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2 Developments in Biotechnology One of the most important disciplines Radical transformation in the fields of (a) agriculture (b) health care (c) industry (d) environment management basic and applied research essential

3 Biotechnology in India Initiative in early 1980s Agencies - DST, CSIR, ICAR, ICMR, UGC National Biotechnology Development Board – 1982 Department of Biotechnology – 1986 Strategy : Creation of Infrastructure Human Resources Development Promotion of R & D Technology Transfer Promotion of Industry Public Private Partnership Regulation International Co-operation

4 Policy Science Policy Resolution, 1958 Technology Policy, 1983 Science & Technology Policy, 2003 Biotechnology Vision, 2003

5 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 VISION

6 OUR MISSION Realizing full potential of biotechnology A well directed effort, significant investment for generation of products, processes and technologies Enhance efficiency, productivity and cost effectiveness. Scientific and technological empowerment of human resource Strong infrastructure for research and commercialization Enhance the knowledge base Nurturing the leads of potential utility Bringing the bioproducts to the market place

7 Product and Process Developmen t Autonomous institutes Research & Development Inter Biotech facilities, national Human Resources Development Bioinformatics Biotech facilities programme support (infrastructure ) Internationalcooperation Internationalcooperation UserAgencies & IndustryUserAgencies & Industry safety BRPC Task forces SAC ( O ) SAC ( DBT) Ethics Organizational Structure

8 1986-2003 Rs 18. 290 billion 1998-2004 OR US$ 522.6 million @ USD 1 = Rs 35/- Adding 30% additional contribution from other S&T agencies supporting biology The investment could be US $ 679.3 Million Investments

9 CORE ACTIVITIES These activities form the basic necessities for implementation of biotechnology programmes and their development in the country both from the viewpoint of application and commercialization. Human Resource Development, Support for New Centres of Excellence, Facilities, Repositories and Services, Basic and Product Oriented R&D, Biotech Product and Process Development, Bioinformatics, International Cooperation, Biotechnology Based Projects for Societal Development Support to the Autonomous Institutions,

10 Special thrust Genomics of human, animals, plants and microbes Network facilities for high throughput screening, functional genomics, microarray and structural genomics Pilot production facility for large-scale validation and testing of important diagnostic kits. Support basic and product oriented research and development. Bioinformatics International cooperation in new areas of modern biology including transgenics, computational biology, pharmacogenomics, neurosciences, etc.

11 Special thrust (continued) Biotechnology based programmes for Societal Development: for weaker sections of population, rural development and women to utilise proven biotechnological tools for generating employment opportunities; empower dedicated youth; provide entrepreneurship training; utilisation of local natural resources and involve NGOs, grass root level organisations, national laboratories and universities Biovillages, biotechnology parks would be an integral part of the societal development programme.

12 Autonomous Institutions National Institute of Immunology, New Delhi National Centre for Cell Sciences Center for DNA Fingerprinting & Diagnostics, Hyderabad; National Center for Plant Genome Research, New Delhi; National Brain Research Centre, Gurgaon; and Institute of Bioresource and Sustainable Development, Imphal Institute of Life Sciences, Bhubaneswar

13 Mission Mode Programmes Genomics : covering humans, plants, animals and microbes with emphasis on genome sequencing of microbes relevant to India Development of new drugs and molecules from important medicinal plants: aims towards search for molecular targets/active principles in medicinal plants with respect to anti-cancer, anti-diabetic, anti-arthritic, anti-brain disorders, immunomodulatory properties and cardio-protective agents..

14 Mission Mode Programmes …... Bioresources characterization and inventorization and documentation from the special ecosystems: To prepare digitized inventories for bioresources – plant, animal, microbial and marine. Production, demonstration and testing of biofuels: The programme focuses primarily on the 4 major aspects for Biofuels and Bioenergy production: Bioenergy plantation, Bioethanol production, Biodiesel and Hydrocarbons production and Alternative sources of hydrogen production. The programme has been initiated with an end-to-end approach, for technology development, demonstration and finally characterization and evaluation.

15 Mission Mode Programmes ………. New generation vaccines: The diseases targeted are Rabies, Cholera, HIV/AIDS, Tuberculosis, Japanese Encephalitis and Malaria. Biotechnological interventions for enhancing food and nutritional security: the programme involves enhancement of the crop productivity, value addition and genetic engineering for enhanced nutritional status with specific emphasis on development of pro-vitamin-A rice in India for alleviation of vitamin-A deficiency and nutritionally enhanced Potato, Chickpea etc.

16 HRD Programmes Post Graduate Teaching Programmes Ph D Programme Post Doctoral Fellowship Short Term Training Programes Industrial Training Seminar, Symposium, Conference Awards and Scholarships Travel Support

17 Post Graduate Teaching General Biotechnology30 Agricultural Biotechnology 7 Medical Biotechnology 3 Marine Biotechnology 2 Neurosciences 3 Industrial Biotechnology 1 Biochemical Engineering 6 Pharmaceutical Biotechnology 1 IPR 1


19 Human Resource Development Post graduate teaching in 54 universities & institutions Number of students benefited - 3000 Biologist scholarships (10+2) - 185 Biotech Industrial training to 350 students Post doctoral fellowships - 400

20 Year of Start – 1986 Total No. of Distributed Bioinformatics Centers- 61 with each one is having focus on a specific area of biotechnology One year Advanced diploma course on Bioinformatics - 5 Interactive Graphics facility – 6 Mirror Sites – 5 Super Computing facility - 1 BIOGRID INDIA – 11 Nodes BIOINFORMATICS NETWORK

21 FOCUS OF THE PROGRAMME Building bioinformatics infrastructure – to build up shared bioinformatics and computational infrastructure from underlying advances in networking framework to hardware resources Bioinformatics integration – full integration of enabling bioinformatics techniques and technologies into biotechnology, health care and life sciences Information and software sharing – encourage sharing of major software and databases within the BTISnet Promote bioinformatics cooperation – national and international Human resource development – the HRD programme on Bioinformatics will be strengthened through systematic manpower development, technical training, scientific exchanges and outreach

22 BIOGRID INDIA Service Providers VPN Network MK Univ., Madurai IISc, Bangalore NBRC, Gurgaon IMT, Chandigarh CDFD, Hyderabad Univ. of Pune Deptt. Of Biotecdhnology, Delhi JNU, Delhi NII, Delhi CBT, DU Campus, Delhi South Campus, DU, Delhi 3640 Router Co-Located at Service Providers Node in Delhi Internet 2 Mbps Leased Line Cisco 2611 Router

23 BIOGRID INDIA To give access to more computational power. To make more data resources readily available. To enable collaborative working and resource sharing through virtual organizations and communities. To create new economic opportunities through new products and services.

24 MIRROR SITES EMBnet (CDFD) PDB (IISc & University of Pune) EBI Databases (Pune) Plant Genome Databases (JNU) Public domain Biotech Software (IMTECH )

25 Subject wise Classification of Developed Databases BROAD SUBJECT AREA AgronomyMarine Biology Aquaculture & FisheriesMedical Sciences BiodiversityMicrobiology & Parasitology Bioinformatics & Computational Biology Molecular Biology & Biochemistry Commercial BiotechnologyPlant Sciences Crop Science & BiotechnologyTaxonomy EntomologyTissue Culture Environmental ScienceVeterinary Science Intellectual Property Rights

26 SOFTWARE CATEGORY Sequence Analysis Molecular Modelling Simulation Studies 2D and 3D Graphics Image processing Statistical Analysis Structure Prediction Bibliographic Evolutionary Studies Analysis of Function RAPD/RFLP/ Restriction Mapping Cytogenetic Studies Primer Design Query and search engines Management Information Systems

27 Some Major Biotechnology Facilities DBT has established 59 major infrastructure facilities 19 in plant Sciences 10 in medical sciences 30 useful for both areas and others 6 Culture collections- Blue green algae Marine cyanobacteria Agriculturally useful organisms Industrial microbes Filaria Tuberculii 2 Animal House Facilities

28 Some Major Biotechnology Facilities ….. 16 Genetic counseling centers established benefiting 18000 families and 4500 tribal families 2 Microarray Facilities 5 Automatic DNA sequencing Facilities 4 genomic /proteomic facilities 10 facilities for drug and molecular design 8 Gene Banks for crops and medicinal and aromatic plants 3 High/medium throughput facilities for screening extracts 5 Centers of Plant Molecular Biology 4 Centers for Genetic Engineering


30 MTCC is now an International Depositary Authority (IDA) Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure from October 2002

31 Research & Development 1986 -2003 More than 2000 R&D projects launched in 20 identified areas. To harness biological wealth and bioresource utilization, National Bioresource Development Board set up and bioprospecting, establishment of gene banks for conservation and bioresource inventorisation and development programmes implemented. Rice genome sequencing project implemented as member of International Initiative to complete the sequencing of part of chromosome 11 completed before time with international appreciation. Complete sequencing of Indian isolate of hepatitis C done

32 Rabies Ready for commercial use in animals – approvals awaited CholeraPhase-IIA clinical trials Rotavirus Phase –I clinical trials, large scale production of GMP materials with industry HIV Malaria Anthrax Others Tuberculosis JEV Pre-clinical evaluation for toxicity and immunogenicity, negotiation for large scale production of GMP materials with industry Pre-clinical evaluation for toxicity and immunogenicity Status of vaccine research

33 Summary of Transgenic Research in India Target Crops/ Vegetables Cotton, Corn, Mustard, Rice, Soybean, Potato, Tobacco, Coffee, Tomato, Brinjal, Cauliflower, Pea, Cabbage, Banana, Muskmelon, Pigeonpea, Chickpea, Bell-pepper, Blackgram, Chilli, Watermelon etc. Transgenes Employed Bt. toxin genes, Herbicide tolerant genes (CP4 EPSPS, Bar gene), Xa21, ctx-B and tcp of V.cholera, Chitinase, Glucanase, ACC synthase, RIP, Protease Inhibitor, Lectin, Ama-1, OXDC gene, Rabies glycoprotein gene, Bar, Barnase, Barstar, GNA gene, Vip-3 gene, Bacterial Blight Resistance gene, Osmotin etc.

34 Over 30 transgenic crops are under evaluation

35 The first year Bt cotton was sown in about 40,000 hac, spread over six states. Farm trials have found: Ôthe GM cotton gave higher yield than conventional varieties. Ôused less pesticide than conventional varieties. The Bt cotton in the year 2003 was cultivated in > 250,000 Acres Seeds were imported in 1996 GEAC approved on March 26, 2002, the first commercial transgenic crop:- Bt cotton Bt Cotton

36 Summary of r-DNA Research in India Number of Institutions engaged ~230 Number of Private Institutions engaged ~ 35 in transgenic research Number of Public funded Institutions ~ 47 engaged in transgenic research Number of Private Institutions engaged ~ 37 in r-DNA therapeutics Other Institutions engaged in basic work ~ 111

37 Technology Transfer About 69 technologies from indigenous R&D leads transferred to industry

38 Technology transfer Products in Market resulting in import substitution and value addition HIV diagnostic kits-Western Blot and ELISA test, Liposome mediated Amphotericin B drug delivery system, Leprosy vaccine (1 st of its kind in the world), 14 diagnostic kits for detection of Pregnancy and contraceptive problems, 12 Packages for bio-remediation of petroleum oil spills, 6 bio-fertilizers, 5 bio-pesticides formulations 6 Plant Tissue Culture protocols

39 Technology parks and incubators A new scheme namely Technology Incubators Pilot Level Facilities and Biotech Parks introduced particularly for promotion of industrial biotechnology The Golden Jubilee Women s Biotechnology Park established at Chennai with 20 industrial modules. Lucknow has been declared as Biotechnology city with implementation of Phase-I activities on Bioinformatics. A Biotechnology park established A Genome Valley established with Biotechnology Incubator in Hyderabad

40 Biotech industrial growth 1998-2003 About 38 companies are operational in modern biotechnological products. Additional 170 companies registered for future production activities

41 INTERNATIONAL COLLABORATION Europe: U.K., Germany, Switzerland, Sweden, Poland, France, Russia, Belarus, North America: USA South America: Brazil, Argentina, Cuba Asia: Multilateral- ASEAN, Asian Cooperation dialogue (ACD), SAARC Bilateral: Myanmar, Vietnam, Malaysia, Thailand, Singapore, Mangolia, China, Japan, South Korea, Syria, Israel, Iran Africa: Sudan, Egypt, Tunisia, Mauritius

42 Regulation

43 GENETICALLY MODIFIED ORGANISMS (GMSs) AND r-DNA PRODUCTS GOVERNED BY Environment (Protection) Act, 1986 - Rules, 1989 Environment (Protection) Act, 1986 - Rules, 1989 Industries (Development & Regulation) Act, 1951 - New Industrial Policy & Procedures, 1991 Drugs & Cosmetics Act, 1940 - Drugs (Price Control) Order - 1995 - Drug Policy-1986 & Modification in September, 1994 & February, 1999. Seeds Act, 1966 Seeds Rules, 1968 Seeds (Control) Order, 1983 Seeds Policy, 1988 Protection of Plant Varieties and Farmers Right Act, 2001

44 r-DNA GUIDELINES 1990 Recombinant DNA Safety Guidelines 1994 Revised Guidelines for Safety in Biotechnology 1998 Revised Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plant Parts

45 Competent Authorities The Genetic Engineering Approval Committee (GEAC) The Review Committee on Genetic Manipulation (RCGM) The Recombinant DNA Advisory Committee(RDAC) The Monitoring and Evaluation Committee (MEC) The Institute Biosafety Committee (IBSC) The State Biosafety Coordination Committee (SBCC) The District Level Committee (DLC)

46 Other initiatives Establishment of patent facilitation cell and to promote national and international patents of indigenous innovations and 112 patents filled with 7 international patents and 7 national patents granted. Revision of biosafety guidelines for transgenic plants. Guidelines for clinical trials of recombinant DNA vaccines formulated and published. Single window application processing mechanism for recombinant products setup. Accession to Budapest Treaty on microorganisms and establishment of International Depository Authority. National bioethics committee setup:Ethical policies on human genome, genetic research and services published.

47 BINASIA 1.An excellent idea for sharing of resources and expertise among the member countries 2.It could also provide close interaction with the scientific community in the region 3.It should provide seamless integration with the individual networks 4.It should provide access to the databases and softwares developed in different countries 5.India will be happy to share the information resources, know-how and expertise to strengthen biotechnology growth in the region

48 BINASIA (Contd..) 6.India would actively participate in taking up joint programmes in human resource development, research & development and sharing of resources and expertise with the member countries 7.Indias bioinformatics expertise will be useful in establishing and managing the web site for BINASIA 8.Organization and participation in short-term training programmes, exchange of overseas fellowships can immediately be implemented 9.Networking of scientists and laboratories for the purpose of joint research programmes in the areas of common interest should also be seriously explored to make BINASIA successful

49 Consult Our Web sites


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