Is Regional Biotech Dominance within Grasp for India?
According to a panel of experts at a roundtable discussion hosted by the *US India Strategic Partnership Forum and NITI Aayog (Prime Minister Modi's policy think tank for transforming India), while India has done some things right, there is still more to be done if it wants to reach this lofty goal.
The Indian government has set a goal of achieving a 100 billion dollar biotech sector by 2025. And why not? The country has seen the growth of this dynamic sector from a mere 500 million dollar industry in 2003 to an 11 billion dollar industry as of 2016. This trend along with India's well recognized role as the "pharmacy of the world" for generic drugs, has led government policy makers to believe this goal is possible.
But is it? Rather, is it achievable under the current environment in India?
Wednesday's forum featured a panel of experts from academia, the government, and the private sector who looked at what India has been doing well in the sector, as well as areas where there is room for improvement. Amit Kapoor, the author of a new report by the Institute for Competitiveness entitled "Competitiveness of the Indian Biotechnology Industry" assessed India's performance across a series of biotech enabling factors as compared to other countries within the region and other successful biotech hubs and concluded that India has done well in the following:
India is home to young, affordable human capital; it has improved its standing in the World Bank's Ease of Doing Business Ranking in four years (albeit this ranking can be further improved); and it has created a world class research infrastructure with government support to kickstart the sector. But even more importantly, the government has identified the sector as economically significant in its overall strategic plan.
The report points out however, that a key ingredient to the growth of the sector -- private investment --is lacking or negligible. It is this investment which is necessary to further the research and development of novel molecules and technologies. It is also this investment which results in the biotech outputs that can push India past the 100 billion dollar goalpost.
What is preventing private sector investment? Several experts pointed out that the unpredictability in the regulatory environment and legal regime contribute to why private sector investment is so dismally low in India. The significant up front costs coupled with the risky nature of the sector requires a scientifically sound regulatory environment and a predictable legal (Intellectual Property) system to quell investor trepidation and spur investment in the sector. These experts pointed to the legal and regulatory systems of other countries in the region, including China and Singapore, where significant systemic reforms (in the case of Singapore) and policy initiatives (in the case of China) have drastically increased investor confidence in the legal and regulatory regimes. While India has been steadily increasing its capacity in both of these areas, policy gaps and "the India way" make it difficult for investors to navigate the system. This leads investors already in India to seek other more attractive alternatives in the region, and deters new investors from coming in.
What can India do? Joe Damond, Executive Vice President for International Affairs for BIO posed a simple question. Is India's strategy for biotechnology inward looking or is it global? Depending on the answer, one can envision significantly varying policies. To be a global player, Damond said, India should revamp its legal and intellectual property system to go above and beyond the bare minimum set by the World Trade Organization's (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS). India can also add a great measure of reliability to its regulatory regime by not only adopting globally recognized regulatory guidelines from the International Council on Harmonization (ICH), but also by engaging at the ground level in ICH as new guidelines are being developed. The panelists also urged Indian policymakers to consider actively engaging not only as an observer, but as an active member of this globally recognized norm setting organization. By aligning its intellectual property system with other successful biotech hubs, by vigorously enforcing these laws, and by adopting globally recognized regulatory standards, India will inject the needed predictability into the system to set it apart from other regional players.
But would doing all of this lead to regional biotech dominance? Not quite. Another important aspect of biotechnology, quite unique from other sectors, is the close partnership of industry with academia. Almost every known successful biotech hub has a system of technology transfer. Thriving biotech hubs in the Boston and San Francisco areas for example, have recognized that publicly funded research is just that... publicly funded research languishing on laboratory shelves... that is, until that research is transferred to a private entity which will invest its own capital or generate investment capital to further research and develop that technology. Bayh Dole-like systems have been adopted by many countries aspiring to become biotech hubs. In most countries, academia industry partnerships which are central to the biotech ecosystem, are no longer taboo. Panel experts recommended that India seek to strengthen these industry academia linkages in order that Indian public funding could bear fruit.
Because the recommendations for increasing Indian biotech competitiveness span across multiple ministries within the Indian government, panelists suggested that an inter-ministerial commission be created to review the existing biotech policies and put forward a holistic approach, as some other aspiring biotech hubs have done. Such an inter-ministerial commission, ideally led by the Prime Minister's Office, would assess the feasibility of these and other recommendations, identify gaps, and itself, recommend pro-biotech policies.
Given the significant investment that India has already made in biotech, if India makes improvement in these areas there is no reason why India can't achieve dominance in the region. That is, if regional dominance is a goal and not simply rhetoric. This remains to be seen. For now, the Indian government has indicated its willingness to hear from stakeholders about how to improve its system for biotech competitiveness. This is the first step in moving towards the goalpost.
*"Innovation in the Biotechnology Sector in India" was held on March 13, 2019 in New Delhi India.