India bars drugmakers from selling mislabelled or fraudulently approved products

economictimes.indiatimes.com

India will bar drugmakers from selling products obtained through false information or mislabelling, under new amendments to the Drugs Rules, 1945. Licensing authorities can now debar offending entities. The Union Health Ministry notified the rules on Thursday, allowing state or central Licensing Authorities to debar entities from filing future applications for a specified period. A show-cause notice and appeal mechanism ensure due process. Previously, regulators pursued such cases through Indian Penal Code FIRs, a slower process. The amendment aims to deter misconduct and ensure drug approvals rely on reliable, scientifically valid evidence.


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India bars drugmakers from selling mislabelled or fraudulently approved products | News Minimalist