700 cough syrup makers subjected to intense audits, Centre tells Parliament

More than 700 cough syrup manufacturers have been subjected to intense audits in coordination with state authorities, Minister of State in the Union Health Ministry Anupriya Patel told Parliament.

In a written response Patel said increased market surveillance sampling of syrup formulations by Central and state drugs regulators had also been done. 

“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. 

In September, complaints of children deaths from Chhindwara, Madhya Pradesh appeared. The deaths were caused by the presence of toxic chemicals, specifically diethylene glycol (DEG) and ethylene glycol (EG), which are industrial solvents. 

Patel said a Central team of experts comprising 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), respectively, visited Chhindwara and Nagpur and undertook a detailed investigation of the reported cases and deaths in coordination with the Madhya Pradesh State Authorities. 

“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. Chemical analysis of these 19 samples indicated that 15 samples were of Standard Quality, while 4 samples were declared Not of Standard Quality (NSQ). As per the test report, the content of DEG in syrup Coldrif manufactured by Sresan Pharmaceuticals located in Kancheepuram, Tamil Nadu, and consumed by the deceased children was found to be 46.28 per cent weight/volume,” she elaborated.

Moreover, the premises of Sresan Pharmaceuticals were inspected and several critical and major violations, including unhygienic storage conditions, were observed. The State Drugs Controller, Tamil Nadu cancelled the manufacturing licence. 

“Further, following the incident, Madhya Pradesh, Tamil Nadu, Odisha and the Union Territory of Puducherry to which the impugned cough syrup batches were supplied, ordered immediate ban and recall of the same. A criminal case has been registered in the matter by Madhya Pradesh and strict action had been taken including the arrest of persons involved. Further, the Drugs Controller directed all state or UT drug controllers on 07.10.2025 to ensure strict compliance with testing requirements  and instructed them to maintain heightened vigilance against spurious and substandard drugs and take prompt action,” Patel said. In the last five years, 1,593 drug samples were declared adulterated and spurious.