum handles cases involving
amounts over ₹1 crore but not exceeding ₹10 crore.
3. National Consumer Disputes Redressal Commission – This is the highest level of
consumer redressal, where complaints exceeding ₹10 crore can be filed.
b. Timeframe for Filing Complaints
Patients can file complaints within two years from the date of the cause of action. However,
the Consumer Protection Act also provides that the redressal forum may extend this period by
one year if there is sufficient cause for delay.
c. Complaint Process
Patients can file complaints against medical professionals or hospitals if they believe they
have received deficient medical services. The complaint must clearly state the details of the
grievance, including the nature of the deficiency in service, the damages, and the relief sought.
Complaints can be filed both electronically or physically at the respective forum.
Once the complaint is filed, the forum will issue a notice to the opposite party (medical
professional or hospital), and both parties will be given an opportunity to present their
arguments and evidence. The forum then passes an order, which could include directions for:
• Compensation for the patient
• Refund of medical expenses
• Correction of errors or providing further treatment
• Punitive damages (in cases of severe negligence or willful misconduct)
4. Rights and Remedies under the CPA 2019
a. Compensation for Damages
One of the major remedies available to patients under the CPA 2019 is the right to seek
compensation for any harm or injury caused by deficient medical services. This includes
compensation for physical injury, financial loss, mental agony, or suffering.
b. Punitive Damages
In some cases, if the medical professional's actions are found to be grossly negligent or
malicious, the court may award punitive damages in addition to the regular compensation.
This serves as a deterrent for healthcare providers who fail to meet the standards of care
expected of them.
c. Consumer Rights
The CPA 2019 ensures that consumers (patients) have the right to receive services that are of
acceptable quality, safe, and effective. The Act guarantees that healthcare providers maintain
transparency regarding the services offered, and that the patient’s informed consent is taken
before any treatment or procedure is conducted.
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d. Power of Authorities
The Consumer Protection Act also provides the redressal forums the authority to order
actions such as cease and desist, issue directions for corrective measures, and impose
penalties on medical professionals or healthcare institutions found guilty of malpractice or
misconduct.
5. Medical Consumer Protection Issues
The medical profession faces challenges in dealing with the evolving nature of consumer
protection. Some of the key issues include:
• Documentation and Proof: In many cases, patients have difficulty providing adequate
documentation to prove their claims, especially in cases where medical records are not
properly maintained.
• Defining Negligence: Medical negligence is complex, and the interpretation of "reasonable
care" can vary. This leads to difficulties in establishing whether a healthcare provider’s
actions meet the required standard of care.
• Consumer Education: Many patients are unaware of their rights under the CPA, and
therefore do not seek remedies for deficiencies in medical services. There is a need for
increased awareness about the consumer rights in medical practice.

3.4 Violence Against doctors and Medical Establishments (Legal provisions)

The relationship between doctors and patients is one based on trust, compassion, and
professional duty. However, in recent years, the medical profession has faced increasing
incidents of violence against healthcare professionals and establishments. Such violence not
only undermines the safety of medical practitioners but also disrupts the healthcare system,
ultimately impacting the quality of care provided to patients. This module examines the legal
provisions aimed at protecting doctors and medical establishments from violence.
Forms of Violence Against Doctors and Medical Establishments
Violence against doctors and medical establishments can take various forms, including:
1. Physical Violence: This includes physical assaults on healthcare workers, such as hitting,
slapping, or even causing grievous bodily harm. It often happens when a patient’s family
members are dissatisfied with the treatment or outcome, leading to frustration and anger.
2. Verbal Abuse: Doctors and healthcare staff are frequently subjected to verbal abuse,
including threats, shouting, and abusive language. This can occur when patients or their
relatives are unhappy with the healthcare services provided, waiting times, or outcomes of
treatment.
3. Property Damage: Medical establishments, particularly hospitals and clinics, may be
subject to property damage, such as the breaking of equipment or furniture. This may also
extend to looting or vandalism in more extreme cases.
4. Threats and Intimidation: In some instances, healthcare professionals may be threatened
with harm if they do not comply with the demands of patients or their families. These
threats may be physical or financial in nature.
5. Harassment: Harassment can include repeated threats, unwanted attention, or stalking,
creating an environment of fear and anxiety for medical professionals.
Causes of Violence Against Doctors
1. Dissatisfaction with Medical Services: The primary reason for violence against doctors is
often dissatisfaction with medical treatment or perceived inadequacies in the healthcare
system, such as delays, wrong diagnosis, or a failure to save a life.
2. Expectations and Pressures: Patients or their families may have unrealistic expectations
of medical professionals and the outcomes of treatments. When these expectations are not
met, it can lead to anger and violence.
3. Overcrowding and Understaffing: Healthcare facilities that are understaffed or
overcrowded often lead to frustration both among patients and medical practitioners. The
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pressure to attend to a large number of patients in a short time can lead to conflicts and
violence.
4. Lack of Communication: Poor communication between doctors, patients, and their
families is a significant contributor to violence. Patients may feel neglected if they perceive
that their concerns are not being heard or addressed.
5. Social Media and Misinformation: The rise of social media has contributed to a growing
environment of misinformation about healthcare, which can fuel anger and violence when
patients or their families believe that doctors are negligent or not performing their duties
properly.
Legal Provisions to Address Violence Against Doctors
The Indian legal system has taken various steps to address the growing concern of violence
against doctors. These provisions are aimed at providing a framework for the protection of
healthcare professionals and ensuring that such incidents are dealt with in a timely and just
manner.
1. Indian Penal Code (IPC), 1860
The Indian Penal Code (IPC) provides general provisions for the punishment of acts of
violence, including those against doctors. Some key sections under IPC that relate to violence
against medical professionals include:
• Section 323: Punishment for causing hurt – This section deals with the punishment for
causing hurt to any person, including doctors.
• Section 325: Punishment for causing grievous hurt – If a doctor is injured severely, this
section provides for a more severe punishment.
• Section 341: Punishment for wrongful restraint – If a doctor is unlawfully restrained from
performing his duties, this section may apply.
• Section 504: Intentional insult with intent to provoke breach of the peace – This section
can be applied in cases of verbal abuse or threats against medical practitioners.
• Section 506: Punishment for criminal intimidation – If a doctor is threatened with harm,
this section applies.
2. The Healthcare Service Personnel and Clinical Establishments (Prevention of
Violence and Damage to Property) Bill, 2019
To address the specific problem of violence against healthcare workers, the Healthcare
Service Personnel and Clinical Establishments (Prevention of Violence and Damage to
Property) Bill, 2019 was introduced in Parliament. The key provisions of this bill include:
• Definition of Offenses: The bill defines violence as any act of physical assault, verbal
abuse, or intimidation directed at healthcare professionals, whether in a clinical setting or
outside it.
• Punishment: The bill prescribes rigorous punishment for those found guilty of violence
against healthcare workers. The punishment may include imprisonment for a term not less
than six months, which may extend to three years, and a fine of up to ₹50,000.
• Wider Applicability: The bill extends to healthcare professionals working in government,
private, or charitable hospitals and clinics.
• Damage to Property: The bill also covers damage to medical equipment, property, and
infrastructure within healthcare establishments.
• Prevention and Protection: The bill provides provisions for the establishment of security
measures and the appointment of security officers to prevent violence against doctors and
medical establishments.
While the bill has yet to become an Act, it marks an important step in recognizing the serious
nature of violence against doctors and medical establishments in India.
3. The Clinical Establishments (Registration and Regulation) Act, 2010
The Clinical Establishments Act mandates the registration of healthcare facilities and their
regulation. Although its primary focus is on maintaining quality and standards of healthcare,
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the Act also indirectly addresses the safety of healthcare professionals. Registered
establishments must adhere to certain security and safety protocols to ensure that both
medical staff and patients are protected from violence.
4. The Consumer Protection Act, 2019
While the Consumer Protection Act, 2019 does not directly deal with violence against
doctors, it does provide for the protection of patients' rights, including the right to seek
redress if they believe they have received substandard medical care. This protection is vital
for doctors as it ensures that any complaints or issues are resolved in a structured manner,
which could potentially reduce the likelihood of violence stemming from patient
dissatisfaction.
5. Judicial Intervention and Court Orders
The judiciary has also played an important role in ensuring that violence against doctors and
medical establishments is taken seriously. Various High Courts in India have passed interim
orders directing the police to take stronger actions in cases where medical professionals face
assault or threats. These judicial interventions also encourage authorities to adopt proactive
measures to protect healthcare workers.
Preventive Measures to Combat Violence
In addition to legal provisions, there are several preventive measures that healthcare
establishments and the government can take to minimize violence against doctors:
1. Creating Awareness: Educating the public about the role of healthcare workers, the
challenges they face, and the consequences of violence against them can help reduce
frustration and violence.
2. Improved Communication: Healthcare providers should strive to improve
communication with patients and their families, providing clear explanations of diagnoses,
treatment plans, and expected outcomes.
3. Security in Hospitals: Hospitals and clinics should invest in adequate security
infrastructure, such as surveillance cameras, security guards, and panic buttons, to ensure
the safety of doctors and medical staff.
4. Training for Healthcare Professionals: Medical professionals should be trained in
conflict management, communication skills, and handling difficult situations to prevent
escalation.
5. Support Systems: Establishing support systems, such as counseling services and legal aid,
for healthcare workers who experience violence can help them cope with the trauma and
ensure their mental well-being.
6. Government Intervention: The government must take a proactive stance in implementing
laws and policies to prevent violence, such as ensuring the speedy registration and
prosecution of cases of violence against doctors.

3.5. Criminal Law Remedies

Criminal Law Remedies in Medical Practice
In the context of medical practice, criminal law remedies are important for addressing various
forms of misconduct, negligence, and violence that may occur in medical establishments.
These remedies are intended to hold medical professionals accountable for wrongful acts and
to provide justice to victims of medical negligence or crimes committed within medical
settings. The legal provisions under criminal law that apply to medical professionals and
establishments include laws relating to medical negligence, medical accidents, violence
against doctors, and unethical practices.
1. Medical Negligence under Criminal Law:
Medical negligence is a key area in criminal law remedies. Under Section 304A of the Indian
Penal Code (IPC), a medical professional can be charged with causing death by negligence if a

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patient's death occurs due to a doctor's failure to exercise reasonable care or skill in their
treatment. The section defines the offence of causing death by negligence as:
• Section 304A IPC (Causing Death by Negligence):
o If a medical practitioner, while providing treatment, causes the death of a patient
due to their negligence, they may be held liable under Section 304A. This provision
does not require the intention to kill, but the accused must have acted negligently or
without due care in a manner that led to the patient’s death.
o Example: A surgeon performing an operation may inadvertently cause death by
failure to adhere to required protocols, or if an anesthetist administers an overdose
due to lack of attention, they could be prosecuted under this section.
2. Criminal Breach of Trust:
If a medical professional or establishment misappropriates funds, resources, or property
entrusted to them by a patient, they may be charged under Section 405 IPC (Criminal
Breach of Trust). This section is relevant in cases where a doctor or a hospital misuses or
steals money intended for the patient's care.
• Section 405 IPC (Criminal Breach of Trust):
o A doctor who has been entrusted with money for a specific purpose, such as for
surgery, but instead uses it for personal reasons, could face criminal prosecution.
o Example: A hospital billing a patient for services not rendered or overcharging for
procedures is liable to prosecution under this provision.
3. Causing Hurt or Grievous Hurt:
When medical practitioners cause physical injury to patients, whether intentionally or
through negligence, they may face charges under sections related to hurt or grievous hurt.
• Section 323 IPC (Punishment for Voluntarily Causing Hurt):
o If a doctor causes injury to a patient intentionally or negligently, they may be
charged under this section for causing hurt. It applies when physical injury or harm
is inflicted during treatment.
• Section 325 IPC (Punishment for Voluntarily Causing Grievous Hurt):
o Grievous hurt, defined under Section 320 of the IPC, includes more severe injuries
such as permanent loss of any body part, loss of vision, or other significant injuries.
If a doctor’s actions cause grievous harm to a patient, they may face criminal
prosecution under Section 325.
4. Criminal Intimidation:
If a doctor or medical professional threatens a patient with harm or instills fear to get them to
comply with treatment or procedures, they may be charged under Section 506 IPC (Criminal
Intimidation).
• Section 506 IPC (Punishment for Criminal Intimidation):
o This section applies when a person uses threats of injury, violence, or harm to
coerce a patient into treatment or compliance. For instance, if a doctor intimidates a
patient to undergo an unnecessary surgery or procedure under the threat of
worsened health or death, the doctor could be held liable under this provision.
5. Medical Malpractice and Medical Negligence under the Consumer Protection Act:
Medical negligence can also be addressed under the Consumer Protection Act, 2019,
specifically when the actions of a medical practitioner lead to injury, death, or financial loss to
the patient. While the primary remedy under this law is civil, the law also provides remedies
that intersect with criminal law if the negligence is deemed willful or gross.
• Section 2(1)(g) of the Consumer Protection Act, 2019 (Definition of Deficiency in
Service):
o A medical practitioner can be sued for deficiency in service if their treatment leads
to injury or harm, and if the negligence is significant enough, the doctor may face
criminal charges.
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6. Violence Against Medical Professionals:

One of the pressing issues in the healthcare sector is the increasing incidence of violence
against doctors and medical establishments. In many cases, patients or their families resort to
violence due to dissatisfaction with treatment or disputes over the quality of care.

• Section 353 IPC (Assault or Criminal Force to Deter Public Servant from Discharge of
Duty):
o If patients or their attendants attack or assault a medical professional while they are
discharging their duties, the offenders may be charged under Section 353 of the IPC.
This provision protects doctors and other healthcare workers who are assaulted in
the course of providing treatment.

• Section 332 IPC (Voluntarily Causing Hurt to Public Servant):

o If the assault on medical personnel results in harm, it is punishable under Section
332. This provision can be applied when a doctor or hospital staff member is
physically attacked during the treatment process.

• The Healthcare Service Personnel and Clinical Establishments (Prevention of

Violence and Damage to Property) Act, 2008:
o This law provides special protection to healthcare professionals. It mandates the
government to create a legal framework for preventing violence against healthcare
workers and provides for the punishment of individuals who attack or threaten
medical personnel. It includes provisions for the protection of hospitals and clinics
as well.

7. Death due to Medical Negligence:

A doctor may face charges for culpable homicide if a patient's death is caused by gross
negligence or intent. In cases where a doctor's actions are so egregious that they result in the
death of a patient, criminal charges for homicide could apply.
• Section 304 IPC (Culpable Homicide Not Amounting to Murder):
o If a patient's death results from extreme or gross negligence, the doctor may be
charged under Section 304 for culpable homicide not amounting to murder. This
applies when the doctor’s actions, while not intended to cause death, are so careless
or reckless that death occurs.

8. Medical Research and Clinical Trials:

Doctors and medical institutions involved in clinical trials or experimental procedures must
ensure they comply with regulations on informed consent and patient safety. Violations can
lead to criminal prosecution under the Indian Penal Code.

• Section 315 IPC (Act Done with Intent to Prevent Child Birth):
o If a doctor conducts an experimental procedure without proper consent or uses a
patient for research without informing them, they could face prosecution under
relevant criminal sections. The protection of participants in clinical trials is essential
for ensuring the lawfulness of medical experiments.

9. Criminal Remedies in Medical Practice:

• Criminal Remedies for Medical Negligence:
o These include the prosecution of doctors or hospitals for negligence leading to
death or injury, depending on the facts of the case.

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• Criminal Remedies for Medical Malpractice:

o Medical malpractice that results in injury or death could lead to criminal charges
like grievous hurt or causing death by negligence.

• Violence against Medical Professionals:

o Laws like Section 353 and Section 332 IPC provide remedies for doctors who face
physical harm during their duty.

• Consumer Protection Remedies:

o Though primarily civil, remedies under the Consumer Protection Act also address
criminal issues in cases of gross negligence or malpractice.

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MODULE 4: Medico –Legal Issues

4.1 Clinical trials of drugs on Humans and Law, Nuremberg code, Helsinki declaration
and Good Clinical practice
Clinical trials are essential to the development of new drugs, vaccines, and treatments, but
they raise significant ethical, legal, and medical issues. In India, the regulation of clinical trials
is governed by several laws and guidelines to protect participants and ensure the safety and
efficacy of medical treatments. This module explores the legal frameworks, ethical
considerations, and procedures involved in clinical trials, along with the protections for
human subjects.
Legal Framework Governing Clinical Trials in India
1. Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940, provides the basic framework for the regulation
of drugs in India. Under this Act, clinical trials of drugs are considered an essential part of
the process before granting approval for the commercial sale of a drug. The Act lays down
the guidelines and procedures for conducting clinical trials, ensuring that they are done in
accordance with the prescribed norms.
2. Drugs and Cosmetics Rules, 1945
The Drugs and Cosmetics Rules, 1945, govern the approval and regulation of new
drugs and the conditions for conducting clinical trials. Rule 122 (DA) of the Drugs and
Cosmetics Rules specifically deals with the requirements for clinical trials, including
obtaining the necessary permissions, documentation, and compliance with ethical
standards.
3. The New Drugs and Clinical Trials Rules, 2019
The New Drugs and Clinical Trials Rules, 2019, brought significant reforms to the
regulation of clinical trials in India. It aims to facilitate faster approval processes for new
drugs while ensuring that the safety and rights of participants are not compromised. Some
of the key provisions include:
o Ethical Approval: All clinical trials must be approved by an institutional ethics
committee.
o Informed Consent: Participants must be provided with adequate information
about the trial, and their informed consent must be obtained.
o Safety of Participants: The trial sponsor must ensure the safety and well-being of
participants, with mechanisms in place to monitor any adverse effects.
4. Indian Council of Medical Research (ICMR) Guidelines
The ICMR provides ethical guidelines for conducting clinical trials, which are legally
binding on researchers. The ICMR guidelines address issues such as informed consent,
compensation for trial participants, confidentiality, and the responsibilities of clinical trial
sponsors. These guidelines complement the statutory provisions under the Drugs and
Cosmetics Act and the New Drugs and Clinical Trials Rules.
5. National Ethics Committee on Clinical Trials (NEC)
The National Ethics Committee on Clinical Trials, constituted under the Ministry of
Health and Family Welfare, ensures that clinical trials adhere to the highest ethical
standards and protect the rights of participants. It reviews proposals for clinical trials to
ensure compliance with ethical and safety protocols.
6. Pharmaceuticals and Medical Devices Bureau of India (PMDBI)
The PMDBI is a body under the Ministry of Health and Family Welfare that is
responsible for regulating the clinical trial process. This includes monitoring adverse
events, conducting audits, and providing support to clinical trial sponsors and researchers.

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Ethical Issues in Clinical Trials

Ethical concerns play a crucial role in the regulation of clinical trials. Some of the most
significant ethical issues include:
1. Informed Consent
Informed consent is a cornerstone of ethical medical practice. Participants in clinical
trials must be given clear, concise information about the trial, including the purpose,
potential risks, benefits, and alternatives. The consent must be voluntary, and participants
must have the ability to withdraw at any time without penalty. The ICMR Ethical
Guidelines stress the importance of ensuring that consent is understood, especially when
participants are vulnerable or lack capacity to fully comprehend the risks.
2. Confidentiality
Clinical trial participants are entitled to the protection of their personal information and
medical history. All details related to the participants, including their identity and any data
collected during the trial, must be kept confidential and used only for the purpose of the
trial.
3. Vulnerable Groups
Special care must be taken when clinical trials involve vulnerable groups such as
children, pregnant women, the elderly, and those with mental disabilities. The ICMR
guidelines and the Drugs and Cosmetics Rules mandate additional safeguards for these
groups, ensuring that they are not exploited in clinical trials.
4. Post-Trial Access to Medicines
One of the ethical concerns in clinical trials is the provision of post-trial access to
the treatment for participants, especially when a drug proves beneficial. In some cases,
participants may not have access to the drug once the trial ends, and provisions should be
made to ensure fair treatment.
5. Monitoring of Adverse Effects
Researchers and sponsors are legally bound to monitor adverse effects during and
after the clinical trial. Serious adverse effects must be reported immediately to the
regulatory authorities, and the participants must be provided with appropriate medical
attention.
6. Benefit to Participants
A key ethical consideration is whether the participants will benefit from the clinical
trial. While many clinical trials aim to develop treatments for the benefit of the wider
population, the risks and potential harm to individual participants must be minimized.

Responsibilities of Sponsors, Investigators, and Regulatory Authorities

1. Sponsors
The sponsors of clinical trials (pharmaceutical companies, research institutions, or
individual researchers) are responsible for the initiation, management, and financing of
clinical trials. They must ensure that trials are conducted ethically, ensure proper
monitoring of participants, and provide compensation for participants in case of any harm.
2. Investigators
Investigators (doctors or medical professionals conducting the clinical trial) have the duty
to ensure that the trial is conducted with due diligence and ethical integrity. They must
provide the participants with the necessary information, ensure proper monitoring of the
trial, and address any adverse effects promptly.
3. Regulatory Authorities
The regulatory authorities such as the Central Drugs Standard Control Organization
(CDSCO) and the Indian Medical Council play a crucial role in overseeing the safety of
clinical trials. They review and approve trial protocols, conduct inspections, and ensure
compliance with legal and ethical standards.
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Legal Consequences of Violating Clinical Trial Regulations

Failure to comply with the regulations governing clinical trials in India can have serious legal
consequences. Some of the legal actions that can be taken in case of violations include:
1. Revocation of Trial Approval
The regulatory authorities may revoke the approval for a clinical trial if it is found to be in
violation of legal and ethical standards.
2. Penalties and Fines
Violations of the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials
Rules, 2019, can lead to significant penalties and fines. In extreme cases, criminal charges
may be filed against those responsible for the violations.
3. Compensation to Participants
If participants suffer harm as a result of participating in a clinical trial, the sponsors and
investigators may be required to provide compensation. This could be in the form of
medical treatment, financial compensation, or other forms of redress.
4. Criminal Liability
In cases of gross negligence, fraud, or intentional harm, criminal liability can arise.
Individuals found guilty of endangering the health or well-being of participants may face
imprisonment or other criminal sanctions.

Nuremberg Code
The Nuremberg Code is a set of ethical principles and guidelines that govern the conduct of
medical experiments and research involving human subjects. It was formulated in response to
the atrocities committed by Nazi doctors during World War II, particularly the inhumane
medical experiments conducted on prisoners in concentration camps. The Code emerged from
the Nuremberg Trials held after the war, in which Nazi physicians and medical professionals
were prosecuted for crimes against humanity, including the conduct of unethical and brutal
experiments on humans.
The Nuremberg Code was established in 1947 during the Doctors' Trial (one of the
Nuremberg Trials), in which 23 Nazi physicians were charged for their roles in medical
experiments. These experiments were conducted without the consent of the subjects and
violated their basic human rights. The Code was one of the first international efforts to
regulate human experimentation and ensure the protection of human rights in medical
research.
Key Principles of the Nuremberg Code:
The Nuremberg Code consists of 10 principles, which are aimed at ensuring the ethical
treatment of human subjects in medical research. These principles are:
1. Voluntary Consent: The voluntary consent of the human subject is absolutely essential.
This means that the subject must be able to understand the nature, purpose, and risks
involved in the experiment and must give consent without any coercion or deceit.
2. Proper Scientific Justification: The experiment must have a valid scientific purpose and
must be designed to yield useful results for the good of society. It should not be based on
mere curiosity or unscientific reasoning.
3. Avoidance of Unnecessary Physical and Mental Suffering: The experiment should be
designed to avoid causing unnecessary physical or mental harm or suffering to the subject.
This principle is focused on minimizing the risk of injury, pain, and suffering.
4. Risk Proportional to Benefits: The potential risks of the experiment must be weighed
against the benefits to society or science. No experiment should be undertaken where there
is a high risk of harm that outweighs the potential benefits.
5. Adequate Protection from Injury: Proper safeguards and measures must be taken to
protect the subject from any potential harm. If there is reason to believe that the
experiment could result in injury or death, it should be terminated immediately.
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6. Qualified Personnel: The experiment should be conducted by qualified scientists and

medical professionals with the appropriate skills and training to ensure the safety of the
subjects.
7. Right to Withdraw: The subject must have the right to withdraw from the experiment at
any time, without any penalty or consequences, should they choose to do so.
8. Termination of Experiment in Case of Harm: If at any point during the experiment, there
is evidence that the subject is experiencing harmful effects, the experiment must be
terminated immediately to prevent further harm.
9. Conducted by Ethical Standards: The experiment should be conducted in a way that
respects the dignity and rights of the participants, adhering to ethical and moral standards.
10. Research Objectives: The research must be designed and executed with the aim of
improving knowledge and advancing science, without causing harm to the participants.

Significance of the Nuremberg Code:

• Human Rights in Research: The Nuremberg Code represents the first significant step in
the establishment of ethical standards for medical research involving humans. It
emphasized the fundamental right of individuals to be treated with dignity and respect,
even in research settings.
• Informed Consent: The concept of informed consent, which is central to modern medical
ethics, is a direct result of the Nuremberg Code. It required that participants in medical
research be fully informed about the nature and risks of the study and voluntarily consent
to participation.
• Medical Ethics and Legal Frameworks: The Code laid the foundation for the
development of international ethical frameworks for medical research, such as the
Declaration of Helsinki (1964), and was a precursor to the ethical guidelines and
standards set forth in modern biomedical and clinical research laws.

Legacy and Impact:

The Nuremberg Code had a profound influence on the development of medical ethics
worldwide. Its core principles are still considered fundamental to the ethical conduct of
medical research and have shaped subsequent legal and ethical standards, including:
• The Declaration of Helsinki (1964): A set of ethical principles that guide medical
researchers worldwide, especially in human clinical trials.
• The Belmont Report (1979): Issued by the U.S. government, this report built upon the
Nuremberg Code and focused on protecting human subjects in biomedical and behavioral
research.
• Regulations and Oversight: In countries worldwide, the Nuremberg Code's principles led
to the establishment of regulatory bodies and guidelines, including Institutional Review
Boards (IRBs) and Good Clinical Practice (GCP) guidelines, to oversee and ensure ethical
standards in clinical trials.

Nuremberg Code and Clinical Trials:

The Nuremberg Code plays a critical role in shaping the conduct of clinical trials and drug
research. It remains a vital reference point for ensuring the ethical treatment of patients in
medical experiments and trials. Clinical trials, particularly those conducted on vulnerable
populations, are required to adhere to the Code’s principles, ensuring that the risks are
justified, consent is obtained, and the dignity of the patient is respected throughout the
process.
Given its ethical principles, the Nuremberg Code has not only influenced global standards in
clinical research but also global health law. It continues to serve as a reminder of the

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atrocities committed during the war and the importance of maintaining the highest standards
in research and medical care.

Helsinki declaration and Good Clinical practice

Clinical trials play an essential role in the medical field as they contribute to the development
of new treatments, drugs, and medical technologies. However, the administration of clinical
trials raises significant ethical and legal issues. These concerns are governed by national and
international laws, which are designed to ensure the protection of human participants.
Nuremberg Code
The Nuremberg Code, formulated in 1947, is one of the earliest and most influential sets of
guidelines for conducting medical experiments on human subjects. The code was developed
after the Nuremberg Trials, where Nazi doctors were prosecuted for conducting inhumane
and unethical experiments on prisoners during World War II. The code’s principles are aimed
at ensuring voluntary participation and minimizing harm to participants.
Key provisions of the Nuremberg Code include:
1. Voluntary Consent: The voluntary consent of the human subject is essential. The person
must be legally capable of giving consent, and the consent must be given voluntarily
without any coercion or undue influence.
2. Scientifically Valid Research: The experiment should be based on prior animal
experimentation and should yield results that justify the experiment.
3. Avoidance of Harm: Experiments should avoid unnecessary physical or mental suffering
or injury.
4. Qualified Experimenters: Experiments should only be conducted by scientifically
qualified professionals.
5. Right to Withdraw: Participants should be free to withdraw from the study at any time
without any consequence.
The Nuremberg Code laid the foundation for the ethical principles governing clinical trials and
is still referenced in modern guidelines for medical research.

Helsinki Declaration
The Declaration of Helsinki was adopted by the World Medical Association (WMA) in 1964
and has undergone multiple revisions. It is a set of ethical guidelines designed to ensure that
clinical trials on human subjects are conducted in a way that protects participants’ health and
rights. Unlike the Nuremberg Code, which was primarily concerned with the voluntary
consent of the participants, the Declaration of Helsinki provides a broader framework for the
ethical conduct of medical research.
Key principles of the Helsinki Declaration include:
1. Ethical Review: Every medical research involving human participants must undergo
ethical review by an independent committee (usually an Institutional Review Board or
Ethics Committee) to ensure the safety and welfare of the participants.
2. Informed Consent: As with the Nuremberg Code, the Helsinki Declaration stresses the
necessity of obtaining voluntary, informed consent from participants. This consent must be
based on a clear understanding of the nature, purpose, risks, and potential benefits of the
trial.
3. Research Protocol: Clinical trials should be based on a well-defined research protocol,
and the research should be scientifically sound.
4. Risk Minimization: The trial should minimize risk to the participants, and where the risk
of harm is significant, the benefits of the research should outweigh the risks.
5. Vulnerable Groups: Special care must be taken when dealing with vulnerable groups
(such as children, pregnant women, and those unable to consent), and they should be
included in trials only if absolutely necessary.
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The Declaration of Helsinki remains a cornerstone of medical ethics worldwide, influencing

national laws and the policies of health institutions and research bodies.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
designing, conducting, recording, and reporting clinical trials. It provides a framework that
ensures clinical trials are conducted with integrity and that the data generated is credible and
reliable. GCP is particularly important for ensuring that the rights, safety, and well-being of
clinical trial participants are protected.
The main principles of GCP include:
1. Ethical Conduct: All clinical trials must be conducted in accordance with the principles of
the Declaration of Helsinki and other applicable ethical guidelines.
2. Scientific Rigor: The trial design must be scientifically sound, ensuring that the research
can provide meaningful and valid results.
3. Informed Consent: GCP requires that participants be fully informed about the study, its
purpose, and any risks, and that consent is given voluntarily.
4. Ethical Review: Clinical trials must be approved by an ethics committee, and ongoing
monitoring must take place to ensure compliance with the protocol and participant safety.
5. Data Integrity: GCP ensures that all clinical data is accurately recorded and reported. This
prevents the manipulation or falsification of results.
6. Monitoring: Trials must be closely monitored by independent bodies to ensure that the
study adheres to ethical guidelines, regulatory requirements, and the protocol.
In India, GCP guidelines are mandated by the Central Drugs Standard Control Organization
(CDSCO), which is responsible for regulating the conduct of clinical trials in the country. GCP
ensures that clinical trials are conducted according to the highest standards of quality and
integrity, thus enhancing the reliability of the trial's results.
Ethical and Legal Challenges in Clinical Trials
While international frameworks like the Nuremberg Code, Helsinki Declaration, and GCP
provide significant guidelines, clinical trials continue to face numerous ethical and legal
challenges:
1. Informed Consent Issues: One of the most persistent ethical concerns in clinical trials is
ensuring that participants are genuinely informed about the risks and benefits of the trial.
This includes ensuring that participants are not coerced and understand their right to
withdraw at any time.
2. Exploitation of Vulnerable Groups: Vulnerable populations, such as children, prisoners,
and those in low-income countries, may be more susceptible to exploitation in clinical
trials. Special protections are required for these groups.
3. Post-Trial Access: Another issue is post-trial access to treatment. Many trials fail to
provide participants with continued access to the treatments or medications they have
been trialing, which can cause ethical concerns, especially when participants have been
exposed to risks.
4. Regulation and Monitoring: There is often a gap between regulations and their
enforcement. While laws and guidelines may exist, rigorous monitoring of trials is essential
to prevent malpractice, ensure participant safety, and uphold ethical standards.
5. International Standards vs. Local Practices: Clinical trials often cross national
boundaries, which can complicate the application of local laws and ethical standards. This
raises concerns about whether international standards like GCP are adequately enforced in
countries with weaker regulatory frameworks.

Further Readings and Case Laws:

• Indian Case Law: Mr. X v. Hospital Z (2017) 1 SCC 370 – This case addresses the issue of
informed consent in the context of medical negligence.
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• International Law: Adolf Eichmann Case – A reminder of how human rights abuses in
clinical trials led to the Nuremberg Code.
• Statutory Law: The Drugs and Cosmetics Act, 1940, and the Clinical Trials Registry
India (CTRI) under the Ministry of Health and Family Welfare, Government of India.

4.2 Road accidents, sexual assaults

Road accidents, often resulting in physical injury, disability, and even death, present
significant medico-legal concerns. These concerns not only relate to the treatment of the
injured but also to the legal implications for both the victims and the perpetrators. The
handling of road accidents from a medico-legal perspective involves multiple dimensions,
including medical treatment, forensic evaluation, legal processes, and the role of law
enforcement agencies.
1. Medical Response to Road Accidents
The first priority in a road accident case is medical care. The medical response involves
providing emergency treatment, diagnosing injuries, and preserving evidence of trauma that
may later be needed in legal proceedings. In many road accident cases, injuries can range from
minor bruises to serious and life-threatening conditions, such as fractures, head injuries,
internal injuries, and spinal cord damage.
Key Medical Considerations:
• Immediate Medical Care: On arrival at the scene or in the hospital, prompt medical care is
vital. In serious cases, the treatment should focus on stabilizing the patient, preventing
shock, and addressing life-threatening injuries.
• Documentation of Injuries: Detailed medical records and documentation of injuries are
critical for both the patient’s health and the legal process. These documents should include
the nature of the injuries, diagnosis, treatment, and any surgical interventions performed.
• Preserving Evidence: In some cases, the cause of injury (such as impact marks, abrasions,
and fractures) can serve as evidence in the investigation. Proper documentation and
preservation of such evidence can be critical in determining fault.
2. Legal Framework for Road Accidents in India
In India, road accidents are governed by several legal provisions, including the Motor
Vehicles Act, 1988, and related provisions in criminal and civil law. The legal framework
provides for compensation, criminal liability, and civil liability in cases of road accidents.
Motor Vehicles Act, 1988:
• Section 166 (Claims for Compensation): This section allows the victim or their legal
heirs to claim compensation for injuries or death caused by a road accident. The
compensation claim can be made against the driver, owner, or insurer of the vehicle
involved in the accident.
• Section 304A (Causing Death by Negligence): This section deals with cases where the
driver is found guilty of causing death due to negligent driving, which is a criminal offense.
Negligence includes not following traffic rules, reckless driving, or driving under the
influence of alcohol.
• Section 279 (Rash and Negligent Driving): This section covers incidents where the
driver’s rash and negligent driving leads to danger to human life, even if it does not result
in death.
Criminal Law:
• Section 304A (IPC): If the road accident results in death due to negligence, the driver may
be charged under Section 304A of the Indian Penal Code (IPC). This section punishes a
person who causes the death of another due to rash or negligent driving.

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• Section 338 (IPC): If the accident causes grievous hurt, the driver can also be charged
under Section 338, which pertains to causing grievous hurt by an act of negligence or rash
driving.
• Section 279 (IPC): In addition to causing death or injury, the act of driving in a rash or
negligent manner in a public place can also lead to charges under Section 279.
3. Medico-Legal Reporting of Road Accidents
Medical professionals play a key role in the documentation of road accidents for legal
purposes. These include providing the required medical certificates, writing post-mortem
reports in case of death, and offering expert medical opinions when required by the court.
Post-Mortem in Road Accident Deaths:
• Autopsy: In cases where road accidents lead to fatalities, a post-mortem examination
(autopsy) is required to ascertain the cause of death. The forensic pathologist examines the
body to determine the nature of injuries and whether they were consistent with the
accident.
• Forensic Evidence: The post-mortem report can provide crucial evidence in determining
whether the cause of death was due to the accident or another factor, such as pre-existing
medical conditions.
Medico-Legal Reports (MLR):
• These reports are a vital part of the legal process in road accidents. The doctor may be
called upon to provide an MLR which includes details of the injuries, treatment provided,
prognosis, and the time and cause of death if applicable.
• An MLR should also document any alcohol or drug influence, which may be crucial in
proving negligence.
4. Role of Insurance in Road Accidents
In cases of road accidents, insurance plays an essential role in compensating the victims or the
legal heirs in case of death. Motor vehicle insurance policies include provisions for liability
coverage that compensates for personal injuries, medical expenses, and death due to
accidents.
Types of Insurance:
• Third-Party Insurance: Under the Motor Vehicles Act, 1988, it is mandatory for all
vehicles to have third-party insurance. This covers compensation claims by victims of road
accidents.
• Comprehensive Insurance: This type of policy provides wider coverage, including
damage to the vehicle and compensation to the driver and passengers in case of injury.
• No-Fault Liability: In some cases, the claimant can file for compensation under the no-
fault liability rule, especially in cases of fatal accidents. This provision is governed under
Section 163A of the Motor Vehicles Act and allows for a quick claim without having to
prove negligence.
5. Judicial Process in Road Accident Cases
In cases of road accidents, the victims or their legal heirs can approach the civil court or the
Motor Accident Claims Tribunal (MACT) to claim compensation. The MACT is the primary
forum for adjudicating compensation claims related to road accidents. The tribunal takes into
account the extent of the injury, medical treatment expenses, loss of earnings, and pain and
suffering caused.
Steps in the Judicial Process:
1. Filing of Claim Petition: The victim or legal heirs file a petition with the Motor Accident
Claims Tribunal (MACT) for compensation. The petition must be supported by evidence,
such as medical records, police reports, and witness statements.
2. Investigation and Evidence Collection: The police investigate the road accident and
prepare a report. Medical reports are presented as evidence, and the victim’s financial and
physical losses are assessed.
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3. Judgment and Compensation: After hearing both parties, the tribunal delivers a judgment
and orders compensation. The compensation may include medical expenses, loss of
earnings, and pain and suffering.
6. Prevention of Road Accidents and Legal Measures
Several preventive measures have been proposed to reduce the occurrence of road accidents.
These measures involve both legal reforms and educational campaigns.
Key Legal Measures:
• Strict Enforcement of Traffic Laws: Implementing stringent penalties for violations like
speeding, driving under the influence of alcohol, and failing to wear seat belts.
• Public Awareness Campaigns: Educating the public about road safety, the importance of
following traffic rules, and the dangers of drunk driving.
• Improved Infrastructure: Enhancing road safety features, such as better signage,
pedestrian crossings, and road dividers, to reduce accidents.
• Use of Technology: Incorporating technology like speed cameras, traffic signal cameras,
and vehicle tracking to ensure compliance with traffic laws.

Sexual Assaults
Sexual assault is a serious crime that involves a violation of an individual’s bodily integrity
and sexual autonomy. The medico-legal aspects of sexual assault involve the documentation
and treatment of physical injuries, as well as the collection of evidence to aid in criminal
investigations and prosecutions.
Key medico-legal considerations in sexual assault cases:
1. Definition of Sexual Assault:
o Sexual assault refers to a range of unlawful sexual activities, from molestation to
rape, without the consent of the victim. Section 375 of the Indian Penal Code
(IPC) defines rape, and sexual assault encompasses various acts that violate a
person’s sexual autonomy.
2. Medical Examination of Victims:
o Forensic examination is essential in sexual assault cases. A medical professional
conducts a thorough examination to identify injuries and collect forensic evidence,
such as semen, hair, or skin samples. These are important for corroborating the
victim's testimony and assisting the investigation.
o Chain of custody is crucial for maintaining the integrity of the evidence collected
during the examination.
3. Consent and Force:
o Determining whether the sexual act occurred without consent or was forced is
central to the case. In cases where the victim cannot provide verbal consent due to
age, mental incapacity, or intoxication, the medical examination helps ascertain the
presence of signs of force or resistance.
o Consent is a critical element in sexual assault cases, and medical reports can
support or contradict allegations of force or lack of consent.
4. Role of the Forensic Expert:
o Forensic doctors or trained professionals perform the medical examination of the
victim and document their findings. This includes identifying injuries such as
bruising, bleeding, or genital trauma.
o Forensic evidence can help corroborate the victim’s story and strengthen the case in
court.
5. Mental Health Impact:
o Sexual assault often leads to psychological trauma for the victim. Medical
professionals, including psychiatrists, may be involved in assessing the mental

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health impact of the assault, including conditions such as Post-Traumatic Stress

Disorder (PTSD).
o The psychological trauma must also be documented, as it can affect compensation
claims and the emotional wellbeing of the victim.
6. Law on Reporting:
o The Indian Penal Code mandates that any form of sexual assault must be reported
to the police. Section 375 (rape) and Section 354 (molestation) are most often
used in sexual assault cases. However, Section 164A of the Criminal Procedure
Code (CrPC) mandates the recording of the victim's statement under oath, which
can be used as evidence.
7. Legal Provisions and Victim Protection:
o The Criminal Law (Amendment) Act, 2013 provides for more stringent
punishments for sexual offences and better protection for the victim.
o Victim compensation: Under the Criminal Injuries Compensation Scheme, the
government provides compensation to the victims of violent crimes, including
sexual assault.
8. Role of the Medical Professional in Court:
o Medical professionals may be called upon to testify in court regarding the medical
examination, the collection of forensic evidence, and the diagnosis of injuries.
o Expert testimony from medical professionals can play a key role in proving the
occurrence of sexual assault and the degree of force used.

4.3 The Drug and Magic Remedies (Prevention of Objectionable Advertisement) Act,
1954
The Drug and Magic Remedies (Objectionable Advertisements) Act, 1954 is an
important piece of legislation in India aimed at regulating the advertisements of drugs and
remedies that make false or misleading claims. The law focuses particularly on the prevention
of advertisements that promote the use of drugs and magical remedies for diseases or
conditions that may lead to harm or are scientifically unsubstantiated.
Key Provisions of the Act
The Drug and Magic Remedies (Objectionable Advertisements) Act, 1954 applies
primarily to the advertising of drugs and remedies related to various health conditions. Here
are the primary elements of the Act:
1. Prohibition of Advertisements of Certain Drugs and Remedies
• Section 3 of the Act prohibits the advertisement of drugs that make false claims about
curing diseases or conditions such as cancer, tuberculosis, diabetes, sexual disorders, etc.
These claims often do not have any scientific basis, and such advertisements are
considered misleading and harmful.
• The advertisement of "magic remedies" is also banned. These remedies are typically
unscientific and promise to cure a wide range of ailments with no real medical evidence to
back their effectiveness. The law specifically targets remedies that claim to offer
miraculous cures or treatments, particularly for diseases like asthma, tuberculosis, cancer,
and so on.
2. Definition of ‘Drugs’ and ‘Magic Remedies’
• Drugs: The Act broadly defines "drugs" in the context of its application, including
substances or medicines intended for use in the treatment or prevention of disease in
human beings or animals.
• Magic Remedies: These are remedies or treatments that claim to cure diseases or provide
solutions to health problems without having any scientifically proven basis. They often
involve herbal concoctions, oils, tonics, or other substances claimed to possess miraculous
curative properties.
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3. Obligations on Advertisers
• Advertisers, manufacturers, and sellers of drugs and remedies must ensure that the claims
made about their products in any form of advertisement are not false, misleading, or
exaggerated. They must provide clear and accurate information about the effects and
benefits of the drug, supported by scientific evidence.
• They are prohibited from advertising their products with claims like "miraculous cures,"
"guaranteed results," or similar unverifiable statements that may mislead the public.
4. Penalties for Violation
• Any person found guilty of violating the provisions of the Act is subject to penalties. These
can include a fine, imprisonment, or both, depending on the severity of the violation. The
penalties are designed to discourage the use of misleading or dangerous advertisements,
ensuring that public health is protected.
• The Act grants powers to enforcement authorities to seize any goods or materials related
to the prohibited advertisements, including advertisements found to be in violation of the
law.
5. Regulation of Specific Claims
• Advertisements claiming to cure or treat diseases such as cancer, diabetes, or tuberculosis
are especially scrutinized. Any unproven or unverifiable claims related to these diseases
are prohibited.
• Advertisements that promote cures for sexual dysfunctions, which may mislead vulnerable
individuals, are also strictly regulated.
6. Role of Regulatory Authorities
• The Ministry of Health and Family Welfare, along with other regulatory bodies like the
Central Drugs Standard Control Organization (CDSCO), plays a crucial role in implementing
the provisions of the Act.
• The Act empowers authorities to monitor and take action against illegal advertisements.
The authorities can also take action against the sale of products that violate the provisions
of the Act.
7. Public Awareness
• In addition to enforcing the Act, authorities and organizations also engage in public
awareness campaigns to educate the public about the dangers of using unapproved or
untested treatments advertised as "miracles" and "cures" for serious health conditions.
• The government has taken steps to highlight the importance of using evidence-based
treatments and medications under the supervision of qualified medical professionals.
Impact and Significance of the Act
1. Consumer Protection: The Act helps protect consumers from deceptive practices and
unproven remedies that could cause harm to health. It ensures that the public is not misled
by advertisements that promise false cures for serious diseases or health conditions.
2. Medical Ethics: It strengthens medical ethics and professionalism in the advertising and
promotion of drugs, encouraging companies to rely on scientific evidence and proper
regulatory channels to market their products.
3. Health and Safety: The primary aim of the law is to prevent harm to public health by
restricting the sale and promotion of unsafe, untested, or unproven health products. It also
deters manufacturers from making exaggerated claims about the efficacy of their products.
4. Legal Enforcement: The Act serves as a deterrent against those who try to profit from
selling unproven medical remedies. Legal enforcement mechanisms are in place to punish
violators, thus enhancing compliance with the law.
Challenges and Criticisms
Despite the efforts made by the government to regulate misleading advertisements, there are
certain challenges and criticisms:

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• Lack of Awareness: Many individuals may still be unaware of the existence of such laws,
and therefore continue to fall victim to the misleading advertisements. There is a need for
stronger public awareness campaigns to inform the masses about their rights and the risks
involved with such advertisements.
• Enforcement Difficulties: Enforcement of the Act can sometimes be difficult due to the
variety of media platforms used for advertising, including print, television, and online
platforms. With the rise of digital media, enforcing regulations on online advertisements
has become a complex task.
• Inadequate Penalties: Critics argue that the penalties for violating the Act may not be
stringent enough to deter individuals or companies from engaging in misleading
advertising. There is a need for tougher penalties to prevent such violations effectively.

4.4 Transplantation of Human Organs Act, 1994

The Transplantation of Human Organs Act, 1994, is an essential legislation aimed at
regulating the removal, storage, and transplantation of human organs in India. The Act was
introduced to tackle the issue of organ donation and transplantation while preventing
unethical practices like organ trade. It seeks to ensure that organ transplants are carried out
in a regulated manner, focusing on the safety and well-being of the donor and recipient. The
main provisions of this law are as follows:
1. Objective and Scope
The main objective of the Act is to regulate the removal, storage, and transplantation of
human organs and tissues. The Act aims to promote organ donation for therapeutic purposes
while ensuring that the process is carried out under proper medical and ethical standards. The
Act applies to the transplantation of human organs in both government and private hospitals.
2. Key Definitions
The Act defines several critical terms, such as:
• Human Organ: A human organ means any part of the human body that is capable of being
removed or transplanted for therapeutic purposes.
• Transplantation: Refers to the transfer of an organ from a donor to a recipient.
• Donor: A person who voluntarily gives an organ for transplantation.
3. Regulation of Organ Donation
The Act sets out strict criteria for organ donation, emphasizing voluntary and altruistic
donation. It prohibits any form of commercial dealing in organs.
• Donation Criteria: The donor must be an individual who is not involved in any
commercial transaction. The Act also mandates that the donor must provide consent
voluntarily. It does not permit the sale or purchase of organs.
• Consent for Donation: Consent must be obtained from the donor or their relatives, and in
the case of deceased donors, consent must be given by a close relative.
4. Authorization Committee
An essential feature of the Act is the establishment of an Authorization Committee. This
committee is responsible for reviewing applications for organ transplants, especially where
relatedness between the donor and recipient is in question. The committee plays a crucial role
in ensuring that organ donation is not done for any commercial or exploitative purposes.
• The committee is empowered to approve or reject the proposed transplantation based on
specific criteria, including medical necessity and the voluntariness of the donor’s consent.
• The committee consists of medical professionals, legal experts, and administrative officers.
5. Types of Organ Donations
The Act allows two types of organ donations:
• Living Donation: A living person can donate organs such as a kidney or a part of the liver.
The Act allows for related as well as unrelated living donations but mandates that
unrelated donors be authorized by the committee.
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• Cadaveric Donation: This is the donation of organs from a deceased person. The law
makes provisions for the removal of organs from a brain-dead person, provided that the
donor has given consent or the family gives consent for donation.
6. Regulation of Organ Transplantation
The Act establishes a framework for hospitals and medical professionals who wish to conduct
organ transplants. Hospitals must be registered with the appropriate authorities, and they
must adhere to guidelines and regulations regarding organ procurement and transplantation.
• Registered Hospitals: Any hospital performing organ transplants must be registered and
recognized under the Act.
• Qualification of Transplantation Professionals: The professionals involved in organ
donation and transplantation (e.g., surgeons, anesthesiologists, etc.) must have specific
qualifications and training.
7. Punitive Provisions
The Act includes provisions for the punishment of those who violate its rules. Offenses under
the Act include:
• Selling of Organs: Any person found guilty of trafficking in human organs can be subjected
to imprisonment, which may extend up to 10 years, along with a fine.
• Illegal Removal or Transplantation: If an organ is removed or transplanted without
following the provisions of the Act (e.g., without proper consent or the Authorization
Committee’s approval), the offenders can face criminal penalties, including imprisonment
and fines.
• Misdemeanors in Transplantation: Medical professionals or institutions found involved
in unethical practices, including unregistered organ transplants, are liable to be
prosecuted.
8. Regulation of Organ Banks
The Act also provides for the establishment of Organ Banks, which are essential in facilitating
cadaveric organ donations. These banks store donated organs until a recipient is found. The
regulation of these banks ensures that organs are preserved under proper conditions and
distributed fairly based on need and priority.
9. Role of the Government
The Act empowers the central and state governments to make rules for the effective
implementation of the provisions related to organ donation and transplantation. The
government is also responsible for establishing monitoring and enforcement mechanisms to
prevent organ trade and illegal transplants.
10. Ethical Considerations and Safeguards
The Act aims to safeguard against the exploitation of both the donor and the recipient. This
includes:
• Preventing commercial trafficking of organs by criminalizing such activities.
• Ensuring that the donor's consent is informed and voluntary, especially in cases involving
unrelated living donors.
• Establishing a robust framework for the equitable allocation of donated organs to patients
who are most in need.
11. Recent Amendments
Over the years, the Transplantation of Human Organs Act, 1994, has undergone several
amendments to address new challenges and improve the efficacy of organ donation and
transplantation systems. These amendments have focused on strengthening the regulatory
framework, improving the transparency of the process, and increasing public awareness
about organ donation.

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4.5 Pre Conception and Pre Natal Diagnostic Techniques Act, 1994
The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection)
Act, 1994 (often abbreviated as PCPNDT Act) was enacted with the primary objective of
preventing female foeticide and controlling the misuse of prenatal diagnostic techniques for
the purpose of sex determination. The legislation was introduced in response to the growing
concern about the increasing number of cases of sex-selective abortions, which
disproportionately affected the girl child in India. This law is designed to curb the societal and
cultural preference for male children, which has led to significant gender imbalances in
certain parts of the country.
Objectives of the Act
1. Prohibition of Sex Selection: The Act makes it illegal to conduct any test, ultrasound, or
prenatal diagnostic techniques for the purpose of determining the sex of the foetus. This
provision aims to prevent sex-selective abortions, a practice where pregnancies are
terminated based on the gender of the foetus.
2. Regulation of Pre-Natal Diagnostic Techniques: The law seeks to regulate the use of
technologies and techniques for detecting genetic and congenital abnormalities, and to
ensure that they are not misused for sex determination purposes.
3. Protection of the Rights of the Female Foetus: The primary aim of the Act is to protect
the female foetus from being subjected to abortion solely based on its sex, which is a
violation of the unborn child’s right to life and dignity.
4. Preventing the Misuse of Modern Medical Technology: The law curtails the misuse of
medical technologies, particularly ultrasonography and amniocentesis, which can be used
to determine the sex of the unborn child, and in turn, reduce female foeticide.
Key Provisions of the Act
1. Prohibition of Sex Selection:
o Section 3 prohibits the use of prenatal diagnostic techniques for the determination
of the sex of the foetus. This section explicitly states that no person shall conduct a
prenatal diagnostic technique for sex selection, either before or after conception.
o This includes tests such as ultrasound and amniocentesis, which are not to be used
to determine the sex of the unborn child under any circumstances.
2. Regulation of Genetic Counselling Centers, Genetic Laboratories, and Clinics:
o Section 4 regulates and prohibits the use of genetic counselling centers and clinics
for sex determination purposes. Any clinic or laboratory providing these services
must be registered with the appropriate authorities.
o The Act requires these institutions to maintain records, and these records must be
available for scrutiny by the authorities to ensure compliance.
3. Punishments for Violation:
o Section 23 provides strict punishments for those found guilty of violating the
provisions of the Act. Any person or institution conducting sex determination or
aborting a foetus based on gender is liable to be punished with imprisonment and a
fine.
o The punishment for violating the law can include imprisonment for up to five years
and a fine of up to ₹10,000 for the first offence. For subsequent offences, the
punishment can extend to imprisonment of up to seven years and a fine of ₹50,000.
4. Mandatory Registration:
o Section 18 mandates that all genetic clinics, laboratories, and counseling centers
must be registered under the provisions of the Act. The registration is essential for
monitoring and ensuring that these establishments follow the laws properly.

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5. Monitoring and Enforcement:

o The Act establishes a Central Supervisory Board and state-level supervisory
boards to oversee the enforcement of the law. These bodies are responsible for
ensuring compliance, inspecting clinics, and taking action against violators.
6. Advisory Committee:
o Section 9 of the Act establishes an advisory committee at both the national and
state levels. The committee advises the government on measures to control the
misuse of prenatal diagnostic techniques and to enhance the implementation of the
law.
7. Public Awareness:
o The law encourages the government and non-governmental organizations to
undertake measures to raise awareness about the harmful effects of sex-selective
abortions and the importance of gender equality in society.
8. Ban on Advertisement:
o Section 22 prohibits the advertisement of prenatal diagnostic techniques. This
includes advertisements promoting the use of such techniques for the purpose of
sex determination, which could encourage individuals to use the technology for
gender-based discrimination.

Significance and Impact of the PCPNDT Act

1. Combating Female Foeticide: The main goal of the PCPNDT Act is to combat the practice
of female foeticide and to curb the societal preference for male children. This law has been
instrumental in creating awareness about the harmful effects of gender-based
discrimination and the consequences of aborting female foetuses.
2. Promoting Gender Equality: By restricting the use of sex determination tests, the law
seeks to promote gender equality by preventing gender-based abortion and encouraging
the birth of female children. It emphasizes that all children, regardless of sex, should have
an equal right to life.
3. Regulation of Medical Practices: The Act also acts as a regulatory framework for the use
of prenatal diagnostic technologies and ensures that they are used for medical purposes
rather than for determining the sex of the foetus. This prevents medical professionals from
misusing their expertise for unethical purposes.
4. Monitoring and Enforcement: The law provides for a robust mechanism for monitoring
and enforcement, including the establishment of supervisory boards at both the state and
national levels. These boards oversee the functioning of diagnostic centers and ensure
compliance with the law.
5. Improved Reporting and Accountability: The requirement for clinics and laboratories to
maintain records and provide annual reports to the authorities enhances transparency in
the use of prenatal diagnostic techniques. This reporting helps authorities track any
suspicious activities related to sex selection.
6. Cultural and Societal Change: Over time, the implementation of the PCPNDT Act has
contributed to a shift in societal attitudes regarding gender. While challenges remain,
particularly in rural and underdeveloped regions, the law has played an important role in
challenging deep-rooted gender biases.
Challenges in Implementation
Despite the noble objectives of the Act, its implementation has faced several challenges:
1. Lack of Awareness: Many individuals, particularly in rural areas, are not fully aware of the
implications of the law or the harmful effects of sex-selective abortions. This lack of
awareness hinders the law’s effectiveness.

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2. Underground Practices: Sex-selective abortions may still be taking place in underground

clinics or through unlicensed practitioners who are operating outside the purview of the
law. These illegal practices make enforcement difficult.
3. Lack of Enforcement: While the law provides for strict penalties, enforcement remains
weak in some areas, particularly in remote regions where the authorities may lack
resources or political will to fully implement the provisions of the Act.
4. Resistance from Traditional Mindsets: The strong cultural preference for male children
persists in some communities, making it challenging to change attitudes and behaviors
regarding gender discrimination.
Recent Developments and Amendments
In recent years, there have been calls for stricter enforcement of the PCPNDT Act, especially in
light of continuing cases of female foeticide in some regions of India. Additionally, there have
been proposals to make the penalties under the Act even more stringent and to increase the
scope of monitoring mechanisms.
The government has also made efforts to raise public awareness through campaigns and
educational initiatives aimed at promoting gender equality and discouraging sex-selective
practices.

4.6 Disaster Management Act, 2005 - Mass Disasters

The Disaster Management Act, 2005 was enacted to provide a legal framework for disaster
management in India, ensuring the timely and effective response to disasters. It establishes
the roles and responsibilities of various authorities and agencies, both at the central and state
levels, to manage disasters in an organized and systematic way.
Key Provisions of the Disaster Management Act, 2005
1. Definition of Disaster and its Management
o A disaster is defined under Section 2(d) as a catastrophe, mishap, calamity, or grave
occurrence in any area, arising from natural or man-made causes, which results in
substantial damage to life, property, and resources.
o Disaster management refers to the measures taken to minimize the impact of such
disasters.
2. National Disaster Management Authority (NDMA)
o The Act creates the National Disaster Management Authority (NDMA), which is
responsible for formulating policies, plans, and guidelines for disaster management.
o The Prime Minister serves as the chairperson of the NDMA, which plays a crucial
role in ensuring coordinated disaster management at the national level.
3. State Disaster Management Authority (SDMA)
o Each state is required to form its own State Disaster Management Authority
(SDMA), which works under the overall guidance of the NDMA.
o The Chief Minister of the state serves as the chairperson, and it is responsible for
the preparation and implementation of disaster management plans at the state
level.
4. District Disaster Management Authority (DDMA)
o The District Disaster Management Authority (DDMA) is formed for every district
in India.
o The District Collector or District Magistrate is the chairperson of the DDMA, which is
responsible for implementing disaster management plans at the district level.
5. Disaster Management Plans
o Every district, state, and union territory must prepare a Disaster Management
Plan to deal with the various types of disasters, which include natural,
technological, and biological hazards.

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o The National Plan, which is formulated by the NDMA, outlines the strategies and
response mechanisms at the national level. The Plan is reviewed and updated at
regular intervals.
6. Disaster Response Fund
o The National Disaster Response Fund (NDRF) and State Disaster Response
Fund (SDRF) are created to meet the expenditure during a disaster. The funds are
used to provide immediate relief, medical aid, and other necessary services during
disasters.
o The NDRF is allocated by the central government, while the SDRF is constituted by
the respective state governments.
7. Role of Local Authorities
o Local authorities are critical in managing disasters, as they are closest to the
affected populations. The Act mandates local authorities to play an active role in
disaster response and preparedness.
8. Role of Ministries and Agencies
o The Act assigns specific roles to various ministries and government agencies for
effective disaster management. For example:
 The Ministry of Health and Family Welfare is responsible for providing
medical assistance during disasters.
 The Ministry of Home Affairs coordinates the disaster management efforts
and ensures that resources are deployed quickly.
9. Training and Awareness
o The Act mandates the government to organize training, awareness campaigns, and
workshops to ensure that both the public and professionals involved in disaster
management are well-prepared.
10. Disaster Response and Recovery
o It emphasizes timely and effective disaster response, including the provision of
shelter, food, and medical treatment.
o Recovery and rehabilitation efforts are also crucial after the immediate response
phase to ensure the restoration of normalcy.

Medico-Legal Aspects of Disaster Management

1. Medical Response to Disasters
o Disasters, especially mass disasters like earthquakes, floods, and industrial
accidents, often result in numerous casualties, requiring quick medical intervention.
Hospitals and medical teams must be prepared to handle large numbers of injured
or ill patients.
o Medical professionals are expected to provide emergency medical care, which may
include life-saving treatment, triage (sorting patients based on severity), and
psychological support.
2. Legal Framework for Medical Assistance
o Medical practitioners involved in disaster management are protected under the
Disaster Management Act and related health laws, as long as they are performing
their duties in good faith and as per established protocols.
o However, the provision of medical services in disaster scenarios can present legal
challenges, particularly in terms of consent for treatment, especially when patients
are unconscious or unable to consent.
3. Mass Casualty Management
o In case of a mass disaster, the management of casualties involves not only providing
medical treatment but also addressing the ethical concerns of patient prioritization.

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o The Indian Medical Council and State Medical Councils provide guidelines and
ethics to handle such situations.
4. Euthanasia and End-of-Life Decisions
o In some disaster situations, medical professionals may have to make difficult
decisions regarding the prolongation of life or when to give priority to other
patients. This may lead to questions of euthanasia or passive euthanasia,
especially if medical resources are limited.
o Legal provisions for Living Wills and Do Not Resuscitate (DNR) orders are critical
in these circumstances.

4.7 Medical Insurance

Medical insurance plays a significant role in modern healthcare systems, providing financial
protection to individuals and families against the rising costs of healthcare services. In India,
medical insurance is an important aspect of the healthcare system, particularly as the cost of
medical treatment continues to rise. This section addresses the relationship between medical
practice and insurance, its legal implications, and the regulatory framework governing
medical insurance in India.
Types of Medical Insurance
There are several types of medical insurance policies available in India, which are tailored to
meet the healthcare needs of individuals, families, and organizations. Some of the most
common forms of medical insurance include:
1. Individual Health Insurance
This type of insurance covers only the individual policyholder. It is ideal for those who do
not have a family to insure under one policy and may have specific medical needs.
2. Family Floater Health Insurance
A family floater policy allows the policyholder to insure their entire family under a single
policy. This includes the policyholder, spouse, children, and in some cases, parents. It is
often a more affordable option compared to insuring each family member separately.
3. Critical Illness Insurance
Critical illness insurance provides coverage for specific life-threatening diseases, such as
cancer, stroke, heart attack, or kidney failure. This type of policy is useful for people
diagnosed with severe illnesses as it offers a lump sum payout to cover treatment costs.
4. Top-up and Super Top-up Plans
These are additional plans that enhance existing medical insurance coverage. A top-up
policy offers higher coverage limits at a lower premium but comes with a deductible,
meaning that the policyholder needs to pay a certain amount out of pocket before the
insurance coverage kicks in. Super top-up plans provide additional coverage beyond the
primary policy but may have higher limits.
5. Group Health Insurance
This type of insurance is provided by employers to their employees or by associations to
their members. It generally offers coverage for a group of people, often at a lower cost than
individual policies. Group health insurance can also extend to dependents and family
members.
6. Critical Illness Riders
These are add-on covers that provide financial protection against the diagnosis of life-
threatening illnesses. This policy pays out a lump sum amount if the insured is diagnosed
with one of the covered critical illnesses.
7. Cashless Health Insurance
Cashless health insurance allows policyholders to avail of medical treatments at network
hospitals without having to pay upfront. The insurer directly settles the bills with the
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hospital, ensuring that the patient does not have to bear the financial burden during
treatment.
Regulatory Framework in India
In India, the medical insurance sector is regulated by the Insurance Regulatory and
Development Authority of India (IRDAI), which ensures that the insurance providers
adhere to guidelines that protect the interests of policyholders. Some key aspects of the
regulatory framework include:
1. Insurance Regulatory and Development Authority of India (IRDAI) Act, 1999
The IRDAI Act mandates that all insurance companies in India are licensed and regulated
by the authority. The primary objective of the IRDAI is to promote the growth of the
insurance industry, protect the interests of policyholders, and ensure fair treatment in the
market.
2. The Consumer Protection Act, 2019
The Consumer Protection Act provides a comprehensive legal framework for the
protection of consumer rights in India. It applies to medical insurance as well, ensuring
that policyholders are not subjected to unfair trade practices, deceptive advertising, or
refusal of claims.
3. The Health Insurance Portability and Accountability Act (HIPAA)
Although HIPAA is not an Indian law, it has an influence on how medical insurance is
handled globally, especially in regard to the privacy and security of health data. The
equivalent in India is the Information Technology (Reasonable Security Practices and
Procedures and Sensitive Personal Data or Information) Rules, 2011, which governs
how personal medical information is stored, shared, and protected.
4. The Medical Insurance Act, 2019 (Proposed)
The Government of India has also been working on the introduction of a new legislation,
namely the Medical Insurance Act, 2019, to standardize and regulate all forms of health
and medical insurance in India, ensuring greater transparency and fairness in claims and
payouts.
5. The National Health Protection Scheme (Ayushman Bharat)
Launched in 2018, Ayushman Bharat is the world's largest government-funded healthcare
scheme, aimed at providing health coverage of up to ₹5 lakh per family per year for
secondary and tertiary care hospitalization. The scheme is designed to provide financial
protection to vulnerable families and has led to an increase in the number of health
insurance beneficiaries across India.
Legal Issues in Medical Insurance
1. Claims and Denials
A major legal issue in medical insurance arises when claims are denied by insurance
providers. This could happen for several reasons, such as the non-disclosure of pre-existing
conditions or non-compliance with policy terms. In some cases, claims may also be denied
due to technicalities such as waiting periods or coverage exclusions. The legal recourse
available to insured individuals includes filing complaints with the IRDAI, approaching the
Consumer Disputes Redressal Forum, or initiating civil suits for breach of contract.
2. Pre-existing Diseases
Medical insurance policies often have clauses related to pre-existing diseases (PED),
which can limit coverage for conditions that existed before the policy was bought. In such
cases, policyholders are required to disclose their medical history during the application
process. Any failure to disclose pre-existing conditions can lead to the rejection of claims,
but there are legal provisions that protect the policyholder from unfair treatment.
3. Exclusions and Limitations
Medical insurance policies also come with a list of exclusions, including conditions or
treatments that are not covered by the policy. Common exclusions include cosmetic
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surgery, infertility treatments, dental treatments, and alternative medicine. Legal disputes
often arise when insured individuals are not fully aware of these exclusions.
4. Portability
The issue of insurance portability arises when individuals wish to switch health insurance
providers while retaining their benefits, such as coverage for pre-existing conditions. The
IRDAI has formulated regulations that allow portability of health insurance policies from
one insurer to another without losing the accumulated benefits.
5. Third-Party Administrator (TPA)
TPAs act as intermediaries between the insurer and the insured for claims processing.
Sometimes, disputes arise over the handling of claims by TPAs, such as delayed payments
or discrepancies in documentation. The legal framework governing TPAs ensures that they
operate transparently and efficiently.
6. Fraud in Medical Insurance
Fraudulent activities, such as exaggerated claims, fake hospitalization, or falsification of
medical records, can lead to legal consequences for both insurers and policyholders.
Insurers have the right to cancel policies if fraud is discovered, and policyholders found
guilty of fraud may face legal prosecution.
Challenges in the Medical Insurance Sector
1. Affordability
One of the key challenges in medical insurance is its affordability. Despite government
schemes like Ayushman Bharat, many low-income groups still lack access to basic health
coverage. This creates a gap in healthcare access, especially for the rural population.
2. Awareness
A lack of awareness regarding the benefits of medical insurance and the complexities
involved in choosing the right plan remains a significant challenge. Many individuals
remain uninsured or underinsured because they do not understand the importance of
having adequate coverage.
3. Claims Disputes
Claims disputes between policyholders and insurers are common and can sometimes
escalate into legal battles. This issue can arise due to unclear terms in the policy,
complicated claim procedures, or improper documentation.
4. Rising Healthcare Costs
As healthcare costs continue to rise, medical insurance premiums have also seen an
increase. While policies have higher coverage limits, the financial strain caused by
increasing premiums poses a challenge for both insurers and policyholders.

Conclusion: Law and Medicine

The intersection of law and medicine plays a critical role in ensuring the protection and
advancement of public health and the rights of individuals. Over the years, medical laws and
regulations have evolved to meet the changing needs of society, ensuring ethical practices,
accountability, and equitable access to healthcare. The legal framework surrounding
healthcare is multifaceted, encompassing various laws, acts, and regulations aimed at
safeguarding the health and wellbeing of individuals, regulating medical professionals, and
addressing medico-legal issues.
The Right to Health is foundational to the healthcare system in India, and the country has
developed a robust healthcare delivery system that includes primary health centers, district-
level hospitals, private corporate hospitals, and multi-specialty hospitals. However, there are
still challenges faced by smaller setups in terms of limitations in resources, infrastructure, and
access to quality care. Efforts to improve healthcare standards have been made through
accreditations such as those by the National Accreditation Board for Hospitals (NABH) and the

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International Organization for Standardization (ISO), which ensure that healthcare facilities
meet internationally recognized standards.
A significant aspect of the legal regulation of medicine is the control of medical profession
through various councils and commissions, such as the National Medical Commission Act,
2019, and the Indian Medical Council (Professional Conduct, Etiquette and Ethics)
Regulations, 2002. These bodies are responsible for regulating the conduct, qualifications, and
ethical standards of medical practitioners in India. These laws also emphasize the importance
of self-regulation through codes of conduct, ensuring that medical professionals maintain
ethical behavior and professionalism in their practice.
The doctor-patient relationship is central to medical law, and it is governed by principles of
informed consent, confidentiality, and respect for the patient’s autonomy. Informed consent,
refusal, and therapeutic privilege are important aspects of medical practice that have legal
implications, ensuring that patients are fully informed about their treatment options and the
risks involved. Similarly, the documentation of medical records and certificates is crucial for
legal protection in case of disputes and malpractice claims.
Medical negligence is one of the most commonly encountered medico-legal issues. The law
recognizes both contributory negligence and the errors that may occur in medical practice,
offering remedies and avenues for compensation in the event of medical accidents. The
Consumer Protection Act, 2019 provides a legal mechanism to address grievances related to
medical services, and doctors and medical establishments are bound to follow the highest
standards of care.
Violence against doctors and medical establishments is another critical issue that requires
legal intervention. The law has provisions that protect medical professionals from violence,
recognizing their essential role in society and the need for a safe working environment.
In medico-legal issues, clinical trials on humans, road accidents, sexual assaults, organ
transplantation, and issues related to drug and magic remedies all require specific legal
provisions to protect individuals’ rights, regulate practices, and prevent harm. Laws like the
Transplantation of Human Organs Act, 1994, the Pre-Conception and Pre-Natal
Diagnostic Techniques Act, 1994, and the Disaster Management Act, 2005, serve as
crucial instruments in addressing these issues. They ensure that medical procedures are
carried out ethically, with adequate safeguards for human rights and dignity.
The legal framework surrounding medical insurance is also an integral part of ensuring that
individuals have access to affordable healthcare, mitigating financial risks associated with
medical treatment.
In conclusion, Law and Medicine form an essential partnership in ensuring that healthcare
systems are ethical, accessible, and just. As healthcare continues to evolve, it is imperative that
the legal landscape adapts to address emerging challenges, such as medical technology
advancements, new treatment methodologies, and the growing concern of medical
malpractice. A comprehensive and dynamic approach to medical law is crucial in safeguarding
public health, maintaining the integrity of the medical profession, and protecting the rights of
individuals seeking medical care.

The End
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