Context: The government is proposing a new Draft National Policy for Medical Devices, 2022 to reduce India’s dependence on import of high-end medical devices.
About Medical devices Industry in India

• India is the 4th largest market for medical devices in Asia.

Medical device is a multi-product sector, with the following broad classification:

• Electronics Equipment
• Implants
• Consumables and Disposables
• IVD Reagents
• surgical instruments

Industry challenges in India
Underdeveloped regulatory framework

• Medical device regulation in India apply to only certain product categories.
• It is a significant obstacle for foreign manufacturers of regulated device types.

Depreciation of rupee

• The weak rupee makes it difficult for some medical device companies to remain profitable in this market, particularly for manufacturers competing with low-cost Chinese products.

Competition

• Foreign manufacturers will encounter significant competition from American, European, and Japanese companies.

Key features of the policy

• Objectives: Adopting public-private partnerships to reduce the cost of healthcare, drive efficiency, and aid quality improvements in medical devices manufactured in the country

The key proposals include

• Incentivising the export of medical devices and related technology projects through tax rebates and refunds
• Increasing government spending in “high-risk” projects in the medical devices sector.
• Single-window clearance system for licencing medical devices
• Pricing environment with no price control on newly developed innovation in the sector
• Allot a dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions and start-ups
• Incorporate a framework for a coherent pricing regulation, to make available quality and effective medical devices to all citizens at affordable prices
• NPPA (National Pharmaceutical Pricing Authority) shall be strengthened with adequate manpower of suitable expertise to provide effective price regulation balancing patient and industry needs.
• Pharmaceuticals Department will also work with industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP)

Need for such policy

• Policy vacuum: India’s medical devices sector has so far been regulated as per provisions under the Drugs and Cosmetics Act of 1940, and a specific policy on medical devices has been a long standing demand from the industry.
• Meaningful expense on R&D: 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.
• Reducing import dependence: With the new policy, the government aims to reduce India’s import dependence from 80 per cent to nearly 30 per cent in the next 10 years.
• Becoming a global hub: It aims to become one of the top five global manufacturing hubs for medical devices by 2047.
• Domestic manufacturing of high-end products: Indian players in the space have so far typically focussed on low-cost and low-tech products, like consumables and disposables, leading to a higher value share going to foreign companies.

Earlier attempts for such policy

• In February 2020, the government 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 necessitated after revelations about faulty hip implants marketed by Johnson & Johnson, exposing the lack of regulatory teeth when it came to medical devices.
• The government said the transition from partial regulation of selected medical services to the complete regulation and licensing of all medical devices is underway.

Steps taken by government to ensure the growth of a vibrant ecosystem of medical devices

• Medical Devices Rules, (MDR) 2017 regulates Clinical Investigation, Manufacture, Import, Sale, and Distribution of Medical Devices.
• Production Linked Incentive Schemes: To boost domestic manufacturing.
• Scheme for Promotion of Medical Devices Parks: establish 4 medical devices parks to provide common infrastructure facilities, create a robust ecosystem for medical device manufacturing, and reduce the manufacturing cost.

By: Shubham Tiwari