Government restricts fixed dose combinations containing 2 chemical compounds for young children

The government has taken stringent measures to protect young children by restricting the production, sale, and distribution of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. These two chemical compounds were previously subject to age-specific warnings for use in children below four years of age.

The latest restriction applies to all formulations containing these ingredients, following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). Health authorities are concerned that the use of such combinations may pose risks to very young children, and safer alternatives are readily available.

Manufacturers are now required to prominently display the warning – "Fixed Dose Combination shall not be used in children below four years of age" – on all labels, package inserts, and promotional materials for these products. This regulatory action, issued under Section 26A of the Drugs and Cosmetics Act, 1940, will be enforced from the date of its publication in the official gazette.