Annexure - I

Pharmacy Council of India

New Delhi

“Syllabus framed under Regulation 7,

List of prescribed equipments and
apparatus under Appendix-A of
The Education Regulations, 2020
For Diploma Course in Pharmacy”
 7. ER-2020 D.Pharm Syllabus – Part I

S. Course Name of the Total Total Theory / Tutorial

No. Code Course Theory / Tutorial Practical Hours
Practical Hours Hours per
Hours per Week
Week
1. ER20-11T Pharmaceutics – 75 25 3 1
Theory
2. ER20-11P Pharmaceutics – 75 - 3 -
Practical
3. ER20-12T Pharmaceutical 75 25 3 1
Chemistry – Theory
4. ER20-12P Pharmaceutical 75 - 3 -
Chemistry –
Practical
5. ER20-13T Pharmacognosy – 75 25 3 1
Theory
6. ER20-13P Pharmacognosy – 75 - 3 -
Practical
7. ER20-14T Human Anatomy & 75 25 3 1
Physiology –
Theory
8. ER20-14P Human Anatomy & 75 - 3 -
Physiology –
Practical
9. ER20-15T Social Pharmacy – 75 25 3 1
Theory
10. ER20-15P Social Pharmacy – 75 - 3 -
Practical

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 PHARMACEUTICS – THEORY

Course Code: ER20-11T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge and skills on the art and
science of formulating and dispensing different pharmaceutical dosage forms.

Course Objectives: This course will discuss the following aspects of pharmaceutical
dosage forms
1. Basic concepts, types and need
2. Advantages and disadvantages, methods of preparation / formulation
3. Packaging and labelling requirements
4. Basic quality control tests, concepts of quality assurance and good
manufacturing practices

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe about the different dosage forms and their formulation aspects
2. Explain the advantages, disadvantages, and quality control tests of different
dosage forms
3. Discuss the importance of quality assurance and good manufacturing
practices

Chapter Topics Hours

1  History of the profession of Pharmacy in India in relation 7
to Pharmacy education, industry, pharmacy practice,
and various professional associations.
 Pharmacy as a career
 Pharmacopoeia: Introduction to IP, BP, USP, NF and
Extra Pharmacopoeia. Salient features of Indian
Pharmacopoeia
2 Packaging materials: Types, selection criteria, 5
advantages and disadvantages of glass, plastic, metal,
rubber as packaging materials
3 Pharmaceutical aids: Organoleptic (Colouring, flavouring, 3
and sweetening) agents
Preservatives: Definition, types with examples and uses
4 Unit operations: Definition, objectives/applications, 9
principles, construction, and workings of:
Size reduction: hammer mill and ball mill
Size separation: Classification of powders according to IP,
Cyclone separator, Sieves and standards of sieves

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 Mixing: Double cone blender, Turbine mixer, Triple roller
mill and Silverson mixer homogenizer
Filtration: Theory of filtration, membrane filter and sintered
glass filter
Drying: working of fluidized bed dryer and process of
freeze drying
Extraction: Definition, Classification, method, and
applications
5 Tablets – coated and uncoated, various modified tablets 8
(sustained release, extended-release, fast dissolving, multi-
layered, etc.)
Capsules - hard and soft gelatine capsules 4
Liquid oral preparations - solution, syrup, elixir, emulsion, 6
suspension, dry powder for reconstitution
Topical preparations - ointments, creams, pastes, gels, 8
liniments and lotions, suppositories, and pessaries
Nasal preparations, Ear preparations 2
Powders and granules - Insufflations, dusting powders, 3
effervescent powders, and effervescent granules
Sterile formulations – Injectables, eye drops and eye 6
ointments
Immunological products: Sera, vaccines, toxoids, and 4
their manufacturing methods.
6 Basic structure, layout, sections, and activities of 5
pharmaceutical manufacturing plants
Quality control and quality assurance: Definition and
concepts of quality control and quality assurance, current
good manufacturing practice (cGMP), Introduction to the
concept of calibration and validation
7 Novel drug delivery systems: Introduction, Classification 5
with examples, advantages, and challenges

PHARMACEUTICS – PRACTICAL

Course Code: ER20-11P 75 Hours (3 Hours/week)

Scope: This course is designed to train the students in formulating and dispensing
common pharmaceutical dosage forms.

Course Objectives: This course will discuss and train the following aspects of
preparing and dispensing various pharmaceutical dosage forms
1. Calculation of working formula from the official master formula

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 PHARMACEUTICAL CHEMISTRY – THEORY

Course Code: ER20-12T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on the chemical

structure, storage conditions and medicinal uses of organic and inorganic chemical
substances used as drugs and pharmaceuticals. Also, this course discusses the
impurities, quality control aspects of chemical substances used in pharmaceuticals.

Course Objectives: This course will discuss the following aspects of the chemical
substances used as drugs and pharmaceuticals for various disease conditions
1. Chemical classification, chemical name, chemical structure
2. Pharmacological uses, doses, stability and storage conditions
3. Different types of formulations / dosage form available and their brand names
4. Impurity testing and basic quality control tests

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the chemical class, structure and chemical name of the commonly
used drugs and pharmaceuticals of both organic and inorganic nature
2. Discuss the pharmacological uses, dosage regimen, stability issues and
storage conditions of all such chemical substances commonly used as drugs
3. Describe the quantitative and qualitative analysis, impurity testing of the
chemical substances given in the official monographs
4. Identify the dosage form & the brand names of the drugs and pharmaceuticals
popular in the marketplace

Chapter Topic Hours

1 Introduction to Pharmaceutical chemistry: Scope and 8
objectives
Sources and types of errors: Accuracy, precision,
significant figures
Impurities in Pharmaceuticals: Source and effect of
impurities in Pharmacopoeial substances, importance of
limit test, Principle and procedures of Limit tests for
chlorides, sulphates, iron, heavy metals and arsenic.
2 Volumetric analysis: Fundamentals of volumetric 8
analysis, Acid-base titration, non-aqueous titration,
precipitation titration, complexometric titration, redox
titration
Gravimetric analysis: Principle and method.

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 3 Inorganic Pharmaceuticals: Pharmaceutical 7
formulations, market preparations, storage conditions and
uses of
● Haematinics: Ferrous sulphate, Ferrous fumarate,
Ferric ammonium citrate, Ferrous ascorbate, Carbonyl
iron
● Gastro-intestinal Agents: Antacids :Aluminium
hydroxide gel, Magnesium hydroxide, Magaldrate,
Sodium bicarbonate, Calcium Carbonate, Acidifying
agents, Adsorbents, Protectives, Cathartics
● Topical agents: Silver Nitrate, Ionic Silver,
Chlorhexidine Gluconate, Hydrogen peroxide, Boric
acid, Bleaching powder, Potassium permanganate
● Dental products: Calcium carbonate, Sodium
fluoride, Denture cleaners, Denture adhesives, Mouth
washes
● Medicinal gases: Carbon dioxide, nitrous oxide,
oxygen
4 Introduction to nomenclature of organic chemical systems 2
with particular reference to heterocyclic compounds
containing up to Three rings
Study of the following category of medicinal compounds with respect to
classification, chemical name, chemical structure (compounds marked
with*) uses, stability and storage conditions, different types of formulations
and their popular brand names
5 Drugs Acting on Central Nervous System 9
 Anaesthetics: Thiopental Sodium*, Ketamine
Hydrochloride*, Propofol
● Sedatives and Hypnotics: Diazepam*, Alprazolam*,
Nitrazepam, Phenobarbital*
● Antipsychotics: Chlorpromazine Hydrochloride*,
Haloperidol*, Risperidone*, Sulpiride*, Olanzapine,
Quetiapine, Lurasidone
● Anticonvulsants: Phenytoin*, Carbamazepine*,
Clonazepam, Valproic Acid*, Gabapentin*,
Topiramate, Vigabatrin, Lamotrigine
● Anti-Depressants: Amitriptyline Hydrochloride*,
Imipramine Hydrochloride*, Fluoxetine*, Venlafaxine,
Duloxetine, Sertraline, Citalopram, Escitalopram,
Fluvoxamine, Paroxetine
6 Drugs Acting on Autonomic Nervous System 9
● Sympathomimetic Agents: Direct Acting: Nor-
Epinephrine*, Epinephrine, Phenylephrine,

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 Dopamine*, Terbutaline, Salbutamol (Albuterol),
Naphazoline*, Tetrahydrozoline. Indirect Acting
Agents: Hydroxy Amphetamine, Pseudoephedrine.
Agents With Mixed Mechanism: Ephedrine,
Metaraminol
● Adrenergic Antagonists: Alpha Adrenergic Blockers:
Tolazoline, Phentolamine
● Phenoxybenzamine, Prazosin. Beta Adrenergic
Blockers: Propranolol*, Atenolol*, Carvedilol
● Cholinergic Drugs and Related Agents: Direct
Acting Agents: Acetylcholine*, Carbachol, And
Pilocarpine. Cholinesterase Inhibitors: Neostigmine*,
Edrophonium Chloride, Tacrine Hydrochloride,
Pralidoxime Chloride, Echothiopate Iodide
● Cholinergic Blocking Agents: Atropine Sulphate*,
Ipratropium Bromide
Synthetic Cholinergic Blocking Agents:
Tropicamide, Cyclopentolate Hydrochloride, Clidinium
Bromide, Dicyclomine Hydrochloride*
7 Drugs Acting on Cardiovascular System 5
● Anti-Arrhythmic Drugs: Quinidine Sulphate,
Procainamide Hydrochloride, Verapamil, Phenytoin
Sodium*, Lidocaine Hydrochloride, Lorcainide
Hydrochloride, Amiodarone and Sotalol
● Anti-Hypertensive Agents: Propranolol*, Captopril*,
Ramipril, Methyldopate Hydrochloride, Clonidine
Hydrochloride, Hydralazine Hydrochloride, Nifedipine,
● Antianginal Agents: Isosorbide Dinitrate
8 Diuretics: Acetazolamide, Frusemide*, Bumetanide, 2
Chlorthalidone, Benzthiazide, Metolazone, Xipamide,
Spironolactone
9 Hypoglycemic Agents: Insulin and Its Preparations, 3
Metformin*, Glibenclamide*, Glimepiride, Pioglitazone,
Repaglinide, Gliflozins, Gliptins
10 Analgesic And Anti-Inflammatory Agents: Morphine 3
Analogues, Narcotic Antagonists; Nonsteroidal Anti-
Inflammatory Agents (NSAIDs) - Aspirin*, Diclofenac,
Ibuprofen*, Piroxicam, Celecoxib, Mefenamic Acid,
Paracetamol*, Aceclofenac
11 Anti-Infective Agents 8
● Antifungal Agents: Amphotericin-B, Griseofulvin,
Miconazole, Ketoconazole*, Itraconazole,
Fluconazole*, Naftifine Hydrochloride

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 ● Urinary Tract Anti-Infective Agents: Norfloxacin,
Ciprofloxacin, Ofloxacin*, Moxifloxacin,
● Anti-Tubercular Agents: INH*, Ethambutol, Para
Amino Salicylic Acid, Pyrazinamide, Rifampicin,
Bedaquiline, Delamanid, Pretomanid*
● Antiviral Agents: Amantadine Hydrochloride,
Idoxuridine, Acyclovir*, Foscarnet, Zidovudine,
Ribavirin, Remdesivir, Favipiravir
● Antimalarials: Quinine Sulphate, Chloroquine
Phosphate*, Primaquine Phosphate, Mefloquine*,
Cycloguanil, Pyrimethamine, Artemisinin
● Sulfonamides: Sulfanilamide, Sulfadiazine, Sulfametho
xazole, Sulfacetamide*, Mafenide Acetate,
Cotrimoxazole, Dapsone*
12 Antibiotics: Penicillin G, Amoxicillin*, Cloxacillin, 8
Streptomycin, Tetracyclines: Doxycycline, Minocycline,
Macrolides: Erythromycin, Azithromycin, Miscellaneous:
Chloramphenicol* Clindamycin
13 Anti-Neoplastic Agents: Cyclophosphamide*, Busulfan, 3
Mercaptopurine, Fluorouracil*, Methotrexate,
Dactinomycin, Doxorubicin Hydrochloride, Vinblastine
Sulphate, Cisplatin*, Dromostanolone Propionate

PHARMACEUTICAL CHEMISTRY – PRACTICAL

Course Code: ER20-12P 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic training and hands-on experiences
to synthesis chemical substances used as drugs and pharmaceuticals. Also, to
perform the quality control tests, impurity testing, test for purity and systematic
qualitative analysis of chemical substances used as drugs and pharmaceuticals.

Course Objectives: This course will provide the hands-on experience on the
following aspects of chemical substances used as drugs and pharmaceuticals
1. Limit tests and assays of selected chemical substances as per the monograph
2. Volumetric analysis of the chemical substances
3. Basics of preparatory chemistry and their analysis
4. Systematic qualitative analysis for the identification of the chemical drugs

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 PHARMACOGNOSY – THEORY

Course Code: ER20-13T 75 Hours (3 Hours/week)

Scope: This course is designed to impart knowledge on the medicinal uses of

various drugs of natural origin. Also, the course emphasizes the fundamental
concepts in the evaluation of crude drugs, alternative systems of medicine,
nutraceuticals, and herbal cosmetics.

Course Objectives: This course will discuss the following aspects of drug
substances derived from natural resources.
1. Occurrence, distribution, isolation, identification tests of common
phytoconstituents
2. Therapeutic activity and pharmaceutical applications of various natural drug
substances and phytoconstituents
3. Biological source, chemical constituents of selected crude drugs and their
therapeutic efficacy in common diseases and ailments
4. Basic concepts in quality control of crude drugs and various system of
medicines
5. Applications of herbs in health foods and cosmetics

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Identify the important/common crude drugs of natural origin
2. Describe the uses of herbs in nutraceuticals and cosmeceuticals
3. Discuss the principles of alternative system of medicines
4. Describe the importance of quality control of drugs of natural origin

Chapter Topic Hours

1 Definition, history, present status and scope of 2
Pharmacognosy
2 Classification of drugs: 4
● Alphabetical
● Taxonomical
● Morphological
● Pharmacological
● Chemical
● Chemo-taxonomical
3 Quality control of crude drugs: 6
● Different methods of adulteration of crude drugs
● Evaluation of crude drugs

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4 Brief outline of occurrence, distribution, isolation, 6
identification tests, therapeutic activity and pharmaceutical
applications of alkaloids, terpenoids, glycosides, volatile oils,
tannins and resins.
5 Biological source, chemical constituents and therapeutic 30
efficacy of the following categories of crude drugs.
Laxatives Aloe, Castor oil, Ispaghula, Senna
Cardiotonic Digitalis, Arjuna
Carminatives and Coriander, Fennel, Cardamom,
G.I. regulators Ginger, Clove, Black Pepper,
Asafoetida, Nutmeg, Cinnamon
Astringents Myrobalan, Black Catechu, Pale
Catechu
Drugs acting on Hyoscyamus, Belladonna,
nervous system Ephedra, Opium, Tea leaves,
Coffee seeds, Coca
Anti-hypertensive Rauwolfia
Anti-tussive Vasaka, Tolu Balsam
Anti-rheumatics Colchicum seed
Anti-tumour Vinca, Podophyllum
Antidiabetics Pterocarpus, Gymnema
Diuretics Gokhru, Punarnava
Anti-dysenteric Ipecacuanha
Antiseptics and Benzoin, Myrrh, Neem, Turmeric
disinfectants
Antimalarials Cinchona, Artemisia
Oxytocic Ergot
Vitamins Cod liver oil, Shark liver oil
Enzymes Papaya, Diastase, Pancreatin,
Yeast
Pharmaceutical Kaolin, Lanolin, Beeswax, Acacia,
Aids Tragacanth, Sodium alginate, Agar,
Guar gum, Gelatine
Miscellaneous Squill, Galls, Ashwagandha, Tulsi,
Guggul
6 Plant fibres used as surgical dressings: Cotton, silk, wool 3
and regenerated fibres
Sutures – Surgical Catgut and Ligatures
7 ● Basic principles involved in the traditional systems of 8
medicine like: Ayurveda, Siddha, Unani and Homeopathy

● Method of preparation of Ayurvedic formulations like:

Arista, Asava, Gutika, Taila, Churna, Lehya and Bhasma

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 8 Role of medicinal and aromatic plants in national economy 2
and their export potential
9 Herbs as health food: 4
Brief introduction and therapeutic applications of:
Nutraceuticals, Antioxidants, Pro-biotics, Pre-biotics, Dietary
fibres, Omega-3-fatty acids, Spirulina, Carotenoids, Soya
and Garlic
10 Introduction to herbal formulations 4
11 Herbal cosmetics: 4
Sources, chemical constituents, commercial preparations,
therapeutic and cosmetic uses of: Aloe vera gel, Almond oil,
Lavender oil, Olive oil, Rosemary oil, Sandal Wood oil
12 Phytochemical investigation of drugs 2

PHARMACOGNOSY – PRACTICAL

Course Code: ER20-13P 75 Hours (3 Hours/week)

Scope: This course is designed to train the students in physical identification,

morphological characterization, physical and chemical characterization, and
evaluation of commonly used herbal drugs.

Course Objectives: This course will provide hands-on experiences to the students
in
1. Identification of the crude drugs based on their morphological characteristics
2. Various characteristic anatomical characteristics of the herbal drugs studied
through transverse section
3. Physical and chemical tests to evaluate the crude drugs

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Identify the given crude drugs based on the morphological characteristics
2. Take a transverse section of the given crude drugs
3. Describe the anatomical characteristics of the given crude drug under
microscopical conditions
4. Carry out the physical and chemical tests to evaluate the given crude drugs

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 HUMAN ANATOMY AND PHYSIOLOGY – THEORY

Course Code: ER20-14T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on the structure and
functions of the human body. It helps in understanding both homeostasis
mechanisms and homeostatic imbalances of various systems of the human body.

Course Objectives: This course will discuss the following:

1. Structure and functions of the various organ systems and organs of the
human body
2. Homeostatic mechanisms and their imbalances in the human body
3. Various vital physiological parameters of the human body and their
significances

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the various organ systems of the human body
2. Discuss the anatomical features of the important human organs and tissues
3. Explain the homeostatic mechanisms regulating the normal physiology in the
human system
4. Discuss the significance of various vital physiological parameters of the
human body

Chapter Topic Hours

1 Scope of Anatomy and Physiology 2
Definition of various terminologies
2 Structure of Cell: Components and its functions 2
3 Tissues of the human body: Epithelial, Connective, 4
Muscular and Nervous tissues – their sub-types and
characteristics.
4 Osseous system: structure and functions of bones of 3
axial and appendicular skeleton
Classification, types and movements of joints, disorders 3
of joints
5 Haemopoietic system 8
● Composition and functions of blood
● Process of Hemopoiesis
● Characteristics and functions of RBCs, WBCs, and
platelets
● Mechanism of Blood Clotting
● Importance of Blood groups

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6 Lymphatic system 3
● Lymph and lymphatic system, composition, function and
its formation.
● Structure and functions of spleen and lymph node.
7 Cardiovascular system 8
● Anatomy and Physiology of heart
● Blood vessels and circulation (Pulmonary, coronary and
systemic circulation)
● Cardiac cycle and Heart sounds, Basics of ECG
● Blood pressure and its regulation
8 Respiratory system 4
● Anatomy of respiratory organs and their functions.
● Regulation, and Mechanism of respiration.
● Respiratory volumes and capacities – definitions
9 Digestive system 8
● Anatomy and Physiology of the GIT
● Anatomy and functions of accessory glands
● Physiology of digestion and absorption
10 Skeletal muscles 2
● Histology
● Physiology of muscle contraction
● Disorder of skeletal muscles
11 Nervous system 8
● Classification of nervous system
● Anatomy and physiology of cerebrum, cerebellum, mid
brain
● Function of hypothalamus, medulla oblongata and basal
ganglia
● Spinal cord-structure and reflexes
● Names and functions of cranial nerves.
● Anatomy and physiology of sympathetic and
parasympathetic nervous system (ANS)
12 Sense organs - Anatomy and physiology of 6
● Eye
● Ear
● Skin
● Tongue
● Nose
13 Urinary system 4
● Anatomy and physiology of urinary system
● Physiology of urine formation
● Renin - angiotensin system
● Clearance tests and micturition

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 14 Endocrine system (Hormones and their functions) 6
● Pituitary gland
● Adrenal gland
● Thyroid and parathyroid gland
● Pancreas and gonads
15 Reproductive system 4
● Anatomy of male and female reproductive system
● Physiology of menstruation
● Spermatogenesis and Oogenesis
● Pregnancy and parturition

HUMAN ANATOMY AND PHYSIOLOGY – PRACTICAL

Course Code: ER20-14P 75 Hours (3 Hours/week)

Scope: This course is designed to train the students and instil the skills for carrying
out basic physiological monitoring of various systems and functions.

Course Objectives: This course will provide hands-on experience in the following:
1. General blood collection techniques and carrying out various haematological
assessments and interpreting the results
2. Recording and monitoring the vital physiological parameters in human
subjects and the basic interpretations of the results
3. Microscopic examinations of the various tissues permanently mounted in
glass slides
4. Discuss the anatomical and physiological characteristics of various organ
systems of the body using models, charts, and other teaching aids

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Perform the haematological tests in human subjects and interpret the results
2. Record, monitor and document the vital physiological parameters of human
subjects and interpret the results
3. Describe the anatomical features of the important human tissues under the
microscopical conditions
4. Discuss the significance of various anatomical and physiological
characteristics of the human body

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 SOCIAL PHARMACY – THEORY

Course Code: ER20-15T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on public health,

epidemiology, preventive care, and other social health related concepts. Also, to
emphasize the roles of pharmacists in the public health programs.

Course Objectives: This course will discuss about basic concepts of

1. Public health and national health programs
2. Preventive healthcare
3. Food and nutrition related health issues
4. Health education and health promotion
5. General roles and responsibilities of pharmacists in public health

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Discuss about roles of pharmacists in the various national health programs
2. Describe various sources of health hazards and disease preventive measures
3. Discuss the healthcare issues associated with food and nutritional substances
4. Describe the general roles and responsibilities of pharmacists in public health

Chapter Topic Hours

1 Introduction to Social Pharmacy 9
 Definition and Scope. Social Pharmacy as a discipline
and its scope in improving the public health. Role of
Pharmacists in Public Health. (2)
 Concept of Health -WHO Definition, various
dimensions, determinants, and health indicators. (3)
 National Health Policy – Indian perspective (1)
 Public and Private Health System in India, National
Health Mission (2)
 Introduction to Millennium Development Goals,
Sustainable Development Goals, FIP Development
Goals (1)
2 Preventive healthcare – Role of Pharmacists in the 18
following
 Demography and Family Planning (3)
 Mother and child health, importance of breastfeeding, ill
effects of infant milk substitutes and bottle feeding (2)

 Overview of Vaccines, types of immunity and

immunization (4)

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  Effect of Environment on Health – Water pollution,
importance of safe drinking water, waterborne diseases,
air pollution, noise pollution, sewage and solid waste
disposal, occupational illnesses, Environmental pollution
due to pharmaceuticals (7)
 Psychosocial Pharmacy: Drugs of misuse and abuse –
psychotropics, narcotics, alcohol, tobacco products.
Social Impact of these habits on social health and
productivity and suicidal behaviours (2)
3 Nutrition and Health 10
 Basics of nutrition – Macronutrients and Micronutrients
(3)
 Importance of water and fibres in diet (1)
 Balanced diet, Malnutrition, nutrition deficiency diseases,
ill effects of junk foods, calorific and nutritive values of
various foods, fortification of food (3)
 Introduction to food safety, adulteration of foods, effects
of artificial ripening, use of pesticides, genetically
modified foods (1)
 Dietary supplements, nutraceuticals, food supplements
– indications, benefits, Drug-Food Interactions (2)
4 Introduction to Microbiology and common microorganisms 28
(3)

Epidemiology: Introduction to epidemiology, and its

applications. Understanding of terms such as epidemic,
pandemic, endemic, mode of transmission, outbreak,
quarantine, isolation, incubation period, contact tracing,
morbidity, mortality, . (2)

Causative agents, epidemiology and clinical presentations

and Role of Pharmacists in educating the public in
prevention of the following communicable diseases:
 Respiratory infections – chickenpox, measles, rubella,
mumps, influenza (including Avian-Flu, H1N1, SARS,
MERS, COVID-19), diphtheria, whooping cough,
meningococcal meningitis, acute respiratory
infections, tuberculosis, Ebola (7)
 Intestinal infections – poliomyelitis, viral hepatitis,
cholera, acute diarrheal diseases, typhoid, amebiasis,
worm infestations, food poisoning (7)

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  Arthropod-borne infections - dengue, malaria, filariasis
and, chikungunya (4)
 Surface infections – trachoma, tetanus, leprosy (2)
 STDs, HIV/AIDS (3)
5 Introduction to health systems and all ongoing National 8
Health programs in India, their objectives, functioning,
outcome, and the role of pharmacists.

6 Pharmacoeconomics – Introduction, basic terminologies, 2

importance of pharmacoeconomics

SOCIAL PHARMACY – PRACTICAL

Course Code: ER20-15P 75 Hours (3 Hours/week)

Scope: This course is designed to provide simulated experience in various public

health and social pharmacy activities.

Course Objectives: This course will train the students on various roles of
pharmacists in public health and social pharmacy activities in the following areas:
1. National immunization programs
2. Reproductive and child health programs
3. Food and nutrition related health programs
4. Health education and promotion
5. General roles and responsibilities of the pharmacists in public health
6. First Aid for various emergency conditions including basic life support and
cardiopulmonary resuscitation

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the roles and responsibilities of pharmacists in various National
health programs
2. Design promotional materials for public health awareness
3. Describe various health hazards including microbial sources
4. Advice on preventive measures for various diseases
5. Provide first aid for various emergency conditions
Note: Demonstration / Hands-on experience / preparation of charts / models /
promotional materials / role plays / enacting / e-brochures / e-flyers / podcasts /
video podcasts / any other innovative activities to understand the concept of various
elements of social pharmacy listed here. (At least one activity to be carried out for
each one of the following):

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 8. ER-2020 D.Pharm Syllabus – Part II

S. Course Name of the Course Total Total Theory / Tutorial

No. Code Theory / Tutorial Practical Hours
Practical Hours Hours per
Hours per Week
Week
1. ER20-21T Pharmacology – 75 25 3 1
Theory
2. ER20-21P Pharmacology – 50 - 2 -
Practical
3. ER20-22T Community Pharmacy 75 25 3 1
& Management –
Theory
4. ER20-22P Community Pharmacy 75 - 3 -
& Management –
Practical
5. ER20-23T Biochemistry & Clinical 75 25 3 1
Pathology – Theory
6. ER20-23P Biochemistry & Clinical 50 - 2 -
Pathology – Practical
7. ER20-24T Pharmacotherapeutics 75 25 3 1
– Theory
8. ER20-24P Pharmacotherapeutics 25 - 1 -
– Practical
9. ER20-25T Hospital & Clinical 75 25 3 1
Pharmacy – Theory
10. ER20-25P Hospital & Clinical 25 - 1 -
Pharmacy – Practical
11. ER20-26T Pharmacy Law & 75 25 3 1
Ethics

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 PHARMACOLOGY – THEORY

Course Code: ER20-21T 75 Hours (3 Hours/week)

Scope: This course provides basic knowledge about different classes of drugs
available for the pharmacotherapy of common diseases. The indications for use,
dosage regimen, routes of administration, pharmacokinetics, pharmacodynamics,
and contraindications of the drugs discussed in this course are vital for successful
professional practice.

Course Objectives: This course will discuss the following:

1. General concepts of pharmacology including pharmacokinetics,
pharmacodynamics, routes of administration, etc.
2. Pharmacological classification and indications of drugs
3. Dosage regimen, mechanisms of action, contraindications of drugs
4. Common adverse effects of drugs

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the basic concepts of pharmacokinetics and pharmacodynamics2.
Enlist the various classes and drugs of choices for any given disease condition
3. Advice the dosage regimen, route of administration and contraindications for a
given drug
4. Describe the common adverse drug reactions

Chapter Topic Hours

1 General Pharmacology 10
 Introduction and scope of Pharmacology
 Various routes of drug administration - advantages and
disadvantages
 Drug absorption - definition, types, factors affecting
drug absorption
 Bioavailability and the factors affecting bioavailability
 Drug distribution - definition, factors affecting drug
distribution
 Biotransformation of drugs - Definition, types of
biotransformation reactions, factors influencing drug
metabolisms
 Excretion of drugs - Definition, routes of drug excretion
 General mechanisms of drug action and factors
modifying drug action

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2 Drugs Acting on the Peripheral Nervous System 11
 Steps involved in neurohumoral transmission
 Definition, classification, pharmacological actions, dose,
indications, and contraindications of
a) Cholinergic drugs
b) Anti-Cholinergic drugs
c) Adrenergic drugs
d) Anti-adrenergic drugs
e) Neuromuscular blocking agents
f) Drugs used in Myasthenia gravis
g) Local anaesthetic agents
h) Non-Steroidal Anti-Inflammatory drugs
(NSAIDs)
3 Drugs Acting on the Eye 2
Definition, classification, pharmacological actions, dose,
indications and contraindications of
 Miotics
 Mydriatics
 Drugs used in Glaucoma
4 Drugs Acting on the Central Nervous System 8
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 General anaesthetics
 Hypnotics and sedatives
 Anti-Convulsant drugs
 Anti-anxiety drugs
 Anti-depressant drugs
 Anti-psychotics
 Nootropic agents
 Centrally acting muscle relaxants
 Opioid analgesics
5 Drugs Acting on the Cardiovascular System 6
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Anti-hypertensive drugs
 Anti-anginal drugs
 Anti-arrhythmic drugs
 Drugs used in atherosclerosis and
 Congestive heart failure
 Drug therapy for shock

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6 Drugs Acting on Blood and Blood Forming Organs 4
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Hematinic agents
 Anti-coagulants
 Anti-platelet agents
 Thrombolytic drugs
7 Definition, classification, pharmacological actions, dose, 2
indications, and contraindications of
 Bronchodilators
 Expectorants
 Anti-tussive agents
 Mucolytic agents
8 Drugs Acting on the Gastro Intestinal Tract 5
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Anti-ulcer drugs
 Anti-emetics
 Laxatives and purgatives
 Anti-diarrheal drugs
9 Drugs Acting on the Kidney 2
Definition, classification, pharmacological actions, dose,
indications, and contraindications of
 Diuretics
 Anti-Diuretics
10 Hormones and Hormone Antagonists 8
Physiological and pathological role and clinical uses of
 Thyroid hormones
 Anti-thyroid drugs
 Parathormone
 Calcitonin
 Vitamin D
 Insulin
 Oral hypoglycemic agents
 Estrogen
 Progesterone
 Oxytocin
 Corticosteroids

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 11 Autocoids 3
 Physiological role of Histamine, 5 HT and
Prostaglandins
 Classification, clinical uses, and adverse effects of
antihistamines and 5 HT antagonists
12 Chemotherapeutic Agents: Introduction, basic principles 12
of chemotherapy of infections, infestations and neoplastic
diseases, Classification, dose, indication and
contraindications of drugs belonging to following classes:
 Penicillins
 Cephalosporins
 Aminoglycosides
 Fluoroquinolones
 Macrolides
 Tetracyclines
 Sulphonamides
 Anti-tubercular drugs
 Anti-fungal drugs
 Anti-viral drugs
 Anti-amoebic agents
 Anthelmintics
 Anti-malarial agents
 Anti-neoplastic agents
13 Biologicals 2
Definition, types, and indications of biological agents with
examples

PHARMACOLOGY – PRACTICAL

Course Code: ER20-21P 50 Hours (2 Hours/week)

Scope: This course provides the basic understanding about the uses, mechanisms
of actions, dose dependent responses of drugs in simulated virtual animal models
and experimental conditions.

Course Objectives: This course will demonstrate / provide hands-on experience in

the virtual platform using appropriate software on the following
1. Study of pharmacological effects of drugs like local anaesthetics, mydriatic
and mitotic on rabbit eye
2. Screening the effects of various drugs acting in the central nervous system
3. Study of drug effects on isolated organs / tissues
4. Study of pyrogen testing on rabbit

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 COMMUNITY PHARMACY AND MANAGEMENT – THEORY

Course Code: ER20-22T 75 Hours (3 Hours/week)

Scope: The course is designed to impart basic knowledge and skills to provide
various pharmaceutical care services to patients and general practitioners in the
community setup.

Course Objectives: This course will discuss the following:

1. Establishing and running a community pharmacy and its legal requirements
2. Professional aspects of handling and filling prescriptions
3. Patient counselling on diseases, prescription and or non-prescription
medicines
4. Scope for performing basic health screening in community pharmacy settings

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the establishment, legal requirements, and effective administration
of a community pharmacy
2. Professionally handle prescriptions and dispense medications
3. Counsel patients about the disease, prescription and or non-prescription
medicines
4. Perform basic health screening on patients and interpret the reports in the
community pharmacy settings

Chapter Topic Hours

1 Community Pharmacy Practice – Definition, history and 2
development of community pharmacy - International and Indian
scenarios
2 Professional responsibilities of community pharmacists 3

Introduction to the concept of Good Pharmacy Practice and

SOPs.
3 Prescription and prescription handling 7
 Definition, parts of prescriptions, legality of prescriptions,
prescription handling, labelling of dispensed medications
(Main label, ancillary label, pictograms), brief instructions
on medication usage
 Dispensing process, Good Dispensing Practices,
dispensing errors and strategies to minimize them

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4 Communication skills 6
 Definition, types of communication skills
 Interactions with professionals and patients
 Verbal communication skills (one-to-one, over the
telephone)
 Written communication skills
 Body language
 Patient interview techniques
5 Patient counselling 10
 Definition and benefits of patient counselling
 Stages of patient counselling - Introduction, counselling
content, counselling process, and closing the counselling
session
 Barriers to effective counseling - Types and strategies
to overcome the barriers
 Patient counselling points for chronic
diseases/disorders - Hypertension, Diabetes, Asthma,
Tuberculosis, Chronic obstructive pulmonary disease, and
AIDS
 Patient Package Inserts - Definition, i mportance and
benefits, Scenarios of PPI use in India and other countries
 Patient Information leaflets - Definition and uses
6 Medication Adherence 2
Definition, factors influencing non- adherence, strategies to
overcome non-adherence
7 Health Screening Services in Community Pharmacy 5
Introduction, scope, and importance of various health screening
services - for routine monitoring of patients, early detection, and
referral of undiagnosed cases
9 Over The Counter (OTC) Medications 15
 Definition, need and role of Pharmacists in OTC medication
dispensing
 OTC medications in India, counseling for OTC products
 Self-medication and role of pharmacists in promoting the
safe practices during self-medication
 Responding to symptoms, minor ailments, and advice for
self-care in conditions such as - Pain management,
Cough, Cold, Diarrhea, Constipation, Vomiting, Fever,
Sore throat, Skin disorders, Oral health (mouth ulcers,
dental pain, gum swelling)

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 10 Community Pharmacy Management
 Legal requirements to set up a community pharmacy 25
 Site selection requirements
 Pharmacy designs and interiors
 Vendor selection and ordering
 Procurement, inventory control methods, and inventory
management
 Financial planning and management
 Accountancy in community pharmacy – Day book, Cash
book
 Introduction to pharmacy operation softwares – usefulness
and availability
 Customer Relation Management (CRM)
 Audits in Pharmacies
 SOP of Pharmacy Management
 Introduction to Digital Health, mHealth and Online
pharmacies

COMMUNITY PHARMACY AND MANAGEMENT – PRACTICAL

Course Code: ER20-22P 75 Hours (3 Hours/week)

Scope: The course is designed to train the students and improve professional skills
to provide various pharmaceutical care services in community pharmacy.

Course Objectives: This course will train the students in the following
1. Professional handling and filling prescriptions
2. Patient counselling on diseases and minor ailments
3. Patient counselling on prescription and / or non-prescription medicines
4. Preparation of counselling materials such as patient information leaflets
5. Performing basic health screening tests

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Handle and fill prescriptions in a professional manner
2. Counsel patients on various diseases and minor ailments
3. Counsel patients on prescription and or non-prescription medicines
4. Design and prepare patient information leaflets
5. Perform basic health screening tests

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 BIOCHEMISTRY & CLINICAL PATHOLOGY – THEORY

Course Code: ER20-23T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on the study of structure
and functions of biomolecules and the chemical processes associated with living
cells in normal and abnormal states. The course also emphasizes on the clinical
pathology of blood and urine.

Course Objectives: This course will discuss the following at the fundamental level
1. Structure and functions of biomolecules
2. Catalytic activity, diagnostic and therapeutic importance of enzymes
3. Metabolic pathways of biomolecules in health and illness (metabolic
disorders)
4. Biochemical principles of organ function tests and their clinical significance
5. Qualitative and quantitative determination of biomolecules / metabolites in the
biological sample
6. Clinical pathology of blood and urine

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the functions of biomolecules
2. Discuss the various functions of enzymes in the human system
3. Explain the metabolic pathways of biomolecules in both physiological and
pathological conditions
4. Describe the principles of organ function tests and their clinical significances
5. Determine the biomolecules / metabolites in the given biological samples,
both qualitatively and quantitatively
6. Describe the clinical pathology of blood and urine

Chapter Topic Hours

1 Introduction to biochemistry: Scope of biochemistry in 2
pharmacy; Cell and its biochemical organization.
2 Carbohydrates 5
 Definition, classification with examples, chemical
properties
 Monosaccharides - Structure of glucose, fructose, and
galactose
 Disaccharides - structure of maltose, lactose, and
sucrose
 Polysaccharides - chemical nature of starch and
glycogen
 Qualitative tests and biological role of carbohydrates

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3 Proteins 5
 Definition, classification of proteins based on
composition and solubility with examples
 Definition, classification of amino acids based on
chemical nature and nutritional requirements with
examples
 Structure of proteins (four levels of organization of
protein structure)
 Qualitative tests and biological role of proteins and
amino acids
 Diseases related to malnutrition of proteins.
4 Lipids 5
 Definition, classification with examples
 Structure and properties of triglycerides (oils and fats)
 Fatty acid classification - Based on
chemical and nutritional requirements with
examples
 Structure and functions of cholesterol in the body
 Lipoproteins - types, composition and functions in the
body
 Qualitative tests and functions of lipids
5 Nucleic acids 4
 Definition, purine and pyrimidine bases
 Components of nucleosides and nucleotides with
examples
 Structure of DNA (Watson and Crick model), RNA and
their functions
6 Enzymes 5
 Definition, properties and IUB and MB classification
 Factors affecting enzyme activity
 Mechanism of action of enzymes, Enzyme inhibitors
 Therapeutic and pharmaceutical importance of
enzymes
7 Vitamins 6
 Definition and classification with examples
 Sources, chemical nature, functions, coenzyme form,
recommended dietary requirements, deficiency
diseases of fat-and water-soluble vitamins
8 Metabolism (Study of cycle/pathways without chemical 20
structures)
 Metabolism of Carbohydrates: Glycolysis, TCA cycle
and glycogen metabolism, regulation of blood glucose

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 level. Diseases related to abnormal metabolism of
Carbohydrates
 Metabolism of lipids: Lipolysis, β-oxidation of Fatty acid
(Palmitic acid) ketogenesis and ketolysis. Diseases
related to abnormal metabolism of lipids such as
Ketoacidosis, Fatty liver, Hypercholesterolemia
 Metabolism of Amino acids (Proteins): General
reactions of amino acids and its significance–
Transamination, deamination, Urea cycle and
decarboxylation. Diseases related to abnormal
metabolism of amino acids, Disorders of ammonia
metabolism, phenylketonuria, alkaptonuria and
Jaundice.
 Biological oxidation: Electron transport chain
and Oxidative phosphorylation
9 Minerals: Types, Functions, Deficiency diseases, 05
recommended dietary requirements
10 Water and Electrolytes 05
 Distribution, functions of water in the body
 Water turnover and balance
 Electrolyte composition of the body fluids, Dietary
intake of electrolyte and Electrolyte balance
 Dehydration, causes of dehydration and oral
rehydration therapy
11 Introduction to Biotechnology 01
12 Organ function tests 06
 Functions of kidney and routinely performed tests to
assess the functions of kidney and their clinical
significances
 Functions of liver and routinely performed tests to
assess the functions of liver and their clinical
significances
 Lipid profile tests and its clinical significances
13 Introduction to Pathology of Blood and Urine 06
 Lymphocytes and Platelets, their role in health and
disease
 Erythrocytes - Abnormal cells and their significance
 Normal and Abnormal constituents of Urine and their
significance

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 PHARMACOTHERAPEUTICS - THEORY

Course Code: ER20-24T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on etiopathogenesis of

common diseases and their management along with quality use of medicines.

Course Objectives: This course will discuss about

1. Etiopathogenesis of selected common diseases and evidence-based
medicine therapy
2. Importance of individualized therapeutic plans based on diagnosis
3. Basic methods for assessing the clinical outcomes of drug therapy

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Help assessing the subjective and objective parameters of patients in
common disease conditions
2. Assist other healthcare providers to analyse drug related problems and
provide therapeutic interventions
3. Participate in planning the rational medicine therapy for common diseases
4. Design and deliver discharge counselling for patients

Chapter Topic Hours

1 Pharmacotherapeutics – Introduction, scope, and objectives. 8
Rational use of Medicines, Evidence Based Medicine,
Essential Medicines List, Standard Treatment Guidelines
(STGs)
2 Definition, etiopathogenesis, clinical manifestations, non-
pharmacological and pharmacological management of the
diseases associated with
(a) Cardiovascular System
 Hypertension 8
 Angina and Myocardial infarction
 Hyperlipidaemia
 Congestive Heart Failure
(b) Respiratory System 4
 Asthma
 COPD
(c) Endocrine System 5
 Diabetes
 Thyroid disorders - Hypo and Hyperthyroidism
(d) Central Nervous System 8
 Epilepsy

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  Parkinson’s disease
 Alzheimer’s disease
 Stroke
 Migraine
(e) Gastro Intestinal Disorders 8
 Gastro oesophageal reflux disease
 Peptic Ulcer Disease
 Alcoholic liver disease
 Inflammatory Bowel Diseases (Crohn’s Disease and
Ulcerative Colitis)
(f) Haematological disorders 4
 Iron deficiency anaemia
 Megaloblastic anaemia
(g) Infectious diseases 12
 Tuberculosis
 Pneumonia
 Urinary tract infections
 Hepatitis
 Gonorrhoea and Syphilis
 Malaria
 HIV and Opportunistic infections
 Viral Infections (SARS, CoV2)
(h) Musculoskeletal disorders 3
 Rheumatoid arthritis
 Osteoarthritis
(i) Dermatology 3
 Psoriasis
 Scabies
 Eczema
(j) Psychiatric Disorders 4
 Depression
 Anxiety
 Psychosis
(k) Ophthalmology 2
 Conjunctivitis (bacterial and viral)
 Glaucoma
(l) Anti-microbial Resistance 2
(m) Women’s Health 4
 Polycystic Ovary Syndrome
 Dysmenorrhea
 Premenstrual Syndrome

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 HOSPITAL AND CLINICAL PHARMACY – THEORY

Course Code: ER20-25T 75 Hours (3 Hours/week)

Scope: This course is designed to impart fundamental knowledge and professional

skills required for facilitating various hospital and clinical pharmacy services.

Course Objectives: This course will discuss and train the students in the following
1. Hospital and Hospital Pharmacy organization and set-ups
2. Basics of hospital pharmacy services including the procurement, supply chain,
storage of medicines and medical supplies
3. Basics of clinical pharmacy including introduction to comprehensive
pharmaceutical care services
4. Basic interpretations of common laboratory results used in clinical diagnosis
towards optimizing the drug therapy

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Explain about the basic concepts of hospital pharmacy administration
2. Manage the supply chain and distribution of medicines within the hospital
settings
3. Assist the other healthcare providers in monitoring drug therapy and address
drug related problems
4. Interpret common lab investigation reports for optimizing drug therapy

S. No. Topic Hours

1 Hospital Pharmacy
 Definition, scope, national and international scenario 6
 Organisational structure
 Professional responsibilities, Qualification and experience
requirements, job specifications, work load requirements
and inter professional relationships
 Good Pharmacy Practice (GPP) in hospital
 Hospital Pharmacy Standards (FIP Basel Statements,
AHSP)
 Introduction to NAQS guidelines and NABH Accreditation
and Role of Pharmacists
2 Different Committees in the Hospital 4
 Pharmacy and Therapeutics Committee - Objectives,
Composition, and functions
 Hospital Formulary - Definition, procedure for
development and use of hospital formulary

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  Infection Control Committee – Role of Pharmacist in
preventing Antimicrobial Resistance

4 Supply Chain and Inventory Control 14

 Preparation of Drug lists - High Risk drugs, Emergency
drugs, Schedule H1 drugs, NDPS drugs, reserved
antibiotics
 Procedures of Drug Purchases – Drug selection, short
term, long term, and tender/e-tender process, quotations,
etc.
 Inventory control techniques: Economic Order Quantity,
Reorder Quantity Level, Inventory Turnover etc.
 Inventory Management of Central Drug Store – Storage
conditions, Methods of storage, Distribution, Maintaining
Cold Chain, Devices used for cold storage (Refrigerator,
ILR, Walk-in-Cold rooms)
 FEFO, FIFO methods
 Expiry drug removal and handling, and disposal. Disposal
of Narcotics, cytotoxic drugs
 Documentation - purchase and inventory
5 Drug distribution 7
 Drug distribution (in- patients and out - patients) –
Definition, advantages and disadvantages of individual
prescription order method, Floor Stock Method, Unit Dose
Drug Distribution Method, Drug Basket Method.
 Distribution of drugs to ICCU/ICU/NICU/Emergency
wards.
 Automated drug dispensing systems and devices
 Distribution of Narcotic and Psychotropic substances and
their storage
6 Compounding in Hospitals. Bulk compounding, IV admixture 4
services and incompatibilities, Total parenteral nutrition
7 Radio Pharmaceuticals - Storage, dispensing and disposal of 2
radiopharmaceuticals
8 Application of computers in Hospital Pharmacy Practice, 2
Electronic health records, Softwares used in hospital pharmacy
9 Clinical Pharmacy: Definition, scope, and development - in 12
India and other countries

Technical definitions, common terminologies used in clinical

settings and their significance such as Paediatrics, Geriatric,
Anti-natal Care, Post-natal Care, etc.

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 Daily activities of clinical pharmacists: Definition, goal, and
procedure of
 Ward round participation
 Treatment Chart Review
 Adverse drug reaction monitoring
 Drug information and poisons information
 Medication history
 Patient counselling
 Interprofessional collaboration

Pharmaceutical care: Definition, classification of drug related

problems. Principles and procedure to provide pharmaceutical
care

Medication Therapy Management, Home Medication Review

10 Clinical laboratory tests used in the evaluation of disease 10
states - significance and interpretation of test results
 Haematological, Liver function, Renal function, thyroid
function tests
 Tests associated with cardiac disorders
 Fluid and electrolyte balance
 Pulmonary Function Tests
11 Poisoning: Types of poisoning: Clinical manifestations and 6
Antidotes
Drugs and Poison Information Centre and their services –
Definition, Requirements, Information resources with examples,
and their advantages and disadvantages
12 Pharmacovigilance 2
 Definition, aim and scope
 Overview of Pharmacovigilance
13 Medication errors: Definition, types, consequences, and 6
strategies to minimize medication errors, LASA drugs and
Tallman lettering as per ISMP

Drug Interactions: Definition, types, clinical significance of drug

interactions

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 PHARMACY LAW AND ETHICS – THEORY

Course Code: ER20-26T 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on several important

legislations related to the profession of pharmacy in India

Course Objectives: This course will discuss the following

1. General perspectives, history, evolution of pharmacy law in India
2. Act and Rules regulating the profession and practice of pharmacy in India
3. Important code of ethical guidelines pertaining to various practice standards
4. Brief introduction to the patent laws and their applications in pharmacy

Course Outcomes: Upon successful completion of this course, the students will be
able to
1. Describe the history and evolution of pharmacy law in India
2. Interpret the act and rules regulating the profession and practice of pharmacy in
India
3. Discuss the various codes of ethics related to practice standards in pharmacy
4. Interpret the fundamentals of patent laws from the perspectives of pharmacy

Chapter Topics Hours

1 General Principles of Law, History and various Acts related 2
to Drugs and Pharmacy profession
2 Pharmacy Act-1948 and Rules: Objectives, Definitions, 5
Pharmacy Council of India; its constitution and functions,
Education Regulations, State and Joint state pharmacy
councils, Registration of Pharmacists, Offences and
Penalties.

Pharmacy Practice Regulations 2015

3 Drugs and Cosmetics Act 1940 and Rules 1945 and 23

New Amendments
Objectives, Definitions, Legal definitions of schedules to
the Act and Rules Import of drugs – Classes of drugs and
cosmetics prohibited from import, Import under license or
permit.

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 Manufacture of drugs – Prohibition of manufacture and
sale of certain drugs, Conditions for grant of license and
conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis,
manufacture of new drug, loan license and repacking
license.

Study of schedule C and C1, G, H, H1, K, P, M, N, and X.

Sale of Drugs – Wholesale, Retail sale and Restricted

license, Records to be kept in a pharmacy
Drugs Prohibited for manufacture and sale in India

Administration of the Act and Rules – Drugs Technical

Advisory Board, Central Drugs Laboratory, Drugs
Consultative Committee, Government analysts, licensing
authorities, controlling authorities, Drug Inspectors.
4 Narcotic Drugs and Psychotropic Substances Act 1985 2
and Rules Objectives, Definitions, Authorities and Officers,
Prohibition, Control and Regulation, Offences and
Penalties.
5 Drugs and Magic Remedies (Objectionable 2
Advertisements) Act 1954
Objectives, Definitions, Prohibition of certain
advertisements, Classes of Exempted advertisements,
Offences and Penalties.
6 Prevention of Cruelty to Animals Act-1960: Objectives, 2
Definitions, CPCSEA - brief overview, Institutional Animal
Ethics Committee, Breeding and Stocking of Animals,
Performance of Experiments, Transfer and Acquisition of
animals for experiment, Records, Power to suspend or
revoke registration, Offences and Penalties.
7 Poisons Act-1919: Introduction, objective, definition, 2
possession, possession for sales and sale of any poison,
import of poisons
8 FSSAI (Food Safety and Standards Authority of India) 2
Act and Rules: brief overview and aspects related to
manufacture, storage, sale, and labelling of Food
Supplements

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9 National Pharmaceutical Pricing Authority: Drugs Price 5
Control Order (DPCO) - 2013. Objectives, Definitions, Sale
prices of bulk drugs, Retail price of formulations, Retail
price and ceiling price of scheduled formulations,
Pharmaceutical Policy 2002, National List of Essential
Medicines (NLEM)

10 Code of Pharmaceutical Ethics: Definition, ethical 5

principles, ethical problem solving, registration, code of
ethics for Pharmacist in relation to his job, trade, medical
profession and his profession, Pharmacist’s oath.
11 Medical Termination of Pregnancy Act and Rules – basic 2
understanding, salient features, and Amendments

12 Role of all the government pharma regulator bodies – 1

Central Drugs Standards Control Organization (CDSCO),
Indian Pharmacopoeia Commission (IPC)
13 Good Regulatory practices (documentation, licenses, 3
renewals, e-governance) in Community Pharmacy, Hospital
pharmacy, Pharma Manufacturing, Wholesale business,
inspections, import, export of drugs and medical devices
14 Introduction to BCS system of classification, Basic concepts 7
of Clinical Trials, ANDA, NDA, New Drug development,
New Drugs and Clinical Trials Rules, 2019. Brand v/s
Generic, Trade name concept, Introduction to Patent Law
and Intellectual Property Rights, Emergency Use
Authorization
15 Blood bank – basic requirements and functions 2
16 Clinical Establishment Act and Rules – Aspects related to 2
Pharmacy
17 Biomedical Waste Management Rules 2016 – Basic 2
aspects, and aspects related to pharma manufacture to
disposal of pharma / medical waste at homes, pharmacies,
and hospitals
18 Bioethics - Basic concepts, history and principles. Brief 2
overview of ICMR’s National Ethical Guidelines for
Biomedical and Health Research involving human
participants
19 Introduction to the Consumer Protection Act 1
20 Introduction to the Disaster Management Act 1
21 Medical Devices – Categorization, basic aspects related to 2
manufacture and sale

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