Daijiworld Media Network - New Delhi

Mumbai, Oct 6: The Maharashtra Food and Drugs Administration (FDA) has ordered an immediate ban on the sale, distribution, and use of Coldrif Syrup, following reports that a contaminated batch of the product is linked to the tragic deaths of children in Madhya Pradesh and Rajasthan. The contaminated batch—Batch No. SR-13, manufactured by Sresan Pharma in Tamil Nadu's Kancheepuram district—was found to contain Diethylene Glycol (DEG), a toxic industrial chemical known to cause acute kidney failure and death if ingested.

In a late-night directive issued on Sunday, State Drug Controller Dr. R. Gahane instructed all license holders and the general public in Maharashtra to immediately halt the sale, use, or distribution of the affected batch. The batch in question was manufactured in May 2025 and set to expire in April 2027. Individuals and businesses in possession of the product have been asked to report it to local drug control authorities without delay.

To aid in swift reporting, the FDA has provided a toll-free helpline (1800 222 365), a mobile contact (98928 32289), and an email ID (jchq.fda-mah@nic.in) for the public to report possession of the syrup. FDA officials in Maharashtra are also working closely with their counterparts in Tamil Nadu to trace the supply chain and assess the distribution footprint of the tainted batch across the state. All Drugs Inspectors and Assistant Commissioners have been tasked with notifying hospitals, pharmacies, and wholesalers to immediately isolate and freeze existing stocks.

The FDA has urged the public to exercise extreme caution, emphasizing that the health risks—especially for children—are severe and potentially fatal. The move by the Maharashtra FDA comes in response to a broader advisory issued by the Central Government, which on Sunday directed all states and Union Territories to tighten surveillance on cough syrups, particularly those given to children, noting that most childhood coughs are self-limiting and do not require such medication.

The Centre has also called for increased vigilance under national health monitoring systems, stressing the need for timely reporting through tools like IDSP-IHIP, improved inter-state coordination, and strict action against pharmaceutical units violating safety protocols. All drug manufacturers have been reminded to comply with the Revised Schedule, and regulatory bodies have been urged to identify and act against any non-compliant units to prevent further public health risks.

Maharashtra’s swift action underscores growing national concern over the safety of pediatric medications, especially following multiple high-profile cases of toxic adulteration in recent years.