Lagatar24 Desk
Chennai: Tamil Nadu’s Drugs Control Department has issued a show-cause notice to Kancheepuram-based Sresan Pharmaceuticals after 16 children died in Madhya Pradesh and Rajasthan due to consumption of its Coldrif cough syrup. The notice demands the company furnish comprehensive production and sourcing details within five days.
Toxic Chemicals, Lapses, And Unhygienic Conditions Found
Government inspectors uncovered over 350 violations in the manufacturing process, categorised as “critical” and “major.” The facility reportedly lacked basic infrastructure, trained staff, and safety measures. Inspections revealed unhygienic conditions, poor ventilation, rusted or damaged equipment, and the absence of air handling units.
Crucially, investigators found traces of toxic diethylene glycol (DEG) — a deadly industrial solvent — and flagged illegal procurement of 50 kg of propylene glycol without invoices. Non-pharma grade chemicals were used, plastic pipes carried liquids without filtration, and effluents were discharged into regular drains. Raw materials were released without testing, and the company had no pharmacovigilance system to track adverse reactions.
Sale Banned, Nationwide Alert Issued
Following the inspection, Tamil Nadu banned the sale of Coldrif syrup from October 1 and ordered the immediate removal of stocks from the market. The state also confirmed product adulteration through lab testing. Production has been halted pending further investigation.
The deaths in Chhindwara triggered a nationwide alert, with Madhya Pradesh, Rajasthan, and Tamil Nadu suspending the sale and use of Coldrif. Madhya Pradesh has also suspended three officials and transferred its drug controller after initial findings linked the fatalities to the contaminated syrup.