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Post at: Apr 16 2022

Draft National Medical Devices Policy 2022

Recent Context

  • In march 2022, Ministry of Chemicals and Fertilizers releases approach paper on 'Draft National Medical Devices Policy 2022' for consultation.
  • Feedback and remarks of the Industry and stakeholders are invited till the 25th of March 2022.

Need of the policy

  • Need to have a holistic policy to accelerate growth and explore the potential of the Medical Devices Sector.
  • The Sector is expected to grow in market size from the present 11 Bn USD to 50 Bn USD by 2025.

Features of the policy-

  • Regulatory streamlining to improve the ease of doing business by optimising regulatory procedures and reducing the number of agencies, as well as harmonisation with global standards to maintain uniformity.
  • Quality Standards and Device Safety in order to offer customers with safe products that adhere to worldwide standards.
  • Increasing competitiveness by providing fiscal and financial incentives to encourage private sector investment in the local industrial environment.
  • Infrastructure Development to provide a best-in-class physical foundation, including medical devices parks with common facilities such as testing centers.
  • Facilitating R&D and Innovation by focusing on improved cooperation in innovation and R&D projects, worldwide collaborations, and partnerships among relevant parties to fill the gap between core curriculum and industrial requirements.
  • Human Resource Management to guarantee applicable curriculum at the higher education level, upskill of various stakeholders, and the development of future-ready HR with the required expertise across the innovative value chain.

Current Scenario of Indian medical device sector-

  • The Indian medical device market has a significant presence of multinational companies with about 80% of the sales by value generated from imported medical devices.
  • Although being one of the top twenty markets for medical devices in the world and Asia's fourth largest market after Japan, China, and South Korea, the medical devices sector in India is quite minor in comparison to the rest of the manufacturing industry.
  • India currently imports 80-90% of medical devices of the USD15 billion market.
  • The involvement of the Indian medical devices sector has been even more visible as India assisted the worldwide fight against the COVID-19 pandemic by manufacturing medical equipment and diagnostic kits, such as ventilators, RT-PCR kits, IR Thermometers, PPE Kits, and N-95 masks.

Significance

  • The policy aims to put in place a comprehensive set of measures for ensuring sustained growth and development of the sector.
  • It will address the future challenges such as regulatory streamlining, human resource skilling, lack of technology and lack of appropriate infrastructure.
  • The Draft National Policy also intends to assist the sector's orderly expansion in the next years.
  • This strategy emphasises self-sustainability and innovation while achieving the basic objectives of accessibility, affordability, safety, and quality.

Way forward

  • The sector need specific coordination and communication among industry and stakeholders.
  • Medical device companies should work to establish India as a manufacturing hub for both domestic and international markets,
  • Pursue India-based innovation in tandem with indigenous manufacturing.
  • They should collaborate under the Make in India and Innovate in India programmes, and produce Low to Medium technology products to serve underserved domestic markets.
  • The goal should also be to increase access and opportunity for both the demand and supply sides of the medical device business through joint policy support.

Conclusion

  • Medical devices are an important and crucial aspect of India's healthcare industry, especially for the prevention, diagnosis, treatment, and management of all medical problems, diseases, illnesses, and disabilities.
  • The sector requires special coordination and communication among Industry and Stakeholders because of its diversified nature, continuous innovation & variation.  The Department, through various programmatic and schematic interventions such as PLI scheme for promoting domestic manufacturing of Medical Devices, Promotion of Medical Devices Parks intends to encourage the domestic manufacturing of Medical Devices.


 


 


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