Coldrif row explained: Why this cough syrup is being pulled off shelves in several states

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 reportedly died following its consumption, news agency ANI reported.

According to official sources, the CDSCO will write to the Tamil Nadu Food and Drug Administration (FDA), urging 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 to ANI.

The affected children are from Madhya Pradesh’s Chhindwara, Rajasthan, and Maharashtra, while Kerala and Telangana have issued public alerts banning the use of Coldrif syrup. Another company supplying cough syrups in Madhya Pradesh, Nextro DS, is also under scrutiny, with its sample results still pending.

“The Nextro DS syrups sample results are still pending, a total of 19 samples were collected that include samples of syrup, antibiotics, antipyretics and ondansetron, consumed by the children who fell ill in the Chhindwara district of Madhya Pradesh,” said official sources.

Officials added that Coldrif tested positive for beyond permissible limits of Diethylene Glycol (DEG) or Ethylene Glycol (EG) as per the Tamil Nadu-FDA’s findings.

“The cough syrup 'Coldrif' tested to have beyond permissible limits of DEG/EG by Tamil Nadu-FDA was also sampled for analysis by Madhya Pradesh, Drug Regulatory Authority, whose final results are still awaited,” official sources said further.

Coldrif cough syrup: States move to ban sales, Centre issues advisory

Following the reports, the Madhya Pradesh government has imposed an immediate ban on the sale of Coldrif and Nextro DS syrups, along with other products manufactured by the same company. Chief Minister Mohan Yadav announced the ban on X.

The Union Health Ministry has also advised that cough and cold medications should not be prescribed or dispensed to children below two years of age. It has written to the Directors of Health Services across all states and Union Territories, asking for strict adherence. Further action against Nextro DS will follow once the final test results are available.

Maharashtra becomes the latest state to halt sales of Coldrif cough syrup

After Madhya Pradesh, Rajasthan, and Kerala, Maharashtra has become the latest state to suspend Coldrif cough syrup's sale and distribution.

Kerala Health Minister Veena George announced that the state’s Drugs Control Department had ordered an immediate halt to all sales of the product as a precautionary measure.

The minister clarified that the flagged batch was not distributed in Kerala but said the government acted “out of an abundance of caution.”

“The Drugs Controller has instructed inspectors to completely stop the distribution and sale of Coldrif syrup in the state,” she said, adding that all eight distributors currently selling the product in Kerala have been directed to suspend operations immediately.
“Medical stores have also been told to remove existing stocks from their shelves,” the minister added.

Diethylene Glycol (DEG) and Ethylene Glycol (EG): Toxic chemicals behind the deaths

Investigations have pointed to Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination as the probable cause. Both chemicals are highly toxic industrial solvents used in paints, dyes, resins, plastics, antifreeze, and brake fluids, and are not meant for pharmaceutical use.

Even small quantities can cause kidney and liver failure, neurological damage, and death, especially in children. Similar DEG-related poisonings have caused fatalities worldwide — notably in The Gambia (2022), where 70 children died after consuming contaminated cough syrups.

Global health alert on DEG contamination

The World Health Organisation (WHO) has issued six global medical product alerts since 2022 for over-the-counter medicines contaminated with DEG/EG, estimating over 300 child deaths worldwide.

To detect such contamination, WHO recommends a two-level testing process — initial thin-layer chromatography (TLC) screening for non-compliance, followed by gas chromatography confirmation at certified laboratories or regional centres.

*With Agency Inputs