What is National Medical Devices Policy 2023?

As per estimates, some 80–85 per cent of the medical devices currently sold in India, mostly high end ones, are imported; while the Indian players and manufacturers have centred their offerings in the low-cost and low-tech products, like consumables and disposables.

With the new policy in place, the Centre aims to reduce India’s import dependence to nearly 30 per cent in the next couple of years; and become one of the top five global manufacturing hubs. The policy push is to look at an export driven manufacturing of high end offerings, which are also affordable to Indian hospitals and laboratories, while reduce import dependence significantly.

The policy also aims to increase India’s per capita spend on medical devices.

India has one of the lowest per capita spend on medical devices at $3, compared to the global average of per capita consumption of $47, and significantly lower than the per capita consumption of developed nations like the US at $415 and Germany at $313.

Apart from import reduction, the policy will also look to make now costly medical devices affordable; and also easily accessible. This will ensure larger use across hospital and provide better quality healthcare and affordable treatment.

Why a policy intervention?

India’s medical devices sector is regulated by the Drugs and Cosmetics Act of 1940 primarily. And the industry has been asking for a specific policy on medical devices.

In February 2020, the Centre notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940.

This was actually necessitated after revelations about faulty hip implants marketed by Johnson & Johnson, exposing the lack of regulatory teeth when it came to medical devices.

How big is the medical devices sector pegged to be?

India’s current market share in the medical device category is 1.5 per cent of the global space or $11 billion (that is ₹90,000 crore) in 2020.

The policy aim is to achieve a 10-12 per cent global market share in the next 25 years with the immediate short term goal is to be $50 billion industry by 2030.

Apparently, US dominates the global market with a 40 per cent market share, followed by Europe and Japan at 25 and 15 per cent respectively.

Why not PLI schemes to push manufacturing in the sector?

The National Medical Devices Policy 2023 will be in addition to the existing PLI schemes that are underway.

The Government of India has already initiated implementation of PLI Scheme for medical devices and support for setting up of four medical devices parks – one each in Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh. Under the PLI scheme 26 projects have been approved, with a committed investment of ₹1,206 crore. And investment of ₹714 crore has been achieved.

Some 14 products have been commissioned and domestic manufacturing of high-end medical devices like Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc – have begun. The remaining 12 products will be commissioned in near future.

Five projects out of total 26 projects have been approved recently, under Category B - for domestic manufacturing of 87 products or product components.

How does the policy work?

National Medical Devices Policy will promote R&D here, establish Centres of Excellence in academic and research institutions, promote innovation hubs, ‘plug and play’ infrastructures and support start-ups.

It will encourage private investments, VC funding and Public-Private Partnerships in the segment.

- Skilling, reskilling and upskilling of professionals in the medical device sector, through help from Ministry of Skill Development and Entrepreneurship; support dedicated multidisciplinary courses in existing institutions to ensure availability of skilled manpower, produce future-ready MedTech human resources.

- Making partnerships with foreign academic institutes and industry organizations to develop med-tech.

- Brand positioning and awareness creation through dedicated export promotion council for the sectorso that there is greater market access.

- Initiate studies and projects for learning best global practices of manufacturing and adopt globally successful models in India.

- Promote more forums to bring together various stakeholders.