India’s vaccine manufacturing prowess

India’s capabilities in the manufacturing of vaccines came to the fore during the COVID-19 pandemic. The world became witness to India’s vaccine manufacturing prowess as India provided equitable access to resilient supply chains and logistics - further strengthening its position in the vaccine segment. 

Although COVID-19 initiated the necessary boost to streamline and optimise manufacturing processes, India’s growth in the vaccine segment has been steady. Over the last two decades, major pharmaceutical companies have invested heavily in increasing their manufacturing capabilities, catering to the huge global and domestic demand. Therefore, India has emerged as a dominant force in vaccines for diseases such as measles, Bacillus Calmette–Guérin (BCG), and Diphtheria, Tetanus and Pertussis (DPT). For instance, India accounts for nearly 90% of the global demand for the measles vaccine [1]. The growth has resulted in dominating the space with 65-70% of the vaccine requirements of the World Health Organization (WHO) being sourced from India. India now supplies ~60% of the global demand for vaccines, with ~33% of vaccines supplied by Telangana’s life sciences ecosystem only [2]. Biologicals and formulations (including vaccines) account for 77.5% of India’s pharmaceuticals’ export portfolio. During the pandemic, by utilising the vibrant vaccine manufacturing ecosystem and adhering to the core Indian philosophy of Vasudhaiva Kutumbakam – the world is one family, India not only provided vaccines to 1.4 billion population but also catered to the world community with India supplying 242 million low-cost and high-quality vaccines to 101 countries [3]. 

India is not resting on its laurels in the vaccine segment. The Government of India (GoI) lays strong emphasis on Research and Development (R&D) with the objective of developing novel technologies to venture into new therapies. The Department of Pharmaceuticals’ recently released draft policy to catalyse R&D and innovation in the pharma and medtech sector (2021) aims to create strong academia-industry linkages, further promoting translational research, and manufacturing processes [4]. Specific and concerted efforts by the government are undertaken to strengthen the pharmaceutical industry - recovering strongly after the COVID-19 pandemic. The GOIs strengthening of pharmaceutical industry scheme lays the framework for streamlined collaborations between different stakeholders with the total financial overlay of 500 crores [5]. Moreover, production-linked incentives encompass a financial overlay of 21940 crores with a strong focus on vaccine development using emerging technologies [6]. The USA, Japan, and Australia are also providing the necessary support to India to further expand its vaccine manufacturing capacities. The expansion of production capabilities will be important for providing equitable access of vaccines to countries in the Indo-Pacific region. Further, global organisations such as Gavi, the vaccine alliance and Coalition for Epidemic Preparedness Innovations (CEPI) are also promoting new-age technologies to produce highly efficient vaccines in the shortest time possible. For instance, CEPI’s 100-day mission aims to develop a new vaccine for a disease X in 100 days [7]. It is an excellent opportunity for India to provide solutions in drug development, manufacturing, and supply chain.

The future of vaccine manufacturing will not be in silos or in an emergency response manner, as was observed during the pandemic. Strong sectoral and cross-organisational collaborations are expected to design novel methodologies to tackle future epidemics and infectious diseases. Financial and strategic investments will push the development of new vaccine manufacturing technologies such as continuous flow processing, additive, and integrative manufacturing. A significant factor in India’s success during the pandemic was the fast and efficient scale-up of manufacturing facilities by Indian pharmaceutical giants. Strong technical knowledge, highly skilled workforce, and scalability are the main factors that will continue to setup advanced standards of production in India. 

Traditionally, India has been a world leader in generics and biosimilars. India is further expected to develop advanced technologies of the future – deep technologies, for instance, cell and gene therapy and artificial intelligence in life sciences. It is expected that the majority of market share for future epidemics and infectious diseases will be shared by companies investing heavily in deep tech. India’s success in the information technology sector can be leveraged to generate new partnership opportunities for the life sciences industry. New technologies will lead to innovation in manufacturing processes. For instance, a crucial component of cell and gene therapy is the utilisation and development of highly efficient viral vectors. Therefore, Indian pharmaceutical players should start investing in viral vector manufacturing plants. Existing 740+ US-FDA approved plants can be optimised for novel innovations in manufacturing processes - keeping India on the right trajectory to achieve the pharmaceuticals’ market size of $ 130 billion by 2030.

This is authored by Dr. Gagan Sharma.