India’s biotech future

The last two decades have seen India make tremendous progress in the area of biotechnology, emerging as a driving force in some areas and a strong contender in others. A recent survey by Ernst & Young has identified India as one of the five emerging biotech leaders in the Asia-Pacific region, the others being Singapore, Taiwan, Japan, and Korea. The firm ranked India third in the region based on the number of biotech companies in the country. India is already the world ’s largest vaccine producer as well as the largest cultivator of Bt cotton. This is both commendable and encouraging considering that the Indian biotech adventure only began in the mid-1980s, with a majority of firms started by first-generation entrepreneurs with limited capital, often generated from their own resources in the absence of significant venture capital funding.
The Indian biotechnology sector today comprises over 350 companies generating revenues of about $2 billion that are estimated to reach $5 billion by 2010. The sector has been growing at between 35 per cent and 40 per cent per annum for the last three years. The current fiscal alone saw revenues cross $2 billion from $1.5 billion the previous year.
Biotechnology, the application of science and technology to modify biological systems for specific uses, encompasses many fields from biopharma to agri-bio and biofuels, to cite a few. Several Indian companies have started inventing and producing biotechnology-based drugs for diseases such as cancer and diabetes. Agriculture is beginning to gain momentum as well, with a focus on transgenic rice, corn, chickpea, and several other food crops, most notably in the area of genetically modified crops such as Bt cotton as well as bio-fuels. India is already building a global leadership profile in Bt cotton where it has the largest area under cultivation, over six million hectares, which is twice that of China. In 2006, India also ranked first in terms of growth in the transgenic crops sector where it registered over 200 per cent compared to the global average of 13 per cent.
Bio-pharma is about innovation, manufacturing and clinical trials. Whilst innovation can happen anywhere, the world today has a huge shortage of clinical and manufacturing capacity. This shortage is a unique opportunity for India which has a large reservoir of scientific manpower, a wide network of research laboratories, fast-growing manufacturing and clinical capabilities. India’s large and diverse patient population is, equally, an advantage from the clinical research and development perspective. Stem cells and regenerative medicine also promise innovative and affordable approaches to addressing the “double burden” of infectious as well as non-communicable diseases such as cancer and diabetes that plague developing countries.
In the area of biofuels and enzymes, the dwindling reserves of fossil fuel, mounting oil prices, and increasing quantities of greenhouse gases have accelerated the focus on promoting the production and use of alternative fuels derived from renewable raw materials. Considering India’s increasing vulnerability on the energy security front, biofuels and industrial enzymes decidedly represent an area of opportunity for Indian biotech.
— Photo: A. Roy Chowdhury

FIELD OF PROMISE: The country’s biotech revolution only began in the mid-1980s. It is now the world’s largest vaccine producer.
On the regulatory front, the environment is well in the process of getting streamlined thanks to the recommendations made by the Mashelkar Committee and the M.S. Swaminathan Committee. It is heartening that the Indian government has now recognised the success of the biotechnology industry. A National Biotechnology Strategy Document has been drawn up as a combined effort of all the stakeholders (government, industry, academia, NGOs) with a sense of urgency. Given the right impetus, the Indian biotechnology sector can undoubtedly steer towards global leadership. However, the challenges should not be underestimated.
Thus far, issues of intellectual property have constituted the main deterrent for the growth of the Indian biotechnology industry. Foreign venture capitalists believe that there is insufficient patent protection and access to patent litigation in India. This perception is slowly changing and there is an increased interest in investing in Indian biotech companies. I am confident that things will continue to improve as more Indian biotech companies enter global markets, especially in the U.S. and Europe.
Another area that needs focus is creating a strong educational foundation in terms of higher and specialised education and forging strong links between industry and academia. While government policies have been largely supportive, there is a need for more innovative, substantive and priority funding. This includes funding from venture capital firms which seem too coy of financing biotech initiatives especially those born out of academic laboratories. There is an immediate need to move from an “imitative” culture toward an “innovative” culture in all our R&D endeavours.
Despite these roadblocks, the Indian biotech sector’s prospects have never looked brighter. The growing capacity in bioprocess engineering, strong manufacturing expertise, competence in recombinant DNA technology, increasing number of bio-partnerships with international players, and the slow but sure transition to a product-driven model are all indicators of the rapid strides made by the industry in a remarkably short span of time. The impressive growth trajectory of about 40 per cent per annum achieved in this short time is indicative of the future of this sector.
India is already a major biotech player in the world and has the potential to become a leader in the near future. The challenge is to make all the Indian players work together to make this happen. It has to happen not only for the sake of the economy but for the sake of the people who will have access to better and more affordable medicine, food and sustainable energy.