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A children's cough syrup produced by Sresan Pharmaceuticals, which is based in Chennai, has been involved in a serious failure regarding drug safety. In the Chhindwara district of Madhya Pradesh, 14 children who were treated for common colds later suffered from severe kidney failure and passed away. Tests showed that the syrup they consumed—Coldrif—had 48.6 percent diethylene glycol (DEG) in its composition, along with traces of ethylene glycol. These substances are industrial solvents that are banned for use in medicine, as even small amounts can be very harmful, especially to children. After these lab results were confirmed, the government of Tamil Nadu prohibited the product and removed it from stores. The Central Drugs Standard Control Organisation (CDSCO) suggested that Sresan’s manufacturing license be canceled, which has now been revoked, and legal action has started against the company. Simultaneously, the Union Health Ministry warned all states and Union Territories that cough and cold syrups should not be given to children younger than two years.
The problem began to surface gradually, then escalated quickly. In early September, Chhindwara experienced a series of deaths of children suspected to have renal failure. Families reported a similar pattern: a mild respiratory issue, a prescription for Coldrif, a short period of improvement, followed by a sudden decrease in urine output and kidney failure. By September 18, local authorities were treating the situation as an emergency. Investigators linked the prescriptions to Dr. Praveen Soni, a government pediatrician who also practiced privately in Parasia, Madhya Pradesh. He has been arrested and suspended from his job. The First Information Report includes both the doctor and Sresan Pharmaceuticals, citing Section 276 of the Bharatiya Nyaya Sanhita (for sale of tainted drugs) and Section 27A of the Drugs and Cosmetics Act from 1940, which can lead to life imprisonment if adulteration results in death.
Additionally, on October 4, the Controller of the Food and Drugs Administration in Madhya Pradesh directed drug inspectors throughout the state to stop the distribution of Coldrif immediately, emphasizing the seriousness of the findings from the Chennai lab. The chemical analysis is alarming. A report from the Government Analyst at the Drug Testing Laboratory in Chennai stated that the syrup was "not of standard quality," noting the presence of 48.6 percent (w/v) diethylene glycol, a concentration that is unsafe for health. This issue traced back to Batch SR-13, which was produced in May 2025 and set to expire in April 2027.
To ensure there was no wider contamination, a team of experts from the National Centre for Disease Control (NCDC), the National Institute of Virology (NIV), and the CDSCO visited Chhindwara and Nagpur. Samples were examined at NIV Pune, the Central Drug Laboratory in Mumbai, and NEERI in Nagpur. The results were limited but clear: nine of ten medications met quality requirements, while Coldrif failed due to DEG levels significantly exceeding acceptable limits.
As a precaution, the administration also stopped the sales of Nextro DS, another cough syrup that some of the children had used; final test results for this syrup are still pending.
