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India Weighs Stricter Controls on Cough Syrup Sales After Contamination Deaths

The review targets a Schedule K exemption that lets unlicensed rural shops sell syrups.

Overview

  • A Drugs Consultative Committee agenda proposes deleting the Schedule K exemption for cough syrups, according to documents reviewed by multiple outlets.
  • Revoking the carveout would end unlicensed sales in villages and require sellers to hold a drug licence with records and inspections, strengthening traceability.
  • Officials say the proposal will be taken up by the DCC and then the Drugs Technical Advisory Board before any amendment to the Drugs Rules, 1945 (Schedule K, Entry 13).
  • The push follows reported deaths of at least 24 children in Madhya Pradesh linked to diethylene glycol–tainted Coldrif syrup, alongside a WHO alert about untracked distribution and probes citing DEG/EG in MP and Rajasthan.
  • In a parallel step, CDSCO has ordered all manufacturers to meet global Good Manufacturing Practices by January 1, 2026 or face closure, after earlier export-linked incidents in Gambia, Uzbekistan and Cameroon.