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THE PHARMA REVIEW (MAY - JUNE 2012)

Drugs Regulatory Affairs in India

Ajaykumar Sharma

Introduction
Drugs Regulatory Body in India — Central Drugs Standard Control Organization (CDSCO)
CDSCO works under the aegis of the Directorate General of Health Services and Ministry of Health and Family Welfare, Government of India (GoI). Under the Drug and Cosmetics Act, the regulation of manufacture, sales, and distribution of drugs is primarily the concern of the State authorities, while the Central Authorities are responsible for approval of new drugs, clinical trials in the country, laying down the standards for drugs, control over the quality of imported drugs, co-ordination of the activities of State Drug Control Organizations, and providing expert advice with a view of bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.

 

 

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