Health Ministry initiates risk-based inspection of drug manufacturing firms, following contamination in some cough syrup samples tested in Tamil Nadu

The Union Well being Ministry has initiated risk-based inspection on the manufacturing premises of 19 medicine throughout six States, following Tamil Nadu’s Meals Security and Drug Administration (FDA) discovering samples of Coldrif cough syrup containing diethylene glycol (DEG) above permissible limits.

The assertion comes amid an ongoing investigation into the deaths of not less than 10 kids, allegedly linked to the consumption of cough syrups in Madhya Pradesh and Rajasthan.

“This transfer will assist discovering out the gaps resulting in high quality failure of drug samples and recommend course of enchancment to keep away from such incidences in future,” the Ministry stated in a press release on Saturday (October 4, 2025).

It added that on the request of the Madhya Pradesh authorities, Tamil Nadu’s FDA had taken samples of Coldrif Cough Syrup from the manufacturing premises of M/s Sresan Pharma in Kanchipuram. Samples had been discovered to comprise DEG past the permissible restrict.

As a part of ongoing investigation, the Well being Ministry stated that six samples had been collected by the Central Medicine Customary Management Organisation (CDSCO) and testing discovered that each one six had been discovered to be freed from DEG and ethylene glycol (EG). Concurrently, the Madhya Pradesh FDA had stated that out of 13 samples collected by their staff, three had been analysed and located to be freed from DEG/EG.

Moreover, the multidisciplinary staff comprising of specialists from the Nationwide Institute of Virology, the Indian Council of Medical Analysis, the Nationwide Environmental Engineering Analysis Institute, the CDSCO and the All India Institute Of Medical Sciences, Nagpur are nonetheless analysing the assorted samples and learning the reason for deaths in and round Chhindwara in Madhya Pradesh.

DEG and EG are industrial solvents utilized in antifreeze, paints, brake fluids, and plastics. Typically, they contaminate pharmaceutical elements like glycerine, usually as a consequence of poor oversight or suppliers utilizing cheaper industrial-grade materials.

Since October 2022, the World Well being Group (WHO) has issued six world medical product alerts for over-the-counter medicines contaminated with DEG/EG. The primary substandard medical merchandise had been recognized within the Gambia with additional points surfacing within the WHO areas of Southeast Asia, Europe, Western Pacific and Japanese Mediterranean. It’s estimated that there have been not less than 300 fatalities amongst kids worldwide.

The cough syrup Coldrif was additionally sampled for evaluation by Madhya Pradesh’s Drug Regulatory Authority, whose outcomes are nonetheless awaited.

The six drug samples examined by CDSCO which didn’t present presence of DEG/EG had been of different medicine and syrups, together with antibiotics, antipyretics, and ondansetron, consumed by kids who fell ailing in Chhindwara district.