How children die from Indian cough syrup

Indian officials are investigating whether safety gaps in the supply of a pharmaceutical ingredient are to blame for the contamination of cough syrup that has killed at least 24 children in recent months, according to three people familiar with the matter.

The three health and drug safety officials from the state of Tamil Nadu said Reuters believe the solvent used to make a batch of Coldrif cough syrup could have been contaminated with a toxic chemical at the time it was supplied to the pharmacist, Sresan Pharmaceutical Manufacturer.

Sresan bought 50 kg of propylene glycol (PG) solvent from local chemical distributor Sunrise Biotech on March 25, which bought it the same day from Jinkushal Aroma, a small company that produces fragrance blends for liquid detergents and other chemicals, according to supplier interviews and an exclusive Naharmacemilutical research report, October 3 by NameRegulator p. Reuters.

The Tamil Nadu Drug Control Department did not respond to repeated requests for comment on its investigation.

Authorities said the Coldrif syrup was highly contaminated with a known industrial toxin, diethylene glycol (DEG). They are investigating how the chemical was added to the solvent, which is used in cough syrup as a base to dissolve its active ingredients.

The deaths, which began in September, have reignited concerns about safety standards in India’s $50 billion pharmaceutical sector, which has been marred by the deaths of more than 140 children in Africa and Central Asia in 2022 and 2023 from Indian cough syrups made with contaminated solvents.

In the wake of these deaths, New Delhi had pledged to improve quality controls.

Indian health officials say DEG is sometimes fraudulently or inadvertently used in medicines instead of the more expensive PG. Ingestion of high levels of it has been linked to acute kidney injury and death in children.

Reuters details for the first time the focus of the Indian investigation, as well as violations of global pharmaceutical safety practices in the delivery of the chemicals to Sresan.

Sresan’s manufacturing license has been revoked and its founder, G. Ranganathan is in custody. Attempts to contact representatives at Sresan’s corporate office and Ranganathan’s home were unsuccessful. Reuters could not identify a legal representative for Ranganathan.

The Central Drug Standards Agency, which oversees pharmaceuticals federally, referred questions to India’s health ministry, which in turn referred Reuters in a government statement saying it is conducting more inspections of drug facilities and reviewing the pediatric use of cough syrups.

Chemical manufacturers usually deliver PG solvents to customers in sealed containers to prevent contamination, but Sunrise confirmed that Reuters that he had repackaged the unsealed solvent before delivering it.

The Drugs and Cosmetics Act of India prohibits the sale and handling of pharmaceutical grade ingredients such as pharmaceutical PG by entities that do not hold drug licenses.

Neither Jinkushal nor Sunrise have licenses to handle pharmaceutical grade ingredients, the two wholesalers confirmed Reuters. The owners told them that they did not know that the PG they sold would be used to make drugs.