The best known among the Indian Systems of Medicine, Ayurveda, has a history of practice and use for over 3,000 years. Along with the other systems of indigenous origin, such as Siddha and the imported systems of Unani and Homoeopathy, it serves large numbers of India''s population, either out of choice, based on their belief, or necessity in the absence of facilities for, and availability of modern treatment.

The total sales of all these systems was around Rs 4,500 crore in 2000, of which Rs 3,700 crore was from Ayurvedic medicines and treatments alone. There are an estimated 7,000 manufacturers of Ayurvedic medicines, with over 99.5% being in the small or tiny sector, each with an annual turnover of less than Rs 5 crore. There are only ten companies in the large sector, with annual sales of over Rs 50 crore each. While discussing these figures, it is important to emphasise that there is hardly any data on the sales of truly Ayurvedic products, conceived, developed, produced and marketed as per traditional Ayurvedic systems and practices.

According to the definitions under the Drugs & Cosmetics Act 1940, Ayurvedic drugs are classified under Clause 3-a and Clause 3-h, the first falling under classical preparations and the second under Patent & Proprietary medicines. Classical preparations are defined as those drugs manufactured exclusively in accordance with the formulae described in the classical texts on Ayurveda, Siddha and Unani Tibb systems of medicine, specified under the First Schedule.

The list has 54 books in Ayurveda including the recent Ayurvedic formularies. The classical texts include Ashtanga Hridaya, Ayurveda Samgraha, Charak Samhita, Sahasrayoga, Sushrta Samhita, Ayur Chintamani, Dravyaguru Nigantu and others.

Patent and Proprietary medicines are defined as those formulations, which are produced and packaged, based on the classical texts, but not included under the classical formulations. For example, a large number of Arishtas, Churnas, Rasayanas, Ghrits and Ras are produced, packaged and marketed in modern galenic forms (except parenterals), of tablets, capsules, powders, syrups, ointments or even gels. Today, in the Indian market, over 70% of all drugs sold under the Ayurvedic label are branded versions of the drugs classified under Patents & Proprietary medicines, which have no resemblance to the classical Ayurvedic products.

While the practitioners registered under the Central Council of Indian medicine number around 5 lakhs, perhaps an equal number practice these systems without approval from the appropriate authorities.

Ayurvedic Drugs In the Global Market: The Myth and The Reality

There has been a general impression that Ayurvedic drugs are already very popular in the global markets. In a recent Conference on "Indian Systems of Medicines- Export opportunities", T. K. Bhaumick, Senior Advisor of CII, in his keynote address stated that "while the current Ayurvedic drugs market is around Rs. 50,000 crore (> 10 billion) in the global herbal market, it is expected to be worth Rs 2,50,000 crores (>$ 50 billion) by 2010". These figures are fictitious, since hardly any of the Ayurvedic drugs as classical formulations or as Patent and Proprietary medicines are exported from India, nor are they manufactured in any of the other countries.

The exports of these products are marginal, largely restricted to countries such as those in the Middle East and East Africa, where, there are sizeable ethnic Indian populations. Attempts by companies, such as the Ayurvedic Company of Great Britain in London which has reportedly tied up with Baidyanath in India to promote Ayurvedic products in Europe are yet to make any dent in those markets.

Several other groups including the Bharathiya Vidya Bhavan''s organisation in U.S.A. are trying to promote this Indian system, its practices and products. A few Universities in the U.S. and Europe have started some optional and peripheral courses in Ayurveda. There is at present more interest around some of the traditional practices such as Yoga, popularized by Indian and International practitioners, and Transcendental Meditation of Maharishi Mahesh Yogi, introduced in many Universities in U.S.A and Europe. It is obvious that, contrary to public perception, these practices are not part of the traditional Ayurvedic heritage. They do not use or involve any products from this system and in that sense, their increasing popularity does not bring in any economic benefits to this Country.

The Role Of Indian Systems Of Medicine in Global Healthcare

Since the ultimate objective of any system of medicine is to provide healthcare to the needy, it is important to assess whether the Indian Systems of Medicine are fulfilling their legitimate role in the Global healthcare scene. Has the real potential of these systems been realized? Among the various components of the Ayurvedic system, classical preparations manufactured according to classical texts are unlikely to gain a foothold in the major markets of the Developed Countries, which follow the standards set by leading Regulatory Agencies such as the US FDA, in the matter of approval of drugs for human use. The current methods of their manufacture and the studies associated with them, including those concerned with safety and efficacy are unlikely to be approved by the regulatory agencies in these countries. The second class of drugs under this system, the Patent & Proprietary medicines are largely products which evolved from these systems, and yet are produced and presented in modern galenic forms, and in that connection have undergone all the necessary tests and controls in their production, packaging, storage, transportation etc.

These products have the potential to be candidates for approval for marketing as prescription drugs provided they go through the safety and efficacy testing required for modern drugs. The U.S. FDA has taken the view that clinical experience available for botanical drugs used in traditional systems of medicine is a valuable input, which can lead to fast track clearance for marketing those drugs, particularly for diseases for which modern drugs have nothing to offer.

Knowledge on Traditional Medicines For Drug discovery

During the last half a century, ever since modern chemotherapy emerged, there have been two major approaches to source chemicals for testing, the synthetic route or natural products. Both have been successfully employed and these continue to be relevant for the future of new drug discovery and advances in medicine. The problem of costs in new drug development is related to the very high costs of failures in new drug discovery. Recent efforts by the major R&D-based Companies have been directed to minimising the high costs and risks of drug research. One of the meaningful approaches will be recourse to the knowledge base and heritage available in traditional system of medicine in India and other Countries.

That natural products could be a major source of new drug leads is obvious, since, of the 520 new drugs approved between 1983-1994, 39% were natural products or their derivatives. A study reported in 1997 mentions that 85% of the treatment regimes of 80% of the World''s population are based on natural products. Almost half of the 20 top selling drugs in 1999, were derived from or developed on the basis of leads available from knowledge of properties of natural products either from traditional use or from modern studies. In order to capitalise on the knowledge base of traditional use of plant-based drugs, as in the case of Ayurveda, the following essential steps should be followed in a systematic manner.

1) Identify the plants being used in traditional therapy in various preparations.

2) Derive commonality in their use for similar disease conditions.

3) Ensure availability of the right plant in a sustainable manner through appropriate conservation strategies.

4) Establish extraction and processing technologies under mild conditions to avoid degradation of active principles contained in them.

5) Carry out confirmatory tests and clinical trials to establish therapeutic efficacy for the identified indication.

6) Do minimal toxicology studies to ensure safety.

7) If the efficacy or safety are not acceptable, carry out further fractionation or even isolation of the active principle responsible for the activity.

8) To improve the activity and/or reduce toxicity, if necessary, carry out semi-synthetic conversions and put the new molecules through the drug development process.

Regulatory standards for drug approvals would be less stringent in the case of plants and their extracts which have a long history of use; however, in the case of molecules isolated from plant material or their chemically converted products, they need to undergo standard drug development modalities. The developmental time frame and costs are also higher for such preparations, compared to natural products. A number of drugs discovered, developed and marketed during the last decade such as Simvastatin, Pravastatin, Enalapril, Clavulinic Acid, Erythromycin derivatives, Clarithro, Azithro and Roxithro mycins, artemesinin-based Artether etc. fall under this category.

Molecular Targets And Natural Products

Natural products, more specifically, plants, constitute the best possible combinatorial library with maximum possible diversity of chemical structural types. With the advent of modern tools of High Through-put screening, they are eminently amenable for screening against molecular targets, developed through pharmaco-genomics and proteomics. The same applies to animals, microbes and marine species, all of them providing a wide range of genetic and chemical diversity. The chemical complexity of natural products'' composition, hitherto thought to be a disadvantage for drug discovery can now be considered as an advantage for the discovery of candidate products for drug development. Certain problems still exist when working with natural products, eg, inconsistency in the quality of samples collected from different sources, supply problems, difficulties in obtaining property protection under present IPR regimes, and the impact of restricted access to Biodiversity under the new legislations agreed upon at the Convention on Biodiversity in Rio-de-Janeiro in 1992.

Strategic Options For India

Pursuing the goal of popularising the ancient Indian system of Ayurveda, which is primarily based on medicinal plants, by promoting and marketing classical Ayurvedic products and practices, in the Global markets, is an uphill task. On the other hand, there is ample opportunity for developing products based on the proven therapeutic utility of medicinal plants used in Ayurvedic medicines and getting them approved as prescription drugs, O.T.C preparations or even as Nutraceuticals, under, for eg., the Food and Dietary Supplement Bill, 1994 of FDA, U.S.A. Screening of medicinal plants, their total or fractionated extracts or active principles responsible for therapeutic activity will continue to be a profitable approach to New Drug Discovery. Of even greater relevance is the possibility of using medicinal plant extracts as Combinatorial Libraries, which may be put through High Through-put Screening, using cell lines, molecular targets based on molecular biology and genetics, as well as conventional in-vivo screening models. The World, thus, has a great opportunity to fully utilise the knowledge base developed over centuries of use of one of the most practiced traditional systems of medicine, Ayurveda. The Department of Indian Systems Of Medicine and Homeopathy, responsible for the development and protection of indigenous systems of medicine and utilization of the Country''s heritage and knowledge base should take the lead in developing suitable strategies and evolving action programmes to ensure high value addition to these valuable resources.

We need to work out property protection modalities to protect these resources from unauthorized exploitation by third parties through pro-active legislation, if necessary, under a ''Sui Generis'' system, outside the purview of conventional IPR protection. The R&D programmes being undertaken in the National Laboratories and the Central Council For Research in Ayurveda and Siddha should take into account the four basic parameters, medical needs, resources requirements, innovative potential and economic gains, while prioritizing the research projects. After all, Developing Countries'' major assets are not their technological strengths, but their biodiversity and indigenous, and often times unique, knowledge base, which have the potential for conversion to wealth and major economic gains, as have been achieved by the OPEC Countries, with their oil reserves.

About the author:

-- The author is a leading scientist, based in Chennai

-- The author is a leading scientist, based in Chennai