Clinical Research Regulation in India and Brazil: An Overview of Current Frameworks and Implementation Gaps

Clinical research in emerging economies has expanded significantly over the past two decades, necessitating robust, transparent, and ethical regulatory systems. India and Brazil two major middle-income countries with rapidly growing clinical trial sectors have implemented substantial reforms aimed at strengthening participant protection, streamlining approval pathways, and improving regulatory oversight. This review provides a comparative examination of the current clinical trial regulatory frameworks in India and Brazil, highlighting their legal foundations, governance structures, ethical oversight mechanisms, and operational requirements. In India, the New Drugs and Clinical Trials Rules (NDCTR) 2019 established a consolidated, clearer, and more time-bound regulatory pathway, with mandatory ethics committee registration and enhanced safety reporting obligations. Brazil, through ANVISA regulations and the National Research Ethics Commission (CONEP), has progressively harmonized ethical and scientific review processes, with noteworthy reforms introduced by Law No. 14,874/2024 and updated ANVISA Resolutions. Despite these advances, both countries continue to face implementation gaps, including delays in multicenter trial approvals, variations in ethics committee capacity, limited inspection resources, and challenges in transparency and post-trial access. Comparative analysis reveals opportunities for regulatory convergence, digitalization of review processes, and strengthened collaboration between national authorities to support global clinical research. Addressing these systemic gaps will be essential for building public trust, enhancing research quality, and positioning India and Brazil as reliable hubs for ethical and scientifically sound clinical trials.