National Medical Devices Policy 2023

What’s in today’s article?

• Why in News?
• Background on Medical Devices Sector
• Need for a Holistic Framework for Medical Devices
• Salient Features of National Medical Devices Policy, 2023

 

Why in News?

• The Union Cabinet approved the National Medical Devices Policy, 2023, which is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality, and innovation.

 

Background on Medical Devices Sector

• The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of medical conditions, diseases, illnesses, and disabilities.
• The medical device is a multi-product sector, with the following broad classifications:
  • Electronics Equipment
  • Implants
  • Consumables and Disposables
  • IVD reagents
  • Surgical Instruments
• The medical devices sector in India is a sunrise sector which is growing at a fast pace.
• The current market size of the medical devices sector in India is estimated to be $11 bn and its share in the global medical device market is estimated to be 1.5%.

 

Need for a Holistic Framework for Medical Devices

• The Government of India has already initiated implementation of PLI Scheme for medical devices and support for setting up of 4 Medical devices Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.
• Under the PLI scheme for Medical Devices, till now, a total of 26 projects have been approved, with a committed investment of Rs. 1200 crore.
  • Production Linked Incentive, or PLI, scheme of the Government of India is a form of performance-linked incentive to give companies incentives on incremental sales from products manufactured in domestic units.
• Building upon these measures, a holistic policy framework to accelerate this growth and fulfil the potential of the sector is the need of the hour.
• There is a need to bring together the range of interventions in a coherent manner that would facilitate focused and efficient support and facilitation for the sector by the respective agencies.

 

Salient Features of National Medical Devices Policy, 2023

• Vision –
  • Accelerated growth path with a patient-centric approach;
  • To emerge as the global leader in the manufacturing and innovation of medical devices by achieving 10-12% share in the expanding global market over the next 25 years;
  • To help the Medical Devices Sector grow from present $11 Bn to $50 Bn by 2030.
• Medical devices sector will be facilitated and guided through a set of strategies that will be cover six broad areas of policy interventions –
• Regulatory Streamlining –
  • In order to enhance ease of doing research and business and further to balance patient safety with product innovation measures.
• Enabling Infrastructure –
  • The establishment and strengthening of large medical device parks, clusters equipped with world class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity.
• Facilitating R&D and Innovation –
  • The policy envisages to promote Research & Development in India and complement the Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India.
  • It also aims at establishing Centres of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups.
• Attracting Investments –
  • Along with resent schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, Start-up mission, the policy encourages private investments, series of funding from Venture Capitalists, and also Public-Private Partnership(PPP).
• Human Resources Development –
  • For skilling, reskilling and upskilling of professionals in the medical device sector, we can leverage the available resources in Ministry of Skill Development and Entrepreneurship.
  • The policy will support dedicated multidisciplinary courses for medical devices in existing institutions.
  • To develop partnerships with foreign academic/industry organizations to develop medical technologies in order to be in equal pace with the world market.
• Brand Positioning & Awareness Creation –
  • Initiate studies and projects for learning from best global practices of manufacturing and skilling system so as to explore the feasibility of adapting such successful models in India.
  • Promote more forums to bring together various stakeholders for sharing knowledge and build strong networks across the sector.
• 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 not only India but also of the world.

 

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Q1) What is the budget for the health sector in 2023?

In 2023-24, the Ministry of Health and Family Welfare has been allocated Rs 89,155 crore. This is an increase of 13% over revised estimates for 2022-23.

 

Q2) What is primary health Centre system in India?

Under the National Health Mission (NHM), Primary Health Centre (PHC) are established to cover a population of 30,000 in rural areas and 20,000 in hilly, tribal and desert areas.

 

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Source: Union Cabinet approves National Medical Devices Policy | PIB