India launches criminal case over toxic cough syrup linked to children’s deaths
Authorities in India have launched criminal proceedings against a pharmaceutical company after 14 children in Madhya Pradesh died from consuming cough syrup contaminated with a lethal chemical.
The tainted product, branded Coldrif, was found to contain 46.28% diethylene glycol, a solvent used in antifreeze and industrial lubricants, far exceeding the legal limit of 0.1%, according to a state laboratory report seen by Reuters.
Police have charged both the prescribing doctor and the manufacturer, Sresan Pharma, based in Tamil Nadu, with offences including culpable homicide not amounting to murder and violation of India’s Drugs and Cosmetics Act. The prescribing doctor has already been arrested, state deputy chief minister Rajendra Shukla told ANI news agency.
The case marks another blow to India’s reputation as the “pharmacy of the world”, which has come under scrutiny following previous cases in which Indian-made cough syrups were linked to child deaths in Gambia, Cameroon and Uzbekistan.
India’s health ministry said regulatory action had been initiated against a unit of Sresan Pharma, while the Central Drugs Standard Control Organisation has recommended cancelling the company’s manufacturing licence. The firm has yet to respond to requests for comment.
Officials said the contaminated batch was sold only domestically, and not exported, placing it outside the scope of new 2023 testing rules for exported medicines. Neighbouring states, including Uttar Pradesh and Rajasthan, have also moved to ban the syrup.
The health ministry has meanwhile urged doctors to prescribe cough syrups for children only when absolutely necessary, noting that most common coughs resolve without medication.
India is the world’s largest supplier of generic drugs, accounting for around 40% of those sold in the United States, a quarter in the United Kingdom and more than 90% in many African countries, according to the national drug regulator.
Thai FDA confirms the toxic cough syrup is not sold or registered in Thailand
The Thai Food and Drug Administration (FDA) has confirmed that the cough syrup linked to the deaths of 14 children in India has not been registered or distributed in Thailand.
Dr Supattra Boonserm, Secretary-General of the FDA, said the agency had conducted an internal review and verified that the product in question was neither licensed nor available in the Thai market. She assured the public that there was no cause for concern regarding the safety of medicines sold domestically.
The substance at the centre of the Indian case, diethylene glycol, is a clear, slightly viscous, odourless and colourless liquid with a sweet taste but high toxicity. Large doses can cause kidney failure and death. The chemical is sometimes found as a contaminant in raw materials used as solvents or sweetening agents. Its presence may result from poor manufacturing control or, in some cases, deliberate substitution to reduce production costs.
Thailand strictly regulates the presence of diethylene glycol in liquid medicines, allowing a maximum contamination level of 0.1%. The FDA also maintains continuous monitoring measures to prevent contamination in pharmaceutical products nationwide.
