Chinese Med

Chinese Med

• 1.
  eCAM Advance Accesspublished October 27, 2005 eCAM 2005; Page 1 of 9 doi:10.1093/ecam/neh140 Review Ayurveda and Traditional Chinese Medicine: A Comparative Overview Bhushan Patwardhan1, Dnyaneshwar Warude1, P. Pushpangadan2 and Narendra Bhatt3 1 Interdisciplinary School of Health Sciences, University of Pune, Pune 411 007, 2National Botanical Research Institute, Lucknow 226 001 and 3Zandu Pharmaceutical Ltd, Mumbai 400 025, India Ayurveda, the traditional Indian medicine (TIM) and traditional Chinese medicine (TCM) remain the most ancient yet living traditions. There has been increased global interest in traditional medicine. Efforts to monitor and regulate herbal drugs and traditional medicine are underway. China has been suc- cessful in promoting its therapies with more research and science-based approach, while Ayurveda still needs more extensive scientific research and evidence base. This review gives an overview of basic prin- ciples and commonalities of TIM and TCM and discusses key determinants of success, which these great traditions need to address to compete in global markets. Keywords: Ayurveda – Chinese medicine – complementary and alternative medicine – traditional medicine Introduction structures and capabilities necessary for natural product- based drug discovery (5). China has successfully promoted Ayurveda, the traditional Indian medicine (TIM) and tradi- its own therapies over the globe with a science-based tional Chinese medicine (TCM) remain the most ancient yet approach. Growing popularity of TCM can be evidenced by living traditions. These are the two ‘great traditions’ with the rapid increase in number of licensed Chinese medicine pro- sound philosophical, experiential and experimental basis. viders in the United States. The Chinese government has Increased side effects, lack of curative treatment for several pledged to create several export-oriented TCM giants in the chronic diseases, high cost of new drugs, microbial resistance coming years (6). Continuous efforts in promotion of the indi- and emerging diseases are some reasons for renewed public genous therapies by China have put TCM in a commendable interest in complementary and alternative medicines (1). position. Global acceptance of Ayurveda is gearing up and It has been postulated that by 2010 at least two-thirds of the there has been a steep rise in the demand for medicinal plants United States population will be using one or more of the from India (7). The Pharmaceutical Research and Develop- alternative therapeutic approaches. Use of indigenous drugs ment Committee report of Ministry of Chemicals, Government of natural origin forms a major part of such therapies; more of India also underscores the importance of traditional know- than 1500 herbals are sold as dietary supplements or ethnic ledge (8). The increasing use of traditional therapies demands traditional medicines (2). Pharmaceutical companies have more scientifically sound evidence for the principles behind renewed their strategies in favor of natural product drug therapies and for effectiveness of medicines. Recent advance- development and discovery (3). For instance, in Europe, ments in the analytical and biological sciences, along with AnalytiCon Discovery has stressed on drug discovery based innovations in genomics and proteomics can play an important on natural product chemistry (4). In the Asia-Pacific region, role in validation of these therapies. Western scientific com- MerLion Pharmaceuticals in Singapore has comprehensive munity views traditional medicines cautiously and stress the concerns related to research, development and quality (9,10). For reprints and all correspondence: Bhushan Patwardhan, PhD, This review delineates the challenges that TCM and TIM Interdisciplinary School of Health Sciences, University of Pune, Pune 411 007, India. Tel/Fax: þ91-20-25691758; need to address to become more acceptable to the world E-mail: [email protected] community. Ó The Author (2005). Published by Oxford University Press. All rights reserved. The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and Oxford University Press are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact [email protected]
• 2.
  2 Ayurveda and traditional Chinese medicine Global Markets, Regulations and Acceptance quality of life, with therapeutic strategies for treatment of spe- cific diseases or symptoms in holistic fashion. Almost half of The global pharmaceutical market was worth US $550 billion the botanical sources used as medicines have similarities; in 2004 (11) and is expected to exceed US $900 billion by the moreover, both systems have similar philosophies geared year 2008. The herbal industry shares about US $62 billion towards enabling classification of individuals, materials and with good growth potential. The World Bank reports trade in diseases. TCM considers the human at the center of the uni- medicinal plants, botanical drug products and raw materials verse as an antenna between celestial and earthly elements. is growing at an annual growth rate between 5 and 15% (12). Water, earth, metal, wood and fire are the five elements of Within the European community, botanical medicine repres- the material world. The world is a single unit and its movement ents an important share of the pharmaceutical market (13); gives rise to yin and yang, the two main antithetic aspects. The the nutraceutical sector is also growing rapidly. In 2001, US actual meaning of the term yin and yang is ‘opposites’, such as $17.8 billion was spent in the United States on dietary supple- the positive and the negative. However, Chinese believe that ments, US $4.2 billion of it for botanical remedies (14). In yin and yang is not absolute but relative. Consistent with the India the value of botanicals related trade is about US $10 bil- modern view of homeostasis, yin and yang are interchanged lion per annum with annual export of US $1.1 billion (15) to meet the view that ‘yang declines and yin rises’ or ‘yang while China’s annual herbal drug production is worth US is raised to produce a decline of yin’. The four bodily $48 billion with export of US $3.6 billion (16). Presently, the humors (qi, blood, moisture and essence) and internal organ United States is the largest market for Indian botanical pro- systems (zang fu) play an important role in balancing the yin ducts accounting for about 50% of the total exports. Japan, and yang in human body. Proper formation, maintenance and Hong Kong, Korea and Singapore are the major importer of circulation of these energies are essential for health. When TCM taking 66% share of China’s botanical drugs export (17). the two energies fall out of harmony, disease develops. The Globally, there have been concerted efforts to monitor qual- physician takes into account this concept while treating ity and regulate the growing business of herbal drugs and tradi- patients. Drugs or herbs are used to correct this imbalance of tional medicine. Health authorities and governments of various yin–yang in the human body (22,23). nations have taken an active interest in providing standardized Ayurveda considers that the universe is made up of combina- botanical medications. United States Congress has fuelled tions of the five elements (pancha mahabhutas). These are aka- rapid growth in the nutraceutical market with passage of the sha (ether), vayu (air), teja (fire), aap (water) and prithvi Dietary Supplement Health and Education Act in 1994. US (earth). The five elements can be seen to exist in the material Food and Drug Administration (FDA) has recently published universe at all scales of life and in both organic and inorganic the International Conference on Harmonization guidance things. In biological system, such as humans, elements are Common Technical Document addressing concerns related to coded into three forces, which govern all life processes. These quality of medicines that also includes herbals (18). The three forces (kapha, pitta and vata) are known as the three National Center for Complementary and Alternative Medicine doshas or simply the tridosha. Each of the doshas is composed has been inaugurated as the United States Federal Govern- of one or two elements. Vata is composed of space and air, ment’s lead agency for scientific research in this arena of Pitta of fire, and kapha of water and earth. Vata dosha has medicine. Its mission is to explore complementary and altern- the mobility and quickness of space and air; pitta dosha the ative healing practices in the context of rigorous science, sup- metabolic qualities of fire; kapha dosha the stability and solid- port sophisticated research, train researchers, disseminate ity of water and earth. The tridosha regulates every physiolo- information to the public on the modalities that work and gical and psychological process in the living organism. The explain the scientific rationale underlying discoveries. The interplay among them determines the qualities and conditions center is committed to explore and fund all such therapies for of the individual. A harmonious state of the three doshas cre- which there is sufficient preliminary data, compelling public ates balance and health; an imbalance, which might be an health need and ethical justifications (19,20). World Health excess (vriddhi) or deficiency (kshaya), manifests as a sign Organization (WHO) is keen regarding traditional medicine or symptom of disease (24,25) (Figs 1 and 2). and has been active in creating strategies, guidelines and stand- ards of botanical medicines (21). The global scenario illus- trates vividly both promise and challenges presented by the Determinants of Success traditional medicines. India needs to identify the extent to which Ayurvedic therapeutics is safe and effective so that it Quality of the Botanical Drugs could get wide global acceptance. Consistency in composition and biological activity are essen- tial requirements for the safe and effective use of therapeutic agents. Quality is the critical determinant of safety and effi- Basic Principles: TIM and TCM cacy of botanical medicines; however, botanical preparations Ayurveda and TCM have many commonalities. The focus of rarely meet the standards of quality, which refers to procedures both the systems is on the patient rather than disease. Both sys- and markers for assessing and verifying the strength of botan- tems fundamentally aim to promote health and enhance the ical raw materials or extracts or formulations thereof (26).
• 3.
  eCAM 2005 3 Basic principles of TCM Symbol for yin and yang Liver Gall bladder Wood Heart Kidney Fire Small intestine Water Urinary bladder Lung Metal Earth Spleen Large intestine Stomach Mutual nourishment cycle - Zang organs Mutual restraint cycle - Fu organs Figure 1. Basic principles of TCM. Chromatographic techniques and chemical marker assisted Vata Kapha characterization of the botanicals does not ensure consistent Akasha Prithvi biological activity or stability (27). Therefore, production of quality botanical medicines has become a challenge to regulat- ory authorities, scientific organizations and manufacturers. Microcosm to WHO (28), USFDA (29), European Scientific Cooperative Vayu Aapa Macrocosm on Phytomedicine (ESCOP) (30) have published standard sets of guidelines to address the concerns. Some of the pro- gressive manufacturers follow them to provide standardized Teja botanical medicine. In India, about 9000 licensed units manu- facture traditional medicines with or without proper standard- ization (31). Indian manufacturers generally follow WHO guidelines for quality control. Adulteration of market samples remains a major problem in domestic and export markets of Indian herbal products. Chemical analysis of some antiarthritic Pitta medicines from Ayurveda has led to a finding that synthetic Figure 2. Basic principles of TIM: relation of pancha mahabhutas and anti-inflammatory drugs like phenylbutazone, indomethacin tridosha. and/or corticosteroids have been added (32). Heavy metals
• 4.
  4 Ayurveda and traditional Chinese medicine such as mercury, arsenic and lead contamination has also procurement of standardized authentic raw material free from become a critical problem (33,34). Market botanicals are toxic contaminants. Improving processing technologies, con- stored under undesirable conditions over the years and may ducting all operations under GMP compliance and mainten- have contamination or adulteration of other materials, which ance of in-process quality control for manufacturing quality thereby adversely affect the efficacy and sometimes even add herbal products also need evidence for therapeutic efficacy, to toxicity. Lack of proper processing of the materials even safety and shelf life. Such approaches remain important in glo- by pharmaceutical firms contributes to decline of the herbal bal promotion of Ayurveda. business. Availability of the desired genotype of plant in the required quantity, free from toxic contaminants and with Government Policies desired therapeutic activity have also become a critical issue (35). China has successfully overcome such difficulties by In China and India formal training is an integral part of the modernizing its traditional medicine profession with national health program, which helps in ensuring quality stand- government-sponsored Good Agricultural Policies (GAPs) and ards in health care delivery. China became successful in integ- Good Manufacturing Practices (GMPs). GAPs stresses selec- rating TCM in the national health care system. Science-based tion of the correct germplasm with high content of stable active approaches were utilized and inculcated in the education of components. The cultivation practices offer Standard Operat- TCM with emphasis on research. Hospitals practicing TCM ing Procedures for use of fertilizers, irrigation systems and dis- treat more than 200 million outpatients and almost 3 million ease management allied with insects and pest prevention and inpatients annually. About 95% of general hospitals in China cure. GAPs also establish standards for noxious and harmful have traditional medicine departments (39). contaminants like heavy metals, pesticide residues and Government of India also has expressed support and encour- microbes in plants. All manufactures of TCM are mandated agement for the TIM. A separate department for Indian Sys- to comply with guidelines laid down by China’s State Drug tems of Medicine and Homeopathy (ISM&H) now known as Administration (SDA) by 2004 and farms producing raw AYUSH (Ayurveda, Yoga, Unani, Siddha, Homoeopathy) ingredients must comply with SDA-imposed standards by was established in March 1995 to promote indigenous sys- 2007. As a result, 1470 companies have qualified for GMPs tems. Priorities include education, standardization of drugs, while 570 failed to meet the standards (36). For marketing of enhancement of availability of raw materials, research and herbal medicine in China, special requirements such as quality development, information, communication and larger involve- dossier, safety and efficacy evaluation and specific labeling ment in the national system for delivering health care. The criteria are required. New herbal drugs must be approved Central Council of Indian Medicine oversees teaching and according to the Drug Administration Laws. training institutes while Central Council for Research in Similar integrated efforts are needed to raise the image of Ayurveda and Siddha deals with interdisciplinary research. Ayurvedic medicines in the global business. Government of Some TIM products are being added into family welfare pro- India has promulgated GMP regulations for traditional systems grams of the government under the World Bank project. These of medicines to improve the quality and standard of medicines are mainly for common diseases like anemia, edema Ayurvedic, Siddha and Unani drugs in pharmacies. New rules during pregnancy, postpartum problems such as pain, uterine delineating essential infrastructure, manpower and quality and abdominal complications, difficulties with lactation, nutri- control requirements came into force from 2000 and form tional deficiencies and childhood diarrhea (40). The govern- part of the Drugs and Cosmetics Act, 1940 (37). Licensing of ment has also established 10 new drug testing laboratories Ayurvedic medicine is also governed under drug and cosmet- for TIM and is upgrading existing laboratories to provide ics act, 1940. Ayurvedic Patent and Proprietary medicines documented high quality evidence to licensing authorities for need to contain only the ingredients mentioned in the recom- the safety and quality of herbal medicines. This replaces the mended books as specified in the Act. For any new herbal earlier ad hoc system of testing that was considered unreliable. medicine safety and efficacy data are mandatory. Depending In 2002, the Council for Scientific and Industrial Research has on nature of herbs and market availability, different require- launched a research program under New Millennium Indian ments exist for submission of clinical trial and safety data. Technology Leadership Initiative scheme in Ayurveda identi- Standardization of herbal drugs is not just an analytical fying three disease areas such as arthritis, diabetes and operation for identification and assay of active principles; hepatic disorders, which afflict large numbers of the Indian rather, it comprises total information and controls to necessar- population. ily guarantee consistent composition of all herbals. A good Many additional concerns need to be addressed. The quality example of this is a polyherbal formulation (ArtrexÒ ) designed of education in many colleges needs to be improved. Under the for the treatment of arthritis that contains four botanicals. The pretext of integration, attempts to make hybrid curricula pro- formulation, standardized using modern scientific tools and ducing inadequately trained graduates remain unacceptable with known markers, has been granted a US patent (38). Valid- for either modern or traditional systems (41). A paucity of ated agro-industrial technologies should be applied for cultiva- funds is noticeable; ISM&H gets only 2% of the total health tion and processing of medicinal plants and manufacturing of budget of the nation. A corrective and promotive policy herbal medicines. Indian herbal drug industry needs to ensure needs to be initiated for TIM to fully realize its potential and
• 5.
  eCAM 2005 5 contribute more meaningfully to integrative health services. Table 1. Citations and patent data for Indian and Chinese medicine (as on September 10, 2005) The industry has not been able to grow and develop optimally during the last few decades. Largely, the achieved growth is Database Key words: Citations/ Key words: Citations/ owing to industry’s own initiatives, in-house research and TIM patents TCM patents development. A national organization, Ayurvedic Drugs PubMed Ayurvedic 1045 Chinese 10 278 Manufacturers’ Association is taking a proactive role to medicine medicine improve quality and research that needs to be nurtured, stimu- TIM 361 TCM 6847 lated and sustained by providing special funding or incentives. Science Direct Ayurvedic 87 Chinese 990 medicine medicine Preparation of formularies and pharmacopoeial standards have been attempted but a lot remains to be done. Numbers of TIM 77 TCM 612 Indian botanical sources and their medicinal uses as in case of Google scholar Ayurvedic 4220 Chinese 476 000 medicine medicine turmeric have been patented by claiming innovations that are TIM 32 900 TCM 68 300 already in the public domain. Necessary measures to protect such intellectual property are important as the retrieval and con- US patent granted Ayurvedic 3 Chinese 195 medicine/TIM medicine/TCM testing of patents is a very costly and time-consuming affair US patent filed Ayurvedic 26 Chinese 259 (42). For this purpose, the Government of India has established medicine/TIM medicine/TCM a Traditional Knowledge Digital Library on traditional medi- cinal plants, which will also lead to a Traditional Knowledge Resource Classification (43). Linking this to internationally The first compound derived from Chinese herbal remedies to accepted International Patent Classification system will mean enter the western market was ephedrine, an amphetamine- building the bridge between the knowledge contained in an like stimulant from ma huang (Ephedra sinica). The next old Sanskrit text and a patent examiner. This may control the was artimisinin, a potent antimalarial from qinghao (Artemisia problem of mistakingly granting patents since the examiner annua). In 2003, Chinese researchers launched a phase II trial will know the Indian rights to that knowledge. It could integrate to test the efficacy of a drug called kanglaite from iijen (Coix widely scattered and distributed references on TIM in retriev- lachryma-jobi) for treating non-small-cell lung cancer (47). able form and will be a major impetus to modern research in This is the first drug from TCM to enter clinical trials in the the developing world. United States. Other drug molecules from TCM are xue baoPG2 (general tonic from Astragalus membracaceus) and camptothecin analogs as CPT11 and topotecan (anticancer Research from Camptotheca accuminata), which have a huge market. Natural products extracts of therapeutic relevance are of para- In 2002, 1141 different traditional plant drugs were registered mount importance as reservoirs of structural and chemical for their therapeutic activities including several new single diversity. A recent review on national pharmacopoeias from compounds from plants as arteannuin (antimalarial), indirubin several countries reveals at least 120 distinct chemical sub- (anticancer), etc. One of the twelve focal points in the current stances from different plants that have utility as lifesaving Five-Year Plan of China’s Ministry of Science and Techno- drugs (44). This has been achieved through chemical and phar- logy is to modernize research in TCM. Pharmacopoeia of the macological screening of only 6% of the total plant species. People’s Republic of China (2000) (48) contains 992 mono- Untapped, hidden wealth in the flora needs to be unearthed graphs of Chinese crude drugs and traditional Chinese patent and explored to cure diseases like AIDS, cancer, diabetes, medicines in which 76 new admissions and 248 monographs etc. Recently, NIH has started extensive research for anti- have been revised. Controlled clinical trials have been initiated inflammatory compounds from turmeric, ginger and boswellia at several hospitals and research organizations to prove the with the aid of Ayurvedic knowledge. Screening of different efficacy and safety of the Chinese medicine (49,50). Recent plants for novel anticancer compounds is also in progress reports on adverse effects of drug like ma huang (51) and with reference experiential data from traditional systems gingko (52) have sounded a cautionary note that promoting tra- (45). Botanical immunodrugs from traditional medicine can ditional medicine from conception to commercialization will provide newer opportunities to bioprospect diverse and syner- not be easy. gistic chemical moieties, which in combination might act on India has world-class expertise and facilities for organic multiple targets and improve the therapeutic spectrum (46). synthesis, isolation and structure elucidation, biological PUBMED, Google scholar and Science direct are the widely screening, toxicological testing and pharmacokinetics. This is recognized web databases of scientific literature. We have supplemented by the expertise for development of agro- given comparative citations for Indian and Chinese medicine technology for cultivation of medicinal plants. Industry parti- using different key words and also provided the patent data cipation to ensure successful upscaling and implementation of USPTO. Visibility of Ayurvedic medicine remains much of technology is increasing. Generation of leads with structural lower as compared with TCM (Table 1). diversities through creation of natural product libraries, identi- Chinese medicine became successful in crossing philosoph- fication of proper targets and their proper validation and ical barriers through constant reworking of the basic system. optimization is of paramount importance (53). India has
• 6.
  6 Ayurveda and traditional Chinese medicine progressive research institutes like Central Drug Research (2002) (75) with 52 monographs on widely used medicinal Institute (CDRI), Central Institute of Medicinal and Aromatic plants growing in India where scientific data have been incor- Plants and National Botanical Research Institute at Lucknow, porated. Regional Research Laboratories (RRL), at Jammu, Harmonization and validation of the complex process of Bhubaneshwar and Jorhat, National Chemical Laboratory at Ayurvedic therapeutics remain important. Novel efforts like Pune, which routinely undertake research on medicinal plants. Ayugenomics (76) aim to understand Ayurvedic concept of Most of them are involved in standardizing the herbal medi- Prakruti from pharmcogenomics perspective to provide a cines and isolating active compounds. Few selected crops base for human classification, diagnostics and customized have been taken for improvement yet there is a need for medicine (77). Projects like AyuSoft (78) aim to develop research on quality planting materials for farmers, conserva- intelligent and interactive software based on Ayurvedic clas- tion of endangered species and to prevent exploitation of the sics as a decision support system. New analytical approaches natural resources. Reserpine (antihypertensive from rauwolfia) like Herboprint (79) use three-dimensional HPLC and is an extremely valuable contribution from Ayurvedic systems. attempt to develop tools for activity-based standardization of Curcumin (54) (anti-inflammatory from turmeric), withaferin botanicals. A (55) (anti-inflammatory from ashwagandha), kutkoside (56) (hepatoprotective from kutki), andrographolide (57) (hep- Supporting Systems atoprotective from andrographis) and vasicine (58) (bron- chodilator and expectorant from vasaka) are chemical entities Apart from the drug manufacturer, many other supporting with attractive scaffolds for drug discovery. industries play important roles in commerce of traditional Controlled clinical trials are important to develop evidence medicine. The whole pipeline covers collectors and breeders, for safety and efficacy. Results from clinical trials are encour- dealers of the plant materials, processing and manufacturing aging (59), but lot more clinical research is required to estab- industry, practitioners of traditional medicine and finally the lish validity of the system. Ayurvedic preparations have been consumers. Presently, Indian systems of medicine use more successfully evaluated for treatment of bronchial asthma than 1100 medicinal plants of which most are collected from (60,61), rheumatoid arthritis (62), ischaemic heart disease the wild. More than 60 species are in great demand (80). The (63,64). Piperine from pipali has come out as a bioenhancer tribal belt of India is rich in these plants and the tribes mainly in recent clinical evaluation (65,66). Botanicals like Withania depend on this trade for livelihood. There are ample of oppor- somnifera (67); Asparagus racemosus (68) have exhibited sig- tunities for adulteration and contamination in the process. nificant vaccine adjuvant activity in experimental systems, Thus, the adequate availability of quality raw materials free which have valuable applications in immunobiological indus- from adulterants at reasonable prices have become a big prob- try. An IND application of Lupin Ltd. is in process and a US lem for industry and the demand is increasing every year. patent has been granted for development of herbal-based anti- However, very few efforts have been made either by govern- psoriatic composition containing Argemone mexicana (69). ment or by industry to seriously study the supply and demand. Standardized fraction of gugulipid from Commiphora wightii Similar to China, India needs to follow GAPs to ensure the use developed by CDRI has been marketed (GuglipÒ , Cipla Ltd) of correct raw materials and cover the entire life cycle includ- for treating hyperlipidemia and atheriosclerosis (70). RRL ing the harvesting, processing, transportation and storage. Jammu has commercialized Boswellia serrata gum resin as Chinese government has developed more than 100 research NSAID (Non-Steroidal Anti-Inflammatory Drug) (SallakiÒ units and encouraged private enterprises to build over 600 Gufic). It is also hypolipidemic. standard planting bases for herbs in great demand. Selection A multicentric study by the Indian Council of Medical of the correct germplasm using modern DNA fingerprinting Research (ICMR) showed promising results that a preparation and chemoprofiling techniques is also a priority (81). India is from Pterocarpus marsupium was effective in reducing levels emerging as a leader in generic drugs and is exporting them of blood glucose and glycosylated haemoglobin in patients to developed countries. This is a result of adopting standard with non-insulin-dependent diabetes mellitus (71). Analysis guidelines and GMPs. However, TIM has yet to capitalize on of most frequently used plant based therapies in Ayurvedic the quality herbal medicine where GAPs are. system revealed that 43% of them have been tested on humans New experiments are beginning to emerge on benefit sharing while 62% have been the subject of one or more animal stud- models for indigenous innovation. For example, Trichopus ies. Among these drugs having sufficient clinical data are gug- zeylanicus, found in the tropical forests of southwestern India gul, brahmi, ashwagandha, amlaki, guduchi, kutki, shatavari was collected by the ‘Kani’ tribal people (a traditionally and shunthi (72) Pharmacopoeia of India (1996) (73) covers nomadic community from the forests of the Agasthyamalai few botanical monographs like clove, guggul, opium, mentha, hills in the Thiruvananthapuram district of Kerala, India). senna, and ashwagandha. The Ayurvedic Pharmacopoeia of Scientists at the Tropical Botanic Garden and Research India gives monographs for 258 different Ayurvedic drugs. Institute (TBGRI) in Kerala discovered uses of this plant that The standards mentioned are quite inadequate to build quality are claimed to boost the immune system. Chemical and phar- of the botanical materials (74). Indian Drug Manufacturers macological investigations carried out initially at RRL, Jammu Association has published Indian Herbal Pharmacopoeia and later at TBGRI showed that the leaves of the plant
• 7.
  eCAM 2005 7 contained various glycolipids and some other non-steroidal References compounds with profound adaptogenic and immune- 1. Humber JM. The role of complementary and alternative medicine: accom- enhancing properties (82,83). The fruits showed mainly modating pluralism. J Am Med Assoc 2002;288:1655–6. antifatigue properties. TBGRI was successful in developing a 2. Legal status of traditional medicine, complementary/alternative medicine: a worldwide reviewWorld Health Organization, Geneva, scientifically validated and standardized herbal drug, based 2001. on the tribal lead (84). The drug was named ‘Jeevani’ and 3. Seidl PR. Pharmaceuticals from natural products: current trends. An Acad Arya Vaidya Pharmacy released it for commercial produc- Bras Cienc 2002;74:145–50. 4. Available at http://www.ac-discovery.com. tion in 1995 (85). TBGRI agreed to equally share the royalty 5. Available at http://www.merlionpharma.com/index.html. with the tribal community. This experiment was acknow- 6. Jiang Y, Wang Y, Yan X. Chinese pharmaceutical companies: an emer- ledged by UNDP by conferring a special award to the con- ging industry. Drug Discov Today 2000;6:610–2. 7. Dubey NK, Rajeshkumar, Tripathi P. Global promotion of herbal medi- cerned scientists (86). cine: India’s opportunity. Curr Sci 2004;86:37–41. 8. Mashelkar RA. Transforming India into the knowledge power. PDRC report, Government of India, 1999. Conclusion 9. Patwardhan B, Chopra A, Vaidya ADB. Herbal remedies and the bias against Ayurveda. Curr Sci 2003;84:1165–6. Numerous drugs have entered the international market through 10. Fabricant DS, Farnsworth NR. The value of plants used in traditional medicine for drug discovery. Environ Health Perspect exploration of ethnopharmacology and traditional medicine. 2001;109:69–75. Progress in genomics and proteomics has opened new gate- 11. Maggon K. Best selling human medicine 2002–2004. Drug Discov Today ways in therapeutics and drug discovery and development. 2005;11:739–42. 12. World Health Organization. Report of the inter-regional workshop on Better understanding of the human genome has helped in intellectual property rights in the context of traditional medicine, understanding scientific basis of individual variation. Drug Bangkok, Thailand, Dec 6–8, 2000. http://www.who.int/medicines/ targets have evolved during the last decade, but the industry library/trm/who.edu.trm-2001-I/who-edutrm-2001-1.pdf. 13. Bodekar G, Kronenberg F. A public health agenda for complementary, remains target-rich and lead-poor trapped in the old mindset alternative and traditional (indigenous) medicine. Am J Public Health and strategies. TIM and TCM, carry many generations’ obser- 2002;92:1582–91. vations that have well-organized and documented data (87). 14. De Smet PA. Herbal remedies. New Engl J Med 2002;347:2046–56. 15. Singh J, Singh AK, Khanuja SPS. Medicinal plants: India’s opportunities. Although scientific studies have been done on a large number Pharma Bioworld 2003;1:59–66. of Indian botanicals, a considerably smaller number of market- 16. Handa SS. Indian efforts for quality control and standardization of herbal able drugs or phytochemical entities have entered the drugs/products. Proceedings of the 1st joint workshop on quality control and standardization of traditional medicine—Indo-China experience, evidence-based therapeutics. China has successfully promoted Jan 8–10, 2004. its own therapies and drugs like ginseng, ma huang and gingko 17. A dream of globalizing the TCM market. Report of the Ministry of with scientific evidences acceptable for the global community. Commerce of the People’s Republic of China, 2003. 18. Guidance for industry, M4: The CTD-quality questions answers/local Approach of integrative medicine by selective incorporation of issues, United States Food, Drug Administration 2004. Available at elements of TCM alongside the modern methods of diagnosis www.fda.gov/ohrms/dockets/dailys/03/Feb03/021103/8. has achieved a great success in China (88). 19. Cooper EL. CAM, eCAM, bioprospecting: the 21st century pyramid. Evid Based Complement Alternat Med 2005;2:125–7. India needs a clear policy for such integration without com- 20. Gavaghan H. Koop may set up new center for alternative medicine. Nature promise on the strategies that are science-based. Efforts are 1994;370:591. needed to establish and validate pharmacoepidemiological 21. Traditional Medicine Strategy 2002–2005. World Health Organization, Geneva, 2002. evidence regarding safety and practice of Ayurvedic medicines 22. Gibert TF. Reflections on traditional Chinese medicine and its (89). Pharmacoeconomic studies on TIM and TCM are rare, pharmacopoeia. Ann Pharm Fr 1998;56:282–5. but can help in understanding cost-effectiveness and cost- 23. Cheng JT. Review: drug therapy in Chinese traditional medicine. J Clin Pharmacol 2000;40:445–50. benefit of traditional medicine. In all such attempts, TCM 24. Hankey A. CAM modalities can stimulate advances in theoretical biology. examples would help India at various levels including policies, Evid Based Complement Alternat Med 2005;2:5–12. quality standards, integration practices, research models and 25. Lad V. The human constitution. In: Ayurveda: The Science of Self-Healing. Wilmot: Lotus Press, 1985, 26–36. the complementary integration where public health is kept at 26. Cardellina JH. Challenges and opportunities confronting the botanical the central position. Both TIM and TCM are great traditions dietary supplement industry. J Nat Prod 2002;65:1073–84. with strong philosophical basis and could play an important 27. Marccus DM, Grollman AP. Botanical medicines—the need for new regulations. New Engl J Med 2002;347:2073–6. role in new therapies, drug discovery and development 28. Quality Control Guidelines for Medicinal Plant MaterialsWorld Health processes. Organization, Geneva, 1998; Available at http://www.who.int/medicines/ library/trm/medicinalplants/qualitycontrolmeth.pdf. 29. Draft guidelines: Guidance for Industry—Botanical drug products— United States Food, Drug Administration—CDER. 2000. Available at Acknowledgments http://www.fda.gov/cder/guidance/4592fnl.htm. 30. EMEA Guidance on Herbal Products The European Agency for the We thank Council for Scientific and Industrial Research, Evaluation of Medicinal Products, London, 2001. Available at www. New Millennium Indian Technology Leadership Initiative emea.eu.int/pdfs/human/qwp/281900en.pdf. Herbal Drug Development Group for discussions. Financial 31. Warude D, Patwardhan B. Botanicals: quality and regulatory issues. J Sci Ind Res 2005;64:83–92. assistance from the University Grants Commission to one of 32. Farnsworth NR. Relative safety of herbal medicines. Herbalgram the authors (D.W.) is also gratefully acknowledged. 1993;29:36A-H.
• 8.
  8 Ayurveda and traditional Chinese medicine 33. Saper RB, Kales SN, Paquin J, Burns MJ, Eisenberg DM, Davis RB, 62. Chopra A, Lavin P, Patwardhan B, Chitre D. Randomized double blind Phillips RS. Heavy metal content of ayurvedic herbal medicine products. trial of an ayurvedic plant derived formulation for treatment of rheumatoid J Am Med Assoc 2004;292:2868–73. arthritis. J Rheumatol 2000;27:1365–72. 34. Ernst E. Toxic heavy metals and undeclared drugs in Asian herbal 63. Gupta R, Singhal S, Goyle A, Sharma VN. Antioxidant and medicines. Trends Pharmacol Sci 2002;23:136–9. hypocholesterolaemic effects of Terminalia arjuna tree-bark powder: a 35. Mukherjee PK. Herbal drugs-toxicity and regulations. In: Quality Control randomized placebo-controlled trial. J Assoc Physicians India 2000;49: Herbal Drugs. New Delhi: Business Horizons, 2002, 39–87. 231–5. 36. China’s new quality control, functional foods and nutraceuticals, 2003. 64. Kumar PU, Adhikari P, Pereira P, Bhat P. Safety and efficacy of Hartone http://www.ffnuag.com/ASP/377/. in stable angina pectoris—an open comparative trial. J Assoc Physicians 37. Sharma DC. India raises standards for traditional drugs. Lancet 2000; India 1999;47:685–9. 356:231. 65. Majeed M, Badmaev V, Rajendran R. Use of piperine as a 38. Patwardhan B. A method of treating musculoskeletal disease and a novel bioavailability enhancer. US Patent 5972382, Sabinsa Corporation USA, composition there of. US Patent 5494668, 1996. 1999 . 39. The State Administration of traditional Chinese medicine of the People’s 66. Atal CK, Dubey RK, Singh J. Biochemical basis of enhanced drug Republic of China. Anthology of Policies, Laws and Regulations of the availability by piperine: evidence that piperine is a potent inhibitor of People’s Republic of China on Traditional Chinese Medicine. Shangdong: drug metabolism. J Pharmacol Exp Ther 1985;232:258–62. Shangdong University 1997. , 67. Gautam M, Diwanay SS, Gairola S, Shinde YS, Jadhav SS, 40. Kumar S. India’s government promotes traditional healing practices. Patwardhan BK. Immune response modulation to DPT vaccine by aqueous Lancet 2000;335:1252. extract of Withania somnifera in experimental system. Int Immuno- 41. Department of Indian Systems of Medicines and Homoeopathy. Govern- pharmacol 2004;4:841–9. ment of India. Annual Report 1999–2000. 68. Gautam M, Diwanay S, Gairola S, Shinde Y, Patki P, Patwardhan B. 42. Barbara AJ, Ginger W. Turmeric patent overturned in legal victory. Immunoadjuvant potential of Asparagus racemosus aqueous Herbalgram 1997;41:11. extract in experimental system. J Ethnopharmacol 2004;91: 43. Ganguli P. Patents and patent information in 1979 and 2004: a perspective 251–5. from India. World Patent Inf 2004;26:61–2. 69. Arora S, Gupta L, Srivastava V, Sanganabhatla N, Sara DB. Herbal com- 44. Goswami A, Barooch PK, Sandhu JS. Prospect of herbal drugs in the age position for treating various disorders including psoriasis, a process for of globalization—Indian scinario. J Sci Ind Res 2002;61:423–43. preparation thereof and method for treatment of such disorders. US Patent 45. Diwanay S, Gautam M, Patwardhan B. Cytoprotection and immuno- 20030194456, 2003. modulation in cancer therapy. Curr Med Chem Anti-Canc Agents 2004;4: 70. Singh K, Chandar R, Kapoor NK. Guggulsterone, a potent hypo- 479–90. lipidaemic, prevents oxidation of low-density lipoprotein. Phytother Res 46. Patwardhan B, Gautam M. Botanical immunodrugs: scope and opportun- 1998;11:291–4. ities. Drug Discov Today 2005;7:495–502. 71. Indian Council of Medical Research. Flexible dose open trail of Vijayasar 47. Normile D. The new face of traditional Chinese medicine. Science in cases of newly diagnosed non-insulin dependent diabetes mellitus. 2003;299:188–90. Indian J Med Res 1998;108:24–9. 48. The Pharmacopoeia of Peoples Republic of China, Pharmacopoeia 72. Khan S, Balick MJ. Therapeutic plants of ayurveda: a review of selected Commission of the Ministry of Public Health, China, 2002. clinical and other studies for 166 species. J Altern Complement Med 49. Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of 2001;7:405–515. traditional Chinese medicine. Br Med J 1999;319:160–1. 73. The Pharmacopoeia of India. Controller of Publication, Government of 50. Cao Y, Shi Y, Zheng Y, Shi M, Lo SK. Blood-nourishing and hard- India, 1996. softening capsule costs less in the management of osteoarthritic knee 74. Raina MK. Quality control of herbal and herbo-mineral formulations. pain: a randomized controlled trial. Evid Based Complement Alternat Indian J Nat Prod 2003;19:11–5. Med 2005;2:363–8. 75. The Indian Herbal Pharmacopoeia. Mumbai, Indian Drug Manufacturer’s 51. Nelson R. FDA issues alert on ephedra supplements in the USA. Lancet Association, 2002. 2004;363:135. 76. Patwardhan B. AyugenomicsÒ : integration for customized medicine. 52. Fong KCS, Kinnear PE. Gingko biloba and retrobulbar hemorrhage fol- Indian J Nat Prod 2003;19:16–23. lowing peribulbar local anesthetic injection for cataract surgery. Postgrad 77. Patwardhan B, Joshi K, Chopra A. Classification of human population Med J 2003;79:531–2. based on HLA gene polymorphism and the concept of Prakriti in 53. Patwardhan B, Vaidya ADB, Chorghade M. Ayurveda and natural product Ayurveda. J Altern Complement Med 2005;11:349–53. drug discovery. Curr Sci 2004;86:789–99. 78. AyuSoft—a decision support system for Ayurveda. C-DAC, (Center 54. Ammon HP, Safayhi H, Mack T, Sabieraj J. Mechanism of anti- for Development of Advance Computing) Pune. Project sponsored by inflammatory actions of curcumin and boswellic acids. J Ethnopharmacol Ministry of Communication and Information Technology, Government 1993;38:113–9. of India, 2004. www.edac.in. 55. Jayaprakasam B, Muraleedharan GN. Cyclooxygenase-2 enzyme inhibit- 79. VijayaKumar D, Raghavan KV. Novel chromatographic fingerprinting ory withanolides from Withania somnifera leaves. Tetrahydron 2003;59: method for standardization of single medicines and formulations. Indian 841–9. Institute of Chemical Technology, Hyderabad, WO 0246739-EP2 56. Dwivedi Y, Rastogi R, Garg NK, Dhawan BN. Picroliv and its 0000991 991-263397CSIR G01N30-88, 2002. components kutkoside and picroside I protect liver against 80. Farooqi AA, Sreeramu BS. History, importance, present status and future galactosamine-induced damage in rats. Pharmacol Toxicol 1992;71: prospects of medicinal crops. In: Cultivation of Medicinal and Aromatic 383–7. Crops. Hyderabad: Universities press, 2001, 1–19. 57. Visen PK, Shukla B, Patnaik GK, Dhawan BN. Andrographolide protects 81. Wo Jizhou Thinking about the situation of research on GAP in rat hepatocytes against paracetamol-induced damage. J Ethnopharmacol China. Proceedings of the 1st joint workshop on quality control and 1993;40:131–6. standardization of traditional medicine—Indo-China experience, Jan 8– 58. Johri RK, Zutshi U. Mechanism of action of 6,7,8,9,10,12-hexahydro- 10, 2004. azepino-[2,1-b]quinazolin-12-one-(RLX)—a novel bronchodilator. Indian 82. Subramoniam A, Evans DA, Rajasekharan S, Pushpangadan P. Effect of J Physiol Pharmacol 2000;44:75–81. Trichopus zeylanicus Gaertn. (active fraction) on phagocytosis by 59. Bhatt AD. Clinical trials of Ayurvedic medicine: myths, realities and peritoneal macrophages and humoral immune response in mice. Indian challenges. J Assoc Physicians India 2001;49:558–62. J Pharmacol 2000;32:221–5. 60. Sekhar AV, Gandhi DN, Rao NM, Rawal UD. An experimental and clin- 83. Susan C, Sethuraman MG, George V, Pushpangadan P. Phytochemical ical evaluation of anti-asthmatic potentialities of Devadaru compound constituents of Trichopus zeylanicus ssp. Travancoricus. J Med Aromatic (DC). Indian J Physiol Pharmacol 2003;47:101–7. Plant Sci 2002;24:703–6. 61. Gupta I, Gupta V, Parihar A, Gupta S, Ludtke R, Safayhi H. Effects of 84. Pushpangadan P. Traditional knowledge & folklore—A benefit- Boswellia serrata gum resin in patients with bronchial asthma: results of sharing model experimented in India. International conference of a double-blind, placebo-controlled, 6-week clinical study. Eur J Med commission on intellectual property rights organized by Royal Society, Res 1998;3:511–4. London, Feb 21–22, 2002.
• 9.
  eCAM 2005 9 85. Pushpangadan P. Biodiversity and emerging benefit-sharing 88. Faass N. Integrating Complementary Medicine into Health Systems. arrangements—challenges and opportunities for India. Proc Indian Natl Gaithersburg: Aspen Publications, 2001. Sci Acad 2002;B68:297–311. 89. Vaidya RA, Vaidya ADB, Patwardhan B, Tillu G, Rao Y. Ayurvedic 86. Available at http://www.undp.org/biodiversity/biodiversitycd/practice pharmacoepidemiology: a proposed new discipline. J Assoc Physicians India.htm#EI. India 2003;51:528. 87. Patwardhan B. Ayurveda: the ‘designer’ medicine: a review of ethno phar- macology and bioprospecting research. Indian Drugs 2000;37:213–27. Received June 13, 2005; accepted October 7, 2005