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At least 15 children died from diethylene glycol poisoning after consuming Coldrif syrup batch SR-13 by Sresan Pharmaceuticals, prompting a Maharashtra FDA emergency advisory
Laboratory analysis confirmed that Coldrif contained 48.6 per cent diethylene glycol (DEG). (PTI Photo)
A deadly batch of cough syrup has left at least 15 children dead and several others critically ill across Madhya Pradesh and Rajasthan, triggering nationwide concern and a probe into the safety of paediatric medicines. The syrup, marketed under the brand name Coldrif and manufactured in Tamil Nadu’s Kancheepuram district, was found to contain dangerously high levels of diethylene glycol (DEG), a toxic industrial chemical used in brake fluid and antifreeze.
According to reports from The Times of India, the deaths were first reported in Chhindwara district of Madhya Pradesh, where children under the age of 12 began developing unexplained kidney failure after consuming the syrup. The affected children were referred to Nagpur’s Government Medical College and Hospital (GMCH) between September 26 and October 4, where doctors soon discovered that all had been given the same brand of cough syrup.
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When routine treatments failed, Dr Manish Tiwari, head of GMCH’s paediatrics department, made the crucial decision to administer Fomepizole, a drug typically used to treat methanol or ethylene glycol poisoning in cases of spurious liquor consumption. “We consulted with leading paediatricians before administering the drug,” Dr Tiwari told TOI, adding, “Two children have started urinating again, though they remain in a deep coma. The remaining four are still anuric. The DEG concentration in the syrup was 48.6 per cent, nearly 500 per cent above the permissible limit.”
Laboratory analysis later confirmed that the Coldrif sample contained 48.6 per cent diethylene glycol (DEG). The syrup’s toxic load not only caused kidney failure but also severe brain damage, doctors said.
At least six children died of renal failure at GMCH, while six others survived in critical condition. “Initially, we couldn’t pinpoint the cause of the renal shutdown,” said Dr Anand Bhutada, director of New Era Mother and Child Hospital, Nagpur, where four children were treated. “Fomepizole appeared to be the only drug that halted the toxin’s effect. Three children recovered and went home; one unfortunately did not survive,” he added.
Before confirming DEG poisoning, teams at GMCH, in coordination with the Nagpur Municipal Corporation’s Metropolitan Surveillance Unit (MSU), carried out extensive clinical, environmental, and entomological investigations. Samples were sent to NIV Pune and NEERI Nagpur to rule out any infectious disease. All tests returned negative, shifting the focus to a drug-induced cause.
Once the DEG contamination was confirmed, GMCH alerted the National Centre for Disease Control (NCDC) and local health authorities. Information on Fomepizole treatment was shared with private hospitals and Chhindwara health officials, with instructions to administer the antidote within 18 hours of exposure.
The Tamil Nadu Drug Control Administration’s report of October 2 formally declared the Coldrif syrup (Batch No. SR-13; Mfg: May 2025; Exp: April 2027) manufactured by Sresan Pharmaceuticals, Kancheepuram, as adulterated, confirming the DEG contamination.
Following the revelation, the Maharashtra Food and Drug Administration (FDA) issued an urgent advisory on Monday, warning the public to immediately stop the sale and use of the affected batch.
“The public is urged to remain cautious and to report any possession of Coldrif Syrup Batch No. SR-13 to the nearest Drugs Control Authority without delay,” the Maharashtra FDA said in a statement, as reported by PTI.
The agency said it was coordinating with Tamil Nadu’s Drugs Control Administration to trace the distribution of the contaminated batch in Maharashtra. Drug inspectors and assistant commissioners have been instructed to alert retailers, wholesalers, and hospitals to freeze all existing stocks.
The syrup, which contains Phenylephrine Hydrochloride and Chlorpheniramine Maleate, has now been banned from sale pending further investigation. “We are taking every necessary step to safeguard public health and prevent further loss of life,” the FDA statement added.
The incident has reignited fears of a recurring menace, toxic contamination in children’s medicines. India has witnessed similar tragedies before, from the 1998 Gurgaon incident to the 2022 Uzbekistan case involving Indian-made syrups.
October 07, 2025, 13:56 IST
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