Health Ministry prohibits 16 fixed dose combinations under Section 26A of Drugs and Cosmetics Act
The Health Ministry announced on 20 June 2026 that it has prohibited the manufacture, sale and distribution of 16 fixed dose combinations (FDCs) for human use.
Summary
The Ministry of Health and Family Welfare announced on 20 June 2026 that it has issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture for sale, sale and distribution of 16 fixed dose combinations (FDCs) for human use, with immediate effect. The FDC ban follows Supreme Court directions for a comprehensive review, under which an Expert Committee of the Drugs Technical Advisory Board (DTAB) found these FDCs to lack therapeutic justification. The banned FDCs include dermatological, analgesic and antispasmodic, and antibiotic-based formulations.
Key facts
- Banned
- 16 FDCs for human use, with immediate effect
- Legal power
- Section 26A, Drugs and Cosmetics Act, 1940
- Basis
- DTAB Expert Committee review, after Supreme Court directions
- Categories
- Dermatological, analgesic/antispasmodic, antibiotic-based
Practice MCQs 3 questions
How many fixed dose combinations (FDCs) did the Health Ministry prohibit, as announced on 20 June 2026?
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Correct answer: D — 16
The Ministry prohibited the manufacture, sale and distribution of 16 FDCs for human use.
Under which provision did the Health Ministry prohibit 16 FDCs on 20 June 2026?
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Correct answer: B — Section 26A of the Drugs and Cosmetics Act, 1940
The notifications were issued under Section 26A of the Drugs and Cosmetics Act, 1940.
The Expert Committee that reviewed FDCs, leading to the ban of 16 FDCs on 20 June 2026, was constituted by which body?
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Correct answer: C — Drugs Technical Advisory Board
Following Supreme Court directions, the Drugs Technical Advisory Board (DTAB) constituted the Expert Committee.