Kerala Bans Coldrif Cough Syrup Following Child Fatalities in Multiple States

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

This action comes amid ongoing investigations into potential contamination in a specific batch of the syrup manufactured by Sresan Pharma, based in Tamil Nadu's Kanchipuram district.

In a statement from Thiruvananthapuram, Minister George explained that although the flagged batch wasn't distributed in Kerala, the government acted "out of an abundance of caution." She confirmed that the Drugs Controller has directed inspectors to completely halt Coldrif syrup distribution and sales throughout the state.

All eight distributors currently selling the product in Kerala have been instructed to suspend operations immediately, and medical stores must remove existing stock from shelves. The Health Minister stated that samples of Coldrif and other cough syrups have been collected for laboratory analysis, with comprehensive inspections being conducted across the state to identify any additional shipments that may have entered through private channels.

According to the minister, this action aligns with national guidelines from the Directorate General of Health Services (DGHS) that prohibit prescribing cough syrups to children under two years of age. Even with valid prescriptions, medical stores have been instructed not to dispense such syrups for infants.

Kerala's decision follows similar bans already implemented by Tamil Nadu and Madhya Pradesh earlier this week, as the Central Drugs Standard Control Organisation (CDSCO) expands its investigation into multiple drug manufacturing facilities across six states.

The controversy initially emerged in early September when several children in Madhya Pradesh's Chhindwara district developed acute kidney failure allegedly connected to contaminated cough syrup. By month's end, nine children had died in Chhindwara, with two additional deaths reported from Rajasthan.

Initial reports from local health authorities indicated that the children had consumed Coldrif or similar formulations containing dextromethorphan, a common cough suppressant. Senior Congress leader Kamal Nath alleged that the deaths resulted from "brake oil solvent" — believed to be Diethylene Glycol (DEG) or Ethylene Glycol (EG) — being mixed into the syrups. Both compounds are toxic and known to cause acute kidney injury when ingested.

At the investigation's center 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). An FSDA official told PTI, "Test samples have been found adulterated. We have sought an explanation from the manufacturer and halted production until further orders."

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

The FSDA stated that 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.

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 stated that these inspections, which commenced on October 3, aimed to identify "gaps that may have led to quality failures" and ensure 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 assigned to analyze samples from 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 DEG and EG. However, subsequent testing in Tamil Nadu reportedly detected DEG contamination in samples collected directly from Sresan Pharma's manufacturing facility.