Maharashtra: "All licensees instructed to immediately stop sale and use of Coldrif Syrup", says FDA

Mumbai (Maharashtra) [India], October 5 (ANI): The Food and Drugs Administration (FDA) of Maharashtra on Sunday issued an urgent public alert instructing the immediate cessation of sale, distribution, and use of Coldrif Syrup, following reports of toxic adulteration linked to the deaths of 11 children in Madhya Pradesh and Rajasthan.

The FDA officials said that they are working closely with the Drug Control Authorities in Tamil Nadu to trace the distribution of the batch in the state. All Drug Inspectors and Assistant Commissioners have been ordered to alert market stakeholders and freeze any existing stock of the affected batch.

"The affected product, Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup), manufactured by Sresan Pharma, Sunguvarchathiram, Kancheepuram District, Tamil Nadu, with a manufacturing date of May 2025 and an expiry date of April 2027, is allegedly contaminated with Diethylene Glycol (DEG), a highly toxic chemical," a statement said.

"All licensees, retailers, wholesalers, hospitals, and the public in possession of the batch have been directed to immediately halt its use and report it to the local Drugs Control Authorities. Citizens can also notify the FDA directly via the toll-free number", a statement further wrote.

Earlier in the day, the Central Drugs Standard Control Organisation (CDSCO) is set to take strict action against Sresan Pharmaceuticals, the manufacturer of Coldrif cough syrup, after several children died from consuming the syrup.

The CDSCO will write to the Tamil Nadu Food and Drug Administration (FDA) to take stringent measures against the company.

"CDSCO to write to Tamil Nadu-FDA to take strictest action against 'Coldrif' Syrup Manufacturer Sresan Pharmaceuticals," said the official sources.

The affected children are from Madhya Pradesh's Chhindwara, Rajasthan, and Maharashtra, while states like Kerala and Telangana have issued public alerts banning the use of Coldrif syrup.

Meanwhile, the Madhya Pradesh government has announced a complete ban on the sale of the cough syrup across the state after children's deaths due to kidney failure. In the past 30 days, 11 children have lost their lives in Chhindwara district due to kidney failure.

The Rajasthan government has also taken swift action, suspending the state drug controller and halting the distribution of all medicines manufactured by Kaysons Pharma. An expert committee is being formed to investigate the issue, and warning labels will be added to potentially harmful drugs.

The Union Health Ministry has advised that cough and cold medications should not be prescribed or dispensed to children below two years of age. The Ministry has written a letter to the Director of Health Services of all states and Union Territories in this regard. (ANI)