Maharashtra FDA has imposed a statewide ban on Coldrif syrup (Batch No. SR-13) after it was linked to 14 child fatalities in neighboring states due to diethylene glycol contamination

NAGPUR: The Maharashtra Food and Drug Administration (FDA) has imposed statewide ban on the sale, distribution, and use of Coldrif syrup (Batch No. SR-13), a paediatric cough syrup linked to at least 14 child fatalities in neighbouring states. The directive, signed by drug controller Dr Gahane on October 5, cites contamination with diethylene glycol (DEG) — a toxic industrial solvent — as the cause of the reported deaths.Meanwhile, FDA’s Nagpur division also restricted sale of Anset syrup after concerns were raised about its safety. The FDA has urged citizens, retailers, wholesalers, and hospitals to cease circulation of the syrup, secure existing stock, and notify local drug control authorities immediately.The alert follows reports from Madhya Pradesh and Rajasthan, where multiple children reportedly died after consuming Coldrif syrup, which contains phenylephrine hydrochloride and chlorpheniramine maleate. Investigations revealed that the syrup, manufactured by Sresan Pharma in Tamil Nadu’s Kancheepuram district (manufactured: May 2025, expiry: April 2027), may have been adulterated with DEG, leading to severe renal failure and other toxic effects.“The FDA was alerted to these tragic child deaths,” the circular states, highlighting the urgent need to prevent further harm. The Maharashtra FDA is coordinating with Tamil Nadu’s drug control authority to track the product’s distribution. Experts warn that even small amounts of DEG — sometimes substituted for pharmaceutical-grade glycerin to reduce costs — can lead to fatal organ failure.In a related local development, the FDA’s Nagpur division also restricted sale of Anset syrup, a paediatric anti-emetic containing Ondansetron, after concerns were raised about its safety. Distributed by a firm based in Wadi in Nagpur, Anset came under scrutiny after grieving families of affected children in Madhya Pradesh shared images of the suspected contaminated syrups via WhatsApp while seeking treatment in Nagpur.Following a tip-off from Nagpur Municipal Corporation (NMC) health officials, FDA joint commissioner Manish Chaudhary circulated the images among pharmaceutical dealers and initiated testing. “We’ve sampled over 20 cough syrups this year,” Chaudhary told TOI. “Coldrif hasn’t been found in Nagpur yet, but Anset samples were collected and sent for analysis. We’ll be inspecting wholesalers next.”The distributor of Anset syrup reportedly stopped supplies immediately upon notification, pending test results. Families have provided bottles of various suspect syrups, which are now under laboratory examination.This two-pronged response — a statewide ban on Coldrif syrup and a localized crackdown on Anset syrup in Nagpur — underscores the FDA’s intensified efforts to address the unfolding crisis and prevent further loss of life.