Government Restricts Manufacture, Sale and Distribution of Fixed Dose Combinations Containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for Use in Children Below Four Years

The Ministry of Health and Family Welfare has restricted the manufacture, sale, and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, requiring a mandatory warning that they shall not be used in children below four years of age. This follows an earlier notification from April 2025 that restricted certain formulations, and has now been extended to all formulations containing these ingredients. The decision is based on recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), due to potential risks and the availability of safer alternatives. Manufacturers must clearly display the warning on labels, package inserts, and promotional literature under Section 26A of the Drugs and Cosmetics Act, 1940.