Daijiworld Media Network - New Delhi
New Delhi, Apr 11: The Ministry of Health and Family Welfare is reportedly considering stricter guidelines on the use of paediatric cough syrups, including a possible ban on prescribing them to children under two years of age and discouraging their use for those below five.
The proposal is part of the draft National Formulary of India (NFI) 2026 released by the Indian Pharmacopoeia Commission, which serves as a reference guide for doctors and pharmacists on drug usage, dosage, and safety.
According to the draft, cough and cold medications should neither be prescribed nor dispensed to children under two years. It further advises that such medicines should generally be avoided in children under five unless there is careful medical evaluation and close supervision.
The move follows a series of tragic incidents in 2025 linked to contaminated liquid medications, where toxic substances like diethylene glycol (DEG) and ethylene glycol (EG) were found in some formulations. These cases prompted renewed scrutiny of drug safety standards.
To address these risks, the commission has updated quality norms for commonly used ingredients such as glycerin, propylene glycol, sorbitol solution, and liquid maltitol—substances that may carry harmful impurities if not properly tested.
Under the proposed guidelines, pharmaceutical companies will be required to use high-quality, pharmacopoeial-grade inputs and conduct rigorous batch-wise testing of both raw materials and finished products in certified laboratories, while maintaining detailed records.
Industry groups, including the Indian Drugs Manufacturers Association, are currently reviewing the draft and are expected to provide feedback before finalisation.
Public health experts have largely supported the move, noting that cough syrups offer limited benefits for infants and young children while posing potential risks. They emphasised that coughing is a natural protective reflex and that treatment should focus on identifying and addressing underlying causes rather than merely suppressing symptoms.