Author: Ms. Jayshree Chandra, Senior Partner & Ms. Sangini Tyagi, Associate at ZEUS Law
Published in asiancommunitynews.com on 4th June 2023
Government of India recently notified the National Medical Device Policy, 2023 (“NMD Policy, 2023”). The NMD Policy, 2023 aims to build upon existing measures and facilitate the orderly growth of the medical device sector, which is projected to grow from $11 billion to $50 billion by 2030.
The policy focuses on creating an enabling ecosystem for manufacturing and innovation, streamlining regulations, promoting training and capacity building programs, and fostering talent and skilled resources aligned with industry requirements.
The policy outlines a plan for the sector’s rapid development to fulfil objectives such as access and universality, affordability, quality, patient-centred care, preventive and health promotion, safety, research and innovation, and skilled labour.
A set of plans encompassing six major areas of government interventions, including regulatory streamlining, enabling infrastructure, facilitating R&D and innovation, attracting investments, human resource development, and brand positioning and awareness creation is contemplated under the NMD Policy, 2023.
It aims to enhance ease of conducting research and business, establish world-class common infrastructure facilities, promote R&D and innovation, attract private investments, develop skilled workforces, and create a dedicated Export Promotion Council for the sector.
- Regulatory Streamlining:
Measures for improving the ease of conducting research and business while maintaining a balance between patient safety and product innovation is the need of the hour. Innovations planned under the policy include developing a “Single Window Clearance System” for licensing of medical devices for easing compliance burden by involving all stakeholder departments/organizations such as AERB, MeitY, DAHD, etc., enhancing the role of Indian standards like BIS, and designing framework for coherent pricing regulations to make available quality and effective medical devices to all citizens at affordable prices. The NMD Policy, 2023 further aims is to establish an institutional framework that will harmonize the regulations of the National Medical Commission (NMC), the code of ethics followed by industry associations, and other relevant entities to promote ethical marketing of medical devices.
- Enabling Infrastructure:
The establishment and strengthening of large medical device parks, clusters, and facilities with excellent common infrastructure near economic zones with necessary logistics connectivity is contemplated under the National Industrial Corridor Programme and the proposed National Logistics Policy 2021 under PM Gati Shakti.
- Facilitating R&D and Innovation:
The policy envisages to promote research and development innovation as contemplated in the proposed National Policy on R&D and Innovation in the Pharma-MedTech Sector through creation of innovation centres, ‘plug and play’ infrastructures, centres of excellence at academic and research institutions, and support for start-ups.
- Attracting Investment in the Sector:
In addition to existing initiatives like Make in India, Ayushman Bharat, Heal-in-India, and the Start-up Mission, the policy contemplates fresh measures to promote private investments, venture capital funding, and public-private partnerships in domestic manufacturing with special focus on start-ups.
- Human Resources Development:
The policy envisages a steady supply of future ready skilled MedTech human resources across the value chain and supporting skill development, reskilling, and upskilling of professionals in the medical device industry through specialized multidisciplinary courses to be offered from existing institutions, and collaborations with foreign institutions.
- Brand Positioning and Awareness Creation:
The policy proposes the establishment of an Export Promotion Council for the sector to address market access issues. It also encourages learning from successful manufacturing and skilling systems worldwide and fosters networking and knowledge exchange across the industry.
The NMD Policy, 2023 is expected to strengthen the Indian medical device industry as a competitive, self-reliant, resilient and innovative sector to meet healthcare needs and requirements of patients not only in India but across the globe. The Indian medical device industry holds huge potential and the foreign companies looking to explore investment and business opportunities may closely follow the interventions and initiatives introduced by the Indian Government in this sector.
(This Article is solely for information purposes, does not constitute legal or professional advisory and should not be relied upon or used as a substitute for legal advice from attorney.)
About the Authors: Jayshree Navin Chandra, Senior Partner at ZEUS Law, has been a practicing lawyer since 2001 with extensive corporate and transactional advisory experience. She advises and represents clients ranging from Fortune 500 companies to start-ups as well as Central and State Government departments and public bodies in a wide range of domestic and cross border transactions, across industries in practice areas including Corporate and Company Law, M&A and Joint Venture, Private Equity, FDI & FII, Real Estate and Infrastructure, Data privacy and protection, Intellectual Property & Commercial Law Advisory.
Sangini Tyagi, is an Associate at ZEUS Law and works in the Corporate & Commercial and Infrastructure & Real Estate practice vertical.
ZEUS Law Associates is an ISO certified full service corporate commercial law firm with a team of dedicated and experienced lawyers well versed in handling domestic and cross border transactions across sectors, jurisdictions and regulatory landscapes. The firm’s practice areas include Corporate and Company Law, M&A and Joint Venture, Private Equity, FDI & FII, Real Estate and Infrastructure, Intellectual Property & Commercial Law, Litigation, Alternate Dispute Resolution, Indirect Tax and NRI Services.