Deadly Contamination: How Substandard Manufacturing Led to Fatal Cough Syrup Poisoning of 16 Children

16 children lost their lives in Madhya Pradesh's Chhindwara after consuming Coldrif cough syrup.

When inspectors arrived at the manufacturing facility of 'Coldrif' cough syrup, responsible for 16 children's deaths in Madhya Pradesh, they discovered alarming conditions: chemicals being heated on gas stoves, plastic pipes leaking residue, rusted equipment, and untrained workers mixing ingredients without protective gear.

The Tamil Nadu Drugs Control Department conducted raids on Sresan Pharmaceuticals in Kancheepuram on October 1 and 2, following an alert from Madhya Pradesh's Food and Drug Administration.

Industrial-grade chemicals used in Coldrif's production were purchased in cash and via Google Pay from local Chennai dealers Sunrise Biotech and Pandia Chemicals, according to an October 3 report by the Tamil Nadu Drugs Control Directorate. This method circumvented proper documentation requirements.

Rather than sourcing propylene glycol, a crucial syrup ingredient, from certified pharmaceutical suppliers, the company obtained it from local chemical traders and paint industry dealers. No testing for deadly contaminants was conducted during procurement.

Inspectors discovered the company used industrial-grade propylene glycol without testing for contaminants such as diethylene glycol or ethylene glycol. Diethylene glycol, commonly used in printing ink, glue, brake fluid, and lubricants, can cause severe damage to kidneys, liver, and the nervous system. Biopsies of the deceased children's kidneys revealed high concentrations of this substance. The lethal SR-13 batch of Coldrif contained a shocking 48.6 percent diethylene glycol, nearly 500 times above permissible limits.

The factory lacked any pharmacovigilance system, meaning no one monitored adverse reactions or managed product recalls.

Production occurred without qualified chemists supervising the process, and raw materials were utilized without quality testing. Water from unverified sources was used without purity testing. The facility lacked air handling units, HEPA filters, ventilation, pest control, and safety logs.

Inspectors reported 39 critical and 325 major violations under the Drugs and Cosmetics Act, 1940, including pest infestations, open drains, missing air filters, and broken equipment.

The fatal Coldrif Syrup Batch SR-13 consumed by victims in Chhindwara was manufactured in May 2025 with an expiration date of April 2027. It had been circulating in the market for months before concerns were raised. According to PTI, this cough syrup batch was also distributed in Tamil Nadu, Odisha, and Puducherry.

Other syrups produced at the same facility—Respolite D, GL, ST, and Hepsandin—were tested and found to meet standard quality requirements.

In Chhindwara, the toxic syrup was prescribed to children, causing more than a dozen to develop acute kidney failure between August and September. Sixteen children, most under five years old, have died. Parents, unaware of the danger, continued administering the syrup prescribed by local doctors.

A senior health official involved in the investigation told NDTV that this tragedy resulted not from a single act of negligence but from a complete system collapse—from unverified chemical purchases in Chennai to inadequate quality control in Kancheepuram and unchecked distribution in Madhya Pradesh.

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

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