DTAB

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…