Kerala Latest State To Ban 'Coldrif' Cough Syrup After Unexplained Deaths

Kerala has become the latest state to suspend the sale and distribution of the cough syrup Coldrif, after reports from Madhya Pradesh and Rajasthan linked the medicine to the deaths of at least 11 children over the past month. Kerala's Health Minister Veena George announced on Saturday that the state's Drugs Control Department had ordered an immediate halt to all sales of the product as a precautionary measure.

The move comes amid an investigation into alleged contamination in a batch of the syrup, manufactured by Sresan Pharma, a company based in Tamil Nadu's Kanchipuram district.

Kerala's Preventive Ban

In a statement issued in Thiruvananthapuram, Minister Veena George said that though the flagged batch was not found to have been distributed in Kerala, the government decided to act "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 Health Minister confirmed that samples of Coldrif and other cough syrups have been collected for testing, and that laboratory analysis is underway. Intensive inspections are also being carried out across the state to identify any additional shipments that may have entered the market through private channels.

According to the minister, the action aligns with national guidelines issued by the Directorate General of Health Services (DGHS), which prohibit prescribing cough syrups to children under the age of two. Even if prescriptions are received, all medical stores have been instructed not to dispense such syrups for infants, she said.

The Cough Syrup Crisis

The decision in Kerala follows similar bans imposed by Tamil Nadu and Madhya Pradesh earlier this week, as the Central Drugs Standard Control Organisation (CDSCO) expanded its investigation into multiple drug manufacturing units across six states.

The controversy first erupted in early September after several children in Madhya Pradesh's Chhindwara district developed acute kidney failure allegedly linked to contaminated cough syrup. By the end of the month, nine children had died in Chhindwara, while two more deaths were reported from Rajasthan.

Initial reports from local health authorities suggested that the children had consumed Coldrif or similar formulations containing dextromethorphan, a common cough suppressant.

Senior Congress leader Kamal Nath alleged that the deaths were caused by the mixing of "brake oil solvent" -- believed to be Diethylene Glycol (DEG) or Ethylene Glycol (EG) -- into the syrups. Both compounds are toxic and known to cause acute kidney injury when ingested.

Tamil Nadu's Factory Under Probe

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 news agency PTI.

The Tamil Nadu government formally banned the sale of Coldrif across the state from October 1 and ordered the immediate removal of stocks from pharmacies and distributors. The company's products were reportedly supplied to Rajasthan, Madhya Pradesh, and Puducherry.

The FSDA said the samples were being sent to government laboratories for further analysis to confirm the presence and levels of Diethylene Glycol contamination. "Until the company provides a satisfactory explanation and test results are verified, production will remain suspended," the official said.

Central Health Ministry's Involvement

The Health Ministry confirmed that the CDSCO had begun risk-based inspections at 19 manufacturing facilities nationwide, covering both cough syrups and antibiotics. The ministry said the inspections, which began on October 3, were aimed at identifying "gaps that may have led to quality failures" and ensuring future compliance with safety standards.

A multidisciplinary team, including experts from the National Institute of Virology, the Indian Council of Medical Research (ICMR), the National Environmental Engineering Research Institute (NEERI), AIIMS-Nagpur, and CDSCO, has been tasked with analysing samples collected from the affected regions to determine the precise cause of the deaths.

Early laboratory results released by the ministry indicated that six samples tested by the CDSCO and three by the Madhya Pradesh Food and Drugs Administration (MPFDA) were free of Diethylene Glycol (DEG) and Ethylene Glycol (EG). However, subsequent testing in Tamil Nadu reportedly detected DEG contamination in samples collected directly from Sresan Pharma's manufacturing unit.