India files criminal case against cough syrup-maker over death of 14 children

Police in India have launched criminal action against a maker of cough syrup whose product was found to contain dangerous levels of a toxic chemical, after the deaths of 14 children suspected to have consumed contaminated medicine.

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.

A sample of the syrup, 'Coldrif', among 19 medicines tested after the deaths in Madhya Pradesh state, contained 46.28 per cent diethylene glycol, far exceeding a permitted level of 0.1 per cent, a state drug laboratory said in a report seen by Reuters.

"The doctor who wrote the prescription has been arrested," Rajendra Shukla, the state's deputy chief minister, told news agency ANI.

Police registered a criminal case on Sunday against the doctor and the manufacturer, Sresan Pharma, located in the southern state of Tamil Nadu.

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.

The company faces accusations of culpable homicide not amounting to murder, adulteration of drugs and manufacturing, selling, or distributing cosmetics in violation of the Drugs and Cosmetics Act.

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 contaminated batch of cough syrup was distributed only within India, according to a document seen by Reuters, so falling outside the scope of a 2023 rule for tests on exports to make sure the impugned chemical is within prescribed limits.

Other states, such as northern Uttar Pradesh and Rajasthan in the west, which border Madhya Pradesh, have also banned the syrup.

India's health ministry has called for the "rational use" of cough syrups for children, recommending "judicious prescribing and dispensing" in an advisory, saying most illnesses causing coughs clear up without use of drugs.

India supplies 40 per cent of generic medicines used in the United States, 25 per cent of all those used in Britain, and more than 90 per cent of all medicines in many African nations, its drug regulator says.