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India Bans OTC Cough Syrups After Child Deaths
17 Jun
Summary
- Over-the-counter access to syrup medicines in India has ended.
- This decision follows child deaths linked to contaminated syrups.
- A doctor's prescription is now mandatory for syrup purchases.
India has enacted a significant regulatory change, removing syrup-based medicines from over-the-counter sales. Effective immediately, a doctor's prescription is mandatory for purchasing many cough syrups and liquid medications. This decision stems from a series of tragic incidents since 2022, where Indian-manufactured syrup formulations were associated with the deaths of over 140 children in Africa and Central Asia, as well as within India.
The World Health Organization issued alerts regarding unacceptable levels of toxic industrial chemicals like diethylene glycol and ethylene glycol found in these syrups. These contaminants can cause severe kidney injury and neurological complications, particularly in young children. The regulatory overhaul targets Schedule K of the Drugs Rules, 1945, which previously allowed certain household remedies, including syrups, to be sold under relaxed conditions.
Beyond contamination concerns, the move addresses widespread self-medication practices. Health authorities aim to strengthen supply chain accountability and ensure medicines are dispensed through licensed pharmacies. This policy is part of a broader crackdown on medicine quality, with nearly 90% of cough syrup manufacturers inspected and compliance measures enforced across the pharmaceutical sector.
