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Revamp and Re-invigorate MedTech, A CII event

The 13th CII Global MedTech Summit 2021, Revamp and re-invigorate the sunrise medical devices sector in India was organized by CII National Medical Technology Forum on September 2-3, 2021. Medical Buyer was its exclusive media partner.

The summit showcased the achievements of the medical technology sector and brought together the country’s healthcare think-tank for acute deliberations and discussions on various aspects of the sector.

The COVID-19 pandemic has brought medical devices right into our households. The general public is now familiar with several medical devices such as the pulse oximeter, ventilator, respirators, oxygen concentrators, personal protective equipment and membrane oxygenators, much beyond the traditional home-use devices of the past like a thermometer or a blood pressure monitor.

What often remains unseen is the state-of-the art technology inside these devices, the attention required for their adequate regulatory oversight and the training of healthcare professionals for safe and effective use of these devices on patients.

The medical devices sector in India comprises large multinationals and small and midsized companies. The sector is growing at a fast pace, and the Government has accorded it the status of a sunrise sector. Government of India has commenced various initiatives to strengthen the medical devices sector, with emphasis on R&D and 100 percent FDI for medical devices to boost the market. From April 2000 to March 2021, FDI inflow in the medical and surgical appliances sector stood at US$ 2.19 billion.

Medical devices sector in India, estimated at  Rs. 77,539 crore (USD 11 billion) in 2020 offers tremendous opportunity for Indian manufacturers, ancillary component manufacturers, distributors, and suppliers to be a part of the growth story. Poised to increase at a CAGR of 35.4% from 2020 to 2025, reaching Rs. 352,450 crore (USD 50 billion) the sector has support of various ministries and departments, who are converging their thoughts and are discussing and implementing ways and means of reducing the burden of regulatory compliance and identifying obsolete regulations and duplicate regulations to make the sector agile and easy to do business in.

Senior government officials representing various ministries and departments shared their views at the inaugural session. Subsequently panel discussions were held. An exclusive report.

Inaugural session

Dr Jitendra Singh, Minister of State (Independent Charge) Science and Technology
“India’s healthcare industry has made several advances during the brief 70 years since Independence and this sector today is recognized as the sunrise sector. We are among the world leaders in medicare and sometimes new technologies are applied here, even before they are rolled out in the West. In spite of that, most medical technologies are not indigenous, and we are still dependent to the extent of 85 percent on imports. One reason has been that, owing perhaps to legacy issues and economic constraints, the healthcare sector has never been given the social or cultural priority it deserves. All that has changed under the leadership of Prime Minister Shri Narendra Modi, who promotes scientific temper among masses, as is evident from the National Hydrogen Mission announced in his Independence Day address to the nation on August 15th this year.

Several initiatives have been undertaken during the last seven years to promote Ease of Business and Make in India. The Prime Minister has encouraged to do away with regulations, that have been hampering growth of the indigenous industry. Earlier, with multiple window clearances, as many as 70 in the small-scale sector, entrepreneurs were very reluctant to invest.

COVID-19 has given a major impetus to develop technologies such as to CSIR in manufacturing ventilators, DBT for vaccine production, and ISRO for liquid oxygen. Instead of department-wise approvals in the ministry, we now go for theme-based projects involving the private sector. Indigenous medical technologies will help reduce dependence on imports and for this the government, private sector, corporates, and scientists, all will have to come together and pool in their resources. A CII study estimates that India’s MedTech sector will grow from USD 11 billion in 2020 to USD 50 billion by 2025”.

Anupriya Patel, Minister of State for Commerce & Industry
“We all know that medical devices have today become a very essential and important constituent of the growing Indian medical industry. The wide range plays an important role in not just catalysing our economy but also in making our lives much more comfortable and easier. And the pandemic, which we have been facing for the past two years, has made us more conscious toward this aspect. We are now moving toward home-based monitoring of parameters.

There are about 750 to 800 domestic medical device manufacturers in the country. And the manufacturing clusters located in the states of Gujarat, Maharashtra, Karnataka, Andhra Pradesh, Telangana, and Tamil Nadu are very useful. The NITI Aayog report has highlighted the investment opportunities in the healthcare sector. These opportunities need to be stitched together.

The industry has seen so many startups that have risen to the occasion and accelerated the development of low cost, scalable, and quick solutions. And the change environment has also contributed in providing an impetus to the expansion of telemedicine and home-based healthcare market. With the global economy expected to expand by 5.6 percent in 2021, and the Indian economy growth projected at 8.3 percent in the fiscal year 2021-22, these put together create a favorable environment for the healthcare industry and encourage investments.

Prime Minister Narendra Modi envisioned making India a USD 5 trillion economy and a global economic powerhouse by 2024-25. And this will not be possible without the contribution of every sector. Medical devices is a sunrise sector and the Government of India has identified it as a priority sector, and is committed to strengthening and energizing the manufacturing ecosystem. The Union Cabinet on March 20, 2020 had announced two schemes, the Promotion of Medical Devices Parks Scheme and the Production Linked Incentive Scheme.

Under the sub-scheme for Promotion of Medical Device Parks, Common Infrastructure Facilities would be created in 4 Medical Device Parks, which is expected to reduce manufacturing cost of medical devices in the country.

The PLI Scheme for promoting domestic manufacturing of Medical Devices would boost domestic manufacturing and attract large investments in the medical device sector, particularly in the identified target segments. It will lead to expected incremental production of Rs. 68,437 crore over a period of five years. The schemes will lead to generation of additional employment of 33,750 jobs over a period of five years. And to substantial reduction in import of target segments of medical devices.

And of course for expanding the export market. India’s exports in the medical devices sector has grown from USD 0.98 billion in 2015-16 to USD 2.3 billion in 2019-20 and to USD 2.5 billion in 2021.  Department of Commerce is presently engaged in consulting the stakeholders trade bodies and associations in creating a separate Export Promotion Council for medical devices. Our vision is to see that the Indian medical device industry is not just self-sufficient for local consumption, but also plays a leading role in the global market.”

S Aparna, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers
“The Indian medical devices sector has been rightly projected as a sunrise sector, more so given the current backdrop of the COVID-19 pandemic and India’s response to the pandemic. The current market size is about USD 11 billion, expected to reach USD 50 billion by 2025.

As the nodal department since 2015, we are acutely conscious of the potential of the medical devices sector. And we are happy to be instrumental in some of the recent government proposals for the sector, which are unprecedented. In addition to various policy initiatives. this includes the schemes for supporting medical devices parks, the PLI scheme for medical devices, and the introduction of postgraduate courses in medical devices by NIPER.

At the same time, we should recognize that there are challenges and size alone cannot be the sole objective of any industry strategy.  I would like to dwell on three aspects that we should work toward.

The first aspect is that innovation-driven diversification permits complex products. India still has a high degree of import dependence, particularly for the high-end value products. This impinges on our stated healthcare goals of access and affordability. In order to support diversification, the government has launched the PLI scheme and we have received a good response from the industry. However, diversification necessitates investments in innovation and adaptive research. It is a matter of pride for us that in India, we do have some mid-sized firms that have developed indigenous technology. And I believe, that their success stories offer lessons that can be replicated in the sector. Also, the tremendous efforts made by industry, supported by PSUs and our scientific departments, to indigenize diagnostic kits, ventilators and oxygen concentrators is testimonial to the commitment and capacity of this sector to meet both domestic and global needs through frugal innovation.

A strong innovation ecosystem must also support startups. The work being done by BIRAC and DPIIT in supporting innovation, offers a replicable model that can be scaled up. Further, the sector can look at exploring tie-ups with technology partners, which can include attracting global players to bring in R&D into India. We have some large global metric companies operating R&D setups in India, and we need more R&D investment, both by domestic and global players. We would welcome suggestions on how these can be incentivized and facilitated. Innovation that meets patient needs, reduces lifetime costs, and increases therapeutic or diagnostic efficiencies are to be pursued, rather than merely cosmetic innovations. Also, Indian medical devices sector should not merely play catch up with other advanced industries, but leapfrog to the futuristic technologies. We must leverage the use of artificial intelligence and machine learning in diagnosis clinical treatment, the growing trends in telemedicine, digital medicine, the proliferation of wearables, personalized devices, tricorders, and many such recent developments.  We have in India, a happy confluence of a strong IT industry, and digital infrastructure that can bring in these innovations for the domestic healthcare sector.

The second aspect is the governance framework, which can assure safety, efficacy, and quality of the medical devices. This is necessary both for patient safety and for global competence. The medical devices industry has shown readiness to move smoothly into a well-regulated framework. The health ministry has issued the medical devices rules in 2017 and the timeline for bringing all medical devices to the licensing framework in a phased manner. However, there is a wide divergence and variety of views within the industry on how the various components of the regulations may be implemented. A related aspect in regulation is the demand side management. It is no doubt, upward bound with the increase in the Indian middle class, with Ayushman Bharat and with PMAY. Yet, it is below the comparable economies. That creates a barrier to investment. We need to look beyond public procurement toward innovative ways to finance asset creation in diagnostics and therapeutic medical devices. My department has been engaging closely with the industry, CII and with regulators on reducing compliance burdens. This is also a top priority for government. We would like to chalk out a systematic roadmap, that would require the support and a collaborative approach from multiple regulators across departments, including tax regulators and the various segments within the industry.  I see a very strong role for broad-based industry organizations like CII, to build consensus in the process of streamlining the regulatory framework and introducing a single interface or portal-based system for the industry.

The third and last aspect that I would like to dwell upon today is the global value chain. In the aftermath of the pandemic-induced disruption to supply chains, key countries, particularly the western advanced economies, are now looking to bring in more domestic manufacturing and diversifying their supply chains. This is both a challenge and an opportunity.

The medical devices sector is multi-disciplinary. It draws upon electronics, engineering, radio imaging, digital technology, material science, biochemistry, medical science, and others. That means that the growth of the medical devices sector is incumbent upon developments in all these fields. A strong and diversified network of supplier and ancillary firms with built-in redundancies is essential for industry development in a self-reliant and resilient manner. Many of these firms are in the SME sector, and they lack access to finance, technology, and skilled manpower. Therefore, I believe that the attention to backward integration will prove to be a strong determinant for global success of the strategy for medical devices”.

Prof K Vijay Raghavan, Principal Scientific Adviser, Government of India
“The MedTech industry needs to succeed in the global market. Indian companies are providing remote services, combining MedTech and AI, sending the analysis  to developing countries across the world. This can truly be transformational for the industry.

Also, today’s internet savvy patient enables combining the delivery of personalized medicine and analysis through telemedicine, making the huge Indian market very attractive.”

Dr Naresh Trehan, Chairman, CII National Council on Healthcare & Chairman & Managing Director, Medanta, The Medicity
“The basic question that we are struggling with is the multi-faceted experiences that we have faced in the last two years. MedTech industry, by and large has been like the pharmaceutical industry, and working at a very low level of technology and value addition.

There has been an overarching concern that is there a critical mass available in India that must move up the value chain. Can we ultimately produce many of the devices that we import today? Some are simple to manufacture. And some are very complex, and require a lot of investment and a huge market size to justify the investment.

The pandemic brought to the fore two challenges. On the one hand, manufacturers lost their regular business because the growth in their usual line of businesses came to a tempered level or completely froze. But on the other hand, it gave them an opportunity to rise to the occasion, to fill the gap, which existed in the technology or the devices required for treatment of COVID-19 patients, which unfortunately came in plenty in our country.

So, if I was to put forth, from the MedTech industry’s viewpoint, the opportunities are great, but they will not translate to immediate margins and profits, will be an investment for the future. That is something outside the purview of our economy and startups.

And India’s not alone in this. There is another three to four billion people in the same boat, or even worse than we are, in economic strength. What applies to us, applies to those four billion people out of the seven billion population on this planet.

We have to start thinking global. There definitely exists a critical mass, which has developed to move up the value chain. It is true that, although the very essence of lots of sophisticated electronic equipment is made in India and all the software is written in India, yet the product is manufactured by different countries. But, then the financial muscle required to accomplish that is quite high.

For the Atmanirbhar scheme there are various stakeholders. The government is a very important partner and is determined to make self-reliance a success. Many regulations and policies are being directed toward making it possible and providing the stimulus to be able to move up to our own expectations. The point is how we are going to prioritize. No country can be everything to everybody. That doesn’t happen. In our endeavor to move forward, the MedTech industry along with the providers, keeping the interest of the patient and the government in view needs to have a quadrangular discussion on where to invest, so that India can move up to a powerful spot in the international arena of MedTech.

There’s an opportunity. Say a CT scanner innovated in India, produced at half the cost, does the job required for our population. It does not need the bells and whistles, that jack up the price. And this includes the four billion patients I was referring to, in Africa, CIS countries and other Southeast Asian countries; we are all under the same burden.

And we need to seize this opportunity now. The idea is not, just to make in India. Let some company come and manufacture it in India. It can just be developed in India and designed in India. Anyway, the software is all written in India in any case. Let the overseas companies come and manufacture it here too, rather than take our inputs and then sell the final products to us at exorbitant prices.

Let us put our heads together, prioritize, and not try to do everything at the same time. We need to get our act together, because the government is very willing and pushing. If we do not take the initiative now, it is our fault, not the government’s. The government is doing all it can, including providing financial stimulus.

And, the Department of Science, the biotech sector in the pharma division, have all been very proactively supporting research and development. Let us get together and innovate and substitute the annual USD 20 billion pharma imports, and USD 9 billion MedTech imports as far as possible with indigenous manufacturing. Our domestic market is huge. We can now also become a major exporter.

While today we merely export syringes, needles, IV fluids, and the like and there is no doubt, they are doing a very good job, let us now take the next step.”

Dr VG Somani, Director, Controller General of India
“Demand generation is one of the most important factors, and India has always had huge demand. The main thing now is whether the patient is able to pay out of his pocket or will pay through the system, and whether the system is generated for that. Access to affordable, good quality medical products is the motto with which all the stakeholders including industry, the government, the policy makers, NGOs, activists are working toward. And that is what we emphasize on from the chair in the World Health Organization of 194 regulators too. Access should be for masses, not only for the classes. And now,  because of the challenges posed by the current pandemic, India is very well positioned. We have been reinventing and filling in the gaps. The introduction of the PLI scheme and the medical parks are such instances.

Another important step is having good regulatory practices, that lead to utmost customer satisfaction. Customers encompass patients, doctors, the industry, NGOs and the government too. Consensus building on how we frame compliant regulation is key. The medical device rule, that is in line with IMDRF global regulatory requirements has been framed, and speedily adopted. And at the same time, we are also pushing for Atmarnirbhar Bharat in a manner that supports good technology. To move fast we have to work hand-in-hand with all the stakeholders. And that’s what we are doing. We assure you all of the best, easiest, digital-friendly, competent and good regulatory practices.”

Sumita Dawra, Additional Secretary, Department for Promotion of Industry and Internal Trade, Ministry of Commerce & Industry
“COVID caused a lot of disruption in the economy, yet it did present a great opportunity to various segments to adapt and grow. And the Indian industry responded to challenges with great resilience. The huge production of ventilators and PPE kits bear testimonial. The government’s commitment of financial outlay of Rs 1.97 lakh crore for the Production Linked Incentive scheme launched for 13 sectors last year is very encouraging. This included promoting Domestic manufacturing of medical devices and boosting India’s bulk drug security covering identified Active Pharmaceutical Ingredients /Key Starting Materials /Drug Intermediates. This provides  an opportunity for taking manufacturing to a greater scale and for nurturing global champions in manufacturing and making India the global hub for manufacturing and exports that we would like to see in the MedTech sector.

Of course, there remain concerns that need to be addressed. A timely clearance is a major one. The Central government is ready for a soft launch of its Single Window System for clearances and approvals for the industry in the country and this would help industries in future. The National Single Window System, which merges clearance portals from multiple ministries across the Government of India as well as approvals from state governments in one place without disrupting existing systems, has made significant progress.

Another step to help the MedTech industry is the creation of an empowered group of secretaries, led by the Cabinet Secretary, to make decisions on cross-cutting policy issues with the help of the project development cells. The group brings together representatives from the Indian government’s 13 ministries and departments to assist and facilitate investors, both domestically and internationally. Wherever an investor encounters an impediment to their investment, whether it is with state governments or other agencies of the Indian government, the Project Development Cell at the domain sector ministry is there to assist them and expedite the process. These activities are also reviewed very closely”.

Sanjay Bhutani, Co-Chairman, CII NMTF and Managing Director, India Bausch & Lomb Eyecare
“In 2020, the Indian medical device market was estimated to be worth over USD 11 billion. And it is expected to grow at a CAGR of a whopping 35.4 percent over the next 5 years. By the end of 2025, the market is estimated to be valued at USD 50 billion. Over the years, the government’s timely and substantive support has been a critical link in a slew of recent MedTech sectoral advancements. To promote the industry, the Indian government has launched a number of efforts to strengthen the medical device sector, with a focus on R&D and 100 percent FDI for medical devices. We are eager to engage in the new products and develop the necessary capabilities as an industry. With COVID-19’s lessons learnt and potential for Atmanirbhar Bharat and ease of doing business, there is no better time than now to assess the sector and infuse it with new vigour and enthusiasm”.

PANEL DISCUSSIONS

Evidence based policy making – Driving the Medtech sector growth in India
There is extensive health and public health literature on the ‘evidence-policy gap’, identifying the need for better evidence to reduce policymaker uncertainty. Successful engagement in evidence-based policymaking requires combining scientific evidence with governance principles, and persuasion to translate complex evidence into simple stories.

Experts comments

Manoj Madhavan, Managing Director, Boston Scientific India Ltd.
“The first and most important requirement for the country to truly tap into demand and become the epicentre of cutting-edge medical device items is to ensure that a thriving R&D system exists.

Many times, the emphasis is solely on production for the sake of making. Manufacturing is excellent for the economy because it creates jobs and allows exports, but R&D in the healthcare system is critical. It is practically impossible for a country to have cutting-edge research and development without a manufacturing infrastructure to back it up, because it makes no sense to undertake all the research and development here and then produce elsewhere. Isn’t that the case with India?

Secondly, for robotics, Artificial Intelligence, and other cutting-edge technologies, the ease of access of physicians and healthcare providers to this technology has to be paramount.

It makes no difference where products are manufactured. If it benefits people and helps patients all around the world, shouldn’t India and Indians have access to it? And it is at this point that we must consider several options. Although there are restrictions and suitable ways of looking at technology, there are countries around the world where specific districts and institutes have better access to technology. But, even if it’s a more recent technology, how can we get it into the country sooner?

We are currently 80 percent reliant on imports, which is unacceptably high for a country like India. We should eventually reach a point where we are truly self-sufficient, but it will be a long road. And we must be very conscious of how we develop that capability so that, over time, we have R&D and can create our own systems that are clearly affordable for India’s DC states”.

 The regulatory landscape for medical devices and diagnostics in India – Opportunities and challenges
As we embark on the path of regulating medical devices, the regulations for medical devices & diagnostics in the country need to support the growth of this innovation driven industry, which will also ensure that Indian medical device industry become globally competitive. Efforts are required to synergize the outcome of various regulatory agencies viz. CDSCO, AERB, BIS, MEITY, DoT, MoHFW, MoCA, DPIIT, MoEF&CC, IPC MVPI and many others in the country for medical device and diagnostics so that the existing multiple bottlenecks are removed and the Honorable Prime Minister’s clarion call for Ease of Doing Business in the medical technology sector achieved. To be globally competitive, and to transform the Indian medical devices industry to a provider of quality products for not just Indian patients, but also global patients, regulations need to be harmonized in line with recommendations of International Medical Device Regulators Forum (IMDRF).

Experts comments

Dr VG Somani, Director Controller General of India, CDSCO, Government of India
“One of the most significant elements in play is demand generation, and India has always had huge demand. The important question is whether the patient can afford to pay out of his pocket or will pay through the system, and whether the system is set up for it.

All stakeholders, including industry, government, policymakers, NGOs, and activists are working toward the goal of providing inexpensive, high-quality medical products. That is also something we emphasize as the chair of the World Health Organization’s 194 regulators. Access should be available to the general public, not only the upper crust. And in light of having met the current pandemic’s challenges, India is in a strong position.

Another crucial stage is to have good regulatory processes that result in the highest level of client satisfaction. Patients, doctors, industry, NGOs, and the government are all customers. It’s critical to reach a consensus on how to frame compatible regulation. The medical device rule has been drafted and quickly adopted, in accordance with IMDRF global regulatory criteria. At the same time, we are promoting Atmarnirbhar Bharat in a way that is technologically sound. To move quickly, we must collaborate with all parties. That is exactly what we are doing. All of the best, easiest, digitally friendly, competent, and good regulatory processes are guaranteed by us”.

Himanshu Baid, Managing Director, Poly Medicure Ltd.
“The MedTech sector is built on four pillars. Medical equipment, implants, IVD, and consumables are examples. So why not put all of the parts that are specialized to one industrial vertical together and build an ecosystem around it? We should create a component in such a way that the entire ecosystem evolves around it. Implants, consumables, and IVD are all in the same boat. I believe that a PLI plan for the entire MedTech industry is also required. PLI is based on incremental sales and incremental revenue, need to bring everything under MedTech for PLI. Need to give incentives for additional sales and incremental revenue. As a result, a company should be rewarded if investments are made and significant revenues created, whether for domestic or export purposes. Why are only a few sectors being targeted? When it comes to medical gadgets, India has the capacity to produce anything under the sun. Take China as an example: China’s manufacturing costs are already relatively high when compared to India’s. And the price we pay for the technical talents we have in India is substantially lower than what we pay in China now. The manufacturing sector is  already facing labor and technology arbitrage. In India, the cost of capital has also decreased. There is nothing to hold us back? The government must encourage PLI, across the board.

Another issue of concern is export incentives. We had a focused product strategy and a focused market scheme before MEIS. That aided India’s export growth. In the last five years, our exports have increased from USD 1 billion to USD 2.5 billion. So, how do we get to a USD 10 billion medical device sector by 2025, or a USD 50 billion medical device industry by 2025? Exports must account for 30 to 40 percent of the USD 50 billion. And the industry will need incentives to get to that high amount of USD 15 to USD 20 billion. More than the 0.5 percent offered by this program.

Is it possible to establish an incentive scheme that encourages industry to grow at a quicker rate? Vietnam, Singapore, Malaysia, and China are good examples. In India, the taxes, higher capital costs, higher electricity costs, and a poorly organized supply chain resulting in significantly higher raw material costs are almost a disincentive to manufacture We ihave apprised NITI Aayog of these challenges around a year and a half ago. The industry, that has the potential to become the world’s factory will definitelyneed governemnt initiative and support”.

Manish Airan, VP Quality Assurance & Regulatory Affairs, Transasia Bio-Medicals Ltd.
“We have the fourth largest market for medical devices in Asia. However, we still rely on imports to the tune of 80 percent. With such a huge reliance on imports, providing affordable healthcare to all is extremely difficult. It is critical that we, as Indian manufacturers, meet India’s regulatory criteria”.

Vijay Kumar, Head – External Affairs & Business Applications India and Neighboring Countries, Roche Diagnostics
“The IVD sector is unique. India’s healthcare burden is high due to its large population. Although the IVD business accounts for only 2 percent of total healthcare costs, it has a 70 percent influence on clinical decision-making. It is a huge collection of knowledge, and plays a unique role in reducing our country’s healthcare burden.”

Diagnostic testing in India – Current practices; Protocols; Reimbursements; Urgent need for a paradigm shift
With the advent of the pandemic, the value of diagnostic tests in providing effective healthcare has been further realized. As we look beyond the pandemic, bigger questions arise; are we sufficiently testing and/or is there is a need to shift from symptom-based diagnosis to diagnostic test-based treatment protocol. In developed economies, almost all treatment decisions are based on the results of diagnostic testing; however, we are yet to adopt the same measures although we are a base for domestic manufacturing of IVDs. Therefore, it is imperative that we focus on the certain nuances in the diagnostic segment in India. This session will focus on diagnostic testing in India, and urgent need for a paradigm shift. It will endeavour to examine the substantial opportunity that diagnostics provide to improve quality and efficiency of treatments and review the potential constraints, including regulatory, reimbursement, market, scientific/technical issues that can inhibit the development, adoption and appropriate use of diagnostic products in India and examine ways to overcome these hurdles.

Experts comments

Dr Anup Anvikar, Director, National Institute of Biologicals
“The COVID-19 pandemic taught us a lot. And, whether it is PPE, other commodities, or, most importantly, diagnostics, the Indian industry has responded admirably to this pandemic. Previously, only a few companies were involved in molecular diagnostics, and the cost of a single test, including reagents, was around Rs. 1000. It’s now less than a hundred rupees. RNA extraction kits, RT-PCR kits, antigen detection kits, and antibody detection kits are manufactured by a variety of companies.

Another thing we’ve noticed over the last few years is that the diagnostic industry’s environment is very favorable, with the government on board, regulatory processes moving quickly, and everyone working together. I attended this session yesterday, and everyone was extremely supportive of the diagnostic industry, and we should take advantage of this opportunity to apply the lessons learned from the COVID-19 pandemic response to other diseases. And we should be involved in developing more diagnostics for more diseases, as well as ensuring that diagnostics are available at our point-of-care, so that diagnostic access is improved.

Even in primary care settings, we have a variety of diagnostics, not just a few, whereas we should be expanding our diagnostics production to ensure that the quality of these diagnostics is maintained. And, in order to ensure better health, diagnostic quality is critical. For the past 30 years, my institute, the National Institute of Biological Sciences, has been involved in monitoring the quality of various biologicals, including diagnostics. And we currently have 275 biologicals under our umbrella, including 171 diagnostics, with more diagnostics being added to our portfolio every month. And, if you inform us that we are developing diagnostics, we are open to requests from various manufacturers. We’d also be delighted to begin monitoring the quality of self-diagnostics. As a result, I eagerly anticipate deliberations on that potency”.

Dr Suchita Markan, Scientist E, ICMR
“We all know that the ICMR was instrumental during the pandemic. When we look at the diagnostic sector, we see that it is not very correlated and that there are many gaps that need to be filled. However, the ICMR’s mandate is to ensure public health on a larger scale. As a result, it was critical at the time to have appropriate policies and guidelines in place, as well as validating the tech diagnostic devices that were being used across the country, to ensure that the right products were being used everywhere. And we’ve got the right outcomes on hat. So, in terms of diagnostics, the ICMR has a significant role to play on a number of fronts.

It’s not just about the diagnostics; it’s also about having the right policy framework in place. We had ramped up capabilities of having these get relegated from one center to more than 50 centers across the country so that the right cuts are used for doing the validation and testing of COVID by partnering with diagnostic players across the country.

In addition, we have a number of programs in the works to assist the medical device and diagnostic industries in developing new products. So that is an overarching role we must play, and nothing will happen unless we work together with industry. As a result, the ICMR is moving away from just promoting R&D and toward the true science of working in a PPP model with the goal of bringing products to market. And I’m looking forward to the session and having meaningful discussions so that we can engage and get some ideas on board, which will help us strengthen our initiatives for bringing products to market with industry”.

Bharath Uppiliappan, Chief Executive Officer, Dr Lal PathLabs
“I am not a medical expert, but what I have gathered over the years in this industry, is there are three stages diagnostics framework prevention, early detection, and cure. If we combine this framework of prevention, early diagnostics, and cure with coverage and regularity, we may be able to build a framework in which we can look at what markets need and what kind of solutions they require. The second point I would like to make is that India is a relatively low-cost diagnostics market. And, the cost of reagents had decreased significantly. As you may be aware, the cost of COVID testing ranged from thousands to hundreds of thousands of rupees. When it comes to medical tourism, an RT-PCR test costs around USD 220 in any US or European countries today, and it costs less than USD 5 in India. So there’s a huge arbitrage opportunity, but that aside, the point is that India has not, or at least we have not, taken a price increase or diagnostics increase in the last 6 years. All of this has been accomplished through volume rate efficiency, and the COVID is a classic example of another country continuing to operate at a price point close to $60. The reason India is not allowed to find it is due to the volume, operating efficiencies, and competitive market forces at play. If we are to reach Tier II, III, and IV cities, the role of digital as an integral medium of service delivery has to come into play”.

Narendra Varde, Managing Director, Roche Diagnostics
“What I would like to point out is that when we look at our healthcare spending, we know it’s among the lowest in the world. What is more shocking is our diagnostic spending, which is less than 2 percent of our total healthcare spending. Then, on top of that, we spend about 2 percent of that 2 percent on diagnostics. So we can imagine that there is a lot of room to improve our budgets and spending on diagnostics, which is something that has come to light with COVID, that attention has been drawn to diagnostics, and that there is now a recognition that yes, diagnostics is important, and that you must first know before you can treat. And I hope that trend continues in terms of policies and regulations encouraging more investment in diagnostics.

When it comes to technology, diagnostics is a massive field. So, for the first time, a large number of people, including the general public, are aware of what an RT-PCR test is. Perhaps two years ago, no one was aware of what an RT-PCR test was. Similarly, in diagnostics, there are a variety of technologies at work, including point-of-care testing, rapid testing, semi-automated testing, and fully automated clear testing. There are other areas such as immunology, chemistry, or hematology that are now available, as well as coagulation, but the point I’m trying to make is diagnostics. It’s a complicated situation; it’s not as straightforward as it appears. Because, when it comes to cancer diagnostics, certain biomarkers may be useful, but you also need immunohistochemistry, sequencing, and genomics, and then there’s digital pathology, which is becoming more common.

The point I want to make here is that we as a country need to understand diagnostics more holistically in terms of what technologies are available and which technologies are applicable where, right? The third point I wanted to make in my opening remarks was about regulation, because diagnostics in India is a very unregulated market. And I believe that awareness already exists. And there is something we need to start working on because when it comes to diagnostics, there is no standard of quality care. And I believe that a large part of the blame lies with us, the general public, because when you say take a blood test, you don’t really think about where your blood is going. Is it going to a reputable lab, such as Dr Lal PathLabs, or is it going somewhere in the back corner, where you have no idea what result you’re getting because it’s done manually or semi-automated and you have no idea what you’re getting? Is the result you’re getting authentic or not, and that’s where a lot more regulations are needed to try and drive you know a higher standard of quality where diagnostics is concerned”.

Dr CS Satheesh Kumar, Sr. Vice President, Agappe Diagnostics Ltd
“The current state of data utilization, I say open discipline, affects every aspect of our lives and treatment, including patient care, surgery, revenue, healthcare, mode of transportation, and telemedicine. As a result, our entire focus was on how to avoid infection. Vaccination was developed in a short period of political time. However, the government has failed to recognize our promising industry’s enormous capacity. We could also make things faster if there is a significant supply gap. As a result, collaboration among all stakeholders in healthcare, including the government, will be essential. We need primary diagnosis and paid analysis to be covered by insurance benefits. Aside from that, a lot of things require some consistency and clarity”.

Futuristic technologies and digital health driving the medical technology industry
Innovation is happening at an overwhelming pace in the MedTech world. An imposing spectrum of rapid innovation, including hundreds of different technologies such as Artificial Intelligence (AI), Augmented Reality (AR), Virtual Reality (VR), Machine Learning (ML), Internet-of-Things (IoT), 3D printing, to name a few and thousands of types of products using them and many more. This coupled with the rise of digital health has been driving the industry. Digital health encompasses a wide range of novel digital technologies related to health and medicine. Such technologies rely on recent advances in the collection and analysis of ever-increasing amounts of data from both patients and healthy citizens. The session will invite deliberations on the ecosystem required to foster the futuristic medical technologies and digital health in the country facilitating predictable data pattern to ensure significantly improved patient outcome. It will attempt to identify the actions required from all stakeholders for seamless implementation of these futuristic technologies in terms of regulation, reimbursement, awareness, and integration within the current and future policy framework.

Experts comments

Chhitiz Kumar, Business Leader, Precision Diagnosis, & Connected Care, Philips India Limited
“Today’s four major issues in the healthcare business are: limited healthcare infrastructure; labor requirements; technology and India’s fragmented healthcare system; and healthcare costs. It is critical to comprehend the function that technology can play in assisting in the resolution of problems.”

MB Bureau

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