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.
- The Sector is expected to grow in market size from the present 11 Bn USD to 50 Bn USD by 2025.