Regulatory Framework
Drugs and Cosmetics Act, 1940 and "Spurious" Drugs
The Drugs and Cosmetics Act, 1940, and its 1945 Rules, govern the manufacture, sale, and quality of drugs in India, including vaccines. Section 17B of the Act defines a "spurious" drug — one manufactured under a false name, imitating another drug in a deceptive manner, bearing a fictitious manufacturer's details, or substituted wholly or partly with another substance. Enforcement is carried out jointly by the Central Drugs Standard Control Organisation (CDSCO) and state drug control authorities.
- Section 17B (spurious drugs) is distinct from Section 17 (misbranded) and other provisions covering adulterated or not-of-standard-quality (NSQ) drugs
- Penalties for manufacturing/selling a spurious drug (not causing death or grievous hurt) range from a minimum of seven years' imprisonment up to life imprisonment, with a fine of at least ₹3 lakh or three times the value of the drugs seized, whichever is higher
- CDSCO, under the Ministry of Health and Family Welfare, is the central regulator for new drug approvals, clinical trials, and coordinating quality alerts; state drug control departments handle local licensing and enforcement
- A "substandard" or Not of Standard Quality (NSQ) finding (e.g., failed potency test) is regulatorily distinct from a confirmed "spurious" finding, though both can trigger recall and investigation
● Tracked since February 19, 2026 · last seen September 06, 2026 · updates as the daily brief publishes
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