An introduction to standard institutions and regulatory authorities such as ICH, WHO, USFDA, MHRA, TGA, BIS, ASTM, ISO, CDSCO

such as
ICH, WHO, USFDA,
MHRA, TGA, BIS, ASTM,
ISO, CDSCO.
Mr. Hemant Alhat

ICH : International Council for Harmonisation
 The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) is
unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical
aspects of pharmaceuticals and develop ICH guidelines.
Since its inception in 1990,
 ICH has gradually evolved, to respond to increasingly global
developments in the pharmaceutical sector and these ICH
ICH has gradually evolved, to respond to increasingly global
developments in the pharmaceutical sector and these ICH
guidelines are applied by a growing number of regulatory
authorities.
 ICH's mission is to achieve greater harmonisation worldwide
to ensure that Safe, Effective & High Quality Medicines are
developed, and registered and maintained in the most
resource efficient manner whilst meeting high standards. Since
its announcement of organisational changes in October 2015,
 ICH has grown as an organisation and now includes 17 Members
and 32 Observers.
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ICH’s Mission
 With ICH’s establishment as an international non-profit
Association under Swiss law on October 23, 2015,
 ICH’s mission has been embodied in its Articles of Association as
follows:
 To make recommendations towards achieving greater
harmonisation in the interpretation and application of
technical guidelines and requirements for pharmaceutical
harmonisation in the interpretation and application of
technical guidelines and requirements for pharmaceutical
product registration and the maintenance of such
registrations;
 To maintain a forum for a constructive dialogue on
scientific issues between regulatory authorities and the
pharmaceutical industry on the harmonisation of the
technical requirements for pharmaceutical products;
 To contribute to the protection of public health in the
interest of patients from an international perspective;
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ICH’s Mission
 To monitor and update harmonised technical requirements
leading to a greater mutual acceptance of research and development
data;
 To avoid divergent future requirements through harmonisation of
selected topics needed as a result of therapeutic advances and the
development of new technologies for the production of medicinal
products;
To facilitate the adoption of new or improved technical research To facilitate the adoption of new or improved technical research
and development approaches which update or replace current practices;
 To encourage the implementation and integration of common
standards through the dissemination of, the communication of
information about and coordination of training on, harmonised
guidelines and their use; and
 To develop policy for the ICH Medical Dictionary for Regulatory
Activities Terminology (MedDRA) whilst ensuring the scientific and
technical maintenance, development and dissemination of MedDRA as
a standardised dictionary which facilitates the sharing of regulatory
information internationally for medicinal products used by humans.
 https://www.ich.org/page/mission
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World Health Organization (WHO)
 World Health Organization (WHO), the United Nations’
specialized agency for Health was founded in 1948.
 Its headquarters are situated in Geneva, Switzerland.
 There are 194 Member States, 150 country offices, six
regional offices.regional offices.
 It is an inter-governmental organization and works in
collaboration with its member states usually through
the Ministries of Health.
 The WHO provides leadership on global health matters,
shaping the health research agenda, setting norms and
standards, articulating evidence-based policy options,
providing technical support to countries and monitoring
and assessing health trends.
 It began functioning on April 7, 1948 – a date now being
celebrated every year as World Health Day. 5
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World Health Organization (WHO)
 Objectives
 To act as the directing and coordinating authority on
international health work.
 To establish and maintain effective collaboration with
the United Nations, specialized agencies, governmental
To establish and maintain effective collaboration with
the United Nations, specialized agencies, governmental
health administrations, professional groups and such other
organizations as may be deemed appropriate.
 To provide assistance to the Governments, upon
request, in strengthening health services.
 To promote cooperation among scientific and
professional groups which contribute to the
advancement of health.
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WHO’s Contribution to World
 The country offices are WHO’s primary contact
points with governments.
 They provide technical support on health matters,
share relevant global standards and guidelines, and
relay government requests and requirements to otherrelay government requests and requirements to other
levels of WHO.
 They also inform and follow up with the host
government on reports of disease outbreaks outside the
country.
 They provide advice and guidance on public health
to other UN agency offices in-country.
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WHO and India
 India became a party to the WHO on 12 January 1948.
 Regional office for South East Asia is located in New Delhi.
 Smallpox
 In 1967 the total number of smallpox cases recorded in India
accounted for nearly 65% of all cases in the world. Of this 26,225
cases died, giving a grim picture of the relentless fight that lay
accounted for nearly 65% of all cases in the world. Of this 26,225
cases died, giving a grim picture of the relentless fight that lay
ahead.
 In 1967, the WHO launched the Intensified Smallpox
Eradication Programme.
 With a coordinated effort by Indian government with the World
Health Organization (WHO), smallpox was eradicated in 1977.

https://www.drishtiias.com/important-institutions/drishti-
specials-important-institutions-international-institution/world-
health-organization-who
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USFDA
 The U.S. Food and Drug Administration (FDA) is
composed of seven Centers responsible for ensuring
the tobacco products, Safety, Efficacy, Oversight
And Security Of The Nation's Human AndAnd Security Of The Nation's Human And
Veterinary Drugs, biological products, medical
devices, food, cosmetics and products that emit
radiation.
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 What is USFDA?
 The government of the United States established the U.S. Food
and Drug Administration (USFDA) as the REGULATORY BODY
that REVIEWS, APPROVES & REGULATES medical products,
including pharmaceutical drugs and medical devices.
 Products the USFDA Regulates
 With this in mind, the agency is mainly responsible for
protecting public health by regulating the following-protecting public health by regulating the following-
 Human drugs and biologics
 Animal drugs
 Medical devices
 Tobacco products
 Food (including animal food)
 Cosmetics
 Electronic products that emit radiation
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Regulatory Process of USFDA
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Responsibilities of the USFDA-
 The regulation responsibilities of the body include-
 Protecting public health by ensuring the SAFETY, EFFICACY, AND
SECURITY of human and veterinary drugs, medical devices, vaccines,
andbiological products.
 to ensure they use medical products and foods with safety.
Empowering the public by giving them accurate, science-based
informationinformation
 ENSURING THE SAFETY of food by properly labeling them.
 Protecting public health by manufacturing, marketing and
distributing tobacco products and providing cautionary measures
to reduce tobacco use by minors.
 Ensuring public safety from radiation released by certain
electronic products.
 Advancing public health by speeding up innovations that make
medical equipment more effective, safer, and more affordable.
 Fulfills the role of Nation’s counterterrorism capability by ensuring
food
 https://www.pristyncare.com/blog/know-about-usfda/
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MHRA
Medicines And Healthcare Products Regulatory Agency
 The Medicines and Healthcare products Regulatory Agency
regulates medicines, medical devices and blood components for
transfusion in the UK.
 Recognised GLOBALLY as an authority in its field, the agency plays a
leading role in protecting and improving public health and
supports innovation through scientific research andsupports innovation through scientific research and
development.
 The agency has 3 centres:
 the Clinical Practice Research Datalink (CPRD), a data research
service that aims to improve public health by using
anonymised NHS clinical data
 The National Institute for Biological Standards and Control
(NIBSC), a global leader in the standardisation and control of
biological medicines
 the Medicines and Healthcare products Regulatory Agency
(MHRA), the UK’s regulator of medicines, medical devices and
blood components for transfusion, responsible for ensuring their
safety, quality and effectiveness 13
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Responsibilities
 The agency is responsible for:
 Ensuring that medicines, medical devices and blood components
for transfusion MEET applicable STANDARDS of safety, quality and
efficacy
 Ensuring that the supply chain for medicines, medical devices and
blood components is SAFE AND SECUREblood components is SAFE AND SECURE
 Promoting international standardisation and harmonisation to
assure the effectiveness and safety of biological medicines
 Helping to educate the public and healthcare professionals about
the risks and benefits of medicines, medical devices and blood
components, leading to safer and more effective use
 Supporting innovation and research and development that’s
beneficial to public health
 Influencing UK, EU and international regulatory frameworks so
that they’re risk-proportionate and effective at protecting public health
 https://www.gov.uk/government/organisations/medicines-and-
healthcare-products-regulatory-
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Therapeutic Goods Administration (TGA)
 The TGA is responsible for Regulating the supply,
import, export, manufacturing and advertising of
therapeutic goods.
 The ARTG (Australian Register of Therapeutic The ARTG (Australian Register of Therapeutic
Goods) contains therapeutic goods that can be
lawfully supplied in Australia.
 The TGA is a part of the Australian Government
Department of Health.
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The role of the TGA
 Evaluate therapeutic goods before they are supplied
 Focus on SAFETY, QUALITY AND PERFORMANCE
 Monitor products once they are on the market
Allow for access to unapproved goods in certain Allow for access to unapproved goods in certain
circumstances
 We do not make decisions based on value for
money or make decisions about which products
receive Government subsidy
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https://www.tga.gov.au/role-
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BIS
Bureau of Indian Standards
 Bureau of Indian Standards (hereinafter referred to
as ‘BIS’) is a statutory body established under the
Bureau of Indian Standards Act, 2016 (hereinafter
referred to as the ‘Act’).referred to as the ‘Act’).
 BIS prescribes the standards for covering goods
and systems under the standardization regime.
 BIS has been identified as the ‘National Standards
Body of India’ and is regulated under the Ministry
of Consumer Affairs, Food & Public Distribution,
and Government of India.
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Functions of BIS
 BIS through its core activities of standardization and conformity
assessment, has been benefiting the economy by providing safe
and reliable and quality goods; minimizing health hazards to
consumers;
 protecting the environment, promoting exports and imports
substitute;
 controlling proliferation of varieties etc.
 The standards and certification scheme of BIS apart from The standards and certification scheme of BIS apart from
benefitting the consumers and industry also support various
public policies especially in areas of product safety, consumer
protection, food safety, environment protection, building and
construction, etc.[1]
 BIS carries out various activities like that of standards formulation,
product certification, hallmarking, laboratory services, training
services, etc.
 However, the primary and most recognized objective of BIS is to
formulate and prescribe the standards for products for their
certification.
 BIS also ensures the harmonious development of the activities
of standardization, marking and quality certification of goods. 19
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Schemes of certification
are covered under BIS
 The following schemes of certification are covered under BIS
 Product Certification Scheme – Applicable for tangible
products; with some products classified under compulsory
certification.
 System Certification Scheme – Applicable for systems/
process
 System Certification Scheme – Applicable for systems/
process
 Foreign Manufacturers Certification Scheme - Applicable for
foreign manufacturers who are engaged in the sale of their
products in India.
 Hallmarking – Applicable for articles made from precious
metals like gold and silver
 ECO Mark Scheme – Applicable for products affecting or
related to the environment
 https://www.lexology.com/library/detail.aspx?g=9e0c0900-
8a29-4a0d-88d8-32c8652dc3e0
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ASTM
American Society for Testing and Materials
 ASTM International, formerly known as American Society for
Testing and Materials, is an international standards
organization that develops and publishes voluntary
consensus technical standards for a wide range of materials,
products, systems, and services.
 Some 12,575 ASTM voluntary consensus standards operate Some 12,575 ASTM voluntary consensus standards operate
globally.
 The organization's headquarters is in West Conshohocken,
Pennsylvania, about 5 mi (8.0 km) northwest
of Philadelphia.
 Founded in 1898 as the American Section of
the International Association for Testing Materials (see
also International Organization for Standardization),
 ASTM International predates other standards organizations such
as the British
Standards BSI (1901), IEC (1906), DIN (1917), ANSI (1918), AFNOR
(1926), and ISO (1947). 21
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 ASTM International has no role in requiring or enforcing compliance
with its standards. The standards, however, may become mandatory when
referenced by an external contract, corporation, or government.[5]
 In the United States, ASTM standards have been adopted, by incorporation
or by reference, in many federal, state, and municipal government
regulations.
 The National Technology Transfer and Advancement Act, passed in 1995,
requires the federal government to use privately developed consensus standards
whenever possible. The Act reflects what had long been recommended aswhenever possible. The Act reflects what had long been recommended as
best practice within the federal government.
 Other governments (local and worldwide) also have referenced ASTM
standards.[8]
 Corporations doing international business may choose to reference an ASTM
standard.
 All toys sold in the United States must meet the safety requirements of ASTM
F963, Standard Consumer Safety Specification for Toy Safety, as part of
the Consumer Product Safety Improvement Act of 2008 (CPSIA). The law
makes the ASTM F963 standard a mandatory requirement for toys while the
Consumer Product Safety Commission (CPSC) studies the standard's
effectiveness and issues final consumer guidelines for toy safety.[9]
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ISO
International Organization for Standardization
 The International Organization for
Standardization (ISO)is an international standard-
setting body composed of representatives from
various national standards organizations.various national standards organizations.
 Founded on 23 February 1947, the organization
promotes worldwide proprietary, industrial, and
commercial standards. It is headquartered in Geneva,
Switzerland,[3] and works in 164 countries.[1]
 It was one of the first organizations granted general
consultative status with the United Nations Economic
and Social Council.
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ISO
International Organization for Standardization
 The ISO is an independent, non-governmental organization, the
members of which are the standards organizations of the 164
member countries.[1]
 It is the world's largest developer of voluntary international
standards and it facilitates world trade by providing common
standards among nations.
 More than 20 thousand standards have been SET, covering More than 20 thousand standards have been SET, covering
everything from manufactured products and technology to food safety,
agriculture, and healthcare.[3]
 Use of the standards aids in the creation of products and services
that are safe, reliable, and of good quality.
 The standards help businesses increase productivity while
minimizing errors and waste. By enabling products from different
markets to be directly compared, they facilitate companies in
entering new markets and assist in the development of global
trade on a fair basis.
 The standards Also Serve To Safeguard Consumers and the end-
users of products and services, ensuring that certified products
conform to the minimum standards set internationally.[3]
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Structure ISO
 ISO is a voluntary organization whose members are
recognized authorities on standards, each one
representing one country. Members meet annually at a
General Assembly to discuss the strategic objectives of ISO.General Assembly to discuss the strategic objectives of ISO.
The organization is coordinated by a central secretariat
based in Geneva.[9]
 A council with a rotating membership of 20 member
bodies provides guidance and governance, including
setting the annual budget of the central secretariat.[9][10]
 The technical management board is responsible for
more than 250 technical committees, who develop the
ISO standards.[9][11][12][13]
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CDSCO
Central Drugs Standard Control Organisation
 The Central Drugs Standard Control
Organisation(CDSCO)under Directorate General of
Health Services,Ministry of Health & Family
Welfare,Government of India is the National
Regulatory Authority (NRA) of India.
 Its headquarter is located at FDA Bhawan, Kotla Road, Its headquarter is located at FDA Bhawan, Kotla Road,
New Delhi 110002 and also has six zonal offices, four sub
zonal offices,thirteen Port offices and seven laboratories
spread across the country.
 The Drugs & Cosmetics Act,1940 and rules 1945 have
entrusted various responsibilities to central & state
regulators for regulation of drugs & cosmetics.
 It envisages / foresee uniform implementation of the
provisions of the Act & Rules made there under for
ensuring the safety, rights and well being of the
patients by regulating the drugs and cosmetics. 26
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 CDSCO is constantly thriving upon to bring out transparency,
accountability and uniformity in its services in order to
Ensure Safety, Efficacy And Quality Of The Medical Product
manufactured, imported and distributed in the country.
 Under the Drugs and Cosmetics Act, CDSCO is
RESPONSIBLE for Approval of Drugs, Conduct of Clinical
Trials, laying down the standards for Drugs, control over the
CDSCO
Trials, laying down the standards for Drugs, control over the
quality of imported Drugs in the country and coordination
of the activities of State Drug Control Organizations by
providing expert advice with a view of bring about the
uniformity in the enforcement of the Drugs and Cosmetics Act.
 Further CDSCO along with state regulators, is jointly
responsible for grant of licenses of certain specialized
categories of critical Drugs such as blood and blood products, I.
V. Fluids, Vaccine and Sera.
https://cdsco.gov.in/opencms/opencms/en/About-
us/Introduction/ 27
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 Within the CDSCO, the Drug Controller General of India (DCGI)
REGULATES pharmaceutical and medical devices, under the
gamut of Ministry of Health and Family Welfare. The DCGI is
ADVISED by the Drug Technical Advisory Board (DTAB) and the Drug
Consultative Committee (DCC). It is divided into zonal offices which
do pre-licensing and post-licensing inspections, post-market
surveillance, and recalls when needed.[3][4] Manufacturers who deal
CDSCO
surveillance, and recalls when needed. Manufacturers who deal
with the authority are required to name an Authorized Indian
Representative (AIR) to represent them in all dealings with the
CDSCO in India.[5]
 Though the CDSCO has a good track record with the World Health
Organization,[6] it has also been accused of past collusion with
independent medical experts and pharmaceutical
companies.[7] CDSCO plans to open international offices in Beijing,
China.[8]
 https://en.wikipedia.org/wiki/Central_Drugs_Standard_Control_Orga
nisation
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 What do GMP, ISO and QSR mean, and how do they differ?
 Posted on by TriLink BioTech
 GMP stands for Good Manufacturing Practices, and refers to a system of
manufacturing that guarantees reproducibility of product quality to set
specifications. cGMP is simply Current Good Manufacturing Practices and
refers to compliance with current regulations. It can be considered redundant
since to be GMP compliant you must comply with current GMP regulations
anyways. The requirements differ depending on what type of product is being
manufactured and whether it is for pharmaceutical or diagnostic purposes. ISO
stands for International Organization for Standardization, which offers a
standard for operating a firm from management through manufacturing. It isstandard for operating a firm from management through manufacturing. It is
more encompassing than GMP. QSR stands for Quality Systems Regulation,
which are GMP standards described by the FDA for the manufacture of
products for the diagnostic industry. The ISO and QSR systems each describe
specific GMP standards. The ISO system pays more attention to the
management of the firm and places a number of reporting loops in the firm to
ensure attention to issues. The QSR system is more focused on the
manufacturing systems, and the validation of those systems. Although neither
standard is required to maintain GMP facilities, it is essential that a firm
satisfies the requirements of the client’s quality system. Generally, this means
conforming to ISO or QSR standards. Every product made at TriLink is
manufactured under GMP. We are compliant with ISO 9001.
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An introduction to standard institutions and regulatory authorities such as ICH, WHO, USFDA, MHRA, TGA, BIS, ASTM, ISO, CDSCO

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An introduction to standard institutions and regulatory authorities such as ICH, WHO, USFDA, MHRA, TGA, BIS, ASTM, ISO, CDSCO