- Why in news
- On 20 June 2026 the Union Health Ministry prohibited the manufacture for sale, sale and distribution of 16 Fixed Dose Combinations (FDCs) with immediate effect. The action follows Supreme Court directions for a review of FDCs.
- What it is
- A Fixed Dose Combination (FDC) combines two or more active drugs in a fixed ratio in one dosage form. The Drugs Technical Advisory Board (DTAB) is the statutory technical body that advises the Centre and the Drugs Consultative Committee on technical matters under the Drugs and Cosmetics Act, 1940. FDCs with no therapeutic justification can be prohibited under Section 26A of that Act in public interest.
- Number banned
- The Centre prohibited 16 FDCs, covering skin preparations, painkiller-antispasmodic mixes and antibiotic-based formulations.
- Role of DTAB
- DTAB set up an Expert Committee to examine FDCs and identify irrational or risky ones.
- Legal basis
- The list records the recommendation as prohibition under Section 26A of the Drugs and Cosmetics Act, 1940.
- Effect and enforcement
- The ban applies across the country immediately, and State Drug Controllers must enforce it.
- Section 26A
- Section 26A empowers the Centre to prohibit manufacture, sale or distribution of a drug in public interest, if it is likely to involve risk to humans or animals or has no therapeutic justification.
Don’t confuse with DTAB vs DCC: DTAB advises the Centre and states on technical matters. The Drugs Consultative Committee (DCC) advises on securing uniformity in administering the Act across states.
Don’t confuse with CDSCO vs DTAB: CDSCO, headed by the Drugs Controller General of India, is the regulator that approves drugs. DTAB is only an advisory body.
Laws, judgments and statutory bodies: 30 Prelims questions since 2013 (what the law says, who chairs, legal basis). In Mains, 44 news-triggered questions, most in GS2, asking for provisions and challenges.
Why it matters
- Removes drugs without therapeutic justification, protecting patients from avoidable risk.
- Strengthens evidence-based regulation and Supreme Court-driven accountability.
Problems
- Banned FDCs often return under new brand names or through state-level licences.
- Weak state drug-control capacity makes enforcement uneven.
Way forward
- Complete the review of all pending FDCs and strengthen CDSCO-state coordination in enforcement.
- Require central approval for new FDCs and publish ban lists with clear tracking of stocks.
Put in your answer
Section 26A, Drugs and Cosmetics Act, 1940: The legal route used to prohibit FDCs in public interest.
Judicial push: The ban follows Supreme Court directions for a comprehensive review of FDCs in the country.
UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
No practice question for this one; the card may still help an answer. Why: 16 irrational FDCs prohibited after a Supreme Court-directed review by a DTAB expert committee. Lasting regulatory topic, but few fresh facts for a statement.
Worth revising until Prelims 2028: most news questions come within two years of the event.