According to a GlobalData poll, 35% of pharmaceutical industry specialists feel the COVID-19 epidemic has accelerated digital transformation by more than five years in the pharmaceutical business. Apart from virtual connections, industry insiders feel that technology has aided Indian Pharma in training and linking doctors with worldwide specialists for information transfer, and that this trend would continue in the future. However, the pharmaceutical business is currently under new pressures. Apart from a clogged supply chain, the rise in raw material and API (active pharmaceutical ingredients or medicinal ingredients) prices are substantially to blame. According to IDMA, industry has been experiencing significant cost increases as a result of imported raw materials and excipients, with some of these increases being quite substantial. While this is a challenge that Indian pharma is now facing, the industry’s main goal is to transition from being the world’s pharmacy to becoming an innovation hub. The FE Pharma Summit will bring together key stakeholders to explore what the sector needs to do to go forward on this path, as well as what role the government may play as an enabler. The role that technology can play in this is also being considered. How can they look at developments in drug discovery, nanotechnology, and other areas and encourage think leaders to debate how to build the industry in a way that is both successful and sustainable? Some say that one approach to deal with Chinese competition is to use sustainable or green manufacturing. Finally, there’s the issue of the constantly shifting regulatory landscape. What some of the more recent provisions may imply for the sector and the future.
On Thursday, March 24th, the first session of the two-day FE Pharma Summit 2022 began with the topic of transforming India from being the world’s pharmacy to emerging as an innovation hub. Leading figures from the Indian pharmaceutical industry, including Dilip Shanghvi, founder and managing director of Sun Pharmaceutical Industries; Pankaj R. Patel, chairman of Zydus Cadila; Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals; and Kiran Mazumdar-Shaw, executive chairperson of Biocon Ltd and Biocon Biologics Ltd, took part in the panel discussion. Making India a centre for clinical trials, as well as taking efforts to develop a market in India for novel pharmaceuticals, as is the case in China, were some of the topics discussed in depth by industry professionals, who presented clear and practical plans to create an Indian market for unique drugs and enabling environment.
Pankaj Patel, for example, advised that a Rs 50,000 crore fund of funds for medicines be established to stimulate research, support research institutes, industry, and generate markets. “That’s how I’d like to go with the voyage.” If that happens, India might have at least five new chemical entities in the globe,” he said. “As a short-term measure,” Kiran Mazumdar-Shaw said, “it would help to ensure academic and corporate partnerships in research if we could delve into the 50, 000 crore National Research Foundation (NRF) that has been created and at least allocate half of that to industrial research, of which the pharma industry deserves a big chunk.”
Kiran Mazumdar-Shaw, executive chairperson of Biocon Ltd and Biocon Biologics Ltd, also thought there was a case for tweaking the Indian accounting system to make R&D a capital investment rather than an expense, so investors could be convinced of the importance of high-risk, high-return investments in innovation to reap the benefits of non-linear growth. “We need regulatory reforms,” she continued, “which the Central Drugs Standard Control Organisation (CDSCO) is proposing on the basis of the need to develop in terms of giving strategic boost to research and innovation in the country.” There is a need to build regulatory science and faster regulatory pathways that are not only constrained by strictures, but also ensure that deemed approval processes are completed in a timely manner. She pointed out that the upcoming new regulations will get us closer to awarding considered approvals, which, if implemented, might speed up the innovation process even more.
She went on to say that the government should provide risk capital grants and incentives for drug innovation, such as the reinstatement of the weighted tax deduction. She also proposed a patent box system. Kiran Mazumdar-Shaw believes that using India’s assets and making India a significant worldwide destination for clinical trials is necessary to accelerate innovation. She claimed that India had good medical centres, CROs, physicians, and other factors that might be used to make the country a popular destination for clinical trials.
Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, agreed that creating an ecosystem would be difficult without government support. Dilip Shanghvi, who agreed with everything his co-panelists and industry friends said, was optimistic that Indian pharma businesses will be able to duplicate their success in the innovation sector, as well as the kind of influence they had in generic medication manufacture. Glenn Saldanha went on to say that the government should promote industry through funding, tax incentives, and regulatory reforms. He cited China as an example of how the country was able to exploit its vast domestic market to attract foreign investors while simultaneously investing in innovation and growing indigenous competence. He also believes that alternate funding mechanisms, such as partnerships, are the only way for many Indian pharmaceutical businesses to fund innovation in the country because they cannot afford to do it all on their own.
“In order to enhance innovation in India, there is a need to streamline regulatory environment, incentivize research and development in such a way that India companies are encouraged to participate in high risk research,” Dilip Shanghvi stated in his closing remarks, agreeing with the other panellists. He also believed that India needs to entice international corporations to do research in the country by developing an environment that would allow them to exploit their research through tax benefits, easy access, and the ability to price their products differently in India.
As India approaches an inflection moment in its global growth journey in the pharmaceutical sector, it is hoped that some of the constructive and realistic ideas and policy measures offered by industry leaders will be mirrored in government policy measures. It is now commonly referred to as the ‘global pharmacy.’ This is due to the fact that it is the country with the most drug manufacturing facilities for tablets and pills outside of the United States, and as a result, global consumption of Indian-made medicines is high. In the case of the United States, which is a lucrative worldwide market for pharmaceuticals, one out of every three tablets used in the country is manufactured in India. India is also a big vaccine producer. However, the epidemic has resulted in numerous unanticipated reversals, with the only good impact being a swift ascent of healthcare into policymakers’ minds, as well as an awareness of the necessity of innovation. Taking use of India’s existing capabilities and embracing some of the industry titans’ recommendations could go a long way toward creating the much-needed enabling environment for innovation.