Overview
- The health ministry issued a notification that prohibits use of fixed‑dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride in children below four years, with the rule published in the Official Gazette on Saturday.
- Manufacturers must place the warning “Fixed Dose Combination shall not be used in children below four years of age” prominently on labels, package inserts and promotional literature for every formulation containing the two ingredients.
- The move implements recommendations from an Expert Committee and the Drugs Technical Advisory Board and rests on regulators' finding that these combinations may harm children under four while safer alternatives are available.
- The order, issued under Section 26A of the Drugs and Cosmetics Act, extends an April 15, 2025 restriction that covered certain formulations and follows a June 2026 push in which the government banned 16 other fixed‑dose combinations judged to lack therapeutic justification.
- Parents, paediatricians and pharmacists should expect manufacturers to relabel stock and update marketing material and regulators to monitor compliance, which could accelerate wider review and phase‑out of other irrational FDCs on the market.