The government intensified its crackdown on cough syrup manufacturers after 26 children died in Madhya Pradesh due to contaminated syrups. Over 700 manufacturers were audited, and central and state regulators conducted increased surveillance, the Rajya Sabha was informed on Tuesday.
In a written reply, Union Minister Anu priya 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 drug regulators has also been done.”
The minister added that in addition to the existing requirements of testing the raw materials used by the drug makers, the Indian Pharmacopoeia Commission (IPC) has mandated testing for toxic substances, such as Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquids before market release.
Responding to the query regarding the probe conducted by the authorities, Patel informed that the government undertook a detailed investigation of the reported cases and deaths.
From a total of 19 drug samples reportedly consumed by the affected children, 4 samples were found to be of substandard quality, Patel highlighted. These samples were collected from the treating private practitioners and nearby retail stores, the minister added.
She further revealed that the contaminated syrup. Coldrif, manufactured by Sresan Pharmaceutical consumed by the children, contained 46.28 per cent DEG, far exceeding the permissible limit of 0.1 per cent. The Drug Regulatory Body, CDSCO, along with the Tamil Naрп government, initiated criminal action against the manufacturer and cancelled the manufacturing license, she highlighted.
“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. Further, following the incident. Madhya Pradesh, Tamil Nadu, Odisha, and the Union Territory of Puducherry immediately banned and recalled the Coldrif stock that came under question.
The Minister also informed of an advisory issued to all State/UT Health Departments and healthcare facilities to ensure rational use of cough syrup sin children below 5 years.
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.
