INDIA- India has emerged as a premier destination for multinational corporations conducting clinical trials marking a significant shift in the pharmaceutical landscape.
Specialists in the field cite the nation’s simplified, accessible, and expedited trial processes as key factors driving this trend.
Over the past decade, India has witnessed a substantial expansion in Phase two and Phase three clinical trials, with growth rates ranging between 15% to 18%.
This growth is attributed to ten amendments made to the Drugs and Cosmetics Act of 1940, streamlining regulatory procedures.
Novartis’ chief of global clinical operations, Badhri Srinivasan, explained at the 18th Annual BioPharma & Healthcare Summit in Boston, “Given where we are, given what the landscape in the international community has happened, the regulators in India are starting to move and make changes to it.”
“Since 2013, there have been 10 modifications to that act to try to make clinical trials easier, more accelerated, more accessible, et cetera.”
Novartis, one of the world’s largest pharmaceutical companies, underscores the pivotal role of these regulatory adjustments in facilitating smoother clinical trial operations.
Speaking at the summit, 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.”
“We foresee a number of opportunities that we can start slowly with one to two pivotal trials in the next year or so and then build that experience organically.’’
Anticipating further improvements, particularly with a forthcoming 2023 act, stakeholders emphasize India’s potential for accelerated trials, enhanced transparency, and standardized processes.
Additionally, India’s evolving hospital networks, expanding access to patients across tier two and tier three cities, enhance its appeal as a clinical trial destination.
India’s attractiveness for clinical trials is further underscored by its potential to expedite the delivery of medicines to patients. With feasible, scalable, and predictable trial processes, India presents a promising environment for companies seeking to bring medicines to market faster.
Dr. Christopher Corsico, Global Head of Development at GSK, noted, “However, 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’s skilled population and robust infrastructure offer a conducive environment for conducting trials, with significant improvements noted in trial timelines and quality standards.
Dr. Uli Broedl, Senior Vice President and Head of Global Clinical Development at Boehringer Ingelheim, highlighted, “It is an absolute misperception that quality was poor. Infrastructure stepped up.”
“We are currently at Boehringer Ingelheim running a large phase three global programme, where India participates in obesity.”
This strategic approach allows companies to harness India’s capabilities and contribute to global trial efforts, optimizing trial outcomes and reducing timelines.
India’s ascension as a premier destination for clinical trials signifies a transformative shift in the global pharmaceutical landscape.
As the nation continues to refine its regulatory framework and infrastructure, stakeholders are presented with unprecedented opportunities to capitalize on India’s potential while addressing existing challenges.
With collaborative efforts and strategic initiatives, India is poised to play a pivotal role in advancing global clinical research and enhancing patient access to life-saving treatments.
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