Govt restricts manufacture, sale of fixed dose combinations two chemical compounds for children below 4 years

The Indian government has curtailed the production, distribution, and sale of fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under the age of four. This restriction was announced in a government press release following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB).

The government cited potential risks to young children and asserted that safer alternatives are available. Manufacturers have been instructed to prominently display a warning on all packaging materials stating that these combinations are not suitable for children under four years of age. The directive is enforceable under Section 26A of the Drugs and Cosmetics Act, 1940, and will take effect from the date of its publication in the official gazette.

Previously, the government had banned 16 specific fixed-dose combinations in June 2025, deeming them to have insufficient therapeutic justification and posing greater risks than benefits. The latest restriction expands the scope of banned formulations to encompass all products containing these two compounds.