India restricts specific cold medicines for children under four

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. Under Section 26A of the Drugs and Cosmetics Act, 1940, manufacturers are now required to display a prominent warning on product labels, package inserts, and promotional materials stating that the combination “shall 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) regarding the potential risks of these combinations in young children. Health officials noted that safer alternatives are available for this age group. Medical professionals have emphasized that children should not be treated as “smaller adults” when prescribing medication and advised parents to seek professional guidance, noting that many childhood viral illnesses resolve without medication.