When inspectors entered the factory in Tamil Nadu that made Coldrif cough syrup, the syrup linked to the deaths of 15 children in Madhya Pradesh, they saw vats of chemicals boiling on open gas stoves, plastic pipes leaking sticky residue, and rusted equipment lying around. Workers without gloves or masks were carelessly mixing ingredients, NDTV reported.
Following an alert from the Madhya Pradesh Food and Drug Administration (FDA), Tamil Nadu’s Drugs Control Department raided the Sresan Pharmaceuticals unit in Kancheepuram on October 1 and 2.
Dangerous chemical sourcing
According to the officials, the company had bought industrial-grade chemicals, meant for paints and glues, instead of medical-grade ingredients. The purchases were made in cash and via Google Pay from two small Chennai dealers, Sunrise Biotech and Pandia Chemicals, to avoid paperwork and traceability.
The company also sourced propylene glycol, a key syrup ingredient, from local chemical traders and paint industry dealers instead of certified pharmaceutical suppliers. No tests were done to check for deadly contaminants before it was used in production.
Toxic ingredients, no safety checks
Inspectors also found that the propylene glycol used contained diethylene glycol, a highly toxic chemical normally used in brake fluids, lubricants, and glues. This substance can severely damage the kidneys, liver, and nervous system.
Tests on the kidneys of the children who died in Chhindwara showed high levels of diethylene glycol poisoning. The Coldrif batch in question, SR-13, contained 48.6% diethylene glycol, almost 500 times the permissible limit.
The company had no quality testing system and no monitoring of adverse reactions or recalls. There was no pharmacovigilance mechanism in place, meaning that once the product left the factory, no one tracked its safety or side effects.
What major violations were listed?
The inspection team listed 39 critical and 325 major violations under the Drugs and Cosmetics Act, 1940. Among them were absence of qualified chemists or pharmacists on site, use of untested raw materials and impure water from unknown sources, no ventilation, HEPA filters, or pest control.
The officials also found open drains and dirty equipment and missing records, safety logs, and quality checks.
The factory had none of the basic safety systems that pharmaceutical manufacturing requires. It was clear that production continued unchecked for months.
The deadly batch of Coldrif syrup
Batch SR-13 of Coldrif syrup, the one consumed by children in Chhindwara, was manufactured in May 2025 and was valid until April 2027. It circulated freely in the market for months before the alarm was raised. Reports suggest that the same batch had also been distributed in Tamil Nadu, Odisha, and Puducherry.
Notably, other syrups made in the same facility, Respolite D, GL, ST, and Hepsandin, passed quality tests. But Coldrif turned out to be fatally flawed.
Between August and September, doctors in Chhindwara prescribed the syrup to children suffering from fever and cough. Soon after, several of them developed acute kidney failure. Fifteen children, most under five years old, died.
As per the NDTV report, a senior health official involved in the investigation said that the tragedy was not a single act of negligence but a complete system collapse from unverified chemical purchases in Chennai to a lack of quality control in Kancheepuram and the unchecked distribution in Madhya Pradesh.
Following the raids, the Tamil Nadu Drugs Control Authority ordered Sresan Pharmaceuticals to stop production and froze all its stock. The company’s license has been suspended, and a show-cause notice has been issued.
In Madhya Pradesh, two drug inspectors and a deputy director of the Food and Drug Administration were suspended. Chief Minister Mohan Yadav also transferred the state’s Drug Controller, Dinesh Maurya. A doctor in Chhindwara has been arrested for negligence.
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
Find the best of Al News in one place, specially curated for you every weekend.
Stay on top of the latest tech trends and biggest startup news.