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Dr T K Mukherjee Scientist & Consultant--Traditional Knowledge, IPR & Science Editor E-mail: [email protected]; +91-9871819795

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Microsoft PowerPoint - Session 3.4 - Mukherjee.pptDr T K Mukherjee Scientist & Consultant--Traditional Knowledge, IPR & Science Editor
E-mail: [email protected]; +91-9871819795
Traditional Systems of Medicine
Biodiversity Traditional Knowledge
Cultural heritage
Two of the world's 18 biodiversity hotspots
47,000 plant species (7% of the world’s flora)
81,000 animal species (6.5% of world’s fauna)
15,000 Medicinal Plants
Of 1,500 Medicinal Plants, 500 are used in the preparation of drugs
…Indian Biodiversity About 33% of the country's recorded flora are endemic About 62% of the known amphibian species are endemic Nearly 50% of the lizards are endemic 26 recognized Endemic centers 89 National parks and 504 Wildlife sanctuaries Ten biogeographic regions 5 world heritage sites, 12 biosphere reserves, and 6 Ramsar wetlands
…Indian Biodiversity
Of the 49,219 plant species, 5,150 are endemic about 30% of the world's recorded flora
Homeland of 167 cultivated species; 320 wild relatives of crop plants
79 mammals, 44 birds, 15 reptiles, and three amphibian species are threatened Nearly 1,500 plant species are considered endangered; 120 medicinal plants are rare or endangered
…Indian Biodiversity
Around 25,000 plant based formulations are used in folk medicine
Over 8,000 herbal product-manufacturing units
Of 880 species currently used in herbal industry
Around 60 species are imported, about 60 species are cultivated and about 760 species are harvested from the wild
Medicinal Plants: Main Issues
Safety Biological (contaminants) Environmental (pesticides, heavy metals) Chemical (eg. Aristolochic acid I and II present in Aristolochia sp appear to be responsible for Chinese Herbs Nephropathy)
Quality (Authenticity) Standardisation Selection of marker compounds Adulteration / misidentification
Medicinal Plants: Limitations Raw material from wild
Adulteration & substitution
Lack of comprehensive Herbal Pharmacopoeia
Lack of Public Test Houses
Lack of Safety Evaluation Facility
Poor investment in R&D on herbals
Lack of trained manpower
Ginseng Brazilian Ginseng: Suma (Pfaffia paniculata)
Indian Ginseng: Ashwagandha (Withania somnifera) Alaskan Ginseng: Devil’s Club (Oplopanax horridum) American: Panax quinquefolium
American Red Desert: Caniagre (Rumex hymenosepalus)
Dwarf Ginseng: Panax trifolius Chinese/ Korean: Panax ginseng Sanchu: Panax notoginseng Japanese: Panax japonicus
Himalayan: Panax pseudoginseng Pearl: Panax elegantior
Medicinal Plants: Genuine plant identification
Pashanbheda Bergia ligulata Coleus aromaticus (C. forskohlii) Rotula aquatica (Mysore) Ammania baccifera (South India) Didymocarpus panicellata (Bengal)
Sankhapushpi Clitorea ternatea Convolvulus pluricaulis Evolvulus alsinoides
Brahmi Bacopa monierri Centella asiatica
Medicinal Plants: Standardisation Pharmacognostical
Physico-chemical Ash-value; pH; Optical Rotation; Specific Gravity; Hardness; Disintegration time; Elemental Composition
Phytochemical Extractive Values; Chemical profiling; TLC Fingerprinting Markers: Bio-active; Biologically; Chemical
Residual Analysis Heavy Metals; Pesticides; Toxins; Radioactive; Fumigants; Pathogens; Fungicides
India: Medicinal plants distribution
Bio-geographic zones Plant species
The Trans Himalayan zone 700 Northwest and West Himalayas 1,700 Central and Eastern Himalayas 1,200 Desert 500 Semi-arid 100 Western Ghats 2,000 Deccan Peninsula 3,000 Gangetic Plain’ 1,000 North-East India 2,000 Islands (Andaman, Nicobar and Lakshadweep) 1,000
Depletion of Medicinal Plants
Progress of Species Adulteration Limits Genetic
Crop Improvement Detrimental to Poor Quality Environment Raw Drugs Limits Cultivation/
Export Prospects Poor Quality Medicine
Detrimental to Limits Economic Poor Healthcare Pharmaceutical Industry Progress
Medicinal plants : Conservation
Sacred groves
Ex-situ conservation Field gene banks
Herbal gardens
Systems Chinese Ayurveda Unani Siddha Homoeo Tibetan Folk medicine Modern
No of plants 30%-50%
2,351 979
Correct taxonomic identification/ authentication Habit/ Habitat Reproductive Biology Identification of right genotype Medicinal plant parts: plant parts/gum/resin, etc. Collection: location, stage, time, post-harvest, storage Organoleptic examination of raw drug Examination by touch, odour, taste Microscopic/molecular examination Chemical composition: TLC/HPTLC/HMR/Mass spectrometry DNA fingerprinting Biological activity Shelf life of raw drugs Regulatory control
Some Ayurvedic plants with proven therapeutic activity
Acorus calamus Tranquillizer Aegle marmelos Antidirrhoea Asparagus racemosus Immuno-modulator Bacopa monnieri Improve memory Chlorophytum borivalianum Immuno-enhancing Commiphora mukul Hypolipidaemic Eclipta alba Hepatoprotective Gloriosa superba Antitumour Picrorrhiza kurroa Antihepatotoxic Rubia cordifolia Antistress Silybum marianum Hepatoprotective Terminalia chebula Antiaging
Trade About 6,000 plants are being traded all over the world
In Germany: 1543 plants are used in medicine; 2000 plant sp are used in Europe World herbal trade at US$ 120 billion; expected to reach US$ 7 trillion by 2050.
In India About 960 species of medicinal plants are estimated to be in trade of which 178 species have annual consumption levels in excess of 100 metric tonnes Domestic turnover of herbal products between 7,000/- to 8,000/- crores per annum Foreign trade related to finished herbal products as well as raw material Rs 3,600/- crores Domestic and export turnover of herbal products to increase up to Rs 14,500/- and Rs 09,000/-, respectively by 2012 Domestic trade of the AYUSH industry is of the order of Rs. 80 to 90 billion (1US$ = Rs.50). The Indian medicinal plants and their products also account of exports in the range of Rs. 10 billion
Export (Plant based medicine products worth)
China Rs 22,000/- crores
India Rs 462/- crores
Medicinal plants (India) 10,000 Ayurveda 1,800 Siddha 1,100 Unani 750 Homoeopathy 300 Traditional Medicine 4,700 Chinese 300 Allopathic system 100
Plant Drug formulations
Codified tradition 25,000
Traditional practitioners 6,000
Herbal Industries 800
Herbal Gardens (No of Species) Aushadhiya Upvan, Ranchi (219) Aushadhiya Udyan, Jabalpur (72) Azad Herbal Garden, Kanpur (59) Azad Herbal Garden, Kanpur (59) Botanical Garden, Nauni-Solan (42) Coastal Ecosystem Herbal Garden, Annamalainagar (31) Dhanvantari and Sanjivani Herbal Garden, Junagadh (125) Dhanvantari Udyan, Rahuri (215) Gopabandhu Ayu Mahavidyalaya, Herbal Garden, Puri (167) Herbal Garden of NIU - Kottigepalya, Bangalore (111) Herbal Garden, SKN College of Agriculture, Jobner (63) Herbal Garden, TBGRI, Karimancode, Kerala (113) Inst Himalayan Bioresources Technology (CSIR), Palampur (94) KFRI Medicinal Plants Garden, Peechi (209) Model Med Plants Garden, Pantnagar (73) RRI (Ayu) JN Ayu Med Plants Garden & Herberium, Kothrud (91)
Herbal Medicine Are
Finished labelled products that contain active ingredients such as aerial or underground of plant or other plant material or combinations thereof, whether in the crude state or as plant preparations
Are not The medicines that containing plant material combined with chemically defined active substances including chemically defined isolated chemical constituents of the plant
(WHO)
Traditional Medicine Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness (WHO)
Traditional Medicine: Benefits to Mankind
Cinchona tree (Cinchona officinalis) native people of the Andes and Amazon for treating Malaria Dart poison (of Strychnos guianensis and Chrondodendron tometosum) by Amazon Indians: anesthesia, muscle relaxant Leaf of Jaborandi tree (Pilocarpus jaborandi) Brazilian Folk Medicine for eye disease, rheumatism, inflammation, etc
Coca (Erythroxylum coca) native people of Andes for toothache, altitude sickness, now cocaine as local anesthetic Periwinkle (Catharanthus roseus) from Madagascar: for Leukaemia
African Plum-tree (Prunus africana): for Benign Prostatic Hypertrophy
Hoodia Cactus (Hoodia gordonii) San people of South Africa to stop unbearable hunger and summon limitless energy
Jeevani (Trichopus zeylanica) Kani tribes of Kerala use as an energy booster to perform strenuous jobs
Traditional Medicine in drug development Jeevani /Aeogyapacha (Trichopus zeylanicus) (Kani) Anti- fatigue, Immunity
Hoodia gordonii cactus South African Bushman (San) Appetite suppressing
Artemisia annua (China) Malaria
Sutherlandia microphylla (S Africa) as tonic to increase energy; for AIDS
Coix lacryma-jobi (China) Kanglaite (seeds) for lung, liver & breast cancer
Panax ginseng/ Panax quinquefolium, tonic/immunostimulant
St John’s Wort (Hypericum perforatum) in mild depression
CSIR coordinated programme on new herbal and bioactive molecules
Natural Resources Modern Science Traditional Knowledge
to create a Virtual Organisation through Networking
CSIR University Experts User Industry
Drug Discovery and Development Process
Target Lead Lead Preclinical Clinical Identification Identification Optimisation Studies Trials
(Phase I, II, III,IV)
Drug Clinical Trials Ph III Traditional
To Pharmacology Safety Phytochemistry Knowledge
Market Relevant Science studies
Drug Discovery Platform Traditional and Modern Knowledge
Plants /Microbial Diversity
In-vivo screening
New Drug
Reverse Pharmacology In Ayurvedic medicine research: clinical experiences, observations and available data becomes a starting point In conventional drug research: comes at the end In Ayurveda-based drug discovery: uses Reverse Pharmacology ‘Drug candidates are first identified based on large scale use in the population, then validated in clinical trials’
Highly productive and cost-effective
Correlates traditional drug action
Reverse Pharmacology Three stages/phases
Clinical Observation: bio-dynamic effects of standardized TM (Ayurvedic drugs)
Exploratory: dose activity in in-vivo /in-vitro models to evaluate key targets
Leads are evaluated critically for resource allocation & state-of-the art experimental studies; tolerability, drug- interactions, dose-range, target-activity
Experimental: study of plants/molecule at different levels of biological organisation; Safety, Efficacy and Preventive/Therapeutic dimensions of new/natural drug
Golden Triangle (Chitrakoot declaration, 2003)
Traditional Medicine (ISM)
Modern Science Modern Medicine (Technological advances) (Evidence based clinical practice)
*Asmon developed by IICB, Kolkata for treating bronchial asthma
WHO Guidelines: for the regulation of herbal medicines in the South-East Asia Region
Cover following issues: Classification of herbal medicines
Minimum requirements for assessment of safety
Minimum requirements for assessment of efficacy
Quality assurance
Safety Monitoring of Herbal Medicine in Pharmacovigilance Systems
Good Agricultural and Collection Practices (GACP) for Medicinal Plants
National Policy on Regulation of Herbal Medicine
Methodologies on Research and Evaluation
Convention on Biological Diversity (CBD)
Signed in 1992
States have sovereign rights over their own biological resources
States are responsible for conserving their biological diversity and for using their biological resources in a sustainable manner
Prior Informed Consent: Sharing of Information
With Restriction: non-monetary benefits
On Commercial basis: Benefit Sharing
On No-cost basis for personal application or household use only: Artisans, farmers, etc. without any obligations to share benefits
With further research or value addition in it: by pursuing further research
Any other
Classified & codified Non-classified & non-codified
Wound healing properties Neem (EPO 436257) 14.09.1994; 10.05.2000
Fungicidal activity Ayahuasca (Banisteriopsis cappi) (US 5751) 07.11.84; 03.11.99 Basmati (US 5663484) 02.09.1997; 20.08.2001
Traditional Knowledge Digital Library (TKDL) Objectives and Target Audience
Prevent Misappropriation of Indian Traditional Knowledge
Break Format & Language barriers
Multilingual (French, German, Japanese, English & Spanish)
Conditions for Grant of Patents Novelty /Prior Art Non Obviousness Utility
Conclusion Medicinal Plants