Maharashtra citizens are safe as no Coldrif syrup is supplied in the State, says FDA
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Maharashtra citizens are safe as no Coldrif syrup is supplied in the State, says FDA
The FDA has issued an urgent advisory calling for the immediate suspension of sale, distribution, and use of Coldrif Syrup. 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 the distribution of all medicines from another manufacturer, Kaysons Pharma. The Central Drugs Standard Control Organisation (CDSCO) is expected to take strict action against the manufacturer and has asked Tamil Nadu’s FDA to do the same. The FDA has instructed all pharmacies, hospitals, wholesalers, and license holders to immediately stop handling the affected batch.
The appeal comes amid growing concerns over an adulterated batch of the syrup. The FDA had issued an urgent advisory earlier on Sunday (October 5, 2025), calling for the immediate suspension of sale, distribution, and use of Coldrif Syrup.
The affected lot (Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate), Batch No. SR-13) was manufactured in May 2025 by Sresan Pharma, based in Sunguvarchatram, Kancheepuram district, Tamil Nadu. The batch is set to expire in April 2027. Laboratory analysis revealed the presence of Diethylene Glycol (DEG), a toxic chemical commonly found in industrial products such as anti-freeze. Ingestion of DEG can cause kidney failure and has been linked to multiple deaths.
Speaking to The Hindu, FDA Joint Commissioner (Drugs) 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. They confirmed that Coldrif cough syrups were not supplied in the State. It is difficult to trace whether someone travelled from Maharashtra to neighbouring States, bought the cough syrup and brought it here. Nevertheless, we issued the statement in the 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 ID: 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 remains 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 do the same.
The public alert also stated that all licensees and users are instructed to immediately stop the sale, distribution or use of Coldrif Syrup, Batch No. SR-13, and report those in possession of the syrup 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 the 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.