New rule mandates warning on Chlorpheniramine and Phenylephrine combinations.
The Government of India has imposed restrictions on the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The move requires manufacturers to display a warning stating that these medicines should not be used in children below four years of age.
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), which reviewed the potential risks associated with the use of these combinations in young children. The Government stated that safer alternatives are available for this age group.
Earlier, through a notification issued on April 15, 2025, the Government had restricted certain FDCs containing the same ingredients with a similar age-specific warning. The latest notification extends the requirement to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
Manufacturers have been directed to display the warning, “Fixed Dose Combination shall not be used in children below four years of age,” on product labels, package inserts and promotional materials. The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health.
