India is expected to become the hub for biotechnology sector following the trend of IT industry. Biotechnology is playing a valuable role to serve the world’s rising population. The demand for eatables is estimated to double by 2050. Biotech had already provided good and healthy food, water, air and pharmaceuticals to the growing population and solutions to the deteriorating ecological individuals and systems in the form of White, Green and Red revolutions. It has also been proven to be a boon in the areas like advances in drug development and discovery and biomedicals.
Biotechnology has made it possible to develop an entire organ from the stem cells. The recent research is exploring the area of providing personalized medicines also, for individuals, to prevent side effects and to increase the targettability and efficacy of the drug molecules. Indian biotech sector had set a target of $5 billion in revenues by fiscal 2010-11. It has already touched US $2 billion in 2006-07. The world has big expectations from India as, it has a vast pool of skilled man power with low cost, which draws attention of the entire world to invest in Indian Biotech industry. The current article is focused mainly on the biopharmaceutical companies and their progress. Following is the division of the contribution of different sectors of biotech which contributes towards the revenue generated by the entire biotech Industry in India.
There are many focus areas in India on which the biotechnology business and research is based. As said earlier, India being a country, of low cost labor, highly skilled personal and diverse climate conditions and races, many parts of the world, have shown a great interest in investing money and establishing their research organizations in India. The best suited focus areas are clinical research and pharmacogenomics & Personalized medicine. Other hot and emerging areas are Genetic engineering and molecular biology (basis of all biotech related field), bioinformatics, genomics, proteomics, diagnostics and therapeutics, conservation of the endangered species, production of certain products (animal/plant based) in the fermenters at industrial scale, stem cells and regenerative medicine, artificial tissue and organs transplants, alternative fuels, bio sensor and analytical, nanotechnology, renewable energy (fuel cells), waste reduction (Environment protection and remediation) fermentation technology and enzyme engineering for chemicals, antibiotics and other medical product development, agricultural and forest residues and slaughterhouse wastes utilization.
Biotech companies in India
Besides R & D for Indian companies, multinational companies also got attracted towards utilising the opportunities for discovery research in India as, India offers encouraging environment and all other basic requirements to do so. AstraZeneca and GE, for instance, already have
significant research centres in India.
The Indian pharmaceutical industry has an export component of about 58%. Its revenue stood at US$ 1.75 billion in 2007-08, a 70% share of total biotech industry revenue. About 47% of the pharmaceutical revenue came from vaccines. Of the top 20 pharmaceutical manufacturing companies in the Asia-Pacific, 14 are Indian. Within the country, more than 250 Biotech companies are registered companies. They contribute almost to 50% of the Biotech business of the Biotech market. Out of top 10 companies, the top five companies are home-grown.
The association of Biotechnology called ABLE (The Association of Biotechnology-Led Enterprises) was aiming to grow the industry to $5 billion in revenues generated by 1 million employees by 2009. Of the $110 million invested in 14 biotech projects globally, the International Finance Commission of the World Bank has given $43 million to four projects in India.
The emerging India's biotech capital is Bangalore. The US-based Biogen Idec, one of the pioneers of the biotech industry, has set up an Indian subsidiary with the objective of doing research and development (R&D) and integrating India into its global clinical development programs. Amgen, billed as the world's biggest biotech company, is said to be planning a direct presence in India with its own clinical development center. There are many other global majors such as Genentech, Genzyme, Agilent Technologies' biotech division, and HistoGenetics which have either just set up base in India or are in the process of doing so.
India's own first biggest Biotech Company is Biocon which is mainly focusing in R & D of the biotechnological products. Ms Kiran Majumdar Shaw has signed a memorandum of understanding with Deakin University in Australia for joint multidisciplinary research focused on biotechnology and biosciences.
This company was originally an extension to an Irish chemicals company seeking to break into the Indian market, Biocon is now the leading biotech in India, bringing in Rs 646.36 crore (almost $150 million) in revenue for fiscal year 2004. Biocon was initially involved in producing the enzymes. Recently, it has entered in biopharmaceutical market. It has already launched Insugen, a bioinsulin to the market. Indian biotech major Biocon has posted a revenue of Rs 2,405 crores ($540 mn) for the financial year ended March 31, 2010. The profit after tax recorded at Rs 293 crores ($65.8 mn)
Mumbai also has many big pharmaceutical biotech companies like: US Vitamins and Reliance Life Sciences etc. Reliance is prominently working in the area of stem cell research. “Cipla (Mumbai)” is the leader in domestic sales and it distributes its 800-odd products in over 140 countries as well. Similarly, the “Serum Institute of India” is proud to be the world’s largest producer of measles and DTP vaccines, and its portfolio includes other vaccines, antisera, plasma products and anticancer compounds.
Two, out of every three children in the world are immunized with one of their vaccines. The Serum Institute earned Rs 565 crore ($130 million) in revenue in fiscal year 2005, selling mainly to UN agencies and to the Indian government. Nicholas Piramal is also Mumbai based, reputed name in Indian pharmaceutical company. It’s, a company grossing $350 million per year, started its existence with the 1988 acquisition of Nicholas Laboratories and grew through a series of mergers, acquisitions and alliances. For 2005-06, NPIL's recorded a turnover of Indian Rupee 14,100 million and profits after tax were Rs 1,700 million.
Centers of industrial research and marketing abroad
After Bangalore, Hyderabad is the second hub of biotech in India. Hyderabad-based Shantha Biotechnics has set up an independent subsidiary. It has its research centre in San Diego, which is involved in developing human monoclonal antibodies. Other big names in this sector are Dr. Reddy's Laboratories, Transgene Biotek, and Bharat Serums and Vaccines, each have subsidiaries or research units in the United States, focused on early R&D. Ranbaxy is another hot shot in the Indian market in the field of pharmaceutical biotechnology. It takes in $1.174 billion in revenues for a net profit of $160 million in 2004. This company earns 78% of its income overseas markets. It has offices in 44 countries manage manufacturing in seven countries and distribution in over 100. By 2012, Ranbaxy hopes to be one of the top five generics producers in the world, and it consolidated its position with the purchase of French firm RGP Aventis in 2003. Ranbaxy Laboratories has strengthened its vaccine and biologics manufacturing capabilities by acquiring India-based Biovel Lifesciences. Hyderabad based Dr. Reddy acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare.58% of Dr. Reddy’s revenues come from generic drugs.
Benefits of developing biotech sector
There are several biotech based pharmaceutical products present in the market. Initially they were originated abroad and their cost was unaffordable for the common people in India. Indian biotech companies have been hugely successful in bringing down the price of drugs. For instance, Hyderabad-based Shantha Biotechnics has made hepatitis B vaccine available at a cost of $1.25 per course, in comparison with the multinationals' version that carries a price tag of $125. Shantha Biotechnics supplies nearly 40% of the United Nations Children's Fund's global hepatitis B vaccine requirements, which is distributed in developing countries of Africa, Asia and Latin America
Problems of Indian biotechnology sector
As said earlier India has every potential to grow in the biotech sector but, the main problem for its progress is to get financial funding. Many dream projects could not develop into reality because of lack of funding. Government has started supporting the companies and people who are working in the Biotech area long back. Few areas, for example: Stem cell researches, nanobiotechnology, cell culture, monoclonal antibody production, cancer research, are given priority by the government for funding.
Venture capital, which is a relatively young industry in India, has also supported biotech Industry. Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.
Biotech companies are increasingly looking to banks for funding. Bank of America and Citibank are eyeing India's biotech sector, and some funds from abroad are beginning to trickle in, including investment from the International Finance Corp, the private sector arm of the World Bank group.
The strategy for the 11th five year plan (2007-2012) is to provide products and services at affordable prices and make India globally competitive in the emerging bioeconomy. Emphasis is being laid on sectors such as: agriculture and food biotechnology, industrial biotechnology, medical biotechnology, bioengineering, nanobiotechnology, bioinformatics and IT enabled biotechnology, bioresources, environment, intellectual property & patent law, international cooperation and meeting the basic needs of the society.
Biotechnological products
Currently following products: r-DNA pharmaceuticals such as HBsAg vaccine, Erythopoietin, G-CSF, a-Interferon, and Insulin have been approved for manufacturing and marketing in India, while others such as GM-CSF, ?-Interferon, Interleukin, Blood Factor VIII, Streptokinase, Human growth hormone, tPA, Follicle Stimulating Hormone, and Human protein C, from different companies, are permitted for marketing.
Promotion of biotechnology in health research
The Government of India has taken several policy initiatives to encourage involvement of both the public and the private sector in modern biotechnology based health research. The more important of them are:
a) Small Business Innovation Research Initiative (SBIRI) to encourage pre-proof-of concept research and innovation with potential for commercialization,
b) Biotechnology Industry Partnership Programme (BIPP) aimed at generating IPR and allowing the industry partner to retain IPR at the same time protecting the interests of the public sector partners, and
c) Biotechnology Industry Research Assistance Council (BIRAC) to act as an interface between the public and private sectors catalyzing R & D and innovation, and to manage BIPP and SBIRI.
At present in India, there are six major agencies responsible for financing and supporting
Research in the realm of biotechnology apart from other sciences. They are Department of Science and Technology (DST), Department of Biotechnology (DBT), Council of Scientific and Industrial Research (CSIR), Indian Council of Medical Research (ICMR), Indian Council of Agriculture Research (ICAR) and University Grants Commission (UGC), Department of Scientific and Industrial Research (DSIR). DST, DBT and DSIR are part of Ministry of Science and Technology while ICMR is with Ministry of Health, ICAR with Ministry of Agriculture and UGC with Ministry of Human Resource and Development. DSIR is the funding agency for CSIR and both of them independently fund biotechnology related research programmes.
Critical issues
There are certain issues to discuss while showcasing the scope of Indian biotechnology to the entire world. Putting banes and restriction on certain type of research and products delays and demote that kind of research. Genetic engineering companies specifically therefore face regulatory constraints, public protests and court injunctions domestically, and have started to conduct their release experiments involving recombinant organisms in countries where obstacles appear to be fewer due to laxer legislation and lower public awareness.
In case of exporting the products to other countries, currently the companies have to face lots of difficulties for example the policies of government are not so flexible to promote this kind of export. Secondly when our products reach to the global market, the companies have to pass through more stringent tests and standards as there has been a norm of Indian products to be of lower quality.
When we talk about the technologies transfer and clinical research promotion, there are chances that, developed countries can use us like guinea pigs by testing their technologies on us. It is of very much concern in case of CROs and agri biotech products. CROs have given a good business and it was expected that, by 2010, global contract research will reach $15.1 billion. The Confederation of Indian Industry has said that India's share could be about $1 billion. More than 100 pharmaceutical companies are currently outsourcing clinical trials to Indian companies. But, while dealing with the technology transfer the care should be taken as socially desirable transfer of technology can take place while undesirable and hazardous transfer can be prevented. In many of the countries the GMs are banned or restricted to be used but in India few people are promoting it. There is a risk that these policies have been implemented being biased for the MNCs and can spoil the native flora of India.
Problems of using biotech products
If we think of using genetically modified organisms to be used for various purposes, there are chances that they get mixed up with the native natural species and this can lead to spread of the modified character to the natural genetic pool. Unlike hazardous chemicals such as pesticides and ecologically harmful substances like CFCs, the products of genetic engineering cannot be removed from the market. As George Wald has said in 'The Case against Genetic Engineering', 'the results will be essentially new organisms, self perpetuating and hence permanent. Once created, they cannot be recalled.' There is another concern about the environment, using GMs in the agriculture can lead to wiping of the various natural species out. Preference of using, pest resistant, drought resistant or salt resistant plants, can lead to this kind of situation.
Future of biotechnology
Future of biotechnology is quite bright as it has tremendous potential to fulfill all the needs of mankind . For the growth of this sector, government is really playing an important role by providing funding to various research organizations and companies but, we have to remember the fact that, it is businesses not Governments which create wealth and it is wealth which can promote the growth in any sector. Governments can only give an initial push.It is true that Government should create an environment in which business can thrive and prosper. Future of biotechnology lies in almost all the areas specifically the agricultural biotechnology, regenerative medicine, nanotechnology and pharmaceutical biotechnology. However we have to use it carefully as it can be the most dangerous tool existing in this world and can be used willingly or unintentionally to disturb the peace and life on this earth.
Acknowledgement: We would like to acknowledge Sujata Basu, Saransh Jain and Aman Malik for their support in collecting the data and other information for the article. u
Dr Rachana is Asst. Prof, Biotechnology, JIIT, UP,Gaurav Pathak is Assistant, Indian Pharmacopeia Commission Ghaziabad, UP and Preeti Mishra is B.Tech student of biotechnology, JIIT, UP