Madhya Pradesh authorities took approximately two weeks to raise the red flag regarding the deaths of children potentially linked to the Coldrif cough syrup. The incident has sparked widespread concern and investigations into the manufacturing and distribution of the drug. The tragedy has so far claimed the lives of 20 children in Madhya Pradesh. Seventeen of the deceased are from the Chhindwara district, two from Betul, and one from Pandhurna. Five children are currently undergoing treatment for kidney failure.
The crisis began in early September 2025 when children started exhibiting symptoms such as cold and mild fever. They were prescribed routine medications, including cough syrups, and initially appeared to recover. However, their symptoms soon returned, followed by a sudden decrease in urine output, leading to kidney infections and, tragically, death. Kidney biopsies revealed the presence of diethylene glycol contamination.
The state government has responded by banning the sale of Coldrif across Madhya Pradesh and initiating a Special Investigation Team (SIT) to investigate the matter. The SIT will also extend its investigation to Tamil Nadu, where Shreesan Pharmaceuticals, the manufacturer of Coldrif, is located. The Tamil Nadu government had already banned Coldrif following reports of deaths in Madhya Pradesh.
Dr. Praveen Soni, a pediatrician who prescribed Coldrif to many of the affected children, has been arrested and charged with negligence causing death. He was also suspended from his position as a government doctor. The FIR also mentions Sresan Pharmaceuticals, holding them accountable for manufacturing adulterated drugs. Reports indicate that Dr. Soni's bail has been rejected. Protests have erupted, with doctors launching an indefinite strike against the arrest, demanding action against the drug manufacturer and those who approved the syrup's use.
The cough syrup samples were found to contain 48.6% diethylene glycol (DEG), a toxic substance used in industrial solvents, far exceeding the permissible limit of 0.1%. DEG can be fatal even in small amounts.
In response to the crisis, several states, including Punjab, Kerala, Tamil Nadu, Madhya Pradesh, Uttar Pradesh, and Jharkhand, have banned Coldrif and launched investigations. The Union Health Ministry has issued advisories to all States/UTs against prescribing cough-cold medications to children below two years, with general recommendations against their use for children below five years. The Rajasthan government has also banned cough syrups containing Dextromethorphan for children under five years of age.
This is not an isolated incident, as India has witnessed several cough syrup-related deaths over the past three decades. The Coldrif tragedy highlights gaps in pharmaceutical safety oversight and the urgent need to strengthen drug quality and protect children. The Union Health Ministry has ordered strict compliance with revised Schedule M norms, updated GMP standards under the Drugs and Cosmetics Act, 1940. These norms mandate Quality Risk Management, supply chain traceability, DEG/EG testing, data integrity, and pharmacovigilance systems, effective by December 31, 2025.
