CDSCO Tightens Drug Safety Reporting Rules, Asks Firms to File PSURs From Actual Launch Date
The issue arose because CDSCO observed cases where companies received approval for a new drug but launched it commercially much later. In some such cases, firms were submitting PSUR data from the original approval date instead of the actual market launch date. According to the regulator, this practice could lead to the loss of important post-launch safety information, especially adverse effects that may only become visible after wider use among patients.