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Biodiversity Wealth and Opportunities for Asia Pacific Countries in Biotechnology

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Title: Biodiversity Wealth and Opportunities for Asia Pacific Countries in Biotechnology


1
Biodiversity Wealth and Opportunities for Asia
Pacific Countries in Biotechnology Herbal
Technology
  • P. Pushpangadan
  • National Botanical Research Institute
  • (Council of Scientific Industrial Research),
  • Rana Pratap Marg, Lucknow-226001
  • (September 2003)

2
WORLD TRADE AND ECONOMIES THE PARADIGM SHIFT
  • Resource based economies to Knowledge based
    economies
  • 21 st Century will be the Century of
    Knowledge
  • A nations ability to convert knowledge in to
    wealth and social good through the process of
    innovation will determine its future ( R A
    Mashelkar, 2001)

3
21st Century
  • 21st century is the century of Biology powered
    and propelled by scientific knowledge and
    technological expertise
  • Three technologies namely
  • Biotechnology
  • Herbal technology
  • Information technology (Bioinformatics)
  • are going to be the most powerful elements that
    are crucial for prosperity and welfare for the
    people of nations.

4
Herbal technology
  • All technologies for the manufacture of value
    added plant products can be called as herbal
    technology
  • Herbal drugs and pharmaceuticals,
  • Nutraceuticals,
  • Functional foods, designer foods or health foods
    and health drinks
  • Cosmaceuticals
  • Biocontrol agents
  • Biopesticides

5
WORLD TRADE AND ECONOMIES THE PARADIGM SHIFT
  • Resource based economies to Knowledge based
    economies
  • 21 st Century will be the Century of
    Knowledge
  • A nations ability to convert knowledge in to
    wealth and social good through the process of
    innovation will determine its future ( R A
    Mashelkar, 2001)

6
Genesis of the Global Concern on Biodiversity
Conservation
  • UNEP constituted an ad-hoc Working Group of
    Technological and Legal experts to prepare an
    international legal instrument for conservation
    and sustainable use of Biodiversity which
    resulted in CONVENTION ON BIOLOGICAL DIVERSITY
    (CBD).
  • 171 countries signed CBD in June 1992 during the
    Earth summit at Rio de Janeiro.
  • CBD came - into force as an International Law on
    29th Dec. 1993.
  • 186 countries are now parties to CBD (as on Feb.
    2003)

7
Conservation of Biodiversity Strategies
Priorities
IUCN, UNEP WWF 1980 came out with the first
Global Strategy for Conservation. This Strategy
defined conservation as Management of human use
of biodiversity so that it may yield the greatest
sustainable benefit to present generation while
maintaining its potential to meet the needs and
aspirations of future generation This definition
involves two complementary components
Conservation and sustainability
8
Biodiversity TK Capital Assets of Asia-Pacific
Countries
  • Biodiversity and TK are two invaluable capital
    assets of South countries for
  • Building up IPR- covered bio-industrial
    enterprises
  • Herbal Drugs
  • Pharmaceuticals
  • Natural product development sectors
  • Generating economic wealth and improving quality
    of life and well- being of people

Contd.
9
Biodiversity TK Capital Assets of Asia-Pacific
Countries (Contd.)
  • Building up ST capability in advanced
    technologies of bioprospecting
  • Human resource development in Biotechnology,
    Bioinformatics and Bioprospecting
  • Empowering local and indigenous communities for
    conservation, sustainable use and building up
    location specific biodiversity enterprises
    through ST intervention

10
Biodiversity TK Bridging the North-South Gap
  • Asia-Pacific countries SHOULD
  • Develop capability in biotechnology,
    bioinformatics and bioprospecting through
    national, regional and global biopartnership
    programmes
  • Address and resolve the issues of access to and
    transfer of genetic resources and technologies
    between North- South countries
  • Contd..

11
Biodiversity TK Bridging the North- South
Gap Asia-Pacific Countries should
  • Prevent bio-piracy and misappropriation of
    genetic resources and TK
  • Develop an international system for protection of
    TK
  • Develop effective mechanisms for fair and
    equitable benefit sharing and technology transfers

12
Convention of Biodiversity (CBD) Relevant
Provisions of CBD
  • Article 3 recognizes the sovereign rights of
    States over their biological resources.
  • Article 15 states that when access to genetic
    resources is granted, it shall be on mutually
    agreed upon terms and subject to Prior Informed
    Consent.
  • Incentives to biodiversity-rich countries to
    conserve and sustainably use their genetic
    resources, including joint research, access to
    transfer of technology (Articles 15,16).

13
Relevant Provisions of CBD (Contd...)
  • Article 16.2 addresses issues surrounding the
    access to and transfer of technology, governed by
    patents.
  • Article 16.5 anticipates the difference in
    objectives between IPR regimes and the CBD and
    seeks to ensure that IPRs don't run counter to
    the CBD.
  • Article 8(j) underlines the need to protect TK
    and points to the potential benefits to be
    realized from such knowledge through involvement
    of its holders and equitable benefit-sharing.

14
Relevant Provisions of TRIPs on Biological
Resources
  • Under Article 27, virtually all inventions are to
    be patented if they are new, involve an
    innovative/inventive step and are capable of
    industrial application.
  • Exceptions to patentability include plants,
    animals ( other than microbes) and biological
    processes for the production of the above.
    However plant varieties must be protected either
    by sui generis or by patenting (27.3(b)).

15
Relevant Provisions of TRIPs on Biological
Resources (Contd.)
  • Article 30 confers limited exceptions to the
    rights conferred on patent holders, taking into
    account the legitimate interests of third
    parties.
  • Article 29 imposes two conditions on patent
    applicants that they disclose the invention
    clearly and completely enough for a person
    skilled in the art to reproduce it and it 'may'
    require an applicant to provide information
    concerning the applicant's corresponding foreign
    applications and grants.

16
TRIPS-CBD Relationship
  • Absence of explicit compatibility, Difference of
    approach and priority given to issues which are
    ultimately related. This has led to violation of
    the CBD (Articles 8,15 16).
  • TRIPs ignores a vast range of valuable,
    traditional knowledge (TK) because it doesn't
    meet the standards of patentability.

17
TRIPS-CBD Relationship (Contd..)
  • TRIPs undermines CBD in cases of biopiracy, by
    putting the burden of proof on the source country
    rather than patentee. Identification of unique
    source material as required in Art.29 of TRIPs is
    insufficient. Lack of transparency in the patent
    application procedure.
  • TRIPs doesn't require the recognition of domestic
    laws protecting access to genetic resources and
    TK and subsequent benefit sharing.

18
The Need to Amend the TRIPs Agreement
  • Absence of a clear reference to CBD and the
    relationship with CBD could hinder the
    implementation of the latter by violating the
    primary principle of sovereignty over genetic
    resources.
  • TRIPs should provide international recognition of
    relevant domestic legislation of its member
    countries, especially as far as access and
    benefit sharing issues are concerned.

19
The Need to Amend the TRIPs Agreement (Contd...)
  • It is far more cost effective in the long run to
    establish an internationally accepted solution
    through TRIPs for the prevention of biopiracy.
  • TK associated patents have fetched large profits
    and it makes ethical and economic sense for TRIPs
    Agreement to recognize a need for benefit
    sharing.

20
The Need to Amend the TRIPs Agreement (Contd...)
  • It is far more cost effective in the long run to
    establish an internationally accepted solution
    through TRIPs for the prevention of biopiracy.
  • TK associated patents have fetched large profits
    and it makes ethical and economic sense for TRIPs
    Agreement to recognize a need for benefit
    sharing.

21
Bioprospecting and the new IPR regime
Given the global trends in capturing the
intellectual property markets, the Third World
nations in the Asia pacific now needs to look
ahead for the best possible ways and means by
which they can generate IPR and build up IPR
covered bioindustrial regimes. Biotechnology
(BT), Information Technology (IT) and Herbal
Technology (HT) are the three fast emerging and
powerful areas of RD in current century. The
rich biodiversity, associated knowledge systems
and human resources etc. are the strength of
Asia-pacific countries, and therefore have the
best opportunity.
22
Bioprospecting
  • Chemical Prospecting
  • Drugs and pharmaceuticals
  • Pesticides
  • Cosmetics
  • Food additives
  • Other industrially valuable
  • Chemical products
  • Gene Prospecting
  • Genetic engineering
  • Crop development
  • Fermentation
  • Cell culture
  • Bionic Prospecting
  • Designs
  • Sensor technologies
  • Architecture
  • Bioengineering
  • Biomodeling

23
Bioprospecting Linkages and leads
Biodiversity IK/TK
Biotechnology
Bioprospecting
Information technology
  • Drug development
  • Pharmaceuticals
  • Agrochemistry
  • Cosmetics
  • Proteins
  • Enzymes
  • New crop varieties
  • GMOs
  • GM foods
  • Designs etc.

Herbal technology
Conservation
Sustainable use
Benefit sharing
Bioinformatics
IPR
24
IPR Issues / Benefit Sharing Strategies
  • Appropriate Procedures for IPR Protection/Benefit
    sharing
  • Documentation Registration of TK Medicinal
    plant use Conservation at local , state and
    national level.
  • Contribution to TKDL TKRC
  • Value addition to TK Indigenous Medicinal
    Plants Scaling up IPRs
  • Herbal drugs, Pharmaceuticals, Natural products
    byproducts, Nutraceuticals, Functional foods, etc.

25
Some features of international health care
  • Health care policies largely market driven by the
    pharmaceutical industry diverting attention from
    health preservation to illness cure
  • Prevention and eradication of diseases undermines
    the economic basis of this industry
  • No satisfactory drugs available for most of the
    degenerative disorders characteristic of graying
    population and for re-emerging resistant
    infections
  • Many currently used modern drugs do not have
    valid proven clinical utility.
  • USA has among the highest per capita annual
    expenditure on health care (3600) but still
    about 15 population is denied even basic care
    facilities (the best Indian state like Kerala
    have an annual per capita expenditure 15)

26
Herbal drugs in international health care
  • Economic aspects
  • Global market of herbal drugs, Nutraceuticals
    60 billion with 6 annual growth rate. Major
    share of Chinese and Koreans. Indian share
    variously estimated at 0.35-3.0. Chinese
    production increased 200 between 1995-1999.
  • Local acceptance
  • Developed
  • USA 42 use CAM spending over 29 billion US and
    629 million visits in 1998.
  • UK 28 use, spent 1.6 billion pounds and 127
    million visits in 1998.
  • Australia 60 use, A 620 billion in 1999.
  • Developing
  • Malaysia Per capita consumption of traditional
    drugs, more than double of modern
    pharmaceuticals.
  • S.Korea Per capita consumption of traditional
    drugs 36 more than modern drugs.
  • African countries 9 to 10 patients attending
    hospital OPD have first consulted a traditional
    healer.

27
Advantages of herbal drugs
  • Modern drugs can produce serious side effects
  • Latrogenic diseases fourth leading cause of
    death in USA and other developed nations (JAMA,
    April 1998).
  • Side effects of drugs kill more Americans
    annually than the world war II and Vietnam war
    combined (M. Rath N. Y. Times 28.2.2003).
  • Around 2600 persons died in the Twin Tower
    tragedy on 11th September 2001 causing global
    repercussions. It is, however, not recognized
    that about the same number die in USA from side
    effects of prescription drugs every 10 days
    (JAMA, April 1998).

28
Herbal drugs are best suited for
  • PRIMARY HEALTH CARE
  • INFECTIOUS DISEASES
  • AIDS and other viral infections
  • Opportunistic infections
  • MDR infections (e.g. T.B., Malaria)
  • DEGENERATIVE GERONTOLOGICAL CONDITIONS
  • Osteoporosis
  • Chronic arthritis like osteoarthritis and
    rheumatoid arthritis
  • Neurological like Alzheimer, Parkinsonism
  • Anti-aging
  • Metabolic disorders
  • Diabetes
  • Dyslipidemias
  • Other conditions
  • Microcirculatory disorders
  • Liver diseases
  • Immunostimulants
  • Anti-cancer
  • Drugs affecting male libido

29
Standardization of Herbal drugs Raw Drugs
  • Passport data of Raw Plant Drugs (Crude drugs)
  • Correct taxonomic identification authentication
  • Study on the medicinal part root, stem, bark,
    leaves, flowers, fruits,nuts, gum, resins etc.
  • Collection details Location, stage
    development/ growth of the plants, time,
    pre-processing storage etc.
  • Organoleptic examination of raw drug
  • Evaluation by means of sensory organs touch,
    odour taste
  • Microscopic molecular examination
  • Chemical composition (TLC, GLC, HPLC, DNA
    fingerprinting)
  • Biological activity of the whole plant
  • Shelf life of raw drugs

30
Standardization of Herbal drugs- Herbal
Formulation
  • Follow defined Good Manufacturing Practices (GMP)
  • Scientific Verification
  • Toxicity evaluation
  • Chemical profiling
  • Pharmacodynamics effect of drug in the body
  • Pharmacokinetics absorption, distribution,
    metabolism, mechanism of action and execution
  • Dosage
  • Stability and shelf life
  • Presentation and Packing
  • Therapeutic merits Compared with other drugs

31
Good Practices/Techniques in Herbal Products
  • Good Survey of literature (Ancient Modern)
  • Develop and Observe Norms of
  • Good Agricultural Practices (GAP)
  • Good Collection/Harvesting and Post Harvest
    Handling Practices (GCP/ GHP GPHP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices (GCP)
  • Good Manufacturing Practices (GMP)
  • Good Marketing Techniques (GMT)

32
Parameters required for quality evaluation of
herbal drugs
33
(No Transcript)
34
DARU HARIDRA - A Controversial drug of Ayurveda
  • Three plants used as Daruharidra
  • In Northern India Berberis aristata DC. (Family-
    Berberidaceae),
  • In Southern part Coscinium fenestratum (Gaertn.)
    Colebr (Family- Menispermaceae),
  • In Easter part Coptis teeta Wall. (Family-
    Ranunculaceae)
  •  
  • Berberine is the active constituent present in
    all the three species thus on the basis of
    berberine all of these can be used as substitutes
    of Daruharidra. However, scientific
    investigation also suggest that different
    Berberis species viz. B. asiatica, B. chitra and
    B. lycium can also be used as substitute of
    Daruharidra as all the species have almost
    similar chemical profile.

35
Different vernacular Names of Berberis spp.
Arabic -
Ambarbaris Bhutia -
Tsema Bengali -
Darvi Canarese -
Bagisutra English - Indian
Barbery, Tree turmeric Greek
- Lykion indikon Garhwal Himalayas -
Kingora, Kilmora, Kashmal Hindi
- Daruhaldi, Darhald, Chitra Jaunsar
- Kashmoi Japanese
- Indo-ohbaku Latin
- Berberis Malayalam -
Maradarisina, Maramanjal Nepal
- Chitra, Chotra Persian
- Bedana, Chitra, Zirishk Punjab
- Chachar Himanchal Pradesh - Kammul,
Kashmal, Kaumul Sanskrit -
Daruharidra, Darvi Tamil -
Maramanjal, Mullukala Telugu
- Kasturipaspu Urdu -
Ambar 
36
Medicinal uses of Berberis spp.
  Ayurveda It is bitter and at the same
time hot and pungent useful in boils, diabetes,
affections of ear, eye and mouth. The decoction
is very useful preperation for opthalmic
infection, cough, poison and boils.
Local health traditions (folk remedies) of
Berberis spp. in Northern India B. aristata DC.
and B. asiatica Roxb.  In Garhwal region (U.
P.) In Dhanulti and Raithal locality near to
Uttarkashi of U.P. Rasaut a root extracts is
used for Eye conjuctivitiis, Malarial fever,
Skin diseases.  In Kumaun region (U. P.)  In
Ranikhet locality of Nainital (U.P.) Decoction
of root bark is used in eye troubles. local
people they use root extract for treating fever
and skin diseases. Roots are also used for snake
and scorpion bite.  B. Chitria Lindl.  In Kangra
valley (Himanchal Pradesh) The filtered
decoction of root is used for treating
conjunctivitis and other ophthalmic diseases.
 B. Lycium Royle In Kangra vally(Himanchal
Pradesh)The decoction of root is given orally as
blood purifier. Raw fruits are also eaten for
digestive disorders. Leaves are used as fodder.
It is taken with the juice of radish for jaundice.
37
Market Survey of Berberis Spp.
 Roots of Berberis spp. are collected in fairly
large quantities in Chamba District Of Himanchal
Pradesh and in Tehri-Garhwal of Uttar Pradesh
during Aug., Sept. and are being sold in the
nearby markets or to the traders which finally
reach the drug markets of India. Different market
samples are identified as Trichur samples -
Stem of Coscinium fenestratum. Banglore samples
- Root of Coscinium fenestratum. Amritsar,
Aligarh, Dehradun, Hyderabad, Jammu, Lucknow, and
Varanasi samples- the different Berberis species.
38
Major constituent of Berberis spp.
Berberine
39
Quantitative Estimation of Berberine in different
Berberis species
40
Quantitave estimation of berberine in different
market samples of Berberis spp.
41
Comparative HPTLC profile of Berberine in
different market samples
42
Densitometric scan of different samples of
Berberis spp. at UV 266 nm
43
Berberis aristata D.C.
Brief Taxonomic description
B. aristata DC., Syst. Nat. 28.1821 Hook f.
Thomson in Fl. Brit. India 1110. 1872 pp.
Naithani, Fl. Chamoli 146.1984 Sharad, LWG
221239, 1998.   Berberis aristata DC. is a large
deciduous shrub usually 1.8-3.6 m high twigs
whitish or pale yellowish brown, erect
cylindrical, smooth and strongly striate blaze
5-7.5 mm, bright yellow with coarse reticulate
fibres leaves 3.8-10 x 1.5-3.3 cm, obovate or
elliptic, entire or spinous-toothed, base
gradually narrowed, with prominent reticulate
nerves, glossy dark green above and glossy pale
green beneath flowers numerous, stalked
inflorescence a simple drooping raceme, bracts
small, linear, acuminate sepals 8 or 9,
imbricate, oval, petaloid, yellow petals 6, in
two whorls, strongly imbricate, concave, bright
yellow veined with two oval linear glands at the
base of the lateral veins stamens 6 equal,
hypogynous, opposite and slightly shorter than
the petals ovary simple, 1-celled, with a few
erect ovules style short, stigma peltate fruit
a small berry about 7-10 mm, ovoid or oblong
ovoid, blue black with a whitish bloom tipped
along with the persistent style and
stigma.   Flowering and Fruiting August
October
44
Berberis aristata DC. Macroscopic Microscopic
T.S. cellular structure of stem (x 100)
Dried Root
T.S. of the root (x 100)
Fruits and Seeds
TLS of the root (x100)
Powder study (x400)
45
Botanical Analysis of root of Berberis aristata DC
Macroscopic Woody, yellowish brown, cylindrical, knotty with thin brittle bark. Cut surface bright yellow Fracture hard, texture short, odourless and bitter in taste.
Outline Circular
Cork cells Brown, 10-20 Layered, rectangular
Cortical zone 30-35 layered, parenchymatous, filled with tannin, starch grains and rhomboidal crystals of Ca-oxlate.
Sclereids Solitary or in group of 2 to 10
Pericyclic fibres Mostly solitary but sometimes in groups of 2 to 10.
Alkaloidal contents Present
Vessels Solitary or in group of 2 or 3
Medullary Rays Heterogenous, 2 to 4 cells broad, pitted, filled with starch and alkaloidal content
46
HPTLC profile and densitometric chromatogram of
B. aristata root
47
THE AYURVEDIC THERAPEUTIC STRATEGY
  • Determine PRAKRUTI (Constitution) by -history
    taking -observations
  • NIDANA (Diagnosis)
  • Nature, degree and extent of imbalance of
    Tridoshas. Library of 5800 clinical signs and
    symptoms in Ayurvedic texts
  • CHRONOBIOLOGY Impact of season, time and
    environment on Tridoshas.
  • SWASTHAVRUTA Life style modification
  • AHARA Dietary modifications
  • PANCHAKARMA Purification of the body
  • AUSHADHI "Designer Medicine" unique for the
    particular patient prepared from a Pharmacopoeia
    utilising 1200 plants, 100 minerals and 100
    animal products in numerous formulations.

48
OBJECTIVES OF RESEARCH ON AYURVEDIC DRUGS
  • Improved formulations and reduced number of
    Ayurvedic drugs
  • Use of GMP procedures and QC
  • Certified shelf life and improved dosage form
  • Validated indications and contraindications
  • Deletion of obsolete or toxic formulations
  • Use of Ayurvedic drugs in modern clinical
    practice
  • Inclusion in essential list of drugs
  • Adjunct to existing drugs
  • Treatment of diseases where modern drugs not
    available or unsatisfactory
  • Development of suitable formulations,
    standardized extracts or active constituents
  • IPR protection wherever feasible
  • Inclusion in Pharmacopoeias.

49
OBJECTIVES OF RESEARCH ON AYURVEDIC DRUGS
  • New indications for Ayurvedic drugs
  • Development of new drugs for Ayurvedic practice
  • Utilizing leads from other countries
  • Study of unscreened flora, specially endemic or
    threatened species
  • Studies on Ayurvedic drugs for veterinary use

50
Development of new drug/ novel uses for Ayurvedic
drugs
  • Utilization of new leads on natural products from
    other countries. Several of these plants or
    related species are found in India
  • The vast unscreened flora of the country and
    published activity data on some of these
  • Study of further accessions from families
    yielding active plants

51
Vision of Herbal Drug Industry
To provide intellectual capital to make
available safe, cost effective, affordable
therapeutics to the people of Indo-Pacific region
to help to reduce the percentage of mortality,
morbidity and to emerge as significant players in
the global market place.
52
BIOPARTNERSHIP RELEVANCE OF APCTT
APCTT can bring the Asia-Pacific Countries should
come together to develop Strategies for
  • Easy and regulated access to genetic resources
    TK and biotechnologies
  • Exchange of information pertaining to
    conservation and sustainable use of biogenetic
    resources and associated TK
  • Mutually Agreed Terms
  • Prior Informed Consent
  • Equitable Benefit Sharing Agreement

53
BIOPARTNERSHIP RELEVANCE OF APCTT
APCTT can help Asia Pacific Countries
  • Build up ST Capabilities
  • Capitalize biodiversity and TK for
    bioindustrial development
  • Insulate from Biopiracy
  • Ensure national sovereign rights over
    biodiversity and TK
  • Empower local and indigenous communities,
    including women
  • Build up location specific biodiversity
    enterprises using local bio-resources and TK
    through ST applications

54
BIOPARTNERSHIP RELEVANCE OF APCTT
APCTT can help in Capacity building and Training
for Asia-Pacific countries
  • AREAS Biodiversity TK
  • Biotechnology
  • Bioinformatics
  • Bioprospecting

55
APCTT can help in in Capacity Building and
Training for Asia-Pacific countries
  • STRATEGIES
  • 1. Development of Transparent Policies and
    Mechanisms to ensure
  • Access to and transfer of genetic resources and
    technologies among participating countries
  • Evolving equitable benefit sharing models based
    on sustainable use and S T based value addition
    to bioresources and associated TK

Contd...
56
STRATEGIES (Contd.)
2. Promotion of multi-country collaborative RD
projects on various facets of Bioprospecting,
particularly herbal drug and pharmaceutical
prospecting and other natural product development
sectors 3. Generation of IPR- covered products,
processes, technologies and services, and thereby
converting the bio-resources and associated TK in
to economic wealth of the country and its people.
57
Action Programme
  • Important points that the biodiversity rich
  • third world nations should undertake
  • Complete inventory documentation of all
    Biological resources including the microorganisms
  • Check list/database of the floristic wealth of
    the nation along with the associated knowledge
    system
  • Ground check to know the actual situation and
    identify the gaps
  • Study - genetic diversity, distribution pattern,
    association pattern and gradients
  • Identify- rare, endemic and endangered status of
    spp. , if any.

58
Action Programme
  • Prepare -passport data of all important and
    endemic biodiversity. Passport data should cover
    morphological, cytological, chemical and
    molecular level (DNA/gene level) information so
    as to prevent bio/gene piracy.
  • Identification of problems and solutions in
    conservation, threatened status of species,
    ecosystems -with causes of threats.
  • Identification of problems and solutions in
    conservation.

59
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