India’s clinical trials landscape has undergone a significant transformation through regulatory reforms, greater alignment with global standards, and the adoption of emerging technologies. India remains an attractive destination for clinical research due to its diverse patient pool, skilled investigators, strong healthcare infrastructure, and cost advantages. The introduction of the New Drugs and Clinical Trials Rules, 2019 brought greater regulatory clarity, defined approval timelines, strengthened participant protections, and improved compensation mechanisms. Recent amendments have also enhanced accountability for Clinical Research Organisations (CROs). The sector is increasingly embracing artificial intelligence, decentralised and hybrid trials, and real-world evidence for drug safety monitoring. These reforms have helped position India as one of the world’s leading clinical trial destinations while maintaining a strong focus on patient welfare and ethical standards.
Please click here to read the full article by Sidharrth Shankar, Partner, and Eshika Phadke, Senior Associate, published in International Bar Association.
Sidharrth (Sid) is a seasoned corporate lawyer and also the co-chair of the corporate practice with a core focus on private equity and mergers & acquisitions. Sid has substantial experience advising global private equity funds, multinational corporations and strategic investors on complex cross-border transactions across a broad spectrum of industries over the last two and a half decades, with over two decades in JSA itself.