Medical Devices Policy, 2023

The medical devices sector in India holds a pivotal role in the country's healthcare landscape, working in tandem with healthcare providers, pharmaceuticals, and the healthcare insurance industry. Recognized as a sunrise sector, the Indian medical devices industry is experiencing rapid growth, with an estimated market size of $11 billion (approximately ₹90,000 Cr) in 2020, constituting 1.5% of the global medical device market. The sector's expansion is fueled by factors such as a growing and aging population, increased per capita income, demand for healthcare infrastructure, and the rise in diagnostic and healthcare services.

Despite its potential, the medical device sector requires a comprehensive policy framework to ensure sustained growth and development. The current policy aims to create a conducive environment for the sector's orderly growth, aligning with public health objectives of access, affordability, quality, and innovation. The policy seeks to complement government initiatives such as 'Atmanirbhar Bharat' and 'Make in India,' emphasizing domestic investments and production of medical devices.

Key Objectives of the Policy:

Regulatory Streamlining for Patient-Centric Innovation

Recognizing the imperative to balance patient safety with innovation, the policy advocates the establishment of a 'Single Window Clearance System' for licensing medical devices. This system, aligned with the National Single Window System, seeks to eliminate duplication of efforts, reduce compliance burdens, and facilitate a smoother regulatory pathway. To enhance standardization, the Bureau of Indian Standards and other bodies will expand standards, fostering quality and global competitiveness. A coherent pricing regulation framework, in alignment with the Drugs (Prices Control) Order, aims to make high-quality medical devices accessible to all citizens at affordable prices.

Enabling Infrastructure for Growth

To boost competitiveness, the policy emphasizes the establishment and strengthening of large medical device parks and clusters with world-class infrastructure. These facilities, strategically located near economic zones, will enhance scale, quality, and productivity, aligning with the National Industrial Corridor Program and the proposed National Logistics Policy. The policy also underscores the need for testing and certification facilities, ensuring the quality, safety, and efficacy of medical devices. Phased manufacturing of critical components will further fortify domestic manufacturing against supply chain disruptions.

Facilitating R&D and Innovation

Given the innovation-driven nature of the medical device sector, the policy champions the integration of next-generation technologies such as 5G, 6G, IoT, and AI. Collaboration between academic institutions and industry is encouraged, with a focus on joint R&D projects. Centers of Excellence (CoEs) and innovation hubs will be established, fostering a conducive environment for research and product development. Existing resources under various institutions will be converged to maximize the utilization of government-funded inventions.

Attracting Investments for Indigenous Manufacturing

In addition to existing schemes, the policy proposes measures to attract private investments, including risk-based financing and engagement with venture capitalists. New financing models, such as blended finance, will be explored, leveraging initiatives like the Start-up mission to encourage startups in the medical devices sector. Policies like Public Procurement (Make in India) and Ayushman Bharat will be harnessed to promote domestic manufacturing.

Human Resources Development for a Skilled Workforce

To meet the sector's evolving needs, the policy outlines plans to develop a skilling ecosystem aligned with the Skill India program. Resources from the Ministry of Skill Development and Entrepreneurship will be leveraged for skill development across the value chain. Multidisciplinary courses for medical devices will be introduced, ensuring a skilled workforce for futuristic medical technologies. Collaboration with foreign academic/industry organizations is also encouraged.

Brand Positioning and Awareness Creation

The policy emphasizes the creation of a dedicated Export Promotion Council and coordinated efforts with the Ministry of Commerce and Industry to enhance global competitiveness. Stakeholder engagement will be strengthened through studies of global best practices, proactive communication on safety standards, and the promotion of forums for knowledge sharing.

Monitoring and Evaluation for Sustainable Impact

The policy underscores the importance of monitoring and evaluation to achieve Sustainable Development Goals and enhance healthcare indices. Quantitative metrics will be developed to measure equity in access, affordability, self-reliance in manufacturing, and overall healthcare improvements. Economic indicators like market size, exports, and Foreign Direct Investments will be tracked, ensuring the policy's effectiveness.

In conclusion, India's National Medical Devices Policy marks a strategic and holistic approach to propel the medical device sector into a realm of innovation, growth, and global competitiveness, all while prioritizing patient safety and accessibility.