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Kids Under 4: Cold Meds Now Restricted
23 Aug
Summary
- Fixed-dose combinations of chlorpheniramine and phenylephrine banned for children under four.
- Government cites risks of drowsiness, agitation, and rapid heartbeat in young children.
- Manufacturers must prominently display warnings against use in children under four.
The Central government has issued a significant restriction on the manufacture, sale, and distribution of fixed-dose combination (FDC) medicines containing chlorpheniramine maleate and phenylephrine hydrochloride. This decision specifically targets children below four years of age, deeming these FDCs potentially risky for this vulnerable group.
Health experts emphasize that these combination cold medicines can lead to adverse effects in young children, including excessive drowsiness or agitation and rapid heartbeat. Given their limited benefit for common colds, safer alternatives like saline nasal drops, adequate hydration, and honey (for children over one year) are now being promoted by medical professionals.
This regulatory action follows a review process that began in 2023 and involved extensive re-examination in 2024 and 2026 with pediatricians and the Drugs Technical Advisory Board (DTAB). The latest notification, effective upon publication in the Official Gazette, ensures that all such formulations, whether manufactured or imported and marketed in India, are covered by the restriction. The directive was issued under Section 26A of the Drugs and Cosmetics Act, 1940.
