India’s role in medical product space represents both a unique opportunity and an important responsibility: FDA Commissioner
Apr 22,2024 Washington: 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 U.S. 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. Source: Healthworld