Draft National Policy for the Medical Devices 2022: The Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilizers has released an Approach Paper for the Draft National Policy for the Medical Devices, 2022 on its website for a consultation.

The Department has invited feedback and remarks of the Industry and stakeholders, till the 25th of this month on the Draft Policy.

Salient features of the Draft:

1. Regulatory streamlining to improve the ease of doing business by optimizing regulatory processes and reducing the number of agencies, as well as harmonization with global standards to maintain uniformity.
2. Quality Standards and Device Safety in order to provide safe devices to the consumers in accordance with the global standards.
3. Building Competitiveness through fiscal and financial support for stimulating the development of the local manufacturing ecosystem with private sector investments.
4. Infrastructure Development to provide a best-in-class physical foundation, including medical devices parks with common facilities such as testing centers, to improve cost competitiveness and enhance the attraction of domestic manufacturers.
5. 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.
6. 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.
7. 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.

Objectives of the draft:

• Recognizing the need for a comprehensive policy to help the Medical Devices Sector flourish and explore its potential, the DoP published this approach paper, after extensive stakeholder consultations, for the Sunrise Sector of Medical Devices, popularly called as MedTech Sector.
• The Draft Policy aims at addressing the core objectives of accessibility, affordability, safety and quality in the medical device sector, with a focus on self-sustainability, innovation, and growth.
• This Policy envisions that by 2047 -

• India will be having a few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs.
• India will be home and originator to 25 high-end futuristic technologies in MedTech
• India will have a MedTech Industry of $100-300 Bn size with 10-12% of Global Market Share.

Need for National Policy for the Medical Devices:

• Medical devices are an important and crucial aspect of India's healthcare industry, especially for the prevention, diagnosis, treatment, and management of all medical problems, diseases, illnesses, and disabilities.
• The medical device is a multi-product sector, with the following broad classifications:

1. Electronics Equipment
2. Implants
3. Consumables and Disposables
4. IVD reagents
5. Surgical Instruments 

• The Medical Device Sector was mainly unregulated until 2017 when the CDSCO drafted Medical Device Rules, 2017 were framed 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 the 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., RT-PCR kits, IR Thermometers, Ventilators, PPE Kits and N-95 masks.
• Through a coherent policy framework, the Department intends to -

• Promote domestic medical device manufacturing through a variety of programmatic and schematic measures.
• Reduce India’s import dependence to nearly 30% in the next 10 years.
• Increase India’s per capita spending on medical devices.

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

Note: India has one of the lowest per capita spend on medical devices at $3 compared to the global average of per capita consumption $47.

What are the initiatives by the Government of India in the Medical devices field?

The initiatives by the Government of India (GoI) in the Medical devices field are as follows:

1. PLI Scheme for promoting domestic manufacturing of Medical Devices.
2. Promotion of Medical Devices Parks.
3. Medical devices have been recognized as a sunrise sector under the ‘Make in India’ campaign in 2014.