Daijiworld Media Network - New Delhi

New Delhi, Dec 2: Over 700 cough syrup manufacturers across the country have come under stringent scrutiny following the deaths of several children in Madhya Pradesh due to contaminated cough syrup, Union Minister of State for Health Anupriya Patel informed Parliament on Tuesday.

At least 26 children—mostly below the age of five—from Chhindwara, Pandhurna and Betul districts reportedly died from kidney failure after being given Coldrif cough syrup.

In a written reply in the Rajya Sabha, Patel said, “More than 700 cough syrup manufacturers have been subjected to an intense audit in coordination with state authorities. Increased market surveillance and extensive sampling of syrup formulations have also been undertaken by central and state drug regulators.”

To strengthen safety protocols, the Indian Pharmacopoeia Commission has amended the Indian Pharmacopoeia (IP) 2022, making it mandatory to test finished liquid formulations for Diethylene Glycol (DEG) and Ethylene Glycol (EG) before they reach the market.

A detailed probe into the deaths led authorities to collect 19 drug samples from local practitioners and nearby pharmacies. Laboratory analysis traced the cause to DEG contamination in Coldrif syrup manufactured by Sresan Pharmaceutical, based in Kancheepuram, Tamil Nadu.

The DEG content in the consumed batch was found to be 46.28% w/v—an alarming violation of the permissible limit of 0.1%. Four samples were also declared Not of Standard Quality (NSQ).

Subsequent inspection of the manufacturing facility revealed multiple major and critical violations of Good Manufacturing Practices, including unhygienic storage conditions. The CDSCO and Tamil Nadu authorities have initiated criminal proceedings against the company and cancelled its manufacturing licence.

Following the findings, Madhya Pradesh, Tamil Nadu, Odisha, and Puducherry immediately banned and recalled Coldrif from the market. Patel noted that Madhya Pradesh has registered a criminal case and arrested individuals linked to the incident.

The Union Health Ministry has also issued an advisory to all states and UTs urging rational use of paediatric cough syrups. Drug controllers nationwide have been instructed to enforce strict testing protocols and maintain heightened vigilance against spurious or substandard medicines.