New Delhi: More than 700 cough syrup manufacturers across the country are under intense audit following the deaths of 26 children in Madhya Pradesh linked to contaminated Coldrif syrup, Union Minister of State for Health Anupriya Patel informed the Rajya Sabha on Tuesday.
The children, all under five, were from Chhindwara, Pandhurna and Betul districts and reportedly died of kidney failure after consuming the syrup.
Patel said both Central and state drug regulators have increased market surveillance and stepped up sampling of syrup formulations.
She added that the Indian Pharmacopoeia Commission has amended the Indian Pharmacopoeia 2022 to mandate testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) not only in raw materials but also in finished oral liquid formulations before their release into the market.
A government investigation collected 19 samples from private practitioners and nearby retail outlets.
Tests traced the contamination to Coldrif syrup manufactured by Sresan Pharmaceuticals in Kancheepuram, Tamil Nadu.
The DEG content in the batch consumed by the deceased children was found to be 46.28% by volume — far exceeding the permissible limit of 0.1%. Four samples were declared Not of Standard Quality.
Subsequent inspections at Sresan Pharmaceuticals revealed major violations of Good Manufacturing Practices, including unhygienic storage conditions.
The CDSCO, in coordination with Tamil Nadu authorities, has cancelled the company’s manufacturing licence and initiated criminal action.
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Following the deaths, Madhya Pradesh, Tamil Nadu, Odisha and Puducherry banned and recalled Coldrif. A criminal case has also been registered in Madhya Pradesh, and arrests have been made.
Patel said the Centre has issued an advisory to all states and UTs to ensure rational use of paediatric cough syrups.
Drug controllers have been instructed to maintain heightened vigilance against spurious and substandard medicines and ensure strict compliance with testing protocols.
