The Centre is planning to tighten regulations on paediatric cough syrups, with the health ministry proposing to bar their prescription for children below two years and discourage their use for those under five, Mint reported Saturday. The move, part of the draft National Formulary of India (NFI) 2026 released by the Indian Pharmacopoeia Commission (IPC), signals a significant shift in prescribing norms following a series of contamination-linked deaths last year.
The draft NFI standardises drug information on dosage, indications, contraindications and side-effects, aiming to guide doctors and pharmacists towards safer prescribing practices. It explicitly states that “cough and cold medications should not be prescribed or dispensed to children under two years”, and are generally not recommended for those below five without careful clinical evaluation and close supervision.
The regulatory tightening comes after repeated concerns over the presence of toxic industrial solvents such as ‘diethylene glycol (DEG)’ and ‘ethylene glycol (EG)’ in liquid oral formulations. These contaminants can cause acute kidney failure and have been linked to over 140 deaths globally in recent years, including cases in Gambia, Uzbekistan and Cameroon. In India, contaminated cough syrup was associated with at least 24 deaths in late 2025.
To address the issue, the IPC has updated standards for high-risk excipients such as glycerin, propylene glycol, sorbitol solution and liquid maltitol, ingredients that may carry DEG impurities. Manufacturers are now required to use pharmacopoeial-grade solvents and conduct rigorous batch-wise testing of both raw materials and finished products in approved laboratories, maintaining detailed records.
The draft also places responsibility on pharmaceutical firms to independently test inputs and final products, reinforcing accountability across the supply chain. Industry bodies, including the Indian Drugs Manufacturers Association, are currently reviewing the draft for feedback.
Public health experts have welcomed the move, noting that cough syrups offer limited therapeutic benefit for young children and may pose avoidable risks. Doctors emphasise that cough is a natural protective reflex and that treatment should focus on underlying causes rather than symptom suppression. Non-drug measures such as hydration, saline drops and honey (for children above one year) are often preferred.
The latest proposal follows multiple product recalls and advisories issued by health authorities in a broader push to strengthen drug safety standards and restore confidence in India’s pharmaceutical sector.
