TN Drug Regulator Issues Show Cause Notice To Sresan Pharma After Child Deaths Linked To Coldrif Syrup
Sresan Pharmaceuticals faces a show-cause notice after its Coldrif syrup was linked to child deaths due to diethylene glycol contamination.
The Tamil Nadu Drugs Control Department has issued a show-cause notice to Sresan Pharmaceuticals in Kancheepuram after 14 children in Madhya Pradesh and two in Rajasthan reportedly died after consuming the company’s Coldrif cough syrup. The notice directs the firm to furnish detailed information within five days, including production quantities, raw material invoices, analysis certificates, propylene glycol purchase records, packaging details and the master manufacturing formula.
Show Cause Notice Issued To Sresan Pharma
A state inspection exposed over 350 violations in the company’s production process, categorised as “critical” or “major.” Officials said the facility lacked qualified staff, essential safety systems, and proper hygiene standards. Inspectors found poor ventilation, rusted equipment, and no air handling units, along with unsanitary manufacturing areas.
The probe also revealed the use of non-pharmaceutical grade chemicals. While propylene glycol is permitted in food and cosmetics, Sresan Pharmaceuticals allegedly procured 50 kilograms illegally without valid documentation, as per a report on India Today. Tests detected traces of diethylene glycol (DEG) — a toxic industrial solvent — in the syrup. Other lapses included the use of plastic pipes for liquid transfer, no filtration systems, and unsafe disposal of chemical waste into public drains.
Officials said raw materials were cleared without proper testing, and the firm had no pharmacovigilance system to monitor adverse reactions. Finished products were reportedly stored in dusty corridors, raising contamination risks.
Following the findings, the Tamil Nadu government banned the sale of Coldrif syrup from October 1 and ordered the recall of all existing stocks. Samples from the facility were confirmed to be adulterated, and production has been suspended pending further investigation.
The child deaths in Chhindwara have triggered a nationwide alert, prompting states including Madhya Pradesh, Rajasthan, and Tamil Nadu to suspend sales of Coldrif syrup. Madhya Pradesh has also taken disciplinary action, suspending three officials and transferring its state drug controller after the initial probe linked the fatalities to the tainted medicine.
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