700 plus cough syrup makers under scrutiny after child deaths in MP: Anupriya Patel
New Delhi: Over 700 cough syrup manufacturers across India are under intense scrutiny following the deaths of 26 children in Madhya Pradesh after consuming the contaminated ColdRif syrup, Union Minister of State for Health Anupriya Patel informed Parliament on Tuesday.
Most of the victims were under five and died due to kidney failure.
In a written reply in 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 sampling of syrup formulations by Central and State drugs regulators has also been done."
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.
As per IANS, 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.
Read also: 12 more pharma firms booked in Varanasi cough syrup scandal
