FUTURE OF INNOVATION: AN INDIAN PERSPECTIVE

“India has missed opportunities due to a dysfunctional system, and its contribution to pharmaceutical innovation has been modest.” Dr Ram Vishwakarma.

This article is based on the presentation given by Dr Ram Vishwakarma, Director Indian Institute of Integrative Medicine (Council of Scientific & Industrial Research) at a Synergia Foundation Hybrid Roundtable

Categorising the future of innovation in the pharma industry is a tall order to predict. The track record of pharmaceutical innovation over the last 100 years has been amazing. Today we have solutions for the majority of the problems faced by humankind.

The animal world contributed to our study of physical sciences, and then biology drove this revolution. Of course, distribution problems remain and will continue as these are managerial problems, non-scientific problems.

Science has created a multi-trillion industry globally, and within India, the employment generated by the pharmaceutical industry is amazing. ”

One clear thing is that the innovation in this sector will be driven by biology, not chemistry. Two decades back, chemistry was the driver for innovation and did phenomenally well.

But now the playing field has changed, and with the revolutions in biology, it provides opportunities for small molecules from the biological system. Small molecule therapeutic development is a fundamental shift, a renaissance in old natural products. Out of the 1500

It is concerning that disruptive changes are coming for the Indian pharmaceutical industry, especially in the regulatory environment. For example, in the U.S., there is a proposal to shift the biopharmaceutical manufacturing base back to America, and they are now heavily investing in creating these facilities odd molecules from FDA approved list, more than half will be first in class from nature.

Nature will continue to provide solutions to problems because we now have a greater understanding.

For example, next-generation adjuvants come from our understanding of plant science, as plants share the same inherent, innate pathway humans have in their systems. And these changes are happening globally.

In this natural product area, particularly for delivery offers in class two, important contributions include synthetic biology, which will provide partial solutions to climate issues. India is involved in this phenomenal research. Then is chemical ecology, which provides a role for the small molecule.

In the past, we found a molecule and developed atorvastatin from a natural product that was hit and trial method. All this has changed as now we have a scientific understanding of the role of these molecules.

Bangalore has taken some initiative in synthetic, medicinal chemistry-driven approaches globally. Now, we can have a starting point or privileged scaffold, a particular type of protein target.

And there are new ways to look at the Protein-Protein interaction (PPI), which was not available for most of 20 to 25 years of continuous failure. Now Protein-Protein interaction inhibitors are taking shape and moving up the regulatory pipeline.

One new development, which will have a major impact, is mile orthogonal chemistry which was figured in last year’s Nobel Prize and is about what can be done with chemistry in water, a living cell.

It will allow both understanding the biology and developing thera peutics required at a site.

India has missed opportunities due to a dysfunctional system, and its contribution to pharmaceutical innovation has been modest, failing to make a mark in molecule discovery in the global market.

It is concerning that disruptive changes are coming for the Indian pharmaceutical industry, especially in the regulatory environment. For example, in the U.S., there is a proposal to shift the biopharmaceutical manufacturing base back to America, and they are now heavily investing in creating these facilities. Otherwise, these facilities were in India or China. Recently, France announced that it would manufacture all its antibiotics and oncology products domestically.

Therefore, the Indian pharmaceutical industry must recalibrate for the next 20 years. Changes are happening in Africa and the Middle East, mainly because of the mishandling by rich countries during the COVID crisis.

Now they have realised they cannot depend on the Western world to supply vaccines and therapeutics in extreme crises.

Egypt and other African countries have come together in Africa, and international philanthropic organisations are pumping money to create new manufacturing capacities. In the long run, it may be a good thing for the industry because it will move from API and generic to a much greater emphasis on innovation. India has failed to analyse the industry topdown. If in the next 10-year India wants to develop five new therapeutics, it must be careful how much investment it can make on the best base of parameters.

Indian policymakers in India must factor in the high failure rate in industry innovation. India has reached the stage where it has a responsibility to provide solutions not only to India but also to grow for the rest of

To achieve this, some of the things will have to be addressed upfront. For example, we need greater integration with global knowledge, innovation and translation ecosystem; no country-specific therapeutic discovery exists.

There is an urgent need for government-industry jointly funded and managed transformational centres. But these should not become silos of some government departments manned by regular government servants.

For something as large a scale as India, 100 of these centres across the country could leverage the knowledge that is created in the system. There should be tax credits for innovation.

There are a lot of companies in Bangalore and Hyderabad that are the backbone of the innovation system in India and should not be considered only as service providers because the quality of the service they provide is recognised by the very best in the world.

We do not have to develop a parallel infrastructure to replace them; we should support them by whichever way we can. Human resources are critical, the physician-scientists.

There is a gap between academia and hospitals. Hospitals must be brought closer to research institutions.

On the regulatory side, broader expertise is needed with the regulator. During the COVID crisis, it was seen that many of the innovations made abroad could not be brought to India in a quick enough time frame.

The regulatory system needs to be proactive and supportive, and it should help innovators to walk through the regulatory path rather than become a hindrance.