Government releases draft paper on national medical devices policy

national medical devices policy

The Department of Pharmaceuticals (DoP) has issued a draft paper on national policy for medical devices, asking for feedback and remarks of the industry and stakeholders, till 25 March. The Ministry of Chemicals and Fertilizers expressed that the department of pharmaceuticals has published the approach paper after comprehensive 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 billion to $50 billion by 2025.

The presented National Medical Devices Policy 2022 seeks to put in place a comprehensive set of standards for ensuring sustained growth and development of the sector and handling the challenges of the industry such as regulatory streamlining, skilling of human resources, and lack of technology for high-end equipment and scarcity of appropriate infrastructure, through a coherent policy framework. The draft national policy further aims to foster orderly growth of the sector for the coming years. This policy, while addressing the core objectives of accessibility, affordability, safety, and quality, focuses on self-sustainability and innovation.

Currently, nearly 80 per cent of the medical devices used in the country are imported products, particularly high-end devices and medical equipment.

The key features of the draft national policy include:

  • Regulatory facilitating 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 measures and security of the devices in order to deliver safety devices to the consumers, in harmony with the global standards.
  • Building competitiveness via fiscal and financial support for encouraging the development of the local manufacturing ecosystem with private sector investments.
  • Infrastructure development to provide the best-in-class physical foundation, including medical devices parks with common facilities such as testing centers, to improve cost competitiveness and sweeten the attraction of domestic manufacturers.
  • Facilitating R&D and innovation with a focus on enriched conspiracy 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 assure suitable 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 percent of Global Market Share.

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