New Delhi, Dec 2 (PTI) More than 700 cough syrup manufacturers were subjected to intense audit and increased market surveillance sampling of syrup formulations was done by central and state drugs regulators in the wake of children deaths allegedly due to consumption of contaminated cough syrups, Rajya Sabha was informed on Tuesday.
Upon receipt of reports of a cluster of child deaths from Chhindwara, Madhya Pradesh, a central team of experts visited Chhindwara and Nagpur and undertook a detailed investigation of the reported cases and deaths in coordination with the Madhya Pradesh state authorities, Minister of State for Health Anupriya Patel said in a written reply.
The team comprised an epidemiologist, a microbiologist, an entomologist, and drug inspectors from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), and Central Drugs Standard Control Organisation (CDSCO).
A total of 19 drug samples, reportedly consumed by the affected children, were collected from the treating private practitioners and nearby retail stores for testing, Patel said.
“Chemical analysis of these 19 samples indicated that 15 samples were of standard quality, while 4 samples were declared not of standard quality (NSQ),” she stated.
“As per the test report, the content of Diethylene Glycol (DEG) in Syrup Coldrif manufactured by Sresan Pharmaceutical located in Kancheepuram, Tamil Nadu and consumed by the deceased children was found to be 46.28 per cent w/v,” Patel said in her reply.
The premises of M/s Sresan Pharmaceuticals was inspected. Several critical and major good manufacturing practices violations including unhygienic storage conditions were observed, the matter regarding the criminal action against the manufacturer was taken up by CDSCO with the Tamil Nadu government, she said.
The state drugs controller Nadu cancelled the manufacturing licence.
Further, following the incident, Madhya Pradesh, Tamil Nadu, Odisha and Puducherry, where the impugned cough syrup batches were supplied, ordered immediate ban and recall, Patel informed.
Criminal case has been registered in the matter by Madhya Pradesh and strict action has been taken including the arrest of persons involved.
An advisory has been issued on October 3 to health departments and healthcare facilities of all states and Union territories to ensure rational use of paediatric cough syrups, Patel said.
Further, the Drugs Controller (India) directed all states and Union territories drug controllers on October 7 to ensure strict compliance with testing requirements under the Drugs Rules, 1945, and on October 21 instructed them to maintain heightened vigilance against spurious and substandard drugs and take prompt action under the Drugs and Cosmetics Act, 1940.
“More than 700 cough syrup manufacturers have been subjected to intense audit in coordination with state authorities and increased market surveillance sampling of syrup formulations by central and state drugs regulators has also been done,” Patel stated.
In addition to the existing requirements of testing the raw materials, the Indian Pharmacopoeia Commission, Ghaziabad has issued an amendment to Indian Pharmacopoeia (IP) 2022, to also mandate the testing for DEG and Ethylene Glycol (EG) in oral liquids at finished product stage before market release, she said. PTI PLB ZMN
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