BIOSUCCESS
INDIA
INDIA’S BIOTECH STRENGTH GAINING GROUND The Indian biotechnology sector is one of the fast growing knowledgebased industries in India and is expected to play a key role in shaping India’s rapidly developing economy, says Mohinder Nayyar.
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he Indian biotechnology sector is one of the fastest growing knowledgebased industries in India and is expected to play a key role in shaping India’s rapidly developing economy. Presently, India is ranked among the top 12 biotech players in the world, and is the third biggest in Asia-Pacific in terms of the number of biotech companies. The investments in this industry have been growing robustly over the past few years and have reached US$ 637 million. The industry had achieved annual turnover worth US$ 2.5 billion in fiscal year 2007–08, after having registered a compound annual growth rate (CAGR) of more than 25 per cent over the previous few years. Around 50 per cent of the total biotech market is shared among the 20 leading companies in the country. The export accounts for nearly 55 percent while the domestic consumption accounts for nearly 45 percent of
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this industry. The current global financial and economic slowdown has certainly made an impact on this industry. India contributes around 2 percent of the global biotech industry. There are some 325 biotechnology companies operating in the country, employing around 20,000 scientists. The industry can be divided into five distinct segments – biopharmaceuticals, bio-services, bioagriculture, bio-industrial, and bioinformatics. According to the fifth survey on the industry conducted by Biospectrum and Association of Biotechnology Led Enterprises (ABLE) jointly, nearly 40 percent of the companies operate in the biopharma sector, followed by the bioservices (21 percent), bio-agri (19 percent), bioinformatics (14 percent) and lastly the bio-industrial segment (5 percent). India has over 100 research organizations in the country focused on different areas of research in the biotechnology area. The government has been playing a proactive role to promote this industry. It has recently launched a Biotechnology Industry Partnership Programme to provide industry, the support by cost sharing on high risk discovery and innovation projects. The programme is being funded by a budget outlay of US dollars 74 million during the current 5-year Plan. The major objective of this programme is to increase the global competitiveness of Indian industry in new and promising technologies. The said package will underwrite the risk of research and development of innovative molecules and processes. It will be open to all innovative biotechnology companies,
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which are looking to do research in agriculture, health, bio-energy and green manufacturing. This helps to also fulfil the Department of Biotechnology’s strategy to spend 30% of its R&D investment in partnership with industry. The country is already laying down some strong foundations, which will eventually help the industry to increase its share in the global market. The examples include setting up of Centres of Excellence and expanding the educational and research facilities.
INDIAN BIOTECHNOLOGY INDUSTRY The Indian Biotechnology industry was slow to start, but has been gaining momentum for the past couple of years. Although, the current share in the global biotech market is relatively low, it has necessary potential to become a prominent player in this market. According to the latest survey carried out by Association of Biotech Led Enterprises (ABLE), the biotechnology industry in India has notched up a growth of 20 per cent during 2007–08 and the revenues earned were worth US$ 2.56 billion as against US$ 2.1 billion during the previous fiscal. The biotech industry had recorded average growth of more than 30 percent in some of the previous years. Bio-pharma is the industry’s largest segment accounting for 67 per cent of the overall revenues, as per 200708 data. The shares of other segments are: bio-services (15 percent), bio-agri (12 percent), bio-industrial (4
percent) and bio-informatics (2 percent). As mentioned above, this industry has a strong export linkage. The bio-pharma industry is accounted for largely by research, development and production of biosimilars or follow-on biologics – copies of established biologic drugs. Gaining strength from the ongoing R&D, the biopharma segment is expected to reach US$ 5.5 billion by fiscal 2013. The total bio-pharma industry, consisting of therapeutics, vaccines, diagnostics, and other products such as statins, recorded a massive 26.9% growth in fiscal year 2007 and continues to be the largest contributor to the overall biotech market in the country. The good performance of the bio-pharma sector is attributed to the strongly growing vaccine business which accounted for about 50% of the total bio-pharma business in fiscal year 2007. Interestingly, India is one of the largest producers of traditional vaccines in the world. The producers of Hepatitis B vaccine continue to register robust growth, and more and more companies are focusing on under-served markets such as HIV, Japanese Encephalitis and high-value combination vaccines. The vaccine business will remain dynamic in future, taking the overall bio-pharma market up. Diagnostics and therapeutics businesses, which account for about 16 percent and 12 percent respectively of the bio-pharma market, are driven by a rise in chronic diseases and huge investments being poured into the healthcare infrastructure with several path labs and hospitals opening up in India. The bio-pharma sector will further get a drive from the fact that India is forecasted to become a key
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bio-generics supplier to the developed world in near future. Notably, the top five players in bio-pharma segment have a 45 percent share of the market, and out of the top ten companies, seven are vaccine manufactures. As per a KPMG report, the Indian firms have a huge advantage over their counterparts in western markets because of relatively lower R&D costs, so the industry can afford to be somewhat less risk-averse. The country’s drug industry is building product capabilities in bio-similars, particularly in products such as recombinant insulin, GCSF, interferon alpha, erythropoietin, and has started to move into monoclonal antibody (MAb) products and recombinant vaccines. Other fast growing areas include bio-engineering, which develops new tissue engineering processes and biomaterials for therapeutics. India is also trying to play a prominent role in the genomics space. The Indian genes have been mapped and now the country is moving towards open source drug discovery. About INR 5 billion will be allocated for this, which is good for the industry and the society. The Indian law allows stem cell research for therapeutic cloning, but prohibits reproductive cloning. The Indian Council of Medical Research and the Department of Biotechnology have laid down the Guidelines for Stem Cell Research and Therapy for adult, cord blood and embryonic stem cells in response to the support provided by the Government to facilitate stem cell research in India so as to improve understanding of human health and disease, and evolve strategies to treat serious diseases.
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The government plans include setting up an exclusive fund to support stem cell research in the country. There are also initiatives taken by the private sector to foster research in this field. For example, the Reliance Life Sciences Institute has a good ranking amongst the top institutes worldwide working on stem cell research. India shows promising potential and is fast becoming an important hub for outsourcing of clinical trials and contract research. The key success factors for India are - a large pool of qualified scientists and engineers, institutional infrastructure, existing and upcoming cost-competitive research facilities, and a diversified patient pool. Besides this, the country also has diverse species of flora and fauna that give the added advantage for biotech companies to carry on their research and drug discovery effectively. With the new legislation putting in place a product patent regime post 2005, the business conditions for bio-services have been further improved. According to a report by RNCOS, the aforesaid factors would help India to increase its share in the global clinical trials from less than 2 percent (2007) to 5 percent by 2012. The burgeoning clinical trials market in India is likely to create more business opportunities for a number of associated industries, including in vitro diagnostics market, and data management, as well. India is ranked fourth in the world among Bt crops growing countries, in terms of cultivated hectares. The bioagri is driven primarily by Bt cotton seeds, as these seeds market alone was estimated to be worth US$ 203 million last year. The bio-pesticides and bio-fertilizers estimated to have a combined market
value of US$ 19.5 million in the country, and among bio-fertilizers, phosphate-solubilising micro-organisms market witnessed the highest growth. The country gave its nod for commercial cultivation of Bt cotton in early 2002. After six years, in 2008, 30 seed companies were engaged in production of 274 Bt cotton hybrids. Growing manifold, the Bt cotton acreage today accounts for about 80 per cent of the total area under cotton cultivation. Parallel with the introduction of Bt cotton, the yield of cotton increased from 308 kg/ha in 2002 to 560 kg/ha in 2008 and is projected to increase to 591 kg/ha in 2009. This has generated impressive economic gains for Indian farmers and enabled India to emerge as a net exporter of cotton from being a net importer. Remarkably, India emerged as the world’s second largest cotton producer in fiscal year 2007. According to a study report by Rabo India Finance Limited, the country has the potential to also become a major producer of transgenic rice and several genetically modified (GM) or engineered vegetables. The research work is being carried in many crops. These include rice, cotton, eggplant, potato, tomato, corn, cabbage, castor, citrus fruit, black gram, and groundnut. Bt. Brinjal (eggplant) is the first biotech vegetable food crop, which is under consideration of the regulatory body for commercial approval in 2009. No doubt, the bio-agri continues to be one of the fastest growing segments in the overall biotech industry. A diverse set of Indian companies is involved in the development of innovative technology in the bio-
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diesel area, which is well supported by the government in order to decrease the reliance on imported fuel. India has recently initiated a Bio-fuel Policy which seeks to convert at least a major part of the 60 million hectares of wastelands into farmlands for oilbearing crops which can produce biodiesel in plenty. There is no doubt that this policy will give further boost to the existing efforts by the private and public sector institutions to ensure the nation’s energy security. The policy has set an ambitious target of 20 percent blended bio-diesel by 2017. This means a production of 15-16 million tons of bio-diesel and a coverage area of over 30 million acres of bio-fuel plantation. Though the policy has been announced only less than a year ago, some companies, e.g. Reliance, have made significant investment in the bio-fuels arena by now. The bioinformatics sector is successfully creating synergies between the IT and biotechnology industry. Certainly, the bioinformatics industry benefits from the strength of the IT industry in India. There are three distinct kinds of bioinformatics companies in India now. Almost all the large IT services companies in India have been looking at bioinformatics with interest from as early as the year 2001. The major Indian IT companies have large life sciences divisions. In terms of overall size, some estimates run close to $1 billion in business that this segment generates for the IT services companies, although the actual bioinformatics content of what many of these companies do is difficult to measure. A second group consists of
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companies that began as start-ups a few years ago. Notably, some early bioinformatics companies have turned into broader contract research organizations and their bioinformatics business has become a minor part of their strategy. The third is captive bioinformatics groups within large pharmaceutical and biotechnology companies that use some bioinformatics for their research. Some of the big IT companies offer services relating to data mining, scientific visualization, information storage or simulation of DNA sequences.
The bio-industry segment is concentrated with 70 percent of India’s enzyme market. There are some 15 companies in India that are involved in the enzymes business. There are also players with focus on new areas of application, such as food processing, animal nutrition, dairy, aquaculture, marine etc. According to a Frost & Sullivan study, growing awareness and increased investments have led to the growth of biotechnology applications in the food and beverage and dietary supplements sector. The Indian food processing industry has seen some promising product developments such as probiotic fortified yoghurt, buttermilk, omega fortified health drinks and baby foods. A lot more can be achieved through cutting edge R&D in the meadow of biotechnology resulting in innovative food and beverage products with improved functional and health benefit. India has a number of biotech clusters, and these are located mainly in Bangalore (Karnataka), PuneMumbai (Maharashtra), Hyderabad (Andhra Pradesh), NCR Delhi, and Ahmedabad-Vadodara (Gujarat).
The global bioinformatics market is expected to grow at a CAGR of 16 per cent over 2007–10, whereas in India the growth is expected to be at a higher rate - 25 percent. Though the Indian bioinformatics sector is growing rapidly, its share in the global market is still miniscule. With a general revival of fortunes in the genomics, the business prospects for bioinformatics companies look good.
The other major locations for biotech industry include Kolkata and Lucknow. Bangalore has the largest number of biotech companies in the country. Hyderabad has witnessed a lot of infrastructural development in the biotech domain wherein a Knowledge Park, Biotech Park, Genome Valley and other projects are operational giving this city an advantage over many others.
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The other reason is to leverage the skilled manpower in terms of R&D activities in India. The demand for all the products - separation, instrumentation, mass spectrometry, surface sciences, lab automation, or general lab equipment - is on the rise mainly from the generic drug manufacturers and contract research organizations.
As the government has adopted a proactive policy on setting up of industry-specific special economic zones, many public and private enterprises are in the process to set up new biotech zones/parks in the country. The industry is now aiming to achieve a revenue of $5 billion by 2010. This optimistic outlook has its roots in foreign companies increasingly investing in India. According to industry players, escalating research and development expenses and stringent policies are making manufacturers from the regulated markets look towards India for cutting costs. A Frost and Sullivan report says that multinational pharmaceutical and biotechnology companies from western Europe and the US are using India and China for their phased studies on emerging markets. Besides, cheaper clinical trials and extra benefits, such as availability of good technical abilities, are boosting foreign investments, says the report. The pharmaceutical manufacturing hubs such as Delhi, Mumbai, Chennai, Ahmedabad, Hyderabad and Bangalore are fast improving their abilities to provide enhanced collaborative and outsourced R&D services. Currently, such services include drug discovery and validation processes,
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and, in the fields of pathway analysis (study of effect of toxic or radioactive substances on humans), genomics (study of gene sequences), proteomics (study of proteins) and translational research (investigation and experiments on patients and volunteers). In this context, Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon group, a leading biotech company, has said, “Co-development agreements are leading to interesting models.” Many leading Indian biotech companies have entered into collaborative arrangements with overseas companies, such as Merck & Company, GSK, Eli Lilly, Bristol Myers Squibb, and Ortho-McNeil Janssen. Over the last few years, Asia, and more so India, has been a high growth market for the global life science suppliers. Almost all the global majors like Agilent Technologies, Bio-Rad, GE Healthcare, Invitrogen, Millipore, Pall, Perkin Elmer, Shimadzu, Thermo Electron, and Waters Corporation have strengthened their presence and market hold in India. These global companies are consolidating their presence in India for two main reasons. One, growing Indian market has become more important for foreign companies.
With strong growth in R&D and production, the bio-supplier industry is also on a robust growth path, almost 30 percent growth annually. Some of the developments in recent times bear testimony to the robust growth momentum in Indian biotech industry: According to a report released by Med Ad News last year, Biocon had found a place amongst top 25 biotechnology companies worldwide. Biocon Limited was the only Asian company to feature in this ranking at number 20. The companies were ranked according to their revenues. Serum Institute of India is possibly the world’s largest vaccine manufacturer of measles and DTP vaccines. Biocon is the largest manufacturer of insulin in Asia. Asia’s first and the world’s second human DNA bank has been set up at the Biotech Park in India (Uttar Pradesh State). The members of the DNA bank will receive a microchip-based DNA card containing information of their fingerprints, and anthropological details. Biovel, an integrated biotechnology firm, launched Asia’s first Bio Safety Level-4 (BSL-4) manufacturing facility, specifically
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designed to facilitate product development and manufacturing of vaccines like Foot and Mouth Disease vaccine (FMD).
POTENTIAL GROWTH OF THE BIOTECHNOLOGY INDUSTRY According to a report jointly prepared by the Confederation of Indian Industry (CII) and KPMG some time back, the Indian biotechnology sector has excellent potential and is expected to touch US $5 billion mark by 2010. No doubt this sector, like many other sectors, is feeling the impact of the present global economic slowdown. Therefore, attaining the US$ 5 billion mark may not be so easy now. Nevertheless, the following factors will be driving the growth:
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Growing population and improving incomes Emerging lifestyle diseases Increasing investment in infrastructure and R&D, both by public and private sectors Increasing outsourcing opportunities in the manufacturing Emerging contract research market
The bio-pharma segment is expected to continue its dominance in the overall Indian market. The vaccine manufacturers will certainly be the leading force. With respect to diagnostics, many products are being imported into the country, but at the same time there is a new competitiveness emerging from the local players. Furthermore, the therapeutics remain the thrust in Indian R&D, with human insulin being the most common area of research. The
reason is that India has over 37.5 million people suffering from diabetes and the number is rising. India has 25 per cent of the world’s haemophiliac population, therefore plasma proteins is an emerging market here. The country has been sourcing plasma proteins from MNCs such as Baxter, and no doubt there is good potential for manufacturing plasma proteins locally and indigenously. Monoclonal Antibodies (mAbs) are also a fast-growing market especially in oncology and auto-immune diseases. Furthermore, India has 3 million cancer patients and 700,000 new cases are added every year, that is why more and more Indian companies are looking for collaborations with foreign companies in this field. Indian biopharma companies are also
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cost-competitive “eco system” for biotech companies. In bio-industrial area, the segments like industrial enzymes and renewable energy hold good business prospects.
GOVERNMENT INITIATIVES
looking to compete in the space of New Biological Entities and make them a key source of growth in the long term. They are exploring partnership models such as joint product development and joint marketing to build a distinguished presence in this segment. Bio-agri is also developing quite well in India. The country is the second largest food producer after China and therefore, offers enormous opportunities for transgenic crops. The usage of Bt cotton has made a remarkable impact on the farming community. The Indian farmer has been quick (than what was perceived earlier) to adopt new technology as he could see real value in it. The commercial approval of more transgenic plants is likely to push further growth in this segment. According to an analysis, if bio-fertilizers were used to substitute 25 percent of chemical fertilizers on 50 percent of India’s crop, the market potential would be 235 thousand MT, compared to only 13 thousand MT now. Also, the biopesticides are expected to grow at an annual rate of 10- 15 percent in the short term. Similarly, the business prospects in bio-services, bioinformatics, and bio-industrial are enormous as India continues to offer
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The Indian government has been consistently endeavoring to provide and foster an environment conducive to biotech development since 1986. The government approved a national biotechnology development strategy last year. It was an outcome of a long nationwide consultation process involving multiple stakeholders. A key element of the strategy is the setting up of a National Biotechnology Regulatory Authority (NBRA). This will provide a single window biosafety clearance of genetically modified products/processes. This is something that the industry has been demanding for a long time as, without such an institution, the release of biotech products into the Indian market gets unduly delayed. Presently, a draft bill for the establishment of NBRA is being circulated for inter-ministerial consultation. The Department of Biotechnology is pushing for increasing public-private partnerships in research and development. DBT has earmarked 30 per cent of its budget for such collaborative research. The government has also launched a Biotechnology Industry Partnership Programme (BIPP) and a Biotechnology Industry Research Assistance Programme (BIRAP). These schemes are one of the most enabling mechanisms to promote biotech industry R&D and public private partnership programmers. The government aims to support the industry also by expanding the pool of researchers,
creating a higher quality technical workforce, and creating industrial platforms, that can eventually build sustainable growth for the biotech sector. Establishing partnerships with key foreign countries active in biotech is also a remarkable initiative by the Indian government. This has been helping the country to adopt the best practices out of the shared experiences, thereby improving the R&D infrastructure. The government is trying to boost the sector by facilitating requisite infrastructure in terms of biotech parks (some examples are TICEL Bio Park in Chennai & ICICI Knowledge Park in Hyderabad) and Special Economic Zones. Some new technology clusters are being planned in the various fields of biotechnology. For example, discussions are being held to set up a biotechnology cluster in the University of Agricultural Sciences, Bangalore campus close to National Centre for Biological Sciences. The government has also initiated a project to conduct genome-wide research on a range of agronomically important crops. In order to facilitate foreign direct investment in the biotechnology sector, all project proposals exceeding FDI of US $ 22 million, are handled by the Department of Biotechnology (DBT)’s Fast track Committee. The DBT has also taken initiatives to link 63 bioinformatics centres in India to promote networking of information resources. The availability of funds for DBT has been drastically increased by the government.
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During the current 5-year Plan (2007-2012), the biotechnology sector receives government funding amounting to INR 65 billion as compared to INR 14.5 billion in the previous 5-year Plan. Following are some of the incentives being offered generally by the Indian government to the biotechnology sector: Allows Income Tax benefit weighted deduction of 150% for R&D expenditure as well as on international patenting costs until 2012. Offers exemption/concession on import duties on specified items for R&D and clinical trial equipment. Offers Service tax exemption on clinical trials of new drugs including vaccines and herbal remedies. Considering biotechnology for priority sector lending, the government encourages banks to lend money to biotech companies. Offers Excise duty and Sales tax exemption for bio-diesel. Offers tax benefits to Venture Capitalists investing in biotech industry. Offers support for industry research under the “New Millennium India Technology Leadership Initiative (NMITLI)”. It has been launched to catalyze innovation oriented scientific and technological developments in selected niche areas by synergizing the best competencies of publicly funded R&D institutions, academia and private industry. Two broad categories of projects are supported under NMITLI – nationally evolved projects and industry originated projects. Financial support will be provided under NMITLI in the form of
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Grants-in-Aid to institutional partners in public domain and as soft loan. With its Small Business Innovation Research Initiative (SBIRI) for a small and medium business unit (the company should have a well established in-house R&D unit with not more than 500 employees and recognized by Department of Scientific and Industrial Research), the government offers an alternative financing possibility for biotech start ups. Generally and subject to fulfillment of the terms and conditions laid down by the Department of Biotechnology, a start-up is provided up to a maximum of US$ 100,000 as a grant in a first phase to enable the company to undertake innovative pre-proof-of concept research and late stage development and commercialization of the innovation research. Further financial assistance is offered as soft loan carrying interest rates ranging from 1-2 percent. Furthermore, the advanced companies are offered equity financing through the SME Growth Fund of Small Industries. The Ministry of Science and Technology is promoting a number of centres of excellence for biotechnology. These institutes with state-of the art technology and highly skilled labour collaborate with the private industry.
CONCLUSIONS India is already globally recognised as a manufacturer of economical, high quality bulk drugs and formulations. The opportunities in the Bio-Parma segment are promising. For example, the bio-pharma companies are
already playing an important role in the global vaccines market. With many more innovative indigenous recombinant therapeutic products in the pipeline, and with USFDAcompliant facilities, the business prospects look quite bright. With regard to clinical trials, India offers many advantages in this particular space. Furthermore, the global evolution of the genomics business in areas such as “Next Generation Sequencing” and “Consumer Genomics” etc., in the coming future holds good business potential for bio-informatics companies in India. Overall, with a large base of skilled and cost competitive scientific manpower, easy availability of raw material such as plants and animals, and human genetic diversity, and a well-developing scientific infrastructure with a big network of research laboratories, India has potential to gradually become a leading global player in biotechnology. The setting up of a biotech regulator and more positive evolution of the intellectual property regime in the country can further help in increasing India’s share in the global biotech industry. The Indian biotech companies do look out to have access to the latest technology from the developed countries as well as to the marketing support in the foreign markets. Indian researchers need to partner with quality researchers from developed countries as such shared experiences often lead to adoption of best practices and a number of bilateral programmes are already under implementation. The author is with the Swiss Business Hub India, Embassy of Switzerland. He can be contacted by e-mail: mohinder.nayyar@eda.admin.ch
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SUGEN LIFE SCIENCES PVT LTD, TIRUPATI
SOARING HIGH IN THE ‘BIO’SPHERE The mission of Sugen Life Sciences is to provide high quality comprehensive drug testing and R&D services (preclinical and clinical) to biophar maceutical companies for fast-track drug development, and provide practical training to biomedical researchers in modern drug discovery and development.
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ugen Life Sciences Pvt Ltd is a Biopharmaceutical Contract Research Organi zation (CRO) that focuses on Contract Research and drug testing services in the toxicology, animal models of human diseases and clinical trials; Research and Development: Cancer, Inflammation and Diabetes; and Short-term practical training: Drug Discovery and Development.
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Sugen Life Sciences was established in 2005 with the objective of providing high quality drug testing services to support Indian and international biopharmaceutical companies for fast track drug development. Sugen’s own R&D efforts focus on providing scientific basis of Indian System of Medicine (e.g., Ayurveda) by using advanced drug discovery technologies. The purpose of short-term industry-oriented practical training in modern drug discovery is to train young scientists in latest technologies related to preclinical biology & drug discovery and to motivate them towards careers in biomedical research. To achieve these objectives Sugen Life Sciences has constructed a new research facility with advanced and well-equipped laboratories where in vitro biochemical assays, cell culture studies and in vivo experimental animal models can be performed. The in-house R&D programs are recognized by the Department of Scientific and Industrial Research (DSIR), Government
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of India. We have a CPCSEA (Committee for Purpose of Control and Supervision of Experiments on Animals) approved animal house to perform studies in selected animal species (rats, mice and rabbits). Sugen is an ISO9001 certified company and Good Laboratory Practices (GLP) are followed to perform the experiments.
ACCOMPLISHMENTS With enthusiastic support from investors and international scientific advisers, it has been possible to
C. Damodar Reddy, Director, Sugen
establish good laboratory facilities. For the past three years the company has established core infrastructure (Cancer biology, cell biology and biochemistry labs and animal facility), assembled an outstanding team of motivated scientists and completed a number of projects. “All the studies conducted by Sugen will continue to be in strict compliance with Indian and international regulatory guidelines. Significant progress has been achieved in preclinical toxicology, clinical trials, short-term practical training and R&D, primarily due to the dedication and motivation by the employees of Sugen. In addition, Sugen attracted support from the Government of India for R&D and training programs. With the core
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research facilities in place, Sugen is seeking to expand and undertake additional challenging projects. We have identified national and international network of collaborators / sponsors / consultants to participate in our programs,” said C. Damodar Reddy, Director, Sugen Life Sciences.
SKILLED RESOURCE India lags behind in biotechnology and biomedical research. One of the main reasons for this inadequacy is the lack of well-trained workforce, which may be attributed due to the limited practical training opportunities available to the young researchers and millions of college graduates. “One of the potential solutions is for the local and central governments to expand the existing practical training opportunities (Masters level or above) nationally through partnership with the Industry. In this respect, Sugen has taken the lead in obtaining support from the Department of Biotechnology, Government of India to provide training to talented young scientists in biomedical research and drug discovery and development,” said V. Vikram Reddy, Director, Sugen Life Sciences.
Sugen, with its advanced scientific knowledge and research facilities also collaborates with many higher educational institutions in Tirupati, which benefits the local community. Sugen, with its international (USA) presence and contacts, regularly invites leading scientists to Tirupati area for scientific seminars and discussions, where the local scientific community is also invited,” said Damodar.
FUTURE VISION The goal of Sugen is to emerge as one of the leaders in offering highest
V. Vikram Reddy, Director, Sugen
LOCAL IMPACT AND BENEFITS
quality comprehensive drug discovery and development services. The objective is to develop Sugen as an international biopharmaceutical CRO which offers comprehensive services where it is a one-stop shop for a majority of services in drug discovery & development.
The presence of Sugen in a smaller city like Tirupati directly contributes to its economy and offers exciting opportunities for talented researchers contributing to the enrichment of local and regional communities. “Additional projects and contracts which we secure will directly increase training and employment in Tirupati, where Sugen continues to be the sole leader in biopharmaceutical industry.
“Sugen will work with the Government of India to establish advanced drug discovery technologies / core facilities. Sugen will play a key role in integrating these networks to promote biopharma activity in Tirupati and integrate these efforts into the society which will have multiple benefits and contribute to local economy and development of Tirupati area,” said Vikram.
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BIOTECHNOLOGY
NURTURED, MATURED AND STRENGTHENED India is fast gaining recognition in the field of clinical trials and a large number of organisations are providing research and development expertise to global pharmaceutical companies. Industry reports also suggest the Indian biotechnology industry is slated to become a USD 5 billion industry by 2010.
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he Department of Biotechnology in consultation with various stakeholders had formulated a ‘National Biotechnology Development Strategy’, later approved by the Government. The policies of this strategy were translated into schemes, programmes and projects to be implemented in the 11th plan (20072012). Vision of the 11th plan was to “create biotechnology based tools and technologies that address the problems of the largest section of the society, provide products and services at affordable prices and make India globally competitive in the emerging bio-economy.” Though the main headliner from the previous year had been the ‘economic recession’, and when most industry sectors suffered huge setbacks and losses, one sector stood out – biotechnology. The Indian biotechnology sector’s overall turnover in
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2008-09 had registered a growth with USD 2.51 billion, as compared to USD 2.13 billion from the year 200708. Bio-pharmaceuticals contributed USD 1.6 billion; bio-agriculture nearly USD 311.28 million; bio-industrials with USD 99.19 million and bioinformatics grew 15% to touch USD 45.65 million. Already having posted a turnover of over USD 2.6 billion by June of 2009, the Indian biotechnology industry had virtually confirmed the future predicted by industry reports. According to a report by the Confederation of Indian Industry (CII) and consultancy firm KPMG, the Indian biotechnology sector was likely to become a USD 5 billion industry by 2010. The report stated, “India is ranked among the top 12 biotech destinations in the world and is the third biggest in Asia-Pacific in terms of the number of biotech companies.� India has also well established itself as a preferred clinical trials destination. KPMG has estimated that India will capture 15% of the global clinical research outsourcing market, which is projected to touch USD 23 billion, by 2011. The Federation of Indian Chambers of Commerce and Industry (FICCI) in a joint study with Ernst & Young revealed that the industry-sponsored Phase II and Phase III clinical trial study sites in India have grown by 116% over the past year, with the country ascending from rank 18 to 12 amongst the 60 most active countries. India participates in 7% of the global Phase III trials and 3.2% in the Phase II industry sponsored trials.
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The Stem Cell Global Foundation, a New Delhi-based organisation promoting stem cell research, estimates the business to be growing at an annual growth of 15% and cross USD 450 million next year. Moreover, India has joined an elite group of countries including the US, UK, China, Canada and South Korea, which have successfully decoded the human genome indigenously.
genetic engineered plants and therapeutic proteins. Synchrotron X-ray beam (BM14) was acquired for a 6 year term at the European Synchrotron Research Facility, France in partnership with Medical Research Council, U.K and European Molecular Biology Laboratory, for macromolecular crystallographic services to 130 Indian scientists and training of the field.
HUMAN RESOURCE DEVELOPMENT
BIOINFORMATICS
To ensure a steady flow of young scientists and technologists in the life sciences sector, the department continued to support ongoing post graduate teaching programmes; 62 universities and 8 new universities were added to this list. Number of fellowships for PhD was increased from 100 per year to 250 per year, besides 100 postdoctoral and 50 biotechnology overseas associate-ships. 21 candidates were selected for specialised training in medical genetics, stem cell research, nano-biotechnology, transgenic animal models, devices & implants and bioenergy/energy bioscience etc. A programme to strengthen biotechnology component in existing life sciences courses at undergraduate level was initiated in 35 selected colleges.
RESEARCH FACILITIES, RESOURCES AND SERVICES Nineteen facilities had been established so far, for services and related research in terms of genomics, proteomics, micro-molecular crystallography, microbial culture collections and regulatory experiments for
With objectives of providing infrastructural support for Bioinformatics research, training of manpower, and bridging gaps for accelerated growth of biotechnology and life sciences, 22 new Bioinformatics centres were established, of which, 15 were in NE States. Special Fellowship Scheme for PhD enrolment in bioinformatics was initiated and 20 R&D projects in bioinformatics were supported.
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Research & Development projects of national relevance with emphasis on basic and translational research in all areas of biotechnology such as agriculture, food and nutrition, human and animal health, industrial and environmental technologies etc. were supported. Basic R&D support was promoted for new sciences for discovery and high level innovation centred on genomics, RNA biology, proteomics, systems biology, stem cell biology and nano-sciences.
GENOMICS AND GENOME SEQUENCING As a participant in the international rice genome sequencing programme,
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Indian laboratories sequenced 16 Mb of chromosome-11 (against a target of 14 Mb), containing 1443 genes from the total of 3754 genes in rice genome. Similarly, genome sequencing of chromosome-5 of tomato was taken up and 4000 EST markers with 2 BAC genomic libraries out of total of 322000 clones are being characterised towards buffalo genome studies; an EST database ‘Wild Silkbase’ had been developed hosting information on construction, characterisation and analyses of ESTs (about 35,500) from the wild silkworm species. This is the largest EST database developed for any lepidopteron insect after Bombyx mori.
After Ahmedabad based Zydus Cadila, Bharat Biotech is the second vaccine manufacturer from India to commence this work. Two more pharmaceutical companies, Panacea Pharmaceuticals and Serum Institute of India also got the DCGI approval and were close to beginning Phase-I trials. Since April 2009, H1N1 has killed over 12,500 people in 210 countries, with India reporting 1,135 deaths till January 18 2010. At present, Glaxo, Novartis, Baxter and Sanofi Pastuer manufacture the H1N1 vaccine, while India imports 1.5 million doses from Sanofi Pastuer to immunise health workers testing and treating people infected with H1N1.
STEM CELL RESEARCH VACCINES AND DIAGNOSTIC STUDIES Phase-II clinical trials of Rota viral vaccine had been completed without any serious adverse effects and preparation for Phase-III trials are progressing well. The cell bank and technology for production of recombinant Malaria vaccine were transferred to Bharat Biotech International Limited (BBIL), Hyderabad for developing a master cell bank. A novel candidate for dengue vaccine was developed and expressed in the yeast and purified to near homogeneity in high yields. Work on an indigenously manufactured vaccine against the H1N1 (swine flu) virus was initiated. Bangalore based Bharat Biotech started Phase I clinical trials to test the safety of HN-VAC, its cell-culture based H1N1 vaccine candidate, after getting an approval from the DCGI.
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Systematic basic and translational research started in the country for the first time from the 11th plan. CMC-DBT Centre for Stem Cell Research established at CMC, Vellore for the purpose had become fully operational. Noteworthy leads in R&D include: Four human embryonic stem cell lines generated and deposited in UK stem cell bank and NCCS, Pune; Immortalised breast stem cell lines with the potential to continuously initiate mammo-spheres successfully generated; Phase-I clinical study on acute myocardial infraction using autologous bone marrow mononuclear cells implemented at five hospitals in the country.
the country finalised jointly by the Department of Biotechnology, Ministry of Science & Technology and Indian Council for Medical Research (ICMR), have been submitted to the Ministry of Health and Family Welfare for further processing. National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) is being constituted jointly by the Department of Biotechnology and ICMR as per these guidelines.
PROGRAMMES FOR DEVELOPMENT The Stanford India Biodesign (SIB) programme was launched for a five year term. Through this leadership training programme in biomedical technology, a group of next- generation innovators & entrepreneurs will be developed to create new medical technologies. First SIB Centre has been established jointly at AIIMS in New Delhi, in conjunction with IIT Delhi. A programme on Nanobiotechnology was launched during the 11th plan with projects in the areas of agriculture, environment and drug delivery. Some interesting projects include synthesis, characterisation and application of surface functionalised magnetic metal nano-particles for bio-separation and
India along with seven other countries became a part of “Stem Cell Network on Asia Pacific” (SNAP). Guidelines for stem cell research in
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diagnostics; role of nano-particles for plant pathogen detection at early stage and waste management; nanocomposites as sensors and their use as smart delivery vehicles for pesticides; environment friendly amphilic copolymers for crop protection; nano-filters for water purification, delivery of bioactive molecules etc. Similarly 35 projects on RNAi technology were also funded. A Grand Challenge Programme was initiated to support biotechnology interventions which can bring about significant value addition, cost effectiveness and competitiveness in products and processes. Seven such programmes were launched in Microbial prospecting for genes and molecules, Vaccines, Food Science and Nutrition, Accelerated Molecular Breeding, Biodesign, Gemomics and Bio-energy, and Biofuels. One lakh microbial strains had already been collected and screened accomplishing a target of 7000 per month. Food and Nutrition programmes for biofortification of wheat, rice and maize, clinical trials of RUTF for severe acute malnutrition, ultra rice-iron and zinc fortified designer crops, neutraceuticals for wellness and zinc for acute diarrhoea were also started. Under energy Grand Challenge, Energy Bioscience Multidisciplinary Centre had been established at UACT, Mumbai. In addition, Algal Biofuel Network was launched and elite Jatropha Plantation was taken up for conservation and tissue culture.
PUBLIC PRIVATE PARTNERSHIPS Three new schemes - the Ignition Grant to reach scientist-innovators, Small Business Innovative Research Initiative (SBIRI) and Biotechnology
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Industry Partnership Programme (BIPP) had been instituted. Of the 602 proposals received 56 were approved for funding and 15 more were in the process for consideration. The Biotechnology Industry Partnership Programme was launched in 2008 as a viable gap-funding scheme on cost sharing basis for achieving competitiveness in frontier biotechnologies, and to fill the gap for providing public support in development of high risk futuristic technologies focussed on ‘breakthrough research’, creating intellectual property rights and benefits for society. The response to BIPP’s first call was excellent with 80 proposals and 50 concepts within a month of announcement; 9 proposals were technically approved for funding. To promote innovation in SMEs, the ‘Biotechnology Industry R&D Assistance Programme’ was commenced as an interim project approved to promote and facilitate industrial research through technology transfer, IP management, technology acquisition and technology forecasting. Implementation of this programme over the next few years would enable graduation to fullfledged council through EFC to act as a formidable interface between academia and private sector, particular SMEs and start-ups to nurture and catalyse innovation.
INVESTMENTS POTENTIAL
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Growth in the biotechnology industry can mainly be attributed to investments, outsourcing activities and exports. A survey from the Association of Biotech Led Enterprises
(ABLE) suggested that 56% of the sector's total revenue of USD 1.44 billion came from exports. Around 70 % of exports were from bio-pharmaceuticals and 26 % from bio-services segments. Private equity (PE) investments in the Indian life sciences sector reached USD 183 million during the 10 months between January and October 2008, compared with around USD 173 million for the same period in 2007. According to an industry survey carried out by ABLE, biotechnology industry in India had notched up a growth of 20 % during 2007-08 and the revenues earned were worth USD 2.56 billion as against USD 2.1 billion during the previous fiscal. Reports have also highlighted that revenues of nearly USD 2.6 billion had been attained mid-year in 2009. Research services touched USD 500 million and bioinformatics were at USD 250 million. Further, in accordance with the industry reports, and going by the current trend and the new biotech policy of the central government, the Indian biotechnology sector is poised to generate anywhere between USD 13 billion to USD 16 billion by 2015.
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INTERVIEW
“IT IS ALL ABOUT GOING TOWARDS EXCELLENCE, BOTH IN EDUCATION AND RESEARCH� Prof. M.K. Bhan, Secretary, Ministry of Science & Technology, Department of Biotechnology, Government of India speaks about the renewed interest in the University system and the specific goal being pursued towards the same. DBT has moved very purposefully to engage with the university system in order to strengthen and upgrade their capabilities for quality work in life sciences. What are the drivers of this renewed interest?
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here is a consensus that we need to correct a historical error in some ways. Our earlier thinking was that universities are places for education and research institutes for strategic or applied research. This model seems to be an over simplification. Further, universities have been denied adequate resources, effective leadership, good governance and level of autonomy that would allow them to pursue excellence. There is too much of a top driven model of governance. The research institutes are like small universities where a few even do strategic research. They are able to attract good faculty because of their greater resourcefulness & small size and as a result take a large chunk of competitive funding. The end result is a distancing of education from
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research. Students without research experience are not effective and creative. Younger the age, at which one is exposed to research, longer lasting is the impact. Universities have thousands of young undergraduates in addition to postgraduates and Ph.Ds and it is here that research must be supported more intensively and more effectively than has been done in the past. In fact, translational centre must be located in university campuses. The second driver is the realization that we need a certain proportion of our universities to be science intense with an ambition to become world class in science, in innovation and in education. Of the 5000 odd universities in the United States, just 50 contribute about 70% of the total intellectual property. So there has to be an elite group on the top of a solid average. While the HRD ministry and other similar bodies focus on improving the average competence of the universities, DBT will try to build the elite group of say about 20-25 universities. It will do so
by supporting education and research at the masters and PhD levels in those universities that have the potential, based on past performance. That is where our focus is. What are the specific goals that are being pursued in this initiative and how do you intend to go about it? As the fist step we send out a team to the selected universities to help undertake an analysis of strengths and weaknesses in infrastructure, inter-disciplinary research programs, skill and leadership gaps. Based on this analysis, we encourage the university to create a proposal to address the identified weaknesses and enhance strengths. Areas in which support may be given include infrastructure, buildings, and centralized equipment (for example, major technology platforms) and to provide funds that act as glue to bring disciplines together. We negotiate with the University for major indicators of success to which they have to commit before funds are given. I will illustrate
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this with some examples. Institute of Chemical Technology (ICT), Mumbai is an institution famous for its chemical and engineering strengths and its ability to work in a privatepublic partnership model. It has produced some of the outstanding business leaders of India. Our analysis showed that ICT has great potential in power and energy research but serious weaknesses in molecular biology. So our negotiations with ICT led to the creation of a new centre around bio-energy. We supported new faculty in molecular biology with a research program focused on bio-energy. This has been a transforming grant for ICT and they have now started doing very effective research. In the next couple of years, the inter-disciplinarity and the quality of their PhD program around bio-energy will increase substantially in both numbers and quality. The other goal of this support was to encourage and push for a greater engagement with industry in this sector, and promote molecular biology and genetic engineering for breakthroughs in bioenergy sector. ICT has responded marvelously in terms of speed and focus. And this is a wonderful experience of what I would call as redesign. Another example is that of the University of Hyderabad (UOH). We supported a new life science centre which includes biological science, chemical science, physics and all the disciplines that are relevant to research and innovation in life sciences. This has improved their ability to scale up their Ph.D. program not only in terms of numbers but also quality. UOH committed to a 4-fold increase in Ph.D. enrollment,
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and noticeable improvement in the citation index or other measures of research productivity. They agreed to add new faculty and redesign their Ph.D. and masters level programs to be more interdisciplinary. This will fulfill DBT's goal for producing Ph.D.’s of high quality and greater inter-disciplinary content. Under the leadership of Dr. Hasnain, ably supported by other leading departments, UOH moved with speed, skill and dedication and the result is an excellent new centre. We are currently engaging the Banaras Hindu University, a university with a rich diversity of disciplines and Osmania University, which attracts a large number of students from rural background in discussion for redesign. We are working with State Agricultural Universities in a similar effort but with one difference. Identifying their research strengths, we strengthen their networked programs to bring greater research content into the education process. We have done this with Punjab Agricultural University, Tamil Nadu Agricultural University, University of Agricultural Sciences- Dharward and GB Pant University of Agricultural Sciences & Technology. Is DBT expanding this program? If yes, at what rate and in which direction? As you can see in these examples there is a variety in the interventions as well as outcomes. In general, it is all about going towards excellence both in education and research. We hope to take about 2 or 3 universities every year and expect to cover about 30 in 10 yrs. The process of negotiation and engagement is repetitive, serious and requires critical thinking.
This limits our ability to handle not more than 3 universities in a year. We are trying to be slow and deliberate but to support quality and that is our philosophy at the moment. In your approach the focus is on tweaking existing institutions and marrying their rich past with the needs of the future, instead of building new ones. Did you find a latent hunger for change waiting to be tapped? When a university is deprived of support and autonomy for a number of years it loses appetite and ambition. A purposeful engagement revives that ambition. When we approach universities our first goal is to rekindle optimism, hope and faith, and remind them of the areas in which they have excelled. When I went to BHU, I was hugely inspired by the sheer scale of what had been created in India so long ago. I almost had the feeling that we had gone off to sleep for so long. So you are looking at some of these glorious universities that have had a great past but haven't been nurtured well in recent times. My feeling is they could show progressive excitement at future possibilities when they realize that we are coming not with incremental funding but with decisive support. That is really the key. I know of many people who would advise us to give them only what they can absorb. But when the approach is therapeutic you need to invest appropriately. That is why we focus on giving large decisive grants than small allocations which result in modest goals and outcomes. Courtesy: www.biotechnews.in, News portal of the Department of Biotechnology, Government of India.
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