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DRUG DISCOVERY AND DEVELOPMENT: TRADITIONAL MEDICINE AND ETHNOPHARMACOLOGY

Bhushan Patwardhan
  • Country of Origin:

  • Imprint:

    NIPA

  • eISBN:

    9789389992076

  • Binding:

    EBook

  • Number Of Pages:

    356

  • Language:

    English

Individual Price: 1,850.00 INR 1,665.00 INR + Tax

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While biotechnological advances, genomics and high throughput screenings or combinatorial and asymmetric syntheses are opening new opportunities in drug discovery, the industry is facing serious innovation deficit.  The total number of new molecules registered per year has dropped in contrast to expected increase.  Post marketing failures of blockbuster drugs have become major concerns of industries.  On the other side, globally there is a major shift to sue of traditional medicine involving complementary and alternative therapies.  Ethnopharmacology and traditional medicines have contributed in past significantly in the process of natural product drug discovery.  There are two clear tracks where ethnopharmacology has potential to contribute in future drug research.  First, as a discovery engine to provide new targets, leads, and second, use of quality assured and standardized traditional medicines.  In this scenario, it is important to understand the mechanisms of drug discovery and pharmaceutical development with a focus on herbal drugs and neutraceutical.  This book provides historical perspective, future prospects and significance of ethnopharmacology in drug research.  It also provides important steps in botanical drug discovery and development including bioprospecting, quality control, standardization, pharmaceutics, stability, pharmacokinetics, and bioavailability with examples from ethnopharmacology and herbal medicine.  One of the important feature of this book is to give an excellent insight to Good Laboratory and Good Clinical Practices along with very useful summary steps involved in filing IND or NDA of botanical products.  The book also gives Regulators’ perspective of validating claims and how ethnopharmacological or traditional medicines need different approach.

0 Start Pages

ACKNOWLEDGEMENT This book is an outcome of group work of over 15 years and I thank each one of my students, associates and mentors who helped and guided me during this exciting journey of natural product: drug discovery and development. Many of my research associates and students have contributed by providing help in literature search and making useful notes. I specially mention Kalpana Joshi, Preeti Chavan (biotechnology, microarray), Yogita Ghodake (pharmacogenomics), Dyaneshwar Warude (quality, safety, and standardization), Girish Tillu (AyuSoft), Manish Gautam (pharmaceutics), Ashok Vaidya, Rama Vaidya and Amrutesh Puranik (history, reverse pharmacology, pharmacoepidemiology), Sanjay Mishra and Dada Patil (stability, preclinical). I wish to thank all the scientists and authors whose work has been cited in this book and also to various national and international bodies whose documents have been referred and cited including. I would like to especially mention the valuable resources from WHO, US FDA, ICH, ICMR, and CSIR. Much of the book is based on reviews published by our group in various Journals especially Current Science, Journal of Ethnopharmacology, Evidence-based Complementary and Alternative Medicine, Journal of Scientific and Industrial Research, Indian Journal of Natural Products and few of the studies I did for the WHO Commission on Intellectual Property Innovation and Public Health (CIPIH) and International Union of Pure and Applied Chemists (IUPAC). I wish to thank many who inspired and remained strong supporters specially Dr. R.A. Mashelkar, Dr. Ashok Vaidya, Dr. G.N. Qazi, Dr. P. Pushpangadan, Dr. Arvind Chopra, Dr. Narendra Bhatt, Dr. Darshan Shankar, Dr. Mukund Chorghade, Dr. Avinash Patwardhan and Dr Alex Hankey. A special appreciation and thanks to Ms Sarah Kimball, Rotary International Ambassadorial Scholar 2006-07 and a casual student of MPH course at the School of Health Sciences for valuable help in writing two chapters (Chapter 1 and 17) and also for thorough editing of the entire document. I thank the authorities of the University of Pune for granting me a sabbatical leave that facilitated this book. A special thanks to the Manipal Group of Institutions for offering gracious Fellowship and hosting me at Manipal and Bangalore whenever required during the writing of this book. Finally, I wish to thank the entire management of New India Publishing Agency, New Delhi for suggesting, pursuing and also for accepting to publish this monumental work.

 
1 Overview of Medical and Drug Development

To fully explore the history of medical and drug development, it would be necessary to go back as early as 13,000 BCE, where drawings on the Lascaux caves in France suggest that humans were using plants for medicinal purposes. Since then, medical traditions have evolved and dissolved across societies all over the globe. Natural products including plants, animals and minerals have been the basis of treatment of human diseases. The last two centuries have seen a focus on scientific medicine, with a focus on drugs whose effects that have been proved by the scientific method. Yet given this setting, many of the major pharmaceutical corporations have renewed their strategies in favor of natural product drug discovery. Numerous drugs have entered the international pharmacopoeia via the study of ethnopharmacology and traditional medicine. At this point in history, it is possible for both traditional and western medicine to benefit from collaboration between the two disciplines. For traditional medicines, newer guidelines of standardization, manufacture and quality control and scientifically rigorous research on the scientific basis for traditional treatments will be required. In return, traditional medical traditions can offer a more holistic approach to drug design and myriad possible targets for scientific analysis. Powerful new technologies such as automated separation techniques, high-throughput screening and combinatorial chemistry are revolutionizing drug discovery. Traditional knowledge can serve as powerful search engine, which will greatly facilitate intentional, focused and safe natural product drug discovery and help to rediscover the drug discovery process. By looking at the historical trends in drug and medical developments, it is possible to understand how current drug development will benefit from this partnership.

1 - 12 (12 Pages)
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2 TM / CAM and Ethnopharmacology

Historically, the terms alternative, complementary or traditional medicine (TM) all referred to a genre of health care practices or services that got bound together as a class through the logic of reductio-ad-absurdum, or because of their “absence from the mainframe of” what has come to be known as Modern Medicine (MM). However, since Stephen Fulder1 , the identities of TM have become more distinct, MM-TM blending more active and, the line separating the two more fuzzy. To date, the World Health Organization offers the most comprehensive definition of TM2 . WHO defines traditional medicine as including diverse health practices, approaches, knowledge and beliefs incorporating plant, animal, and/or mineral based medicines, spiritual therapies, manual techniques and exercises applied singularly or in combination to maintain well-being, as well as to treat, diagnose or prevent illness. The phraseology MM/TM is syntactically incorrect because it is contended that medicine as such, modern or otherwise, evolves and progresses through traditions. The major difference between the various traditions of health care practices is that MM rode the crest of the high wave of reductionist-scientistic rigor of modernity3 to reach the shore of global acceptability while the others never crossed the threshold of geographical and cultural locality, remaining untested, neither proved nor disproved. Darwinian principle of survival of the fittest also endorses a truism that survival is a proof of fitness. Given this principle, it makes sense that TM as we know of it today may be useful for promoting human health. Moreover, most TM considers human beings and their health in the context of their environment. This criteria, not only defines TM apart from MM but also provides for a reason as to why lately TM is emerging out of long hibernation. Developmentally, MM isolated “human” from its global environmental context as a static, stand-alone, complete, total and delimited system in itself. While this reductionist approach has a very high pay off for the first 90% of human health problems, it fails when dynamic non-linear complex systems elements kick in (I’m not exactly sure that you mean by this phrase). TM covers some parts of those hidden variables and thats the utility to modern mankind.

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3 Natural Product and Drug Discovery

The R&D thrust in the pharmaceutical sector is focused on development of new drugs, innovative/indigenous processes for known drugs and development of plant based drugs through investigation of leads from the traditional systems of medicine. In addition, many nutraceuticals are being consumed from unregulated markets for their perceived benefits in health care and improvement of quality of life. Natural pharmaceuticals, nutraceuticals and cosmeceuticals are of great importance as a reservoir of chemical diversity aimed at new drug discovery and can be explored as potential antimicrobial, cardiovascular, immunosuppressive, and anticancer drugs. Around 80% of all such products are of plant origin; their sales exceeded $ 65 billion in 2003. Examples of plant products and derivatives used by the pharmaceutical industry include Paclitaxel, Vincristine, Vinblastine, Artemisinin, Camptothecin, Podophyllotoxin and such. The nutraceutical marketplace in Europe is estimated to be $ 9 billion, while the US marketplace, estimated to be $10-12 billion in 2003, is expanding at a compounded rate of more than 20% per year. US Congress has fueled the rapid growth of nutraceuticals with the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. Globally, there have been efforts to monitor quality and regulate the growing business of herbal drugs and traditional medicine.

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4 Innovation and Drug Discovery

Contrary to “Law of Finite Biology” though the number of genetic codes will exhaust soon in an exponential way (presumably leading to solutions to every known genetic anomaly related health problem), the number of NCE (New Chemical Entity), their number being finite99 too, will run out of fuel soon too, despite unraveling of genomic decoding. The bleak scenario in the pharmaceutical field is a testimony to the latter surmise. As many a wise scholar has pointed out, the era of single molecule drug seem to drawing curtains. However, unlike what seems common sense, the era of combinational drug therapies of MM paradigm probably will not foot the bill. Just as very high speed serial computing simulates parallel processing but does not make real time parallel processing, mixtures of prima facie complementary medicinal molecules will perhaps not make combinational recipes. The fundamentals of non-linear dynamical complex systems (NLDCS) paradigm demand so. The odds against success with such efforts are close to odds of success of creating life one bit at a time out of mixing C, H and O molecules in a jar would be. The number of genes might be finite, but data on their combinations (and their corresponding effects) and more so on their permutations (one has to only imagine the vastness of those possibilities) would, as of now or in near future, cause an information overload and comprehension failure100 (limitation of human biological brain apparatus) pitting researchers and industry against a futility barrier. However, TM provides a silver lining to these bleak analyses. Analytical comprehension of TM recipes, regimens or techniques might be unachievable by contemporary science, empirical testing of their efficacy and safety being doable and therefore taken care of, TM can provide an outlet to the drug discovery impasse because the same natural forces that shaped multi-gene interaction into complex and dynamical mode have created some of, if not all, TM solutions.

63 - 82 (20 Pages)
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5 Bioprospecting and IPR

Ethnopharmacology and Traditional medines use natural resources as medicines. They have developed the knowledge of this through the generations of traditions and experiences. Therefore the protection of this knowledge and protection of natural resources both remain critical. Bioprospecting involves sustainable, ethical and legal processes to access natural resources and use them judicially so that the business needs do not pose any threat to nature and to people. One important consideration is assuring the preservation of traditional knowledge, particularly oral knowledge, within communities, for the potential benefit of others. Developing mechanisms to document traditional knowledge, such as national inventories, can be beneficial in identifying cases where conservation or cultivation is needed, based on an understanding of existing natural resources used for medicinal purposes. Decisions about access and ownership of information can also be made (including those relating to intellectual property rights, where appropriate) once methods have been found to collect and preserve traditional knowledge. On the other hand, the livelihood of traditional healers may depend on maintaining the secrecy of their healing methods - one argument for consulting with traditional healers as part of the process of planning and executing the collection, storage and testing of traditional medicines. Extending some form of intellectual property protection to traditional knowledge, of which traditional medical knowledge is a significant part, is being actively debated in WIPO and other international forums. Existing intellectual property regimes can offer protection for purified compounds (produced by scientists and companies) isolated from a natural medicine. But traditional medicines, whose method of action may not be well understood, and which often consist of mixtures of different active substances, may not meet criteria for patentability. The principal impetus for international debate is a desire to compensate the holders of traditional knowledge appropriately for the use of their knowledge by others, or to prevent so-called “biopiracy” where knowledge or genetic materials are used without the consent of the holder. China and Kenya are examples of countries that have modified their laws in an effort to accommodate traditional medicine. It is not intended that the Commission should enter into this debate, except in so far as aspects of it may be relevant to its terms of reference, in particular stimulating innovation in traditional medicine with the purpose of expanding access to affordable medicines.

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6 Safety and Regulatory Issues

Safety is a primary concern regarding traditional and complementary therapies. There are two aspects of safety evaluations. First, to ensure that the right quality of material and apt possesses are used from sourcing to marketing; and second, there is no contamination, adulteration or spiking. Few studies have reported adulteration with steroids in some traditional Chinese dermatological preparations. In an analysis of Chinese herbal creams prescribed for dermatological conditions, Keane et al. found that eight of eleven creams analyzed contained steroids194. Spiking with corticostreoinds has been observed in some market preparations claimed to be useful in the treatment of arthritis and asthma195. Recently, Saper et al. from Harvard Medical School have reported heavy metal content of Ayurvedic herbal preparations and have recommended mandatory toxic heavy metal testing196. There have been few reports of heavy metal toxicity following traditional medicine use197,198. Such studies are important and needed, however they are more related to the quality control failures of the mass manufacturing activities. Often they are wrongly used to limit the use of TM. In reality, such a QC failure should not be considered as a general negative notion to create a bias against TM. We certainly need effective QC and regulation of herbal medicines, without limiting public access to these preparations and ensuring public interest and constituting restrictive trade practice.

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7 Quality Control and Standardization

Despite its existence and continued use over many centuries, and its popularity and extensive use during the last decade, traditional medicine has not been officially recognized in most countries. Consequently, education, training and research in this area have not been accorded due attention and support. The quantity and quality of the safety and efficacy data on traditional medicine are far from sufficient to meet the criteria needed to support its use worldwide. The reasons for the lack of research data are due to not only to health care policies, but also to a lack of adequate or accepted research methodology for evaluating traditional medicine235. The statement from General Guidelines for Methodologies on Research and Evaluation of Traditional Medicines (World Health Organization, 2000) highlights the need for consensuous in addressing the problems related to the quality of botanical drugs, which ultimately is a critical determinant of safety and efficacy of medicine. Further, the distribution and widespread sale of adulterated, misbranded, spurious botanical drug products and marked increase in misleading health claims of these products demands proper regulations on botanical medicine to protect public health236. Considering these two issues development of parameters for quality control standardization and regulatory norms for controlling the growing business of botanicals is a big task. Various regulatory authorities, research organizations and botanical drug manufacturers are constantly contributing to developing guiding principles addressing issues related to quality, safety and efficacy237. In this chapter we have highlighted problems associated with quality control of the botanicals and tried to guide a way towards a globally acceptable quality standard.

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8 Herbal Pharmaceutics Stability and Pharmacokinetics

Typically herbal pharmaceutics may include any medicinal or functional food preparations such as phytopharmaceuticals, single or poly herbal formulations, and nutraceuticals made out of botanical materials. This includes two broad categories. First, there are many evidence based formulations and mixures that may or may not be based on traditional knowledge or practices. The second group includes all the traditional or ethnopharmacological preparations. Bringing herbal medications from either group to the market will require a pharmaceutics approach balanced with an understanding of the original context in which the treatment was used. As an example, Ayurvedic medicines have been used safely for many years on a wide variety of patients. Medications that have not been altered from their original form have de facto gone through a type of safety testing. When a traditional medicine is prepared differently, then it is essential to validate the drug safety to be sure that the effects of the new procedure don’t cause harmful effects. In this same way, the value of animal testing to establish safety and toxicity is not as critical if the botanicals are used in traditional forms. Suitable animal models help in understanding the mechanism of action or pharmacodynamics of medicines. However, it is well known that no good animal models exist for many human diseases, such as asthma, diabetes, and rheumatism. The use of modern technology in making traditional preparations more contemporary and scientific is important but it should not compromise the original basis and principles described in tracditional medicine. The following examples highlight some of the concerns of this approach.

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9 Preclinical and Clinical Evaluation

The development of a new drug begins typically in the chemistry laboratory and is followed by a wide range of biological studies in vitro (cells/tissues) and in vivo (animals), which forecast what the agent would do in humans. The focus of these studies moves from evaluating the safety of a drug for use in humans to looking at its clinical relevance. Pharmacodynamics involves a set of biological studies both in vitro and and in vivo to get a better understanding of the mechanism of action of a drug. Preclinical studies mainly include safety and toxicity to ensure its safety for use in humans. Typically, preclinical in vitro, in vivo, and Phase I testing may not be necessary if preliminary data on safety are available. However, preclinical data or clinical observations are still necessary to justify a rationale for use and safety in initial clinical studies. Three main screening approaches are generally used in drug development. Simple Screening evaluates substances that have a particular property by one or two tests. There is no need for a series of tests in which the interpretation of results of one test may depend on others. Blind Screening is used for a new plant extract where no adequate pharmacological information is available. Blind screening may give clues for potential activity and worthiness to probe further for pharmacological activities. Programmed screening involves a new plant extract or substance with known pharmacological effects and results in more precise information.

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10 Regulatory Guidance to Industry

This guidance explains when a botanical drug may be marketed under an over-the-counter (OTC) drug monograph and when FDA approval of a new drug application (NDA) is needed. In addition, this document provides guidance to sponsors on submitting investigational new drug applications (INDs) for botanical drug products, including those botanical products (or botanicals) currently lawfully marketed as foods and dietary supplements in the United States. This guidance also discusses several areas in which, because of the unique nature of botanicals, FDA finds it appropriate to apply regulatory policies that differ from those applied to synthetic, semisynthetic, or otherwise highly purified or chemically modified drugs (including antibiotics). In particular, the guidance states that applicants may submit reduced documentation of preclinical safety and of chemistry, manufacturing, and controls (CMC) to support an IND for initial clinical studies of botanicals that have been legally marketed in the United States as dietary supplements or cosmetics without any known safety concerns.

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11 Validating Health Claims and Pharmacoepidemiology

Review of Health Claims Regulators of different countries have different procedures and views to review health claims of traditional medicine, herbal medicines, botanicals, functional foods, nutraceuticals, health products, diatory supplements and such other natural forms of materials intended to use for health promotion. However, if such products carry any therapeutic or health benefit claims then the regulators may provide general guidance and demand for sufficient evidence base in support of such claims. For instance, U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (CFSAN) provides general guidance to review of health claims in functional foods and dietary supplements. Ethnopharmacological preparations involving herbal medicine and traditional medicines prepared from natural ingredients also will need similar process. The scientific review process for health claims of such products is comprehensive and mainly focuses on review of individual studies324

211 - 226 (16 Pages)
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12 Biotechnology in Herbal Drug Research

The main purpose of herbal drug technology is to convert botanical materials into medicines with a focus on standardization and quality control with proper integration of modern scientific techniques and traditional knowledge. The use of chromatographic techniques and marker compounds to standardize botanical preparations has limitations because of their variable sources and chemical complexity. DNA-based molecular markers have utility in fields like taxonomy, physiology, embryology, genetics etc. DNA based techniques have widely been used for authentication of plant species of medicinal importance. Pharmacognosy mainly addresses the quality related issues using routine botanical and organoleptic parameters of crude drugs, and chemoprofiling assisted characterization with chromatographic and spectroscopic techniques. The new pharmacognosy includes all the aspects of drug development and discovery where the biotechnology driven applications play an important role. Current focus on chemotype-driven fingerprinting and related techniques require integration with genotype-driven molecular techniques so that an optimal characterization of botanical materials is possible. This review provides a brief account of various DNA based technologies that are useful in genotyping and quick identification of botanicals with suitable examples.

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13 Microarrays and High Throughput Screening

In the area of pharmaceutical discovery, screening methods continue to play a major role in drug discovery. The screening process is simply testing molecular entities (compounds/natural products) for activity to advance those that exhibit the desired activity. This process has evolved over time in both the testing methods and in the degree of testing. Originally, the screening was done entirely by dosing animals and studying their responses. Then came test tube experiments and now, testing is conducted either with cell lines or with purified proteins in miniaturized test tubes called microplate wells. Screening by microplate has allowed the degree of testing to increase from a very small selected set of compounds to libraries, which contain thousands of test substances. Technological improvements in many areas of science and information technology have led to the evolution of screening methods from time consuming, animal dosing studies to high throughput screening (HTS) methods that have the potential to generate very large datasets of information in a very short time. Today, developments in bioinformatics have opened up the possibility of virtual (in silico) screens for targets where there is sufficient knowledge of the target or of its ligand. High throughput screening has become a pivotal part of drug discovery for identifying potential lead molecules for specific disease targets. The success of screening is measured by several factors including the throughput and costs of the assays, but ultimately by how many of the HTS hits progress forward through the drug discovery pipeline. Miniaturization of assays by conversion from 96- to 384- to 1536- wells to well-less platforms, such as microarrays and the utilization of automated equipments are methodologies implemented to increase the throughput and reduce the cost of the screen.

247 - 268 (22 Pages)
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14 Pharmacogenomics and Ethnopharmacology

Genetics forms the basis of human life. All individuals have a physical and physiological self, determined by the interactions of genes and environment. Pharmacogenetics is the connotation used to study how heritability affects an individual’s response to drugs.494 The term ‘Pharmacogenomics’ represents systematic identification of all human genes, their products, interindividual variation and intraindividual variation in expression and function over time. It focuses on candidate genes and may include transcriptome and proteome information that affect drug metabolism, pharmacokinetics, and pharmacodynamics. It helps in predicting the patient’s response to a drug and to design new drugs495. Pharmacogenetics is study of single genes and the effects on drug response while pharmacogenomics is related to overall variation in genome. A gene is considered polymorphic when a mutation appears in more than 1% population, which may be present in the form of single nucleotide polymorphism (SNP), simple sequence length polymorphism (SSLP) and nucleotide addition or deletion. After the Human Genome Project, study in this field is accelerated dramatically. It was found that out of 1.4 million SNPs identified in the human genome, over 60,000 are present in the coding region496. These SNPs lead to miscoding of the various proteins that plays crucial role in the biological processes. If a point mutation is present in the gene coding region for various drug-metabolizing enzymes, drug target and drug transporters, it can lead to many non-therapeutic and unpredictable drug responses. In United States, over two million people suffer from severe adverse drug reactions per year and about 100,000 cases are life threatening497.

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15 Ethnoinformatics and Ayu Soft

Very few traditional systems have a fair level of documentations in place. Most of the little traditions, the flow of knowledge is mainly through word of mouth, however, the great traditions such as Ayurveda and Traditional Chinese Medicine do have a good level of documentation. For instance, Ayurveda means science of life in Sanskrit and aims at holistic management of health and disease. It remains one of the most ancient medical systems widely practiced in Indian subcontinent and has a sound philosophical, experiential and experimental basis541. Charak Samhita and Sushrut Samhita (100-500 B.C.) are main Ayurvedic classics, which describe of over 700 botanicals along with their classification, pharmacological and therapeutic properties542,543. A classic diagnostic text Madhav Nidana includes over 5000 signs and symptoms. During the course of evolution and years actual practice, the interpretation of such documents developed different schools of thoughts and resulted in wide variations in understandings. Similar situation also exists in other systems including TCM. These differences often raise issues related to authenticity and correctness of Traditional Knowledge (TK). Thus systematic documentation, interpretations and harmonization of concepts and practices remain a major challenge in most of the systems of TM. Many governments, professional and community organizations have undertaken such documentation and harmonization exercises. Projects like Traditional Medicine Knowledge Digital Library, AyuSoft, Triskandha Kosha and Medicinal Plants Database of FRLHT are attempting systematic documentation of Ayurveda in India544. Other databases such as The NAPRALERT (NAtural PRoducts ALERT) developed by Professor Norman Farnsworth contain bibliographic and factual data on natural products, including information on the pharmacology, biological activity, taxonomic distribution, ethno-medicine and chemistry of plant, microbial, and animal (including marine) extracts. Another project relates to the Global IP, Benefit Sharing and Traditional Medicine Database. It is being developed as a component of the Global Information Hub on Integrated Medicine from the work of the Commonwealth Working Group (CWG) on Traditional and Complementary Health Systems, now directed by the Malaysian Ministry of Health. This Information Hub is planning to create a network of legal centers, scholars and NGOs working together to develop a comprehensive legislative and policy review, information resource and exchange on issues pertaining to IP rights over traditional medical knowledge and the use of medicinal plants545. Other than such efforts, there is limited systematic documentation of TM knowledge and practices.

295 - 300 (6 Pages)
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16 Systems Approaches and Reverse Pharmacology

The traditional medicines are actually used in human for number of years and therefore its clinical existence comes as a presumption. However, for bringing more objectivity and also to confirm traditional claims, systematic clinical trials are necessary. In Ayurvedic medicine research, clinical experiences, observations or available data becomes a starting point. In conventional drug research it comes at the last. Thus, the drug discovery based on Ayurveda follows a ‘Reverse Pharmacology’ path546. Nevertheless, all the critical Pharmacopoeial tests such as dissolution time, microbial, pesticide and heavy metals contamination etc. must be in accordance with global standards. It is important to ensure that all the Ayurvedic medicine manufacture is in accordance with Current Good Manufacturing Procedures for herbal products547,548. There have been concerns about quality standards and safety issues of herbal medicines549. The need for new regulations for botanical medicines has also been frequently stressed and some such regulations are coming in force in different parts of the world550,551.

301 - 314 (14 Pages)
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17 Future Perspectives

Looking forward, it is clear that traditional and western medicine have the potential for rich collaboration that benefits both disciplines. There is growing interest in this partnership, as shown by the number of international journals now dedicated to such research, such as Journal of Ethnopharmacology, Complementary Therapies in Medicine, eCAM, Alternative Therapies in Health and Medicine, and the Journal of Alternative and Complementary Medicine. Even the WHO has taken note of the rich possibilities of the future of TM, having put out such documents as ‘WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine’ and ‘WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants’. Despite this enthusiasm, there are several areas where the international community will need to focus their attention if the goal of integrating botanical medicines for the good of human health is to be reached.

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18 End Pages

Glossary and Abbreviations

 
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