SP-01
POSITIVE LIST OF MEDICINAL PLANTS FROM INDIA TO
EUROPEAN UNION
Palpu Pushpangadan
Amity Institute for Herbal and Biotech Products Development, Peroorkada, Trivandrum
The safety and efficacy of herbal medicine is closely related with the quality of the source materials used in production. The quality of source material is, in turn determined by intrinsic factors (genetic) and extrinsic factors (environmental conditions, cultivation and harvesting time, field conditions and post harvest/collection and transport and storage). Therefore it is very difficult to perform quality control on raw materials of herbal medicine. In a global survey by WHO (WHO, 2005) on Regulation of herbal medicines particularly on the regulatory status of herbal medicines, regulatory requirements, number registered herbal medicine products and quality control requirements, such as GMP, monograph etc. gave the following results. Before 1988, there were only 14 Member State with regulations relating herbal medicines, but a figure increased to 53 member states (37%) having laws and regulations in 2003, of those member states without current laws on regulations, 42 (49%) declared that these regulations were in the the process of being developed. Such results show that Member States are increasingly involved in developing the regulation of herbal medicines. The question about the regulatory status of herbal medicines also show interestingly, that in most Member States (97 out of 142 respondents) herbal medicine are sold as over – the- counter medicines, in contrast to 50 Member States where herbal medicines are sold as prescription medicines. Medical claims, health claims and nutrient contents claims are the most common types of claims with which herbal medicines may legally be sold (90 Member States allow medicinal claims, 62 allow health claims and 49 allow nutrients content claims) The collected information about herbal medicines also shows that 86 member status (61%) have a registration system for herbal medicine and 17 have 1000 or more registered herbal medicines. The general lack of knowledge on the traditional drug authorities and the lack of appropriate evaluation methods are factors that delay the creations of updating the national policies, laws and regulations for Traditional Medicine. In order to meet there challenges, the WHO TM Strategy 2002 – 2003 developed with four primary objectives: farming policy, enhancing safety, efficacy and quality access, and inpromoting national use. Resolution of Traditional Medicine was adopted at the fifty sixth World Health Assembly held in 2003. The resolution requested WHO to support the Member State by providing to internationally acceptable guidelines and technical standards and also evidence based informations to assist member status in formulating policy and regulations for the safety, efficacy and quality, safety and efficacy mentioned were at best only subjective in the absence of objective means to evaluation available to modern day science (Choudhary 2003) The European Union has introduced a new legislation called the "Traditional Herbal Medicinal Product Directive" for fast track registration of traditional medicinal Products of plant origin. This directive seeks from Traditional medicine makers to show evidence of safe usage the Eu member nations, for market authorization of a product.The European Union has an agreement that all the countries would have their herbal industries and product under the identical medicine control by the end of 1992. The only major country to achieve tight control was UK and as a result most herbal products were thrown out of use market. The commission is preparing both positive (Approved monographs) and a negative (unapproved monographs). The commission received safety data according to doctrine of absolute proof of safety. The commissions attempted to ensure that there medicine were reasonably safe when used when according to the dosage, contradiction and other warring and provisions specified in the monographs. The commission takes the position that as long as the scientific data provided reasonable verification of particular historic use, the commission would grant the positive evaluation. Most positively evaluated monographs are based on the open clinical studies or data derived from filed studies, patent, patient case records and pharmacological research or proprietary data submitted by individual companies. The commission is also made many negative evaluations of herbal drugs and herbal plants which is known as a negative or unapproved list/drugs. The Traditional Herbal Medicine Product Directive (THMPD) is amendment made to the EU Directive regulating regarding medicinal products. The directive 2001/83/EC of the European parliament and of the council is aimed to include a new provision for traditional herbal medicine products. The directive which came in to force in Member States in October 2005, provides a transition period up to 2011 before it is fully implemented. Products regulated by the directive benefits from a fast track drugs regime where the need to supply costly safety studies can be avoided if it can be demonstrated that the products in question has been used safely over a period of 30 years, of which 15 must be in an Eu member status. It is in this context the classical Indian System of Medicine uses over 2000 plant species, there are about 260 species of global interest and 52 of them can be prioritized on the base of their proven safety and efficacy. Combining the strengths of knowledge base of the Traditional Systems such as Ayurveda with dramatic power of combinational sciences can help for the scientific evidence of plants using Ayurveda. The Golden Triangle approach proposed in the Chitrakoot declaration (Figure 1) of National Botanical Garden and Research Institute's convention 2003 have amply demonstrate the efficacy of Ayurvedic medicinal plants. It adopts a reverse pharmacological approach. Reverse pharmacology will prove "Scientific Evidence" and it operates in three phases as described below. 1) Experimental – a robest documentation of clinical observations of the biodynamic effects of standardized Ayurvedic drugs by meticulous record-keeping; 2) Exploratory - studies for toleranility drug-interaction, dose-range finding in ambulant patients fo defined subsets of the disease and Para clinical studies in simple in vitro and in vivo models to evaluate the targetactivity and 3) Experimental - studies, basic and clinical at several level of biological organizations, to identify and validate the reverse pharmacological correlates of Ayurvedic drugs safety and efficacy. Such a creative research endeavor requires excellent team-work of multisystem and multidisciplinary experts. Reverse Pharmacology, for drug development, has been highly productive and cost-effective too in the recent past". Indian contribution by Reverse Pharmacology to therapeutic revolution will have to eventually integrate sate –of- art high through- put screening, combinatorial chemistry and effects of the old or novel compounds/plants on human gene expression and proteomic.( Vaidya 2006)
Table 1: Some Ayurvedic plants with noted/proven therapeutic activity.
S.No. Plant name Therapeutic activity
1. Acorus calamus L. Tranquillizer
2. Aegle marmelos (L.) Corr. Anti-diarrhoea
3. Ale vera (L.) Burn. F. Atherpsclerotic synderome
4. Andrographis paniculata Hepatoprotective and
(Burm.f.) Wall. Immunomodulator
5. Asparagus racemosus Willd. Galactogogue, uterine sedation and
Immunomodulator
6. Azadirachta indica. Anti fungal and immunomodulator
7. Bosewellia serrata L. Antiarthritic and antiinflamatory
8. Bacopa monnieri (L.) Penn Improve memory
9. Berberis asiatica DC. Antidiarrhoeal
10 Boerhavia diffusa L. Diuretic, anti-inflammatory
11 Cannabis sativa L. Psychactive
12. Cassia fistula Cathartic
13. Cassia angustifolia Cardiotonic
14. Celastrus paniculatus Willd. Immunomodulator, memory enhancer
15. Centella asiatica (L.) Urbal Memory enhancing, would healing
16. Coccinium fenestratum Hepatoprotective
17. Chlrophytum arundinaceum Baker Immunoenhancing
18. Chrorophytum borivalianum Immunoenhancing
Sabt. and Fern
19. Commiphora mukul Hypolipidemic
20 Commiphora wightii (Arn.) Hypolipidemic Bhandri
21. Convolvulus microphyllus Neural regeneration and synaptic
22. Coptis teeta Wall. Febrifuge, antidiarrhoeal
23. Crocus sativus L. Cardiotonic
24. Curcuma longa L. Syn. Anti- ingflammatory, anti-oxidant
C. domesticate Val. And anti-bacterial
25. Eclipta alba (L.) Hassk. Hepatoprotective
26. Embelia ribes Burn. F. Antifungal and anttheletic
27. Evolvulus alsinoides L. Immunododulators
28. Garcinia cambogiodes (Graham) Hyperlipidemic
29. Garcinia gummi-guta (L.) Antiobese
30 Garcinia indica (Thouars) Choisy Hypolipidemic
31. Gloriosa superba Antiobese
32 Gymnema sylvestre (Retz.)R. Br. Hypoglycemic
33. Momordica charantia L. Hypoglycemic
34 Nardostachys jatamansi DC. Neurotonic
35. Ocimum sanctum L. Anti-stress, adaptogenic
36. Phyllathus amarus Schum. Hepatoprotective
37. Phyllathus emblica L. Syn. Antioxidant
38. Picrrorrhiza kurrooa Royle ANtithepatotoxic
39. Piper lngum L. Immunomodulator
40. Piper nigrum L. Bioavailability enhancer
41 Rauwolfia serpentine Benth Anti-hypertensive
42 Rubia cordifolia Antistress carminativ
43 Saraca asoca (Roxb.) De Wilde
44. Sida spp. (S. cordata(Burm. F. Tranquilizer
45. Silibum marianum Gaertn. Hepatoprotective
46. Solanum melongena L. Antitussive
47. Swertia chirayita (Roxb. Ex Adatogenic, Febrifuge
48. Terminalia achebula Retz. Antiaging
49. Tinospora cordifolia (Willd.) Immunoenhancing, adaptogenic
50. Tribulus terrestris L. Diuretic, antihypertensive
51. Wedelia calendulacea Less Hepatoprotective
52 Withania somnifera L. Anticancer, Immunimodulator
Reference:
- Choudhary, Jayesh 2003. Standardization on Traditional Medicine Nature Biology 22(3) 263-265
- Vaidya A 2004 Reverse Pharmacological Correlates of 'Ayurvedic Drug actions Indian Journal of Pharmacology
- WHO 2003 http:#WWW.who.int/mediacentre/factsheets/fs134/en
- WHO, 2005 National Policy on Traditional Medicine and Regulation of Herbal Medicines, Report of a Global Survey, Word Health Organization, Geneva
SP-02
THE GLOBAL GENOMA AYURVEDA INITIATIVE: TRANSLATING THE WISDOM OF AYURVEDA and UNANI INTO THE MOLECULAR LANGUAGE OF GENOMICS and SYSTEMS BIOLOGY.
Krishna K Banaudha, Georges St. Laurent and Ajit Kumar
The George Washington University,School of medicine, Washington DC, USA
Six thousand years ago, the Reshi Bharadwaj of traditional Hindu culture set the stage for the modern Science of Genomics and Molecular Biology when they declared that "all the features of our universe are found inside every living cell." These concepts from traditional Indian culture represent a central truth, now urgently needed in our modern day society. As a result of the human genome, deciphered in 2001, a unique opportunity exists to establish a broad scientific acceptance of Ayurveda and Unani by Western Science, and widespread use in western medicine. Genomic tools now provide a new level of clarity and resolution for understanding the molecular networks of human physiology, as described by the Vedas, and how these molecular networks evolve during Ayurveda and Unani treatments. The St. Laurent Institute announces Genoma Ayurveda, a global initiative in partnership with Ayurveda and Unani experts throughout India, to decipher the molecular universe of Ayurveda and Unani in human physiology. The Genoma Ayurveda initiative uses genomics, proteomics, micro-fluidics, nanotechnology, and Bioinformatics to scientifically validate the healing capabilities of Ayurveda and Unani. Data generated by these high-throughput techniques are processed by Systems Biology tools, which use massive amounts of computing power to create a truly holistic view of the human cell at the molecular level. By profiling the multidimensional molecular landscape of human physiology in response to Ayurveda and Unani, the Genoma Ayurveda initiative aims to translate the wisdom of Ayurveda into a detailed high resolution molecular language.
SP-03
BIOACTIVITIES OF ALPINIA CALCARATA
Lakshmi S.R.Arambewela1, L.D.A.Menuka Arawwawala2 and W.D. Ratnasooriya3
1PGI Exports and Member, Sri Lanka Ayurvedic Drugs Corporation, Sarasavi Lane,
Castle Street, Colombo ,Sri Lanka , E mail larambewela@yahoo.co.uk
2 Industrial Technology Institute, Colombo, Sri Lanka
3Dept. of Zoology, University of Colombo, Colombo, Sri Lanka
Alpinia calcarata belongs to family Zingiberaceae and is distributed in tropical countries such as Sri Lanka, India, Malaysia, China, Indonesia and Japan. This plant is used in traditional systems of medicine and a survey on "Traditional treatment in Sri Lanka for chronic arthritis" has indicated that A. calcarata in an important ingredient in decoctions prescribed for arthritis patients. Therefore studies on this plant were initiated.
The GC-MS studies on the essential oils of A. calcarata grown in Sri Lanka resulted in the identification of 18 compounds and the major compound was 1, 8 cineol. This composition is different to those reported for A calcarata grown in other countries To investigate the antinociceptive activity different doses (100,250, 500,750,1000mg/kg) of ethanol and the water extracts were orally administered to rats and the reaction times were determined using hot plate, tail flick and formalin tests. The antinociceptive activities of both extracts were comparable to that of pethidine. The anti-inflammatory activity of A. calcarata was determined by carrageanan induced rat paw edema model using four doses (250, 500, 750, 1000 mg/kg) Significant and dose dependent anti inflammatory activity of hot water (HWE) and hot ethanol extracts (HEE) of A.calcarata rhizomes was observed. The maximum effect was evident with 500 mg/kg dose of both extracts. The anti inflammatory effect of HEE was higher than that of HWE and was comparable to indomethacin (5 mg/kg) Three doses (500,750, 1000 mg/kg ) of HWE and HEE were evaluated for gastroprotective activity against ethanol induced gastric ulcers in rats. Oral administration of extracts provided a significant protection of gastric damage and was superior to that of cimetidine. The hot water extract significantly inhibited gastric volume and acidity while the gastric mucosal secretion remained unaltered. The A. calcarata extracts were well tolerated. No overt signs of toxicity, hepatotoxicity or renotoxicity were observed. These results demonstrate the therapeutic potential of A. calcarata extracts to be used as a safe herbal anti inflammatory agent subject to clinical trials.
SP-04
DIVERSITY AND UTILIZATION OF GENUS CARALLUMA (ASCLEPIADACEAE) IN INDIA
T. Pullaiah, S. Karuppusamy and A. Ugraiah.
Department of Botany, Sri Krishnadevaraya University, Anantapur. A.P. India.
E.mail: Pullaiah @ Yahoo.co. in
Caralluma, a genus of about 100 species is distributed in the driest parts of India, Arabia, Pakistan, Africa and Myanmar. Plants of this genus are succulent herbs. Greater number of species is reported from South Africa. Out of 14 species reported from India, 11 species are concentrated over in Peninsular India. 5 species and 5 varieties are strictly endemic to India. Gravely and Mayuranathan (1931) have brought out a monograph on genus Caralluma in India, but after their work three more new species were described from India. Plowes (1995) reclassified the genus Caralluma and according to him Indian Caralluma includes three sub-genera. Even with all this there exists greater difficulty in identification and nomenclature on this genus worldwide. Many of Indian Caralluma species are exhibiting more intermediate forms in their habitat due to their interhybridizable potency. Gravely and Mayuranathan (1931) have described 5 varieties under Caralluma adscendens. One of these varieties has been elevated to the species level Caralluma geniculata recently by molecular systematics. A number of Caralluma species are being used by local inhabitants for their primary health care. Plants of this genus are used as food and appetite suppresser among the poor people. The present study highlights the morphological diversity of Caralluma in India and utilization of different species by local inhabitants.
SP-05
CONSERVATION ASSESSMENTS OF THREATENED MEDICINAL PLANTS IN NEPAL
Krishna K. Shrestha
Central Department of Botany, Tribhuvn University,
Kirtipur, Kathmandu, Nepal
Nepal comprises nearly 1,800 species of medicinal plants, of which about 400 species are common ingredients in Ayurvedic, Amchi and traditional folk medicine, and more than 100 species of medicinal plants are of trade value. The Conservation Assessments and Management Plan (CAMP) held in Pokhara, Nepal in 2001 listed 51 species of threatened medicinal plants. Three species were designated as Critically Endangered (CR), 14 species as Endangered (EN), 23 species as Vulnerable (VU), three species nearly threatened, and remaining eight species are data deficient (DD) or Least concern (LC). The Government of Nepal endorsed Herbs and NTFP Coordination Committee (HNCC) in 2002, and prioritized 30 species of medicinal plants for conservation, and recommended 12 species of medicinal plants for cultivation. A short list of 30 priority species of traded medicinal plants was prepared by Ethnobotanical Society of Nepal (ESON) in 2006, through extensive consultation of the literature, field visits of selected areas, and also through interviews with individual experts. Several indicators were used such as: levels of commercial or local demand, rarity, growth rate, potential for regeneration, success of propagation, and Nepal Governments' priority for conservation, included in different conservation categories (IUCN, CITES, Nepal government, CAMP workshop, etc). ESON, with support from Plantlife International, in 2007 conducted a research project 'Community-based Conservation and Sustainable Utilization of Potential Medicinal Plants in Rasuwa district'. In collaboration with local community-based organizations, ESON initiated the management of medicinal plant resources by involving Tamang ethnic communities in inventory, monitoring, sustainable harvesting, processing, marketing, and in situ conservation of potential medicinal plants. Emphasis is also given in the identification and conservation of threatened habitats in the buffer zone. Attempt will be made to continue similar type of work within the national park, in coordination with the concerned authorities and local communities.
SP-06
EFFECTS OF TDZ ON THE CALLUS INDUCTION and ESTABLISHMENT OF PLANT REGENERATION FROM CALLUS OF PLUMBAGO INDICA
T.Shimada, W.D.T.Maduwanthi and K.Hirimburegama
Department of Plant Sciences, University of Colombo, Colombo, Sri Lanka
Plumbago indica is a perennial herbaceous plant with long succulent roots. It is an exotic plant and is probably native to Southeast Asia. In Sri Lanka, it is found in anthropogenic localities and only under cultivations. The roots of P. indica are commonly used in indigenous medicine of Ayurveda. It contains an orange yellow pigment named Plumbagin (2-methyl-5-hydroxy -1,4-naphthoquinone) which has several pharmacological activities. Although P. indica can be easily grown under local conditions, the domestic production is at a minimum level due to lack of organized cultivation. It is propagated only vegetatively by stem cuttings. It was revealed that more than 90% of the industrial requirement is imported from India. In vitro propagation has been achieved by some researchers by using the meristem culture technique, but its efficiency needs to be improved. The main object of the study is to develop a technology for mass production of P. indica plants through callus culture of leaf explants. Somaclonal variation of regenerated plants from calluses is investigated and the plants with high contents of Prunbagin are selected for subsequent propagation . The vigorous calluses with shoots was obtained from leaf explants of P. indica on the medium containing TDZ 1.0 mg/L and IAA 1.0 mg/L. The shoots were propagated on the medium containing BA 0.5 mg/L and IAA 0.5mg/L. The shoots developed roots by transplanting onto the medium containing Adenine Sulfate 15.0 mg/L and IBA 1.0 mg/L. Many regenerated plants were acclimatized and grown in the green house.
SP-07
CONSERVATION AND CULTIVATION OF ENDANGERED MEDICINAL PLANTS BY DABUR NEPAL
Sarvepalli Badari Narayan
Medicinal Plant Project, Dabur Nepal Ltd, Kathamndu, Nepal
The Himalayas are home to world's unique biodiversity wealth and considered as one of the important "Hotspot". Nepal is rich in biodiversity of medicinal and aromatic plants (MAPS)which are classified under RET sp. Global concern over the loss of biological diversity due to the unsustainable harvesting methods accelerated the need for conservation of the same. More than 1740 plant species have been recorded as MAPS species in this region and majority of them are on continuous decline in their number and abundance. Due to the rapid loss of these important herbs, Dabur Nepal was proactive in its approach, to visualize and establish a state of the art facility -'Medicinal Plant Project' at Banepa near Kathmandu, Nepal, in the year 1998. To develop a sustainable source of MAPS and protect the delicate natural resources of the Himalayas. Dabur is renowned for Ayurvedic medicines and herbal health care preparations from over a century. Our Medicinal Plant Project conserved and cultivated more than 25 important MAPS sp like Chiriata, Kuth, Kutki Taxus etc. in different agro-climatic zones ranging from Terai plains to high hills of the Himalayas, spreading across 18 districts and 46 cooperatives as a major source of livelihood marginal farmers.
SP-08
LEADS FROM PLANTS LEAD TO CONSERVATION
Arvind Saklani
Natural Products-Botany,Nicholas Piramal Research Centre,
1-Nirlon Complex, Goregaon (E),Mumbai- 400063
email: asaklani@nicholaspiramal.co.in
The mankind cannot survive without plants. Apart from basic needs plants have been source of medicines since ancient ages to the modern world. The finding of cinchona in 17th century, followed by digitalis, morphine, and so on, and then introduction of synthetic aspirin, a derivative of a plant-based drug, compelled human beings to believe in the wonders of the diverse floristic wealth and vow their heads in front of the plants- the best combinatorial chemist. A large number of plants used in the traditional medicine have now become a part of the modern world health care system and the introduction of herbals in the form of nutraceuticals and dietary supplements are also changing the plant-based drug market, which is estimated to be more than $26 billion by 2011 at an average annual growth rate (AAGR) of 6.6% between 2006 and 2011. Interestingly, a total of 26 plant-based drugs were approved/ launched during 2000–2006 and a total of 91 plant-derived compounds are under clinical trials. The resurgence of plant-based drugs, mainly for the treatment of cancer, immunological and CNS related diseases, is certainly exciting. Over 60 compounds are in the pipeline, as anticancer drugs alone, from plant sources.
These all discoveries have made the source plants immortal. In this process, several issues also cropped up revolving around the plant-prospecting, which are related to IPR, benefit sharing, biopyracy etc. This resulted into educating the discoverers to support the source country or the indigenous society sharing the traditional medical knowledge, financially or helping in the developmental activities and also in conservation of indigenous plant resources. We must appreciate that the drug discovery programs helped quite a few potential wild plants hitherto unknown to the science and to the society, which not only found a place in the farms to uplift economy of the farmers, but also assured their own survival. The Coleus forskohlii is one such common example in India. We are very rich in biodiversity and associated TEK. It is important to know the potential of each and every floristic component that we have. This would not only help in identifying leads but would also give us a strong support to set priorities and ways for conservation of the species.
1 comment:
really nice....
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