The recent ban on Coldrif cough syrup across multiple Indian states has sent shockwaves through the country’s healthcare system, as authorities scramble to address a public health crisis linked to at least 14 child deaths. Manufactured by Sresan Pharmaceuticals in Chennai, Coldrif has become the center of a grave drug-safety failure, prompting urgent regulatory action, criminal investigations, and calls for stricter oversight of pediatric medicines.
The tragedy began unfolding in early September 2025 in Madhya Pradesh’s Chhindwara district, where a string of pediatric deaths was reported. According to News18, families described a hauntingly similar pattern: children were treated for routine colds, prescribed Coldrif syrup, and initially showed signs of improvement. But soon after, they suffered a sudden drop in urine output, followed by acute kidney failure. By September 18, local authorities had declared an emergency, as the death toll climbed to 14, with additional suspected cases emerging in Rajasthan.
Laboratory analysis by the Drug Testing Laboratory in Chennai revealed the horrifying culprit: Coldrif samples contained a staggering 48.6% diethylene glycol (DEG), an industrial solvent that is strictly prohibited for medicinal use. Ethylene glycol, another toxic compound, was also detected. Both chemicals are commonly found in antifreeze and brake fluids, and even minute quantities can be lethal, especially for children. As Mathrubhumi noted, DEG poisoning is notorious for causing severe kidney damage, neurological harm, and has a grim history of deadly mass poisonings worldwide.
The batch at the heart of the crisis, labeled SR-13, was manufactured in May 2025 and set to expire in April 2027. The chemical evidence was damning: the Government Analyst in Chennai declared the syrup “not of standard quality,” and the findings left little doubt about the cause of the children’s deaths. To rule out broader contamination, central expert teams from the National Centre for Disease Control (NCDC), the National Institute of Virology (NIV), and the Central Drugs Standard Control Organisation (CDSCO) tested other medicines. The results were clear—nine out of ten medicines met quality standards, but Coldrif failed dramatically.
In the wake of the tragedy, state governments moved swiftly. Tamil Nadu was the first to ban Coldrif statewide starting October 1, 2025, ordering all stocks off shelves. Madhya Pradesh quickly followed, suspending not only Coldrif but all products by Sresan Pharmaceuticals. According to News18, Chief Minister Mohan Yadav called the deaths “extremely tragic” and promised that “the guilty are not spared.” The state also announced financial assistance of Rs 4 lakh for each bereaved family.
The crackdown didn’t stop there. Kerala, though it hadn’t distributed the tainted batch, suspended sales and issued a recall as a precaution. The state’s Health Minister, Veena George, confirmed that all eight distributors and pharmacies were directed to clear their shelves. Maharashtra’s Food and Drug Administration seized stocks of the implicated batch, while Telangana issued a public alert instructing hospitals, retailers, and wholesalers to halt use immediately. Rajasthan, which reported four child deaths during the same period, launched its own inquiry, though it has not established a definitive link to Coldrif as of early October.
The regulatory response escalated rapidly at the national level. The CDSCO recommended the cancellation of Sresan Pharmaceuticals’ manufacturing license—a move that was swiftly enacted. Criminal proceedings have begun against the company, and Dr. Praveen Soni, a government pediatrician in Madhya Pradesh, was arrested and suspended for prescribing Coldrif. He remains under investigation for alleged negligence and for continuing to prescribe the syrup despite reports of adverse effects. The FIR, as reported by News18, names both the doctor and Sresan Pharmaceuticals, invoking laws that carry penalties up to life imprisonment when adulteration causes death.
The Union Health Ministry, alarmed by the scale of the tragedy, issued an advisory on October 6, 2025, instructing doctors not to prescribe cough and cold syrups to children under two years of age. The Directorate General of Health Services reinforced that such medications are not recommended for children under five unless absolutely necessary, and even then only with careful supervision and appropriate dosing. These advisories reflect a growing consensus among experts, including ICMR Director General Dr. Rajiv Bahl and Director General of Health Services Dr. Sunita Sharma, who emphasized that most pediatric coughs are self-limiting and do not require medication.
In a bid to prevent similar disasters, the Union Health Ministry convened an emergency meeting with all states and Union Territories on October 5, 2025. States were directed to enforce India’s upgraded Good Manufacturing Practices code (Revised Schedule M) and to flag non-compliant units for immediate action. Drug Controller General of India Dr. Rajeev Raghuvanshi noted that manufacturers must align with the revised norms by December 2025, with risk-based inspections already underway in 19 units across six states, including Tamil Nadu, Madhya Pradesh, Maharashtra, Gujarat, Himachal Pradesh, and Uttarakhand. Nineteen samples of various medicines, including cough syrups, antibiotics, and antipyretics, are currently under laboratory testing.
Surveillance has also been intensified through the Integrated Disease Surveillance Programme (IDSP–IHIP), with a renewed emphasis on inter-state coordination to rapidly flag and test unusual clusters of illness. The Union Health Ministry has ordered all states to audit pediatric syrup manufacturers and submit compliance reports within 30 days.
Globally, the danger posed by diethylene glycol and ethylene glycol in medicines is well documented. The World Health Organisation has linked similar contaminations to mass casualties in several countries. After The Gambia reported seventy child deaths in 2022, the WHO issued a series of global alerts. It now estimates that more than 300 child deaths worldwide since 2022 have been caused by DEG/EG poisoning.
As investigators trace the procurement and production chain for Batch SR-13, the Coldrif tragedy serves as a stark reminder of the catastrophic consequences when pharmaceutical oversight fails. The swift response from Indian authorities—banning the syrup, launching criminal probes, and tightening regulations—signals a determination to restore public trust and prevent future tragedies. But for the families in Chhindwara and beyond, the pain of loss lingers, and the demand for accountability remains as urgent as ever.