Novartis still for a wait and watch on basic research from India

Badhri Srinivasan, Head Global Development Operations, Novartis speaks exclusively to Business Today on a range of issues from investing into basic research from India, the regulatory scenario in the country to where it sees India fitting into its global growth strategy. Excerpts:

Business Today: Could you begin by giving us a sense of the work being done out of India by Novartis and how it fits into the overall scheme of things for Novartis globally?

Badhri Srinivasan: We are very strong on development in India and we think the strength of India today is in the development space and we leverage that quite substantially. And when I say development, it is the entire spectrum from conducting clinical trials, supporting clinical trials, the analytics around it as well as the submissions, reporting and working with regulatory authorities around the world. That spectrum has matured a lot for us. So, if you look at a lot of our drugs today much of those activities get supported from India and sometimes even led out of India.

BT: Some examples will help...

Srinivasan: The greatest example is Entresto(tm) (sacubitril/valsartan) tablets, previously known as LCZ696, to reduce the risk of cardiovascular death and hospitalisation for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF). The US Food and Drug Administration (FDA) approved it in July 2015. We supported all of the clinical development here. A lot of high-end analytics were performed here in India apart from the submission and marketing and reimbursement strategy worldwide was supported out of India. The other example is KISQALI, a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It was approved by the U.S. Food and Drug Administration (FDA) in March 2017. Significant portion of the development and regulatory support for it came from India. If you look seven to 10 years ago, this was not possible. India was very much of a transactional entity supporting high-end activities that were done elsewhere. That is not true anymore. For me, India is the largest global site that I have in my portfolio.

BT: When you say the largest, what are the metrics that come to you mind?

Srinivasan: In terms of the number of people that I have; in India we have approximately 4000 people. Of these, we have 1500 or so in development activity (that would be clinical trials and supporting activities) alone. The balance is IT infrastructure, support services and shared services.

BT: What about basic research? Is that at some stage going to happen from India as it has been out of China for Novartis?

Srinivasan: We feel that it will. I don't think it is there yet. The infrastructure for basic research is not yet mature for that to happen. We are waiting and watching as the ecosystem has to mature. The focus on basic research has to mature. The quality of research has come a long way and has to continue to grow and the amount of people working on basic research. Basic research requires a lot of infrastructure-the lab infrastructure and the platforms that are needed to do some of the more advanced basic research. That needs to grow as well. So, we look at the ecosystem as a whole.

BT: How do you look at the regulatory scenario in India now?

Srinivasan: From an ecosystem perspective, if you look at the regulatory side. It is lot more mature and forward looking today. There are lot more partnerships that are happening between the regulators and learning from other regulators like the USFDA (US Food and Drug Administration). We welcome all of that and we are very delighted to see that the regulatory environment is maturing. That helps us quite a bit as it enables us to function much more smoothly and have a good dialogue with the regulators and we want that to continue. If I look at regulators around the world, the way I interact with Germany is very different from the way I interact with the US, which again is very different from the way I interact with Singapore, for example. Each of those regulators and for a good reason, have a focus that is geared to their market. Sometimes, it is the right focus and sometimes it becomes a sticky situation where the focus is perhaps not there. To be very blunt, I think the Indian regulators, had a hard time with it many years ago. They have come a long way. Is there more to go? Yes, absolutely. But if you look at the progress that has been made, it is actually quite good. We are quite encouraged by the progress that has been made. It is also good that there is a good dialogue between the industry and the regulators. We did not see that before. That dialogue is a healthy dialogue. It shouldn't be one sided.

BT: Where do you see Novartis making new investments here? Or where will you want to invest your dollar, or shall we say the rupee here?

Srinivasan: The growth for us in India will continue. We are very strong on India. The areas that we will focus on will be increasing leadership from India-leadership of trials, activities, infrastructure from India. What that means is that we may have more things centred from India, being led out of India for the world. That off course does not mean that we will focus less on the world.