Introduction of various regulatory agencies

1. Name: Sk. Shaik Banu
Reg.No.12P21R0050
Course: B.Pharmacy IV -I Sem
Guide:
Mr. Voleti.Vijaya Kumar M.Pharmacy.,
Assistant Professor,
Dep of Pharmaceutics,
RAO'S College of Pharmacy,
NELLORE
Principal :
Dr. P. Shanmuga Pandiyan M.Pharmacy.,
Ph.d.,
RAO’S College of Pharmacy,
NELLORE

3. Contents
Definitions
Introduction
Functions of DRA’s
Regulatory agencies in US
- FDA
Canadian HPFBI
Australian TGA
Regulatory agencies in India
-CDSCO
-IPA
-DTAB
-IPC
-ICMR

4. Definitions
■Regulatory Affairs is a comparatively new profession which has
developed from the desire of governments to protect public health,
by controlling the safety and efficacy of products in areas including
pharmaceuticals, veterinary medicines, medical devices, pesticides,
agrochemicals, cosmetics and complementary medicines
■Drug Regulatory Affairs is a function which regulates the
pharmaceutical science in order to facilitate trade / business in and
outside the country of origin for public interest

5. Introduction:
.
To protect consumer’s health
against harm resulting from
poor quality medicinal
products, drug regulatory
agencies have been developed
in many industrialized
countries of the world.

6. Functions of DRA’s
■Licensing, registration and labelling of new pharmaceutical
products.
■Inspection of manufacturing facilities and distribution
channels
■Training of health care professionals
■Arrangement of awareness programmes for general public

7. US FDA
TGA
HPFBI
CDSCO

8. United states food and drugs
administration
.
•It is an agency of one of the United States federal Human Services.
•The main role of FDA is to protect and promote public health by
controlling and monitoring the manufacture, import, transport, vaccines,
cosmetics etc.
•It also evaluates the applications for new drugs, biologicals, medical
devices, food and infant formulae.

9. Offices of inspectorate Responsibilities
Office of the commissioner Centre for scientific activities, policy making and planning,
women’s and minority health initiatives, scientific activities.
Centre for biologics evaluation & research To provide information regarding safe and appropriate use of
biological therapeutic agents to common public.
Centre for devices & radiological health To provide accessible science-based information about the
products to the consumers
Centre for drug evaluation and research To regulate prescription as well as OTC drugs including
biological therapeutics and generic drugs like sunscreen
lotions etc.
Centre for tobacco products To establish and enforce advertising and promotion
restrictions pertaining to tobacco products.
Centre for veterinary medicines To review and evaluate the available data regarding safety
and efficacy of marketed animal drugs as well as animal drugs
under investigation.
Centre for food safety and applied nutrition It assures the safety & appropriate labeling of almost all the
food products except meat products in US
National centre for toxicological research To advance scientific approaches and tools.
Office of regulatory affairs investigators inspect the production and
warehousing facilities and investigate complaints,

10. Canadian Health Products and
Food Branch Inspectorate
■It helps canadians to maintain and improve their health whilst
respecting individual choices and circumstances, aims at listing
canada among the countries with the healthiest people in the
world.
■The primary function of HPFBI is to implement a national
compliance and enforcement program for the products that are
under the regulation of Health Canada.

11. The HPFBI has 10 responsibility offices which are
discussed below:
Offices of inspectorate Responsibilities
1 Director General’s office To liaise with other directorates, other
branch offices and the office of
Assistant Deputy Minister.
1 Inspectorate Ottawa Licensing activities
2 Laboratories To ensure support to inspection and
investigations
6 Regional Offices To conduct inspection and
investigations.

12. ■It was formed under the Therapeutic Goods Act 1989 to
regulate therapeutic goods including medicines, medical
devices, blood, tissues and blood products in Australia,
thereby protecting public health and safety.
■It also aims to make sure that the Australian community,
within a time frame has access to new therapeutic goods.

13. Organisation structure:
Offices Responsibilities
Market Authorization Group (MAG) To decide whether or not to approve the
therapeutic goods imported, exported,
manufactured and supplied in Australia.
Monitoring and Compliance
Group(MCG)
It monitors the therapeutic products
approved for the supply in Australia
Regulatory Support Group It provides regulatory support services
like legal, human resource management,
finance, information technology and
parliamentary management services.

14. Functions of TGA:
■Evaluation of the quality, safety and efficacy of prescription
drugs and other drugs like OTC medicines, alternative
medicines and medical devices.
■To control the export of drugs and medical devices from
Australia.
■To control drug and device advertisements.
■To monitor adverse drug reactions.

15. ■It is a drug regulatory organization of India.
■The vision of CDSCO is to protect and promote public health
in India and its mission is to safeguard and enhance public
health by assuring safety, efficacy and quality of drugs,
cosmetics and medical devices.

17. Functions:
■Laying down the safety and quality standards for drugs,
cosmetics, diagnostics, and devices.
■Regulatory the marketing of new drugs.
■Publishing and updating the Indian Pharmacopoeia.
■Guiding on technical matters and monitoring adverse drug
reactions.
■Screening the drug formulations that are available in the
Indian market.

18. ■Indian Pharmaceutical Association (IPA) is the premier
professional association of pharmacists in India.
■The association has more than 10,000 members from various
parts of the country and it operates in India through 17 state
branches & more than 33 local branches
■The Indian Pharmaceutical Association (IPA) has demanded
to amend the Drugs &Cosmetics Act and Rules 1945 to make
only the pharmacy graduates eligible to become expert staffs in
the pharma manufacturing units

19. Drug Technical Advisory Board (DTAB)
■The Central Government constitute a Board (to be called the
Drugs Technical Advisory Board) to advise the Central
Government and the State Governments on technical matters
arising out of the administration of D&C, Act 1940

20. The Board shall consist of the following members:
10 ex-officio
members
5 Nominated
members
5 Elected
MembersDTAB
-20 members

21. Activities and responsibilities
■It advices matter related to drugs.
■The nominated and elected members of the Board shall hold
office for three years, but shall be eligible for re-nomination and
re-election.
■The Board may, subject to the previous approval of the central
Government, regulating its own procedure.

22. General body
(19
Members)
Governing
body
(10members)
CIPL lab
Scientific
body
23 experts
IPC
secretariat
IPC

23. Responsibilities
■Development of comprehensive monographs.
■Accord priority to monographs of drugs included in the
national essential drug list and their dosage forms.
■Preparation of monographs for products that have normally
been in the market for not less than 2 years.

24. Indian council of Medical Research (ICMR)
■The Indian Council of Medical Research
(ICMR), New Delhi, the apex body in
India for the formulation, coordination and
promotion of biomedical research, is one
of the oldest medical research bodies in
the world.

25. Indian Council of Medical Research
Structure and
organization

26. Responsibilities
■Extramural research is promotes by ICMR by establishing
■Open ended research is conducted on the basis of applications
for grants in aid received from scientists in non-ICMR Research
institutes, Medical colleges and Universities located in different
parts of the country.

27. References
1. Hasumati Rahalkar, Historical Overview of Pharmaceutical Industry and Drug
Regulatory Affairs, Kurz, Pharmaceut Reg Affairs 2012, S11-002
http://www.slideshare.net/BeenaMaddi/international-regulatory-agencies
http://www.fda.gov/
http://www.hc-sc.gc.ca/index-eng.php
https://www.tga.gov.au/
6,8 http://www.slideshare.net/sampathramaswamy1/regulatory-aspects-17409779
7.http://www.ipapharma.org/
9. http://www.ipc.gov.in
10. http://www.icmr.nic.in