NEW DELHI (Realist English). Indian authorities are investigating whether failures in the chemical supply chain led to the contamination of a cough syrup that has killed at least 24 children since September, according to three Tamil Nadu health and drug safety officials familiar with the probe.
Investigators believe the solvent used to manufacture a batch of Coldrif syrup — propylene glycol (PG) — may have been contaminated with diethylene glycol (DEG), a toxic industrial chemical that has been linked to multiple mass poisonings worldwide. The PG was supplied to drugmaker Sresan Pharmaceutical Manufacturer in March.
According to an internal investigation report dated October 3 and reviewed by Reuters, Sresan purchased 50 kg of PG from distributor Sunrise Biotech, which had acquired it the same day from Jinkushal Aroma, a small firm that normally makes fragrance blends for detergents and industrial chemicals. Neither Jinkushal nor Sunrise holds a licence to handle pharmaceutical-grade ingredients — a violation of India’s Drugs and Cosmetics Act.
Sunrise admitted to repackaging the solvent before delivery without tamper-proof seals, a breach of global pharmaceutical safety practice. Chemical suppliers typically deliver PG in sealed containers to prevent contamination. Jinkushal also confirmed it broke open the original 215-kg sealed barrel — manufactured by South Korean firm SK picglobal — and subdivided it for resale.
SK picglobal said it strictly prohibits repackaging and does not guarantee the quality of products once they are broken into smaller containers.
Contamination and systemic failures
Authorities say the Coldrif syrup was “heavily contaminated” with DEG. High doses cause acute kidney failure and have historically led to mass child fatalities, including more than 140 deaths in Africa and Central Asia in 2022–2023 linked to Indian-made syrups containing tainted solvents.
New Delhi promised tighter quality controls after those incidents, but the Coldrif case suggests deep structural gaps remain.
Inspectors found hundreds of “critical” and “major” violations at Sresan’s plant near Chennai — including falsified records and unhygienic storage — though they have not yet linked those breaches directly to the DEG contamination.
Sresan’s manufacturing licence has been revoked, and founder G. Ranganathan is in custody. Attempts to contact the company were unsuccessful.
Regulatory oversight questioned
Despite Sresan’s history of violations — including penalties in 2020, 2021, 2022 and 2023 — the plant had not been inspected since 2023, according to Tamil Nadu officials. State and federal regulators have not explained the lapse.
The Central Drugs Standard Control Organisation referred queries to India’s health ministry, which said only that it is expanding inspections across the sector and re-evaluating paediatric cough syrups.
Officials say they have yet to determine how DEG entered the supply chain, and whether the contamination resulted from cost-cutting, negligence or fraud.
With India’s $50bn pharmaceutical industry already under global scrutiny, the deaths have renewed calls for an overhaul of the country’s fragmented regulatory system — and for strict enforcement of basic safeguards in handling pharmaceutical ingredients.