India’s ministry of health and family welfare has launched criminal proceedings after at least 14 children died in Madhya Pradesh and Rajasthan, reportedly following the consumption of a locally produced cough syrup found to contain toxic levels of an industrial solvent.
A sample of the syrup, Coldrif, tested among 19 medicines collected in affected areas, was found to “contain diethylene glycol (DEG) beyond the permissible limit”, the health ministry said.
The syrup was manufactured by Sresan Pharma, based in Kanchipuram in Tamil Nadu.
DEG, a chemical found in products like antifreeze, cosmetics, and lubricants, can trigger symptoms ranging from vomiting and abdominal pain to acute kidney failure, which the World Health Organization warns can be fatal.
“The doctor who wrote the prescription has been arrested,” Rajendra Shukla, deputy chief minister of Madhya Pradesh, told ANI, adding that a criminal case had been registered against the manufacturer.
Authorities cited charges including culpable homicide not amounting to murder, drug adulteration, and violations of the Drugs and Cosmetics Act.
The federal Health Ministry convened an emergency high-level meeting with state health secretaries and drug control officials to address the crisis. Discussions focused on enforcing stricter oversight of cough syrup production, promoting rational prescribing practices, and expanding surveillance systems to prevent further tragedies.
Regulatory action has also been taken against a unit of the company, the health ministry said, without giving details, and the Central Drugs Standard Control Organisation recommended cancellation of its manufacturing license. Sresan Pharma did not immediately respond to a Reuters request for comment. If convicted, the company and its officials could face fines and jail terms of up to life.
“The deaths of children in Chhindwara due to Coldrif syrup are extremely tragic. The sale of this syrup has been banned across Madhya Pradesh. A ban is also being imposed on the sale of other products from the company that manufactures the syrup,” chief minister of Madhya Pradesh Mohan Yadav wrote on X.
Medical experts have warned of the severe dangers posed by DEG contamination.
Dr YK Gupta, National Scientific Advisor to the Pharmacovigilance Programme of India, said: “There is no safe permissible limit for these chemicals. Even trace amounts can be harmful.”
In Madhya Pradesh, the local administrations have banned both Coldrif and another cough syrup, Nextro-DS, as a precautionary measure, local media reported. According to The Economic Times, the test report for Nextro-DS is awaited.
Families of the deceased reported that children initially showed mild cold symptoms but rapidly deteriorated into kidney-related complications following medication intake, The Times of India reported.
The crisis has reignited concerns about India’s pharmaceutical safety standards. Known as the "pharmacy of the world", India has faced scrutiny for the quality of its pharmaceutical exports, with its cough syrups being linked to child deaths in Cameroon, Gambia and Uzbekistan over the past few years, according to Reuters.
The country supplies nearly 40 per cent of generic medicines used in the US, 25 per cent in the UK, and over 90 per cent in many African nations.
Meanwhile, states including Rajasthan, Tamil Nadu, Kerala, and Madhya Pradesh have banned the sale of Coldrif.
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