1. Issues in Bioprospecting: Lessons from the Field
P. Pushpangadan
National Botanical Research Institute
Rana Pratap Marg, Lucknow
IUCN South Asia Regional Training Programme on Bioprospecting, Access and Benefit Sharing, NBRI, 10-12, January 2005

2. WHAT IS BIOPROSPECTING?
Exploration of biodiversity for commercially valuable genetic and biochemical resources
- Eisner 1989, Reid et al. 1993
The systematic search for genes, natural compounds, designs and whole organisms in wild life with a potential for product development by biological observation, and biophysical, biochemical and genetic methods without disruption to nature.
- Nicolas Mateo et al., 2001

3. Bioprospecting: Major Areas
Chemical prospecting
Drug 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
Bio-modeling

4. Bioprospecting : Essential elements
RAW OR VALUE – ADDED MATERIALS/DERIVATIVES
(GENETIC RESOURCES / TK)
LEAD BASED or MECHANISM BASED
COLLECTION, SOURCING, ACQUISITION
(Through PIC, MAT, and MTA)
EXTRACTION SCREENING
RANDOM
PRIMARY SCREENS
BIOMOLECULES – BIOLOGICAL ACTIVITY/GENES – TRAITS
ISOLATION & CHARACTERIZATION
STRUCTURAL ELUCIDATION
TRIALS & TESTS
(CLINICAL, GENETIC STABILITY, BIOSAFETY)
IPR GENERATION / PROTECTION
BENEFIT SHARING
SECONDARY SCREENS
PRODUCT DEVELOPMENT
MARKETING

5. Bioprospecting: Major Areas
Biodiversity &
IPR/TK
Sustainableuse
Benefit
sharing
Bioinformatics
IPR
Biotechnology
Information
technology
Herbal
Bioprospecting
Conservation
Drug Development
Pharmaceuticals
Agro-chemistry
Cosmetics
Proteins
Enzymes
New crop varieties
GMOs
GM Foods, Designs. etc

6. Elements of Natural Product Mechanism-based Screening
Selection of molecular target
Purification of reagents
Development of assay
Drug design
IDENTIFICATION OF LEAD
Natural product screening
Synthesis & SARA studies
Selection development candidate
Compound bank screening
Combinatorial chemical libraries

7. Elements of Natural Product Discovery-Random Screening
ACQUISITION
Raw material: field collections, culture collections, screening libraries, etc
EXTRACTION
PRIMARY SCREENS
ISOLATION & CHARACTERIZATION
STRUCTURAL ELUCIDATION
PRE-CLINICAL & CLINICAL DEVELOPMENT
SECONDARY SCREENS

8. TOXICOLOGICAL AND EFFICACY EVALUATION
Prospecting for drugs and pharmaceuticals from traditional knowledge (Ethnopharmacological Approach)
Bioactive Molecules
Product Development & Pharmaceutics: Dosage Forms
TOXICOLOGICAL AND EFFICACY EVALUATION
Activity Guided Isolation
Selection of Effective combinations of extracts
Pharmacodynamics
Bioactive Extracts
Pharmacokinetics
Multi-centric, Randomized,
Clinical Trials
Final Product
Marketing & Benefit Sharing with the Traditional Communities
Interaction with Traditional communities and obtaining Ethno medical information with Prior Informed Consent
Selection of Potential Herbal(s)/Formulation(s)
Literature Survey
Development of Scientifically
Validated herbal drugs/formulations
Clinical Dosage forms
Safety Efficacy Evaluation
The Product Development
Shelf Life Studies

9. Bioprospecting Programmes - Examples
InBio – Merck Agreement: Beginning of a Bioprospecting Era
Shaman Pharmaceuticals
International Cooperative Biodiversity Groups (ICBG)

10. Bioprospecting Programmes : Examples from India
CSIR Coordinated Programme on Drug Discovery ( )
New Millennium Indian Technology Leadership Initiative (NMITLI) – Planning Commission/CSIR( )
Dept. of Biotechnology – Bioprospecting and Molecular Taxonomy Programme( )

11. Issues of Bioprospecting
Access and Benefit Sharing (ABS)
Access Norms and Policies
Ownership and Sovereign Rights on Biodiversity – Who owns the resources?
Prior Informed Consent (PIC) – Principles and Practices
Mutually Agreed Terms (MAT)
Material Transfer Agreements (MTA)

12. Issues of Bioprospecting(Contd..)
Access and Benefit Sharing (ABS)
Benefit Sharing
Monetary Benefits
Access fees.
Up – front payments.
Milestone payments.
Sharing of Royalties.
License fees in case of commercialization.
Special fees to be paid to trust funds supporting conservation and sustainable use of biodiversity.
Salaries and preferential terms on mutually agreed terms.
Research funding.
Joint ventures.
Joint ownership of relevant intellectual property rights.

13. Issues of Bioprospecting(Contd..)
Access and Benefit Sharing (ABS)
Benefit Sharing
Non-monetary Benefits
Sharing R&D results
Collaboration in S&T and development programmes (Biotechnology)
Participation in Product Development
Collaboration in Education and Training
Admittance to ex situ facilities and databanks
Institutional Capacity Building
Human Resource Development
Information Exchange
Contribution to Local Economy
Contribution to other domestic benefits
Food and Livelihood security benefits
Social Recognition
Joint IPRs

14. Issues of Bioprospecting(Contd..)
Conservation of biodiversity.
Sustainability of Genetic Resource Stocks
Uncertainties and opportunistic behaviors
Success rate of bioprospecting programmes
Market Trends
National and International Legal and Policy Environment
Capacity Building in Biodiversity inventorying, and bioprospecting technologies
Biotechnology
Herbal Technology
Information Technology

15. Issues of Bioprospecting(Contd..)
Intellectual Property Rights(IPR) Protection
Traditional Resource Rights of Indigenous Communities
Bioethics and Biosafety
Transgenics
Transgenic foods
Transgenic medicines

16. Tribal Settings in India
Benefit sharing with an indigenous community (tribe) – A Case Study
Tribal Settings in India
India has over 70 million tribals belonging to over 550 communities inhabiting in 5000 villages located in and around forests region of the country.
About 217 different dialects are spoken by tribal communities in India.

17. Tribal Settings in India
Benefit sharing with an indigenous tribe (Contd..)
Tribal Settings in India
Population of the individual tribe is as large as about 5 million in Madhya Pradesh and as small as 21 like Onges of Andaman Islands.
The tribals in the country occupy about 18.74% of the total area of the country, mainly in the hilly and forest areas of 19 states and union territories.

18. 10000 plant species are used by tribes of India
Benefit sharing with an indigenous tribe (Contd..)
10000 plant species are used by tribes of India
8000
Medicinal
Total species
325
3500 Edible
425
Pesticides
1000 Others
550 Fibre
Gums, Resins & Dyes

19. INDIAN SYSTEMS OF MEDICINE
Benefit sharing with an indigenous tribe (Contd..)
INDIAN SYSTEMS OF MEDICINE
8000 species
Ayurveda
900 sp.
Unani
700 sp.
THE INDIAN FLORA (ca species)
Siddha
600 sp.
Modern
30 sp.
Amchi
250 sp.

20. Benefit sharing with an indigenous tribe (Contd..)
The Kani experiment
During the course of an ethnobotanical exploration, Pushpangadan and co-workers (1987) came across an interesting use (anti-fatigue) of a lesser known wild plant while conducting the study on the forest dwelling Kani Tribe of South Western Ghat mountains.

21. Benefit sharing with an indigenous tribe (Contd..)
The Kani Tribe
‘Kani’, a semi-nomadic tribal community inhabits in the forested mountains in and around ‘Agasthyamalai’ of the southern Western Ghat region of India. Their population as per the 1991 census of India is 1618.

22. Interaction with Kani Tribe
Benefit sharing with an indigenous tribe (Contd..)
Interaction with Kani Tribe
In December 1987, a team of scientists led by Dr. Pushpangadan was conducting an ethno-botanical survey and exploration in the Agasthya hills, of the Western Ghats in South India with the help of two young Kani men as guides.
During this visit, the author and his colleagues noticed that the Kani men were not taking any food and were eating only some small dry fruits. But they were quite energetic and agile.

23. Interaction with Kani Tribe
Benefit sharing with an indigenous tribe (Contd..)
Interaction with Kani Tribe
After a strenuous mountain trek, the author (Pushpangadan) and colleagues got exhausted and were taking rest. Then the Kani men accompanying them offered those dry fruits saying that when
consumed they would reduce fatigue and provide energy.

24. Scientific Investigations
Benefit sharing with an indigenous tribe (Contd..)
Scientific Investigations
Collected adequate samples of this plant for detailed investigations at Regional Research Laboratory, (RRL), Jammu. Soon after reaching back at RRL, Jammu, Dr. Pushpangadan
conducted the first scientific test to validate the Kani’s claim on the anti-fatigue property of Arogyapacha.

25. Benefit sharing with an indigenous tribe (Contd..)
Filing of patents
Three patents on the different pharmacological activities of the compounds isolated from this plant were made by RRL, Jammu.

26. Drug “Jeevani” was ready
Benefit sharing with an indigenous tribe (Contd..)
Drug “Jeevani” was ready
Within a period of seven years a scientifically validated, standardized herbal formulation ‘Jeevani’ was formulated with ‘Trichopus zeylanicus’ and three other medicinal plants as its ingredients. Evaluations related to toxicity, efficacy, shelf life and clinical properties were carried out by TBGRI, and the drug was ready by the end of 1994.

27. Drug “Jeevani” was released
Benefit sharing with an indigenous tribe (Contd..)
Drug “Jeevani” was released
After the necessary pharmacological evaluation and clinical study, the drug was released for commercial production.

28. Bottlenecks in implementation of the same
Benefit sharing with an indigenous tribe (Contd..)
Bottlenecks in implementation of the same
However, it took almost two years to transfer this benefit to be transferred to the Kani tribe due to inherent problems of the tribe.
Kani tribe is an unorganized semi-nomadic forest dwelling tribe. They later organized themselves and formed a trust with over 50% of adults from Kani Tribe as its members.

29. Actual transfer of money
Benefit sharing with an indigenous tribe (Contd..)
Actual transfer of money
to Kani tribe
TBGRI transferred the money due to Kani tribe (Indian Rupees 650 thousand) in Feb They are now regularly getting 50% of royalty.

30. Impact on Removing Poverty from this Initiative
DWELLING
Past
Present

31. Impact on Removing Poverty from this Initiative
LIVING CONDITIONS
Past
Present

32. Bioprospecting Contracts
Any Bioprospecting contract should include:
Entry of access fee
Collection fee for samples collected
Processing fee for processing done, if any
Royalty on the final product

33. Contract on Access to Traditional Knowledge could include:
Access or consent fee for obtaining the consent of the appropriate community for accessing closely held knowledge that is protected through a sui generis legislation
An access fee for accessing information containing in biodiversity registers or other documents in the case of public domain or quazi public domain knowledge.
A royalty on the final product that is developed from TK, by the bioprospector

34. Safeguarding IPRs of indigenous/ local communities and Benefit-sharing
Survey, inventory & documentation of the indigenous knowledge system and preparation of community registers
Preparation of Electronic Database
(Access to Patent Office)
Access to Database with prior informed consent
Negotiation and signing of agreement(s)
Development of marketable product/s (with S&T intervention)
Commercialization of the products
Benefit sharing with the indigenous/ local communities

35. Thank You