Drugs and Cosmetics Act, 1940
India's Drug Regulatory Framework
The Drugs and Cosmetics Act, 1940 (DCA) is the principal legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. It establishes a dual regulatory structure where the Central Drugs Standard Control Organisation (CDSCO) under the Drugs Controller General of India (DCGI) handles regulatory approvals, while State Drug Regulatory Authorities (SDRAs) are responsible for manufacturing licences and routine inspections.
- Section 18: Prohibits manufacture, sale, or distribution of drugs that are not of standard quality, or are misbranded, adulterated, or spurious
- Section 27: Penalties for manufacture/sale of adulterated drugs -- imprisonment up to 5 years and fine (enhanced to 10 years to life if causing death under Section 27(d))
- Section 16: Empowers Central Government to appoint Drug Inspectors; Section 21: Powers of inspectors to enter, inspect, and take samples
- Drug regulation is a concurrent subject (Entry 19, List III, Seventh Schedule) -- both Centre and States have jurisdiction
- CDSCO: National Regulatory Authority under Directorate General of Health Services, Ministry of Health & Family Welfare
- State licensing authorities grant manufacturing licences, conduct factory inspections, and take samples for testing
- CAG 2024 report found that in Tamil Nadu, only about two-thirds of required drug inspections were carried out between 2016-2021, and as few as half the expected samples were tested
● Tracked since February 12, 2026 · last seen June 20, 2026 · updates as the daily brief publishes
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