Rust, Filth, Neglect: Factory Made 'Killer' Cough Syrup Despite Violations

Vats of chemicals being heated on gas stoves, plastic pipes oozing residue, rusted equipment and untrained workers mixing ingredients without gloves or masks - inspectors were in for a shock when they reached the premises where 'Coldrif' cough syrup, behind the deaths of 16 children in Madhya Pradesh, was manufactured.

Following an alert from the Madhya Pradesh Food and Drug Administration, Tamil Nadu's Drugs Control Department raided Sresan Pharmaceuticals on October 1 and 2 in Kancheepuram.

Questionable Procurement

The industrial grade chemicals used to manufacture Coldrif were bought in cash and through Google Pay from local dealers Sunrise Biotech and Pandia Chemicals in Chennai, an October 3 report by the Tamil Nadu Drugs Control Directorate stated. This helped avoid documentation.

The company sourced propylene glycol, a key syrup ingredient, from local chemical traders and paint industry dealers instead of certified pharmaceutical suppliers. The procurement went ahead without any tests for deadly contaminants.

Negligent Production

Inspectors found that the company used industrial grade propylene glycol, procured without testing for contaminants like diethylene glycol or ethylene glycol. Diethylene glycol, used in the manufacture of printing ink, glue, brake fluid and lubricants and known to cause severe kidney, liver and nervous system damage, was found in high concentration when biopsies were conducted on the kidneys of the children who died. The deadly SR-13 batch of Coldrif was found to have an astonishing 48.6 percent of diethylene glycol, nearly 500 times above the permissible limit.

The factory had no pharmacovigilance system, which means that no one tracked adverse reactions or recalls.

Untrained Staff, No Quality Tests, Rampant Violations

No qualified chemists were present to oversee production, while raw materials were used without any quality tests. The water used in production was drawn from unknown sources and not tested for purity. There were no air handling units, no HEPA filters, no ventilation, no pest control and no safety logs.

The inspectors reported 39 critical and 325 major violations under the Drugs and Cosmetics Act, 1940, ranging from pest infestations and open drains to missing air filters and broken equipment.

About The Fatal Batch

The Coldrif Syrup Batch SR-13, consumed by the victims in Chhindwara, was manufactured in May 2025 and set to expire in April 2027. It had been circulating freely in the market for months before any alarm was raised. Cough syrup from this batch has also been distributed in Tamil Nadu, Odisha and Puducherry, PTI reported.

Other syrups made in the same facility - Respolite D, GL, ST, and Hepsandin - were tested and found to be of standard quality.

What Followed

The toxic syrup was prescribed in Chhindwara, where more than a dozen children developed acute kidney failure between August and September. 16 have since died, most of them under five years of age. Parents, unaware of the danger, continued to administer the syrup prescribed by local doctors.

A senior health official involved in the investigation told NDTV 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.

The Tamil Nadu Drugs Control Authority has since issued a stop-production order and frozen all stock from Sresan Pharmaceuticals. A show-cause notice has been served, and the company's license is under suspension.

Madhya Pradesh Government Takes Action

The Madhya Pradesh government suspended two drug inspectors and a deputy director of the food and drug administration. Chief Minister Mohan Yadav also transferred the state's Drug Controller Dinesh Maurya, while a doctor from Chhindwara was arrested for medical negligence.