India_Country Paper1.doc
Biotechnology in India – 2006
Upendra N. Behera.
Joint Secretary, DBT.
Biotechnology is globally recognized as a rapidly emerging, complex and far reaching new technology. Biotechnology can, over the next two decades,deliver the next wave of technological change that can be as radical and pervasive as that brought about by IT. The recent and continuing advances in life sciences clearly unfold a scenario energised and driven by the new tools of biotechnology. The convergence of advances in biology – genomics, proteomics, bioinformatics and information technologies is driving the emergence of a new bioeconomy.
A large number of therapeutic biotech drugs and vaccines are currently being marketed, accounting for a US$ 40 billion market and benefiting over a hundred million people worldwide. Hundreds more are in clinical development. In addition to these, there are a large number of agri-biotech and industrial biotech products that have enormously helped people. The global biotech industry recorded a turnover of US$ 64 billion during 2003. Employment generation, intellectual wealth creation, expanding entrepreneurial opportunities, augmenting industrial growth are a few of the compelling factors that warrant a focused approach for this sector.
It was way back in 1980s when Government of India considered the need for creating a separate institutional framework for strengthening biology and biotechnology research in the country. The scientific agencies like Council of Scientific & Industrial Research, Indian Council of Agricultural Research, Indian Council of Medical Research, Department of Science & Technology, University Grants Commission and some others were supporting research in modern biology. However, it was with the establishment of the National Biotechnology Board in 1982 that the area got a systematic impetus. Human resource development, creation of infrastructure facilities and support to research and development in carefully identified areas were given the highest priority. Based on the success and impact of the activities of the National Biotechnology Board, Government of India in February 1986 established a separate Biotechnology Department under the Ministry of Science & Technology. There have been major accomplishments and the field has tremendously moved forward covering the areas of basic research, agriculture, healthcare, environment, bioinformatics, human resource development, industry, safety and ethical issues, etc.
Biotechnology industry in India has been growing at an average annual rate of 40 %during the last five years and its turnover during 2004-05 exceeded US$ 1 billion. Biotechnology as a business segment for India has the potential of generating revenues to the tune of US$ 5 Billion and creating one million jobs by 2010 through products and services. This can propel India into a significant position in the global biotech sweepstakes. Biopharmaceuticals alone have the potential to be a US$ 2 billion market opportunity largely driven by vaccines and bio-generics. Clinical development services can generate in excess of US$ 1.5 billion whilst bioservices or outsourced research services can garner a market of US$ 1 billion over this time scale. The balance US$500 million is attributable to agricultural and industrial biotechnology.
India has many assets in its strong pool of scientists and engineers, vast institutional network, and cost effective manufacturing. There are over a hundred national research laboratories employing thousands of scientists. There are more than 300 college level educational and training institutes across the country offering degrees and diplomas in biotechnology, bio-informatics and the biological sciences, producing nearly 500,000 students on an annual basis. More than 100 medical colleges add 17,000 medical practitioners per year. About 300,000 postgraduates and 1500 PhDs qualify in biosciences and engineering each year.
India is reorganized as a mega bio-diversity country and biotechnology offers opportunities to convert our biological resources into economic wealth and employment opportunities. Innovative products and services that draw on renewable resources bring greater efficiency into industrial processes, check environmental degradation and deliver a more bio-based economy. Indian agriculture faces the formidable challenge of having to produce more farm commodities for our growing human and livestock population from diminishing per capita arable land and water resources. Biotechnology has the potential to overcome this challenge, to ensure the livelihood security of 110 million farming families in our country.
The efforts in the last two decades have directed notable interventions in the public and private sectors to foster life sciences and biotechnology. There has been substantial progress in terms of support for R&D, human resource generation and infrastructure development. With the introduction of the product patent regime in January 2005, India has created the right environment for innovation.
2. Human Resource Development
Biotechnology is a knowledge-based technology, which needs to be driven by a flow of new ideas and concepts in the development of new tools for research, new processes for manufacturing and innovative business models. Trained manpower and expertise in India belong to classical and modern biology/ biotechnology. While in many developed countries it has become difficult to find young generation of classical biologists to supplement the interdisciplinary modern biotechnology research, India has still adequate expertise in the fields like biochemistry, organic chemistry, taxonomy, pharmacology and traditional systems of medicine. Most of present day modern biologists had long or short-term training in laboratories of USA and Europe. The programme of the government to award short and long term overseas post doctoral fellowships has been very successful in this effort. The post graduate programme at 55 universities and institutions fully supported by the Department of Biotechnology train about 1000 students every year. This programme aims at creating trained human resource at the post-graduate level in general biotechnology, agriculture biotechnology, medical biotechnology, Pharmaceutical Biotechnology, marine biotechnology, neurosciences, biochemical engineering and industrial biotechnology. The Department also provides a large number of doctoral and post doctoral fellowships. Tailor-made industrial attachment and training programmes add value to the technical skills of these students so as to make them suitable for advanced R&D and production activities. Besides, a large number of other government and private universities run their own M.Sc. and B.Tech. programmes in biotechnology.
A large number of short-term training programmes of 4 – 6 week duration are conducted to provide hands-on training to mid-career scientists from academic/research institutions and also to technologists and scientists in advanced and emerging research techniques in multi-disciplinary areas of biotechnology. The Department of Biotechnology supports 12 to 15 short term training courses every year. Government of India funds a number of awards and fellowships such as Distinguished Biotechnologist Award, National Bioscience Award for Career Development, National Women Bioscientist Award, Biotechnology Product, Process Development and Commercialization Award, etc. in recognition of the talent as measures of motivation and promotion. Biotechnology Scholarships are provided to bright students to attract them to undergraduate courses in biosciences.
3. Infrastructure :
Since 1986, there has been concerted effort by the Government of India towards capacity building both in terms of human resource and sophisticated infrastructure for R&D. As a result at present, there are world class facilities for DNA sequencing, protein engineering, bioprocessing, crystallography, molecular graphics and modeling, PL3 and PL4 level containment for work on dangerous pathogens, prescribed glass/animal houses for transgenic animal/plant research, repositories of microorganisms important in agriculture, healthcare and industry, ex-situ and in-situ gene banks for crops and endangered medicinal and aromatic plants, medium and high throughput screening facilities for drugs and pharmaceuticals, biosensors, Nuclear Magnetic Resonance machines, different mass spectrometers for various purposes, GM testing labs, micro arrays, automated DNA sequencing as well as robotic plasmid isolation equipment. Most of the facilities could be shared by the both public and private research laboratories. There are about 200 laboratories with state-of-art of equipment and facilities for recombinant DNA research. Many private sector R&D facilities also have sophisticated equipment in most of these areas and some of them are paid up service facilities for researchers.
4. Research & Development :
Indian R&D of science and technology had been mostly government sponsored. India has a huge infrastructure and research network in place driven by nodal agencies like The Department of Biotechnology (DBT), Indian Council for Agricultural Research (ICAR), The Council for Scientific and Industrial Research (CSIR), and Indian Council for Medical Research (ICMR). With the new patent regime in place, public private collaborations on the research front are now emeging and most of the companies are catching up with discovery- led innovations.
CSIR has a network of 40 laboratories and 81 field stations,extension centers and regional centers all over India to undertake R&D in several disciplines including biotechnology. It has more than 22,000 highly qualified multidisciplinary professionals. ICAR promotes science and technology programs in agricultural research and education and carries out research directly through ICAR institutes, national research centers, project directorates and also in association with the State Agricultural Universities (SAUs) through the all India coordinated research project systems. This vast network of ICAR has manpower of about 30,000 personnel out of which nearly 7000 are engaged in active research and its management. The 30 SAUs employ about 26,000 scientists for teaching, research and extension education; of these over 6,000 scientists are employed in the ICAR supported coordinated projects.
The ICMR formulates, coordinates and promotes biomedical research in India. Its network consists of 21 permanent research institutes/centers (national institutes) located in different parts of India and six regional medical centers. The ICMR national institutes offer opportunities for research in the area of medical biotechnology.
There have been tremendous advances in various fields of biotechnology, be it cell biology, molecular biology, computational biology or recombinant technology, genomics or proteomics. Basic research studies are very important as these studies can eventually prove path breaking in unfolding the unknown mechanistic details of any evolving system. The Department has been supporting basic research in various emerging areas. Continued support in basic research to develop expertise and understand basic biological processes for further applications in protein engineering, drug and molecular design and identified potential molecules for development of vaccines and diagnostic for infectious diseases has led to important breakthrough.
4.1. Agriculture :
4.1.1. Crop Biotechnology :
Agriculture in India accounts for nearly 65% of the country’s employment, 26% of the total GDP and nearly 20% of total export earning and supplier of raw material to major industries. Agriculture is not only the backbone of Indian economy and food security but also a way of life, a tradition and anchor of overall livelihood opportunity for about 70 % of India’s one billion population. Agriculture, therefore, is and will continue to be central to all strategies for planned socio-economic development of the country. Despite major advances in agriculture and strong growth in food production in the latter part of the twentieth century, food security for the masses continues to be an area of concern. The application of biotechnology techniques in the agriculture sector can potentially improve food security by raising crop tolerance to adverse weather and soil conditions, by enhancing adaptability of crops to different climates and by improving yields, pest resistance and nutrition, particularly of staple food crops.
Genetic modification of crops is one such method allowing individual characters (gene, factor or trait) to be transferred into crop plants. With the advent of genetic modification through genetic engineering in early eighties, the natural barrier of only intra-specific exchange of characters was removed and scientists were able to identify and transfer specific genes associated with desirable traits from one organism to the organism of other species that otherwise cannot breed naturally. With these techniques genes from varied class of organisms like bacteria, virus or even animal may be transferred into plants to develop genetically modified plants having exclusively changed characteristics controlled by the specific gene. This gives scientists/ breeders a broader access to desirable traits from any living organism and its possibility of transferring it with much faster rate and greater precision.
India’s R & D programme aims at addressing major problems of priority crops, development of transgenics, quality improvement and basic research in the area of plant molecular biology. There are number of multi-institutional projects e.g. characterization of quality traits in wheat; development of molecular methods for hybrid seed production in mustard; development of transgenic cotton, rice, mungbean and tomato for resistance to various biotic stresses; salinity and dehydration stress tolerance in rice; cloning of responsive genes and their promoters and development of wheat varieties with resistance to leaf and stripe rust using molecular marker technology.
After standardization of transgenic technology, now emphasis is on development of large number of transgenics in cotton, rice, mungbean and tomato followed by diversification, molecular characterization and field evaluation. The international obligation of Rice genome sequencing data was fulfilled by the end of December 2002. Under the collaborative programme, transgenic Brassica is being tested for male sterility, herbicide resistance and Alternaria blight in the field conditions. Transgenic system in indica rice and wheat has been developed. Rice has been transformed with codA/COR47, AtHSP100 and PDC gene while wheat transformed with HVA1 to confer stress resistance. All the transgenics have been characterized at the molecular level for gene integration. Studies have been conducted to transform indica rice plants with P5CS gene to make it more tolerant to salinity. The assessment of transformed plants harboring this gene as a single copy showed promising results and further efforts are on to pyramid one more gene for higher tolerance to salinity.
4.1.2. Animal Biotechnology :
The main thrust of R&D in this area is to improve productivity in livestock; to characterize indigenous breeds of livestock animals and to develop cost effective and commercially viable disease diagnostics and vaccines. A complete health package for infectious bovine rhinotracheitis (IBR) disease including diagnostics and vaccine has been developed. The technology of inactivated tissue culture vaccine for IBR has been transferred to the industry. Repositories of blue tongue virus isolates and leptospira isolates have been created and made available to researchers for further studies. For development of diagnostics for Blue tongue (BT) virus, antigens have been developed, purified and tested. Immunodiagnostic test for trypanosomiasis has been standardized and its efficacy in field conditions has been observed to be 75 to 80%. Rabies vaccine for animals using laboratory rabies strain PV-11 seed virus has been developed. Recombinant protective antigen against anthrax has been developed and technology transferred to the industry.
Embryo transfer technology in cattle, buffalo, goats and camel has been standardized and is in practice. Crossbred Sahiwal bull produced through open nucleus breeding programme is being used in National Artificial Insemination programme. 18 lines of transgenic mice have been produced and made available to researchers. Cell cultured based rabies vaccine for animals has been developed and the technology transferred to the industry. Reconstituted collagen sheet for wound and burn healing has been developed and transferred to industry.
4.1.3. Aquaculture and Marine Biotechnology :
The main activities in this sector are development of recombinant diagnostics and vaccines for major diseases in aquaculture; molecular biology of Indian species, identification of useful genes and development of indigenous gene constructs for fish transgenesis; genomics & proteomics studies in aquaculture species; isolation of bioactive molecules from aquatic organisms for therapeutic and industrial applications; in vitro tissue culture, cell culture system development in various aquaculture species; front-line demonstrations to prove techno-economic viability of seed production and aquaculture in non-traditional species; and programmes on new feed development, nutrition, breeding, spawning agents, health and post harvest aspects etc. for enhancing aquaculture productivity. The R & D emphasis is on structural and functional genomics related to indigenous freshwater, estuarine and marine species; expression of novel genes coding for bioactive macromolecules for therapeutic and industrial applications; development of marine biomaterials, bio-adhesives, bio-flocculents, bio-surfactants, medical implants, biopolymers, bioplastics and novel enzymes; bioremediation/antifouling agents from aquatic organisms; and development of cell/tissue culture in cultivable marine organisms, invertebrates and seaweeds etc.
A heat killed whole cell vibrio vaccine using a virulent strain of Vibrio harveyi has been developed. This has shown immune response in shrimp (Penaeus monodon) and the technology has been transferred to industry.A polyclonal antibody based immunodiagnostic kit has been developed for detection of different bacterial pathogens in finfish and shellfish. The technology has been transferred for commercialization. The kits are useful as on-farm, rapid diagnostic kits to detect bacterial and viral diseases of finfish and shellfish. Diagnostic kits have also been developed for viral diseases in shrimp and commercialized. A polyclonal antibody-based immunodiagnostic assay has also been developed for the detection of white spot syndrome virus.
4.1.4. Seribiotechnology :
Sericulture in India is an important cottage industry based on agroforestry earning valuable foreign exchange. Presently, sericulture is practised in more than 60,000 villages providing employment to 6 million rural families. Silk production has reached over 15,000 tonnes and India is the second largest silk producer (18% of world production). In spite of continuous increase in silk production, the productivity continues to be a major concern. Apart from increasing silk productivity, efforts are being made to develop silkworm as bioreactor for producing biomolecules of commercial importance. Expression of marker proteins (luciferase and green fluorescent protein) have been successfully achieved in cell lines and larval caterpillars of silkworm (Bombyx mori) employing recombinant Bm NPV vector harbouring reporter genes. The work has been well appreciated and the glowing silkworms appeared on cover page of two issues of American Journal – Biotechniques. Studies are continuing for production of a few veterinary vaccines using this system.