Insights
Regulating contact research organisations
October 7, 2024The Ministry of Health has recently introduced a new chapter, VA, dedicated to Contact Research Organisations (CROs) within the New Drug and Clinical Trials Rules, 2019 (NDCT Rules). These amendments, collectively referred to as the CRO Amendment, define CROs as “sponsors or entities belonging to academic, commercial, or other categories, or any other legal entity to whom the sponsor may delegate or transfer the tasks, duties, or obligations related to a clinical trial (CT) or bioavailability or bioequivalence study (BA/BE Study).” We will now delve into the key provisions of these amendments.
