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The Economic Times

Economy / The Economic Times

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Drugmakers must report safety data from launch date, not approval date: CDSCO

India's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be submitted from the actual market launch date. This change aims to strengthen patient safety monitoring. Previously, reports were based on the regulatory approval date. The new rule ensures that real-world data from patients is included.

10 May 2026 10:50 am