FIRST EXPERT GROUP MEETING ON BINASIA

29-30 APRIL 2004, BANGKOK

BIOTECHNOLOGY DEVELOPMENTS IN INDIA

U. N. BEHERAJOINT SECRETARY

DEPARTMENT OF BIOTECHNOLOGYMINISTRY OF SCIENCE & TECHNOLOGY

GOVERNMENT OF INDIA

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

Biotechnology in India

Initiative in early 1980’sAgencies - DST, CSIR, ICAR, ICMR, UGCNational Biotechnology Development Board – 1982Department of Biotechnology – 1986Strategy :• Creation of Infrastructure• Human Resources Development• Promotion of R & D• Technology Transfer• Promotion of Industry• Public Private Partnership• Regulation• International Co-operation

Policy

Science Policy Resolution, 1958

Technology Policy, 1983

Science & Technology Policy, 2003

Biotechnology Vision, 2003

“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 VISIONOUR VISION

OUR MISSIONRealizing 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

Product and Process

Development

Autonomous institutes

Research &

Development

Inter Biotech facilities, national

Human Human ResourcesResources

DevelopmentDevelopment

Bioinformatics

Biotech facilitiesprogramme support(infrastructure )

International cooperation

User Agencies & Industry

safety

BRPC Task forces

SAC ( O ) SAC ( DBT)

Ethics

Organizational Structure

1986-2003

Rs 18. 290 billion 1998-2004OR

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

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 DevelopmentSupport to the Autonomous Institutions,

Special thrust

Genomics of human, animals, plants and microbesNetwork 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.

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.

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

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..

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.

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.

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

Post Graduate Teaching

• General Biotechnology 30• Agricultural Biotechnology 7• Medical Biotechnology 3• Marine Biotechnology 2• Neurosciences 3• Industrial Biotechnology 1• Biochemical Engineering 6• Pharmaceutical Biotechnology 1• IPR 1

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

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

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

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, DUCampus, Delhi

South Campus, DU, Delhi

3640 Router Co-Located at Service Providers Node in Delhi

Internet

2 Mbps Leased Line

Cisco 2611 Router

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.

MIRROR SITES

• EMBnet (CDFD)• PDB (IISc & University of Pune)• EBI Databases (Pune)• Plant Genome Databases (JNU)• Public domain Biotech Software

(IMTECH)

Subject wise Classification of Developed Databases

BROAD SUBJECT AREA

Agronomy Marine Biology

Aquaculture & Fisheries Medical Sciences

Biodiversity Microbiology & Parasitology

Bioinformatics & Computational Biology

Molecular Biology & Biochemistry

Commercial Biotechnology Plant Sciences

Crop Science & Biotechnology Taxonomy

Entomology Tissue Culture

Environmental Science Veterinary Science

Intellectual Property Rights

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

Some Major Biotechnology FacilitiesDBT 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 algaeMarine cyanobacteria Agriculturally useful organisms Industrial microbes Filaria Tuberculii

2 Animal House Facilities

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

MICROBIAL TYPE CULTURE COLLECTIONS HOME PAGE

www.mtcc.res.in

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

Research & Development1986 -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

Rabies Ready for commercial use in animals – approvals awaited

Cholera Phase-IIA clinical trials Rotavirus Phase –I clinical trials, large

scale production of GMP materials with industry

HIV Malaria Anthrax

Others TuberculosisJEV

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

Summary of Transgenic Research in India

Target Crops/ VegetablesCotton, 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.

Ready for field

trials(3) Under

green house trial(16)

Ready for greenhouse

trial(3)Released for commercial cultivation

(1)

Large scale field

trials(1)

Under Field trials(3)

Over 30 transgenic crops are under evaluation

• The first year Bt cotton was sown in about 40,000 hac, spread over six states.

• Farm trials have found: the GM cotton gave higher yield than

conventional varieties. used 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

Summary of r-DNA Research in IndiaNumber of Institutions engaged ~ 230 Number of Private Institutions engaged ~ 35in transgenic research

Number of Public funded Institutions ~ 47engaged in transgenic research

Number of Private Institutions engaged ~ 37in r-DNA therapeutics

Other Institutions engaged in basic work ~ 111

1 1 4

35

5

2

42

27

Food BT Micropropagation Others

Health Care Vet care roducts biofertilisers

biocontrol agents Environment Aquaculture/marine

Herbal products

Technology TransferAbout 69 technologies from

indigenous R&D leads transferred to industry

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 (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

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

Biotech industrial growth

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

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

Regulation

GENETICALLY MODIFIED ORGANISMS (GMSs) AND r-DNA PRODUCTS

GOVERNED BY

Environment (Protection) Act, 1986 - Rules, 1989Environment (Protection) Act, 1986 - Rules, 1989Industries (Development & Regulation) Act, 1951 - New Industrial Policy & Procedures, 1991Drugs & Cosmetics Act, 1940 - Drugs (Price Control) Order - 1995 - Drug Policy-1986 & Modification in September, 1994 & February, 1999.Seeds Act, 1966Seeds Rules, 1968Seeds (Control) Order, 1983Seeds Policy, 1988Protection of Plant Varieties and Farmers’ Right Act, 2001

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”

Competent AuthoritiesThe 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)

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.

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

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. India’s 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

Consult Our Web siteswww.dbtindia.nic.inwww.btisnet.nic.in