India’s drug regulator is considering changes to cough syrup labels to discourage their use in children below four years of age. The proposal includes a prominent red warning on bottles as well as a pictorial representation of school-age children to make it clear that the medicines are intended for older children.
The move comes amid continued concerns over cough syrups being prescribed to infants and young children despite an October 2025 advisory from the Directorate General of Health Services (DGHS) urging caution over their use in paediatric patients.
