India has robust manufacturing capability with sufficient skilled manpower to foster innovation

Give us an overview of the major advancements, shifts and trends in healthcare and lifesciences due to the COVID-19 pandemic. How will these spur investments in the research and manufacturing of biopharmaceuticals in India?

The pandemic made the world rethink the way of doing business across industries. It’s no different for the biopharma industry. One of the major disruptions seen in 2019-2020 was the immediate need to ensure that the production of raw materials critical for the development of drugs and vaccines and other essentials for maintenance of the healthcare system was not affected. However, with multiple countries around the world going into lockdown to contain the spread of the pandemic, there was a large-scale shortage and an inability to access raw materials due to international transportation restrictions and protectionist measures. This made businesses reconsider and rethink the way they sourced their raw materials from a single source/country. Experts have underscored the need to build resiliency through diversification to offset risks posed by factors such as natural disasters, political upheaval and disease outbreaks.

Over the past few years, lifesciences companies have faced intensifying pressure from many directions, including cumulative regulatory necessities, constant technological advances and intense pricing pressure. Moreover, the unprecedented pandemic has accelerated the need to modernise compliance and upraise the value and partnerships within syndicates as well as external stakeholders.

India is an emerging hub in the biopharma and biosimilar industry and currently tops the chart for domestically-approved biosimilars and clinical trials surpassing the US and Europe. Hyderabad is a major scientific and R&D hub with over 800 lifesciences companies and an emerging destination for biopharma, biosimilars and vaccine manufacturing in India. Given India’s prevalence of cancer, diabetes, rheumatoid arthritis, respiratory and other immune-mediated diseases, there is a need to manufacture affordable biosimilars and further develop novel approaches in biologics and vaccines, and revolutionise cell- and gene-therapy manufacturing. Pockets of promise have already emerged – for instance, a startup backed by the Indian Institute of Technology and the National Cancer Institute in the US, which has been the “knowledge partner” for the research effort, hopes to deliver a cut-price CAR-T cell therapy.

There is also an unmet need to cater to India’s rare and neglected diseases where our capabilities in biopharma and vaccines can be explored further.

With the lessons learnt from the coronavirus pandemic and prior biological calamities, it is important to have a further structured ecosystem for pursuing different variations in the biopharma and lifesciences space to manage future biological risk.

India has already demonstrated its strength with COVID-19 vaccine manufacturing as well as developing its own vaccines. However, we cannot ignore the fact that there are individuals who are vaccinated, who can still be prone to infections with new SARS-CoV-2 strains, and a large part of the world still remains unvaccinated.

On the other hand, business and manufacturing automation also saw an unprecedented uptake to ensure that business continuity was in place and optimised, based on the challenges that they encountered. Repurposing of already approved molecules for additional indications, including the COVID-19 virus, was also looked into. During this period, digital acceptance grew to unprecedented levels across industries that changed the way research and development, sales and marketing, learning and development, health care professional engagement, etc. were conducted. Almost all documentation from the laboratory, the regulatory departments, to the doctor’s clinic, became paperless. Even audits were carried out in real-time and remotely. The pandemic is also estimated to have triggered the development and release of a tsunami of digital health apps in 2020.

The pandemic has underscored the need for global benchmarks of quality and supply reliability for pharma/biopharma products. So, as a major player, how is the Indian biopharma industry working towards global harmonisation for biopharma regulatory guidelines and drug discovery?

The rigorous and robust regulatory process in the biopharma segment can, at times, lead to uncertainties in approval timelines for products. During the pandemic, various regulatory bodies, governments and pharmaceuticals companies came together to find solutions to fast track development and approval timelines in view of the unprecedented situation. In doing so, they were able to collaborate towards regulatory transparency, continuous dialogue with regulators, advance mutual recognition agreements (like the FDA has with EU member states, etc), application and acceptance of digitisation of records. This is an ongoing process, and will potentially be the way forward to ensure an effective and streamlined regulatory system.

India has also been moving towards Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership, but needs support from across industry/stakeholders. The pandemic has also shone the light on the potential to accelerate regulatory processes as well as the importance of partnerships and transcending boundaries both in R&D (as we saw for COVID-19 vaccines) and on the regulatory front.

India has been working to address concerns around long approval timelines; for instance, setting up a new API manufacturing plant in India historically could require securing several approvals from multiple departments of state and central governments. With multiple regulatory bodies directly or indirectly engaged in framing rules and guidelines for the pharma and bulk drug segments in India, this can, at times, lead to sub-optimal allocation of resources at the policy-making level. However, for instance, the new Production Linked Incentive (PLI) scheme for active pharmaceutical ingredients (APIs)/key starting materials (KSMs) aimed at self-reliance and securing the country’s medicine supplies, provides for time-bound clearances. Approval timelines have also been streamlined in the clinical trial segment in the country.

Access and innovation are the buzzwords in the lifesciences industry, not just in India, but across the world. So, which are the focus areas for the industry to build and accelerate progress on both these fronts? Why?

The most important buzzwords in the lifesciences industry globally are ‘innovation’ and ‘access.’ While these have been well-known in the industry earlier, the pandemic has spotlighted the multiple roadblocks to ‘innovation’ and ‘access’ to the forefront and full view of the world.
Innovation – The pandemic has served to spur biopharma research and development (R&D) backed by the multi-billion dollars provided by governments to support the development of vaccines and drugs. However, the ‘Big Pharma’ remains continuously in the hunt for new assets amid some challenges in late-stage development, as evidenced by continued targetted licensing deals and mergers and acquisitions, while investment flows into the biotech/bioventure sectors remain strong.

Oncology remains the main R&D focus globally, with the now well-established immunooncology approaches and newer modalities such as gene therapy, and even “post gene therapy” research continuing to progress. Rare diseases continue to generate interest given the high medical need and the possibility of profitable niche positions amid limited competition. Meanwhile, completely new options such as digital therapeutics continue to nudge the ‘Big Pharma’ interest, investment and deals.

The pandemic-related difficulties in recruiting and running clinical trials have accelerated the development of new approaches to this phase of development including decentralised trials, the use of virtual tools and remote monitoring, as well as the greater exploration of real-world evidence in the R&D process. Multiple initiatives are underway at major regulatory agencies globally to guide these changes and build them into processes in the future.

Access – Continuing inequities in global access to COVID-19 vaccines have cast a spotlight on wider issues around access to new medicines and medical technologies, and some of the existing global COVID vaccine distribution programmes have missed their targets. While companies have recently renewed their commitment to the COVID-19 Vaccines Global Access (COVAX) facility, the R&D-based industry continues to be generally opposed to intellectual property waivers around the vaccines, instead of focusing on increased production capacity and selected licensing deals.

More broadly, the innovative pharma industry continues to be involved in multiple individual company schemes, such as patient-assistance programmes, to improve access to selected products. At present, much of the access debate is focussing on the costs of newer and expensive, but often highly effective, technologies such as gene and cell therapies.

The industry faces the challenge of communicating the broader health and economic benefits of these one-time treatments. Part of its approach has also been to encourage holistic debate on the funding and efficiency of healthcare systems and the overall economic benefits of new medicines to create sustainability and the financial headroom to accommodate such treatments.

What is the strategic approach needed for India to move away from mere incremental innovation and become a global player in innovative drugs? What are the strengths to focus on and the challenges that can hinder the country from achieving its research and innovation potential?

It is well-known that investment in research and development across sectors is the only way to remain competitive in the age of globalisation. With a population of around 139 crore Indians, there is no dearth of talent. However, the focus on developing high-quality scientific breakthroughs has not been a focus area for many years. With the pandemic forcing individuals, organisations and institutions to bring out frugal and scalable solutions to solve the multitude of healthcare and other problems that the country was facing, there were a large number of solution providers that came forward to save the day. Now that it’s evident that talent is available but has to be nurtured, a long-term approach needs to be followed with:
◆ a focus on nurturing scientific talent at the entry-level as seen in the approach of the Indian Pharmaceutical Alliance (IPA).
◆ fostering more industry-academia collaboration for breakthrough research.
◆ building separate R&D setups/subsidiaries with sufficient funds and autonomy.
Innovative startups should be spotted and encouraged early on with financing, so they don’t have to look offshore for support. Venture capital firms should step in where publicly-held companies are unable to. Another route for achieving the goal of accelerated high-quality research is through partnerships with global research-based biopharma companies, and companies like Biological E and Gennova Biopharma are set to bring cutting-edge mRNA technology via this route.

On the policy front, the Indian government has set the right tone by offering incentives for areas like cell and gene therapy, apart from building self-sufficiency in APIs. Now, the industry needs to follow through with the right intent and execution.

India has robust manufacturing capability, with sufficient skilled manpower to foster innovation and the COVID-19 vaccines developed by Bharat Biotech and Zydus Cadila are examples. The challenge lies in shifting focus from easy gains to a high-risk approach that might not always be welcomed by shareholders, but could yield dividends in the long term.

At the same time, one needs to remember that India’s “Pharmacy of the World” status is on account of the economically viable drug options it engineers, without which several low- and middle-income countries would be bereft of options. The COVID-19 vaccines are a classic example of the invaluable contribution India makes globally.