Catalysing and Accelerating a New Phase in Indian Biopharma

The Indian pharmaceutical industry became ‘the pharmacy of the world’ primarily because of its capabilities to produce quality generic drugs cost-effectively through ‘reverse engineering’ skills. A similar success story lies behind biogenerics produced through the biotech route. These remarkable successes have laid a solid foundation for a cash-rich and confident pharmaceutical industry to successfully cater to the ever-growing need for affordable medicines across the globe. The recent pandemic, and the daunting possibility of more such pandemics in the future, open a great opportunity for both vaccines and biopharmaceuticals. All stakeholders need to create a vibrant ecosystem in India, where the development of not only biogeneric medicines but their improved versions (biobetters) as well as new molecular entities are energized to foster a Pharma Revolution 2.0 for creating public goods in the health sector for a world increasingly beset by life-threatening situations and well-being challenges. To take advantage of this opportunity, India has a lot to learn from the leading economies in biopharmaceuticals. There is a need to rapidly evolve from smart processes (for biosimilar) to smart(er) new molecules. The pre-existing policy framework needs to be tweaked to encourage innovation (e.g., a fast-track regulatory pathway for structurally incremental but therapeutically beneficial biobetters) on the one hand, and to bring risky capital, so as to evolve a skilful and well-thought-out road map, on the other hand, for this transition. A close connection is required among organizations operating in upstream and downstream functions of biopharmaceuticals. To make it work, analysis of past successes—as well as gaps in the value chain—that need improvement are discussed to propose a viable action plan.