BIOTECHNOLOGY IN INDIA

1. BIOTECHNOLOGY IN INDIA U. N. BEHERA Joint Secretary Department of Biotechnology Ministry of Science & Technology Government of India Bangkok – January 24, 2006 BINASIA - INDIA

2. Biotechnology - a definition The application of science & technology to living organisms as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services BINASIA - INDIA

3. An indicative list of Biotechnologies • DNA (the coding): genomics, pharmaco-genetics, gene probes, DNA sequencing/synthesis/amplification, genetic engineering. • Proteins and molecules (the functional blocks): protein/peptide sequencing/synthesis, lipid/protein glyco-engineering, proteomics, hormones, and growth factors, cell receptors/ signalling/ pheromones. • Cell and tissue culture and engineering: cell/tissue culture, tissue engineering, hybridisation, cellular fusion, vaccine/ immune stimulants, embryo manipulation. • Process biotechnologies: Bioreactors, fermentation, bioprocessing, bioleaching, bio-pulping, bio-bleaching, biodesulphurization, bioremediation, and biofiltration. • Sub-cellular organisms: gene therapy, viral vectors. • Bioengineering: biomaterials, biosensors, biomedical devices and bioinstrumentaion. • Biofertilisers and biopesticides. BINASIA - INDIA

4. Amazing Biotechnology • more than 300 biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases, including various cancers, Alzheimer’s disease, heart disease, diabetes, multiple sclerosis, AIDS and arthritis • responsible for hundreds of medical diagnostic tests that keep the blood supply safe from the AIDS virus and detect other conditions early enough to be successfully treated – e.g. home pregnancy test • biotechnology foods such as papaya, soybeans and corn – quite popular • Biopesticides and other agricultural products also are being used to improve our food supply and to reduce our dependence on conventional chemical pesticides • clean up hazardous waste more efficiently by harnessing pollution-eating microbes without the use of caustic chemicals • cleaner processes that produce less waste and use less energy and water in such industrial sectors as chemicals, pulp and paper, textiles, food, energy, and metals and minerals • DNA fingerprinting, a biotech process, has dramatically improved criminal investigation and forensic medicine, as well as afforded significant advances in anthropology and wildlife management • Global business US $ 64 in 2004 BINASIA - INDIA

5. Biotechnology in India Initiative in early 1980’s 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 BINASIA - INDIA

6. Institutions & Manpower • Number of hospitals : 16,000 • Number of doctors : 500,000 • Number of research institutions : 200 • Number of Scientists : 25,000 • Medical graduates produced : 17,500 per yr • Science graduates produced : 500,000 per yr • Number of Agriculture Univs. : 40 BINASIA - INDIA

7. 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 BINASIA - INDIA

8. Post Graduate Teaching • General Biotechnology 43 • Agricultural Biotechnology 10 • Animal Biotechnology 3 • Medical Biotechnology 3 • Marine Biotechnology 2 • Neurosciences 3 • Industrial Biotechnology 1 • Biochemical Engineering 7 • Pharmaceutical Biotechnology 1 • Genetic Engg. & Bioprocess Dev. 1 • Molecular & Bioprocess Tech. 1 • Clinical Biochem. & Biotech. 1 • IPR 1 TOTAL 77 BINASIA - INDIA

9. 65 Centres under the Bioinformatics Information System Network (BTISnet) 12 Nodes on the Virtual Private Network (VPN) BIOGRID 77 Universities and Institutions where post graduate teaching in biotechnology is supported by DBT BINASIA - INDIA

10. Bioinformatics Network • Year of Start – 1986 • Total No. of Distributed Bioinformatics Centers- 65 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 –12 Nodes BINASIA - INDIA

11. Infrastructure DBT has established 63 major infrastructure facilities - 20 in plant Sciences - 11 in medical sciences - 32 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 BINASIA - INDIA

12. Other Major Facilities • 17 Genetic counseling centers established benefiting 18000 families and 4500 tribal families • 2 Microarray Facilities • 5 Automatic DNA sequencing Facilities • 6 genomic /proteomic facilities • 10 facilities for drug and molecular design • 8 Gene Banks for crops, medicinal and aromatic plants • 3 High/medium throughput facilities for screening extracts • 1 fMRI Facility • 5 Centers of Plant Molecular Biology • 4 Centers for Genetic Engineering BINASIA - INDIA

13. Research & Development1986 - 2005 • More than 2500 R&D projects launched in 20 identified areas. • National Bioresource Development Board set up for bioprospecting and bioresource utilization. • Establishment of gene banks for conservation and inventorisation of bioresource. • Rice genome sequencing as a member of International Initiative - sequencing of part of chromosome 11 completed. • Participating in International Consortium on Silk Worm Genomics and Tomato Genome Sequencing. • Complete sequencing of Indian isolate of hepatitis C done. BINASIA - INDIA

14. Number of health-biotechnology papers published by developing countries Source: The Economist – Dec 11, 2004; Institute for Scientific Information; Science Matrix BINASIA - INDIA

15. Number of health-biotechnology patents (Major developing countries) issued by US in 2003 Source: The Economist – Dec 11, 2004; Institute for Scientific Information; United States Patent and Trademark Office BINASIA - INDIA

16. Agriculture Biotechnology - Crops Focus : - Improved Productivity - Drought, Salinity Tolerance - Reduced Yield due to Pests/Diseases - Nutritional Enhancement Crops : - Rice, Wheat, Cotton, Mustard , Chickpea, Potato Pigeonpea, Mungbean, Sugarcane Strategy : - Transgenics & Marker based Molecular Breeding - Cloning and Characterization of New Genes and Promoters BINASIA - INDIA

17. Crops Wheat Rust: Durable resistance to leaf and stripe rusts using molecular marker technology in bread wheat (DWR,DWR-RS, PAU, ARI & NCL) Rice:Salinity and dehydration stress tolerance: Cloning of responsive genes, their promoters and development of transgenics (ICGEB, UDSC, IARI, BI, UOH) Sugarcane:12,956 EST’s generated and deposited in genbank. 9000 genomic clones and several thousand cDNA clones developed from high sugar and red-rot resistant lines Crop Improvement for Better Nutrition in rice, sweet potato and cassava using AmA1 Gene Use of molecular marker technology approach in wheat quality breeding BINASIA - INDIA

18. 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. BINASIA - INDIA

19. Transgenic Crops under Trial • Under green house trial : 19 • Under limited field trial : 3 (Rice, Mungbean, Mustard) • Large scale field trial : 1 (Cotton) • Released for commercial production : 1 (Cotton) BINASIA - INDIA

20. Plant Biotechnology • Areas : Forestry, Horticulture & Plantation Crops • Status • 57 regeneration systems documented • Protocols standardized for 20 plant species, 10 technologies transferred to industry – Eucalyptus, Bamboo, Teak, Sugarcane, Potato, Black pepper, Coffee, Citrus • Ongoing R&D - Transgenics • Tomato, Grapes, Banana - shelf life • Chilli, Pepper, Ginger, Cardamom – Disease resistance • Populus, leucaena - reduced lignin • Germplasm characterization – Teak, Eucalyptus, Casurina • International Solanaceae Genome initiative launched • India to sequence chromosome 5 of tomato • Functional genomics of tomato – nutritional quality, shelf life, disease resistance • Production and demonstration of quality planting material of Bamboo BINASIA - INDIA

21. Tomato Genome Sequencing BINASIA - INDIA

22. Animal Biotechnology • Diagnostics for Peste-des-Petitis Ruminants (PPR) detection commercialized • Reconstituted Bovine collagen for wound and burn healing commercialized • Multicentric programme on buffalo genomics launched : Characterisation of traits of economic importance • Multicentric programme on bovine tuberculosis • Programme on animal nutrition BINASIA - INDIA

23. Aquaculture & Marine Bacterial immunostimulant for shrimp health management developed Bioreactor system developed for water quality management in prawn hatchery New source of insulin from carp adipose tissue Quality agar extracted from seaweed (Gelidiella acerosa) Efficacy of DNA-based vaccine for Aeromonas infection in carps under evaluation Shrimp Genomics launched – Comparative and functional genomics Diagnostics and vaccines transferred to industry • Immunodiagnostic kit for detection of bacterial pathogens in finfish and shellfish • Combi kit for simultaneous detection of White Spot Shrimp Virus and Monodon Baculo Virus • Heat killed whole cell vibrio vaccine, shows immune response in shrimp • Immunodot detection kit for white spot shrimp virus Technology ready for transfer • Bioreactor technology in shrimp hatcheries through bacterial conservation for denitrification BINASIA - INDIA

24. Seribiotechnology • Improved quality and productivity in silk • Silkworm genome sequencing • Over 400 molecular markers generated • India participating in International Consortium on Lepidopteran Genomics: More than 10,000 ESTs of muga silkworm and mori silkworm characterized • Three high yielding hybrids of silkworm released to farmers • Network projects initiated for use of molecular markers in breeding of disease-resistant silkworm and pest- and disease-resistant mulberry • Molecular characteriztion of non-mulberry silkworm (Tasar, muga, eri) • Spider silk • Biophysical properties of spider silk proteins produced by Indian species • Sourcing of spider silk genes and expression in Bombyx mori • Prospecting of Indian spiders venom for therapeutic purposes • Application of nanobiotechnology to spider silk BINASIA - INDIA

25. Medicinal & Aromatic Plants • Four national gene banks established - about 3500 accessions • Two specialized germplasm banks set up for plants used in Indian System of Medicines • Production of high value therapeutic compounds in cell culture (Podophyllotoxin, guggulsterones Z&E, camptothecin and azadirachtin) • Isolation and characterization of new thereapeutic leads (for anticancer, antiamoebic, antidiabetic, bioenhancers, immunomodulatory). • Clinical trial of standardized herbal preparations - Terminalia arjuna – left ventricular dysfunction • Five technologies transferred to industry; several other leads under discussion with industry • Herbals for veterinary health care - priorities identified • Functional genomics of selected medicinal and aromatic plants • Plants as bioreactor for production of biomolecules (antigens for cholera, rabies), antibodies for therapeutics and industrial enzymes BINASIA - INDIA

26. Biofertilizers • 23,000 ha demonstrated for use of biofertilizers; 50,000 farmers benefited • 10 packages for Integrated Nutrient Management developed for specific cropping system of varied agroclimatic zones • A network project on development of efficient strains of biofertilisers launched at 11 centres • Liquid biofertilizer technology – being developed BINASIA - INDIA

27. Biopesticides • Technology Development and Demonstration • 24 Integrated Pest Management technology packages developed; 7 transferred to industry • Over 150,000 ha covered in different agroclimatic zones; 65,000 farmers benefited • Insect sex pheromones successfully synthesized and field-tested for the mass trapping of brinjal shoot and fruit borer • More than 615 plant extracts prospected as source of pesticides; 11 promising leads short listed for further investigation • Product Development • ‘Bioprahar’: biopesticide (for cabbage and cauliflower) developed by ICGEB, launched commercially (2004) BINASIA - INDIA

28. Bioprospecting • Bioprospecting of genes / molecules – • 96 stress related genes identified, characterized and cloned, salt resistance gene transferred to rice and mung bean, field trials of transgenic rice being conducted • Product development – • Microbial biofertilizers for coastal region • Biopesticide for bollworm (Helicoverpa) • SOD antioxidant – skin cream • Over 4000 plant species from Western Himalayas and Western ghats screened for natural dyes; nine short listed as potential sources • Network project on lac biotechnology initiated • Chemical and genetic profiling, conservation – 6 endangered medicinal plant species BINASIA - INDIA

29. Microbial Diversity • Arid Zones : 48 Saline tolerant algal species, screened for pigment production, soil conditioning and nitrogen fixation • Cold Habitats : > 100 bacterial species isolated from soil and water samples from Antarctica • Hot Springs and sulfur springs : > 150 Actinomycetes species isolated, potential rifamycin producer identified • Hydrocarbon contaminated Sites : 12 oil refineries screened, > 350 bacteria species isolated, thermophilic Bacterial consortium developed for enhancing Oil recovery from Oil wells • Marine Sources: > 500 Bacterial isolates screened for secondary metabolites, benzoate and phenol degraders identified • Forest Belts: Virgin ecosystems, novel entomopathogenic and keratinolytic fungi Isolated and identified • Enhancement of Oil Recovery from dead Oil wells - Bacterial Consortium developed which on being injected in sick oil wells under high pressure leads to oil recovery, tested in 25 Oil Wells of ONGC, helped in extraction of 4500 cubic meters of oil worth US$675000 BINASIA - INDIA

30. Environment Biotechnology • Conservation of endangered animals – especially big cats – through embryo transfer technology and tissue banking • Use of lichens as indicators of environmental pollution • Bioremediation of degraded ecosystems • Green technologies to treat industrial effluents (paper & pulp, dyes, distilleries, tanneries etc) • Bioscrubber for removal of obnoxious industrial emissions • 14 technology packages developed; 5 under use by industry • Programme on microbial approaches to combat global warming BINASIA - INDIA

31. Medical Biotechnology • Vaccines • Diagnostics • Therapeutics • Stem Cell Technology • Biomedical Engineering • Nanomedicines • Clinical Trials and Clinical Research BINASIA - INDIA

32. Vaccines • Rabies : DNA vaccine, phase III animal trials completed. • Cholera : Recombinant oral vaccine, Phase II trial. • Malaria : Phase I clinical trials initiated. • Rotavirus : Phase I clinical trials underway • JEV : Vaccine technology transferred to industry • HIV/AIDS : DNA candidate for subtype ‘C’ developed • Anthrax : Phase III clinical trials initiated. • Infectious Bovine Rhinotracheitis: Commercialised (cattle) BINASIA - INDIA

33. Transferred to the Industries & Launched in the Market : Western Blot for HIV-I & II : HIV/AIDS Naked Eye Agglutination : HIV/AIDS System (NEVA) ELISA : Hepatitis ‘C’ ELISA : Leishmaniasis ELISA : Alpha-feto Protein (Pregnant Women) Transferred, yet to be launched : IgM Mac ELISA : Dengue Japanese Encephalitis West Nile IgM – ELISA : Hepatitis ‘A’ Urine Based ELISA : Reproductive Hormones Under Development & Negotiations for Transfer : DAT : Toxoplasmosis Haemagglutination Assay : Leishmaniasis IFA : Rabies Species Specific Tests : Snake Bites PCR Assay : Tuberculosis Multiplex PCR : STD PCR : Leptospirosis In-vitro Assay : Anti-Inflammatory Drugs Immunochromatogrpahy/ : Tuberculosis / ELISA Assay PCR Assay : Typhoid Diagnostics BINASIA - INDIA

34. Diagnostics : New initiatives Future Plan: New Innovative Technologies, easy to perform rapid, affordable including those that detect Multiple Diseases through Syndrome Approach useful for Medical Practices and Public Health Programmes New platforms : • Optical Thin Film Biosensors • Micro Electro Mechanical Systems (MEMS) for Disease Diagnosis • Quantum Dots • Single diagnostics • Tuberculosis, malaria, TORCH, Viral load in HIV, Neonatal sepsis, Thyroid function, STD, Typhoid, Mycosis, Cardiac screen, diabetic screen • Syndromic Detection: • Malaria, Typhoid, Dengue and Tuberculosis • HIV/HCV, HBV, Malaria and Syphilis infections in blood for transfusion • Indigenous production of control panels, sera. BINASIA - INDIA

35. Stem Cell Research • To establish stem cell banking facility in the country. • To develop well characterized stem cell lines. • Potential use of embryonic stem cell lines to generate various organs. • Regeneration of tissues for stem cells obtained from aborted foetus • Basic understanding of the signaling mechanisms and differentiation of stem cells. BINASIA - INDIA

36. Bioengineering • Tissue Engineering and Stem Cells • Biomaterials for Therapeutics • Biomedical Devices • Biomedical Instrumentation • Biosensors BINASIA - INDIA

37. Nanobiotechnology • Nano-particles for diagnostic/therapeutic use • Biosynthesis of Nano-particles • Biological templates for nano-particle assembly • Bio-nano composites • Imaging/sensing of Nano-particles/bio-molecules BINASIA - INDIA

38. Technology transferProducts 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 (1st 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 BINASIA - INDIA

39. Biotech Products in Indian market • r DNA Hep ‘B’ vaccine • Recombinant streptokinase • Erythropoietin • α, β, γ – interferon • Haemophilus influenzae B vaccine • Human insulin • Human Growth Hormone • Human Interleukin • Streptokinase • Granulocyte Colony Stimulating Factor • Follicle Stimulating Hormone • Tissue Plasminogen Activator BINASIA - INDIA

40. Biosafety Regulations • Recombinant DNA Safety Guidelines (1990) • Revised Guidelines for Safety in Biotechnology -toxicity and allergenicity evaluation (1994) • Revised Guidelines for Research in Transgenic Plants & Guidelines for Preclinical and clinical data for r-DNA based vaccines, diagnostics and other biologicals (1998) • Ethical policy on Human Genome and Genetic research and services (2000) • Regulations being simplified in an ongoing dynamic process. BINASIA - INDIA

41. Other initiatives • Establishment of patent facilitation cell to promote national and international patents of indigenous innovations • 112 patents filled - 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. BINASIA - INDIA

42. Indian Biotechnology Industry Number of biotech companies : 300 Global ranking in terms biotech companies : 11 Investment growth in last 5 years : 50 % per annum Annual Turnover (Apr 04 – Mar 05) : US $ 1.07 Billion Annual increase : 37 % Percentage of global business (2004-05) : 1.6 % (2003-04) : 1.5 % (2002-03) : 1.2 % Exports : 43 % Major areas : Biopharma, Bioservices, Bioindustries, Bioagriculture, bioinformatics, Biosupplies BINASIA - INDIA

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44. Indian Biotech Industry 2004-05 BINASIA - INDIA

45. Sectoral Growth %2004-05 BINASIA - INDIA

46. Indian Biotech Industry BINASIA - INDIA

47. Indian Biotech Exports BINASIA - INDIA

48. Indian Biotech Domestic Market BINASIA - INDIA

49. Indian Biotech Grows BINASIA - INDIA

50. Areas of oppurtunity in India • Vaccines, dignostics and therapeutics • Biomedical devices, instruments and sensors • Bioartificial organs using tissue engineering and stem cells • Clinical trial and contract research • Agriculuture – disease and pest resistant, drought and salinity tolerant seeds and plants • Biofertilisers and Biopesticides • Bioinformatics BINASIA - INDIA