Focus on innovation, government-industry synergy key for India to become pharmacy of the world

Indian pharma industry currently ranks third in terms of pharmaceutical production by volume. This makes us a clear leader in the generics market. However, in terms of value, we rank 14th. To move up the value chain and get into the top 10 by 2030, we must focus on pharma innovation, which accounts for 2/3rd of the global pharma market value, developing an innovation-based pipeline of next-generation drugs and solutions to address the unmet needs of patients of India and the rest of the world. The Indian pharma industry is strongly positioned in terms of production capacity and is also committed to growth. Many of the larger companies have already increased their investments in innovative drug development and may be boosted further by the government’s policies that incentivize their efforts through schemes like production-linked incentives (PLI) and the upcoming research-linked incentive (RLI). Even the small and medium-sized pharma companies can now upgrade their facilities to global manufacturing standards and unlock their innovation potential supported by government schemes aiding technology upgradation, setting up of common research facilities, and effluent treatment plants in pharma clusters. Our industry is largely reliant on the import of patented drugs and critical raw materials like Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs). We must become self-sufficient and competitive in KSMs and APIs to boost the growth of this sector. The government’s PLI scheme is designed to boost API production and research, and in the long run, can address the concerns of drug security of the rest of the world, currently largely dependent on Chinese supplies. While the PLI scheme will largely help us grow bigger by volume, the eagerly awaited RLI is expected to improve our capacity to innovate and shift from being a low-value high-volume to a high-value high-volume player in the global pharma market. A multi-pronged approach to innovation The R&D and clinical trials in the Indian pharma industry are traditionally risk-averse as they face several obstacles that may stifle innovation, such as a convoluted approval process, sketchy guidelines for new drug development, and underpowered and understaffed regulatory bodies. Many of these are currently getting addressed, boosting the industry’s efficiency and competitiveness through many government initiatives like RLIs, grants, subsidies and higher tax aids for R&D designed to incentivize investment in innovation. Innovation in the industry can be achieved through a multi-pronged approach involving not only such favourable policies but also an enabling regulatory ecosystem, robust funding, activating industry-academia linkages, and providing high-quality infrastructure. We need to build our appetite for risk capital to fund mid to late-stage development, given the long gestation period and high failure rates typical of this industry. Currently, the average Indian pharma industry funding for research and innovation stands at 10 per cent, just about half that of the companies from the developed world. While this share must increase to match the global standards, the government, which mostly funds the early innovation in drug discovery, too must raise the funding ceiling and stretch the funding period from the current maximum. Industry-academia collaboration is an established global template of innovation and the pharmaceutical and biotech companies are accordingly aligned with the academic research ecosystem. AstraZeneca and the University of Cambridge, Novartis and Harvard/MIT, Amgen and the University of Ireland or Singapore Biopolis and NUS are a few such very strong examples. Collaborations like this in India too can attract talent from both digital and life-sciences backgrounds and can enhance capabilities across the industry’s value chain, from new drug development to manufacturing. High-quality infrastructure is the key to innovation. The government paved the way by facilitating the emergence of incubators for innovation and we already have over a hundred of them boosting various start-ups. This incubator ecosystem is a ready opportunity for the Indian pharma companies to boost their product portfolio and pipeline, and therefore also becomes their responsibility to collaborate with the government to enhance infrastructure by upgrading the quality of the national labs and boosting capabilities for new types of testing methodologies. Innovation can also thrive in a rationalised regulatory ecosystem with strong governance, procedural transparency, and well-defined approval timelines. Such a simplified yet overarching regulatory system would facilitate the ease of R&D and faster approvals. Innovation in Indian pharma key to the India growth story Indian pharma contributes about 2 per cent to India’s GDP and around 8 per cent to our total merchandise exports. Our aim to become the global pharma market leader is critically dependent on serving the global patient needs and therefore large-scale innovation and production boost. The recent pandemic did witness the government announce some incentives to accelerate innovation and fund development. It is now high time for the industry to get into mission mode to increase the risk appetite and achieve the collective ambition of reaching $130 billion by 2030. This can become a reality only if the industry and government synchronize their efforts to collectively become a global leader substantially boosting our GDP and providing a brilliant shine to the make-in-India story. The author is Senior General Manager - Innovation, Bharat Serum & Vaccines Ltd. Views are personal. Read all the Latest News , Trending News ,  Cricket News , Bollywood News , India News and Entertainment News here. Follow us on Facebook, Twitter and Instagram.