Centre Bars Chlorpheniramine-Phenylephrine Fixed-Dose Combinations for Children Under Four

24 August 2026National

The Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of fixed-dose combinations of the antihistamine Chlorpheniramine Maleate and the decongestant Phenylephrine Hydrochloride for children below four years, covering syrups and drops alike. The order invokes Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the Centre to restrict a drug in the public interest, and follows assessment by the Drugs Technical Advisory Board (DTAB). Packs, labels, inserts and promotional material must now carry the warning that the FDC is not for under-fours. It widens a 15 April 2025 notification and follows June 2026's ban on 16 irrational FDCs.

Static GK

Drug regulation in India runs on the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 | CDSCO, the national drug regulator, is headed by the Drugs Controller General of India (DCGI) under the Ministry of Health and Family Welfare | A fixed-dose combination (FDC) contains two or more active pharmaceutical ingredients in a single dosage form

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