As many as 26 children from Chhindwara, Pandhurna, and Betul districts of Madhya Pradesh, mostly under the age of five, reportedly died due to kidney failure after they were administered the Coldrif cough syrup.
"More than 700 cough syrup manufacturers have been subjected to an intense audit in coordination with state authorities. Increased market surveillance sampling of syrup formulations by Central and State drugs regulators has also been done," Patel said in a written reply in Rajya Sabha.
In addition to the existing requirements of testing the raw materials, the Indian Pharmacopoeia Commission, Ghaziabad, has issued an amendment to the Indian Pharmacopoeia (IP) 2022, to also mandate the testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquids at the finished product stage before market release, she added.
The Minister informed that the government undertook a detailed investigation of the reported cases and deaths, wherein 19 drug samples were collected from the treating private practitioners and nearby retail stores.
The reports traced it to the content of DEG in Syrup Coldrif manufactured by Sresan Pharmaceutical located in Kancheepuram, Tamil Nadu.
Patel noted that the DEG content in Syrup Coldrif consumed by the deceased children was found to be 46.28 per cent weight by volume (w/v) -- significantly exceeding the permissible limit of 0.1 per cent. Four of the samples were also declared Not of Standard Quality (NSQ).
Following this, the government inspected the premises of Sresan Pharmaceuticals and found "several critical and major Good Manufacturing Practices (GMP) violations, including unhygienic storage conditions".
The CDSCO, along with the Tamil Nadu government, initiated criminal action against the manufacturer and cancelled the manufacturing licence.
Further, following the incident, Madhya Pradesh, Tamil Nadu, Odisha, and the Union Territory of Puducherry immediately banned and recalled Coldrif.
"Criminal case has been registered in the matter by the State of Madhya Pradesh, and strict action has been taken, including the arrest of persons involved," Patel said.
She also informed of an advisory issued to all State/UT Health Departments and healthcare facilities to ensure rational use of paediatric cough syrups.
The Drugs Controller has also directed all State/UT drug controllers to ensure strict compliance with testing requirements and instructed them to maintain heightened vigilance against spurious and substandard drugs and take prompt action.
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