New Delhi: To meet the evolving healthcare needs, the Union Cabinet, chaired by Prime Minister Narendra Modi, approved the Medical Device Policy, in 2023. The medical device experts hailing the decision informed that the policy aims to accelerate the growth path for the medical device sector with a patient-centric approach and achieve a 10–12 per cent share in the global medical device market in the coming two and a half decades.
Currently, India’s share in the global medical device market is estimated to be 1.5 per cent. The policy is expected to help the medical device sector grow from the present $11 billion to $50 billion by 2030. As per the Union Ministry of Chemicals and Fertilizers (MoC&F), the policy will accelerate growth and fulfill the potential of the sector.
Reaffirming this, Dr Mansukh Mandaviya, Union Minister of Health and Family Welfare, pointed out in his press briefing on Wednesday that the policy aims to increase domestic production of these devices, thereby reducing the import of such equipment. India’s reliance on importing medical devices saw a substantial increase in 2021–22.
The Association of Indian Medical Device Industry (AiMeD), an industry association, conducted an examination of data from the commerce ministry and found that medical device imports increased by a record 41 per cent to Rs 63,200 crore in 2021–22 from Rs 44,708 crore in FY21.
The industry experts informed that it was a long pending and highly anticipated policy decision, and the move has the potential to channel growth prospects for MedTech innovations as well as create an ecosystem enabling the large-scale manufacturing of medical devices in the country.
Industry stakeholders informed that the regulations, training, and trade promotion of the medical device industry are divided among various agencies in the government, both at the centre and state levels, due to the diversity and multidisciplinary character of the sector. The present policy intends to implement a complete set of coordinated emphasis areas for the sector’s growth.
While highlighting that the approval of the National Medical Devices Policy, 2023, by the Union Cabinet is a welcome step towards making India self-sufficient in the medical devices market, Arvind Sharma, Partner, Shardul Amarchand Mangaldas & Co., said, “This provides an opportunity to boost domestic production of medical devices and reduce the need for imports. Increased domestic production will also result in better local access, affordable prices, and a chance to innovate within the medical device sector of the country. While providing a lucrative picture for the future of the medical devices sector, the policy embodies a framework that promises simultaneous efforts towards six core focus areas in the medical devices sector. This presents us with an extremely positive outlook for the medical devices sector in India, and one can hope to see exponential growth in the coming years.”
To meet the public health objectives of access, affordability, quality, and innovation, the policy is expected to facilitate the orderly growth of the medical device sector. The policy lays a roadmap and highlights a set of strategies covering six broad areas of policy interventions.
These include regulatory streamlining to enhance ease of doing research and business and further balance patient safety with product innovation measures such as the creation of a Single Window Clearance System’ for Licensing of Medical Devices; co-opting all the stakeholder departments to enhance the role of Indian Standards like BIS and designing a coherent pricing regulation.
The policy envisages promoting research and development in India and aims to establish centres of excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures, and support for start-ups.
“It was a long-awaited policy by the MedTech sector the first draft was done in June 2014. We hope this policy will address and help traders and importers start investing in factories and end the import dependency. India saw ever-rising imports of Rs 63,000cr imports last year which went by 41 per cent last year. With this policy India will hope to become atmanirbhar and also globally competitive and become top five suppliers worldwide,” said Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd & Forum Coordinator, AiMeD.
Welcoming the NMDP and expressing that we are encouraged by the spotlight turned on R&D, Pavan Choudary, Chairman MTaI, said, “While India has only 1.5 per cent of the global medical device market, it already has eight per cent share of the MedTech R&D workforce already. This is a fertile and proven area to focus on. In addition to this, the skilling and upskilling of healthcare workers augur well for patient care and manpower exports.”
In order to facilitate the production of future ready MedTech human resources skills, reskilling, and upskilling of professionals in the medical device sector, the policy will support dedicated multidisciplinary courses for medical devices in existing institutions. It also encourages private investments, a series of funding from venture capitalists, and public-private partnerships.
For brand positioning and awareness creation, the policy envisages the creation of a dedicated Export Promotion Council for the sector to deal with various market access issues as well as initiate studies and projects for learning from global practices of manufacturing and skilling systems so as to explore the feasibility of adapting such successful models in India.
“The emphasis on creating a systematic brand positioning and awareness creation programme is long overdue and laudable. From what is available so far in the public domain, it seems like a policy that harnesses both domestic and international currents to optimally forge the path ahead,” added Choudhary.
The Union Cabinet has also given the green light to establish 157 nursing colleges, ensuring 15,700 seats for nursing aspirants willing to undergo training and further education. “Adjacent to the announcement, we have also happily noted that the government is planning to open 157 nursing colleges. This is another well-chosen space, as it is estimated that new technologies like artificial intelligence (AI) which may make the desktop healthcare worker (even many doctors) redundant, will not impact the nursing staff so adversely. This policy has a note of enduring prudence to it,” concluded Choudhary.
Apart from strengthening existing infrastructure, the state governments will establish large medical device parks with the requisite logistics connectivity. Under the Production Linked Incentive (PLI) Scheme for medical devices, the government has already initiated implementation and extended support for the setting up of four medical device parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.
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