The World Health Organization (WHO) has requested clarification from Indian authorities regarding whether a cough syrup, Coldrif, linked to multiple deaths in India, was exported to other countries. This request follows reports of at least 14 children's deaths in Madhya Pradesh due to acute kidney failure, with suspicions pointing to the Coldrif syrup manufactured by Sresan Pharmaceuticals. The syrup was found to contain dangerously high levels of diethylene glycol (DEG), a toxic industrial solvent.
The WHO's inquiry seeks to determine if a Global Medical Products Alert is necessary, which would put health regulators worldwide on alert for the implicated product. The global health body is awaiting formal confirmation from India before making a decision.
The incident has brought India's drug regulations under intense scrutiny, particularly concerning generic cough syrups. This is not the first time that contaminated cough syrups produced in India have been linked to fatalities. In 2022-23, the deaths of 66 children in Gambia and 23 in Uzbekistan were traced back to similar products manufactured in India. These earlier incidents led the WHO to issue a global warning and prompted a clampdown on drug exports by India.
The recent deaths have triggered a swift response within India. The manufacturing license of Sresan Pharmaceuticals is at risk of revocation pending a decision by the federal health ministry. Police in Madhya Pradesh have launched a manslaughter investigation, naming Sresan Pharmaceuticals and the prescribing doctor as accused. Madhya Pradesh, Rajasthan, and Kerala have banned Coldrif. Maharashtra has also banned the sale, distribution, and use of Coldrif syrup.
The Tamil Nadu Drugs Control Department has issued a stop-production order to Sresan Pharmaceuticals after samples were found to be adulterated with DEG. A 26-page inspection report revealed over 350 violations at the Sresan Pharmaceuticals facility, including unhygienic conditions, rusted equipment, and the illegal use of non-pharma-grade chemicals. It was found that the company used industrial-grade propylene glycol, sourced from local chemical traders and paint industry dealers, without testing for contaminants. The deadly SR-13 batch of Coldrif was found to have an astonishing 48.6 percent of diethylene glycol, nearly 500 times above the permissible limit.
The Union Ministry of Health and Family Welfare has reportedly placed blame on the Tamil Nadu Food and Drug Administration (TN-FDA). According to ministry sources, State Drug Controllers are primarily responsible for ensuring regulatory compliance at manufacturing units. The Central Drugs Standard Control Organisation (CDSCO) had recommended the cancellation of the manufacturing license after DEG was detected.
Health officials are currently working to locate and confiscate the remaining bottles of the implicated cough syrup. Door-to-door surveys are being conducted to trace the distributed bottles.
