New Delhi (Gurpreet Singh): In a significant regulatory intervention to protect paediatric health, the Union Ministry of Health and Family Welfare has prohibited the manufacture, sale, and distribution of all Fixed Dose Combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for infants and young children, mandating a strict warning label barring their use in patients under four years of age.
The nationwide directive follows comprehensive scientific evaluations and recommendations by a specialized Expert Committee alongside the statutory Drugs Technical Advisory Board. Health authorities noted that administering these active pharmaceutical combinations poses potential clinical risks to young children, particularly when safer and age-appropriate therapeutic alternatives remain readily accessible.
Under the new order, pharmaceutical manufacturers are legally required to prominently display the mandatory advisory, “Fixed Dose Combination shall not be used in children below four years of age,” across all product packaging, carton labels, package inserts, and promotional literature. The comprehensive measure expands upon an earlier notification issued on April 15 that placed restrictions on select formulations, now bringing every product containing both active ingredients under the mandatory safety restriction.
The statutory notification has been enforced under Section 26A of the Drugs and Cosmetics Act, 1940, taking immediate effect upon its publication in the Official Gazette to protect public health and streamline paediatric prescription practices nationwide.
