1. TRADITIONAL MEDICINE: PROMOTION, REGULATION AND INTEGRATION IN HEALTH CARE NITYA ANAND 16.11.2006

2. TM is a very valuable resource, which is used extensively in developing countries for health care and has withstood the pressure of modern medicine. Of late, there is increasing interest in them in developed countries too, as an alternative to the high cost modern medicines; for promotive and preventive health care, for disease conditions with inadequate treatment with modern drugs and for non-life threatening diseases because of lower incidence of side effects reported with them than with modern drugs. There is, thus, now a global interest in TM and the time is ripe for taking an integrated view of the two to provide the optimal health care benefits to all. PERSPECTIVE

3. Traditional Medicine covers health practices. Its strength is the holistic approach both in: a)health practices which cover maintenance of good health and long life prescribing diets, life style and codes of conduct conducive to the maintenance and promotion of positive health as well as the use of drugs for the prevention and cure of diseases wherever needed; b) In therapeutic treatment taking a view of the whole body as an integrated system and any treatment is thus directed not to any one tissue or organ but to the total body system as a whole. TM is thus not only a compendium of medicaments but a general approach to maintenance of positive health. HOLISTIC BASIS OF TRADITIONAL MEDICINE

4. TM implies that its origin was in the remote past and the tradition has remained alive for centuries, which underlines the benefits it provided for health care as nothing survives long in nature unless it provides benefits. However, there have been dramatic advances in science since these discoveries were made and the methods used in the practice of TM should have been suitably transformed by taking advantage of these scientific advances. The identity of TM should be maintained to its origin but its presentation and usage need to be exposed to modern scientific developments which are a common human heritage. The thrust of this talk would be how these benefits of TM can be optimized through exposure to modern scientific methods. SCIENTIFIC INPUTS FOR TM

5.  Plant drugs being multi-component, require more sophisticated R & D inputs for their development and usage than the modern single component drugs, but by and large opposite is the case and the scientific inputs used for plant drugs development are rudimentary and conform more to the traditional methods of “remote past”.  Plant drugs development must be based on the more sophisticated recent scientific advances in drug development, especially in methods of production, formulation, analysis to ensure quality, reproducibility, safety and clinical efficacy. Research inputs for TM

6. Analytical methods and separation techniques offer unprecedented opportunities for analysis and standardization of complex mixture. The standardization has to include:  The identification of plants, the agriculture practices to be followed for cultivation, post-harvest technology, storage conditions of raw materials;  The manufacturing process to be followed with analytical profile of the extracts;  Formulations to be used, shelf-life of products and  Pharmacopoeial standards for QC. Each one of these areas is a special task in itself and SOPs would need to be developed for each stage carefully. STANDARDIZATION OF PLANT DRUGS: 1

7. Apart from morphological (pharmacognostic) and chemo- taxonomic methods, DNA finger printing has emerged as an important tool for characterisation of the cultivars; this facility must be more commonly created and employed. Similarly, for analysis of multi-component mixtures the identification of a single active constituent or a marker compound would not be enough, quantitative finger-print of major components would be desirable, which can be done by HP-TLC or by LC-MS-MS spectrum, if necessary. The analysis should also ensure that the microbial contamination, pesticide residues and heavy metals are within the permitted levels with each drug. STANDARDIZATION OF PLANT DRUGS: 2

8. SAFETY It is necessary to ensure that the natural chemical constituents of TM’s drugs are safe on long use, which in the course of their normal traditional medicine usage may not have been found out. All herbal drugs, therefore, must go through the normal regulatory animal toxicology studies with special tests as and when required. These studies should also include interaction with other commonly used drugs and also studied for their effect on Cytochrome P-450 enzymes.

9. CLINICAL EFFICACY The WHO has issued very pragmatic guidelines for clinical evaluation of traditional medicines. These insist no longer on randomized double-blind controlled clinical trials for traditional medicine and give much flexibility of study designs, such as based on single case study where the patient serves as his/her control, and even within the TM own frame-work, but insist that the treatment protocol followed, findings and results must be fully documented and peer reviewed. These recommendations must be followed in spirit. If a traditional medicine has to be evaluated for a new use or was to be compared in efficacy to a modern drug, this would of course require the normal Phase 2 and Phase 3 multicentered Clinical Trials as with modern drugs.

10. SYSTEM OF REGISTRATION OF TRADITIONAL SYSTEM MEDICINE For each drug: a separate dossier must be submitted with Standard Operation Procedure (SOP) for manufacture, for analytical procedure for standardization and quality control; for safety & regulatory toxicology studies and for clinical efficacy to be approved by an Expert Committee and only then licensed for marketing. The test laboratories’ infrastructure would need to be greatly augmented & updated. This will require strengthening of the regulatory enforcement machinery also.

11. NEED FOR AN INTERFACE BETWEEN TRADITIONAL & MODERN MEDICINE FOR HEALTH-CARE : A balanced view has to be taken of the place of TMs for the health-care needs of the community vs. the modern drugs in different situations.  In life-threatening infectious diseases well proven modern drugs must be used  For life-style diseases, degenerative disorders or primary health-care needs, TM with highly favourable pharmaco- economics should be preferred. Each country should have a Standing Committee on Essential Drugs to draw guidelines for the use of Traditional Medicines vs. Modern Drugs for different health care needs.

12. REGIONAL COOPERATION & HARMONISATION Traditional medicines practised by different countries may be different, but the general features and issues are very similar. Countries practising TM would have much to learn from each other’s experience. It would be helpful to form Regional Standing Committees to coordinate the practices of TM in the countries of a region. The cooperation and coordination would include: a)Harmonisation of quality control criteria b)Exchange of plants or chemical reference substances obtained therefrom c)Sharing of Analytical Testing Facilities d)Sharing Pharmacopoeias

13. NEW FACETS FOR RESEARCH ON TRADITIONAL MEDICINES  As source of Drugs with New Mechanisms of Action: Antimalarial: artemisinin; Anticancer: vinca alkaloids and taxol; Hypolipidemia: Guggulsterone  Source for Molecular diversity and New Pharmacophores  Source for Multi-component drugs for diseases requiring Multi-target approach: Metabolic syndrome, Degenerative disorders  Need for clinical profiling of Traditional Medicines with Multiple Actions: curcuminoids, withanolides, ocimum extract There is need to open new vistas for the contribution of traditional medicine which would also enrich modern drug research.

14. Study of the Scientific Basis of Traditional Medicine TM’s holistic view in therapeutic terms implies that the treatment of a disease should be directed not to a single tissue or organ but to the body as whole as the body organs are interconnected and mutually dependent. The holistic view of the fast emerging System Biology looks at living systems as multi-component or interconnected networks which should be considered while treating disease. The two concepts are so close. How useful and important it would be to study basic principles of Traditional Medicine in the light of the recent development in Systems Biology concepts. This will also bring out the essence of the convergence between ancient and modern thinking of body functions.

15. Indian Experience: Traditional Medicine Traditional Systems of Medicine in India are fully recognized and are in the main-stream of Medical and Health Care in India. Government has provided much encouragement and support for research on the traditional medicines. Some of the significant steps taken by the Government in this direction are:- 1.Setting up of National Laboratories with a priority for Research on TMs 2. Setting up of Department of AYUSH, with Central Council for Research on Ayurveda & Siddha with constituent Research Institutes and Centres, totally dedicated to research & development of TMs

16. Registration Indian Experience: Traditional Medicine Traditional Medicines are recognized in the Drugs and Cosmetics Act of India since 1964, and as modified in 1982 This allows marketing of drugs/formulations of TMs described in authoritative texts of these systems named therein This system, however, does not require registration of individual drugs with specified quality control, safety or clinical efficacy standards The manufacturing premises have to conform to Schedule M laying down GMP standards The system thus needs to be further upgraded and strengthened to require registration of individual drugs with specified QC, safety & clinical efficacy standards & then allow for marketing.

17. DOCUMENTATION: TRADITIONAL KNOWLEDGE DIGITAL LIBRARY (TKDL) A most significant Indian contribution to this field has been the steps taken to create the TKDL in five modern languages. This will help in: Identifying Traditional Medicines and constituent plants used for particular diseases Prevent misappropriation of Traditional Knowledge/ Information for wrong patenting This is a very useful move and is needed for every country. This Indian TDKL database can serve as a very useful model to follow.