The Union government has intensified its crackdown on cough syrup manufacturers after contaminated formulations in Madhya Pradesh caused multiple child deaths.
Minister of State for Health Anupriya Patel told Parliament that authorities are auditing more than 700 manufacturers nationwide under heightened regulatory scrutiny.
The deaths of 26 children from Chhindwara, Pandhurna, and Betul districts raised nationwide concern after reports indicated that the victims, most of whom were under the age of five, suffered fatal kidney failure.
They had reportedly been administered Coldrif cough syrup, which was later found to be contaminated with toxic chemicals.
Patel stated that both Central and State drug regulators increased market surveillance and sampling of syrup formulations.
She noted that regulatory teams coordinated with state authorities to conduct audits of over 700 companies involved in manufacturing cough syrups.
The Indian Pharmacopoeia Commission also introduced an amendment requiring mandatory testing of oral liquids for Diethylene Glycol (DEG) and Ethylene Glycol (EG) at the final product stage before release into the market.
The government launched a detailed investigation into the reported deaths. Officials collected 19 samples from private practitioners and nearby retail outlets.
Laboratory analysis traced the contamination to Syrup Coldrif, manufactured by Sresan Pharmaceuticals based in Kancheepuram, Tamil Nadu.
The DEG level in the consumed batch measured an alarming 46.28 per cent weight by far exceeding the permissible limit of 0.1 per cent. Four samples were also classified as Not of Standard Quality.
Following these findings, authorities inspected the manufacturer’s premises and discovered serious Good Manufacturing Practices violations, including unhygienic storage conditions.
The Central Drugs Standard Control Organisation, in coordination with the Tamil Nadu government, initiated criminal action and cancelled the company’s manufacturing licence.
In response to the crisis, Madhya Pradesh, Tamil Nadu, Odisha, and Puducherry immediately banned and recalled the Coldrif syrup.
Patel confirmed that a criminal case has been registered in Madhya Pradesh and that several individuals linked to the case have been arrested.
The Health Ministry has also issued advisories to all states and Union Territories, urging rational use of paediatric cough syrups.
Drug controllers nationwide now enforce strict testing compliance and maintain heightened vigilance against substandard drugs. They also take swift action whenever violations surface.
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