India's role in medical product space represents unique opportunity: FDA

The role of India in the medical product field represents both a unique opportunity and an important responsibility, the head of the US Food and Drug Administration has said, ahead of the annual India-US BioPharma & Healthcare Summit.

The summit will take place in Boston later this week.

Dr Robert Califf, US FDA Commissioner will be one of the keynote speakers at the 18th edition of the annual largest gathering of pharma and healthcare sectors from the two countries, organised by USA India Chamber of Commerce.

During the day-long summit, Dr Califf will share insights from his significant visit to India last September, which holds paramount importance for both countries, USA India Chamber of Commerce said in a statement on Sunday.

I recently visited India with a central purpose in mind to strengthen our collective efforts to advance the development and availability of medical products that both our countries and the rest of the world need, he said.

I knew, going into my trip, that our FDA investigators had identified issues in India demanding our attention relating both to manufacturing quality and concerns about the conduct of clinical trials performed in support of drug applications and so I repeatedly spoke about the importance of prioritising a culture of quality and practices that ensure the integrity of manufacturing and clinical data, Dr Cliff said.

One of the key messages during my visit to the capital city of New Delhi and the pharmaceutical and technology hub Hyderabad was that India's role in the medical product space represents both a unique opportunity and an important responsibility. I returned to the US from India, enthusiastic about our future together in our common mission to improve human health, he said.

Among prominent speakers at the summit are Biogen CEO Chris Viehbacher, R&D heads like Andrew Plump of Takeda, Marcus Schindler of Novo Nordisk, Robert Plenge of BMS, and academic leaders Marc Tessier-Lavigne of Stanford and George Daley of Harvard Medical School.

Indian government's innovation-driven top leadership, coupled with India's substantial skilled manpower, positions the country as a trusted Partner of Choice for BioPharma research and development, clinical research, and manufacturing, said Karun Rishi president of USAIC.

With its ability to scale up manufacturing capacity while maintaining high-quality standards, India is primed to play a pivotal role in producing life-saving medicines for global consumption, addressing critical concerns regarding BioPharma supply chain and health security, he said.

Notable figures from the Indian pharma industry, including Dilip Shanghvi of Sun Pharma and Hari Bhartia of Jubilant Bhartia Group, will participate in the summit.

Dr Andrew Plump, president of R&D at Takeda, will be recognised with the prestigious "Distinguished Service Award" at the upcoming USAIC's 18th Annual Biopharma & Healthcare Summit.

This award celebrates Dr. Plump's remarkable vision and unwavering commitment to catalysing industry-academic partnerships, fostering interdisciplinary translational biomedical research and development, and pioneering innovative solutions for a healthier world, the media release said.

Dr. Noubar Afeyan, founder & CEO, of Flagship Pioneering said India is well-positioned to play a critical role in accelerating innovation within the life sciences globally, given its population size, proven track record in the large-scale manufacturing of drugs, growing work in clinical development, and its emergent capabilities in biotech research.

"India with its large talent pool and growing economy is not only manufacturing for the world but also innovating for the world, especially in the field of biotechnology, pharmaceutical and R&D, said Hari Bhartia, founder and co-chairman, of Jubilant Bhartia Group.

While India continues to play a crucial role in global pharma supply chains, becoming an R&D and innovation hub is the next frontier that we should aspire for, he added.

Dr. Plump said Takeda remains eager to explore opportunities for building impactful partnerships that could lead to advances for patients in India and around the world.

Recognising the necessity of global collaboration, USAIC endeavours to drive transformative medical innovation not only for India but also for the broader global community, Rishi said.

Global collaboration is paramount to advancing transformative medical innovation, benefiting not only India but also the entire world. By pooling together diverse expertise, resources, and perspectives from across nations, we can accelerate the pace of innovation, enhance the quality of healthcare delivery, and address pressing global health challenges more effectively, he said.

According to Rishi, over the past 18 years, USAIC has engaged extensively with top global BioPharma leaders and investors, witnessing remarkable progress in India's life sciences innovation ecosystem.

This growth is further propelled by pragmatic supportive policies implemented by the Indian government, positioning India as a strategic partner for the US and other Western countries in the BioPharma domain.

Despite the current global geopolitical and economic challenges, India remains a beacon of hope, poised to continue its upward trajectory for the foreseeable future, he said.