Context

• The government is proposing a new Draft National Policy for Medical Devices 2022 to reduce India’s dependence on import of high-end medical devices.

Key Features of the Draft National Policy for Medical Devices 2022

• Adopting public-private partnerships to reduce the cost of healthcare, drive efficiency, and aid quality improvements in medical devices manufactured in the country
• The key proposals in the Draft National Policy for Medical Devices 2022 include:

1. 1. Incentivising the export of medical devices and related technology projects through tax rebates and refunds
   2. Increasing government spending in “high-risk” projects in the medical devices sector
   3. Single-window clearance system for licencing medical devices
   4. Pricing environment with no price control on newly developed innovation in the sector
   5. Allot a dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions and start-ups
   6. Incorporate a framework for a coherent pricing regulation, to make available quality and effective medical devices to all citizens at affordable prices
   7. NPPA (National Pharmaceutical Pricing Authority) shall be strengthened with adequate manpower of suitable expertise to provide effective price regulation balancing patient and industry needs.
   8. Pharmaceuticals Department will also work with industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP)

Need for National Policy for the Medical Devices 

• India’s medical devices sector has so far been regulated as per provisions under the Drugs and Cosmetics Act of 1940, and a specific policy on medical devices has been a long standing demand from the industry.
• Nearly 80% of the medical devices currently sold in the country are imported, particularly high-end devices. This new policy aims to reduce India’s import dependence to nearly 30% in the next 10 years , and become one of the top five global manufacturing hubs for medical devices by 2047.
• The policy aims to increase India’s per capita spending on medical devices. India has one of the lowest per capita spend on medical devices at $3 compared to the global average of per capita consumption $47, and significantly lower than the per capita consumption of developed nations like the USA at $415 and Germany at $313.

Strategic Objectives of the Draft National Policy for Medical Devices 2022

• The National Medical Devices Policy 2022 lays down a clear roadmap for accelerated growth of the medical devices sector while promoting safety and quality to systematically achieve key principles & objectives of the National Health Policy 2017 viz.
• Access, Equality & Universality: The policy strongly advocates to reach the masses and provide equity and universality in the absence of physical infrastructure through automation and providing virtual presence.

  

• Affordability: The policy aims to improve clinical outcomes through early diagnosis of diseases and increased accuracy in treatment to reduce the lifetime cost of disease burden.
• Patient Centred & Quality Care: The policy aspires to improve the quality of care by improving clinical outcomes and convenience of the patients.
• Preventive & Promotive Health: The policy strives to make people more aware and vigilant, enabling them to lead a healthier lifestyle by achieving extensive application of medical devices in early screening and diagnosis for early detection / prevention and management of diseases.
• Security: The availability of the medical devices for the diagnostic, therapeutic, clinical and research purposes should depend on the strong local manufacturing capabilities, with lesser dependence on imports.

Data on Medical Devices Sector

• Medical devices industry in India has the potential to reach $50 bn by 2025. Around 65% of the manufacturers in India are domestic players operating in the consumables segment and catering to local consumption with limited exports.
• MNCs lead the high technology end of the Medical Devices market with extensive service networks.
• There are 750–800 domestic Medical Devices manufacturers in India, with an average investment of $2.3– 2.7 mn and an average turnover of $6.2-6.9 mn. There are six Medical devices manufacturing clusters – Gujarat / Maharashtra / Karnataka / Haryana / Andhra Pradesh & Telangana / Tamil Nadu.
• The per capita spend on medical devices in India is very low at USD 3, compared to global average of per capita consumption of USD 47 as well as the per capita consumption of developed nations like USA at USD 415 and Germany at US$ 313.
• The domestic players, who constitute around 65% of the medical device manufacturers in India, focus on low-cost low-technology devices such as consumables and disposables catering to local consumption with limited exports.

Reference:

https://indianexpress.com/article/explained/india-draft-medical-devices-policy-explained-7820757/

https://pharmaceuticals.gov.in/sites/default/files/Public%20Notice%20and%20Approch%20paper%20on%20draft%20NMDP%202022.pdf

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