On cough syrups, a long overdue prescription

The Centre’s decision to remove cough syrups from Schedule K of the Drugs Rules , 1945 — the list of medicines that can be sold without a prescription — is a belated but necessary acknowledgement of a regulatory failure that has persisted for years and resulted in multiple tragedies. In October 2025, over 20 children died across Madhya Pradesh and Rajasthan after consuming locally procured cough syrups. Between December 2019 and January 2020, there were similar casualties in Jammu. These domestic disasters came on top of a scarred international record: India-made cough syrups have been tied to the deaths of more than 140 children in Africa and Central Asia since 2022. Cough syrups occupy an anomalous position in India’s drug regulation framework. While recognised as medicines, many formulations — crucially those under Entry number 13 of Schedule K — benefitted from exemptions that enabled their sale through channels subject to weaker oversight than licensed pharmacies. This has fostered a culture of self-medication, poor prescription discipline and fragmented accountability across the supply chain. Particularly affected are vulnerable communities, especially in villages with a population of less than 1,000, where their sale was permitted — in MP, for instance, it was found that the cough syrup in question, Coldrif, contained diethylene glycol far in excess of permissible limits. The change in law translates to a shift in access. All syrup-based medicines, including cough syrups containing opioids like codeine, can no longer be purchased over the counter. Yet the prescription mandate, on its own, is unlikely to be sufficient. Drug regulation in India suffers from a Centre-state coordination deficit, and investigations after tragedies have repeatedly pointed to loopholes in quality control and inspection, raising uncomfortable questions about the capacity of regulators to monitor a rapidly expanding pharma sector. Concerns also remain about rural India, where limited access to healthcare facilities risks pushing people toward unlicensed vendors. The new rule must, therefore, be accompanied by rigorous enforcement, greater transparency in reporting adverse events, and investment in rural healthcare. The country must focus on a regulatory culture that prioritises patient safety over crisis management.