Maharashtra FDA Halts Sale of Coldrif Syrup Linked to 14 Child Deaths

The Food and Drugs Administration (FDA) in Maharashtra has issued an urgent order to halt the sale of Coldrif Syrup following reports linking the medication to the deaths of 14 children in Madhya Pradesh. The syrup is suspected to have been contaminated with Diethylene Glycol (DEG), a toxic chemical known for its potential to cause severe health complications, including acute kidney failure.

The batch in question, identified as Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup), is labeled with Batch No. SR-13. It was manufactured in May 2025 and is set to expire in April 2027. The Maharashtra FDA has instructed all license holders, retailers, and healthcare facilities to immediately cease the sale, distribution, or use of this batch. Those in possession of the syrup are urged to report it to local Drug Control Authorities without delay.

FDA Response and Public Safety Measures

According to the official notification, the Maharashtra FDA is collaborating with the Drug Control Administration (DCA) in Tamil Nadu to track the distribution of the contaminated product within the state. All Drugs Inspectors and Assistant Commissioners have been directed to alert retailers, wholesalers, and hospitals to freeze any stocks of this batch they may have on hand.

The FDA has also provided a toll-free number—1800 222 365—and an email address for the public to report any information related to the syrup. “All necessary measures are being taken to prevent further harm,” the notification stated, emphasizing the importance of public caution during this investigation.

In a separate but related development, a government doctor has been arrested in connection with the case. An FIR has been filed against both the doctor and the manufacturer of the cough syrup, following allegations that they continued to prescribe the contaminated syrup for nearly a month despite awareness of its adverse effects.

Impact on Public Health and Regulatory Actions

The Madhya Pradesh government has taken decisive action by banning the sale of Coldrif Syrup in response to the alarming number of child fatalities. Lab analyses have confirmed the presence of DEG in the syrup, which poses a serious health risk. The situation has prompted a case to be registered at Parasia Police Station against both the pharmaceutical company, Sresan Pharma, and the doctor involved.

As investigations continue, the FDA and local authorities are focused on ensuring that the public is safeguarded from further risks associated with the contaminated syrup. The tragic loss of young lives has highlighted the critical need for stringent quality control measures in pharmaceutical manufacturing and distribution.

Authorities are urging anyone with information regarding the syrup to come forward, as they work to prevent additional cases and bring those responsible to justice.