After the death of at least 20 children in Madhya Pradesh due to the consumption of contaminated cough syrup, the Central Drugs Standard Control Organisation (CDSCO) on Wednesday issued a strict advisory for drug controllers of all states and Union Territories and instructed them to ensure every batch of raw material and finished formulation is properly tested before use or sale.
The advisory, dated October 7, 2025, was sent by Dr Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI), to drug regulators of all states and union territories, according to a report by News18.
The DCGI wrote in the advisory that recent inspections have found several manufacturers not testing each batch of excipients and active ingredients for compliance with prescribed standards before use. Such lapses, the advisory warned, violate the Drugs Rules, 1945, which mandate testing of every batch in approved laboratories and maintenance of complete records.
The advisory also urges state regulators to intensify inspections and ensure that no batch of medicine is released without proper testing.
States have also been asked to monitor manufacturers’ quality-control systems and take “necessary measures to ensure testing, sampling, and verification before release of the batch to the market", News18 reported.
Excipients are the inactive substances used in a medicine—they don’t have any therapeutic effect themselves but are essential to make the drug stable, safe, and consumable. In cough syrups, excipients include substances like glycerin, propylene glycol, sorbitol, and sweeteners that give the syrup its texture, taste, and fluidity.
This order comes after 20 children lost their lives in Madhya Pradesh while undergoing treatment for kidney failure following the consumption of the 'contaminated' Coldrif cough syrup, according to a report by the Hindustan Times.
The Tamil Nadu government on Tuesday evening sealed the pharma unit that was producing the now-banned cough syrup. Meanwhile, a special investigation team (SIT) of the Madhya Pradesh police also visited the company's registered office in Chennai as well as its manufacturing unit in Kancheepuram as part of its probe into the child deaths.
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