India restricts cold-drug FDCs for children
Analysis based on 21 articles · First reported Aug 21, 2026 · Last updated Aug 22, 2026
The restriction may reduce sales of pediatric cold and allergy medications containing these ingredients in India, potentially affecting pharmaceutical companies that manufacture such FDCs. The move could also prompt a shift toward safer alternatives and increase regulatory scrutiny on other FDCs, impacting the broader Indian pharmaceutical market.
On August 22, 2026, the Bangladesh — Ministry of Health and Family Welfare of India issued a notification under Section 26A of the Drugs and Cosmetics Act, 1940, restricting the manufacture, sale, and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age. The notification mandates that manufacturers display a clear warning on labels, package inserts, and promotional literature stating that the FDC shall not be used in children below four years. This action extends an earlier restriction from April 15, 2025, which covered certain FDCs with these ingredients, to all formulations containing them. The decision follows recommendations from an expert committee and the India — Drugs Technical Advisory Board (DTAB), which cited potential risks to young children and the availability of safer alternatives. The restriction is part of a broader regulatory push to phase out irrational or unapproved drug combinations from the Indian market, following a India — Supreme Court of India directive for a comprehensive review of FDCs. In June 2026, the ministry had already prohibited 16 FDC drugs for human use across the country.
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