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Draft National Medical Devices Policy 2022

  • IAS NEXT, Lucknow
  • 15, Mar 2022
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In line with the mandate of promoting aspects of the medical device industry, the Department of Pharmaceuticals, realising the need to have a holistic policy to accelerate growth and explore the potential of the Medical Devices Sector, has published this approach paper, after extensive stakeholder consultations, for the Sunrise Sector of Medical Devices, popularly called as MedTech Sector. The Sector is expected to grow in market size from the present 11 Bn. USD to 50 Bn. USD by 2025.

Salient Features

  • Regulatory streamlining in order to optimize regulatory processes and multiplicity of agencies for enhanced ease of doing business, along with harmonization with global standards to ensure standardization.
  • Quality Standards and Safety of the Devices in order to provide safe devices to the consumers, in harmony with the global standards.
  • Building Competitiveness through fiscal and financial support for stimulating the development of the local manufacturing ecosystem with private sector investments.
  • Infrastructure Development to provide best-in-class physical foundation, including medical devices parks with common facilities such as testing centres, to improve cost competitiveness and enhance attraction of domestic manufacturers.
  • Facilitating R&D and Innovation with a focus on enhanced collaboration in innovation and R&D projects, global partnerships, and joint ventures among key stakeholders to bridge the gap between academic curriculum and industry requirements.
  • Human Resource Development to ensure relevant curriculum at higher education level, skilling of various stakeholders, creation of future-ready HR with required skill sets across the innovation value chain.
  • Awareness Creation and Brand Positioning in creating awareness and positioning India as a hub for manufacturing of medical devices as part of the “Make in India, Make for the World” initiative.

This Policy envisions that by 2047, our Country

  • Will be having few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs;
  • Will be home & originator to 25 high-end futuristic technologies in MedTech
  • Will have a MedTech Industry of $100-300 Bn size with 10-12% of Global Market Share.