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NEW DELHI — Health Ministry is reportedly considering banning prescriptions of paediatric cough syrups for children under two years and discouraging their use for those under five.
Reports said that the move under a draft of the National Formulary of India (NFI) 2026, released by the Indian Pharmacopoeia Commission, marks a notable shift in prescribing norms after a series of contamination-linked deaths last year.
There was, however, no official word from Health Ministry on the reports.
The draft NFI, which acts as a guide for doctors and pharmacists by standardising drug information on dosage, indications, contraindications and side‑effects, explicitly states that “cough and cold medications should not be prescribed or dispensed to children under two years”.
Further, it added that such medications are generally not recommended for those below five without careful clinical evaluation and close supervision.
The draft also placed the onus of independently testing inputs and final products on pharmaceutical firms to ensure accountability across the supply chain. Industry bodies, including the Indian Drugs Manufacturers Association, are currently reviewing the draft for feedback.
The move follows contamination‑linked deaths in 2025 linked to toxic industrial solvents such as diethylene glycol (DEG) and ethylene glycol (EG) found in liquid oral formulations.
The Indian Pharmacopoeia Commission (IPC) updated standards for high-risk excipients including glycerin, propylene glycol, sorbitol solution and liquid maltitol, to tackle the contamination issue as these ingredients may carry DEG impurities.
Manufacturers are mandated to use pharmacopoeial-grade solvents and conduct rigorous batch-wise testing of key inputs and finished products in approved laboratories, with detailed records maintenance.
Public health experts and doctors welcomed the move, saying cough syrups offer only limited therapeutic benefit for infants with disproportionate risks.
Cough is a natural protective reflex and treatment should focus on underlying causes rather than symptom suppression, they said.