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

The Union Health Ministry has initiated risk-based inspection at the manufacturing premises of 19 drugs across six States, following Tamil Nadu’s Food Safety and Drug Administration (FDA) finding samples of Coldrif cough syrup containing diethylene glycol (DEG) above permissible limits.

The statement comes amid an ongoing investigation into the deaths of at least 10 children, allegedly linked to the consumption of cough syrups in Madhya Pradesh and Rajasthan.

“This move will help finding out the gaps leading to quality failure of drug samples and suggest process improvement to avoid such incidences in future,” the Ministry said in a statement on Saturday (October 4, 2025).

It added that on the request of the Madhya Pradesh government, Tamil Nadu’s FDA had taken samples of Coldrif Cough Syrup from the manufacturing premises of M/s Sresan Pharma in Kanchipuram. Samples were found to contain DEG beyond the permissible limit.

As part of ongoing investigation, the Health Ministry said that six samples were collected by the Central Drugs Standard Control Organisation (CDSCO) and testing found that all six were found to be free of DEG and ethylene glycol (EG). Simultaneously, the Madhya Pradesh FDA had said that out of 13 samples collected by their team, three were analysed and found to be free of DEG/EG.

Additionally, the multidisciplinary team comprising of experts from the National Institute of Virology, the Indian Council of Medical Research, the National Environmental Engineering Research Institute, the CDSCO and the All India Institute Of Medical Sciences, Nagpur are still analysing the various samples and studying the cause of deaths in and around Chhindwara in Madhya Pradesh.

DEG and EG are industrial solvents used in antifreeze, paints, brake fluids, and plastics. Sometimes, they contaminate pharmaceutical ingredients like glycerine, often due to poor oversight or suppliers using cheaper industrial-grade material.

Since October 2022, the World Health Organization (WHO) has issued six global medical product alerts for over-the-counter medicines contaminated with DEG/EG. The first substandard medical products were identified in the Gambia with further issues surfacing in the WHO regions of Southeast Asia, Europe, Western Pacific and Eastern Mediterranean. It is estimated that there have been at least 300 fatalities among children worldwide.

The cough syrup Coldrif was also sampled for analysis by Madhya Pradesh’s Drug Regulatory Authority, whose results are still awaited.

The six drug samples tested by CDSCO which did not show presence of DEG/EG were of other drugs and syrups, including antibiotics, antipyretics, and ondansetron, consumed by children who fell ill in Chhindwara district.