The Maharashtra Food and Drug Administration (FDA) recently issued an urgent directive from Mumbai, mandating the immediate halt of sales, distribution, and use of Coldrif Syrup. This action follows tragic reports from Madhya Pradesh and Rajasthan, where several child deaths have been linked to the product.
The specific product in question, Coldrif Syrup (containing Phenylephrine Hydrochloride and Chlorpheniramine Maleate), from Batch No. SR-13, was produced in May 2025 by Sresan Pharma in Sunguvarchathiram, Kancheepuram district, Tamil Nadu, with an expiry date of April 2027. Crucially, laboratory tests confirmed the presence of Diethylene Glycol (DEG), a highly toxic chemical commonly used in industrial antifreezes. Ingestion of DEG can lead to severe kidney failure and has been implicated in numerous fatalities.
Reassuring the public, FDA Drug Controller D.R. Gahane stated to The Hindu, “Our State and citizens are safe.” He confirmed that discussions with Tamil Nadu’s Drug Control Authorities revealed no distribution of the problematic Coldrif cough syrup batch within Maharashtra. While acknowledging the slim possibility of individuals acquiring the syrup from other locations and bringing it into the state, the FDA proceeded with the public advisory as a precautionary measure to ensure maximum safety.
The FDA has issued clear instructions to all pharmacies, hospitals, wholesalers, and license holders to immediately cease handling the affected batch and to report any existing stock to their local drug control authorities. For public vigilance, citizens can report possession of the syrup through a toll-free number (1800222365) or via email (jchq.fda-mah@nic.in) or mobile (9892832289).
To enforce this directive, Drug Inspectors and Assistant Commissioners have been dispatched across the market to notify stakeholders and ensure that any remaining stock is swiftly impounded. The Central Drugs Standard Standard Control Organisation (CDSCO) is anticipated to take stringent measures against the manufacturer and has requested Tamil Nadu’s FDA to initiate legal proceedings.
This public alert strongly reiterates that all licensees and the general public are instructed to immediately discontinue the sale, distribution, or use of Coldrif Syrup, Batch No. SR-13, if currently in their possession, and promptly report it to the relevant local Drugs Control Authorities without delay.
This critical incident has prompted swift responses from several other states. For instance, Uttar Pradesh has also banned Coldrif cough syrup following reports of 14 deaths in Madhya Pradesh. Madhya Pradesh itself has imposed a complete ban on the syrup after multiple child fatalities in its Chhindwara district. Rajasthan has taken action by suspending its state drug controller and halting the distribution of all medicines from another manufacturer, Kaysons Pharma, while also establishing an expert committee for further investigation.
Furthermore, the Union Health Ministry has advised against prescribing cough and cold medications to children under two years of age, issuing comprehensive guidance to health departments across all states and Union Territories to reinforce this crucial safety measure. This comes amidst broader concerns regarding the safety of such pharmaceutical products.