India restricts specific drug combinations for children under four

The Indian Health Ministry has imposed new restrictions on the manufacturing, sale, and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under the age of four.

Following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), the government mandated that manufacturers include a clear warning on labels, package inserts, and promotional materials stating: “Fixed Dose Combination shall not be used in children below four years of age.” The decision aims to mitigate potential health risks to young children, noting that safer therapeutic alternatives are available.

The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health. This move expands upon previous restrictions that only applied to specific formulations containing these two ingredients, now extending the requirement to all such combinations.