CDSCO
India's Drug Regulator and Approval Framework
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals, medical devices, cosmetics, and diagnostics. It functions under the Ministry of Health and Family Welfare. The Drugs and Cosmetics Act, 1940 (D&C Act) is the principal statute governing drug regulation in India. CDSCO approves new drugs, clinical trials, and imports; State Drug Controllers handle the licensing of manufacturing and sale.
- CDSCO established under: Drugs and Cosmetics Act, 1940 (amended multiple times, most recently through the Drugs, Medical Devices and Cosmetics Bill — under deliberation as of 2025).
- Drug Controller General of India (DCGI): Head of CDSCO; appointed by the Central Government.
- New Drug Approval: For a new molecular entity (NME) — requires Phase I, II, III clinical trials; CDSCO review of dossier; approval by Subject Expert Committees.
- New Drugs and Clinical Trials Rules, 2019: Reformed the approval process; introduced accelerated approval for drugs for serious/life-threatening conditions.
- Drugs, Medical Devices and Cosmetics Bill (draft, 2022; revised 2023): Proposed comprehensive replacement for the 1940 Act — addresses regulatory gaps for biologics, medical devices, and digital health products.
● Tracked since February 18, 2026 · last seen April 25, 2026 · updates as the daily brief publishes
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