CDSCO to urge TN FDA to take strict action against ‘Coldrif’ syrup manufacturer: Sources

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) is set to take stringent action against Sresan Pharmaceuticals, the manufacturer of Coldrif cough syrup, following reports of several child fatalities linked to the product, ANI reported, citing sources.

Earlier, the Madhya Pradesh government banned the sale of Coldrif cough syrup following the death of 14 children in Chhindwara due to suspected renal failure, with officials stating the drug samples were found to contain a highly toxic substance.

In the wake of these developments, CDSCO will formally write to the Tamil Nadu Food and Drug Administration (FDA), urging it to take the strictest measures against the company.

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

Affected children, state alerts, and ongoing investigations

The affected children are from Madhya Pradesh’s Chhindwara, Rajasthan, and Maharashtra. Meanwhile, Kerala and Telangana have also issued public alerts, banning the use of Coldrif syrup. Another company, Nextro DS, which supplies cough syrups in Madhya Pradesh, is also under scrutiny, with 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," official sources said.

Official sources added, "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."

State ban and health ministry advisory

The Central Drugs Standard Control Organisation (CDSCO) has also initiated risk-based inspections at the manufacturing units of 19 drugs, including cough syrups and antibiotics, across six states, the Union health ministry said on Saturday.

A sample of the syrup, tested by the government drug analyst at the Drug Testing Laboratory in Chennai, was declared "Not of Standard Quality" by the Tamil Nadu Directorate of Drug Control, officials said here.

The action by the Madhya Pradesh government came in the wake of the deaths of 14 children in Chhindwara district due to suspected kidney failure. Of these, 10 deaths were reported in Parasia subdivision since September 7, local officials said.