Chennai: A shocking 26-page report from the Tamil Nadu government has exposed a horrifying trail of negligence at Sri San Pharmaceuticals, the manufacturer
of Coldrif cough syrup, which has been linked to the deaths of 17 children in Madhya Pradesh and Rajasthan. The investigation uncovered a staggering 39 critical and 325 major deficiencies, painting a picture of a facility that produced toxic syrup instead of safe medicine, operating with what the report suggests was a complete disregard for patient safety.
A Factory of Filth and Toxic Substitution
The report describes a manufacturing environment that was the antithesis of pharmaceutical standards. Production and storage occurred in filthy, unhygienic conditions plagued by dirt, mud, and insect infestations. The factory lacked the most basic necessities, including a proper drainage system, effective pest control, and validated cleaning procedures. This was compounded by a catastrophic failure in quality control. The investigation revealed that the company used non-pharmaceutical grade propylene glycol, a key ingredient in cough syrup.
Most alarmingly, lab analysis confirmed the presence of 48.6% W/V Diethylene Glycol and traces of Ethylene Glycol, both highly toxic industrial solvents commonly used in products like brake fluid and plastics. The procurement of the raw materials was itself clandestine, with the propylene glycol purchased in 50-kg lots on different dates without any invoices, and payments made via cash or Google Pay.
Systemic Collapse and Regulatory Aftermath
Beyond the immediate toxic contamination, the report detailed a systemic collapse of Good Manufacturing Practices at every level. The company operated without qualified staff, a functioning quality assurance system, or any standard operating procedures to handle quality defects or initiate a product recall. There was no system for producing purified water, and chemical waste was reportedly discharged directly into public drains.
In the wake of these findings and the tragic child deaths, the Tamil Nadu government has taken swift action. The state has banned the sale of Coldrif cough syrup and ordered the plant to stop all production indefinitely. The fallout has spread across state lines, with Madhya Pradesh and Rajasthan also suspending the sale and use of the syrup. Authorities in Madhya Pradesh have suspended three officials and transferred the state drug control officer as the investigation into the deaths continues.
