The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has released on its website, an Approach Paper for the Draft National Policy for the Medical Devices, 2022, inviting feedback and remarks of the Industry and stakeholders, till the 25th of March 2022. 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 thiz 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.

The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities. The Medical Device Sector has remained largely unregulated till 2017 when Medical Device Rules, 2017 were framed by CDSCO for comprehensive regulation of MDs in a phased manner, especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic Act, 1940

The medical device is a multi-product sector, with the following broad classifications: (a) Electronics Equipment; (b) Implants; (c) Consumables and Disposables; (d) IVD reagents; and (e) Surgical Instruments. 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. The Indian medical devices sector’s contribution has become even more prominent as India supported the global battle against COVID-19 pandemic through the production of medical devices & diagnostic kits, e.g., Ventilators, RT-PCR kits, IR Thermometers, PPE Kits & N-95 masks.

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. Realizing that the sector demands high level of coordination between the regulators which have a specific legal function but are spread over various Departments such as DoHFW, D/o Consumer Affairs, Atomic Energy Regulation Board, National Institute of Biologicals, MoEF&CC, etc, the DoP attempts to resolve many of the issues through the institutional arrangements viz Standing Forums, Regulatory Round Tables, etc.

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 and the salient features are as follows;

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.

The Draft policy can be accessed at https://pharmaceuticals.gov.in/policy.