Department of Biotechnology
Ministry of Science & Technology
Govt. of India
New Delhi - 110 003

BIOTECHNOLOGY - A VISION
(Ten Year Prespective)

This document represents the vision of many distinguished biotechnologists of the country and some eminent non-resident Indian scientists associated with the programmes and advisory committees of the Department of Biotechnology. We gratefully acknowledge their advice and inputs. It is also illustrative and brings out the possible future areas for biotechnological enterprises. Thus the goals outlined in the vision document are achievable within ten years for a biotechnology based, environmentally sound and sustainable societal development and a bioindustrial revolution through excellence in bioscience innovations, discoveries and increasing understanding of life processes.

VISION STATEMENT

"Attaining new heights in biotechnology research, shaping biotechnology into a premier precision tool of the future for creation of wealth and ensuring social justice - specially for the welfare of the poor".

OUR MISSION

• Realising biotechnology as one of the greatest intellectual enterprises of humankind, to provide the impetus that fulfills this potential of understanding life processes and utilizing them to the advantage of humanity.
• To launch a major well directed effort with significant investment, for harnessing biotechnological tools for generation of products, processes and technologies to enhance the efficiency and productivity and cost effectiveness of agriculture, nutritional security, molecular medicine, environmentally safe technologies for pollution abatement, biodiversity conservation and bioindustrial development.
• Scientific and technological empowerment of India's incomparable human resource.
• Creation of a strong infrastructure both for research and commercialisation, ensuring a steady flow of bioproducts, bioprocesses and new biotechnologies.

Part - I

EXECUTIVE SUMMARY

In order to realise the full potential of biotechnology as a frontline area of research and development with an overwhelming impact on society, the Indian biotechnological enterprise will be systematically nurtured at three distinct levels. The focus would be on : basic research in modern biotechnology, including genomics and bioinformatics; agriculture, plant and animal biotechnology; medical biotechnology; environment and biodiversity; biofuels; product and process development and bioinstrumentation; human resource development; creation and strengthening of infrastructure in existing and new institutions; biotechnology for societal development; biosafety, ethical issues and biotechnology related policy issues; conduct of cutting edge research, large scale demonstrations, partnership with private and public sector industries for commercialisation and marketing of bioproducts.

Enhancing the knowledge base and generating highly skilled human resource :
"The national bioscience research endeavour in elucidating the molecular basis of plant, animal and microbial life processes will be honed to the cutting-edge by applying global standards. Necessary informational resources will be systematically developed through data banks, inventories, and germ plasm repositories. Human resource development in biosciences and biotechnology will be enhanced to achieve widespread excellence in both teaching quality and support resources. At least 20 Distinguished Professorships in Biotechnology would be instituted to recognize the excellence and provide opportunities for furthering research. Awards and incentives would be instituted to recognize meritorious efforts. Selected missions in identified areas would be launched.

Nurturing leads of potential utility :
Life technology development leads emerging from the bioscience enterprises will be vigilantly identified and fostered in three major areas; agriculture, health care and the environment. Widely available information resources will be developed for this interface via regulated and comprehensive repositories, systematic biological standardisation, and patent support mechanisms. Industrial transitions will be facilitated with large-scale demonstrations and seed partnerships. Pro-active steps will be taken to address societal concerns by establishing transparent mechanisms of systematic public dissemination of bio-information, and by putting into place comprehensive stringent frameworks for both bioethics and biosafety.

The widely spread bioinformatics network would be maximally utilised to ensure connectivity as also sharing and exchange of information, nationally and internationally, data analysis, software development and for dissemination of information. The required infrastructure facilities would be strengthened and created wherever necessary.

Bringing bio-products to the marketplace :
Innovative policies will be developed and implemented, in conjunction with other government departments and agencies, to enhance the biotechnological landscape for investment, to champion Indian biotechnology in the global marketplace, and to design innovative as well as defensive strategies for global intellectual property rights. Systematic interventions at this level will include pilot-scale production and training units, short- as well as long-term partnerships with the biotechnology industry, and coordination of public investment in societally essential products with low commercial returns. We aim at achieving excellence in this field, indigenous self reliance and international competitiveness.

Part - II

MILESTONES

Modern biotechnological research has a long gestation period. Innovation chain would consist of basic research resulting in research leads; evaluation of research results; product and process development; at this stage involvement of industrial partners or enhanced public investment would be necessary. Commercialisation by industry with appropriate market survey including packaging of technologies would then follow. For the identified areas, the products expected to be generated would form the milestones of the vision statement. In addition, completion of the inventories of biological resources, their characterisation, data mining and annotation for genomics would be carried out within a stipulated time schedule in a mission approach. There are significant elements of unpredictability involved in innovative research in life sciences on one hand, and in the entrepreneurial and market enthusiasm for potential technologies on the other, necessitating caution in the confident prediction of definitive milestones. Therefore, it will not be possible to present the milestones on an annual basis. The vision document stipulates a 10 year profile and accordingly, the milestones and hallmarks of progress are indicated below :

The Knowledge Base :

Basic Research in New Biology and Biotechnology

In the identified areas, mechanisms, relationships and pathways would be evolved leading to the strengthening of the knowledge base and potential leads for product and process development. In the areas of genomics and bioinformatics, basic research would be more time targeted and related to the identified products. The genomics and bioinformatics infrastructure and networking would be completed within 2-3 years. After the completion of 5 years, about 1000 trained experts in bioinformatics would be available with a large number of database and with abilities for data mining, data annotation, comparative and functional genomics.

Agriculture

Transgenics of rice, brassica, moongbean, pigeonpea, cotton, potato, tomato, and some vegetables like cabbage, cauliflower etc. would complete field assessment and some of them would be ready for the large scale seed production by 2005. Nutritionally enhanced potato and BT- cotton are among the important ones. Transgenic wheat with more protein content and better quality and also higher lysine content and marker assisted breeding programme is expected to be introduced in farmers' field by 2003-2005. The sequencing of Chromosome 11 in rice would be completed by 2005 with an annual contribution of 2 Mb to international rice genome project. This would ensure that India would have the total information on rice genome; and functional genomics work would start by identification of the important markers and genes.

Edible vaccines, particularly for cholera, rabies and hepatitis B, work on which is already under progress, would be ready for clinical trials by 2003-2004, with an expression gene in tomato, cabbage and banana.

Biofertilizers and Biopesticides

Transgenic biofertilizers and biopesticides, particularly botanicals which already have been developed, would have been field tested for commercial production and atleast 20 more technology packages would be ready for testing.

Bioprospecting and Molecular Taxonomy

It is expected to complete the prospecting and molecular characterisation and documentation of the economically and ecologically important hot spots of biodiversity in the country, such as the Western Ghats and the Northeastern Region, by 2004, in complementation of classical approaches. The molecules thus identified would be simultaneously taken up for product development : drugs, vaccines, biofertilizers, biopesticides and therapeutics. The characterisation and inventorisation of much of the biological resources in Andaman and Nicobar islands would be completed by 2005. A bio-monitoring system for fragile ecosystems rich in biodiversity would be put in place by 2003.

Plant Tissue Culture

Complete packages, different tissue culture protocols for coffee, tea, spices and apple would be ready for commercialisation by 2002-2003. The regional hardening facilities to provide the benefit of the tissue culture technology at the grassroot level would be expanded to cover the most plant rich regions of the country which need massive afforestation and wasteland recovery.

Medicinal and Aromatic Plants

A number of herbal products are expected to be in market starting from 2001 onwards. These would be in the form of new formulations, immunomodulators and drugs. The diseases addressed are septic shock, diabetes, malaria and cancer. At least 20 agro-biotechnological packages for many herbal products would be introduced for higher and better yield.

Animals

Vaccine research for major livestock diseases such as haemorrhagic septicaemia, recombinant vaccine for Anthrax would be ready for evaluation. Vero cell based rabies and Zona pellucida peptide for fertility control in dogs would complete the evaluation by 2002. Diagnostics for PPR (Peste-des-petis-ruminants) and Blue Tongue are ready for evaluation which would be completed by 2002. Bovine Tuberculosis diagnostic kit is under development. A diagnostic kit for White Spot Virus in prawns would be completing its evaluation by the end of 2001. Animal feed through conversion of lignocellulasic material and its enrichment would be a major research priority. As soon as it is ready for evaluation, it would go for field testing. Genomic studies would be taken up for major livestock species e.g., buffalo and would reach an advanced stage by the end of the Tenth Plan. Transgenic fish expressing growth hormone gene are expected for further evaluation towards the end of 2001.

Marine Resources

Secondary information on inventorisation would be put on a digitized database by 2002. Some interdisciplinary projects on product development would be launched specially for food and nutritional security and producing important therapeutics. This will commence from 2001.

Environment and Biodiversity

Bioremediation and waste recycling in specific locations would be undertaken by new microbial consortia and within 3 years atleast 10 more locations would be covered in addition to the existing ones. The development of bioindicators and biosensors would take 2-3 years. By 2003, a number of biosensors for pollution control, specially the enzyme based ones would be available. A plan of action for specific ecosystems with biotechnological interventions would be ready for implementation for deserts, islands, coastal region, mangroves and mountainous ecosystem by 2001-2002.

Medical Biotechnology

Diagnostic kits for major infectious diseases like tuberculosis, malaria, Japanese Encephalitis, HIV, dengue, hepatitis as well as non-communicable diseases like hormonal disorders (several of which have already been licensed to industry) would be in the market by 2002. Upscaling and commercialisation of PCR- based diagnostics would be completed by 2002 onwards. The DNA vaccines for rabies in dogs would be ready for manufacture in 2002- 2003. The cholera vaccine would complete its trials by 2004-2005. Vaccines for HIV, TB and malaria are expected to enter Phase-I& II trials by 2004-2005. Rotaviral diarrhoea vaccine would enter Phase-I trial in 2001 and is expected to obtain the approvals in 2 years. A vaccine for Hepatitis C would enter Phase-I clinical trials by 2003. Gene therapy trials against cancer will be initiated in 2001- 2002.

Upscaling and probably commercialisation of the newer genomics- based technologies (e.g., microarrays) would commence from 2002 onwards and some would be in market by the end of the Tenth Plan period.

Reproductive health and contraceptive research would continue to be major priority.

Bioengineering of Crops for Biofuels and Bioenergy

Identification and development of crops for bioengineering for biofuels and bioenergy would take at least 2-5 years for completion of various objectives. Field testing of such crops may begin during the Tenth Plan.

Industry

More Public- Private partnerships will be forged in order to develop joint R & D programmes for commercially viable projects. Production units for recombinant biologicals, DNA chips and related materials would be set up between 2002-2005. A large number of decentralised production units, at least 100, for biofertilizers and biopesticides in the small scale sector would be established all over the country with new technology packages by the end of the Tenth Plan.

Human Resource Development

Fifty teachers and 1000 students per year would be trained in emerging areas of biology and biotechnology leading to 250 trained teachers and 5000 scientists in 5 years. In addition, short term and long term programmes would result in training of more than 1000 technicians, scientists, industrialists, IPR experts, covering the whole arena of biotechnology research and commercialisation. In 10 years at least 15000-20000 students would be trained in various biotech ventures.

Biotechnology for Societal Development

At least 100 projects in 5 years directed to specific sectors, location specific and based on natural resources, would be implemented. It is expected that these projects would generate a minimum of 5000 and upto 10,000 employment opportunities in the rural areas, particularly for women and the SC/ST population. The beneficiaries from these programmes are expected to be 15-20 lakhs in 5 years. The Biovillage concept would be significantly expanded to have at least 100 biovillages by the end of the Tenth Plan and 200 in 10 years with focussed biotechnology activities. Genetic counselling programmes would be expanded further.

Infrastructure and Institution Development & Safety Guidelines

At least 10 States will have Biotechnology Parks or Incubators. A dozen genome sequencing facilities, a major national facility for proteomics and genomics, and 20-25 hardening units would have been established. Biosafety guidelines would be in place and the implementation modalities would be further firmed up involving even the State level institutions and the NGOs. Facilities for filing patents, training of personnel on IPR matters and evolving various policy issues on IPR matters with regard to the patenting in biotechnology would be completed by 2002-2003. Based on present trends in biology research in the country, we expect an extensive portfolio of patents to emerge within a ten-year- period.

By 2002, with the start of the Tenth Five Year Plan, various procedures of clinical trials, clearances and approvals for genetically modified foods, recombinant vaccines and biologicals would be streamlined and implementation guidelines issued. A single window clearance system would be set up.

Research programmes on risk assessment (food safety, ecological aspects) and the socio-economic impact of new technologies would be substantially strengthened. Country-wide programmes would be launched in order to sensitize the public in regard to the use of gene technologies in agriculture, health and environment.

Possibilities would be explored to establish Centres of Excellence in existing institutions, or set up new centres in carefully chosen frontier areas of biology and to give programme- based support as per national priorities to institutions and universities.

Part - III

TEN YEAR PERSPECTIVE

Sustainable development ensuring food, nutritional, health, environmental and livelihood security of the people by harnessing the powers of biotechnology would be a dream of the scientific community. Translating these dreams into reality would give a major impetus to our socio-economic progress. Time-bound, mission mode, result oriented projects to be taken up for : utilisation of the full potential of the genomics revolution for humankind, plants, animals and microbes; to develop new vaccines, diagnostics, drugs and drug delivery system; to produce a large number of low-cost, affordable small proteins and therapeutics using the plants and animals as bioreactors; to engineer crops with enhanced nutritional status, biotic and abiotic resistance and introduce precision farming with new quality traits for productivity enhancement; and to develop environmentally friendly technology packages for pollution control, biodiversity conservation and restoration of damaged ecosystems. Long term support would continue for basic research on all aspects of molecular biology, genetics and genomics, proteomics and neurosciences. Well-defined missions to develop products, processes and technologies addressing the problems of the nation would be launched.

Research and development, demonstration and commercialisation in the above areas and implementation of some selected missions would be our endeavour. To integrate information and biotechnology revolution as a single technological and economic force and establish a large number of biological data banks would facilitate rapid progress of biotechnology. Transgenics as an important strategy in agriculture would produce bioengineered crops to become a source of enzymes, vaccines, biochemicals, etc.; crops with resistance to biotic and abiotic stresses such as salinity, drought and water logging; nitrogen fixation in cereals using more efficient microbes and value addition along with nutritional enhancement of important edible crops would be a mission. In vitro mass propagation of the desired planting material, genetic control through identification and manipulation of genes and its implication in the forestry sector would help in rapid regeneration of forests and also result in the enhanced production of industrial timber. Development of a large number of diagnostics for major diseases, genetic disorders, cancer, tuberculosis, HIV, malaria, better understanding of the human brain from molecular to systems level to enable control and treatment of large number of currently uncurable neurological disorders and development of new generation vaccines including the DNA vaccine would move fast. Our inherent strength of Ayurveda and traditional systems of medicine would be optimally utilised through biotechnological interventions. Realising that the present century would greatly depend on medicines from plant-based systems, development of new molecules, drugs, prospecting of new genes and the whole field of pharmacogenomics would be a mission.

It is becoming increasingly obvious that systems that combine biological and chemical molecules on the one hand, and physical devices and electrodes on the other, have a huge potential for many applications.

In order to generate a critical mass of expertise, a strong infrastructure and directed support, the critical areas for investment over a ten year period have been outlined.

Our vision for Biotechnology research, development and commercialisation, in the next 10 years would thus focus on :

• Basic Research in New Biology and Biotechnology
  (a) Genomics
  (b) Bioinformatics
  (c) Basic biological phenomena with potential application
• Agriculture, Plant and Animal Biotechnology
• Environment and Biodiversity
• Medical Biotechnology
• Biofuels
• Bioprocesses, Product Development, and Bioinstrumentation
• Human Resource Development
• Creation and Strengthening of Infrastructure in Existing Institutions and setting up new Institutions
• Biotechnology for Societal Development
• Biosafety, Ethical and Proprietary Issues

Basic Research in New Biology and Biotechnology

Long-term support for the following critical areas :

• Molecular and genetic phenomena associated with processes of infection, progression of disease (infectious and systemic) and the underlying pathology, both in animals and plants.
• Molecular approaches to community dynamics in crop rhizosphere ecosystems to assess soil-dependent and genotype dependent changes and utilisation of this information in use of indigenous and genetically-modified microorganisms.
• Redirect physiology of root cells towards a richer microbial community in rhizosphere.
• Development of suitable micro-assay and high throughput assay systems to assess the therapeutic potentiality of the naturally existing and structural and functional characterization of the molecules.
• Biosensors are invaluable in the design and operation of automated and environmentally benign processes, used in the detection of minute amounts of antigen/antibodies in body fluids, monitoring, and control food additives, food safety factors, and bioremediation technologies. Biosensors are attractive because they can harness the inherent specificity of many biochemical / immunological processes to allow for accurate and highly specific detection. To design, construct, probe, and alter sensitive and highly specific biosensors and incorporate them into transducing and reporting systems.
• Metabolic engineering using recombinant DNA technology to enhance the activities of cells by manipulating its metabolic pathways and enhancing the potential of organism-producing antibiotics etc.
• Tissue engineering for the development of biological substitutes to restore, maintain, or improve human tissue function - employing the tools of biotechnology and material sciences as well as engineering concepts to explore structure-function relationships in mammalian tissues would be a challenge. This emerging technology could provide for substantial savings in health care costs and major improvements in the quality and length of life for patients with tissue loss or organ.
• Exploring the potential of stem cells for therapeutic purposes

Genomics: Structural and Functional

• To establish GEN-NET INDIA to identify and control genetic disorders prevalent in the country.
• Exploit the knowledge created by Human Genome Sequencing and also that of some pathogenic organisms and parasites so as to generate diagnostic and therapeutic products of special relevance for the country mostly for dreadful diseases like malaria, HIV, tuberculosis, cancer and brain disorders.
• Identifying genomic factors responsible for genetic disorders, development of molecular diagnostics and personalised drugs for the treatment, understanding of the biochemical pathways of the diseases leading to a safe and powerful treatment regime. Comparative genomics, functional and structural genomics, studies of single nucleotide polymorphism, proteomics, data annotation, integration and analysis.
• Creation of DNA ploymorphism maps and databases of the peoples of India for predictive and preventive healthcare.
• Creation of microarray facilities for defining the expression and functions of genes. For important crops like rice, wheat, brassica, chickpea, a map-based marker assisted technology development for precision breeding, as well as gene identification through in situ molecular hybridization.

Functional Genomics

• To exploit the sequence information we have to understand the specific biological functions encoded by a sequence through detailed genetic and phenotypic analysis. For this purpose, genetic resources, e.g. mutants, isogenic lines, elite breeding lines, and high throughput facilities such as microarrays and proteomics would be developed. The programme would initially focus on selected high-priority traits such as tolerance to biotic and abiotic stresses. Bioinformatics capability for analytical and computational ability to infer gene function based on sequence information is equally essential. To enhance scientific knowledge and to discover new genes for crop improvement, a national functional genomics program is needed to make information from functional genomic studies broadly available to address practical problems.
• Mapping of the buffalo and the silk worm genomes.
• Comparative genomics of pathogenic microbes.

Bioinformatics

• Development of new algorithms, softwares and tools for data mining and data warehousing applications especially related to human, plant and microbial genomes; establishment of small software groups and companies to develop competence for identification of useful genes; strengthening the infrastructure for supporting complex and computationally intensive problems such as protein folding and other problems in structural biology; and establish linkages with epidemiological data to discover the genetic basis of several diseases affecting certain communities in India.
• To set up dedicated network centres for developing data warehouses, data design, data mining from single and multiple databases and mirror sites to decipher the international data available in public domain to co-relate the function of individual sequences.
• Exploitation of microbial genome information using strong bioinformatics machinery. These goals would be realised through an institutional framework of a national-level autonomous bioinformatics centre. Training of personnel would be expanded many fold to train atleast 200 personnel per year to have a core group of 1000 trained experts in five years.

Agriculture, Plant and Animal Biotechnology

Crops

Major thrust on :

• Higher productivity
• Enhanced nutritional status
• Value addition to crops as therapeutics

Stability against stresses : Insect pests and diseases still continue to cause heavy crop losses. Focussing on specific crops and problems, transgenic and / or marker-assisted selection approaches shall be developed and used to evolve stress-tolerant crop varieties.

Yield enhancement : Three approaches are contemplated to raise the genetic ceiling to yield viz.,
i) exploitation of hybrid vigour
ii) search for and use of still unexploited, yield-related gene blocks (QTLs) and
iii) engineering of biosynthetic pathways of starch, protein and oil. Whereas male sterility by anther/ pollen specific expression of toxin/ protoxin gene(s) would be engineered to extend hybrid technology to non-hybrid crops like Brassica, marker associated gene blocks relating to yield shall be identified using QTL techniques in landraces and progenitor species of crop plants. Manipulation of key / rate-limiting enzymes in the pathways of starch etc., will be attempted for achieving new yield thresholds. Development and deployment of map-based and marker-assisted technologies for precision breeding in crop plants like rice, wheat, brassica, chickpea etc. Special focus on designer crop plants that carry specifically selected genes with traits that allow them to thrive in particular environment or produce valued consumer characteristics through the application of structural/functional genomic approaches.

Nutritional quality improvement : Exotic and indigenously identified candidate genes to be exploited to enhance the level of the essential nutrients such as iron, zinc, vitamins, balanced proteins etc. in major crops. Correction of antinutritional factors known to exist in specific pulse and oilseed crops. A time-bound mission to be launched.

Edible vaccines for diseases, particularly for cholera, hepatitis, and rabies would be developed and tested for large- scale production.

Biofertilizers and Biopesticides

Developing transgenic biofertilizers, by increasing copy number of nif genes; incorporation of hup genes, wherever hydrogenase enzyme is not produced and knocking off negative regulatory gene from the regulatory operon.

Bioprospecting and Molecular Taxonomy

• Bioprospecting wild plants for commercially valuable genetic and biochemical resources, specially to cover the endangered species. Instituting a country-wide biomonitoring system for biodiversity with a focus on fragile ecosystems.
• Completion of molecular characterization and documentation of the economically important biological resources specially from the Hot Spots of Biodiversity covering plants, animals and microbes.
• The bioprospecting of bioresources using biotechnological tools is now being referred to as "genetic gold rush". Relatively common or inexpensive raw materials would be transformed through high technology into highly refined and desirable commodities.
• Prospecting of genes and molecules and taking the leads further for product development.

Plant Tissue Culture

• Developing complete packages for improvement of priority crops - coffee, tea, apple, spices.
• Continued large scale production of forest tree species.
• Development and use of micropropagation for multiplication of root stocks and scions in selected varieties of fruit crops like mango and hairy root culture for production of secondary metabolites in general and those relevant to food industry.
• Promoting application of tissue culture technology at grass root level and its adoption by the end user.
• Utilization of tissue culture for enrichment of genetic diversity.
• Genetic manipulation of cell culture in forestry for disease resistance and reduction of regeneration time.

Medicinal and Aromatic Plants

Herbal Drugs and Nutraceuticals : Genetic engineering of medicinal plants to give uniform expression of active constituents with minimum seasonal / climatic variations. To develop crops with value addition in terms of proteins, minerals, vitamins and biomolecules of therapeutic and also of industrial interest

Animal Biotechnology

• Development of recombinant diagnostics and vaccines for major diseases in livestock/fish and establishment of required cell lines and their banking facilities.
• Transgenic animals can be employed either as biofactories for the production of commercial products or as living models for the study of human diseases and evaluation of pharmaceuticals. The use of transgenic animals for these purposes can be more economical or, in the case of human disease and drug models, more realistic than are conventional alternatives.
• Transgenics for productivity improvement and disease resistance, development of experimental animal models for specific important diseases and desirable products/pharmaceuticals.
• Techniques for cloning, both embryonic and somatic, by multiplication of elite animals.
• Development and formulation of improvised animal/fish feed.
• Development of genetic markers for animal breeding programmes.
• Considering the importance of the mouse as the model organism for human genetics, and the paucity of expertise in the country in the area, efforts will be made to initiate and support research in mouse genetics.

Marine Resources

The phenomenal biodiversity in the coastal and oceanic habitats can offer biochemicals useful in the Nutrition, Pharma, Cosmetic and Industrial sectors. Production systems would be designed that mimic tropical environments leading to extremely high costs, taking note of the light intensity, warmth, cheaper costs of personnel and raw materials apart from the strengths of local strains. Efforts to rehabilitate coastal communities with large-scale research, demonstration and training would add to economics of the region.

Environment & Biodiversity

• Collection, Conservation and Sustainable Use of Bio-diversity : A large project on characterization of natural resources by DNA fingerprinting, assessment of their relative potential and improvement for enhanced performance to be launched.
• Bioremediation - location-specific projects.
• Waste recycling and wasteland reclamation as large-scale demonstrations.
• Development of biosensors, bioindicators.
• Ecosystem-specific projects with biotechnological interventions - desert, islands, coastal, mangroves and mountain, for damaged ecosystems.

Medical Biotechnology

• Continued efforts on newer vaccines specially for malaria, tuberculosis, cholera, HIV, rabies, and Japanese Encephalitis, which should be ready in the next 2-5 years.
• Multidisciplinary projects on gene therapy and stem cell research.
• Suitable, cost-effective diagnostics for infectious, genetic and malignant diseases/ disorders, low-cost kits for steroid and reproductive hormones. Promoting indigenous development/ production of probes/ primers, ELISA plates, monoclonals, enzymes and other reagents required for diagnosis of local strains of causative agents for HIV, malaria, hepatitis, cholera, tuberculosis, JEV by expanding lab-scale activities or by collaborating with industry. Kits for abnormalities of Chromosome 21, common thalassaemia mutants; cancers, infectious diseases and custom primers.
• Developing strategies for prevention and cure of diseases induced by faulty diet, lifestyle and immunological disorders such as juvenile diabetes, coronary heart disease, obesity and anaemia.
• Molecular medicine approaches for cancers and cardiovascular disorders.
• Microbial genomics with special reference to emerging and re-emerging diseases.
• Research into reproductive human health and contraception.

Neurosciences

• Research on neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and motor neuron disease which would include study of molecular genetics of some of these disorders as well as understanding the etiopathogenesis of these disorders particularly with respect to the role of environmental toxins in the sporadic forms of these diseases.
• Consequences of HIV infection in the nervous system (neuro-AIDS) constitute an important area for research.
• Another area of concern relates to childhood related disorders (such as autism, attention deficit hyperactivity syndrome and dyslexia) considering the demographic profile in the country. Research on these disorders using modern imaging techniques is important.
• Computational neuroscience research would focus on development of computational simulations of neural information processing for understanding brain function and development of newer computational tools such as neural networks etc through the understanding of brain function. In addition, focus would be on "Neuroinformatics", an emerging area of neuroscience so far not initiated in the country.

Biofuels & Bioenergy

• Production, demonstration and utilization of biomass and for generating raw material for bioengineering for the production of liquid, gaseous fuel - a mission mode project.
• Bioengineering : Viable bioengineering processes to be developed for upscaling and pilot production of alternative source of energy involving fermentation technology with the application of identified microorganisms.

Bioprocesses, Product Development, and Bioinstrumentation

• Biotechnology products, being health- friendly and bioprocesses for them being environment-safe, are receiving increasing attention. Therefore efforts will focus on: a. Development of small peptides/ proteins/ carbohydrates present in animals/ humans as therapeutics; b. enzyme-mediated synthesis of chiral drugs; c. microbe/ enzyme-based processes specially for paper, leather, arsenic etc. for pollution control; c. microbe-engineered/ rDNA processes for biomolecules/ drugs; d. microbes/ enzymes for waste disposal, especially plastics; e. streamlining of guidelines for biotech. products.
• Biomedical instruments are fundamental to enhance biotechnological activities including research and development and product development. A close collaboration between electrical engineering / computer science faculty / professionals and biomedical / agricultural faculty and researchers is needed in the country. Special efforts would be made to integrate diverse discipline/professional required to attain self-reliance in this field.
• Spatial and temporal control of biofilm formation, analysis of autoinducers (e.g. homoserine lactones as predominant signals) and use of new optical tools including confocal laser microscopy for assessment of complex community structures and their use in environmental and industrial sector would be given special boost. Quorum sensing as a general phenomenon in pathogenesis would be encouraged.

Industry

• To conceptualise and implement the concept of "Contract pharma".
• To convert selected research leads into products, close interaction with private and public sector specially for development of vaccines and diagnostics and for agricultural products. Establish production units for recombinant biologicals, microtitre plates, primers and DNA chips.
• Decentralized production units, atleast 100 for biopesticides and biofertilizers would be in small scale industrial sector.
• To simplify and institute single window clearance mechanisms for biotech products.
• To set up "Biotech Product Development Fund" and "Technology Platforms".

Human Resource Development

• A major expansion of human resource development programme to cover all the universities and in some cases, even colleges to introduce biotechnology education and training. Developing mechanisms for training of the faculty with the provision of 50 teachers per year for a period of 5 years. At least 1000 students per year would be trained to generate a strong work force of 15000-20000 in ten years.
• Short term and long term training for target groups, young scientists and industry.

Infrastructure and Institution Development

• Biotechnology parks, repositories, hardening units, genome sequencing facilities, new centres of excellence as per the need to be created.
• Strengthening of existing infrastructure facilities with expansion wherever necessary.
• Creation of centres of excellence in frontier areas in existing institutions, and where necessary, start new centres in carefully chosen frontier areas.
• Infrastructure for undertaking investigations in the frontier areas of research (Functional genomics, Proteomics, Bioinformatics), containment facilities as required under biosafety regulations and exclusive units for dealing with intellectual property rights to be built.
• Setting up facilities for sequencing (DNA and protein) on payment basis so that this routine yet necessary information could be retrieved without wasteful expenditure and resource. This would go a long way in rapid characterization of the large diversity that will be added to the existing gene pool. This will also hasten the process of any species / genus descriptions since this too would not now be feasible without 16S sequence availability. Considering the expanse of the country and likely inventory of the gene pool, perhaps 6 sequencing facilities as a commercial venture would be required in next 2 years. In 10 years 12-15 facilities with industry cooperation to be set up.

Biotechnology for Societal Development

• At least hundred projects location and natural resource specific - with specific involvement of society in Biotechnology-based programmes to be launched. Emphasis on the rural sector. Biovillage concept to be enlarged with at least 200 units all over country.
• Genetic counseling for the needy groups.
• Country- wide interactive programmes will be undertaken in order to sensitize society on aspects of safety, ecological impact and related issues arising out of the new biotechnology.

Biosafety, Ethical and Proprietary Issues

Establishing transparent, expeditious and scientific principles of biosafety and rigorous implementation of the biosafety guidelines to be ensured. Wherever necessary, testing, containment and certification facilities to be established. For safeguarding ethical, legal social and economic issues relating to biotechnology research, product testing of GM food, labeling, policy guidelines to be perfected and regionally implemented.

IPR in Biotechnology

India will have to take initiatives to frame appropriate strategies and policies, in order to maximize the benefits and minimize the disadvantages from the new regime. It is therefore essential to :

• enhance the knowledge of various issues regarding patents amongst the various cross sections of the people by organizing suitable time-bound tailor-made training/awareness programmes at national and international levels;
• create adequately trained and knowledgeable IPR professionals in the area of Biotechnology; atleast 2 centres in the Universities;
• institution of suitable awards and scholarships;
• stimulate and encourage innovative activities for promoting IPR;
• augment mechanisms for effective protection and facilitation of IPR;
• expeditiously disseminate the information using print media, internet, seminar and symposium;
• institute techno market surveys, feasibility studies, patent related databases and services, customized information services, patent networking, invention review committees, future vision reports and technology transfer services;
• evolve policies for IPR in various emerging issues; and
• make the country a major power in matters relating to IPR in biotechnology.