Innovative ecosystem will make India attractive: Judith Love & Amitabh Dube

What are the focus areas for Novartis in India right now and what has changed over the years?

Judith Love (JL): Novartis has had a commitment to India for many years. We are here since 1947. We were the first to open a global corporate centre, and that commitment has continued. We are celebrating the centre’s 25th anniversary this year. Our commitment as an organisation has not shifted. I think we just realised the strategic importance and the size of India.

You have got a large population; non-communicable diseases (NCDs) are growing, the economy is growing, and many stakeholders are open to seeing the ecosystem as more favourable for innovation.

All of these factors combined mean that while India was important before, it becomes even more important now.

What was the reason behind the pharma major’s decision to exit Novartis India Limited? Was it not a good fit?

JL: It is less about whether it is a good fit and more about strategically where we think we have to close the biggest need, and that is bringing innovation. Our mantra for Novartis is to reimagine medicine…. We work in highly innovative, cutting-edge, first-in-class medicines in oncology, cardiovascular, neuroscience, and immunology; that became our principal focus. We really want to make sure that these innovations reach the patients who need them. 

The largest burdens in India are in cardiovascular disease and oncology. That is where the greatest innovations are needed.

Are there plans to review the decision of exiting the publicly listed Indian arm?

JL: No, because we actually have great partnerships within India with Indian companies. It is not that we are taking products away. We are making them available to the Indian population, but through partnerships with international players. So, no, it is not something that we are thinking of reversing.

Amitabh Dube (AD): I would not call the exit a divestment. It was more like a partnership that gave a win-win opportunity. Our winning strategy is to play in innovation. We are a pure-play innovation company.

There are other strengths of the players in India. Through those players, some of the products can reach patients and benefit them significantly.

JL: It allows better focus for two companies to actually ensure that more patients benefit, and that ultimately is the objective.

What is India’s pecking order in your global scheme of things, regarding investment and revenue?

JL: I have probably got the most diverse and dynamic region with 31 countries. I do not tend to look at it just from revenue, but future potential too. In India, the economy is growing, and so is the burden of disease. The need for science is growing and appreciated. The ecosystem is evolving. We have extensive partnerships. So, it is less of a pecking order, but rather how we can work together to realise that future potential.

How is the growth in investments here? 

JL: In terms of investments, we have a global capability centre (GCC) with 9,000 associates as part of the health ecosystem within India. We have had that level of investment and focus for many years, starting right from research, commercialisation and global functions covered here. We have three development hubs across the world, and a large one in India. So we have that commitment to clinical trials. Today, we work with 330 clinical trial sites and run over 60 global clinical trials. So the investment is not a number or percentage, it is a view of investing across the ecosystem to try and actually help it evolve to bring in more innovation.

AD: India is one of the countries globally that has the full ecosystem of Novartis–from biomedical research and early drug discovery to development, operations and commercialisation. So, the commitment is huge.

How do China and India compare in terms of pharma potential? 

JL: There are two things that come to mind between China and India. The first one is just a time difference. If I look back and see China a while back, it probably looks a little bit like India today. So, it is just a different point in time. 

Another big difference is that the burden of disease and the population are increasing in India. So the needs are greater in India, which is important for a healthcare company to recognise.

Is India’s regulatory price cap a challenge?

AD: I do not think that is a big problem. The biggest advantage is that India is evolving very significantly on regulatory reforms, even pricing reforms, and the government is trying to make India a competitive market.

As we scale ourselves with these reforms and fasten ourselves in the innovation journey, we will be in the same space as in China.

Given India’s large NCD burden, with cardiovascular diseases and cancer being major components, how is Novartis planning to counter the upcoming patent cliff for some of its small molecule oncology drugs?

JL: A patent cliff is very normal in the life of a pharmaceutical company. We know the lifespan of a given product when we get it through development. We understand that our pipeline and the products coming through are the things that will actually carry you through for that patent life. All of those things are within the control of the company. So, we have one of the strongest pipelines in the pharmaceutical industry to ride these waves out.

Things like regulatory data protection (RDP) and having good intellectual property (IP) within the Indian environment are topics of ongoing discussion.

We are always fulfilling our pipeline with breakthroughs to cover the patent cliff.

Many global pharmaceutical companies in India have been discussing a 10-year regulatory data exclusivity period for first-time filers of a novel drug. Where are those discussions headed right now?

AD: We very firmly believe that regulatory data protection (RDP) is an essential component of the innovation-required ecosystem. If you want drug discovery to happen, both from an innovative industry side and for a local Indian ecosystem of innovation to grow, RDP is the basic fundamental that is required. You want the data that you generate to be protected for a couple of years, because that is the reward for the innovation that you have. 

So we have been very actively discussing, and the good part is that the government is also hearing and is trying to evaluate what would be the best option from all the perspectives to look at….. In countries where there has been RDP, there has been an eight-fold increase in clinical trials. There has been a 100 per cent increase in investments in innovation coming in. There have been faster new molecules globally being launched in those countries.

JL: In India, we strongly believe we need a generics ecosystem that is strong, and an innovation ecosystem that is strong. It’s not one or the other; it is one and the other. The RDP helps boost this, but it is not at the expense of the other ecosystem.

What specific plans does Novartis have for India on the innovation side?

JL: There is one that is coming up very soon. We have gone into an early filing strategy to try and bring a major advance in Urticaria to India….. This type of a breakthrough is important because there are around 10 million Urticaria patients within India. It is an incredibly heavy burden disease that has actually not had breakthroughs for a very long time. So it is an innovation that we are in the midst of bringing.

We were the first to bring a siRNA (small interfering RNA) for lipid lowering in the cardiovascular (CVD) space. We are committed not only to CVD, where you can modify your risk factors through diet and exercise, but also to some of the genetically-based diseases as well.  

In oncology, we are leading in radioligand therapy (RLT), and there is a lot more that we are doing in that space across different tumour types.

We have got a lot of readouts for the second half of the year. So just watch this space!

India has been stepping up its manufacturing focus. Does Novartis have any plans to manufacture in India? 

JL: We want to look way beyond manufacturing. As I said, you can have your generic ecosystem, but we must build our innovation ecosystem. We build an organisation to look at the holistic picture. That is why we have chosen to invest in research, development, commercialisation, and operations…. We have worked with some local manufacturers to partner and obtain active pharmaceutical ingredients (API).

But, what will make India an attractive manufacturing proposition for Novartis?

JL: I think the number one for us to make India attractive is to create an innovative ecosystem. That means it is an environment where you do want to come in quickly, as RDP and clinical trial infrastructure are there, the regulatory pathway is set, and we have access-related mechanisms. All of that ecosystem needs to be shaped. It is not the job of one party, but the job of so many players. I think that will make not just manufacturing, but investment in India attractive by creating the right ecosystem.

Does the fact that Novartis global CEO (Vasant Narasimhan) is of Indian origin have any bearing on its  strategy for the country?

JL: The development hub in India got set up when our CEO was the head of drug development. So, it is an advantage, but I think it is an advantage that he actually has got an R&D background. We have been lucky to have him for the last nine years.

What are the challenges in doing business in India and what changes have you seen in terms of ease of doing business over the years?

JL: There is no doubt that the government is going to positive lengths to start to reform the health environment and make it more attractive for innovation. But the barriers today, probably the most important one for an innovative company like ours, would be RDP, since it all starts with building the foundation that you have your innovations protected for the period that they should be.

AD: If you compare five years back to what it is today, we are making reforms that are required from the industry perspective. There’s a strong commitment and desire to make changes across the board. 

The part we want to see a bit more is the speed of change. The speed at which external innovation is happening needs to match the speed of reforms that the government is making.

There’s a huge amount of competition across the board, across countries. So, if you want us to stand out, we need to commit. We need to bring in those reforms. But it’s also that the reforms have to be at the right time.

When do you see India really making the cut in relation to manufacturing?

JL: When the reforms get done. When you look at Japan, China, Germany, they have RDP, good IP and regulatory paths that are reliable pathways. They have all of these baseline requirements to form an innovative ecosystem, which is why they are growing like they are and investment is going there.

There is no doubt that investments will come to India, but we have got to get some of these fundamentals. The good news is that there is willingness and momentum to make changes.