- India proposes banning cough and cold syrups for children under two years.
- Draft NFI 2026 follows contamination-linked deaths and safety concerns.
- Pharma firms will face stricter testing and compliance require
In a sweeping move by the Indian Pharmacopoeia Commission, doctors across the country will soon be barred from prescribing cough and cold syrups to infants under two, as reported by Livemint this Saturday.
The proposal, outlined in the draft National Formulary of India (NFI) 2026, follows a string of tragic incidents where toxic contaminants in certain medicinal batches led to severe health complications and fatalities. The draft of a new proposal released by the Indian Pharmacopoeia Commission (IPC) has been designed to enhance safety for infants and toddlers, the report said.
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The guidelines establish an absolute restriction, but are only permitted after a careful clinical evaluation and require close supervision by both medical professionals and guardians, it added.
According to the report, the draft proposal includes the following points:
- By standardising essential drug data, including dosage, indications, contraindications, and side effects, the draft NFI establishes a comprehensive regulatory framework to eliminate clinical ambiguity.
- The measures include maintaining records by manufacturers about the use of pharmacopoeial-grade solvents and performing rigorous batch-wise testing in approved laboratories.
- Additionally, the draft mandates that pharmaceutical companies independently test inputs and final products, bolstering supply chain accountability
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Incident of Illicit Syrup
The regulations, considered to be in reinforcement, follow repeated global alarms over toxic industrial ingredients used in syrups, specifically diethylene glycol (DEG) and ethylene glycol (EG), found in liquid oral medications. These lethal contaminants, which can trigger rapid acute kidney failure, have been linked to more than 140 deaths worldwide including countries like Gambia and Uzbekistan. Domestically, contaminated cough syrup was associated with at least 24 fatalities in late 2025, prompting an urgent overhaul of safety protocols, mentions a Business Standard report.
To mitigate these risks, the Indian Pharmacopoeia Commission (IPC) has significantly updated standards for high-risk compounds, including glycerin, propylene glycol, and sorbitol, which are prone to carrying DEG impurities, as per the report.
The Indian Drug Manufacturers' Association (IDMA) and other key industry bodies are currently evaluating the draft guidelines to prepare their formal feedback, it added.
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