As the monsoon gathers pace, civic authorities are gearing up to deal with the spectre of malaria, chikungunya and an assortment of other maladies. Yet, while two-thirds of the world’s people are at risk from these and other debilitating diseases, no vaccines have yet been developed to prevent them.
Even where vaccines exist — such as for dengue and the human papilloma virus, the precursor of cervical cancer — they don’t target the strains prevalent in India. Or they are prohibitively expensive. Since it costs an average of $800 million to bring a single new drug to market, most R&D budgets focus on developing drugs that fetch high returns. This leaves the diseases that afflict the developing world with few takers.
India is well-placed to fill this gap. Two key strengths have enabled India to reach its pinnacle position as the world’s largest manufacturer of high quality generic medicines and vaccines.
India’s academia has established a strong base in scientific research that helps identify potential new drugs. The private sector too has mastered reverse-engineering drugs and vaccines freed from patent protections.
But these strengths alone will not be enough to take the country forward. Today, rapid advances in genetics, nanotech and biotech are revolutionising the fundamentals of the industry.
A whole new era of discovery and innovation lies before us. But before India can capitalise on its potential, it will need to work on its key weaknesses. Today, too many promising leads fail to make it to market because of the missing link between discovery and development.
Since neither the public nor the private sector can go it alone in such a complex, high-cost, high-risk environment, a bridge will need to be created between academia, industry and government — the triple helix of medical innovation.
In the US, early stage incubators at universities such as Stanford, Cornell, MIT and Harvard serve as hubs for the development of new drugs and medical devices. After this, the country’s vibrant venture capital market takes the prototypes forward.
Its investment in startups helps validate the prototypes for efficacy, safety and consistency, and takes the product to the market. In Israel and South Korea, government-led initiatives draw in the private sector, and large pharma companies take the pioneering work of small industries forward.
India, too, is now seeking to strengthen this value chain. Five years ago, GoI set up the Biotechnology Industry Research Assistance Council (Birac) with this explicit purpose.
Since then, Birac has supported a number of startups, and fostered collaboration within the biopharma innovation ecosystem. Birac is now focused on promoting a more collaborative R&D environment and leveraging the expertise of local and international players, from both the public and private sectors, to take the industry forward.
Specifically, Birac aims to foster talent in research and nurture next-generation technical skills among scientists, researchers and others across the different stages of product development. It also seeks to improve the success rate of promising leads, accelerate the development of new products, and equip the industry to carry out the full spectrum of validation activities.
Clinical trials are currently a critical bottleneck. It will be important to provide companies with advanced shared facilities to conduct these trials, link clinical trial units with networks of expert advisers and international bodies so that they comply with the best global standards, and strengthen all the institutions involved in the adoption of global innovations, technologies and licensing models.
Recently, the World Bank joined hands with Birac to help scale up its efforts across the industry. Initiatives such as this, in which an industry goes beyond ‘Make in India’ to ‘Innovate in India’, will hopefully pave the way for private investors to follow, and raise the industry’s long term competitiveness.
Ahmad and Sole are country director and senior private sector specialist respectively, World Bank, India
This opinion piece was originally published in the Economic Times on 8th September, 2017.