Following the tragic deaths of children in Madhya Pradesh linked to contaminated cough syrups, the central government has issued a stringent directive to state and Union Territory drug regulators to ensure comprehensive testing of all medicines before they reach the market.
The advisory, dated October 7, 2025, was issued by Dr Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI), who emphasised the critical need for testing both raw materials, including excipients, and finished formulations. “It has been observed that manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients before use in the manufacturing of drug formulations," the advisory stated.
Dr Raghuvanshi’s communication urged state regulators to intensify inspections and ensure that no batch of medicine is released without proper testing. Regulators have also been asked to closely monitor manufacturers’ quality-control systems and take “necessary measures to ensure testing, sampling, and verification before release of the batch to the market."
Excipients, the inactive substances in medicines, are crucial for drug stability, safety, and palatability. In cough syrups, common excipients include glycerin, propylene glycol, sorbitol, and sweeteners that give the syrup texture, taste, and fluidity.
Also read: Doctor made scapegoat in MP cough syrup deaths: FAIMA
Experts note that failures in testing excipients and active ingredients have been responsible for past tragedies in India and abroad, including incidents in Rajasthan, Jammu, The Gambia, and Uzbekistan.
The DCGI warned that lapses in batch testing violate the Drugs Rules, 1945, which mandate the testing of every batch in approved laboratories with complete documentation. “You are requested to ensure that the testing of each batch of the drugs as well as raw materials used in manufacturing including excipients is carried out either in the manufacturer’s own laboratory or in a laboratory approved by the licensing authority," the advisory said.
Global health authorities, including the World Health Organisation (WHO), have repeatedly urged India to strengthen surveillance and regulatory mechanisms to prevent such avoidable incidents. The latest directive signals a move by the Centre to reinforce compliance at the state level and prevent a repeat of the cough syrup contamination crisis that has tarnished India’s reputation as the “pharmacy of the world."
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