Indian Cough Syrup Tragedy: Safety Lapses & Contaminated Supply Chain Blamed for Child Deaths
A tragic investigation is underway in India following the deaths of at least 24 children, primarily linked to contaminated Coldrif cough syrup. Officials are scrutinizing potential safety breaches in the supply chain of a crucial pharmaceutical ingredient, a solvent believed to have been tainted with a toxic chemical.
The Contamination Trail Uncovered
The inquiry, detailed by health and drug safety officials from Tamil Nadu state, suggests that propylene glycol (PG), a solvent used in the cough syrup, may have been contaminated with industrial toxin diethylene glycol (DEG) around the time it was supplied to Sresan Pharmaceutical Manufacturer. Sresan acquired 50 kg of PG from local distributor Sunrise Biotech on March 25, which in turn purchased it from Jinkushal Aroma, a small company typically dealing in fragrance blends, on the same day. Neither Jinkushal nor Sunrise possessed the necessary drug licenses to handle pharmaceutical-grade ingredients, a critical regulatory lapse.
Adding to the concern, both Jinkushal and Sunrise confirmed repackaging the solvent without tamper-proof seals before delivering it. While SK picglobal, the South Korean manufacturer of the original PG, strictly prohibits repackaging, the solvent's journey saw its original sealed 215 kg barrel broken down and redistributed multiple times. The owners of Jinkushal and Sunrise claimed unawareness that the PG would be used for medication and denied handling DEG.
Systemic Failures and Regulatory Oversight
This incident casts a fresh shadow on India's $50 billion pharmaceutical sector, which previously faced international scrutiny after over 140 children died in Africa and Central Asia in 2022 and 2023 due to contaminated Indian-made cough syrups. New Delhi had, at that time, promised improved quality controls.
The investigation into Sresan Pharmaceutical Manufacturer has revealed alarming systemic failures. State regulators found hundreds of "critical" and "major" violations at Sresan's factory near the southern city of Chennai, including unhygienic storage and data falsification. The company's manufacturing license has been revoked, and its founder, G. Ranganathan, is in custody. Despite a history of penalties for previous violations in 2020, 2021, 2022, and 2023, Sresan's factory had not been inspected since 2023, missing mandatory annual checks. The precise point and individual responsible for the DEG contamination remain under investigation, as authorities delve into how the toxic chemical entered the solvent.