CDSCO
Mandate and Regulatory Authority
The Central Drugs Standard Control Organisation (CDSCO), operating under the Directorate General of Health Services within the Ministry of Health and Family Welfare, is India's National Regulatory Authority (NRA) for drugs, cosmetics, medical devices, and clinical trials. Its primary statutory basis is the Drugs and Cosmetics Act, 1940, which empowers it to regulate drug imports, approve new drugs, set quality standards, and coordinate with State Drug Control Organisations.
- Drugs and Cosmetics Act, 1940: Principal legislation governing manufacture, distribution, sale, import, and export of drugs and cosmetics in India.
- CDSCO headquarters: FDA Bhawan, Kotla Road, New Delhi; six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories.
- Functions: Approval of new drugs and clinical trials; regulation of medical devices and cosmetics; laying down quality standards; regulating drug imports; providing expert oversight to state drug controllers.
- The Drug Controller General of India (DCGI) heads CDSCO and is the national-level authority for new drug approvals and clinical trial permissions.
- Schedule H and Schedule H1 of the Drugs and Cosmetics Rules, 1945: Prescription-only drugs list; H1 covers higher-risk antibiotics and controlled substances with stricter dispensing rules.
● Tracked since February 18, 2026 · last seen April 25, 2026 · updates as the daily brief publishes
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