Explained: India’s draft medical device policy and why it is needed

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The government is proposing a new policy to reduce India’s reliance on importing high-end medical devices. Some of the proposals include incentivizing the export of medical devices and related technology projects through tax rebates and refunds, increasing government spending on “high-risk” projects in the device sector devices and a one-stop clearance system for licensing medical devices.

In a policy paper on a draft National Medical Device Policy, 2022, the Pharmaceuticals Department of the Ministry of Chemicals and Fertilizers proposed adopting public-private partnerships to reduce the cost of healthcare , increase efficiency and contribute to improving the quality of medical devices. made in the country. It also proposes to allow a pricing environment without price controls on newly developed innovations in the sector.

What is the need for such a policy?

Nearly 80% of medical devices currently sold in the country are imported, especially high-end devices. So far, Indian space players have generally focused on low-cost, low-tech products, such as consumables and disposables, resulting in a higher value share for foreign companies. .

With the new policy, the government aims to reduce India’s dependence on imports from 80% to almost 30% over the next 10 years and become one of the world’s top five manufacturing centers for medical devices. here 2047.

India’s medical device sector has so far been regulated under the provisions of the Medicines and Cosmetics Act of 1940, and a specific policy on medical devices has been a longstanding request from the industry.

In February 2020, the government notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as medicines under the Medicines and Cosmetics Act, 1940. This was necessitated after revelations about defective hip prostheses marketed by Johnson & Johnson, exposing the lack of regulatory teeth when it comes to medical devices.

The government has said the transition from partial regulation of some medical services to full regulation and licensing of all medical devices is underway and expected to be completed by October 2023, requiring clearer articulation in terms of quality assurance and certification.

The policy also aims to increase India’s per capita spending on medical devices. India has one of the lowest per capita expenditures on medical devices at $3, compared to the world average per capita consumption of $47, and significantly lower than the per capita consumption of developed countries like the United States. United at $415 and Germany at $313.

What are the main areas of intervention of the draft policy?

The main focus areas of the draft policy include incentivizing basic technology projects and exports through tax refunds and rebates, creating a one-stop customs clearance system for granting licenses for medical devices, identification of critical suppliers, reduction of risks and decarbonization of the supply chain, promotion of procurement, encouragement of cross-industry collaboration, creation of a central pool of suppliers and workers, setting up a mechanism dedicated to local industry engagements with international regulatory bodies and increasing the share of medical technology companies in research and development to around 50%, among other things.

It also proposes to allocate a dedicated fund to encourage joint research involving existing industry players, reputable academic institutions and startups. It will also include a framework for coherent price regulation, in order to provide all citizens with effective and quality medical devices at affordable prices.

“The NPPA (National Pharmaceutical Pricing Authority) needs to be strengthened with adequate manpower and appropriate expertise to provide effective price regulation that balances patient and industry needs and incorporates innovation and the costs of life cycle as factors in regulating the prices of medical devices,” the government said. The pharmaceutical department will also work with industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP). The government has invited comments on the draft until March 25.

How big is the medical device industry?

According to the approach paper, by 2047, India is expected to be home to $25 billion of medical technology companies and will reach a global market share of 10-12% in the medical device sector to arrive at an industry from 100 to 300 billion dollars.

Globally, the market is expected to reach $433 billion by 2025 and is currently dominated by the United States with a 40% market share, Europe with a 25% share, and Japan with a 15% share. The sector is also poised for growth in other emerging markets such as Thailand, where the medical device market was valued at $27 billion and expected to grow 8-10%, and Brazil where the market is growing at a CAGR 5.8%. . In China, the sector is valued at approximately $96 billion and has been growing at a rate of more than 20% for several years.

What are the other measures to promote the manufacturing of medical devices in India?

The government has noted that the medical device sector in India suffers a considerable cost of manufacturing inability compared to competing economies, including due to lack of adequate infrastructure, supply chain and logistics. national governments, high cost of financing, insufficient energy availability, limited design capabilities, low focus on research and development (R&D) and skills development, etc. approved applications of manufacturing commitments worth more than Rs 730 crore for the production of devices such as CT and MRI scanners, dialyzers, anesthesia unit ventilators, transcatheter aortic heart valves , stents, cardiac obturators and others.

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