Madhya Pradesh, Tamil Nadu, Kerala ban Coldrif cough syrup after toxic chemical found linked to child deaths

A directive issued by the state drug controller, accessed by Aaj Tak, stated that the syrup—manufactured by Sresan Pharmaceutical in Tamil Nadu’s Kanchipuram district—was declared “non-standard and defective (NSQ)” based on a Tamil Nadu Drug Control Directorate report dated October 2.

The report revealed that the Coldrif sample contained 48.6% Diethylene Glycol (w/v), a toxic substance known to cause acute kidney and liver failure. Officials concluded that the syrup was “unsafe for human consumption.”

Following the findings, the Madhya Pradesh drug controller ordered an immediate halt to the sale, distribution, and disposal of Coldrif across the state. All available stocks were directed to be sealed and preserved until further instructions.

Officials were instructed to collect additional samples from various districts and send them for laboratory testing. Any remaining batches of Coldrif in circulation are to be seized and frozen pending further analysis.

Wider crackdown after fatalities

The ban follows a similar move by the Tamil Nadu government, which had prohibited Coldrif sales on October 1 after suspicions emerged linking it to the deaths of at least 12 children — nine in Madhya Pradesh, two in Maharashtra, and one in Rajasthan.

Preliminary investigations had suggested that several children fell critically ill after being given Coldrif, prompting health authorities to send samples for testing.

Chief Minister Mohan Yadav called the deaths “extremely tragic,” adding that swift action had been taken against the manufacturer and its products.

He said the state sought a probe from the Tamil Nadu government and “acted immediately upon receiving the lab report confirming contamination.”

Kerala issues precautionary suspension

In a preventive move, Kerala Health Minister Veena George on Saturday announced the suspension of Coldrif sales and distribution in the state, following reports from Madhya Pradesh and Rajasthan.

Although the affected batch was not sold in Kerala, the state’s Drugs Control Department instructed distributors and pharmacies to halt sales as a precaution. Samples of Coldrif and other syrups have been collected for testing.

The Union Health Ministry, meanwhile, advised doctors to avoid prescribing cough syrups to children under two years of age amid rising nationwide concern.

Tamil Nadu factory under scrutiny

At the centre of the investigation is Sresan Pharma, the manufacturer of Coldrif, whose facility in Sunguvarchathram near Kanchipuram has been sealed by Tamil Nadu’s Food Safety and Drug Administration (FSDA).

"Test samples have been found adulterated. We have sought an explanation from the manufacturer and halted production until further orders," an FSDA official told PTI.

The Tamil Nadu government formally banned the sale of Coldrif across the state from October 1 and directed pharmacies and distributors to immediately remove existing stocks.

The company’s products were reportedly supplied to Rajasthan, Madhya Pradesh, and Puducherry.

FSDA officials said samples were being sent to government laboratories to confirm the extent of Diethylene Glycol contamination.

"Until the company provides a satisfactory explanation and test results are verified, production will remain suspended," the official added.

Central ministry steps in

The Health Ministry confirmed that the Central Drugs Standard Control Organisation (CDSCO) had launched risk-based inspections at 19 pharmaceutical manufacturing units across the country.

The inspections, which began on October 3, aim to identify “gaps that may have led to quality failures” and ensure adherence to safety standards.

A multidisciplinary team comprising experts from the National Institute of Virology, ICMR, NEERI, AIIMS-Nagpur, and CDSCO has been tasked with analysing collected samples to determine the exact cause of the fatalities.