Indian authorities are probing whether a contaminated pharmaceutical solvent slipped through a chain of unlicensed suppliers and into a batch of cough syrup that killed at least 24 children, a case that has reignited fears over safety standards in one of the world’s largest drug-manufacturing hubs.
Three senior health and drug-safety officials in Tamil Nadu told Reuters they suspect the solvent used in the Coldrif cough syrup – propylene glycol, or PG – was tainted with the industrial toxin diethylene glycol (DEG) before it reached the manufacturer, Sresan Pharmaceutical.
Investigators say the contamination likely occurred around the time the PG was supplied to Sresan on March 25 by local distributor Sunrise Biotech, which had itself purchased the chemical the same day from Jinkushal Aroma, a small supplier that typically makes fragrance blends for detergents.
The revelations, detailed in an Oct. 3 report by Tamil Nadu’s pharmaceutical regulator and shared exclusively with Reuters, expose deep cracks in the oversight of India’s $50 billion pharmaceutical sector.
The Coldrif deaths, which began in September, echo two earlier mass fatalities in Africa and Central Asia in 2022 and 2023 linked to Indian-made cough syrups contaminated with DEG. Those tragedies forced New Delhi to pledge stricter controls on drug ingredients, but the new case suggests systemic weaknesses persist.
Authorities say DEG is sometimes fraudulently or mistakenly used in medicines because it is cheaper than pharmaceutical-grade PG. Even small amounts can trigger acute kidney failure in children.
Indian regulators are now examining how DEG entered the supply chain and whether the breach came from mishandling, deliberate adulteration or unsafe storage conditions.
The Tamil Nadu Drugs Control Department has not responded to repeated requests for comment.
The investigation has already triggered consequences for Sresan. Its manufacturing license has been revoked, and its founder, G. Ranganathan, is in custody.
Attempts to reach Sresan’s offices or Ranganathan’s family were unsuccessful, and Reuters could not identify a legal representative.
Federal regulators, meanwhile, referred questions to the health ministry, which said only that inspections of drug factories nationwide are being intensified and the safety of pediatric cough syrups is under review.
A central concern for investigators is the way chemicals changed hands before reaching Sresan.
PG is typically delivered in sealed containers to prevent contamination, yet Sunrise admitted it repackaged the solvent before delivery.
Neither Sunrise nor Jinkushal holds the licenses required to handle pharmaceutical-grade ingredients, a violation of India’s Drugs and Cosmetics Act.
Their owners insist they did not know the PG they sold would be used in medicines and say they do not handle DEG at all.
According to documents reviewed by Reuters, the PG supplied to Sresan had been manufactured by South Korea’s SK picglobal and exported in a sealed 215-kg drum to an Indian distributor before ending up with Jinkushal.
The drum’s seal was broken at Jinkushal’s shop, where the solvent was repackaged and later subdivided again by Sunrise.
SK picglobal confirmed that the certificate of analysis attached to the shipment appeared genuine and stressed that it prohibits repackaging or unsealed redistribution, warning that quality cannot be guaranteed once containers are opened.
It did not say whether such restrictions are written into its sales contracts.
Even before the children’s deaths, Sresan had a history of run-ins with regulators.
Four officials familiar with the matter say the company and its founder were penalized multiple times between 2020 and 2023, though documentation was not provided.
Tamil Nadu’s health minister recently told lawmakers that Sresan had been fined for “minor violations” in 2021 and 2023.
Despite those issues – and despite rules requiring annual inspections – the factory had not been examined since 2023, according to two state health officials.
Inspections conducted after the fatalities uncovered hundreds of “critical” and “major” lapses, including unhygienic storage and falsified data, according to the Oct. 3 report.
While regulators did not directly link those violations to the deaths, the findings add to mounting questions about how the contamination happened and how a factory with a checkered record avoided closer scrutiny.
Investigators have not yet established precisely where or how the solvent was tainted.
