 Before I hand it over to you, Sanat, it's great to have you joining us. Sanat Tadapatiye, who's been a fantastic supporter of the USAIC. Sanat is the president of a very powerful group at Merck, the Merck Manufacturing Group. Sanat will be moderating a panel on innovation in India. And I will say that in our theme of end-to-one to end-to-a-billion that we've used in the past, we focus on innovation and access, and the two are truly inseparable. If you look across the globe and you look at countries that are strong in access, these are always countries that have strong innovation foundations. So with that said, Sanat, I'll hand it over to you in the panel. Thank you, Andy. So good morning, good afternoon, and good evening, everybody. Before I go into the panel, let me remind everyone that please, please do not forget to participate in our online polling. Below the video window, you will scroll down to find the right panel, which gives you the polling question and submit your answers there. The polling will open for one minute and will announce the results before the next panel. And thank you for doing that. So let me first start with thanking the USAIC for hosting this summit. And indeed, it's my distinct proud privilege to be moderating this panel discussion on India innovation landscape among four very established leaders in India. So the context of the panel is that we know that India is aiming to become a $5 trillion economy by 2025. And that means the India pharmaceuticals market, which is already the third largest in terms of volume and 13th largest in terms of value, is also expected to grow to $100 billion by 2025. We also know that India is the largest provider of the generic medicines and that to globally. Indian pharmaceutical sector already supplies over 50% of the global demand for various vaccines. 40% of the generic demand in the US and 25% of all medicines in UK. And that's a tremendous accomplishment. If you look at our anti-retroviral drugs, 80% of them are used globally to combat AIDS and they're supplied by Indian pharmaceutical companies. And that's been a tremendous progress that has happened over many years. And therefore India is rightly called the global pharmacy of the war. However, while India's pharmaceutical industry growth has been impressive, to further propel India towards the next stage of economic development, what we need is the industry to be generating much more value through innovation. And in particular address those roadblocks that are holding back the biotech innovation in the shape of, you know, and when I say biotech innovation, that's also supposed to meet the increasing demands brought on by a growing middle class population and a faster than expected aging population, which will continue to add pressure to the India's healthcare system. So let's try to get the thoughts of this distinguished panel to understand how true innovation in the shape of end-to-end drug delivery and development infrastructure or how boosting technological innovation in pharma, biotech and healthcare startups or how the innovation focus can shift from development to research while helping India realize its vision of growing to $100 billion market in 2025. So that's the context. And let me start with Amitabh. Amitabh, Pharma Vision 2020 was a great government commitment and initiative to make India a global leader, not just in the production of low-cost generic medicines, but also to, you know, lead in the area of end-to-end discovery and development. And the objective and ambition was to make India one of the top five pharmaceutical innovation hubs, and that means launching one out of every five or ten novel drugs globally. We also know that the country's relatively liberal regulatory regime also makes it a very promising location for stem cell research, for cell engineering, for cell-based therapeutic R&D, all of that. And it also has very well-established strengths in IT, you know, meaning that it can emerge as a leader in the area of computer science, statistics, mathematics, and all of that will go well to analyze and interpret biological data crucial for modern biotech research. So as the CEO of Neeti Iyog, Amitabh, what do you think is the vision and plan of the government of India to meet, you know, the aspirations of the future? So, Sanat, let me first thank the U.S. India Chamber of Commerce for inviting me to this very fascinating discussion on innovation landscape in India. Coming to your question, Pharma Vision 2020 envisages to make India a global leader in drug discovery, innovation, end-to-end drug manufacturing, and we in government of India are fully committed towards this. We've taken very far-reaching reforms to streamline the clinical trial and regulatory approval processes to facilitate innovative drug discovery in very close partnership with the private sector. And all the pharmaceutical manufacturing companies and all of us are working in collaboration to drive the ease of doing business. We've set up bio incubators for nurturing entrepreneurship and for scaling technologies. We are developing world-class clinical trial infrastructure to increase the number of beds per thousand population. We recently launched, the Prime Minister recently launched the National Digital Health Commission on our Independence Day, 15th August. Electronic health records will be created for individuals which will be valuable, enormously valuable for research purposes. And if you look at our states, a state such as Maharashtra, Karnataka, Delhi, Tamil Nadu have a very, very strong innovation landscape and are contributing to the bio economy. We've jumped up in the ranks of being one of the most innovative nations in the global innovation index just this week. And in the last decade, India has seen the largest number of approved biosimilars which are serving the needs of patients globally. Evidence suggests that clusters provide a very conducive environment for innovation. And the Department of Pharmaceuticals has just launched a production-linked incentive scheme. That is, if you invest and you produce beyond your base level and you keep producing higher and higher, we keep providing you incentive. And this is a unique scheme for enhancing size and scale of manufacturing in India. We've also pushed for a new scheme for promotion of bulk drug park scheme to boost production of active pharmaceutical ingredients. You know, we were greatly dependent on the Chinese supply chain. We're planning to do this complete manufacturing in India. And we are also pushing for key starting materials and giving impetus to the innovation ecosystem in India. We've also established centers of excellence in the National Institute of Pharmaceutical Education and Research. And we are working towards a very robust innovation landscape through various innovators such as human capital investment in R&B, safety, legal environment, regulatory environment to provide a world-class, truly world-class bioparma research output. Thank you very much. Thank you. Thank you, Amitabh. That was a very good kaleidoscope of how India is setting itself to advance innovation. So Vijay, can I build on Amitabh and ask you that if you look at the Indian performance in the last couple of years, it's been tremendous when it comes to making incremental innovations. You know, if you look at the way the Indian companies have made the control release delivery system using microspheres, they have gone for alternative cell forms, be it CIPLA, be it, you know, Dr. Reddy is all of them. And some of them have developed the ones daily formulations for CIPLA, and all those antibacterials. And I have to say that many of them have received a priority rating from FDA, which basically means that all these drugs demonstrated significant improvement over existing drugs. And that's fantastic. But the reality is that the discovery of novel molecules requires a very different approach. And if you look at R&D expenses to GDP for India, it's still below 1%. Whereas China, which was below 1%, is already a 2%, and it's aiming to be 5%. So is there a way we can think of India needing an ecosystem building on the foundations of its distinctive capabilities, which it already has in the area of value chain, like manufacturing, like product development, like process innovation, which has been so good in India for many years. So both the public and private organizations in the life sciences sector in India perhaps need to invest in the development of skills, in the development of infrastructure and culture to be able to transform the country into a life sciences innovation, how of the world. And because you have been so closely involved in these areas for a long time and as the principal scientific advisor to the government of India, what are your thoughts on how to foster the innovation system or how and what interventions will be needed for that. And once you answer that, maybe you may also like to talk about the question that you're raising with Ken as to what role the regulatory framework can play in helping India in the future given the learning out of COVID-19. Thank you, Sanat. There's a lot to unpack over there. Let me begin by saying that the challenge of getting returns on investment through innovation is a global one. Big industry, big pharma, putting in a huge amount of resources also faces a challenge having grabbed all the relatively obvious innovative parts now to get new ones in a manner which has impact on lives in a positive way is very tough. So the question is, are resources alone enough? No question resources are necessary and I'll come to that. Now, keep in mind that resources are necessary, but how does one use them? Keep also in mind a dramatically changing situation globally in a manner which favors Indian context hugely. And that changing context is something which has been talked about for a while but now is being implemented and that is personalized medicine. A personalized medicine was seen still recently as a fancy way of having individual oriented medication made available. Today in India, because of the rather dramatic scaling up of telemedicine and a variety of ways of teleconsulting, you're going to see a situation where personalized medicine at the grassroot level in a population of more than a billion is going to be feasible. This opens up a very critical aspect for innovation which is feedback. Feedback from people about what effects Medicaid has on their lives on such a scale will drive innovation enormously. In addition, innovation today will also be driven not just by investment of resources but by the sheer volume of quality efforts in that field. So India can bring in two aspects. One, this feedback process and increase the volume of talented people, increase the number of talented people looking at innovation, then low probability events can happen at a higher frequency because of the sheer number of talented people doing that. That would require international collaborations on scale that is eminently feasible. Now last point about resources. Absolutely right. Our GDP investment in R&D needs to go up, particularly industry investment in industry R&D. Right now 70% of the resources in our R&D comes from government and that should be inverted 30% should come from industry and that's happening. Now the big problem which industry has in India is it is not capital shy, it has got capital but it is short on risk capital. Now the question therefore is when industry invests, how do you mitigate risk? There are Indian institutions. Our R&D institutions, our universities, our Indian Institute of Technology can mitigate risk because of talented people, extraordinary infrastructure and massive space to build collaborative setups. So both Indian industry on scale as well as international industry coming in for investment can mitigate risk and take on adventurous projects which look at personalized medicine in a very, very new way. So I think that given the strong IT anchor of many of this, Amitabh here has pioneered many of those kinds of outreach in multiple sectors. We're going to see actually a mechanism by which low probability heavy investment research is transformed into higher probability broader based research of quality yielding more results for both India and the world. Thank you Vijay. You really developed it very well on the foundation that was built by Amitabh. So Naresh, in tune with what I heard now from Amitabh and Vijay, the Indian industry has made attempts at new drug discovery and development. And as we heard from Ken Frazier a little while ago, the successful launch of a new drug is a very, very long process. And we went in more through a process where there are five years where there was a complete drought in discovery of drugs. So we do go through that process in the industry. But given the fact that the Indian efforts in this area of new drug discovery still falls below the industry averages, is there a way we can do things differently knowing that expecting success in this particular domain is going to be very challenging? And I would particularly call out the area of innovation by the Indian industry which was briefly touched by both Amitabh and Vijay. And what is the scope in future of the Indian academic research? The industry-academia collaboration is perhaps the need of the hour. And this could happen only when the academia focuses on quality research aligned with the needs of the market. It's not just a quantity, it's also about the quality. And we know that India has a very well-developed scientific base with a large number of highly skilled researchers and scientists. We also know that India is one of the sixth most biodiverse countries with an 8,000-kilometer coastline. It has an enormous wealth of marine organisms that could provide fertility for drug research. So my question is that you have been yourself a very renowned cardiovascular surgeon. You have a tremendous passion for integrated healthcare and that's why you created the Medanta and the Med City and we saw that advertisement a little while ago. What do you think India can enable an R&D ecosystem of change, innovation and growth to help India transition into truly an innovation company? So first of all, let me thank USAIC for this opportunity to share our part. I represent the last mile, the clinical mile. And as we all have talked about, the collaboration and in this whole ecosystem is now ready in India as Amitabh and Pragavan has already established the will of the government to actually promote the innovations as we move forward. You may all be aware that for four years there was a hiatus when India took a pause to look at the regulatory mechanism and make it robust and bring it to international standards so that we would then be able to conduct our trials according to the world-class acceptance and also that credibility would increase of data coming out of India. So we on the one hand have established a 60-bed proof-of-concept unit at Medanta. We have done participated in many developments right now and it's welcome that the regulatory that came into effect in 1718 has really helped us to get up and running again and I think as you would know the strengths of India, like you said, there is a very robust way of the pharmacy to the world. We have a very diverse gene pool in India from the north to the south. There is a whole multitude because like I said earlier at one occasion that Alexander moved in from Europe and they were very generous with their sperm so there was a lot of fertilization in India, North India. Then Jangees Khan came from the northeast and that again provided another mixture of gene pool. The true Dravidians were actually now from more to the south. So we have all the material that is needed for innovation and progressively taking the new molecules to market. Yes, this whole system has actually come together recently. We have done some work with Bharat Biotech on vaccines for developing vaccines for Jigandh Muniya and Dengi. We have already done some work now, COVID related with the StoC and we are doing a lot of this work right now as we speak in Medanta. So from phase one to phase three, we have the entire ecosystem available. Our partnerships with the pharmaceutical industry is actually developing at a very rapid pace. The recognition that the regulatory is in place so that the data and the conclusions are internationally accepted. We will move and I have favoritly said that India has been a master copycat and as we always say biosimilars and genetic drugs but India is moving by will and action towards innovation and discovery of new molecules has already happened. But the regulatory was such that many of our bio companies went overseas to do their trials. That is not necessary anymore because the regulations in India are very very robust, liberal and also recognizing the strength of our own clinical trial like all the three phases that it's there and we can utilize them now more and more and it's happening already as we speak and I think it's a great opportunity for all international collaborators also to pick these opportunities in India and helping not only the Indian companies but international companies taking them from a bench to market. So I think what you just said and what the previous speakers have said that chain is now complete to go to the next step. Thank you, Naresh. Thank you and we'll dive a little deeper into some of these thoughts after we speak with Hari. Hari, let me change the tack a little bit. I said that and all of you know that India has been so successful, right? We have around 147 FDA formulation sites in India. China has only 45 of them. We have 38% of the ANDAs that come from India and the U.S. About $180 billion worth of generic drugs come to the U.S. So many successful plans and therefore it's a very natural kind of a thought that India is so uniquely placed to enhance the supply chain capabilities through the largest provider of generic drugs, not just to U.S. but globally for a long time. And the same holds good for vaccines, right? But it is also a fact that 63% of the Indian pharmaceutical imports are API and intermediates and it's also a fact that 70% of those imports come from China. So having run this sprawling jubilant pharma and you've seen how globally you run the business, do you think from an Indian perspective, from a macro perspective, is it time for India to diversify its sourcing and develop the domestic capacity so that it remains kind of self-reliant while being the global pharmacy of the world for the future in a sustainable manner? Thank you Sanat and thank you USAIC for organizing this very important panel with very important people like all of you. I'll come to this supply chain issue. But I'm dying to say something on the innovation because it's very close to my heart and I would just like to add to some of the comments made here. You know, if I study the U.S. system of innovation and the culture, one thing which Amitabh highlighted is the cluster approach, the cluster and the innovation ecosystem that U.S. offers. It's really a mecca for innovation and that's why we invested a lot in U.S. to learn that. In terms of the collaboration that we see between academia and the venture capital, the small, medium to large pharma companies, the seeding of early stage research by the government, and the vendors, all the vendors associated with it, top class human resource. And if I compare this innovation ecosystem with India, I find we have all the elements. We have all the elements. We have great human resource. In terms of contract research, we have been doing drug discovery in India for the last 20 years. Many of the biotechs which have gone into human trials, many of the drugs which big pharma have probably been invented here. So India's innovation ecosystem has been working. But what lacked was the ability to take risk and that risk capital which Amitabh also pointed out and Vijay also pointed out. And I think that situation is changing very fast. I think there is a newfound confidence that we see in the last four, five years in Indian companies to take risk. The prices of drugs because we start importing innovative drugs into India, patients are paying high prices. So today an Indian company can go into an innovative drug even for an Indian market because we could produce that drug at a much affordable price. And of course, if you can take that drug to the US market, then of course you get much higher prices and get reward for the initial high amount of risk that you take. As you know, if to launch a drug in the US market, you need a billion dollar or probably more in these cases. So I can assure you that in Indian innovation ecosystem is working and is working in a manner that we will see more and more drugs coming out of India. Presently our own company is doing, taking two drugs to human trial in US and we are going to take one drug in India, especially to bring a very affordable, we want to bring an affordable in cancer, immunology, a drug in India. So I think like us, there are many companies that you see coming to the supply chain. I must say that India was the leader in API. We are home for the best chemistry for last 50 years. We lost that advantage at some point because the Chinese company built huge capacity at one point of time. I remember 15 years back going to China, visiting a company they were operating at 10%. I said, why have you built such a large capacity? They said, no, we have been supported by the government to build large capacity. And we are going to take a large share of the global market. So what Indian companies faced is really a situation where prices were used to supply either intermediates or in some cases, final APIs. I think the Indian companies in the last 10 years have become bigger in scale. They are increasing their size and starting to build a parallel supply chain in India. I can tell you in two years will be completely free from any requirement to import from China. I can assure you that and like us, there are many companies who are doing it. Because A, even if we have to pay a little bit higher initially in India, companies have realized to build a reliable supply chain, you need to build capability in India itself. Actually, the capability exists is just that when we compete sometimes, we compete with companies which are so subsidized by the state that it is difficult. So that was one of the core reasons. So I think India will be a great supplier to US market and will be vertically integrated as Amita pointed out. Government has come out with now some very good schemes to build high capacity API plants and also key starting raw materials. So I think all that will play start playing in the next few years. Thank you, Harry. Thank you for sharing not just about the supply chain innovation that should take place, but also on the innovation that is taking place and what should take place. Now, we also have right now Chris B. Walker, who has joined us. So Chris, would you like to ask us a question? I don't know what you can hear me. Okay. Just committed the major zoom error. I was trying to speak while muted. Thanks very much. I chair the Research and Development and Manufacturing Investment Committee of the COVAX facility that is trying to develop two billion doses and get that produced by the end of 2021. One of the things that we're looking at quite often are where can we find more manufacturing capacity. And one of the things that I'm certainly seeing is that the level of investments that we're putting into both research and development and manufacturing not only can provide an opportunity to get vaccines for countries around the globe, but also offer an opportunity for companies to really accelerate their ability to do R&D and development of vaccines. And do you see this? It's hard to talk about an opportunity within COVID, but this opportunity where there's additional funding and the acceleration of vaccine, do you see this as an opportunity to increase R&D spending in India and build a particular capability in vaccines? Is this... Go ahead. Anybody can answer. Vijay, do you want to talk? Please go ahead. Chris, I think yes. The answer would be yes. I'll just give you an example. When COVID happened, there were five companies including ours. We signed a licensing agreement for Remdesivir and between the time it licensed it, in two months the product was launched, not only for India, but it is being now exported for 127 countries. So this is one small example, but definitely there are many new opportunities on vaccines that are coming up. India has large vaccine capacity. Some of the companies are known to be the supplier to the world actually. So they are partnering with many of the vaccine companies in US and other parts of the world to really participate in that supply chain. On the research side, there are two or three Indian companies who are working on... Now the clinical trials are going on. Hopefully they will be successful and many more such initiatives will happen. I'll just stop here and maybe Vijay can add more on that. Yeah. Thank you, Chris. You know what's taking off from what Hari said. It is true that Indian generics manufacturers and vaccine manufacturers have made a huge impact. Two out of three vaccines given to children all over the world come from India. But what is amazing as a consequence of this horrible pandemic is the way these big companies, smaller companies, our entrepreneurs and our academia have all gone into vaccine development, drug development in a very audacious, ambitious manner. In other words, the daring to be truly imitative and not being merely emulator has happened. And having tasted these new directions, I don't think we're going to see that stopping. As Ken said earlier in a previous panel, you need different kinds of vaccines, different roles for different kinds of vaccines. And therefore, this innovative ability in the vaccine front, in the drug discovery front, in devices and other technologies are going to see a daring to capture need of different populations and serve them. So I think this is a new direction, which is a genuine one. Thank you. Amitabh Narish, do you like to talk? Give your viewpoints, please. Well, I think, you know, if large scale supplies for vaccines for vast millions of people across the world have to be made, they will be eventually made from India because India is the vaccine capital of the world. And that's 65 to 70% of the vaccine capacity lies in India. And we have some outstanding organizations. But more than that, they've collaborated with the world. You know, some of the leading us right now who are doing all the innovation today. And therefore, I see that my personal perspective is that India will play a very key role in this exercise. But more than that, I think the COVID-19 pandemic has really given impetus to a lot of innovation in India. Actually, we were all importers of PPE or ventilators. You know, none of them were being made in India. And today we have over 500 companies which are doing manufacturing of PPE. We are a leading exporter. And in ventilators, I think all our automobile companies, we are a center for compact manufacturing. All of them became great ventilator manufacturers. So India really builds a supply chain for that. But more than that, huge innovation for, you know, as far as sample collection at home, mobile lab, diagnostic solutions, all of them. And then huge innovation in terms of telemedicine guideline and innovation of new phenomenal app on telemedicine where all the private sectors collaborated with us. And therefore, we are now doing tele-consultations. We are doing a lot of tele-monitoring in remote areas. Huge amount of innovation has taken place in India during the COVID-19 period. And my personal belief is that we see India will really, because we're not pushing for, the Prime Minister has really pushed for the National Digital Health Mission. And India will become a leading technological leapfrogging. And this will ensure equitable health services delivery in India in the future. And every individual Indian will have a unique health ID which will provide access to electronic health records. And this will be quite phenomenal. And this will really see a technological massive level leapfrogging by India. Thank you, Amitabh. Our time is up. So, Nareesh, I would not request you to add any more and let me conclude by saying that thank you very much. Nareesh, Vijay, Amitabh and Hari, it was very good to get your viewpoints, your perspectives. Thank you, Chris, for being able to join us and ask the question. And before I end, let me just remind the audience that you please participate in our online polling below the video window. You can scroll down to find the panel polling question and you can submit your answers there. The polling will be open for one minute and will announce the results before the next panel. So, thank you once again, the panelists, Chris, and thank you audience.