India’s role in medical products represents a unique opportunity: FDA

India’s role in medical products represents both a unique opportunity and an important responsibility, the head of the US Food and Drug Administration said ahead of the annual India-US Biopharmaceutical and Healthcare Summit.

The summit will be held in Boston later this week.

US FDA Commissioner Dr. Robert Califf will deliver the keynote address at the 18th annual largest gathering of the pharmaceutical and healthcare industries of both countries, organized by the US-India Chamber of Commerce.

The American India Chamber of Commerce said in a statement on Sunday that at the one-day summit, Dr Kalif will share insights from his landmark visit to India in September last year, which was significant for both countries.

He said that the main objective of my recent visit to India is to strengthen our collective efforts to promote the development and supply of essential medical products for our two countries and the rest of the world.

I know that during my visit, our FDA investigators in India have identified issues that require our attention, both related to manufacturing quality and concerns about the conduct of clinical trials that support drug applications, so I have repeatedly prioritized its importance. Quality and practice culture that ensures manufacturing and clinical data integrity, Dr. Cliff said.

One of the key messages I conveyed during my visit to the capital New Delhi and the pharmaceutical and technology hub Hyderabad was that India’s role in medical products represents both a unique opportunity and an important responsibility. “I returned from India to the United States with our shared future and our shared commitment to improving people’s health,” he said.

Notable speakers at the summit include Biogen CEO Chris Viehbacher, Techda’s Andrew Plump, Novo Nordisk’s Markus Schindler, BMS’s Robert Plenge and other R&D leaders, as well as academic leaders Marc Tessier-Lavigne of Stanford University and George Daly of Harvard Medical School.

Karun Rishi, president of USAIC, said the Indian government’s top innovation-oriented leadership, coupled with India’s vast pool of technological talent, makes the country a trusted and preferred partner in biopharmaceutical R&D, clinical research and manufacturing.

He said India is poised to play a key role in manufacturing life-saving medicines for global consumption and solving critical issues in biopharmaceutical supply chain and health security due to its ability to expand production capacity while maintaining high quality standards.

The summit will be attended by prominent figures from the Indian pharmaceutical industry, including Dilip Sanghvi of Sun Pharma and Hari Bharatia of the Jubilant Bharatia Group.

President of Takeda R&D. Andrew Plump will receive the prestigious Distinguished Service Award at the upcoming USAIC 18th Annual Biopharmaceutical and Healthcare Summit.

According to media reports, the award recognizes Dr. Plump’s exceptional vision and commitment to fostering industry-academic partnerships, promoting interdisciplinary translational biomedical research and development, and pioneering innovative solutions for a healthier world.

Dr Nawbar Afian, Founder and CEO, Flagship Pioneering, said India is well-positioned to play a pivotal role in accelerating innovation in life sciences globally, with its population size, its proven track record in large-scale pharmaceutical manufacturing. , and its growing population implications. Clinical development efforts and its emerging capabilities in biotechnology research.

Hari Bharatia, Founder and Co-Chairman, Jubilant Bharatia Group, said: “India has a huge talent pool and a growing economy, which not only manufactures for the world, but also innovates for the world, especially in the areas of biotechnology, pharmaceuticals and R&D. “

He added that while India continues to play an important role in the global pharmaceutical supply chain, becoming an R&D and innovation hub is our next frontier.

Dr. Plump said Takeda is keen to explore opportunities to form impactful partnerships that can bring breakthroughs for patients in India and around the world.

Recognizing the need for global collaboration, USAIC is committed to driving transformative medical innovation not just for India, but for the wider international community, Rishi said.

Global collaboration is critical to advancing transformative medical innovations that will benefit not only India but the world He said that by bringing together the diverse skills, resources and perspectives of different countries, we can accelerate the pace of innovation, improve the quality of healthcare services and respond more effectively to pressing global health challenges.

Rishi said that over the past 18 years, USAIC has engaged extensively with leading global biopharmaceutical leaders and investors and has witnessed significant progress in India’s life science innovation ecosystem.

This growth has been further fueled by supportive policies implemented by the Indian government, making India a strategic partner for the US and other Western countries in the biopharmaceutical sector.

He said that despite the current global geopolitical and economic challenges, India remains a beacon of hope and is poised to continue its upward journey in the near future.