Indian Pharmaceutical Industry 2021: future is now February 2021 1 2 12 22 Indian pharma Accelerating research industry: current and innovation scenario and future potential 3 4 88 120 Achieving equitable Strengthening and sustainable manufacturing and supply healthcare base in domestic and global markets 5 144 Improving access to medicines Contents ForewordForeword The Indian Pharma Industry is poised for a big leap forward in this decade. Health, Science and Access and Innovation have always been the two key driving factors for progress in healthcare, not just Innovation have come into sharp focus as never before. The developments over the past year have in India but across the world. The COVID-19 pandemic has further underscored the critical importance of underlined the importance of an innovation ecosystem, a robust infrastructure for production of drugs these aspects to secure both the immediate and the long-term health and wellbeing of our citizens. This and pharmaceuticals and the need to constantly build a huge talent pool of scientists, researchers report provides a detailed view of the tremendous achievements of the pharmaceuticals sector in India, and technologists who can be the arrowheads for the future. India has emerged as a pharmacy to the while also laying a template of what we must do, collectively as stakeholders, to accelerate this progress. world, supplying critical drugs and vaccines in the course of this pandemic. To be able to do this more Important themes of accelerating research and innovation, achieving sustainable and equitable consistently, we will need to have a greater thrust on innovation, investments in new technologies, take healthcare, strengthening manufacturing and supply chains are addressed as both success stories and a futuristic view in our approaches and look at new possibilities that can capitalise on our strengths. Pankaj Patel S Sridhar future imperatives. We take up the need for supporting quality research institutions, upskilling a skilled Building on the theme of Aatmanirbhar Bharat we need to create visibility on ‘Brand India’ centred on workforce and enhancing collaboration between stakeholders and academia. FICCI Pharmaceuticals manufacturing and innovation. We will also need to look at global benchmarks of quality and supply Immediate Past Chair, Committee Mentor reliability to increase pharma exports. As we build capabilities for producing innovative drugs and FICCI Pharmaceuticals Innovation does not only pertain to bringing novel therapies to market, but to exploring new and and Chairman, Zydus complex to manufacture generics, we will be able to access newer global markets. As we do this we will Committee and MD, sophisticated approaches on pricing and funding that take them to patients. We take up the need for India Cadila need to focus on streamlining our regulatory environment and also look at how we can sustain our cost Pfizer Limited to explore innovative new solutions to sustainably enhance access while ensuring that we maintain a competitiveness. Above all, India must look at building next-gen capabilities that will be a differentiator in positive operating environment for R&D investments and risk-taking to thrive. the decade ahead. This is a time for the Indian Pharma Industry to move ahead full throttle, invest for the The renewed focus on leveraging digital technologies to increase awareness, prioritize the needs of the future and catapult itself into a new horizon of growth and opportunities. less economically privileged is heartening. Undoubtedly, global healthcare has taken a drastic turn with its focus on preventive healthcare and it is a step in the right direction towards a healthier tomorrow! We hope that this report serves as a thought starter and a guiding document for all stakeholders to collaborate, envision India’s healthcare future together and bring these goals to life. Innovations from the pharma industry in India and globally are driving better health outcomes. The current focus needs to be on novel and targeted therapies. Scientific advancements along with industry — academia collaborations will benefit the pharma industry and facilitate its growth. Apart from this, technology can be a huge enabler across the value chain starting from diagnostics to treatment and drug delivery. It can help reduce costs, enhance quality of treatment as well as its access. The government has The Indian pharmaceutical industry has grown from strength to strength in the last few decades. The taken initiatives to reduce regulatory approval time and Ayushman Bharat to make drugs accessible to the industry has shown tremendous resilience in its ability to serve people in India as well as across the globe, massive population of India. This report gives a preview of advancements that are leading to changes in ensuring accessibility and most importantly affordability of quality medicines. Gagan Singh Bedi global healthcare. The pandemic has highlighted the growing complexity of challenges that lie ahead and the need to strengthen India’s capabilities, over the next decade, to respond to them adequately. EY has collaborated FICCI Pharmaceuticals with FICCI to put together this report, collated insights from a wide array of stakeholders – the Indian Committee Chair and government, pharmaceutical and healthcare industry leaders, functional experts of the pharma industry Country President & Sriram Shrinivasan and experts in the allied sectors — and complemented it with extensive secondary research, leveraging EY MD, Astra Zeneca India global research outreach, to give you a holistic view of the entire ecosystem. Limited National Health Sciences Leader Leader – EY India The pandemic has also revealed the importance of Digital in all walks of life. This fits in well with two sectors that India is strong in — Technology and Pharmaceuticals and the convergence of both these strengths could make India a leader in the Healthcare of tomorrow. The unique challenges and the way forward have been discussed under chapters dedicated to the objectives of accelerating research & innovation, achieving equitable and sustainable healthcare, strengthening manufacturing and supply chains and improving access to medicines. We must take upon ourselves a moon-shot target for the pharma industry in India, whereby all stakeholders come together on one platform and take a pledge of commercialising Indigenous new chemical entity and new biological entity OR novel drugs (both biological and chemical). This will take unprecedented effort and resources, however if there is anything positive that has emerged from the COVID-19 pandemic, it is that nothing is impossible if we bring in right stakeholders on one platform for the larger good of human-kind. Our very future depends on it. We hope that this report acts as guiding document for the stakeholders, prompting policy as well as action, while we set out to bring the envisioned goals to life. EY remains committed to support all stakeholder of Indian pharmaceutical industry on this journey of future excellence. ExecutiveExecutive Summary Summary The position paper, Indian Pharmaceutical Industry 2021: geographies. The pharma industry will be closely monitored by Figure A: India's growth ambition 2030 future is now, has been written with an objective to reassess governments in all countries in times to come. the Indian pharmaceutical industry’s positioning in the world 10 It is imperative that India reevaluates its current role within 3 130 order, define India’s ambition by 2030 and identify a set of 5 the global pharmaceutical industry, explore possibilities 9 imperatives for all stakeholders to realize this ambition. 120 to consolidate and strengthen its positioning in light of 18 The pharmaceutical industry, along with the healthcare sector geopolitical and economic shifts, attain self-sufficiency as a 1 globally, has been impacted in an unseen way due to the globally competitive pharmaceutical industry with innovation 100 6 2 10 73 outbreak of the COVID-19 pandemic leading to material impact as a guiding principle for future growth. This paper addresses around consumer requirements and preferences accompanied the ambition for the current decade in consultation with 80 34 by macroeconomic, structural and microeconomic changes industry veterans across segments, with inputs from the 1 in the end-to-end value chain. In the midst of the pandemic government, regulators and pertinent industry associations. US$ Bn 60 and a changed world, the pharmaceutical industry across 1 From March 2020 onward, the industry has been hit by 42 the world has responded with agility — from the sequencing 0 debilitating restrictions and impediments to reach customers of the novel coronavirus in January to vaccines being with expectations to operate and supply drugs to those in India 21 5 administered to the first recipient in the United Kingdom by and globally. The pharma industry exceeded expectations in 20 December 2020, with efficacy levels over 90%, exceeding responding to this global crisis, supplying drugs to over 150 21 all expectations of governments and markets across the countries besides meeting all domestic demands. Significant - world. This innovation has been possible owing to the most vaccine capacity ramp up has been achieved over the year Current Business Biosimilars/ Universal API/SM Adult Generics-china, Biosimilars Adult NMEs Ambition extraordinary global efforts: collaboration like never seen size as usual Novel health Import vaccines Japan, others Vaccines