Indian authorities have launched an investigation to determine whether shortcomings in quality control during the supply of a pharmaceutical ingredient caused contamination in a cough syrup that has been linked to the deaths of at least 24 children in recent months, according to three sources familiar with the situation.
The three Tamil Nadu health and drug safety officials told Reuters they suspect that the solvent used to produce a batch of Coldrif cough syrup may have been tainted with a toxic chemical at the time it was provided to the manufacturer, Sresan Pharmaceutical.
According to interviews with the suppliers and an October 3 report by the Tamil Nadu pharmaceutical regulator, reviewed exclusively by Reuters, Sresan purchased 50 kilograms of propylene glycol (PG) from local chemical distributor Sunrise Biotech on March 25. Sunrise Biotech had obtained the PG earlier that same day from Jinkushal Aroma, a small company that produces fragrance blends for liquid detergents and other chemicals.
The Tamil Nadu Drugs Control Department didn’t respond to repeated requests for comment about its investigation.
Authorities have said the Coldrif syrup was heavily 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 for dissolving its active ingredients.
The fatalities, which began in September, have revived concerns about safety standards in India’s $50 billion pharmaceutical sector, which was tarnished by the deaths of more than 140 children in Africa and Central Asia in 2022 and 2023 from Indian-made cough syrups made with contaminated solvents.
In the wake of those deaths, New Delhi had pledged to improve quality controls.
Indian health officials say DEG is sometimes fraudulently or unintentionally used in medicines in place of pricier PG. Ingesting high levels of it has been linked to acute kidney damage and death in children.
Reuters is reporting details for the first time about the focus of the Indian investigation, as well as breaches in global pharmaceutical safety practices in the delivery of the chemicals to Sresan.
Sresan’s manufacturing licence has been revoked and its founder, G. Ranganathan is in custody. Efforts to contact representatives at Sresan’s corporate office and Ranganathan’s home were unsuccessful. Reuters was unable to identify a legal representative for Ranganathan.
The Central Drugs Standard Control Organisation, which oversees pharmaceuticals federally, directed questions to India’s health ministry, which in turn referred Reuters to a government statement saying it was conducting more inspections of drug facilities and reviewing pediatric use of cough syrups.
Chemical makers typically deliver PG solvents to clients in sealed containers to avoid contamination, but Sunrise confirmed to Reuters that it had repackaged the solvent without a seal before delivering it.
Source: The News