India is examining whether failures in the pharmaceutical supply chain led to toxic contamination in a cough syrup linked to the deaths of at least 24 children in recent months, according to officials familiar with the investigation.
Health and drug safety officers in Tamil Nadu say they suspect the solvent used in a batch of Coldrif cough syrup was contaminated with a toxic chemical around the time it was supplied to Sresan Pharmaceutical Manufacturer. The company had purchased 50 kilograms of propylene glycol from Sunrise Biotech, which itself had acquired it the same day from Jinkushal Aroma, a small producer of fragrance blends and industrial chemicals.
Documents and interviews reviewed by Reuters show the solvent changed hands multiple times and was repackaged before reaching Sresan. Authorities believe the Coldrif syrup was tainted with diethylene glycol, a known industrial toxin that has caused mass fatalities in past contamination incidents. Investigators are now trying to determine how the chemical entered the supply.
The deaths, reported since September, have reignited concerns about oversight in India’s pharmaceutical industry, already under scrutiny following the deaths of more than 140 children in Africa and Central Asia during 2022 and 2023 from similarly contaminated Indian-made syrups. India had pledged stricter quality controls after those tragedies.
Officials say diethylene glycol is sometimes illicitly substituted for higher-cost propylene glycol, intentionally or by neglect. Consuming high levels can cause severe kidney failure and death, particularly in children.
For the first time, details have emerged indicating significant lapses in how chemicals were handled and delivered to Sresan. The manufacturer’s licence has been revoked, and founder G. Ranganathan is in custody. Attempts to reach the company or its representatives were unsuccessful.
Chemical distributors Sunrise and Jinkushal confirmed they do not hold licences to handle pharmaceutical-grade materials, as required under Indian law. Both operators said they were unaware the solvents they sold would be used in medication and denied handling diethylene glycol.
The solvent supplied to Sresan was originally manufactured by South Korea’s SK picglobal, which shipped it in a sealed 215-kilogram barrel. Jinkushal broke the seal and repackaged the chemical before passing it on to Sunrise, which then delivered it to Sresan in unsealed containers. SK picglobal says repackaging violates its policies and voids quality assurances.
Following the deaths, inspectors found extensive violations at Sresan’s facility, including unhygienic storage conditions and falsified data. Although these issues were not directly linked to the fatalities in the report, they raise deeper questions about systemic regulatory failure. Officials say the factory had not been inspected since 2023 despite the company’s previous penalties.
The investigation is ongoing, with central authorities conducting broader inspections and reassessing pediatric use of cough syrups as part of a wider safety crackdown.
