India starts criminal investigation after cough syrup-linked deaths of at least 14 children

Indian police have opened a manslaughter investigation into the deaths of at least 14 children linked to a toxic cough syrup, dealing another blow to the reputation of the country’s pharmaceutical industry after a string of similar tragedies in recent years.

Most of the children were under the age of five and died of kidney failure in the past month after consuming cough medicine branded Coldrif Syrup. The syrup contained the toxin diethylene glycol in quantities nearly 500 times the permissible limit, according to a police complaint seen by Reuters.

Diethylene glycol or ethylene glycol toxins were found in Indian-made cough syrups that have killed at least 141 children in The Gambia, Uzbekistan and Cameroon since 2022, and another 12 children in India in 2019, damaging the image of the world's third-biggest drug-manufacturing country by volume.

Landslide kills 15 people on bus in northern India

Read More

“All the children had early symptoms of common cold, flu or fever, and most were under the age of five years,” said the police complaint filed on Sunday in the central state of Madhya Pradesh.

“Most of them were given Coldrif Syrup, following which they suffered from urine retention and acute kidney disorder.”

The report said at least 16 children had kidney problems after taking the syrup, indicating the death toll could rise. It is already one of the worst such recorded cough syrup poisoning in India.

Diethylene glycol, used in products from antifreeze to cosmetics and lubricants, causes symptoms that the World Health Organisation says may range from vomiting and abdominal pain to acute kidney injury, which can cause death.

Homicide charges filed

Police have named Coldrif manufacturer Sresan Pharma as one of the main accused and arrested a doctor who prescribed the medicine to most of the children.

Sresan Pharma did not respond to a request for comment.

Authorities in the southern state of Tamil Nadu, where Sresan is based, found the syrup contained 48.6 per cent diethylene glycol, while tests in Madhya Pradesh showed 46.28 per cent. The permissible limit set by Indian authorities and the WHO is 0.1 per cent.

The company faces charges of culpable homicide not amounting to murder, adulteration of drugs, and manufacturing, selling, or distributing cosmetics in violation of the Drugs and Cosmetics Act, according to the complaint. If convicted, the company and its officials could face fines and jail terms of up to life.

Reuters could not contact the arrested doctor who police said prescribed the syrup, named as Praveen Soni. He told local news channel NewsX on Sunday that it was “difficult to link the deaths to Coldrif because it had been prescribed for a decade”.

Leading exporter of drugs

India's pharmaceutical industry, exceeded in size only by the US and China, is valued at $50 billion. More than half of its value comes from exports, according to government data, with costs of manufacturing in India up to 35 per cent less than the US and Europe.

India supplies 40 per cent of generic medicines used in the US, 25 per cent of all those used in Britain, and more than 90 per cent of all medicines in many African nations, according to health authorities.

Since 2023 and following the overseas deaths, India made it mandatory for syrups to be tested at government-approved labs before export, although the same rule does not apply to locally sold products.