By Sresan Pharma
Copyright thehindu
The Maharashtra Food and Drugs Administration (FDA) on Sunday (October 5, 2025), issued an urgent advisory calling for the immediate suspension of sale, distribution, and use of Coldrif Syrup, following reports of child fatalities in Madhya Pradesh and Rajasthan allegedly linked to the product.
The affected batch, Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate), Batch No. SR-13, was manufactured in May 2025 by Sresan Pharma, based in Sunguvarchathiram, Kancheepuram district, Tamil Nadu. It is set to expire in April 2027. Laboratory analysis revealed the presence of Diethylene Glycol (DEG), a toxic chemical commonly found in industrial products like antifreeze. DEG ingestion can cause kidney failure and has been linked to multiple deaths.
Speaking to The Hindu, FDA Drug Controller D.R. Gahane said, “Our State and citizens are safe. We held a meeting with the Drug Control Authorities in Tamil Nadu to trace the distribution of the batch in Maharashtra and they have confirmed that Coldrif cough syrups were not supplied in Maharashtra. It is difficult to trace now if someone had travelled from Maharashtra to Madhya Pradesh or other locations and coincidentally if they bought the cough syrup and brought it here. Still for safety, we had decided to issue the statement for public interest and safety.”
The FDA has instructed all pharmacies, hospitals, wholesalers, and license holders to immediately stop handling the affected batch and report any stock to local drug control authorities. Citizens can also report possession of the syrup via the toll-free number 1800222365, email jchq.fda-mah@nic.in, or mobile 9892832289.
Drug Inspectors and Assistant Commissioners have been deployed to alert market stakeholders and ensure any remaining stock is frozen. The Central Drugs Standard Control Organisation (CDSCO) is expected to take strict action against the manufacturer and has asked Tamil Nadu’s FDA to initiate proceedings.
The public alert also said that all the licensee and public are instructed to immediately stop sale/distribution/use of Coldrif Syrup, Batch No. SR-13, if anybody is in possession, and report it to the local Drugs Control Authorities without delay.
The incident has triggered responses across several states. Madhya Pradesh has imposed a complete ban on the syrup following the deaths of multiple children in Chhindwara district. Rajasthan has suspended its state drug controller and halted distribution of all medicines from another manufacturer, Kaysons Pharma, while forming an expert committee to investigate.
The Union Health Ministry has also recommended that cough and cold medications not be prescribed to children under two years of age and has issued guidance to health departments across all states and Union Territories.