GS Paper 2
Syllabus: Government policies
Context: Indian Union Cabinet has approved the National Medical Devices Policy, 2023
Need for the policy:
- Nearly 80% of the medical devices currently sold in the country are imported, particularly high-end devices.
- India has one of the lowest per capita spending on medical devices at $3 compared to the global average of per capita consumption at $47.
The objective of the Policy:
- Facilitating orderly growth: The medical devices sector is a fast-growing sunrise sector in India with a 5% share in the global medical device market.
- Accelerated growth with a patient-centric approach
- Achieving a 10-12% share in the expanding global market over the next 25 years (from 1.5% currently)
- Expanding market size to $50 billion by 2030 (from current $11 billion)
- Providing an enabling ecosystem for manufacturing
- Encouraging domestic investments and production of medical devices
- Promote the safety and efficacy of medical devices.
- Provide support in training and capacity-building programs
Strategies to Promote Medical Device Sector:
| Strategy | Example |
| Streamlining Regulatory Processes | Creation of a Single Window Clearance System for Licensing of Medical Devices; coordination between all the stakeholder departments/organizations such as AERB, MeitY, DAHD, etc., Enhancing the role of Indian Standards like BIS; Designing a coherent pricing regulation. |
| Enabling Infrastructure | Developing medical device parks and clusters in line with the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti. |
| Facilitating R&D and Innovation | Supporting R&D and innovation through the establishment of Centres of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups. |
| Attracting Investments in the Sector | Supporting investments through schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, Start-up mission, and encouraging public-private partnerships. |
| Human Resources Development | Skilling, reskilling, and upskilling of professionals in the medical device sector; Supporting dedicated multidisciplinary courses for medical devices in existing institutions; Developing partnerships with foreign academic/industry organizations. |
| Brand Positioning and Awareness Creation | Initiating studies and projects for learning from best global practices of manufacturing and skilling systems, promoting more forums to bring together various stakeholders for sharing knowledge, and building strong networks across the sector. |
Government Initiatives:
- PLI Scheme for medical devices: A total of 14 projects producing 37 products commissioned
- Manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high-end X-ray tubes, etc.
- Support for setting up of 4 Medical devices Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh
- Medical Devices Rules in 2017: The rules classify medical devices into four classes based on associated risks and international standards.
- National Health Policy 2017: It highlights the need to promote R&D and domestic manufacturing of medical devices
Conclusion:
The policy is expected to provide the required support and directions to strengthen the medical devices industry into a competitive, self-reliant, resilient, and innovative industry that caters to the healthcare needs of India and the world.
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Discuss the major provisions of National Medical Devices Policy 2023 (250 Words)
