Bioequivalence and Bioavailability Forum

Hello bharat,

❝ I guess it will be not applicable for international centers.

FDA has recently had some beef with Indian generic drug makers and their subcontractors, and due to those worries FDA are increasing their oversight in the country. A worst case scenario is a generalised import ban that targets not drug makers but an entire country. It could potentially lead to a complete collapse of India's pharma industry. Accordingly, I think CDSCO's move is a partially politically motivated step that serves to increase trust from overseas agencies in an effort to keep the Pharma Industry afloat. That may only happen if at some point the quality stamp is extended to international trials centers.