Ankit Poddar, Director & leader-Healthcare Practice, Candle Partners explains the importance of newly launched Medical Device Policy
On April 26, 2023, the Union government approved the New Union Cabinet and the New Medical Devices Policy, marking yet another audacious move. This follows the draft of the National Medical Devices Policy approach paper published on March 10, 2022. The policy is a first step towards achieving India’s MedTech market independence. Despite the significant delay, we can now affirm that the new medical policy is a step in the right direction.
It will present a chance to increase domestic medical equipment production and decrease the demand for imports. Better local access, more affordable prices, and the opportunity for innovation within the nation’s medical device industry will all follow from increased domestic production.
Why did we need this new Medical Devices Policy?
In India, the market for medical devices is valued $11 billion (with 80 per cent+ imports). Previous regulations’ lack of a clear vision and regulatory problems have been the two main causes of import dependence. Up until 2017, there was not a single law in India that addressed the clearance of medical devices. In the following five years, the strategy is anticipated to help the medical devices sector increase market share from approx 1.5 per cent currently to 10-12 per cent over the next 25 years.
The NMDP specifies six major areas of policy interventions to support the medical device industry:
- Regulatory simplification
- Supportive infrastructure
- Enabling R&D and innovation
- Luring investments
- Investment attraction
- Development of human resources
- Brand positioning and awareness raisin
We will talk more about it in the later part of the article. To address patients’ changing healthcare demands, the policy is anticipated to put the medical devices industry on an expedited path of growth with a patient-centric strategy. Programmes like the National Industrial Corridor Programme and the projected National Logistics Policy 2021 would further aid the expansion of the medical device industry in India.
The National Medical Devices Policy, 2023 is a key step towards giving the Indian medical device industry an enabling policy and regulatory environment. The goal of the strategy is to support the sector’s expansion, improve access to and affordability of medical technology and equipment, and position India as a market leader in the development of new medical devices.
Here are some key highlights to know about the New Medical Devises Policy:
- To date, 14 projects totalling 37 goods have been commissioned, and the remaining 12 products will follow soon. High-end medical devices, including the linear accelerator, MRI scan, mammogram, CT scan, C-arm, high-end X-ray tubes, and MRI coils are already being produced locally.
- Under the National Medical Devices Policy, 5 projects have recently received approval for the local manufacture of 87 goods and product components under Category B.
- A thorough policy framework is urgently necessary to realise the sector’s potential and further encourage growth in the industry.
- Despite efforts by multiple government agencies to support the medical device industry, a cohesive strategy was still lacking.
What are the key features of NMD Policy 2023?
Regulatory streamlining
In order to balance patient safety and product innovation, a “Single Window Clearance System” for licensing medical devices will be developed. This system will make it simpler to conduct research and business.
All pertinent departments and organisations, including DAHD (Department of Animal Husbandry & Dairying) and MeitY (Ministry of Electronics and Information Technology), would be a part of this system.
Enabling infrastructure
Near economic zones, sizable medical device parks with top-notch infrastructure will be built.
To increase convergence and integration with the medical device industry, it will be carried out as planned under the National Industrial Corridor Programme and the projected National Logistics Policy 2021, both of which fall within the purview of PM Gati Shakti.
Facilitating R&D and innovation
In addition to the proposed National Policy on R&D and innovation in the Pharma-medtech sector, the policy seeks to advance research and development in India.
Additionally, it aims to create innovation hubs, ‘plug and play’ infrastructures, centres of excellence in academic and research institutions, and support for start-ups.
Attracting investments
To supplement already-existing programmes like Make in India, the Ayushman Bharat programme, Heal-in-India, and the Start-up mission, the policy promotes private investment and Public-Private Partnerships (PPP).
Human resources development
The Ministry of Skill Development and Entrepreneurship will offer skilling, reskilling, and upskilling programmes as part of the policy to ensure a trained workforce in the medical device industry.
It will also support existing institutions that offer courses specifically on medical devices to develop a skilled workforce for manufacturing, research, and futuristic technologies.
Brand positioning and awareness creation
The programme calls for establishing a specific Export Promotion Council for the industry, which will make it possible to address a variety of market access concerns.
What is the significance of the policy?
We hope the New Medical Devices Policy will give the industry the right guidance it needs for growth. We see the medical industry as self-sufficient, flexible, and innovative. It is so that India meets the healthcare requirements of India and the rest of the world.
A patient-centric approach can put India’s medical devices sector on an expedited path of growth to satisfy the patients’ changing healthcare needs.
It plans to achieve a 10-12 per cent market share in the expanding worldwide market over the next 25 years to achieve an accelerated growth path with a patient-centric strategy and become the world’s leading manufacturer and innovator of medical devices.
With the new strategy, the Centre hopes to make India one of the top five global manufacturing centres and reduce its reliance on imports to about 30 per cent in the coming years. The general strategy does appear to have acknowledged the industry’s concerns, but timely execution will be crucial if we want to get closer to the aim.
- Advertisement -