In May 2023, the Union Cabinet approved the National Medical Device Policy. It aims to make India a global hub for medical device manufacturing and innovation. However, the Parliamentary Standing Committee on Health and Family Welfare pointed out that the policy falls short in some essential places.
In a report on medical devices tabled by the committee, it made several recommendations. And asked the government to strengthen the policy before its widespread implementation.
If you’re wondering what this policy is, why India needs it and how the committee recommendations will strengthen it, don’t worry. Here’s a complete breakdown for you.
Medical Device Policy: An overview
The medical device sector is a rapidly growing sector with the potential to become a major economic driver. According to a research report by MarketResearch.com, India’s medical devices market is projected to grow at a CAGR of ~42% from FY 2023 to FY 2027. It is estimated to reach INR 4358 billion by FY 2027.
While the sector has huge potential, a comprehensive framework supported by guiding strategies is required for its sustained growth and development. The National Medical Device Policy will accelerate the sector’s growth and make India emerge as a leader in the global medical device market.
The government claims that this policy will aid in increasing India’s market share from 1.5% (current market share) to 10-12% in the next 25 years.
Recommendations by the Parliamentary committee
Parliamentary Standing Committee on Health and Family Welfare has recommended 49 significant changes to strengthen the Medical Device Policy. If implemented effectively, these changes could make medical devices more affordable, accessible, and safe for patients.
Here are the key changes recommended by the committee:
#1 Set up a separate department for medical devices
Currently, medical devices come under the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilisers. The committee opines that, though medical devices are medical products, they differ from pharmaceuticals and have no similarities with chemicals.
Therefore, a separate department entirely focused on medical devices is necessary to boost the medical device sector. And help India achieve its ambition to become a global leader. The committee further recommends creating this department under the Ministry of Health and Family Welfare for better regulation.
#2 Formulate exclusive legislation for medical devices
Currently, medical devices are classified as drugs and are governed by laws and regulations under the Drugs and Cosmetics Act. This act falls short in governing medical devices and doesn’t have provisions to penalise substandard devices.
Hence, the committee encourages the government to formulate a separate, well-researched, comprehensive legislation for medical devices. Exclusive regulation is required to ensure only good quality devices that are safe and effective reach the public.
The committee further recommends ensuring that the legislation covers everything from procuring raw materials and skilled manpower to manufacturing and marketing medical devices. Only this will bring about a medical device revolution in the country.
#3 Promote domestic manufacturing of medical devices
As of now, India imports 80% of its medical devices, making them unaffordable to a larger population. The committee recommends strengthening domestic manufacturing to reduce import dependence and improve medical device access to low-income segments.
Indigenous manufacturing of quality medical devices will make India a global leader in medical devices. It will also keep substandard devices which can harm public health at bay.
Furthermore, the committee urges the government to provide financial support, incentives, technical know-how and collaboration between industry and academia to boost India’s medical device sector.
#4 Establish quality standards and certifications for medical devices
Medical devices of substandard quality can put patients’ lives at risk. Needless to say, benchmarks, standards and certification systems for medical devices are highly essential.
The committee recommends establishing a quality management, assurance and certification system that meets global standards and competitiveness. Standardisation will ensure only good-quality medical devices reach the public. And make Indian devices capable of entering the global market.
Additionally, the committee suggests creating stringent adherence policies and strict punishments and penalties for low-standard device manufacturers.
#5 Encourage R&D and innovation in the medical device sector
Well-developed ecosystem and innovation cycle are essential for developing high-end technology and innovative products. Needless to say, the committee recommends nurturing an ecosystem for innovation in the medical devices industry.
Furthermore, it suggests DoP have funds set aside to fund start-ups and SMEs undertaking research projects to improve the quality and efficiency of existing devices and develop breakthroughs in medical devices.
#6 Establish Centres of Excellence (CoE) in medical devices
A well-trained multi-disciplinary team of biomedical engineers, product developers, marketers and medical professionals with expertise in the medical device sector are necessary to build exceptional devices.
Therefore, the committee recommends establishing Centres of Excellence (CoE) at national institutes across the country to train and educate students. This will help meet the high demands of skilled manpower required by the medical devices industry.
#7 Develop medical device parks
While India has huge potential to manufacture medical devices, it relies on importing medical devices (80%) due to high costs and no incentives. As a result, the committee is in line with the government’s decision to develop medical device parks.
The committee recommends developing intergovernmental strategies that offer manufacturers a competitive advantage, logistical support, reduced capital expenditure and benefits of shared manufacturing facilities. Medical device parks will boost domestic manufacturing in India.
Takeaway
Recommendations by the Parliamentary Committee are on par with the government’s aim to make India a global leader in the medical device sector. If implemented effectively, these changes will ensure the medical device industry has guidelines, framework and support to manufacture quality devices. It will also ensure substandard devices do not enter the market.
The ministry has replied positively to the recommendations, indicating the government’s commitment to improving the medical device sector. However, implementation of these changes will require time and effort. The government will have to work closely with medical device industry stakeholders.
To end on a good note, the recommendations by the parliamentary committee and the ministry’s responses give a positive outlook for the future of the medical device industry in India.
What do you think? Let us know in the comments.
