Indian authorities are investigating whether safety lapses in the supply of a key pharmaceutical ingredient led to the contamination of a cough syrup that has killed at least 24 children in recent months, Reuters reported, citing three health and drug safety officials in Tamil Nadu. Early findings suggest that the solvent used to manufacture a batch of Coldrif cough syrup may have been contaminated with a toxic industrial chemical before it reached the drugmaker, Sresan Pharmaceutical Manufacturer.
According to an Oct. 3 investigation report exclusively reviewed by Reuters, Sresan had acquired 50 kg of propylene glycol (PG) — a common base solvent in cough syrups — from Sunrise Biotech, which itself purchased the chemical from Jinkushal Aroma, a small supplier producing fragrance blends and detergent chemicals. Both companies confirmed they had no drug licences required for handling pharmaceutical-grade substances.
Authorities said tests revealed that Coldrif syrup was heavily contaminated with diethylene glycol (DEG), a deadly industrial solvent that has caused mass child fatalities in previous global poisoning incidents. High levels of DEG ingestion can trigger acute kidney failure and death, with children especially vulnerable.
The resurgence of DEG-linked deaths has reignited concerns over India’s $50 billion pharmaceutical sector, which was already under scrutiny following more than 140 children’s deaths across Africa and Central Asia in 2022–2023 tied to contaminated Indian-made cough syrups. Despite government promises to improve oversight, the new investigation exposes persistent gaps in quality control and regulatory enforcement.
Reuters learned that the PG used by Sresan originated from South Korea’s SK picglobal and was shipped to India in a sealed 215 kg barrel. However, Jinkushal Aroma broke the seals, repackaged the solvent in smaller volumes, and sold it to Sunrise, which then delivered it to Sresan in unsealed containers—a breach of global pharmaceutical safety practices.
Both Jinkushal owner Jitender Vishwakarma and Sunrise operator Vipul Jain said they did not handle DEG and were unaware that the PG they sold would be used in medicines. The circumstances under which the contamination occurred remain unclear. Reuters was unable to determine the exact source of DEG or confirm responsibility.
SK picglobal told Reuters that it strictly prohibits customers from repacking or redistributing its products and does not guarantee product integrity once opened and subdivided.
Following the deaths, Tamil Nadu’s pharmaceutical regulator uncovered extensive violations at Sresan’s factory near Chennai. Inspectors documented “unhygienic conditions,” “falsification of data,” and hundreds of “critical” and “major” breaches of manufacturing standards, according to the Oct. 3 report reviewed by Reuters. The report did not definitively link those violations to the fatal contamination.
Sresan’s manufacturing licence has been revoked, and company founder G. Ranganathan has been taken into custody. Reuters’ attempts to reach company representatives were unsuccessful.
Despite Sresan’s history of regulatory penalties — including actions in 2020, 2021, 2022 and 2023 — two state officials told Reuters that the company’s factory had not been inspected at all in 2024, in violation of regulations requiring annual audits.
India’s Central Drugs Standard Control Organisation referred Reuters to a government statement confirming that the health ministry is conducting additional nationwide inspections, reviewing pediatric cough syrup use, and increasing scrutiny of pharmaceutical manufacturing facilities.
With the investigation ongoing, officials have yet to determine how the contamination occurred or who is responsible for the deaths.
