India Cracks Down on Substandard Cough Syrups: 700+ Manufacturers Under Intense Audit

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In response to a cluster of child deaths allegedly linked to contaminated cough syrups, the Indian government has launched a massive crackdown on substandard cough syrup manufacturers. According to Minister of State for Health Anupriya Patel, over 700 cough syrup manufacturers have been subjected to intense audit and increased market surveillance sampling of syrup formulations has been conducted by central and state drugs regulators. A central team of experts, comprising an epidemiologist, microbiologist, entomologist, and drug inspectors from leading institutions, visited Chhindwara and Nagpur to investigate the reported cases and deaths. 19 drug samples, reportedly consumed by the affected children, were collected for testing. While 15 samples were found to be of standard quality, 4 samples were declared non-standard. The investigation revealed that the Syrup Coldrif manufactured by Sresan Pharmaceutical contained high levels of Diethylene Glycol (46.28%). The premises of the manufacturer were found to be in violation of good manufacturing practices, with unhygienic storage conditions observed. The Tamil Nadu government has cancelled the manufacturing license, and a criminal case has been registered in the matter. Following the incident, several states including Madhya Pradesh, Tamil Nadu, Odisha, and Puducherry have ordered an immediate ban and recall of the impugned cough syrup batches. An advisory has been issued to health departments and healthcare facilities across the country to ensure rational use of paediatric cough syrups. The Drugs Controller has directed all states and Union territories to ensure strict compliance with testing requirements and heightened vigilance against spurious and substandard drugs.