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Drugs and Cosmetics Act, 1940

Regulatory Framework

The Drugs and Cosmetics Act, 1940, is the primary legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. It established a dual regulatory structure — Central (for imports and new drugs) and State (for manufacturing licences and distribution).

Key details
  • Section 26A empowers the Central Government to prohibit drugs in the public interest — the provision used for FDC bans.
  • Amended multiple times; in 2008, provisions for clinical trial oversight were strengthened.
  • The New Drugs and Clinical Trials Rules, 2019, further reformed the framework, reducing approval timelines and regulating academic clinical trials.
  • The Drug Price Control Order (DPCO) under the Essential Commodities Act, 1955 governs pricing of essential medicines.
In the news

● Tracked since February 12, 2026 · last seen June 20, 2026 · updates as the daily brief publishes

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