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India Orders All Drugmakers to Meet WHO-Grade Standards by Jan. 1, 2025

The regulator acted after fatal cough syrup contaminations damaged confidence in Indian medicines.

Overview

  • CDSCO issued a notice applying revised Schedule M requirements to every pharmaceutical unit from January 1, with strict action promised for violations.
  • The order, signed by Drugs Controller General Rajeev Singh Raghuvanshi, directs immediate state inspections and elevates enforcement to top priority.
  • Officials rejected further extensions that had previously given smaller manufacturers until December 2025, reversing the staggered timeline.
  • Reporting links India-made cough syrups to more than 140 child deaths across Africa and Central Asia and to 24 deaths in central India.
  • Products cited in coverage include Coldrif from Sresan Pharmaceutical, Respifresh TR from Rednex Pharmaceuticals, and ReLife from Shape Pharma, as industry groups warn of possible closures and higher prices.