India is rapidly emerging as a premier global destination for multinational pharmaceutical companies to conduct clinical trials. This marks a significant shift in the industry landscape, driven by India’s simplified, accessible, and expedited clinical trial processes.
Over the past decade, India has experienced substantial growth of 15-18% in Phase 2 and Phase 3 clinical trials conducted within its borders. This expansion is largely attributed to 10 amendments made to the country’s Drugs and Cosmetics Act of 1940, aimed at streamlining regulatory procedures for clinical research.
At the recent 18th Annual BioPharma & Healthcare Summit in Boston, key pharmaceutical executives highlighted the pivotal role of India’s regulatory reforms in facilitating smoother clinical operations.
Badhri Srinivasan, chief of global clinical operations at Novartis, noted, “Since 2013, there have been 10 modifications to that Act to try to make clinical trials easier, more accelerated, more accessible and more. Major companies such as Novartis underscore how these adjustments have enabled more efficient trial processes in India.
Dr. Sarah Sheikh, head of Global Development at Takeda, emphasized, “We are taking this macro trend into consideration as we’re moving away from the question of should we be in India to when and how we go to India.”
With further regulatory improvements anticipated, including a forthcoming 2023 act, stakeholders emphasize India’s potential for accelerated trials, enhanced transparency, and standardized processes across the clinical research landscape.
Beyond the regulatory environment, India’s evolving hospital networks and expanding patient access in tier 2 and 3 cities enhance its appeal for global clinical trials. This infrastructure, combined with expedited trial processes, positions India as an attractive destination for companies aiming to bring new medicines to market faster.
Dr. Christopher Corsico of GSK noted, “We have seen movement and the timelines actually have decreased by about 30 to 40 percent. So for a pure pharma play, actually if you include India early strategically, you can get them on board and participate in that global trial which brings the back-end benefit.”
Moreover, India offers a skilled population and robust infrastructure well-suited for high-quality clinical research. India’s ascension as a premier destination for clinical trials signifies a transformative shift in the global pharmaceutical landscape.
Dr. Uli Broedl Senior VP and Head of Global Clinical Development at Boehringer Ingelheim highlighted, “It is an absolute misperception that quality was poor. We are currently at a large phase 3 global program, where India participates in obesity.”
As India continues refining its regulatory framework and leveraging its capable research ecosystem, it is well-positioned to play an increasingly pivotal role in accelerating global clinical development programs and enhancing patient access to novel therapies worldwide.
