Public and private entities need to invest in developing innovation-oriented mindset

Where does the Indian pharma industry stand at present in terms of the value chain, innovation, and R&D?

 The road to responding to any disease is paved with Research and Development (R&D) – from understanding the ailment to responding to and eliminating it. This was further illustrated by the pharma sector’s response towards COVID – from sequencing the virus to developing multiple vaccines and therapies; R&D through collaborations across industry, academia and government stakeholders was the key. India’s commitment to spurring R&D and innovation is reflective of its rankings in the Global Innovation Index 2021. From 81 in 2015, we have moved up to 46^th place in 2021. While this may be largely attributable to research in other sectors such as space and IT, the pertinent role of the pharma industry cannot be overlooked.

The sector responded with agility to ensure the continued availability of essential medical solutions in addition to collaborating with stakeholders in developing and ramping up manufacturing of COVID vaccines and medicines, which was instrumental in minimising the otherwise adverse impact of the pandemic across the world and in India. With the focus now shifting towards increasing R&D efforts and to this end, streamlining regulatory pathways, encouraging and incentivising innovators while inviting stakeholders to invest in Indian innovation have been key priorities for the sector.

 The pharma industry is expected to grow from its current size of $42 billion – half of it is exports – to $76 billion by 2030. In fact, with the right approach and policies, we can reach $130 billion in the same period, propelling the economy towards the avowed target of $5 trillion. This will only be possible through a research-led pharma ecosystem which will safeguard against future epidemics and pandemics while propelling industry growth.

This year, the finance minister announced pharma as a sunrise sector in the union budget. What steps are needed to be taken by the industry to achieve and maintain this tag?

 The Indian pharma industry, driven by its strength in the global generics space, has witnessed tremendous growth in the past two decades. While the industry settled comfortably in the niche it carved for itself, the disruption of the pandemic spurred innovation in the sector. From sequencing the virus to repurposing drugs and developing vaccines, the pharma industry responded with agility that prompted India and other major economies to drive the self-sufficiency agenda and recalibrate their global business models. Additionally, the government’s forward-looking initiatives such as the Rs 50,000 crore National Research Foundation (NRF) planned to fund research across science and technology, among others, would further spur innovation.

For India to evolve as an epicentre of biopharma research, however, it is imperative to focus on nurturing high-risk innovation; strengthening government-industry-academia partnerships; as well as providing opportunities for investments in R&D. This is only possible through sustained policy interventions and strategic partnerships which will encourage, recognise, reward and incentivise innovation and R&D.

Undoubtedly, both public and private entities in the Indian pharma space need to invest in developing an innovation-oriented mindset and the allied skills infrastructure to transform the nation into the world’s leading pharma innovation hub. All this calls for steadfast commitment towards the R&D of diagnostics, novel medicines and vaccines that permit patients to live fuller, healthier and happier lives.

 Do you think the sector needs simplification of regulatory approval processes for rapid drug discovery and development? If so, how can it be done?

 As a result of the pandemic, the sector has gradually moved to offer complex and targetted solutions, in addition to generic therapeutics. This fast-moving evolution highlights the need for harmonised guidelines and aligned systems across processes, therapeutic areas, and product categories, as well as a close dialogue with regulators. Furthermore, as we accelerate momentum towards a research-based ecosystem, it is crucial to make the regulatory pathways more conducive, thus instilling confidence in both domestic and foreign investors which will further improve our ease-of-doing-business index.

There is a need to establish transparency through the creation of a single end-to-end digital portal that will act as an interface between the innovators and regulators. Best practices, learnings and challenges from the implementation of the Sugam Portal experience may guide this effort.

In addition to strengthening the IP landscape in the country through well-defined policies and efficient dispute resolution, it is imperative that the current provisions under Rule 101 of NDCT Rule 2019 must be operationalised. This provision allows for fast-track approval for the launch of new drugs that are already approved by certain countries. Notifying the list of countries will significantly reduce delays in bringing global breakthrough therapies that address large unmet patient needs in the country.

How can the “Make in India” initiative enhance the Indian pharma companies’ R&D capacity?

India has great strength in biopharma manufacturing which has helped it emerge as a global leader in the generic space. The government has taken cognizance of the strategic importance of the pharma sector which resulted in a series of bold policy shifts and investments to strengthen the industry. From the PLI scheme for the domestic manufacture of APIs and KSMs to the recent draft policy to catalyse innovation in the pharma and med-tech sector, we have witnessed several policies being instituted which will strengthen the industry and enhance R&D in the country owing to capacity and capability building, streamlining regulations, increasing domestic and foreign investments and collaborations and fast-tracking approvals and dispute resolution mechanisms.

As highlighted by Prime Minister Narendra Modi, the time is ripe to shift from a “Make in India” to a “Discover in India” by promoting frequent and transparent dialogues among all relevant stakeholders and providing competent training to facilitate the thrust needed to achieve the vision of India as the preferred destination for biopharma R&D. These interventions will integrate R&D seamlessly into the larger pharma ecosystem, resulting in greater value-based research output and therapies.

Creating a sustainable and credible environment for innovators to innovate freely and ensuring the protection of their innovations/ideas will go a long way in boosting confidence and investment in R&D efforts and ideas.

Since the launch of the “Make in India” initiative, how has the Indian pharma sector benefitted? What all achievements has it brought for the sector?

 In the last two decades, India’s pharma industry has accelerated its growth in both home and international markets. We have established a leading position in the generics pharma landscape because of the Make in India initiative, contributing more than 20 per cent by volume of global generics and 62 per cent of global demand for vaccines, which has been critical to improve public health outcomes in India and around the world.

The pandemic has highlighted the need for a future-ready model of disease surveillance and care. While the industry was quick to respond to COVID-19, there was an urgent need to also work towards safeguarding against such public health crises. R&D paves the way from understanding the sickness to responding to and eliminating it.

The pharma industry’s reaction to COVID exemplified this point: from sequencing the virus to producing several vaccines and cures, R&D collaborations among industry, academia and government were critical.

Throughout the pandemic, not only has the industry steadily and significantly contributed to the Indian economy, but has also spurred a 200 per cent increase in FDI, besides recalibrating the pharma and healthcare operations to maximise growth and bring optimal value to patients.

With COVID-19 disrupting the functioning of the pharma industry, how can this initiative help pharma stakeholders in the long run?

 The pharma sector in India saw a growth of approximately 13-15 per cent in 2021, with COVID-19 therapy drugs contributing 6.6 per cent to the overall growth. Furthermore, growth in the last two months was primarily driven by therapies used for seasonal diseases more so than COVID-19 therapies.

While the demand for COVID-19 drugs may wax and wane, basis the possibility of future waves, research and development, along with state-of-the-art production units can be leveraged to further shore up the healthcare ecosystem against other diseases, epidemics, pandemics while being able to meet the demands of a growing population. This will be crucial to consolidate India’s position in the global ecosystem.

The onus is now on the industry to sustain the spirit of R&D witnessed over the pandemic to create access to innovative, sustainable, safe, effective and affordable health solutions in addition to leveraging improved production units to generate revenue by expanding the country’s export footprint that will enable the industry to scale new heights.

Anything you would like to highlight/or any message for those working in the industry with regard to the “Make in India” initiative?

India’s healthcare system has always been of strategic importance not only to the country, but the world over. The pandemic, however, was instrumental in highlighting the gaps within the ecosystem, spurring the government into action to introduce a series of landmark reforms that would propel the sector into the future, equipped to address any future pandemics and safeguard patients across the world.

With the introduction and execution of the Ayushman Bharat Health Infrastructure Mission, AB-National Digital Health Mission, coupled with bold reforms in the pharma sector such as the PLI scheme for domestic manufacture of APIs and KSMs, policy to catalyse R&D in the pharma and med-tech sector, along with the recently ear-marked Rs 500 crores to support the pharma clusters and MSMEs to improve sustainability and productivity, there is a holistic purview towards healthcare which will be crucial to tackle any future epidemics and pandemics.

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