India Proposes Ban on Cough Syrups for Children Under 2 Amid Safety Concerns
Govt plans to bar cough syrups for kids under 2 amid safety concerns
Business Standard
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The Indian government plans to prohibit cough syrup prescriptions for children under two years and limit their use for those under five due to safety concerns. This decision follows contamination-related deaths and aims to enhance drug safety standards in the country.
- 01Proposed ban on cough syrups for children under two years old.
- 02New regulations stem from contamination-related deaths linked to toxic solvents.
- 03Draft National Formulary of India (NFI) 2026 aims to standardize drug safety.
- 04Public health experts support the move, emphasizing natural treatment methods.
- 05Pharmaceutical companies will be held accountable for product safety.
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The Indian government is proposing new regulations that would bar the prescription of cough syrups for children under two years of age and discourage their use for those under five. This initiative, part of the draft National Formulary of India (NFI) 2026 released by the Indian Pharmacopoeia Commission (IPC), comes in response to safety concerns following contamination-related deaths linked to toxic industrial solvents such as diethylene glycol (DEG) and ethylene glycol (EG). These contaminants have been associated with over 140 global deaths, including 24 in India in late 2025. The draft NFI aims to standardize drug information, providing guidance on dosage and safety, and explicitly states that cough medications should not be prescribed to very young children without careful evaluation. Pharmaceutical manufacturers will now be required to use pharmacopoeial-grade solvents and conduct rigorous testing of their products. Public health experts have welcomed these changes, advocating for non-drug treatments for coughs in young children, emphasizing the need to address underlying causes rather than merely suppressing symptoms. This proposal follows a series of product recalls and advisories aimed at strengthening drug safety standards in India.
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These regulations aim to enhance the safety of medications prescribed to young children, potentially reducing health risks associated with cough syrups.
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