Favourable Policy Landscape to Drive Innovation in Pharmaceutical Industry

Dr. Navneet Tewatia, Associate Secretary General, Indian Pharmaceutical Alliance

Rising importance of the Indian pharmaceutical industry

The Indian pharmaceutical industry has played a pivotal role in driving better health outcomes across the world through its affordable and high-quality generics medicines. The contribution of the industry has become even more prominent since the last year as India continues to support the global response to the COVID-19 pandemic.  The industry stepped up to meet the challenges posed by the pandemic and ensured consistent supply of medicines needed in the management of COVID-19 (e.g., HCQ, Itolizumab, Remdesivir, Favipiravir, Dexamethasone etc.) across the world strengthening India’s position as the ‘Pharmacy for the World’.

There have been many examples where innovations by Indian companies have improved the quality of healthcare across the world. The Indian industry has pioneered the development of affordable heat-stable fixed-dose combination of Antiretrovirals (ARVs) for paediatric use, alcohol-free and pleasant-tasting granules (combination of four ARVs in the form of granule-filled capsules). This formulation has enabled great advances in the treatment of the children living with HIV in low-and-middle income countries by improving compliance. The Indian industry has also successfully obtained the first-ever WHO approval for rectal artesunate suppositories (RAS) for the pre-referral management of severe malaria in children. The innovations by the Indian industry have also contributed to bring down the treatment costs of life-threatening diseases such as Chronic Myeloid Leukaemia and viral hepatitis C, to less than five percent of the original cost. The prices for Hepatitis B vaccines have also been brought down due to these innovations.

As we look forward, Indian pharmaceutical industry must move up the value chain and build its position in the innovation space to further augment its contribution to Indian and global healthcare.

Favorable Policy Landscape to encourage innovation at scale

Several leading countries such as the US, UK, Israel, Switzerland and China, among others, have built a strong innovation ecosystem for pharma and med-tech. A favorable policy landscape through coherent policies across scientific research, technology scale-up and commercialization, funding, Intellectual Property framework etc. has proven to be a key building block in developing the innovation ecosystem in these countries. Currently, India has  innovation and R&D policies for different product groups with each having different goals and outcomes and vastly different timelines. These numerous policies lead to incoherence and make articulation as well as the implementation challenging. We need to have a robust governance framework that provides favorable regulatory environment to nurture innovation.

There is a scope for strengthening policy framework for pharma innovation and R&D. The framework of the innovation and R&D policy should focus on a common vision to offer universal access to healthcare with equity promoting self-reliance and being responsive to the healthcare needs of the citizens of India. The common goal of the policy should be to promote indigenous drug discovery which would significantly improve India’s position in the pharma value chain. The policy should aim to promote R&D to reduce the burden of neglected diseases in India which would pay for itself in the form of improved social and health outcomes and reduced morbidity.

The innovation and R&D policy should identify and drive synergies between all stakeholders in the drug research and development. Developing these synergies in scientific research, technology commercialization, IT investments, education and skills development, tax, trade, IP, in an integrated manner is essential to drive a sustainable innovation ecosystem.

Vision for a sustainable innovation ecosystem in India

Creating an interconnected network of industry, academia, start-ups, business schools, clinical settings, funding agencies (including VCs) to deliver solutions will help shape the innovation ecosystem in India. While few innovation clusters exist in India, the current infrastructure is limited and concentrated in a nascent innovation hubs in the country, emphasizing the need for more high-quality infrastructure. To support innovation and for pharmaceutical industry to flourish, the government needs to enhance quality of infrastructure which can be achieved by scaling up ‘innovation hubs’ in the country. This would provide industries, academia, incubators a co-location and create a valuable innovation ecosystem. Incentives such as tax exemptions and plug and play facilities, and local regulatory support for speedy approvals should be offered to companies in these parks. Public Hospitals should be provided IT and data management systems to create adequate support for clinical trials and encouraged to participate in clinical trials.

Impact of building a strong innovation ecosystem

Innovation will drive the next wave of growth for the industry with potential to propel projected growth rate from the current 7-8% to 11-12%. This will lead to a substantial increase in the global market share by value enhancing Indian pharma’s significance beyond generics, to biologics, new drug development and incremental innovation thus positioning India as the true “Pharmacy of the World”. It will also mean the Indian pharmaceutical market will feature into top 5 markets by value globally,  from its current rank of 11th and become world’s largest supplier of drugs by volume.

Creating a stable and supportive policy environment for the pharmaceutical industry is a critical step towards building a sustainable innovation ecosystem. The government has a crucial role to play in the growth of the pharmaceutical industry. Building presence in the innovation space is now a high priority for India in order to both address the needs of the healthcare system in the country, as well as maintain relevance in the global pharma and med-tech space. India has several strengths to leverage, and a strong starting position to build on, as it looks to evolve beyond its successful journey of “Make in India” towards the vision of “Discover in India”.