India Bans Anti-Cold Drug for Children Below 4

India’s drug regulator has banned the use of an anti-cold drug combination in children below four years of age and mandated warning labels on drugs, responding to concerns raised about the promotion of an unapproved formulation linked to deaths. At least 141 children globally, including 12 in India, died after consuming domestically-made cough syrups.

The fixed-drug combination includes chlorpheniramine maleate and phenylephrine, commonly used in syrups or tablets for treating common cold symptoms. The World Health Organization advises against using over-the-counter cough syrups for children under five. The move aims to enhance safety and restrict the use of the drug combination in young children.