At least 23 children have died after consuming cough syrup contaminated with diethylene glycol (DEG) in Chhindwara district of Madhya Pradesh, India, with many more hospitalised. The deaths have been linked to Coldrif syrup, manufactured by Sresan Pharmaceuticals in the south Indian state of Tamil Nadu. The firm’s manufacturing licence has been revoked and it has been ordered to permanently shut down.

News of the deaths first emerged in early September, but the cause remained elusive as no post-mortems were conducted due to lack of permission from parents. Testing of syrup samples by drug control authorities from Tamil Nadu state discovered high levels of DEG – whose consumption can cause severe kidney, liver and nervous system damage to in humans. Most of the children suffered kidney failure.

During a raid in early October, the Tamil Nadu drugs controller discovered Sresan had sourced industrial grade propylene glycol from local chemical traders and paint dealers, rather than certified pharmaceutical suppliers. Propylene glycol is non-toxic, and frequently used as a syrup ingredient, but cheaper industrial grades are commonly contaminated with toxic ethylene glycol and DEG. There were no qualified chemists to oversee production at Sresan, and raw materials were not tested for contaminants.

DEG was later found in high concentrations in biopsies taken from the dead children. One Coldrif batch was found to contain over 48% DEG, 500 times the permissible limit. Overall, inspectors noted 39 critical and 325 major violations of the Drugs and Cosmetics Act at Sresan, including pest infestations, zero ventilation, open drains and broken equipment.

A 2024 report from the Comptroller & Auditor General of India revealed a significant and persistent shortfall in drug company inspections and routine sample testing in Tamil Nadu. Between 2016 and 2021, only around two thirds of required inspections were carried out, and as few as half of the expected number of samples were collected and tested.

In Madhya Pradesh, the state government has taken action against Praveen Soni, the doctor who prescribed Codrif syrup to children. Chief minister Mohan Yadav has also suspended the district drug inspector of Chhindwara, Gaurav Sharma; the drug inspector of the surrounding Jabalpur region, Sharad Kumar Jain; and deputy director of the state Food and Drug Administration, Shobhit Koshta. The state drug controller, Dinesh Maurya, has been transferred. The owner of Sresan Pharma, Ranganathan Govindan, on the run since September, has also been arrested and charged with adulteration, endangering the safety of children, and culpable homicide not amounting to murder.

Several child deaths and over 30 hospitalisations in Rajasthan have also been linked by parents to a different cough syrup, made by Kaysons Pharma. The state government initially denied any link, but later suspended the state drug controller and froze distribution of 19 medicines manufactured by Kaysons. Its cough syrup containing dextromethorphan had failed quality tests 40 times, but was still being supplied before the freeze. The state health department has now exonerated Kaysons and blamed deaths on children overdosing on the syrup.

In the wake of this tragedy, multiple state governments have banned sale and distribution of cough syrups for children. The matter also reached the Supreme Court last week via a public interest litigation seeking a central government investigation and a nationwide drug safety review, but the petition was dismissed by the Chief Justice of India.

Indian manufacturers were responsible for similar incidents involving exported cough syrups contaminated with diethylene glycol and ethylene glycol, which led to over 140 deaths in The Gambia and Uzbekistan in 2022 and 2023. The World Health Organization has confirmed that the Indian Government has notified it of three contaminated cough syrups, including batches of Codrif, but that none had been officially exported. The WHO is working with the Indian government to mitigate public health risks from these syrups, including informal distribution and exports.