Govt Mulls Ban on Cough Syrups for Children Under 2 in Draft NFI 2026
New Delhi: In a major step toward improving drug safety for young children, the Union Health Ministry is considering a ban on the use of cough and cold syrups in children below two years of age. This proposal forms part of the draft National Formulary of India (NFI) 2026, issued by the Indian Pharmacopoeia Commission (IPC).
The draft guidelines recommend a complete restriction on such medications for infants under two years. Additionally, they advise that cough and cold syrups should generally be avoided in children below five years unless there is a clear medical necessity. This represents a significant change in pediatric treatment practices in the country.
The move comes in the wake of serious safety concerns that emerged following multiple incidents in recent times where contaminated cough syrups were associated with the deaths of children. These incidents prompted closer scrutiny of pharmaceutical quality standards and regulatory systems in India.
To further strengthen drug safety, the proposed guidelines suggest that pharmaceutical companies may be required to conduct independent testing of raw materials as well as finished products before they are released into the market. This measure aims to ensure higher accountability and reduce the risk of contamination or substandard medicines reaching patients, according to a recent media report in NDTV.
Medical experts have also emphasized that cough and cold symptoms in young children are often self-limiting and may not require medication. This supports the rationale behind restricting the use of such syrups in very young age groups.
If these recommendations are implemented, they could significantly alter prescribing practices across India and enhance the safety of pediatric healthcare by reducing unnecessary exposure to potentially harmful medications.
