India alerts WHO after 3 cough syrups found contaminated with toxic DEG; products recalled

On Wednesday (October 8), India informed the World Health Organization (WHO) that three oral cough syrups, manufactured in Tamil Nadu and Gujarat, have been found to contain toxic levels of diethylene glycol (DEG). The affected products have been withdrawn from the market, and the manufacturing companies have been instructed to cease all production of medicinal products. According to reports, the Central Drugs Standard Control Organization (CDSCO) confirmed on October 8 that DEG contamination was detected in at least three cough syrups that had been consumed by children in a cluster of cases. The three affected syrups are Coldrif, made by Sresan Pharmaceuticals in Tamil Nadu; Respifresh TR, produced by Rednex Pharmaceuticals in Gujarat; and ReLife, manufactured by Shape Pharma Private Limited in Gujarat.

Coldrif had a dangerously high DEG contamination level of 48.6%, while Respifresh TR and ReLife had lower but still concerning contamination levels of 1.34% and 0.616%, respectively. The recall follows reports of 20 child deaths in Chhindwara district, Madhya Pradesh, attributed to the consumption of these contaminated syrups. The WHO had contacted Indian authorities on October 1 after media reports surfaced about a number of pediatric deaths and illnesses in Madhya Pradesh and Rajasthan, with symptoms resembling acute renal failure and encephalitis. The deaths were suspected to be linked to contaminated oral syrups.

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The WHO sought clarification from India on the potential connection between these deaths and the affected syrups, as well as concerns about possible exports of contaminated products. The Indian regulator assured the WHO that the contaminated syrups were not exported to any other countries. Additionally, the manufacturers have been ordered to halt production entirely. Although WHO has not yet been provided with information on the origin of the DEG contamination, the global body has expressed concern about the risk of contaminated products being exported, especially through unregulated channels. DEG, a toxic substance used primarily in industrial applications, has been linked to deadly poisoning cases around the world and is not intended for use in pharmaceuticals. India has experienced at least five major DEG poisoning incidents since 1972.

Following the reports, the Indian Health Ministry has conducted inspections at manufacturing units across six states: Madhya Pradesh, Tamil Nadu, Himachal Pradesh, Uttarakhand, Gujarat, and Maharashtra. The ministry has assured the public that measures are being taken to address this serious health risk. WHO has reiterated its commitment to support India in safeguarding public health and will assist in the ongoing investigation into these tragic incidents.