Draft National Policy for the Medical Devices, 2022

In news– Recently, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has released an Approach Paper for the Draft National Policy for the Medical Devices, 2022.

About the Draft National Policy-

This Policy envisions that by 2047, India

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 addresses the core objectives of accessibility, affordability, safety and quality, focusing on self-sustainability and innovation.

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 centers, 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.

Medical devices sector in India-

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.
It has remained largely unregulated till 2017 when Medical Device Rules, 2017 were framed by the Central Drugs Standard Control Organization (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 Indian medical device market has a significant presence of multinational companies with about 80% of the sales by value generated from imported medical devices.
This 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.