Approach Paper on Draft National Medical Devices Policy released

The Department of Pharmaceuticals under the Chemicals and Fertilizers Ministry released an Approach Paper for the Draft National Policy for the Medical Devices, 2022, inviting feedback of the relevant industry stakeholders.

The paper was released following extensive stakeholder consultations for the Sunrise Sector of Medical Devices, popularly called as MedTech Sector. The discussions highlighted the need to have a holistic policy in place to catalyse the growth of the sector and explore the potential of Medical Devices Sector in the country.

The consultation paper stated that, “the medical devices sector in India is an essential and integral constituent of the Indian healthcare sector for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities.”

Some of the key features of the Consultation Paper are:

1. The paper proposed a regulatory framework that optimises the regulatory processes and multiplicity of agencies to enhance the ease of doing business and harmonisation with global standards to ensure standardisation.

2. Quality standards and safety of the devices have also been set out to provide safe devices to the consumers, in alignment with the global standards.

3. It has also been proposed to foster competitiveness through fiscal and financial support to stimulate the development of the local manufacturing landscape with private sector investments.

4. Strategies for Infrastructure development to extend 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 has also been proposed by the paper.

5. A focus on R&D and innovation with an emphasis 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 has also been emphasized upon.

6. Development of human resource to ensure relevant curriculum at higher education level, skilling of various relevant stakeholders, creation of future-ready HR with relevant skills was also discussed.

7. The consultation paper also envisages to focus on awareness and brand positioning to place India a hub of manufacturing medical devices as part of the “Make in India, Make for the World” initiative.