Ayurvedic products – Where we stand in Global Herbal Markets?
Total global herbal market is of size 62.0 billion dollars, in this India’s contribution is only one billion dollars. It is authentically explained that the position of India in the global market is very very poor. 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.
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. In USA our exports have (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. Hence, 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 markets 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 people’s choice have shifted to herbal products, – they now use more of these types of hair oil, shampoo and other cosmetics. Germany’s share in the exports of ayurvedic and Unani medicines has 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
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 Remedies. These guidelines outline standards for quality, quantity, and production of herbal remedies and EEC Directive, undated provide labeling requirements that member countries must meet
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.
EEC Guidelines and Some Favourable Developments Outside India
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. Market Scenario USA There is growing awareness among people in US about health and there is a shift in attitude of the people towards nature care products due to a powerful “green wave”. This is because of the perceived pernicious effects on health of individual of the alternative medicines. It is believed by many in the US now that high-tech medicines do not pay attention to a patient’s belief system and the possible side effects that may be caused by protracted use of allopathic drugs. This has helped the herbal medicines to make an impact in the US market. The World Health Organisation has estimated that at least 25% of all allopathic medicines contain a plant derivative. It is difficult to estimate US herbal market because these activities are not econometrically tracked. However there is strong indication that alternative medicine markets are growing. In US, Ayurveda is not a licensed practice but many health practitioners in related areas do practice some aspects of it. At least several hundred physicians have trained themselves in the US at Ayurvedic institutes. There were approximately 10 Ayurveda clinics in North America that served more than 25,000 patients since 1985. More than 200 physicians have received the training for Ayurveda through the American Association of Ayurvedic medicines. A modern revitalisation of Ayurveda is now being practiced as Maharishi Ayurveda. A number of Indian trained Ayurvedic physicians practice or teach Ayurveda in the United States. The Ayurvedic and Siddha products are not approved medicines in US. They enter US market as para-medicines or health food supplements. FDA approves these medicines to be sold in their domestic market. FDA does not even consider any herb as medicines therefore; they are labeled as dietary supplements. This is one of the reasons for allopathic medical schools not informing their students about the herbal medicines. According to the results of the study conducted by Health Policy Institutes at the medical college of Wisconsin the per capita supply of alternative physicians is expected to rise by 124% between 1994 to 2010 compared to rate of growth of 16% for conventional doctors. Herbal companies dwarf in comparison to pharmaceutical companies, still some companies have gained their foot in US market such as Herbal Life and Madaus, Murdock Schwabe. Herbal Life Company is expanding globally almost adding a new country every year for its products. Some pharmaceutical companies like Novartis have started marketing natural alternatives. In 1992, Congress created the office of Alternative Medicines (OAM) and a program advisory committee within National Institute of Health (NIH). The fund allocated to them has increased from 2 million dollars to 7.4 million dollars. There is research that is being done on herbal medicines major part of them is privately funded. A great deal of money is being given to Bastyr University for research being done on herbal effects on HIV and AIDS. Sales of vitamins accounted for 1.15-1.26 billion dollars, natural medicines took in 270-298 million dollars and herbs 520-560 million dollars in year 1995 alone. Some insurance companies have started covering unconventional medicine through HMO’s. Oxford is the first US insurance company to form a network of alternative practitioners. Other insurers such as American Western Life, Kaiser Permanente, Blue Cross/ Blue Shield, Mutual of Omaha and Prudential offer limited coverage for alternative medicines. But still no insurance companies pay for herbs. Acupuncture has become one of the established health care systems in USA. This therapy has its origin in China. There are about six thousand five hundred acupuncturists in US whereas the Ayurvedic doctors are lesser in number compared to the acupuncturist. Acupuncture, Chiropractic and Naturopathy are the three alternative medicines that are licensed and regulated in US. Homeopathy is the only alternative systems of medicine that has sound educational base and has officially established “alternative” drug production system regulated by FDA. It is considered that the American Herbal market in a complete total perspective. Indian Government and US In a significant move to give the much-needed impetus to propagation of Ayurvedic drugs and medical practices in the United States, the Government of India, in association with the Indian Consulate in New York, will soon set up an Ayurveda Development Board in the US. (Pharmabiz September 26, 2000). A decision to this effect was taken at the Ayurveda Conference held in New York in the second week of September, under the aegis of the department of Indian systems of medicine and Homeopathy (DISM&H). According to a government release, the Board will act as a platform from where information on Indian government’s policies and projects with regard to Ayurveda could be disseminated to the groups/scientists/institutions in the US. Importantly, the Board would function as an intermediary between Indian industry and the US-FDA with a view to identifying the promotional efforts needed to enhance the credibility of Ayurvedic products in that country. Ayurvedic drug exporters from India are now finding it difficult to obtain the FDA approvals which require detailed documentation about the safety and efficacy of the products. One of the mandates of the proposed Board would be with individual Ayurvedic drug manufactures as also apex industrial bodies like the Confederation of Indian Industry. By acting in concert with the US Medical Schools Department of Alternative Medicine, the Board would work towards introduction of academic courses on Ayurveda. Such courses are expected to give exposure training to the US medical graduates and such other qualified groups. As a beginning, a module for training the physicians in the US would be developed. Experts from the Gujarat Ayurveda University would be entrusted to finalize the module, which would be printed and made available widely in the form of an essential curriculum. As part of the program, the DISM&H would also provide sponsorship to selected Ayurvedic college teachers as per the module. In addition, the board will establish a cell to coordinate with all NGO’s who have an interest in the propagation of Ayurveda in various part of the US. Among the main functions of the Board would be alerting the CG’s office or the embassy against any misuse of goodwill of Ayurveda by unscrupulous elements. European Union: In EU, the reform/ wholefood category includes range of health and health related products, food supplements, diet foodstuffs and herbal based remedies, cosmetics and tonics. The movement towards the reform food has been strongest in Germany, United Kingdom and Netherlands. There are no standards specified for the reform/wholefood. Natural food supplements are regulated under food and drug legislation and are not subject to any compulsory medical control or licensing procedure as long as no claim are made on individual product’s behalf regarding its effectiveness in preventing, healing or treating illness or ailment. If the health food products do not fall under the organic or biodynamic food then their sale is regulated by overall legislation on trade in agricultural products and by food and drug regulation. Food supplements – mainly vitamins, minerals, concentrated foodstuffs (e.g. fatty acids, garlic, and lecithin), herbs and herb extracts, and products from other culture with health claims. In last five years according to the study conducted in 1996 the Dutch market health food market has grown rapidly. According to a market survey of the Netherlands it showed that the usage of food supplements is relatively low compared to the other major markets like UK and Germany but has increased substantially in last ten years. Vitamins and other food supplements are sold as OTC product and can be purchased without the prescription of the doctors. Retail sales of food supplements 1995 The European Union market is the second largest market for spices and herbs. In 1997, the total EU import volume of spices and herbs amounted to 260831 tones that represented the 28% of the total imports by the developed world. In 1997 the total world production of spices and herbs was 4.5 million tones, of which 95% was produced in developing countries and of which majority is consumed in domestic markets of these producing countries. In the same year the apparent consumption of spices and herbs in EU was estimated to 158,660 tones with the value of ECU 324 million. In 1998 the total industrial sector amount to 53,900 tones. There are 43 food ingredient manufacturers in EU. The major EU retail markets are Germany, France, United Kingdom, Spain and Italy. The majority of all spices and herbs are imported from India whose export has grown by 52% between 1995 and 1997.
Limitations and Bottlenecks of the System
The medicinal plants have been traditionally obtained from forests and no systematic effort was made in past for developing the package of practices for cultivation of these plants. The best way for propagating plants and most appropriate season for raising new plants is not known for most of the plants. Though the packages of such practices have been worked out for some of the aromatic and medicinal crops have been worked out, but for others it is not standardized. Standards on quality of medicinal plants cannot be specified. The companies want a benefit of Fig.5 Retail sales of food supplements 1995 vitamins 55% garlic 15% herbal extracts 15% spirulin 5% ginseng 5% other 5%range to be given because exact specification is a problem as the standard differs due to places and seasons. There is shortage of medicinal plants especially those that are collected from the forests. There is a growing interest of farmer for commercial plantation of such plants. The ever increasing demand for herbal products and shift in people’s interest in nature has led to indiscriminate exploitation of plants and species from the forest and other places which have led to near about extinction of such species. The investment in large-scale plantation is needed but it would be fruitful only if scientific methods of cultivation are developed. The medicinal plants are being procured in thousands of tones but there is no organised marketing, and there is also no reliable information on their demand & availability and export potential. Procurement of this information is very difficult since the trade of medicinal plants is just unorganised. Under present condition there is absence of co-ordination and linkage between different Departments/Organisation and their field units leading to haphazard development and absence of suitable policy. The needs of the ISM&H pharmacies, practitioners, manufacturers are to be assessed through survey. Non Western medical science so far has failed to claim to originality. The universal attributes of the indigenous knowledge system remains unrecognised due to marginalised political status of the societies (relative position of LDCs) and due to limitation of language and ethnicity. In Western societies they believe in science and proving science. It is difficult to explain the efficacy of Ayurveda & Siddha that is based on knowledge and recorded knowledge in ancient text. The comparative understanding between Ayurveda and modern medicines has not progressed sufficiently to correlate diagnosis of the two systems of medicines or translate Ayurvedic pharmacology in terms of modern pharmacological parameters or reduce Ayurvedic lines of treatment to satisfy Allopathic therapeutic logic. Difficult protocols on registration of drug imports prevail in certain cosmetics. Also registration fee is very high in other countries. In many countries Ayurveda and Siddha is not recognised system of medicines. The rules and regulation to register them as medicines is stringent. While there is extensive literature going back 2500 years to Charka Samhita (Al-Qanoon for unani) mentioning practices and cures, a deficiency of the ISM is that objective data through clinical trials and laboratory work has not been generated to prove the extent of efficacy of individual prescriptions and cures. As a result, the practitioners leading to varying results prescribe a large variety of cures and practices. It will be beneficial if the cures mentioned in the texts are systematically taken up and subjected to laboratory investigation and clinical trials so that their efficacy is established or disproved. This will allow the most effective cures out of the many recommended for a particular condition to be identified, which then can be propagated for extensive use for the benefit of patients. There is one more problem that is faced by the industry. With increase in use of machines in preparing the medicines and other formulations the residue of these machines in form of iron powder is left behind which leads to problem as the desired result could not be achieved. There are no certifying agencies for the se products. Till now only two foreign agencies are taking up this job, one is Swiss based and the other is Holland based agency. This creates problem in the export of these products and there is need for the certifying agency at central level. 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 assistance is provided to specialized scientific institution (government/ semi-government) on project basis (3 years) for development of agrotechniques 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.
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. 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. 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. 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.
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.
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.
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 government-sponsored 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.
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.
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.
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.
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.
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.
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.  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.
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.
Statistics Which Show Contamination of Indian Herbal Products
1. Researchers at Boston University School of Medicine (BUSM) have found that one-fifth of Indian-manufactured Ayurvedic medicines purchased via the Internet contain lead, mercury or arsenic. Using an Internet search, the researchers identified 25 websites featuring 673 Ayurvedic medicines. They randomly selected and purchased 193 products made by 37 different manufacturers for analyses. Overall, 20.7% of Ayurvedic medicines contained detectable lead, mercury and arsenic . Among products containing metals, 75% claimed GMPs or testing for heavy metals
2. Current study was of a patient admitted in Boston hospital with intractable seizures. Tests showed his blood lead level to be 89 (the normal level for adults is less than 2). Interviews with the family revealed that the man, an Indian born professional in his 50s, had been taking Guggulu, an Ayurvedic arthritis medicine, for the past 6 years. The product was then analysed and found to have very high levels of lead, mercury and arsenic.
3. Between April and October 2003, U.S. Food and Drug Administration officials visited stores in Boston and purchased ayurvedic products intended for oral consumption and then tested at the New England Environmental Protection Agency lab. Overall, of the 70 products purchased, 13 products contained lead (median concentration, 40 ΅g/g), 6 contained mercury (median concentration, 20,225 ΅g/g) and 6 contained arsenic (median concentration, 430 ΅g/g) and these had labels recommending their use for infants and children. The contamination issue is a result of poor manufacturing practices.
4. Consultant Clinical Toxicologist, Dr Paul Dargan, of Guy’s and St Thomas’ NHS Foundation Trust, London, with colleagues there and Dr Indika Gawarammana of the Faculty of Medicine and South Asian Clinical Toxicology Research at the University of Peradeniya, Sri Lanka, have investigated to prove that many Ayurvedic medicines contain dangerous quantities of heavy metals, including lead, mercury, thallium and arsenic.
5. The products banned for consumption in the UK market include Karela tables (made by Shriji Herbal Products), Karela capsules (Himalaya Drug Co), Yograi Guggal and Sudarshan tablets (both Zandu Pharmaceuticals), Shilajit capsules (Darbur India), SAFI liquid (Hamdard-WAKF) and Maha Sudarshan Churna Powder (supplied by Zandu Pharmaceuticals, D and K Pharmacy, Chhatrisha and Dabur, India).
6. Recently, a study conducted by Harvard Medical School on Indian ayurvedic medicines found potentially harmful levels of lead, mercury and arsenic in the products like ‘Bal Guti’, ‘Mahayograj Guggulu’, ‘Mahalaxmi vilas Ras’, ‘Safi’, ‘Shilajit’ etc. of some of the leading companies within ayurvedic communities.
The microbial quality and antibacterial properties of two Indian herbal remedies with such claimed efficacy of curing all manners of microbial diseases were assessed. The herbal remedies were discovered to be contaminated with a total of four fungi (Basidiobotrytis sp, Oedocephalum sp, Varicosporium sp and Articulospora inflata) and three bacteria (Bacillus subtilis, Bacillus coagulans and Bacillus cereus)
1. Microbial load was reduced under permissible level of irradiation which is already a well-known decontamination method, but it has received less attention for medicinal plants, especially on fresh herbs. Microbial load behavior, antioxidant activity, and enzymatic inhibition activity were measured for doses up to 50 kGy.
2. In the 55 people tested for the heavy metals, pesticides and herbicide toxins, initially 801 toxins were found in the subjects’ livers, 825 toxins in the breasts and 824 toxins in the brain. Studies proved that natural cellular defense removes heavy metals, pesticides toxic chemicals from body.
Numerous drugs have entered the international market through exploration of ethnopharmacology and traditional medicine. Progress in genomics and proteomics has opened new gateways in therapeutics and drug discovery and development. Better understanding of the human genome has helped in understanding scientific basis of individual variation. TIM and TCM, carry many generations’ observations that have well-organized and documented data. China has successfully promoted its own therapies and drugs like ginseng, ma huang and gingko with scientific evidences acceptable for the global community. The approach of integrative medicine by selective incorporation of elements of TCM alongside the modern methods of diagnosis has achieved a great success in China. It is no exaggeration to say that an ‘Herbal Revolution’ by India is just waiting to happen. India could truly become a global leader in the herbal medicine category by inventing and patenting medicines for several ailments by using a combination or mixture of herbal formulations.
Although herbal medicines have been used for thousands of years, basic research programmes need to be focused on the quality assurance. To overcome contaminations from pesticide residues and heavy metals, there should be control measures to implement necessary SOP at source. Good laboratory practices (GLP) and GMPs are also needed to produce good quality medicinal products. Without all these measures, it is impossible to realize the dream of having a major share of a herbal drug industry despite having gold mine of well documented and well-practiced knowledge of traditional herbal medicines. TCM examples would help India at various levels including policies, quality standards, integration practices, research models and the complementary integration where public health is kept at the central position. Both TIM and TCM are great traditions with strong philosophical basis and could play an important role in new therapies, drug discovery and development processes.
Unfortunately, you cannot necessarily rely on regulators making sure they are safe. There is an urgent need for studies to quantify the frequency and potential risk of heavy metal poisoning from Ayurvedic medicines. Also needed is ‘culturally appropriate education’ that can inform the public of the potential for toxicity associated with the many different products associated with this practice.
The prevalence of a variety of climatic conditions puts India in a supreme position with respect to richness of medicinal flora. As such, India should occupy a significant position in the world trade of botanical drugs. India should focus on agrotechnology, process technology, standardization, quality control, research and development of herbal drugs. Now, the time has come to compile and document available knowledge on our valuable plant resources and to prove their utility scientifically through detailed phytochemical, biological and pharmacological investigations at selected centers in different regions of the country. India should adopt organized cultivation of medicinal plants that have export potential and import substitutions. Efforts should be made to cultivate potential medicinal plants as field crops. Their conservation should be done in appropriate ecological conditions. In order to push India as a significant player in the global herbal product market, herbal products should be standardized as per WHO guidelines.
From these discussions above, we can finally and clearly conclude that, we can grab major share in Global Herbal Drug Markets. And for this, hardwork for RM and Process Standedisation documentations, research (pharmacological screening, toxicity studies, clinical trials), preparations of databases, is inevitable and hence, highly needed to adopt as a national policy and work strategy by Government of India. All further work demands multidisciplinary contribution that means contribution of professionals from other medical sciences and other branches of Science.