New Delhi: The government has imposed restrictions on the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, directing that they carry a warning against their use in children below four years of age.
The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), which flagged potential risks associated with these combinations in young children and noted the availability of safer alternatives.
Manufacturers have been directed to prominently 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 government had earlier imposed similar restrictions on certain formulations containing the two ingredients through a notification issued on April 15, 2025. The latest order extends the requirement to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health, and takes effect from the date of its publication in the Official Gazette.
