Know about few approved regulatory bodies and agencies in technology transfer for drug approval in India as per WHO guidelines.
Approved Regulatory Bodies and Agencies
These are the regulatory agencies of India for new drug approval:
Central Drug Standard Control Organization (CDSCO):
- This is the main authority in charge of drug-related matters for the government.
- It oversees six zonal offices, four sub-zonal offices, thirteen port offices and seven laboratories.
Ministry of Health & Family Welfare (MHFW):
- This ministry used to have two departments – one for health and family welfare and one for health research.
- Each department was supervised by a Secretary of the Government of India.
Indian Council of Medical Research (ICMR):
- This is one of the oldest medical research organizations globally.
- It leads the way in coordinating and advancing biomedical research in India.
Indian Pharmaceutical Association (IPA):
- Established in 1939, this is a prominent association of pharmaceutical professionals in India.
- It has around 13,000 members across the country, covering various aspects of pharmacy practices and education.
Drug Technical Advisory Board (DTAB):
- This is an important body that deals with technical decisions related to drugs in India.
- It operates under the Ministry of Health and Family Welfare as part of CDSCO.
Central Drug Testing Laboratory (CDTL), Mumbai:
- This lab is one of the national labs in India that’s responsible for drug testing.
- It operates under various governmental bodies for health services.
Indian Pharmacopoeia Commission (IPC):
- This is an independent institution under the Ministry of Health & Family Welfare.
- It is responsible for setting drug standards in India.
- Help to improve the quality of medicines.
National Pharmaceutical Pricing Authority (NPPA):
- Created as an autonomous regulator
- This authority ensures that drug prices are fair and medicines are accessible.
- It is part of the Department of Pharmaceuticals.
Drug Controller General of India (DCGI):
- Responsible for approving licenses for certain types of drugs like blood products and vaccines
- This position falls under the Ministry of Health and Family Welfare.
Review Committee on Genetic Manipulation (RCGM):
- Under the Ministry of Science and Technology
- This committee oversees the safety of research projects involving genetically modified organisms.
Genetic Engineering Approval Committee (GEAC):
- Working under the Ministry of Environment, Forest and Climate Change
- This committee oversees activities involving genetically engineered organisms to ensure environmental safety.
These are Approved Regulatory Bodies and Agencies in in India responsible for new drug approval.
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