In an earlier blog post, we took a close look at the National Medical Devices Policy, 2023 (“Policy”), notified by the Department of Pharmaceuticals (“DoP”) on May 2, 2023[1]. We delved into the framework, objectives and core focus areas of the Policy. While the aim of the Policy was clearly to reduce import dependency and establish India as a global manufacturing hub for medical devices, little information was provided on the means to achieve these goals. To draw a holistic picture, we sought guidance from the Approach Paper to the National Medical Devices Policy, 2022 (“Approach Paper”)[2], which was based on similar principles and furthered the same goals as the present Policy. However, the DoP has recently also issued a strategy document on the Policy (“Strategy Document”)[3] to fine-tune and expand on its implementation strategies. In light of the same, this blog post analyses the Strategy Document, measures envisaged thereunder, enforcement priorities and focal points.
An Overview of the Strategy Document
The Policy aims to accelerate growth in the medical devices sector while promoting safety and quality. It is demonstrative of the continuing objective of the government to fructify its “make in India” goals. This ‘responsible’ growth model is aimed at achieving the following missions: access and universality, affordability, quality, patient-centred and quality care, preventive and promotive health, medical devices security, research and innovation, and skilled manpower.
At a time when the digital health sector is gaining traction, it is refreshing to see the Strategy Document’s focus on issues such as technology transfer capabilities, data security, and management of e-waste. This trend revolves around a rapidly growing industry, which can be broadly classified into (a) electronic equipment, (b) implants, (c) consumables and disposables, (d) surgical instruments, and (e) in-vitro diagnostic reagents. The Strategy Document highlights that this growth has been aided by government initiatives, including inter alia ‘Promotion of Medical Device Parks’ Scheme, 2020, ‘Production Linked Incentive Scheme for Medical Devices’, 2020, and ‘Public Procurement (Preference to Make in India)’ Policy, 2017.
In the earlier blog post, we introduced the Policy’s core areas of focus. The Strategy Document focuses on the implementation of each of these areas, as follows:
1. Regulatory Streamlining
At present, there is a multiplicity of regulators to approach for different types of medical devices. For instance, the MD Rules designate the State Licensing Authority for Class A and B medical devices, while the Central Licensing Authority regulates Class C and D medical devices. Additionally, in case of specialised devices such as radiological equipment, service providers are answerable to separate regulators like the Atomic Energy Regulatory Board. Needless to say, such a wide range of regulators magnifies compliance burdens, extends transition timeframes and is a complete anathema to the oft widely stated objective of ease of doing business in India.
To tackle these obstacles, the Strategy Document proposes measures, including the creation of a single window clearance system (online) for licensing of medical devices, enhancement of standardisation and quality compliance, establishment of stronger price control measures and a Uniform Code for Marketing of Medical Devices, strengthening of personal health data security, and adoption of a National Nomenclature for Medical Devices.
A single window clearance system, while efficient in theory, will be tricky to implement. For instance, a unique skillset is required to understand Class A medical devices, as opposed to Class D devices or advanced radiological equipment for that matter. It remains to be seen how a single window for monitoring compliances will account for all such skillsets and intricacies. Perhaps a committee of individuals having specific backgrounds in different types of surgical equipment, radiological equipment, electronic medical devices, storage and transport equipment, etc., may help overcome this obstacle.
The Strategy Document also reiterates the importance of affordable healthcare, regulated by the Drugs (Prices Control) Order, 2013. It speaks of strengthening manpower and expertise within the National Pharmaceutical Pricing Authority (“NPPA”) to effectively regulate medical device pricing while accounting for innovation and life cycle costs.
2. Infrastructure Development
The Policy had shed some light on its objective of enabling infrastructure and enhancing connectivity through expansion of medical device parks and similar clusters (like clinical validation centres). The Strategy Document elaborates on the same, providing a detailed plan on developing this infrastructure. Taking inspiration from the Andhra Pradesh MedTech Zone Ltd. – the country’s first dedicated medical device park – the Strategy Document envisages, inter alia, support to State Governments in allotting land and extending incentives for such parks. This will include a priority list of medical devices to ensure manufacturing of those devices, which are urgently required by the country.
Further, the focus seems to be on setting up of NABL-accredited testing laboratories (created largely under the public-private partnership model) to provide low-cost testing facilities, while maintaining safety and efficacy of medical devices. Apart from setting up full-fledged laboratories, resources available with autonomous institutions and government departments (like MeitY), are also likely to be utilised for testing facilities. This is set to take place alongside measures such as phased manufacturing of critical components of medical devices and e-waste management of obsolete medical devices.
3. Facilitating R&D, Innovation and Intellectual Property
The Policy has placed considerable importance on promoting R&D and innovation through, inter alia, a dedicated fund, industry-academia collaboration, centres of excellence, innovation hubs and intellectual property protection. The Strategy Document elaborates on this mission further.
Speaking of the dedicated fund, while the quantum of funds, source of funds and frequency of influx of such funds remains unclear at this stage, the Strategy Document highlights what the said fund will be devoted towards. This includes support for R&D activities to enhance quality of medical devices, as well as support for joint research initiatives undertaken by consortiums of industry players, including SMEs and start-ups.
The promotion of innovation hubs also forms a large area of focus. In this respect, the Strategy Document places on the Government, the responsibility to encourage indigenous industries in this area, promote courses by industry experts in education institutes, provide regulatory and financial support where required, and expand technology transfer capabilities to convert theory into products. The shift of mindset from theoretical knowledge to practical development/ industry experience is evident, and if implemented with consistency, it is sure to lift India’s medical device industry beyond the level of its western counterparts.
Further, the Strategy Document recommends designated Centres of Excellence (“COE”) in reputed academic and research institutions, which will explore emerging areas like Artificial Intelligence, Internet of Things, and Nanotechnology. These COEs are intended to oversee all stages of medical device development, from designing and prototyping, to development and safety testing. While the establishment of COEs is inarguably an uphill task, the Policy’s intent to foster a facilitative ecosystem for the same is laudable.
A sister concern of innovation is its protection through intellectual property. Recognising this, the Strategy Document proposes a mechanism to promote innovation in medical devices, facilitate start-ups wishing to go global, and help patent holders commercialise their inventions.
4. Attracting Investments in the Sector
The Policy’s goal of expanding domestic manufacturing and innovation can hardly be achieved without considerable influx of private investment. Whether in the form of private equity, venture capital, or angel funding, these inflows are crucial for fostering an ecosystem for manufacturing and indigenous development of the medical devices sector. For these reasons, the Strategy Document focuses on adopting both fiscal and non-fiscal means for attracting investments.
5. Human Resource Development
Given the specialised skillset required for the medical devices industry, the Strategy Document encourages private design schools to teach design-focused courses and further encourages academic institutions to build partnerships with foreign organisations to develop medical technologies. This will take place alongside skilling, reskilling and upskilling of individuals in the medical devices sector, building on the Skill India Mission.
6. Brand Position and Awareness Creation
Finally, the Strategy Document addresses lack of awareness and stakeholder engagement, which severely hinders indigenous progress of India’s medical devices sector. This ranges from lack of knowledge of new medical electronics, to a dearth of collaboration between actors like academics, hospitals, industry, government, and funding institutions. Such lack of convergence exacerbates transaction costs, red tape and procedural delays.
To address this problem, the Strategy Document promotes, inter alia, webinars and workshops to learn from foreign experiences, forums to bring stakeholders together to share industry knowledge and best practices, awareness on safety standards for medical devices, promotional events to relay international spotlight towards the Indian medical devices industry, and feedback sessions to constantly improve on the said measures.
Concluding Remarks
Till now, we only had the Approach Paper to guide our understanding of how the Policy would be implemented. Fortunately, the Strategy Document provides a much clearer and concrete picture. The success of the same, however, can only be adjudged once the implementational steps are underway. It is appreciable that the Policy accounts for its own monitoring and evaluation. This is further advanced by the Strategy Paper, which speaks of the development of quantitative output/ outcome metrics to measure success of the Policy’s strategies. These metrics will address factors such as access & affordability, safety of medical devices, self-reliance on manufacturing, India’s healthcare index, creation of high-value and skilled jobs, improvement in R&D, reduced disease burden, and export promotion. One can hope that not only are these metrics formulated promptly, but also that they are based on established objectives and backed by scientific rationale.
Notwithstanding the monumental efforts which will be required to implement and practically enforce the ideas envisioned by the Policy, the thought leadership demonstrated by the DoP is promising. Time will tell if these policy documents actually translate into actions or end up becoming an academic exercise. The proof will ultimately lie in the proverbial pudding!
For further information, please contact:
Ashwin Sapra, Partner, Cyril Amarchand Mangaldas
ashwin.sapra@cyrilshroff.com
[1] Department of Pharmaceuticals, Gazette Notification bearing F. No. 31026/91/2015-PI-II dated May 2, 2023, available at https://egazette.nic.in/WriteReadData/2023/245630.pdf.
[2] Department of Pharmaceuticals, ‘Approach Paper on Draft National Medical Devices Policy 2022 for consultation’, available at https://pharmaceuticals.gov.in/sites/default/files/Public%20Notice%20and%20Approch%20paper%20on%20draft%20NMDP%202022.pdf
[3] Department of Pharmaceuticals, ‘Strategy Document on National Medical Devices Policy 2023’, available at https://pharmaceuticals.gov.in/sites/default/files/Strategy%20Document%20on%20NMDP%
