Plenary Session I: Bridging the Last Mile for Access to Quality and Innovative Healthcare deliberated on addressing challenges and opportunities while bridging the gap for patient access to quality and innovative drugs, therapeutics, diagnostics, advance medical devices, and healthcare. The discussion focused on access to emerging technology and therapies for the Indian market and creating infrastructure for pharma and MedTech with continued India interest. Mr. Sanjay Bhutani, Honorary Secretary and Treasurer, AMCHAM and Managing Director India & SAARC, Bausch & Lomb, India moderated the session. Special addresses were delivered by Dr. Y.K. Gupta, National Coordinator for Pharmacovigilance Programme of India, Government of India, Dr. Pankaj Kumar Arora, Director, National Health Authority, Ministry of Health & Family Welfare, Government of India and Dr. Suchita Markan, Scientist E, Mission-in-Charge & Member Secretary, Medical Device and Diagnostics Mission Secretariat (MDMS), Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, Government of India. Industry speakers included Mr. Atul Grover, Co-Chairman – Medical Devices Committee, AMCHAM and Managing Director for India and South Asia, BD (Becton, Dickinson, and Company) and Ms. Shobha Mishra Ghosh, Director & Head, Government Affairs & Policy, India & South Asia, GE Healthcare.
Plenary Session II: R&D and Innovation addressed issues and concerns while taking up R&D and innovation in healthcare which is impacted greatly by exponential digital and deep tech innovations. Deliberations focussed on the necessity of an ecosystem approach with policy level interventions which would naturally create an ecosystem to encourage entrepreneurship in collaboration with clinical, scientific and health-economics based research in the country. It also discussed the importance of healthcare providers and patients having access to the training and education necessary to use emerging technologies effectively. The session moderated by Mr. Sumit Agrawal, Associate Director – R&D, Boston Scientific with a special addresses by Dr. Manish Diwan, Head – Strategic Partnership & Entrepreneurship Development, Head – Startup India & Make in India for Biotech Sector, Biotechnology Industry Research Assistance Council (BIRAC) and Dr. Pankaj Kumar Arora, Director, National Health Authority, Ministry of Health & Family Welfare, Government of India. Dr. Amitabha Bandyopadhyay, Kent Chair Professor of Entrepreneurship and Innovation, Head of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur and Mr. Sanjay Vyas, Executive Vice President, India Country Head & Managing Director, Global SBU Head – Safety Services & Logistics, Parexel International India participated in the panel discussion.
Plenary Session III: Appropriate Regulations Ensuring Quality Healthcare and Ease of Doing Business deliberated on streamlining regulatory challenges and explored regulatory and quality priorities, IPR best practices, clinical trials and the importance of harmonization of standards for various regulations across the healthcare continuum, especially for pharmaceuticals and medical devices. This would not only ensure prescribed quality of the product but would also encourage confidence for physicians and patients. Healthcare should not only be cost effective but also offer ease of doing business to ensure sustained access and availability of drugs and devices. The session was moderated by Mr. Kaustav Banerjee, Chairman – Hyderabad Chapter, AMCHAM and Vice President – South Asia, Zimmer Biomet with special addresses by Dr. Sarah McMullen, Country Director – India Office, U.S. Food and Drug Administration and Dr. Ravi Kant Sharma, Deputy Drugs Controller (India), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India. Other esteemed speakers included Dr. Madan Gopal, Adviser – Public Health Administration, NHSRC, Ministry of Health and Family Welfare, Government of India, Ms. Jyotsna Ghoshal, Enterprise Lead, Government Affairs & Policy, India, Global Lead, International Forums, Johnson & Johnson and Mr. Sudhakar Mairpady, Director – Regulatory and Government Affairs – India/South Asia, BD.
In the closing session, Vision and Way Forward, speakers discussed multi stakeholder involvement in contributing to the policy framework for the pharma and MedTech industry. It also summarized the important recommendations derived from various plenary sessions throughout the summit. Speakers included Mr. Umang Chaturvedi, Head of Policy & International Affairs, Mylan, Mr. Antony Prashant, Partner – Consulting, Deloitte Touché Tohmatsu India LLP and Mr. Manoj Madhavan, Chairman – Medical Devices Committee, AMCHAM and Managing Director, Boston Scientific, India Hub. Ms. Elizabeth Jose, Director, AMCHAM gave the vote of thanks.
KEY RECOMMENDATIONS DERIVED FROM THE SUMMIT
- Value based procurement paradigm:
Public healthcare system should transition from cost based procurement paradigm to a value based procurement paradigm so that quality isn’t compromised.
- Healthcare Technology Assessment (HTA):
A robust ecosystem with infrastructure and regulations should be set up for Healthcare Technology Assessment so that the true value of new technology can be ascertained.
- Radical and incremental innovation:
- Importance of balancing radical and incremental innovation.
- Incremental innovation should be promoted because it builds capacity and makes an industry resilient.
- Industry profitability:
It is essential to allow industry to make reasonable profits so that they can continue investing in innovation and stay competitive.
- Manufacturing capacity:
- India was able to ramp up manufacturing capacity rapidly in response to COVID because the groundwork was in place. This carries great lessons for the future.
- Much more capacity is required in industry than we have at present so we can be resilient in the face of future pandemic-like situations and supply chocks.
- Important therapy areas where government is focusing on:
- Primary care
- Assistive technology for the elderly and infirm
- Point of care testing device for renal diseases
- Point of care testing device for liver diseases
- The ecosystem needs to be set up to enable quick commercialization of new technologies. It should involve.
- Quality testing guidelines and infrastructure aligned to regulatory requirements.
- Partnerships between academia, startups and industry players
- Healthcare technology assessment capability
- Guidelines for assessment of operational and financial feasibility of new technologies
- Adoption of technologies that have already proven successful abroad should be accelerated.
- Harmonization of Indian regulations with global ones is required
- Technology transfer should be promoted along with R&D
- Medical device servicing and repair is an overlooked area.
- Healthcare providers should be sensitized on the importance of annual and preventive maintenance of medical equipment.
- Several countries require an AMC contract or equipment insurance to be in place before the equipment can be used. India should consider a similar regulation.
- Quality regulations in India need to be more stringent.
- Hospital accreditations and quality programs such as NABH are not adopted sufficiently in India. Such programs should be made mandatory so that compromises aren’t made.
- Healthcare providers should be penalized for violation of tenets of quality of care so that they remain focused on quality.
- Training of healthcare providers on new technology needs to be more frequent.
- Given the rapid advancements in healthcare technology, refresher trainings should be organized for healthcare providers to introduce them to new technology.
- Medical training curriculum needs to be revised.
- Industry can help in creating and disseminating training content to healthcare providers.
- Pharma innovation and R&D should be promoted.
- India has a huge pharma infrastructure but does very little R&D relative to it. Government should encourage pharma R&D in India.
- Industry players should help accelerate innovation in India.
- Collaboration between industry, academia, startups, and regulators should be promoted.
- Consultative process should be encouraged.
- Consensus building mechanisms should be defined.
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