India flags 3 cough syrups to WHO over contamination, products recalled

India reported to the World Health Organisation (WHO) on Wednesday that three cough syrups—manufactured by Sresan Pharmaceuticals in Tamil Nadu and Rednex Pharmaceuticals and Shape Pharma Private Limited in Gujarat—were contaminated with toxic levels of diethylene glycol (DEG), a toxic, sweet-tasting chemical used in antifreeze and industrial products that can cause serious harm or death if swallowed.

The Central Drugs Standard Control Organisation (CDSCO) confirmed the presence of DEG in the syrups, which had been linked to a cluster of cases involving children. All three products (Coldrif, Respifresh TR, and ReLife) have been withdrawn from sale, and the companies are now prohibited from manufacturing any medicinal products.

The withdrawal of these cough syrups was triggered by reports of 20 child deaths in Madhya Pradesh’s Chhindwara district. The DEG contamination levels in the products varied significantly: Coldrif had a critically high level of $48.6\%$, while Respifresh TR and ReLife contained lesser, but still dangerous, amounts of $1.34\%$ and $0.616\%$.

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The investigation into these syrups began when the WHO reached out to India on October 1, citing media reports of children in Madhya Pradesh and Rajasthan suffering from symptoms resembling acute renal failure and encephalitis, which were suspected to be caused by contaminated oral medicines.

Response to international and domestic concerns

The WHO sought clarification from India regarding both the potential link between the children’s deaths and the contaminated syrups, and the risk of the products being exported.

The Indian regulatory body assured the WHO that none of the affected syrups were shipped to other countries. Furthermore, the manufacturers have been commanded to completely stop all production.

While the source of the Diethylene Glycol (DEG) contamination remains unknown, the WHO has raised concerns about the risk of tainted drugs reaching global markets, particularly via unregulated channels.

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In response to the tragedy, the Indian Health Ministry has launched inspections of manufacturing facilities across six states: Madhya Pradesh, Tamil Nadu, Himachal Pradesh, Uttarakhand, Gujarat, and Maharashtra.

The Ministry has promised the public that comprehensive steps are being taken to mitigate this serious health crisis. The WHO has also affirmed its commitment to supporting India in its efforts to protect public health and assist with the ongoing investigation into these tragic incidents.