FACT WIKI · Institution
Central Drugs Standard Control Organisation
Central Drugs Standard Control Organisation
The Central Drugs Standard Control Organisation functions under India's Directorate General of Health Services.
Roles and functions
Central drug authorities are responsible for approving new drugs and clinical trials in India.
How it works
Central authorities coordinate state drug control organisations and provide expert advice to promote uniform enforcement of the Drugs and Cosmetics Act.
Scope and limitations
Under the Drugs and Cosmetics Act, regulation of drug manufacture, sale and distribution is primarily the responsibility of state authorities. Central authorities have separate responsibilities, including new-drug approval, drug standards and imported-drug quality.
The Drug Controller General of India is responsible for approving licences for specified drug categories, including blood and blood products, intravenous fluids, vaccines and sera.
References
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