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Issues in Bioprospecting: Lessons from the Field P. Pushpangadan National Botanical Research Institute Rana Pratap Marg, Lucknow-226001 IUCN South Asia.

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Presentation on theme: "Issues in Bioprospecting: Lessons from the Field P. Pushpangadan National Botanical Research Institute Rana Pratap Marg, Lucknow-226001 IUCN South Asia."— Presentation transcript:


2 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

3 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 WHAT IS BIOPROSPECTING? Exploration of biodiversity for commercially valuable genetic and biochemical resources - Eisner 1989, Reid et al. 1993

4 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 Bioprospecting: Major Areas


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

7 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 Elements of Natural Product Mechanism-based Screening

8 SECONDARY SCREENS 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

9 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 Clinical Trials Final Product

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

11 Bioprospecting Programmes : Examples from India CSIR Coordinated Programme on Drug Discovery (1996- ) New Millennium Indian Technology Leadership Initiative (NMITLI) – Planning Commission/CSIR(2002- ) Dept. of Biotechnology – Bioprospecting and Molecular Taxonomy Programme(1998- )

12 Issues of Bioprospecting 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) Access and Benefit Sharing (ABS)

13 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.

14 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

15 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

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

17 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. Benefit sharing with an indigenous community (tribe) – A Case Study

18 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. Tribal Settings in India 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. Benefit sharing with an indigenous tribe (Contd..)

19 10000 plant species are used by tribes of India Total species 8000 Medicinal 3500 Edible 1000 Others 550 Fibre Pesticides Gums, Resins & Dyes Benefit sharing with an indigenous tribe (Contd..)

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

21 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. Benefit sharing with an indigenous tribe (Contd..)

22 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 The Kani Tribe Benefit sharing with an indigenous tribe (Contd..)

23 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. Interaction with Kani Tribe Benefit sharing with an indigenous tribe (Contd..)

24 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 Interaction with Kani Tribe consumed they would reduce fatigue and provide energy. Benefit sharing with an indigenous tribe (Contd..)

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

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

27 Within a period of seven years a scientifically validated, standardized herbal formulationJeevani 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 Drug Jeevani was ready Benefit sharing with an indigenous tribe (Contd..)

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

29 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. Bottlenecks in implementation of the same Benefit sharing with an indigenous tribe (Contd..)

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

31 Past Present DWELLING Impact on Removing Poverty from this Initiative

32 LIVING CONDITIONS Impact on Removing Poverty from this Initiative Past Present

33 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

34 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

35 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) Commercialization of the products Benefit sharing with the indigenous/ local communities Development of marketable product/s (with S&T intervention) Safeguarding IPRs of indigenous/ local communities and Benefit-sharing


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