Restriction on all formulations of FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride with mandatory warning against use in children below four years of age

The Ministry of Health and Family Welfare has issued Notification S.O. 4595(E) under Section 26A of the Drugs and Cosmetics Act, 1940, restricting the manufacture, sale, and distribution of all fixed dose combination formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The notification extends earlier safety measures by requiring all such formulations marketed in India to carry a prominent warning stating that the fixed dose combination should not be used in children below four years of age. The action follows a review by an Expert Committee and the Drugs Technical Advisory Board, which concluded that these combinations may pose risks to young children and that safer alternatives are available. Manufacturers must include the warning on product labels, package inserts, and promotional literature. The notification became effective from the date of its publication in the Official Gazette.