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.