The recent changes in the Government seems to have excited the industry but the real test will be to see if the enthusiasm translates to action on the ground, cautions Dr Anil Chauhan, Director, ABLE
India, Bangalore and biotechnology have come a long way in the past 20 years. The biotech industry that was just about emerging internationally and in India in 1994 has now transformed into an industry that is growing in double digits as compared to the overall pharmaceutical market. At this point, biologics contribute about 15 per cent of the global pharma market which is edging close to a $1 trillion. As the population ages the market share of biologics is bound to increase since biotech drugs are the better remedy for cancers, rheumatoid arthritis and other age-related diseases.
The biotech industry in India is approximately $5 billion but had the regulations been more supportive, the biotech industry could have been in the range of $ 7 to 8 billion by now.
Being a high investment industry, investors in the biotech domain need to be aware of any obstacles before they invest. Apparently, Indian and international investors have been hesitant to invest in India for want of clarity on matters related to IPR, environmental permissions, market perceptions, role of NGOs, etc. It comes as no surprise that India has been rated 147 out of 189 countries in the ‘ease of doing business’ in a recent World Bank report.
Globally, investment in biotech has seen its highs and lows but this past year has been a blockbuster as far as the IPOs are concerned. The momentum does not seem to be abating. However, investment in the Indian biotech sector has been anaemic at best.
Challenges and opportunities
The recent changes in the Government seems to have excited the industry but the real test will be to see if the enthusiasm translates to action on the ground. If the clinical trials and crop field trials situation remains unresolved and sub-judice, development of new drugs and biotech varieties will remain confined to labs. Similarly, frequent delays in obtaining permissions, patent challenges, compulsory licenses or price controls also do not bode well for innovation and growth. Transparency, timeliness, predictability are key issues that need to be resolved. The emphasis of the Government on ‘Make in India’ needs to be supported by world-class infrastructure, a rational licensing and approval system, time-bound clearances, improvements in quality control and assurance. Another important driver is the availability of human resources for all phases i.e. from early discovery to development. There appears to be a gap in the skills availability and requirement at most levels. Attempts are being made to fill the gap through finishing schools at the entry level to encouraging Indian researchers and professionals abroad to return to work in India. However, a more basic and wider effort needs to be made to fulfil the future requirements.
India’s success in vaccines production and supply to the developing world has been a great achievement and that lead is expected to continue. Biosimilars are the new developing opportunity that has seen Biocon, Dr Reddy’s Laboratories, Intas Biopharmaceuticals and Wockhardt develop and market biosimilars. In addition to the biologics, genomics will be a second driver that enables personalisation of treatment. Several innovative companies like Strand Life Sciences, Molecular Connections, Mapmygenome, Bigtec Labs operate in this space. In the coming years other opportunities will be those biotech sub-sectors that utilise India’s existing strengths in IT – to develop large scale Big Data capacities and to leverage India’s engineering skills to widen the medical tech space. Manufacturing is another big-ticket item that Association of Biotechnology Led Enterprises (ABLE) has been trying to push. ABLE had submitted a white paper to the PMO in December 2012 suggesting that the Government of India spend atleast Rs 5000 crores to ramp up the manufacturing infrastructure. The recent push by the new government for manufacturing in India is a welcome development.
In the agriculture biotech space the success of BT cotton in the past decade has transformed rural lives in the cotton growing states. A much bigger opportunity awaits several other crops. The current government needs to push for adopting well tested traits in food crops as well. This will help improve India’s food security and the nutritive value of crops while simultaneously protecting the environment.
Unlike the pharma sector that is dominated by large MNCs, biotechs are relatively small in size. The world over, the paradigm is to develop a whole ecosystem of start-ups that serve to keep the Innovations coming in at a rapid pace. Silicon Valley is home to a huge number of start-ups with thousands added each year. The Indian government is trying to promote a similar model and it may well trigger a spurt of growth. Since start-ups need to be sustained to carry on for some years before they enter the real world, funds need to be available from private sources. At this point this is a real challenge. Suggestions have been that the start-ups be allowed to tap the stock markets even though they do not have revenues.
ABLE’s role
ABLE has been advising its members and the government on various issues. One of the most important programmes that it structured is the Biotechnology Entrepreneurship Student Team (BEST) event, supported by the Department of Biotechnology (DBT) of the Government of India. In 2014, the 6th Edition of BEST was held in October. The format involves shortlisting 20 teams (four to five students each) from over 150 teams on basis of theirproposals and the best teams are selected and awarded on basis of their business plan presentations. Thus each year BESTsparks an Innovative spirit in 100 bright youngsters. ABLE plans to scale up efforts in the coming years.
ABLE has conducted similar regional – NEST- in North East India in the past and is currently partnering with BIRAC for Stimulating Bio-Entrepreneurship Talks in various cities and towns that included Coimbatore, Jaipur, Chandigarh and Dharwad. These centres were chosen with an intention to make the programmes more inclusive. In 2012, ABLE developed an ambitious roadmap for the Indian biotech industry targeting a size of $100 billion by 2025.
This was welcomed by the industry and also accepted by the Government as a long-term goal.
Initiatives to boost the sector
Taking into cognisance that the target would remain on paper unless the Indian regulatory system was fine-tuned to be in sync with the other economies, in 2014 ABLE partnered with Biotechnology Industry Organization (BIO) to come out with a white paper on “Accelerating Growth – Forging India’s Bio economy.” This report includes the perspectives of national and international players and recommends steps needed to put the industry’s growth on a fast track.
Showing its support to the Government, ABLE impleaded and was included as a co- respondent in a case filed in the SC court by an NGO against the Government of India attempting to place a ban on field testing of GM crops.
ABLE also showcases the strengths of India’s public and private sector by participating in international biotech events. In 2014, ABLE coordinated the INDIA pavilions at Biotech Japan and BIO International San Diego. In 2015 ABLE will coordinate INDIA pavilions at Biotech Japan, Tokyo; BIO International Philadelphia and Drug Information Association’s 51st Annual Meeting in Washington DC.
Thus, by pushing the right triggers from innovation, promoting trade and India’s perception, ABLE catalyses a symbiotic interface between the industry, the Government, academic and research institutes and domestic and international investors to accelerate the pace of growth of the biotech sector in India that has miles to go.
(The views expressed are personal. The author can be contacted at anil@ableindia.org)