Govt releases draft paper on national medical devices policy for consultation

The department of pharmaceuticals (DoP) has released a draft paper on national policy for the medical devices, inviting feedback and remarks of the industry and stakeholders, till the 25 March.

The department of pharmaceuticals has published this approach paper after extensive stakeholder consultations, for the sunrise sector of medical devices, popularly called as MedTech Sector, the ministry of chemicals said in a statement. This sector is expected to grow in market size from the present $11 billion to $50 billion by 2025.

The proposed policy strives to put in place a comprehensive set of measures for ensuring sustained growth and development of the sector and addressing the further challenges of the sector such as regulatory streamlining, skilling of human resources and lack of technology for high end equipment and lack of appropriate infrastructure, through a coherent policy framework.

The draft national policy further aims to facilitate an orderly growth of the sector for the coming years. This policy, while addressing the core objectives of accessibility, affordability, safety and quality, focus on self-sustainability and innovation.

Key features of draft national policy
Regulatory streamlining in order to optimise regulatory processes and multiplicity of agencies for enhanced ease of doing business, along with harmonisation with global standards to ensure standardisation.

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. LiveMint