ReferIndia News Drug regulator cracks down on delayed safety reporting by pharma companies

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Drug regulator cracks down on delayed safety reporting by pharma companies

Published on: May 8, 2026, 11:47 p.m. | Source: The Economic Times

India's drug regulator CDSCO has issued new rules for drug safety reporting. Companies must now submit safety reports from the actual launch date of new drugs, not from when they were approved. This change aims to capture real-world safety data more effectively. Additionally, all forms and uses of a new drug will be covered under one safety report.

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