Worl wide herbal market states Global Market

Total global herbal market1 is of size 62.0 billion dollars, in this Indias contribution is only one billion dollars. The table in annexure 5 explains the position of India in the global market. European union is the biggest market with the share 45% of total herbal market. North America accounts for 11%, Japan 16%, ASEAN countries 19% and rest of European Union 4.1%. Countries like Japan and China have successfully marketed their traditional medicines abroad. Their alternative therapies are well-accepted in Europe and US. Product like Ginseng the famed aphrodisiac from China is having the same property as of Ashwagandha- an ayurvedic medicine, yet it accounts for over US $ 800 M of international market as compared to all our herbs put together (which is less than US $ I M). When compared to the Chinese and the Japanese level of penetration in the global market India is not at all figuring anywhere. But there are positive signals also for us in the global market. India has 16 Agro-climatic zones, 10 vegetative zones, 15 biotic provinces, 426 biomes, 45000 different plant species and 15000 medicinal plants that include 7000 ayurveda, 700 in Unani medicine, 600 in Siddha medicine and 30 in modern medicine. This makes India one among 12 mega biodiverse countries of the world, which despite having only 2.5 % total land area, accounting for over 8 % of the recorded species of the world. The forecast is that the global market for herbal products is expected to be $5 Trillion by 2050. Herbal remedies would become increasingly important especially in developing countries. India, with its biodiversity has a tremendous potential and advantage in this emerging area. Acupuncture is one such therapy that has gained worldwide recognition.

Global Herbal Market

The exports of Ayurvedic and Unani medicines put up for retail sale to other countries have increased from Rs. 17 crores in 1992-93 to 98 crores in 1998-99. The data is given in Annexure 1(vi). In USA our exports have
1 as

estimated by Dabur Research Foundation

increased from Rs.47 lakhs in 1992-93 to 8 crores in put up for retail sale. USA has stringent rules for the imported products that are used for consumption. These medicines are not exported under the category of medicines but find their way in US market as food supplements and herbal products. Similarly in UK the Indian exports of these products have increased from mere 5 lakhs of rupees to above one crore from the year 1992-93 to 1998-99. European Union is the biggest market in global herbal products. Indian products to other countries like Germany, France, Italy and Netherland have also increased. In 1992-93 Germany was the biggest importer of the ayurvedic and unani medicines followed by Nigeria but their importance decreased drastically in terms of share of the exports of Indian Ayurvedic & Unani products. Russia was the biggest importer and destination market for Ayurvedic and

Unani products in 1996-97. Russia is one of the most important partners for India in the exports of Ayurvedic and Unani finished products. The exports for Ayurvedic and Unani medicines have been increasing but nothing can be predicted from the yearly exports because that has been fluctuating. This section for not put up for retail sale constitutes of raw materials, crude herbs and other products. This requirement keeps changing from one year to other. From the table given in annexure 1(viii) and annexure 1(ix), we can conclude that USA has emerged as one of the important countries as the buyer of Ayurvedic and Unani medicines both put up for retail sale and not put up for retail sale. Among other countries South East Asian countries have also emerged as important market and from the table we can say that India has explored these emerging market but how far is it successful and what is their percentage share in imports of these countries is yet to be answered. UAE is another country, which import from India as herbal product category. In Middle East peoples choice have shifted to herbal products, - they now use more of these types of hair oil, shampoo and other cosmetics. Germanys share in the exports of ayurvedic and Unani medicines have decreased drastically but if we take European Union together their share has increased.

Regulatory Status of Herbal Medicine Worldwide

The World Health Organization (WHO) estimates that 4 billion people--80 percent of the world population--use herbal medicine for some aspect of primary health care. Herbal medicine is a major component in all indigenous peoples' traditional medicine and is a common element in Ayurvedic, homeopathic, naturopathic, traditional oriental and Native American Indian medicine. The sophistication of herbal remedies used around the world varies with the technological advancement of countries that produce and use them. These remedies range from medicinal teas and crude tablets used in traditional medicine to concentrated, standardized extracts produced in modern pharmaceutical facilities and used in modern medical systems under a physician's supervision.

Europe
Drug approval considerations for phytomedicines (medicines from plants) in Europe are the same as those for new drugs in the United States, where drugs are documented for safety, effectiveness, and quality. Two features of European drug regulation make that market more hospitable to natural remedies. 1. In Europe it costs less and takes less time to approve medicines as safe and effective. This is especially true of substances that have a long history of use and can be approved under the "doctrine of reasonable certainty." According to this principle, once a remedy is shown to be safe, regulatory officials use a standard of evidence to decide with reasonable certainty that the drug will be effective. This procedure dramatically reduces the cost of approving drugs without compromising safety.

2. There is no inherent prejudice in Europe against molecularly complex plant substances; rather, they regard them as single substances. The European Economic Community (EEC), recognizing the need to standardize approval of herbal medicines, developed a series of guidelines, The Quality of Herbal Remedies2). These guidelines outline standards for quality, quantity, and production of herbal remedies and
2 EEC

Directive, undated

provide labeling requirements that member countries must meet3. According to these guidelines, a substance's historical use is a valid way to document safety and efficacy in the absence of scientific evidence to the contrary. A guiding principle should be that if the product has been traditionally used without demonstrated harm, no specific restrictive regulatory action should be undertaken unless new evidence demands a revised risk-benefit assessment. Prolonged and apparently uneventful use of a substance usually offers testimony of its safety. The WHO guidelines give further advice for basing approval on existing monographs: If a pharmacopoeia monograph exists it should be sufficient to make reference to this monograph. If no such monograph is available, a monograph must be supplied and should be set out in the same way as in an official pharmacopoeia. To further the standardization effort and to increase European scientific support, the phytotherapy societies of Belgium, France, Germany, Switzerland, and the United Kingdom founded the European Societies' Cooperative of Phytotherapy (ESCOP). ESCOP's approach to eliminating problems of differing quality and therapeutic use within EEC is to build on the German scientific monograph system (below) to create "European" monographs. In Europe, herbal remedies fall into three categories. The most rigorously controlled are prescription drugs, which include injectable forms of phytomedicines and those used to treat life-threatening diseases. The second category is OTC phytomedicines, similar to American OTC drugs. The third category is traditional herbal remedies, products that typically have not undergone extensive clinical testing but are judged safe on the basis of generations of use without serious incident.
3 The

EEC guidelines are based on the principles of the WHO's Guidelines for the Assessment of Herbal Medicines (1991)

The following brief overviews of phytomedicine's regulatory status in France, Germany, and England are representative of the regulatory status of herbal medicine in Europe. France, where traditional medicines can be sold with labeling based on traditional use, requires licensing by the French Licensing Committee and approval by the French Pharmacopoeia Committee. These products are distinguished from approved pharmaceutical drugs by labels stating "Traditionally used for . . ." Consumers understand this to mean that

indications are based on historical evidence and have not necessarily been confirmed by modern scientific experimentation. Germany considers whole herbal products as a single active ingredient; this makes it simpler to define and approve the product. The German Federal Health Office regulates such products as ginkgo and milk thistle extracts by using a monograph system that results in products whose potency and manufacturing processes are standardized. The monographs are compiled from scientific literature on a particular herb in a single report and are produced under the auspices of the Ministry of Health Committee for Herbal Remedies. Approval of such remedies requires more scientific documentation than traditional remedies, but less than new pharmaceutical drug approvals. In Germany there is a further distinction between "prescription-only drugs" and "normal prescription drugs." The formers are available only by prescription. The latter are covered by national health insurance if prescribed by a physician, but they can be purchased over the counter without a prescription if consumers want to pay the cost themselves. OTC phytomedicines--used for self-diagnosed, self-limiting conditions such as the common cold, or for simple symptomatic relief of chronic conditions-are not covered by the national health insurance plan. England generally follows the rule of prior use, which says that hundreds of years of use with apparent positive effects and no evidence of detrimental side effects are enough evidence--in lieu of other scientific data--that the product is safe. To promote the safe use of herbal remedies, the Ministry of Agriculture, Fisheries, and Food and the Department of Health jointly established a database of adverse effects of nonconventional medicines at the National Poisons Unit.

Asia
In more developed Asian countries such as Japan, China, and India, "patent" herbal remedies are composed of dried and powdered whole herbs or herb extracts in liquid or tablet form. Liquid herb extracts are used directly in the form of medicinal syrups, tinctures, cordials, and wines. In China, traditional herbal remedies are still the backbone of medicine. Use varies with region, but most herbs are available throughout China. Until 1984 there was virtually no regulation of pharmaceuticals or herbal preparations. In 1984, the People's Republic implemented the Drug Administration Law, which said that traditional herbal preparations were generally considered "old drugs" and, except for new uses, were exempt from testing for efficacy or side effects. The Chinese Ministry of Public Health would oversee the administration of new herbal products. Traditional Japanese medicine, called kampo, is similar to and historically derived from Chinese medicine but includes traditional medicines from Japanese folklore. Today 42.7 percent of Japan's Western-trained medical practitioners prescribe kampo medicines, and Japanese national health insurance pays for these medicines. In 1988, the Japanese herbal

medicine industry established regulations to manufacture and control the quality of extract products in kampo medicine. Those regulations comply with the Japanese government's Regulations for Manufacturing Control and Quality Control of Drugs.

Developing Countries
Herbal medicines are the staple of medical treatment in many developing countries. Herbal preparations are used for virtually all minor ailments. Visits to Western-trained doctors or prescription pharmacists are reserved for life threatening or hard-to-treat disorders. Individual herbal medicines in developing regions vary considerably; healers in each region have learned over centuries which local herbs have medicinal worth. Although trade brings a few important herbs from other regions, these healers rely mainly on indigenous herbs. Some have extensive herbal material medical. A few regions, such as Southeast Asia, import large amounts of Chinese herbal preparations. But the method and form of herb use are common to developing regions. In the developing world, herbs used for medicinal purposes are "crude drugs." These are unprocessed herbs--plants or plant parts, dried and used in whole or cut form. Herbs are prepared as teas (sometimes as pills or capsules) for internal use and as salves and poultices for external use. Most developing countries have minimal regulation and oversight.

Strategies Adopted:
In view of the point one and point two in the bottlenecks, the Department of ISM&H has undertaken the scheme for development of Agro based Techniques and cultivation of Medicinal plants used in Ayurveda, Siddha, Unani and Homeopathy. Under this scheme central a assistance is provided to specialized scientific institution (government/ semigovernment) on project basis (3 years) for development of agro techniques of identified medicinal plants. In the year 1997-98 total 26 such projects were sanctioned which costed around 124.866 lakhs for the first year of projects. The department proposes to undertake a study at National level covering the manufacturing units and marketing outlets etc. in an effort to have this information. Professional consultant organisations are being hired for the purpose of organising such studies. The department of ISM&H has also set up an expert group to consider and formulate the proposal for setting up of Medicinal Plants Board Act under the act Medicinal Plant Board Act 1999. The Secretary (ISM&H) has signed a Memorandum of Understanding in June 1999 with the Govt. of Russian Federation in Moscow on Cooperation and collaboration in the field of Indian Traditional Systems of Medicine & Homeopathy. Both parties agreed to conduct joint clinical and para-clinical schemes of preparations and methods used in Indian Traditional Systems of Medicine, primarily in Ayurveda as well as

Homeopathy with the view of establishing criteria for evaluation of their efficacy and their proper registration in the Russian Federation. A Russian delegation has visited India as a follow up of MOU entered into with the Government of Russian Federation. In yet another significant move to give impetus to the Ayurveda in US, the Indian government announced that it would soon set up Ayurveda Development Board in the US. Annexure 1 (i) Fig.1. Ayurveda & Siddha sector Domestic market Export Market Raw Material Cultivator Herb Market Pharmacy/Companies Research Institutes Export Household Research institutes Fig. 2. Classification of the Sector Manufacturing Units

Organised Unorganised
Good infrastructure and R&D Small units with less Small sector unit investment in R&D

Annexure 1(ii) Global Herbal Market

Market Size (US $ Bill.) Percentage (%) European Union 28 45 Rest EU 2.4 4 ASEAN 10.8 19 Japan 9.8 16 N. America 6.9 11 Others 4.1 7 Total 62 100 Global Herbal Market
43% 4% 19% 16% 11% 7%
EU Rest EU ASEAN Japan N. America

Others

2 Executive summary During the last decade, popularity of alternative medicine increased significantly world wide with noticeable trends in the United States in particular. This in turn accelerated the global trade of herbal raw materials and herbal products, and created high scope for the Afro-Asian as well as Latin American countries, which are the major suppliers of herbal raw materials in the world. The heterogeneity in the trade regulations in different countries could have caused a differential impact on the global trade and transactions, but globalisation, by its uniform policy, helped to some extent to overcome the impact of this heterogeneity. The global trade of medicinal- and related plant materials was estimated to be of the approx. value 62 billion US$ in 2001. China has been successful in acquiring the single largest share in this export market because of its well-designed national policy on the traditional Chinese medicine. Ginseng is the major item of the Chinese export. Despite contradictory claims regarding India's share in the world market of medicinal plants, one thing is very clear that ideally it should have the second largest share, but the country lags far behind China owing to its unorganised trade system and inadequate policy. The Government of India has however been quite active since 2000 to overcome this problem, and has adopted many measures to give a boost to the export of medicinal plants. A National Medicinal Plant Board has been constituted to facilitate the conservation, propagation and marketing of important medicinal plants, and its statelevel counterparts are also operating to implement this mandate at the level of individual states. So far the value of export is concerned, both India and China have the same problem that most of their export is in the form of low-value added products which lowers the price. However, speaking ethically the current trend is against our age-old tradition of glorification of medicinal plants. Market has become the ultimate goal now, and self-reliance in local health care through the conservation & propagation of medicinal plants is of secondary importance. Hence, many people cultivate medicinal plants not for their consumption but for some use else-where. Of course, even during the British period people used to cultivate poppy, etc. for the end use else-where, but at that time such cases

were rather isolated; but now, thanks to the market-oriented policy of the government, this is going to become a national phenomenon. The case of safed-musli is an example. And since it is the market which decides which plant is to be cultivated or propagated, the role of local health care traditions becomes marginal in the conservation of medicinal plants and hence many traditionally important plants are actually ignored. Globalisation is essentially market-centric, and this marketoriented approach is ultimately derogatory to India's rich and powerful tradition of local health care. And the sufferers of its impact would be the lower income group in particular, though the middle class would also be affected. Overexploitation has been one of the impacts of market forces, which in turn has made many plant species endangered. Although this phenomenon has been noticed well before globalisation started, the global trend in herbal trade has helped to spread it further. Extremely unorganised trading, natural absence of several species of demand in the wild, and bad harvesting/marketing practices are some of the major factors which have helped to more or less neutralise the quantitative impact of the global trend in herbal trade on the medicinal plants of Orissa. However, cases of overexploitation are there. Of late, commercial cultivation of some species is becoming a craze for some people who are lured by the market forces, but cases of failure are not rare. On the other hand, qualitative impact of the global trend has been noticed.
All rights reserved by VASUNDHARA(www.vasundharaorissa.org). For any clarification, contact author at sunlit1968@yahoo.co.in

3 1. Introduction: Medicinal plants assumed commercial significance since millennia, but it is only during the last few decades that this significance has increased remarkably with the growing production as well as popularity of herbal drugs, herbal cosmetics and nutraceuticals. The recent trend has simultaneously led to a heavy pressure on the medicinal plant resources of the country due to increased unsustainable exploitation of the same, and it is in this context that an assessment of the impact of globalisation on such plants/resources has been very pertinent as there is an apprehension that globalisation would lead to the overexploitation of country's resources(including medicinal plants). 2. Research hypothesis:

The study was conducted with an impression that globalisation had accelerated overexploitation of valuable medicinal plants in the state(Orissa). 3.Study methodology: As adequate secondary references seemed lacking on our research topic, hence certain parameters were selected for an analysis of the impact. For instance, an adverse impact of globalisation can be judged from a substantial increase in export of crude plant drugs to western countries during the last decade. Similarly, status of cultivated crops(medicinal) can also serve as an indicator of the nature of commercial interest in medicinal plants. The study was planned to be based on inferences to be drawn on inputs available from traders, Ayurvedic drug manufacturers and other stakeholders; as well as from relevant publications like newspaper reports, articles, trends in import/export, etc. Accordingly, stakeholders like traders were interacted with in and outside Orissa; and export-import data was purchased from the Director General of Commercial Intelligence & Statistics, Kolkata for the years 1987-88 to 200304. 4. Study period: The study was initiated in June 2004 and was completed in July 2005. 5. Results and discussions: 5.1 Globalisation: the concept and the apprehension: Globalisation basically attempts at establishing more or less a uniform order in the world pertaining to trade and economic activities. The endeavour to swiftly enforce such a kind of effort has been facilitated from various directions and in various forms, by some international agencies like the World Bank and International Monetary Fund. Treaties like the General Agreement on Trade and Tariff (GATT) have become the legal means though which this is implemented.
All rights reserved by VASUNDHARA(www.vasundharaorissa.org). For any clarification, contact author at sunlit1968@yahoo.co.in

4 Globalisation has created opportunity for the marketing of several products from the developing and underdeveloped countries, in the western countries. For instance, China's textile business has been increased substantially in the international market. However, the apprehension in the third world countries regarding the consequences of globalisation is based on the fact that the concept of globalisation was basically put forward by

the rich and developed countries of the west in the interest of their own market economy and political strategy. Free market and free trade were supposed to be the two key slogans of this globalisation movement; and the developed countries were supposed to be the major beneficiaries as they intended to take advantage of the relaxations in the regime of different developing as well as under-developed countries so as to exploit the markets and resources of such countries in their interest. In fact, globalisation has been seen and felt as a strategy of recolonising the third world countries. Commercialisation and commodification of not only the resources, but also the value systems related to them, have been the ultimate outcome of globalisation. For instance, the country can now be ready to sell some of its resources, which were earlier not supposed to be saleable given their strategic-,socio-cultural-, or any other importance, if an alluring price is offered for the same. Such a price is normally offered by multinational/trans-national companies (MNCs/TNCs) as their currency has a greater purchase value than ours. As regards medicinal plants in particular, the impact was supposed to have all or any of the following forms: Increase in export/import of raw drugs Increase in the domestic and international business of traditional medicines manufactured from the raw drugs. Significant increase in research on the bio-chemical and clinical performances/properties of med. plants. Significant increase in patenting of herbal products. Boost to the phytochemical industry. 5.2 Global trend of herbal market: Herbals drugs, unless they are adequately standardised in the allopathic way, are almost without any scope of getting prescribed in the western countries. On the other hand, in the developing as well as underdeveloped countries, where the norms are not so strict and also the modern system is yet to completely dominate over the traditional systems, the scope of their marketing is better. Whenever the global trend of the herbal market is discussed, although in the first place it seems

to be concerned about the quantitative increase or decrease in the demand and supply status of herbal materials; the actual emphasis is on the value of trading. It is in this latter context that the role of western countries becomes important as the value of trading becomes significantly higher with respect to the marketing in these countries. Introduction Herbal medicine has been used in India for thousands of years and is increasingly been used worldwide during the last few decades as evidenced by rapidly growing global and national markets of herbal drugs. The global pharmaceutical market was worth US $550 billion in 2004 and is expected to exceed US $900 billion by the year 2009. According to WHO estimates, the present demand for medicinal plants is ~US $14 billion a year and by the year 2050 it would be ~US $5 trillion. Due to high prices and harmful side effects of synthetic drugs, people rely more on herbal drugs and this trend is growing, not only in developing countries but in developed countries too. India has 2.4% of world's area with 8% of global biodiversity. The forests of India are estimated to harbour 90% of India's medicinal plants diversity in the wide range of forest types that occur. In India, around 25,000 effective plant-based formulations are used in traditional and folk medicine. More than 1.5 million practitioners are using the traditional medicinal system for health care in India. It is estimated that more than 7800 manufacturing units are involved in the production of natural health products and traditional plant-based formulations in India, which requires more than 2000 Tones of a medicinal plant raw material annually. [1],[2] Unfortunately, the number of reports of people experiencing negative effects, caused by the use of herbal drugs, has also been increasing. There may be various reasons for such problems, poor quality of herbal medicines due to insufficient attention being paid to the quality assurance and control of these products. Although WHO has developed guidelines for the quality control of herbal drugs which provide a detailed description of the techniques and measures required for the appropriate cultivation and collection of medicinal plants, there is still a lacuna between this available knowledge and implementation, because farmers and other relevant persons like producers, handlers and processors of herbal drugs are not much aware of WHO's guidelines and they continue their work as before without any quality control measures which results in inferior quality of herbal drugs with lots of contaminants like heavy metals, pesticides and microbes. Hence, training for farmers and other relevant persons is an important measure to be taken to ensure good quality of raw herbal drugs. Contamination with excessive banned pesticides, microbial contaminants, heavy metals and chemical toxins causes various deformities like congenital paralysis, sensory neural defects, liver and kidney damage etc. These contaminants may be related to the source of herbal drugs, if these are grown under contaminated environment. Chemical toxins may come from unfavourable post harvest techniques, wrong storage conditions or chemical treatment during the storage period etc.

Some of these environmental factors may be controlled by implementing good source, good agricultural practices (GAPs) and standard operating procedures (SOP) for producing good quality herbal products. [3],[4],[5],[6] Herbal medicines may be associated with a broad variety of microbial loading and exert an important impact on the overall quality of herbal products and preparations. Generally, herbs are valued for their distinctive aroma, colour and flavour. Unfortunately, they are often contaminated with high levels of bacteria, molds and yeasts; if untreated, the herbs will result in rapid spoilage of the foods and can also result in serious food-borne illness. Post harvest and post-processing, herbs are always contaminated with microorganisms from the plants themselves, soil, water, air and dust. A wide spectrum of microorganisms and microbial loads has been previously reported in medicinal plants. Risk assessment of the microbial load of medicinal plants has therefore become an important subject in the establishment of modern Hazard Analysis and Critical Control Point (HACCP) schemes or International Standards Organization (ISO) standards. Most countries set maximum dose regulatory limits and these higher limits allow for higher levels of microbial control. Gamma irradiation in the range of 3-10 kGy reduces the total aerobic viable cell counts in highly contaminated spices and dry herbs to 103-104 CFU/g. Gamma irradiations is better than ethylene dioxide treatment (Food and Environmental Protection Section Joint FAO/IAEA Division Nuclear Techniques in Food and Agriculture International Atomic Energy Agency, 1999). [4],[7] According to microbiological criteria for spices that have been recommended by the International Commission on Microbiological Specifications for Foods (ICMSF, 1974), spices are of an unacceptable quality when the bacterial counts exceed 106 CFU/g and the numbers of molds are higher than 104 CFU/g. The herbs could be contaminated by human handlers during harvesting or processing. Coliform bacteria were also detected in all herbs, at levels varying with the season. The highest levels were found in herbs harvested in the summer due to high temperatures which enhanced bacterial growth, even in dried powdered herbs. The presence of coliforms implied the possibility of faecal contamination and inadequate sanitation management, while the herbs were being grown. According to WHO and European Pharmacopoeia, herbal drugs must meet the modern hygienic standards, which aim at low microbial load or the absence of pathogenic microorganisms. WHO, USFDA , European Scientific Cooperative on Phytomedicine (ESCOP) have published standard sets of guidelines to address the concerns. [8],[9],[10] Contamination of herbal drugs with heavy metals is also of prime concern. The poor quality control of these products causes health hazard, as some products may have unusually high concentration of potent and poisonous ingredients that may be fatal if consumed unknowingly. Herbal medicine products can be sold as dietary supplements, which are not required to undergo rigorous testing before entering the marketplace. Indeed, the Dietary Supplement Health and Education Act (DSHEA) do not require proof of safety or efficacy. This leads to heavy metal poisoning, so it is required to have a mandatory test of all imported dietary supplements for toxic heavy metals. The sorts of problems that could arise from toxicity include seizures, high blood pressure, kidney damage and developmental delay in children. The reasons for the heavy metals could be

contamination from groundwater or the addition might be intentional as Ayurvedic medical texts do argue that heavy metals are good for health. The main cause is the lack of good agricultural practices (GAP). Arsenic poisoning could manifest as nausea, abdominal pain, vomiting, muscle cramps, heart abnormalities, liver damage, anaemia and reduced motor nerve function, while lead poisoning can cause weight loss, insomnia, dizziness, swelling of the brain and paralysis. Mercury poisoning could be associated with tremors, insomnia, memory loss, slowed sensory and motor nerve function and reduced mental function. [11],[12],[13] International Market Scenario of Traditional Herbal Products Traditional Chinese Medicine (TCM) uses over ~5000 plant species, while India uses about ~7000. But still in the international market, TCM is well established when compared to Indian Ayurvedic medicine, which is in such a tenuous condition, and the way they have grown to be accepted and developed have been haphazard and informal. It is for these reasons why the Indian herbal medicines market is reputedly worth around ~US $1 billion worldwide, as against the global market for herbal medicines which is in the region of US $62 billion, with the Chinese herbal medical market said to be worth ~ US $19 billion. A huge opportunity awaits the ingenious Indian pharmaceuticals, to be availed through innovation, patents and trademarks [Figure 1]. India has enormous resources of medicinal and herbal plants. The pre-historic knowledge of Ayurveda and its applications to cure illnesses effectively has not been explored fully by India. If this happens successfully, India could gain a very significant competitive edge in the global market, especially in the pharma, beauty care and healthcare segments. There is a lot of scope for India to achieve global leadership through export of quality produce and products from medicinal and aromatic plants. But India seems to be lagging behind and is ranked third in the herbal medicine category, with less than 2% of global market share, while China occupies nearly 30% of the market [Figure 2] and [Figure 3]. According to an Ayurveda expert, Chinese herbal medicines, which rarely contain 10% scientific base when compared with the Indian Ayurvedic system, are doing better than India by 50-fold. [14],[15] The major reasons may be: 1. There have been a very large number of Chinese people immigrating into the USA and they support Chinese culture. There are only few Indians in America and only five colleges that provide training in Ayurveda. Globally, Chinese herbs are more preferred probably because of the research which the western countries are conducting on these herbs. As in India, the medicinal herbs hardly undergo 'double blind trials' to establish their real usefulness. The scientific base for Indian herbal medicines is lacking. [16],[17],[18] 2. China has been willing to actively export its medical system. Under government sponsorship, China produced translated books and sent them to America. The crude herbs and finished herbal products have been imported by Chinese immigrants and made available to anyone who wanted them. By contrast, the Indian government is not involved in export of Ayurveda and few Indian writers

have made an effort to have their books published for an American audience. [19],
[20]

3. The Chinese medical system's basic concepts of yin and yang and five elements, the unusual practice of acupuncture, TUI NA (therapeutic massage) have attracted attention from a diverse group of people. In contrast, the three doshas, the emphasis on dietary restrictions and the importance of such methods as oil massage and various purification procedures, has attracted a much smaller audience. The most heavily promoted traditional Ayurvedic practice is Panchakarma (a purification procedure). In the USA, it is offered as a several day event (requiring the person to make a major change in their normal schedule and habits) that has a high expense leaving it open only to the wealthy. In contrast, an acupuncture session usually lasts about half an hour and can be fit into most schedules, and it has a modest cost per session. [21],[22],[23] 4. Further, the quality of herbal materials from China has been better than those from India in many instances (due to differences in quality control procedures). Quality control, standardization, scientific methods of production and evaluation were completely missing in India. China has successfully overcome such difficulties by modernizing its traditional medicine profession with governmentsponsored GAPs and Good Manufacturing Practices (GMPs). GAPs stress selection of the correct germplasm with a high content of stable active components. The cultivation practices offer SOPs for use of fertilizers, irrigation systems and disease management allied with insects and pest prevention and cure. GAPs also establish standards for noxious and harmful contaminants like heavy metals, pesticide residues and microbes in plants. All manufactures of TCM are mandated to comply with guidelines laid down by China's State Drug Administration (SDA) by 2004 and farms producing raw ingredients must comply with SDA-imposed standards by 2007. [24],[25],[26]

Although Chinese medicine has gained considerable ground, it cannot be compared with the most significant import of India so far in the international arena that is Yoga which is a part of the Ayurvedic medical system. A well-directed effort could result in Ayurveda having a standing somewhat similar to that of Chinese medicine, while continuation of the laissez-faire approach that seems to have marked this field up to now could mean that bits and pieces of Ayurveda will simply be subsumed into the general arena of Complementary and Alternative Medicine (CAM). Nevertheless, the Indian herbal medicine market is growing at a steady pace of between 15% and 20% every year. Indian and Chinese medicines have a lot in common. Some Chinese herbs that were imported into India include green tea and cinnamon and some essential oils such as oil of bergamot, citronella oil, essential oils of geranium, spearmint oil, essential oil of vetiver, anise oil, cinnamon bark oil, eucalyptus oil and ginger oil. [27],[28] Examples of successful companies, such as Himalaya Drug Company (HDC), Emami, Aswini, Ayur, Dabur, Cholayil Pharma, etc., that have patented their herbal and ayurvedic products in India and abroad. [29]

Determinants of Success Government of India also has expressed support and encouragement for the Traditional Indian Medicine (TIM). A separate department for Indian Systems of Medicine and Homeopathy now known as AYUSH (Ayurveda, Yoga, Unani, Siddha, Homoeopathy) was established in March 1995 to promote indigenous systems. Priorities include education, standardization of drugs, enhancement of availability of raw materials, research and development, information, communication and larger involvement in the national system for delivering health care. The Central Council of Indian Medicine oversees teaching and training institutes, while Central Council for Research in Ayurveda and Siddha deals with interdisciplinary research. [30],[31] India has world-class expertise and facilities for organic synthesis, isolation and structure elucidation, biological screening, toxicological testing and pharmacokinetics. This is supplemented by the expertise for the development of agro-technology for the cultivation of medicinal plants. Industry participation to ensure successful upscaling and implementation of technology is increasing. India has progressive research institutes like Central Drug Research Institute (CDRI), Central Institute of Medicinal and Aromatic Plants and National Botanical Research Institute, at Lucknow, Regional Research Laboratories (RRL), at Jammu, and Bhubaneshwar, North East Institute of Science and Technology (NEIST), Jorhat, National Chemical Laboratory, at Pune, which routinely undertake research on medicinal plants. Most of them are involved in standardizing the herbal medicines and isolating active compounds, quality planting materials for farmers, conservation of endangered species and to prevent exploitation of the natural resources.
[32],[33]

Analysis of most frequently used plant-based therapies in the Ayurvedic system revealed that 43% of them have been tested on humans, while 62% have been the subject of one or more animal studies. Among these, drugs having sufficient clinical data are guggul, brahmi, ashwagandha, amlaki, guduchi, kutki, shatavari and shunthi Pharmacopoeia of India (1996) covers few botanical monographs like clove, guggul, opium, mentha, senna and ashwagandha. The Ayurvedic Pharmacopoeia of India gives monographs for 258 different Ayurvedic drugs. [34] Presently, Indian systems of medicine use more than 1100 medicinal plants of which most are collected from the wild. More than 60 species are in great demand. The tribal belt of India is rich in these plants and the tribes mainly depend on this trade for livelihood. There are ample of opportunities for adulteration and contamination in the process. Thus, the adequate availability of quality raw materials free from adulterants at reasonable prices has become a big problem for industry, and the demand is increasing every year. However, very few efforts have been made either by government or by industry to seriously study the supply and demand.

India needs to follow GAPs to ensure the use of correct raw materials and cover the entire life cycle including the harvesting, processing, transportation and storage. The selection of the correct germplasm using modern DNA fingerprinting and chemoprofiling techniques is also a priority. [35] The domestic herbal market has now crossed the Rs.5000 crore mark, and is set to reach further heights this year. Herbal exports from India are worth Rs.450 crore, whereas even a decade back the amount was barely Rs.100 crore. This may not be a huge sum when compared to the Chinese herbal exports market which is worth Rs.2000 crore, but the sheer potential of the Indian herbal companies should make people sit up and take notice. The biggest stumbling block facing the Indian herbal care segment is still the lack of trust it generates in the developed markets like Europe and USA. It is widely believed that Indian herbal extracts do not undergo rigorous toxicity tests. Indian firms would have to be better in promoting themselves internationally, especially in regulated markets. Indian herbal extracts will have to undergo stricter toxicity tests to win the confidence of the developed world. [36],[37],[38] Numerous drugs have entered the international pharmacopoeia via the study of ethnopharmacology and traditional medicine. 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. Traditional medical practices can offer a more holistic approach to drug design and myriad of possible targets for scientific analysis. Powerful new technologies such as automated separation techniques, high-throughput screening and combinatorial chemistry are revolutionizing drug discovery and this will help to rediscover the drug discovery process. [39],[40],[41]

Safety of herbal medicines Although it is widely perceived that "natural" products are safe, the evidence suggests that CAM use is not without risk. Of 90 patients with rheumatoid arthritis, 82% had tried more than one form of alternative medicine or therapy, including dietary modification, and 31% of these patients had experienced at least one adverse effect.8 Of 1701 consecutive patients admitted to the Prince of Wales Hospital, Hong Kong, three (0.2%) had had adverse effects attributed to traditional Chinese medicines and 75 (4.4%) to "Western" medications.9 A review of 5563 enquiries received by the National Poisons Unit, London, showed that 77.7% involved vitamin preparations and 19.3%, herbal extracts, royal jelly, hormonal products and other natural products. Exposure was linked to adverse effects in 49 (0.9%) of these cases.10 In ascertaining whether a substance is associated with an adverse effect, the medical literature may be of limited help -- there may be no previous report of such an event, as was the case for fatal anaphylaxis which occurred in an 11-year-old child with asthma after her third exposure to royal jelly.11 Prior to this event, contact dermatitis had been documented with royal jelly (which contains proteins, carbohydrates, amino acids, vitamins, lipids and fatty acids), but the allergen had not been identified.12 At the time of

the child's death, the Adverse Drug Reactions Advisory Committee (ADRAC) of the Commonwealth Department of Health and Family Services had three reports of adverse reactions to royal jelly on file: one of anaphylaxis and two of bronchospasm (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972-May 1993; personal communication). Raised awareness of this problem resulted in the TGA advising manufacturers to label royal jelly products to warn of their potential to cause severe allergic reactions in people who suffer from asthma or allergies.13 ADRAC have now received a total of 18 reports of allergic reactions to royal jelly, including two fatalities (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972February 1997; personal communication).

INDIAN HERBAL TRADE IN WORLD SCENARIO

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KayaClinic.com The utilization of herbal drugs is on the flow andthe market is growing step by step. The annual turnover of the Indian herbal medicinal industry isabout Rs. 2,300 crore as against the pharmaceuticalindustry's turnover of Rs. 14,500 crores with a growthrate of 15 percent . The export of medicinal plantsand herbs from India has been quite substantial in thelast few years. India is the second largest producer ofcastor seeds in the world, producing about 1,25,000tonnes per annum. The major pharmaceuticals exportedfrom India in the recent years are isabgol, opiumalkaloids, senna derivatives, vinca extract, cinchonaalkaloids, ipecac root alkaloids, solasodine,Diosgenine/16DPA, Menthol, gudmar herb, mehdi leaves, papian, rauwolfia guar gum, Jasmine oil, agarwood oil, sandal wood oil, etc. The turnover ofherbal medicines in India as over-the-counter products,ethical and classical formulations and home remediesof traditional systems of medicine is about $ one billionand export of herbal crude extract is about $ 80 million. The herbal drug market in India is about $1 billion. In India, It is estimated that there are about 25,000licensed pharmacy of Indian system of medicine.Presently about 1000 single drugs and about 3000compound formulations are registered. Herbal industryin India uses about 8000 medicinal plants.However, none of the pharma hasstandardized herbal medicines using active compoundsas markers linked with confirmation of bioactivity ofherbal drugs in experimental animal models. about 8000 drug manufactures in India, there arehowever not more than 25 manufactures that can beclassified as large scale manufactures.

The annualturnover of Indian herbal industry was estimated aroundUS $ 300 million in Ayurvedic and Unani medicinewas about US $ 27.7 million. In 1998-1999 again wentupto US $ 31.7 million and in 1999-2000 of the totalturnover was US $ 48.9 million of Ayurvedic andherbal products. Export of herbal drugs in India isaround $ 80 million. Some of the highly consumedmedicinal plants are presented in the Table 3 withreference to their turnover.

Tulsi Benefits
Tulsi plant has a lot of significance for mankind, due to the manifold medicinal benefits it provides. Tulsi leaves are widely used in the preparation of Ayurvedic medicines. It is known to promote the longevity of life. The extracts obtained from the plant are extensively brought to use for curing various diseases such as the common cold, inflammation, malaria, heart disease, headaches, stomach disorders, kidney stones, heart disorders, and many more. The Indian basil Tulasi also aids in the purification of atmosphere. Tulasi plant serves as a fabulous repellant in fighting against flies, mosquitoes and insects. It is especially valuable in combating malarial fever. It is said that at the time of establishment of Victoria gardens in Bombay (now Mumbai), the workers became victims of mosquito bites and suffered from chronic malaria. Seeing the pitiable situation of the workers, some of the Hindu managers recommended the plantation of Tulsi plant in the garden. On following their advice, fruitful results were obtained. Thus, holy basil Tulsi helped to abate the growth of mosquitoes and control malaria. There are numerous uses of Tulsi plant. The plant is increasingly finding its way in the Ayurvedic treatment of diseases. Tulsi leaves are widely used due to their healing power. It is a tonic for the nervous system and thus, helps a great deal in sharpening the memory. This aromatic plant supports the removal of phlegm and catarrhal matter from the bronchial tube. It also works wonders in preventing stomach disorders. The herb Tulsi is known to cure the respiratory disorders. The decoction prepared by mixing honey, ginger and Tulsi leaves is quite helpful in combating bronchitis, influenza and asthma. The leaves of Tulsi plant are extremely beneficial during the rainy season, when diseases like malaria and dengue victimize the country. Boil the tender leaves of Tulsi in tea and give it to the patient. The juice extracted from Tulsi leaves serves as the best remedy to bring down fever. Tulsi is an essential ingredient in the preparation of Ayurvedic cough syrups. It is highly useful in getting rid of cold and flu. Even, for sore throat, the leaves of medicinal plant Tulsi is of great value. Just boil the leaves of Tulsi in water and ask the patient to gargle with this decoction. Tulsi has the ability to strengthen the kidneys. For those suffering from the problem of renal kidney stones, the decoction prepared by mixing the juice of Tulsi leaves with honey, if taken sincerely for six consecutive months can oust these stones via the urinary tract. For maintaining healthy heart, Tulsi is of utmost value. It helps in lowering the level of cholesterol in blood. Thus, Tulsi plant serves as the most effective remedy to combat cardiac diseases.

Benefits of the Tulsi (Ocimum Sanctum)

In traditional Indian medicine system called Ayurveda, Tulsi (Holy Basil) is considered as a tonic to retain youth and avoid aging. Vitamin C, Vitamin A, Phytonutrients and the essential oils in Tulsi, are excellent anti oxidants and protects the body from nearly all the damages caused by the free radicals. . Tulsi reduces blood glucose levels. Thus it is useful for diabetics. Tulsi contains vitamin C and other anti oxidants (such as Eugenol), which protect the heart from harmful effects of free radicals. . Tulsi reduces total cholesterol levels. Thus it is useful for heart disease patients.Tulsi also reduces blood pressure. . Tulsi helps in building up stamina , use it to prepare herbal tea. . Tulsi is useful in the treatment of respiratory system disorders. A decoction of the leaves, with honey and ginger is an effective remedy for bronchitis, asthma, influenza, cough and cold. A decoction of the leaves, cloves and common salt also gives immediate relief in case of influenza. They should be boiled in half a liter of water till only half the water is left and add then taken.Tulsi is an important constituent of many Ayurvedic cough syrups and expectorants. It helps to mobilize mucus in bronchitis and asthma. Chewing tulsi leaves relieves cold and flu. . Tulsi is used as mouth wash for reducing tooth ache.Its leaves, dried in the sun and powdered, can be used for brushing teeth. It can also be mixed with mustered oil to make a paste and used as toothpaste. This is very good for maintaining dental health, counteracting bad breath and for massaging the gums. It is also useful in pyorrhea and other teeth disorders. . Tulsi is an excellent mouth freshener and oral disinfectant and its freshness lasts very long in the mouth. Holy Basil destroys more than 99 percent of the germs and bacteria in the mouth and this effect lasts long. It also cures ulcer in the mouth. It is also known to help inhibit growth of oral cancer caused by chewing tobacco etc. . Tulsi (Holy Basil) is an excellent anti biotic, germicidal, fungicidal and disinfectant and very efficiently protects our body from nearly all sorts of bacterial, viral and fungal infections. Fever is mainly caused due to infections from protozoa (in case of malaria), bacteria (typhoid), viruses (flu) and even allergic substances and fungus. Actually, fever is not an ailment in itself. It is just a symptom which shows that our body is fighting against infections. The tremendous disinfectant, germicidal and fungicidal properties of Tulsi destroys all these pathogens discussed above and heals fever. It is an old practice in India to have decoction of Tulsi leaves and flowers in cases of fever . Tulsi leaves are regarded as an 'adaptogen' or anti-stress agent. Recent studies have shown that the leaves afford significant protection against stress. Even healthy persons can chew 12 leaves of basil, twice a day, to prevent stress.It also has immunomodulatory properties. . Many herbal cosmetics contain tulsi. Tulsi purifies blood. Applied locally, Tulsi juice is beneficial in the treatment of ringworm and other skin diseases and hence used in skin ointments. Tulsi leaves or oil extracted from it on the body keeps mosquitoes and other insects away. . Insect Bites: The herb is a prophylactic or preventive and curative for insect stings or bites. A teaspoonful of the juice of the leaves is taken and is repeated after a few hours. Fresh juice must also be applied to the affected parts. A paste of fresh roots is also effective in case of bites of insects and leeches.Tulsi acts as insect repellant. So it is used to store grains also. . Tulsi is useful in Eye Care & Headache. You can be free from conjunctivitis, boils and many other problems of eyes (which are caused due to viral, bacterial or fungal infection) by washing your eyes with water where few leaves of Tulsi are soaked. It also soothes eyes and reduces stress. A regular consumption can protecteyes from all the damages done by the free radicals, such as cataract, macular degeneration, glaucoma, vision

defects, opthalmia etc. due to the high anti oxidant properties of its essential oils, vitamin A, vitamin C, etc. Headaches caused due to migraine, sinus, cough and cold, high blood pressure, etc. can be effectively controlled by the use of Tulsi. Camphene, Eugenol, Cineol, Carvacrol and Methyl Chavicol have excellent analgesic, sedative, anti congestive and disinfectant properties. . Recent research shows that tulsi does have analgesic ( pain killer) properties similar to COX 2 inhibitor drugs. . Ursolic acid, a chemical in tulsi may have a role as antifertility ( contraceptive) agent in future. . Tulsi, being detoxifier and mild diuretic in nature, can help reduce uric acid level (main culprit as far as kidney stones are concerned) concentration in the blood as well as helps cleaning of the kidneys through urination. Acetic acid (CH3COOH) and certain components in its essential oils also facilitate dissolution of the stone. It has painkiller effects and help bear the pain from kidney stones. . Tulsi can protect from radiation poisoning and also heal up damages from it. It acts as a vaccine against pox if consumed regularly. It is anti carcinogenic and it found to be effective in healing nearly all types of cancer and tumors.

Reasearch & Development Research

& Development division of Tulasi Seeds Pvt. Ltd. was started in 1994 with a view to develop superior hybrids and OPVs for higher yield, early maturity, better quality and resistance to biotic & abiotic stresses in major crops. The DSIR (Dept. Of Scientific and Industrial Research), Ministry of Science & Technology, Govt. of India, New Delhi after thorough verification, the R&D activities available with us, were pleased to accord recognition to our in-house R&D . Due to the continuous efforts at R & D division, several high yielding hybrids in crops like Cotton, Hot Pepper, Maize, Sunflower, Sorghum, Pearl millet, Okra, Egg Plant, Watermelon, Gourds etc have been developed. Very popular and revolutionary Tulasi BG II/Bt cotton hybrids have been approved by the Govt. of India, New Delhi for commercial cultivation and these BG II / Bt hybrids are showing excellent performance in farmers fields.

Tulasi products are known for their excellent quality. The seed production, processing, quality tests and packing of seeds are done as per stringent
Quality Assurance

quality assurance norms. Seed quality implies to genetical, physical, physiological and health components. Utmost care is taken at the time of seed production, processing, storage and distribution by continuous quality testing. A well equipped quality control laboratory is available where quality tests like seed germination, physical purity, moisture, health etc are conducted. Genetic purity tests (Grow Out Tests) are conducted at Tulasi research farm. A separate quality control squad is available for thorough checking at seed production fields and processing plants. Proper guidance is also given for maintaining hygiene conditions at seed processing plants and seed storage godowns.

What is Tulsi (Holy Basil)?

"The Queen of Herbs" - is the most sacred herb of India. Tulsi (Ocimum sanctum), although also known as Holy Basil, is a different plant from the pesto variety of Basil (Ocimum basilicum). Tulsi has been revered in India for over five thousand years, as a healing balm for body, mind and spirit, and is known to bestow an amazing number of health benefits. ORGANIC INDIA is pleased to offer Organic Tulsi, for the first time, as a stress-relieving, energizing and delicious tea. For our ORGANIC INDIA Tulsi Tea Collection we utilize a proprietary combination of 3 varieties of Tulsi: Rama Tulsi (Ocimum sanctum), Krishna Tulsi (Ocimum sanctum) and Vana Tulsi (Ocimum gratissimum). Each variety lends its own distinct and characteristic taste that contributes to the delicious flavor and aroma of our blend.

What are the health benefits of Tulsi?

Tulsi is rich in antioxidant and renowned for its restorative powers, Tulsi has several benefits:

Relieves stress / adaptogen Bolsters immunity Enhances stamina Provides support during cold season Promotes healthy metabolism A natural immuno-modulator

"Modern scientific research offers impressive evidence that Tulsi reduces stress, enhances stamina, relieves inflammation, lowers cholesterol, eliminates toxins, protects against radiation, prevents gastric ulcers, lowers fevers, improves digestion and provides a rich supply of antioxidants and other nutrients. Tulsi is especially effective in supporting the heart, blood vessels, liver and lungs and also regulates blood pressure and blood sugar." Dr. Ralph Miller, former Director of Research for the Canadian Dept. of Health and Welfare.

How can Tulsi offer so many health benefits?

The unique chemistry of Tulsi is highly complex. Tulsi contains hundreds of beneficial compounds known as phyto-chemicals. Working together, these compounds possess strong antioxidant, antibacterial, antiviral, adaptogenic, and immune-enhancing properties that promote general health and support the body's natural defense against stress and diseases. The essential oils in the leaves of Tulsi that contribute to the fragrance and refreshing flavor of Tulsi Tea, are a particularly rich source of valuable phyto-chemicals.

What is an adaptogen?
An adaptogen is an agent that helps the body adapt more efficiently to stress. Adaptogens reduce the intensity and negative impact of the stress caused by mental tension, emotional difficulties, poor lifestyle habits, disease and infection, pollution and other factors. Tulsi is one of the most effective adaptogens known.

What are antioxidants?

Antioxidants slow down the process of excess oxidation and protect cells from the damage caused by free radicals. When cells are attacked by free radicals, excess oxidation occurs which damage and destroy cells. Antioxidants stop this process. The cellular damage caused by free radicals can be responsible for causing and/or accelerating many diseases. Tulsi is rich in antioxidants and is recommended to guard against free radicals and protect from damaging excess oxidation.

What is an immuno-modulator?
An immuno-modulator is an agent that balances and improves the immune response of the body in fighting antigens (disease causing agents such as bacteria, viruses, microbes, allergens etc.) and maintaining health.

How soon can I expect to see results from drinking ORGANIC INDIA Tulsi Teas?
Some of Tulsi effects are quite immediate, while others develop gradually after weeks of regular use. For example, you may feel more relaxed and energized after the first cup. Although Tulsi has many specific effects on different body systems, its main benefits arise from its impressive general capacity to assist the body's natural process of healing and maintaining health. Tulsi overall health promotion and disease prevention effects are powerful, but often subtle. For example, you may simply notice that you do not seem to be bothered by stress or common illnesses, such as colds or flu, nearly as often as before. Or you may notice that you generally tire less easily. As with many other herbal supplements, it usually takes at least a week or so of consistent use for the body to experience major benefits.

ABSTRACT Herbal medicines are widely used for treatment of human ailments in various systems of medicines like Ayurvedic, Homeopathic, Sidha, Unani and other regional systems of medicines. Herbal drug products classification vary from country to country, some categories include functional foods, dietary supplements and traditional medicines. Critical problem in the evaluation of herbal drug products is that these are complex mixtures of constituents and the constituents responsible for the therapeutics effects are unknown which also complicates the stability of these products. A detailed literature survey and search on internet for regulations of herbal drug products in Europe, US and India was performed to identify recently introduced changes in regulations or newly introduced regulations. Committee for Herbal Medicinal Products (HMPC) Committee of European Medicines Agency (EMA) is developing guidelines for quality, nonclinical studies, clinical efficacy and safety. Traditional herbal medicines registration scheme (THMRS) has been recently introduced by Medicines and Healthcare Products Regulatory Agency (MHRA, UK). US FDA has issued draft guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation. Drugs and Cosmetics Rules have been amended recently to control the quality, safety and efficacy of herbal drug products in India. It has been found that regulations for herbal drug products in Europe and United States are more stringent than in India which has been reflected by some reports of safety issues of Indian herbal drug products exported to these countries. Introduction Herbal Medicine, sometimes referred to as Herbalism or Botanical Medicine, is the use of herbs for their therapeutic or medicinal value. An herb is a plant or plant part valued for its medicinal, aromatic or savory qualities. Herb plants produce and contain a variety of chemical substances that act upon the body.

Herbalists use the leaves, flowers, stems, berries, and roots of plants to prevent, relieve, and treat illness. From a "scientific" perspective, many herbal treatments are considered experimental. The reality is, however, that herbal medicine has a long and respected history. Many familiar medications of the twentieth century were developed from ancient healing traditions that treated health problems with specific plants. Today, science has isolated the medicinal properties of a large number of botanicals, and their healing components have been extracted and analyzed. Many plant components are now synthesized in large laboratories for use in pharmaceutical preparations. For example, vincristine (an antitumor drug), digitalis (a heart regulator), and ephedrine (a bronchodilator used to decrease respiratory congestion) were all originally discovered through research on plants.

History of Herbal Medicine Herbal medicine is the oldest form of healthcare known to mankind. Herbs had been used by all cultures throughout history. It was an integral part of the development of modern civilization. Primitive man observed and appreciated the great diversity of plants available to him. The plants provided food, clothing, shelter, and medicine. Much of the medicinal use of plants seems to have been developed through observations of wild animals, and by trial and error. As time went on, each tribe added the medicinal power of

herbs in their area to its knowledgebase. They methodically collected information on herbs and developed well-defined herbal pharmacopoeias. Indeed, well into the 20th century much of the pharmacopoeia of scientific medicine was derived from the herbal lore of native peoples. Many drugs commonly used today are of herbal origin. Indeed, about 25% of the prescription drugs dispensed in the United States contain at least one active ingredient derived from plant material. Some are made from plant extracts; others are synthesized to mimic a natural plant compound. Undisputedly, the history of herbology is inextricably intertwined with that of modern medicine. Many drugs listed as conventional medications were originally derived from plants. Salicylic acid, a precursor of aspirin, was originally derived from white willow bark and the meadowsweet plant. Cinchona bark is the source of malaria-fighting quinine. Vincristine, used to treat certain types of cancer, comes from periwinkle. The opium poppy yields morphine, codeine, and paregoric, a treatment for diarrhea Laudanum, a tincture of the opium poppy, was the favored tranquilizer in Victorian times. Even today, morphine-the most important alkaloid of the opium poppy-remains the standard against which new synthetic pain relieves is measured. Prior to the discovery and subsequent synthesis of antibiotics, the herb echinacea (which comes from the plant commonly known as purple coneflower) was one of the most widely prescribed medicines in the United States. For centuries, herbalists prescribed echinacea to fight infection. Today, research confirms that the herb boosts the immune system by stimulating the production of disease-fighting white blood cells. The use of plants as medicine is older than recorded history. As mute witness to this fact marshmallow root, hyacinth, and yarrow have been found carefully tucked around the bones of a Stone Age man in Iraq. These three medicinal herbs continue to be used today. Marshmallow root is a demulcent herb, soothing to inflamed or irritated mucous membranes, such as a sore throat or irritated digestive tract. Hyacinth is a diuretic that encourages tissues to give up excess water. Yarrow is a time-honored cold and fever remedy that may once have been used much as aspirin is today. In 2735 B.C., the Chinese emperor Shen Nong wrote an authoritative treatise on herbs that is still in use today. Shen Nong recommended the use of Ma Huang (known as ephedra in the Western world), for example, against respiratory distress. Ephedrine, extracted from ephedra, is widely used as a decongestant. You'll find it in its synthetic form, pseudoephedrine, in many allergy, sinus, and cold-relief medications produced by large pharmaceutical companies. The records of King Hammurabi of Babylon (c. 1800 B.C.) include instructions for using medicinal plants. Hammurabi prescribed the use of mint for digestive disorders. Modern research has confirmed that peppermint does indeed relieve nausea and vomiting by mildly anesthetizing the lining of the stomach. The entire Middle East has a rich history of herbal healing. There are texts surviving

from the ancient cultures of Mesopotamia, Egypt, and India that describe and illustrate the use of many medicinal plant products, including castor oil, linseed oil, and white poppies. In the scriptural book of Ezekiel, which dates from the sixth century B.C., we find this admonition regarding plant life: "..and the fruit thereof shall be for meat, and leaf thereof for medicine." Egyptian hieroglyphs show physicians of the first and second centuries A.D. treating constipation with senna pods, and using caraway and peppermint to relieve digestive upsets. Throughout the Middle Ages, home-grown botanicals were the only medicines readily available, and for centuries, no self-respecting household would be without a carefully tended and extensively used herb garden. For the most part, herbal healing lore was passed from generation to generation by word of mouth. Mother taught daughter; the village herbalist taught a promising apprentice. By the seventeenth century, the knowledge of herbal medicine was widely disseminated throughout Europe. In 1649, Nicholas Culpeper wrote A Physical Directory, and a few years later produced The English Physician. This respected herbal pharmacopeia was one of the first manuals that the layperson could use for health care, and it is still widely referred to and quoted today. Culpeper had studied at Cambridge University and was meant to become a great doctor, in the academic sense of the word. Instead, he chose to apprentice to an apothecary and eventually set up his own shop. He served the poor people of London and became known as their neighborhood doctor. The herbal he created was meant for the layperson. The first U.S. Pharmacopeia was published in 1820. This volume included an authoritative listing of herbal drugs, with descriptions of their properties, uses, dosages, and tests of purity. It was periodically revised and became the legal standard for medical compounds in 1906. But as Western medicine evolved from an art to a science in the nineteenth century, information that had at one time been widely available became the domain of comparatively few. Once scientific methods were developed to extract and synthesize the active ingredients in plants, pharmaceutical laboratories took over from providers of medicinal herbs as the producers of drugs. The use of herbs, which for most of history had been mainstream medical practice, began to be considered unscientific, or at least unconventional, and to fall into relative obscurity.

Herbal Medicine Today The World Health Organization (WHO) estimates that 4 billion people, 80% of the world population, presently use herbal medicine for some aspect of primary health care. Herbal medicine is a major component in all indigenous peoples traditional medicine and a common element in Ayurvedic, homeopathic, naturopathic, traditional oriental, and Native American Indian medicine. WHO notes that of 119 plant-derived pharmaceutical medicines, about 74% are used in modern medicine in ways that correlated directly with their traditional uses as plant medicines by native cultures. Major

pharmaceutical companies are currently conducting extensive research on plant materials gathered from the rain forests and other places for their potential medicinal value. Today, the U.S. Pharmacopoeia, with its reliance on herbal compounds, has been all but forgotten. Most modern physicians rely on the Physician's Desk Reference, an extensive listing of chemically manufactured drugs. It is important to note that each entry in this enormous volume, in addition to specifying the chemical compound and actions of a particular drug, also includes an extensive list of contraindications and possible side effects. Rather than using a whole plant, pharmacologists identify, isolate, extract, and synthesize individual components, thus capturing the active properties. This can create problems, however. In addition to active ingredients, plants contain minerals, vitamins, volatile oils, glycosides, alkaloids, bioflavanoids, and other substances that are important in supporting a particular herb's medicinal properties. These elements also provide an important natural safeguard Isolated or synthesized active compounds can become toxic in relatively small doses; it usually takes a much greater amount of a whole herb, with all of its components, to reach a toxic level. Herbs are medicines, however, and they can have powerful effects. They should not tee taken lightly. The suggestions for herbal treatments in this book are not intended to substitute for consultation with a qualified health care practitioner, but rather to support and assist you in understanding and working with your physician's advice. Substances derived from the plants remain the basis for a large proportion of the commercial medications used today for the treatment of heart disease, high blood pressure, pain, asthma, and other problems. For example, ephedra is an herb used in Traditional Chinese Medicine for more than two thousand years to treat asthma and other respiratory problems. Ephedrine, the active ingredient in ephedra, is used in the commercial pharmaceutical preparations for the relief of asthma symptoms and other respiratory problems. It helps the patient to breathe more easily. Another example of the use of an herbal preparation in modern medicine is the foxglove plant. This herb had been in use since 1775. At present, the powdered leaf of this plant is known as the cardiac stimulant digitalis to the millions of heart patients it keeps alive worldwide. There are over 750,000 plants on earth. Relatively speaking, only a very few of the healing herbs have been studied scientifically. And because modern pharmacology looks for one active ingredient and seeks to isolate it to the exclusion of all the others, most of the research that is done on plants continues to focus on identifying and isolating active ingredients, rather than studying the medicinal properties of whole plants. Herbalists, however, consider that the power of a plant lies in the interaction of all its ingredients. Plants used as medicines offer synergistic interactions between ingredients both known and unknown.

The efficacy of many medicinal plants has been validated by scientists abroad, from Europe to the Orient. Thanks to modern technology, science can now identify some of the specific properties and interactions of botanical constituents. With this scientific documentation, we now know why certain herbs are effective against certain conditions. However, almost all of the current research validating herbal medicine has been done in Germany, Japan, China, Taiwan, and Russia. And for the most part, the United States Food and Drug Administration (FDA), which is responsible for licensing all new drugs (or any substances for which medicinal properties are claimed) for use in the United States, does not recognize or accept findings from across the sea. Doctors and government agencies want to see American scientific studies before recognizing the effectiveness of a plant as medicine. Yet even though substantial research is being done in other countries, drug companies and laboratories in the United States so far have not chosen to put much money or resources into botanical research. The result is that herbal medicine does not have the same place of importance or level of acceptance in this country as it does in other countries.

Common Herbs and Herbal Preparations Herbs are available in a variety of forms, including fresh, dried, in tablets or capsules, or bottled in liquid form. You can buy them individually or in mixtures formulated for specific conditions. Whatever type of product you choose, the quality of an herbal preparation-be it in capsule, tablet, tea, tincture, bath, compress, poultice, or ointment form-is only as good as the quality of the raw herb from which it was made. Generally, herbs fall into two categories: wild-grown and farm-grown. A wild-grown herb is one that grows naturally, without human intervention. As a result of natural selection, plants tend to be found in places with conditions that optimize their growth. For example, horsetail grows best in moist, swampy areas, while arnica thrives at high altitudes in alpine meadows. The process of gathering herbs from their natural habitats is called wildcrafting. The disadvantage of wild-grown herbs is that there is no guarantee the plants haven't been exposed to chemicals and pesticides. Herbs harvested from a meadow, for example, may have been exposed to chemical drift from a crop-dusted farm nearby. Exhaust fumes from passing traffic may have settled invisibly on plants growing near a country road. Water-loving plants, like horsetail, may be rooted in the bank of a polluted stream. Because of the possibility of contamination, unless you are very sure of the source of wildcrafted herbs, organic herbs grown commercially may be a better choice. Organic farm-grown herbs are becoming increasingly available, as more and more herb farms are being established. With careful management, organic herb farms can provide a steady supply of quality herbs to the consumer. To produce top-quality products, herb farmers require a great deal of specialized

knowledge. For maximum potency, it is important that particular herbs be harvested at the optimum moment. For example, echinacea is gathered in the spring, winter, and fall, but not in summer, when the plant's energies are concentrated on growth and flowering. Responsible farmers use compost and organic matter to fertilize and replenish the health of the soil. For obvious reasons, we favor the use of certified organically grown herbs, produced without the use of synthetic fertilizers or chemical pesticides. As of this writing, not all states have agencies inspecting and certifying organic growers, so to be sure you are getting pure, pesticide-free herbs grown without chemical contamination, check the label for the words "certified organic" before you make a purchase. The name of the certifying agency should be specified on the label. Two reliable organizations that certify organic products are the Organic Growers and Buyers Association and California Certified Organic Farmers. Organic products grown in the states of Washington and Texas should be certified organic by the Department of Agriculture of the relevant state. As of this writing, federal legislation on requirements for labeling a product "organic" has been passed, but is not yet being fully implemented. Once it is, it should be easier to be sure that you are buying a genuine organic product. Hopefully this will take place in the next few years.

Administering Herbal Treatment Herbs and prepared herbal compounds are available in different forms, each of which has its own particular characteristics. Your health food store will have individual herbs as well as complex herbal formulations, including raw herbs, tinctures, extracts, capsules, tablets, lozenges, and ointments. Here's a look at what's available.

Tinctures If the label says tincture, the preparation contains alcohol. In a tincture, alcohol is employed to extract and concentrate the active properties of the herb. Alcohol is also a very effective natural preservative. Because a tincture is easily assimilated by the body, it is a very effective way to administer herbal compounds. Tinctures are concentrated and cost-effective. However, the full taste of the herb comes through very strongly in a tincture. Children-and adults, too-may find the taste of some herbs unpleasant. Goldenseal, for example, is bitter-tasting. Another concern when using tinctures is the presence of the alcohol. If you wish to lessen the amount of alcohol in a tincture before giving it to your child, mix the appropriate dose with one-quarter cup of very hot water. After about five minutes, most of the taste of the alcohol will have evaporated away, and the mixture should be cool enough to drink.

Extracts Extracts can be made with alcohol, like tinctures, or the essence of the herb can be leached out with water. When purchasing a liquid extract of an herb, the only way to be certain of the extraction process (alcohol or water) is to read the label. Extracts offer essentially the same advantages and disadvantages that tinctures do. They are the most concentrated form of herbal treatment and therefore the most cost-effective. They are easy to administer, but have a strong herbal taste.

Capsules and Tablets Capsules and tablets contain a ground or powdered form of raw herb. In general, there seems to be little difference between the two in terms of clinical results. Because finely milled herbs degrade quickly, it is important that herbs be freshly ground and then promptly encapsulated or tabeleted, within twenty-four hours of being powdered. When making your selection, read the label to make sure fresh herbs have been used in the product. With the exception of certain herbal concentrates in capsule form, both capsules and tablets tend to be much less strong and potent than tinctures and extracts.

Teas There are many delicious blends of herbal teas on the shelves of your health food store; they need no introduction here. You'll find loose herbs ready for steeping, herbal formulations aimed at specific conditions, and convenient pre-bagged teas. Some are just for sipping; some are medicinal. When your child is ill, a comforting cup of herbal tea (medicinal or not) is a wonderful way to give additional liquids.

Lozenges Herbal-based, nutrient-rich, naturally sweetened lozenges are readily available in most health food shops. You'll find cold-fighting formulas, natural cough suppressants, some with decongestant properties. Many are boosted with natural vitamin C. Choose lozenges made without refined sugar.

Ointments, Salves, and Rubs From calendula ointment (for broken skin and wounds) to goldenseal (for infections, rashes, and skin irritations) to aloe vera gel (to cool and speed the healing of minor burns, including sunburn) to heat-producing herbs (for muscle aches and strains), there's a wealth of topical herbal-based products on the market. Your selection will depend on the condition you are treating.