From UPSC perspective, the following things are important :
Prelims level : Not much
Mains level : National Policy for Medical Devices, 2022
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.
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.