Pharmaceutical regulatory authorities of India

Information about pharmaceutical regulatory authorities in India and information about WHO and aAyush

1. Pharmaceutical Regulatory Authorities
Of India
SEMINAR PRESENTATION
Prepared by:-Rutuja Nale
First year
M.Pharm semester2 (PQA)
Rajarambapu College Of Pharmacy
Kasegaon
Guided by:-Prof. Archna Dhole
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Date :-8 June 2021

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Content:-
•Introduction
•Regulatory Bodies
1.Central drug standard control organization (CDSCO)
2.Indian pharmaceutical association (IPA)
3.Drug technical advisory board (DTAB)
4.Central drug testing laboratory (CDTL)
5.Indian pharmacopoeia commission (IPC)
6.National pharmaceutical pricing authority (NPPA)
7.Indian council of medical research (ICMR)
•DETAILS OF
1.World health organization (WHO)
2.AYUSH
3.ICMR

3. India’s Ministry of Health and Family Welfare (MoHFW)
1.Central drug standard control organization
(CDSCO)
2.Indian pharmaceutical association (IPA)
3.Drug technical advisory board(DTAB)
4.Central drug testing laboratory (CDTL)
5.Indian pharmacopoeia commission (IPC)
6.National pharmaceutical pricing authority (NPPA)
7.Indian council of medical research (ICMR)
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4. SIX-ZONAL OFFICES
Mumbai, Kolkata, Chennai , Ghaziabad ,
ahmedabad,
Hyderabad
Seven laboratories
Kolkata,Mumbai, Chennai,kasauli ,
gujarati,
Chandigarh, Hyderabad
Port offices
Delhi, Kolkata, Indore, Hyderabad , Cochin,
Visakhapatnam, krishnapatnam ,
Ahmadabad,Bangalore, Hazira,
Goa, Mumbai , Chennai
Sub –zonal offices
Benguluru , Varanasi, Goa , Jammu and
Kashmir ,
Indore , Guwahati, Bandi
CDSCO
HEADQUARTERS
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6. Drug approval process:-
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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 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.

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•Sugam builds a comprehensive database of the various permissions and
licenses issued by State FDAs.
•This includes details of manufacturers, manufacturing site and drug
formulations.
•Manufacturer can view their consolidated data about permissions issued
to them from State FDA.

9. INDIAN PHARMACEUTICAL ASSOCIATION
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•Connecting The Pharmacists and Pharmaceutical Scientists of India —The
Indian Pharmaceutical Association (IPA) is the National body representing
over 1 million pharmacists and pharmaceutical scientists from Industry,
Academia, Regulatory, Hospital and Community Pharmacy and work to
meet the India’s health care needs.
•IPA is a non-governmental organization that has been in official relations
with the FIP and WHO.
•IPA is member of Drug Technical Advisory Board (DTAB), Ministry of Health
and Family Welfare, Government of India.
•IPA has been awarded “Best Professional Organisation Award -2015” by
Indian Association Congress.

10. IPA PUBLICATION
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11. DrugsTechnicalAdvisoryBoard
•Drugs Technical Advisory Board is astatutory bodyconstituted under theDrugs and Cosmetics
Act, 1940.
•The function of DTAB is to advise the Central government and State government on technical
matters related to drugs and cosmetics.
Section3oftheDrugsandCosmeticsAct,1940
•The Central Government, after consultation with
the Drugs Technical Advisory Board (DTAB),
specifies the devices intended foruse in human
beings or animals as drugs.
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12. 1.Central Drugs Testing Laboratory, Mumbai, Maharashtra
2.Central Drugs Laboratory, Kolkata, West Bengal
3.Central Drugs Testing Laboratory, Chennai, Tamil Nadu
4.Central Drugs Testing Laboratory, Hyderabad, Andhra Pradesh
5.Central Drugs Laboratory, Central Research Institute, Kasauli, Himachal
Pradesh
6.Regional Drugs Testing Laboratory, Guwahati, Assam
7.Regional Drugs Testing Laboratory, Chandigarh
A. Central Drugs Testing Laboratories
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15. TheNational Pharmaceutical Pricing Authority(NPPA) is a government regulatory agency that
controls the prices of pharmaceutical drugs inIndia.
[1]
.National Pharmaceutical Pricing Authority
(NPPA) was constituted vide Government of India Resolution dated 29th August, 1997 as an
attached office of the Department of Pharmaceuticals (DoP),Ministry of Chemicals and
Fertilizersas an independent Regulator for pricing of drugs and to ensure availability and
accessibility of medicines at affordable prices.
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16. The World Health Organization is a specialized agency of the United Nations responsible for
international public health. The WHO Constitution, which establishes the agency's governing
structure and principles, states its main objective as "the attainment by all peoples of the highest
possible level of health".
What is the WHO definition of health?
Health is a state of complete physical, mental and social well-being and not merely the
absence of disease or infirmity.
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18. 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.
The Council's research priorities coincide with the National health priorities, such as: control and
management of communicable diseases, fertility control, maternal and child health, control of
nutritional disorders, developing alternative strategies for health care delivery, containment
within safety limits of environmental and occupational health problems; research on major non-
communicable diseases like cancer, cardiovascular diseases, blindness, diabetes and other
metabolic and haematological disorders; and mental health research and drug research
(including traditional remedies).
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