India Eyes Label Change for Children's Cough Syrup

India's drug regulator is reviewing a proposal to alter cough syrup labels, specifically aiming to prevent their use in children under the age of four. The proposed changes include adding a prominent red warning stating, "WARNING: Cough syrup should not be used in children below 4 years of age." Additionally, a visual depiction of school-aged children might be incorporated on the packaging to emphasize that the medicine is intended for older children. This move comes in response to ongoing concerns and reports that cough syrups continue to be prescribed to infants and young children, despite an advisory issued in October 2025 by the Directorate General of Health Services (DGHS) recommending against such practices. The issue was escalated after a complaint alleged continued prescription to infants below two years. Consequently, an internal technical committee of the Central Drugs Standard Control Organisation (CDSCO) reviewed the matter in April 2026. This committee suggested consulting the Indian Council of Medical Research (ICMR) regarding any related proposals and assessing the feasibility of label changes with stakeholders. ICMR indicated no ongoing work on this specific issue. In a related regulatory development, the Union health ministry amended drug rules in June 2026, removing syrup-based medicines from the over-the-counter category. This amendment, effective from June 9, 2026, necessitates a doctor's prescription for purchasing cough syrups and other previously non-prescription syrup medications, thereby strengthening regulatory oversight.