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Regulator Finds Lapses in 90% of Indian Cough Syrup Firms
23 Feb
Summary
- Nearly 90% of cough syrup makers inspected found with compliance issues.
- Inspections follow deaths linked to Indian-made cough syrups abroad.
- Regulator aims to match US FDA standards with more staff and AI.
India's drug regulator has found widespread compliance issues among cough syrup manufacturers, with nearly 90% of inspected companies showing lapses. These findings come after Indian-made cough syrups were associated with over 140 children's deaths in various countries since 2022. The inspections highlighted failures in testing raw materials and adhering to manufacturing standards.
Drug Controller General of India Rajeev Raghuvanshi stated that serious non-compliances are being addressed to reform cough syrup production. The agency is also working to enhance its operations to match the standards of the U.S. Food and Drug Administration. This includes plans to create approximately 1,500 new positions and utilize artificial intelligence for application reviews.
Furthermore, the regulator has simplified export clearance processes by removing the requirement for 'no-objection certificates' for drugs destined for the U.S., Europe, Australia, Japan, the UK, and Canada. This initiative aims to expedite exports and conserve resources for the Indian pharmaceutical industry.
