India Proposes Prescription-Only Sale of Cough Syrups After Child Deaths

The Union health ministry has proposed amending the Drugs Rules, 1945 to remove cough syrups from Schedule K, a move that would make their sale permissible only with a valid prescription from a registered medical practitioner. The proposal follows recent incidents, including the deaths of more than 20 children in Madhya Pradesh linked to contaminated cough syrup, as well as earlier international cases involving Indian-made products.

Under the draft amendment, the word “syrup” would be deleted from the list of household remedies exempted from prescription requirements, ending the over-the-counter sale of cough syrups. The draft will remain open for public objections and suggestions for 30 days after publication in the Official Gazette.

The Drugs Consultative Committee has supported the change and raised concerns over the use of high-risk excipients such as propylene glycol and its toxic impurities, diethylene glycol and ethylene glycol. Regulators have also directed stricter testing of raw materials, cancellation of faulty manufacturing licences, and stronger oversight to prevent future contamination and protect public health.

31-12-2025