Among the many traditional health care streams of the world, Ayurveda is unique in its sound foundation of documented theories and operational guides
Every living body of knowledge needs constant support of research for its growth. Ayurveda, the traditional health care science of India, is, indeed, a living organised body of knowledge which has stood the test of time and continues to provide primary health care support to a considerable segment of the Indian society. Among the many traditional health care streams of the world, Ayurveda is unique in its sound foundation of documented theories and operational guides. The earliest of documentation dates back to 1500 BC and the hundreds of other treatises that followed present an organised body of ancient wisdom which is still the basis of contemporary practice of Ayurveda.
However, the present global aspirations and challenges that this tradition needs to encounter make it imperative that the complex layers of its principles and applications are validated in a manner that is understood by the global man. Moreover, there is also a need for upgrading that knowledge base inorder to enhance its contemporaniety. This, obviously, has to be achieved with the able support and benign aid of modern science. That, perhaps, is the first axiom of research in Ayurveda. The "purists" among classical Ayurveda practitioners may react to this proposition by withdrawing to their hallowed precincts of ancient canons with a sense of threat. To be sure, the rigid protagonists of modern science also may feel aghast at the blasphemous suggestion. Both look with suspicion at the prospect of a marriage between ancient wisdom and modern science, for their own separate reasons. The history of evolution of ayurveda during the past several centuries provides ample proof for the way it has profited by receiving inputs from other streams of knowledge. Fermentation and metallurgy are just two examples of extraneous methods which were internalised quite early by ayurvedic pharmacy. How allopathic system has profitably adapted principles and methods of chemistry, physics and even engineering is there for every body to see.
There is no reason why such an open approach could not be followed now by Ayurveda for its growth.
A word of caution may be in place in this context. The ayurvedic pedagogy is not based on the cartesian methodology which is the essence of modern science. A certain amount of appropriateness needs to be incorporated while attempting to understand and interpret the contentions of a system of knowledge by using the tools of another system.
It is in this background that the objectives are to be set and modalities are to be evolved for ayurvedic research. The core objective of contemporary ayurvedic research is essentially to enhance its inherent strengths in order to equip it to meet the challenges of modern times. That will enable ayurveda to take its due role in the global health care scenario.
There are two major components to the scope of ayurvedic research. There is a complex and typically Indian conceptual component. And there is an involved and rather universal functional component. In spite of close dependence of the latter on the former, the research efforts are to be designed and carried out in separate and distinct streams. The herbal based medical armamentarium of ayurveda is rather well known. But its less known philosophical concerns and propositions need also to be brought to the front to ensure that the practical arm does not leave its basic conceptual frame work.
What primarily interests the pharma personnel is the capability of ayurvedic drugs to mitigate modern ailments. Then, there is a very serious concern about their safety. The research front is agog with activity in both these areas. Research in India is progressing in three major platforms. There are "official" research being undertaken by governmental institutions. Central Council for Research in Ayurveda and Siddha is established by the government for the purpose. Central Drug Research Laboratory is a modern research centre capable of undertaking advanced research on drugs. Secondly, there are industry supported research. Thirdly, there is a recent major effort by the government, which is known as Golden Triangle Partnership. Here, the government takes the role of a facilitator for initiating research programmes jointly undertaken by national laboratories and pharma industries.
Coming to the functional component of research, the focus has been on three major components, viz. drug development, medi-cinal plant studies and clinical studies, in that order of importance.
Drug related research
There are several branches of research under this head. Efforts are made to develop new drugs based on classical texts, efforts are made to look for bioactive molecules, efforts are also made to improve user-compliance of drugs. The industry based research which has been going on in the past several years has brought to the market many new herbal based formulations. They are essentially take-offs from classical knowledge. They are mostly new polyherbal combinations useful for many common ailments. They also possess better user-compliance in terms of smaller dosage factor and easiness of administration.
But a recent effort initiated by the government deserves particular reference. It is a multi-institutional and multi-disciplinary effort of great potential, known as the CSIR Co-ordinated programme on bioactives. The national apex science body CSIR (Council of Scientific and Industrial Research) is partnering with a hundred year old ayurvedic institution (Kottakkal Arya Vaidya Sala) to look for the presence of bioactive molecules in classical formulations and to characterise them, isolate them as also to develop new drugs which will satisfy the rigorous quality standards of universal drugs. Some formulations and several molecules have come out of this ongoing joint venture, which have received international patents. Another important programme named NMITLI (New Millennium Indian Technology Leadership Initiative) has resorted to a unique "reverse pharmacology" approach to standardise and validate formulations based on classical prescriptions as well as modern scientific principles. These are two faces of serious efforts to take useful ayurvedic formulations from the classical frame-work for developing into modern medicaments.
Reference must also be made to the efforts made by the Department of Science and Technology to support extramural research in pharmaceutical sector. Capable centres like the JSS College of Pharmacy are given accreditation by DST to take up pharmacology studies on herbal drugs. Preclinical studies are made there to establish safety, toxicity, efficacy and stability of herbal formulations.
An area which deserves particular mention is heavy metal related toxicity of ayurvedic medicines. The recent sensation generated by the 2004 JAMA paper on the observation of heavy metal presence higher than permissible levels in some medicines available at super markets in Boston in USA, initially created responses on the spur. It has also prompted technology institutes and others to subject metal based drugs to detailed studies. These medicines belong to a special category called "rasoushadhy", meaning mercury based drugs.
The fact that these medicines were in common usage for several centuries without any major report of harmful effects, has got some scientists interested in understanding the chemical and physical profiles of their metal content. The involved methods of processing of these drugs are being critically examined by these scientists.
Thus, drug development, drug standardisation, drug characterisation and user compliance, apart from molecule designing are some major areas of contemporary ayurvedic research. One remarkable feature of this multi-pronged effort is that research laboratories, technology institutes, pharma industry and the government are all equal partners in this endeavour. If these efforts succeed, standardised ayurvedic drugs and their derivatives will become available to patients across in the world.
Medicinal plants related research
The ayurvedic drug industry is crucially dependent on the natural resource base of medicinal plants. The Indian bio-diversity is very strong. But some core areas are under threat of extinction. Similarly, the unorganised development of ayurvedic practice has brought in some dilution in material fidelity. This is the background in which medicinal plant related research has gained importance. National Medicinal Plants Board and Department of Biotechnology of the government are parent bodies which look after major activities in the field. Major National Centres like Central Institute for Medicinal and Aromatic Plants and National Botanical Research Institute have capabilities to undertake advanced research. There are centres in private sector also. The Centre for Medicinal Plants Research at Kottakkal is one such centre devoted to study of ayurvedic herbs. There are two core issues to research in this area. The standardisation of medicinal plant species and the enhanced cultivation of standardised plants. Botanical and phytochemical standardisation studies have generated many monographs on plant species. Modern techniques like HPLC, HPTLC and GC-MS have come handy for the purpose. As new updated data become available, the Government has been able to upgrade its ayurvedic Herbal Pharmacopoeia. As far as the cultivation of medicinal plants is concerned, the possibility of employing tissue culture technique for micropropagation of genuine plant species is being exten-sively studied.
Clinical studies
Clinical studies for ayurvedic medicaments is an area fraught with complex issues. The philosophy of drug application as well as the diagnostic and therapeutic approaches are unique in ayurveda, where a lot of subjective parameters get employed. The therapy is primarily patient-specific rather than ailment-specific. Recent findings based on human genomic mapping may support this approach. Moreover, food regimen and other subjective factors also have important roles in therapy. In this background, it has not been possible to put in place a dependable clinical trial protocol for Ayurvedic drugs and the unique panchakarma therapy. Indian Council of Medicinal Research, as the prime body for such matters, has been making efforts to develop appropriate modalities. WHO has recently brought out an innovative protocol for trials with herbal drugs, which have some unique features like treating a patient as his own control.
Even in this scenario, there have been several attempts, particularly from the universities to make comparative studies with ayurvedic drugs. This is an area which needs strengthening of research methods and their tools.
Conceptual studies
As mentioned earlier, research on the conceptual frame work of Ayurvedic science is no less important, even though it may not be of primary interest to the pharma-personnel at large. Ayurveda has an individual-specific approach to disease and treatment. It places every human being in a humour-based slot and devices approaches to deal with his ill-health. It needs particular mention that efforts have been initiated to examine this approach on the human genomic platform. Similarly the humour-specific character of herbs is also being studied. The theory of rasayana, which deals with rejuvenation of human system against ageing factors, is also being looked from modern scientific view point. It is heartening to note that some of the senior scientists of the country and a few reputed research centres and universities are getting involved in this multi-disciplinary endeavour. It is hoped that, in the long run, the findings of this venture will extend the acutely needed theoretical support to the modern research on drug delivery systems proceeding elsewhere.
Academic backgrond
A passing mention should be made here about the general academic and statutory background of ayurvedic practice. There are two ayurveda universities and a couple of hundred colleges imparting undergraduate and post-graduate teaching. There is a uniform syllabus of study for the whole nation. Only qualified and registered ayurvedic physicians can practice. There is a legion of such practitioners spread all over the country.
On the drug side, the government brought ayurvedic medicine manufacture and distribution under the provisions of Drugs and Cosmetics Act in the late sixties. It recognised 56 classical textbooks as official formularies. Thereafter, government brought out its own official ayurvedic formulary and subsequently the pharmacopoeial standards. Every manufacturer of Ayurvedic medicines needs to obtain a license from the drug controlling authority under the provisions of the D&C Act. GMP certification was made mandatory for manufacturers in 2002 under Schedule-T of D&C Act. Heavy metal testing has recently been made compulsory for medicines being exported.
There is a lot of activity and enthusiasm in the ayurvedic sector. Health care is an area where India can legitimately claim a lot of originality and self esteem. There is a general realisation among policy makers, industry leaders and research scientists that India should put its right foot forward to offer the world its unique capabilities in health care services.
(The author is chief (R&D), Kottakkal Arya Vaidya Sala, Kerala)