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  • 1. Health Administrator Vol : XX Number 1&2 : 115-119Pg. 29. INITIATIVES OF INDIAN COUNCIL OF MEDICAL RESEARCH IN SCIENTIFIC VALIDATION OF TRADITIONAL MEDICINE Nandini K, Kumar, Vasantha Muthuswamy, N.K. Ganguly The ‘Science of life’ as reflected in the wisdom Research in Homoepathy (CCRH) and Central and experience of ancient physicians has globally Council for Research in Yoga and Naturopathy rekindled curiosity of man searching for an answer (CCRYN), the Council never lost its basic interest in Traditional Systems of Medicine to quell the in the scientific evaluation of these time-honoured emerging dissatisfaction with prevalent treatment ancient systems of medicine. Irrespective of the modalities of Modern Medicine for chronic or transfer of the CDRS in 1970, the Council continued refractory diseases. This interest had found an research on indigenous drugs by promoting open- echo in ICMR’s research initiatives on indigenous ended research in traditional medicine through ad- drugs right from the Council’s very inception as is hoc research schemes and fellowships. One such evident from the significant support given by the scheme which had evoked keen interest was the Council to the pioneering work of the late Sir Ram ICMR/WHO project on the efficacy of Ayurvedic Nath Chopra, the Father of Indian Pharmacology, treatment for Rheumotoid arthritis at Coimbatore in the formative years of his career in India. Much first and then as another sub-unit of the same later, through Ministry of Health, ICMR in project at Chennai in 1982. One year later the collaboration with then Central Council of Ayurvedic interim analysis of data collected on the revised Research and Central Scientific and Industrial protocol designed by a sub-Committee of Research (CSIR) had the privilege of conceiving, Rheumatologists showed that the Ayurvedic line of designing and technically implementing the unique treatment (as practiced by the TRM experts at Composite Drug Research Scheme (CDRS) Coimbatore) had analgesic/anti-inflammatory during 1964-1970.1 During this period nine ‘circuits’ activity similar to the first line of modern anti- were set up in different parts of the country, each rheumatic drugs like the salicylate group of drugs comprising four units.2 An advisory committee on did not possess any disease-remitting activity. indigenous drugs constituted in 1963 for this Scheme, brought together for the first time experts In the wake of the renewed global interest in in the Ayurvedic System of Medicine and Modern the Traditional Systems of Medicine and China re- Medicine (pharmacologists and clinicians) and discovering the well-known anti-malarial drug scientists (botanists and phytochemists) for Qinghaosu from the common Artemesia plant selecting and screening reputed Indian Medicinal marking an important milestone in global medicine plants for biological activity on the basis of their in this direction, ICMR was inspired to strive for a therapeutic claims. First batch of 58 medicinal similar breakthrough in Indian Medicine. Dr V plants was screened and nearly eight of these Ramalingaswami, then Director General of the reached an advanced stage of investigation. In Council directed Dr. G.V. Satyavati to take up the 1970, the Government of India transferred this task. Considering that the Pharmaceutical Industry unique Scheme to the then newly constituted in India, the foremost in the entire Third World, Central Council for Research in Indian Medicine and provides excellent facilities for generating quality Homoepathy (CCRIMH). products due to availability of high expertise in related specialized science to develop Subsequently, with the branching of the combinatorial chemistry, new synthetic molecules CCRIMH into several independent Councils, such and plant derived candidate drugs, the efficacy of as Central Council for Research in Ayurveda and these new molecules may most often be proved Siddha (CCRAS), Central Council for Research in futile. Therefore, the safer and cheaper alternative Unani Medicine (CCRUM), Central Council for would be to simultaneously seek ways to 1 Research on Indian Medicinal Plants. In ICMR Bulletin vol. 2 No. 4, August, 1972. 2 Four Units comprised Clinical Unit of Ayurvedic and Modern Medicine physicians, Pharmacognosy Unit for botany, Chemistry Unit and Pharmacology Unit. 115
  • 2. standardize the already existent treatment facilities for monitoring each aspect of this new modalities of traditional medicine. Keeping this in diseases oriented activity including timely supply mind, the Council reconstituted its Advisory Group of authentic traditional drugs for trial purpose on Traditional Medicine comprising outstanding through a multicentric and multidisciplinany experts in Ayurveda, Siddha, Unani and Yoga approach. This activity was ably supported by the systems on the one hand and experts in different Central Biostatistical Monitoring Unit of National branches of Modern Science / Medicine including Institute of Epidemiology (Institute of Research in pharmacolgists, phytochemists, botanists and Medical statistics then) which helped in designing clinicians on the other hand. Representatives of the trial protocols, drug dispatch, monitoring and the CCRAS as well as CCRUM were also analysis of the data. Two Advanced Centres i) at members of this Advisory Group. On the basis of Central Drug Research Institute, Lucknow on the recommendations of the Scientific Advisory Pharmacological Evaluation of Selected Traditional Board of the ICMR, Task Forces / Study Groups on Remedies and (ii) at Regional Research laboratory, some of the priority areas met in December, 1983 Jammu (earlier at Punjab) for standardization, and January, 1984 to review certain time-honoured Quality Control and Formulations of selected traditional therapies and also to provide valuable Traditional remedies were set up to provide addition to the existing therapeutic armamentarium. necessary inputs for experimental studies and The concept of reverse pharmacology was applied formulations for human study subjects. and the experts formulated time-bound goal- oriented projects on traditional remedies for Anal In the 8th plan period the leads obtained in the fistula; Diabetes mellitus, Viral hepatitis, Bronchial first Phase were pursed and consolidated. asthma, Urolithiasis, Filariasis, Kala-azar and Khaarasootra, a medicated thread used for Anal Wound healing. fistula was found to be a safe, ambulatory and cost- effective alternative to surgery.3 The Russians For the seventh five year plan period, apart showed keen interest in adopting this method. from the multicentric drug-oriented / disease Pharmacopoeial standards have been achieved oriented research, the vision of Traditional Medicine and a Monograph was prepared as also video- (TRM) programme was also to constitute Task coverage of its production and quality control. A Forces for preparation of compendium of traditional major breakthrough was achieved with the remedies / techniques on the basis of scientific hepatoprotective drug. Picrorrhiza kurroa at the evaluation for preparation of Monograph on Council’s Advanced Research Centre at CDRI, Medicinal Plants of India, for cultivation of medicinal Lucknow. Two active principles kutkoside and plants in collaboration with the ICAR, CSIR, National picroside showed synergistic activities and the Botanical Survey etc and for synthesis / combination was named Picroliv, which later paved manufacture of selected plant products. Interaction the way for a controversy over a similarly named with sister organizations like CCRAS, CCRUM, but differently proportioned product of the same plant CCRYN etc. on the one hand, and the CSIR, ICAR, in USA. This compound has undergone successful on the other were also on the cards. The Council Phase I and Phase II trial in India and is ready for also proposed to work out fruitful research schemes Phase III trial. In Diabetes the plant drug, Vijaysar in collaboration with the unique “Ancient Insights showed promising results consistently. 4 The and Modern Discoveries” (AIMD) project of the clinical leads obtained in the other three areas could Bharatiya Vidya Bhavan, Mumbai and also have not be pursued further for various reasons although beneficial collaborative projects with international experimental studies gave encouraging results organizations like the WHO, UNICEF and others. including Kala-azar and would healing, the two But due to constraints of funds and infrastrudture areas not yet taken up clinically. Newer identified only multicentric trials in six thrust areas viz. Anal areas like Benign Hypertrophy of Prostate, HIV/ fistula, Diabetes mellitus, Viral hepatitis, Bronchial AIDS, ischaemic heart diseases, ageing, and asthma, Urolithiasis and Filariasis and a pilot study Cancer also could not be taken up. An “Illustrated on snake bite could be taken up. A Central Manual of Commonly Used Indian Plant Drugs” was Coordinating Unit was created at the ICMR brought out as an ICMR-CSIR effort during this Headquaters with essential manpower and other period. An Institute for Research in TRM was also 116
  • 3. proposed at Belgaum, Karnataka. The Advanced demand for the plant drug from Vijaysar, steps were Research Centre at CDRI, Lucknow was set-up taken for a dialogue between related Government and another centre for Clinical Pharmacology in agencies agencies to conserve Vijaysar trees, Traditional medicine was initiated at KEM Hospital, prevent their misuse as timber and start their Mumbai. cultivation by using appropriate agro-technolgy.6 The proposed Centres for Advanced Research will During the 9th plan all the strategies which were be Centre for Advanced Research in Yoga at planned during the 7th plan were to be initiated after Swami Vivekananda Yoga Research Foundation, prioritizing thrust areas based on strength of Bangalore and Centre for Advanced Research for available resources and infrastructure for validating Reverse Pharmacology in Traditional Medicine at a limited number of drugs. The area of viral Bhavan’s S.P.A.R.C, Mumbai. diseases like Herpes Zoster, Polio, HIV/AIDS, Viral Hepatitis, and ischaemic heart diseases, ageing, The Centre for Advanced Research at CDRI, cancer, identified earlier by the Council were to be Lucknow focussed on three traditional remedies, taken up during this period. Multicentric clinical trials namely, Picrorhiza kurroa (root and rhizome) for on Vijaysar (Pterocarpus marsupium) in newly hepatoprotective activity, Centella asiatica (whole diagnosed cases of Diabetes mellitus (including plant) for wound healing and Terminalia chebula extended study) were initiated. 5 The encouraging (fruit) for adaptogenic activity. Phase II multicentric results obtained from these trials led to another clinical trial on Picroliv was carried out in Mumbai, multicentric trial in two groups – uncontrolled Jaipur, Varanasi and Lucknow. Phase III double diabetics on single hypoglycemic drugs and those blind clinical trial using placebo is being carried out who opted for it. Under the inter-agency programme in patients of tuberculosis receiving multi drug a second centre was set up in Clinical therapy and alcoholic cirrhosis in Mumbai at Seth Pharmacology for pharmacokinetics, bioavailability G.S. Medical College and T.N. Medical College. In and herb-drug interaction studies at BYL Nair pattern profiling of Picrolive, a total of 27 Hospital, Mumbai, and for Standardisation and components were detected by HPLC, fourteen Quality Control of Selected Herbal Remedies / components of which were quantified, and seven Natural Products at National Institute of wee structurally characterized based on MS/MS Pharmaceutical Education and Research, fragmentation and available literature. Experimental Chandigarh. studies on Centella asiatica showed that both the plant extract and its marker (K008) are potent In the 10 th plan validation of traditional angiogenic with significant wound healing activity knowledge was proposed on Shakhotak (Streblus in normal and diabetic wounds. Further, the extract Asper) for Wucherarian and Bancroftian filariasis, and its fractions also showed significant anti- Arjuna (Terminalia arjuna) for cardiovascular amnesic activity. The shelf-life and accelerated diseases, Varun (Crataeva nurvala) for Benign stability studies of the alcoholic extract and Hypertrophy of Prostate, and a co0mpound asiaticoside indicated stability for more than 2 formulation for cancer. Other activities included years. Terminalia chebula and its marker (K022) finger printing of selected herbal preparations, showed significant anti-stress activity in various agrotechnology of selected plants for various stress models. Shelf-life and accelerated stability clinical trials – Picrorrhia kurroa and Pterocarpus studies of alcoholic extract and K022 indicated that marsupium, and technology transfer to both are stable for more than two years. Pharmaceutical industries of Kshaarasootra and Vijaysar. On account of the expected increase in 3 Multicentric randomized controlled clinical trial of Kshaarasootra (Ayurvedic medicated thread) in the management of fistula-in-ano. Indian Journal of Medical Research (B) 94: 177-185, 1991. 4 Flexible dose open trial of Vijayasar in cases of newly-diagnosed non-insulin-dependent diabetes mellitus. Indian J. Med Res 108, July 1998, pp 24-29 5 Efficacy of Vijaysar (Pterocarpus marsupium) in the treatment of newly diagnosed patients with type 2 diabetes mellitus: A Flexible Dose Double-Blind Multicentre Randomized Controlled Trial”. ICMR Study Group. Diabetologia Croatica, 34- 1, 2005. 117
  • 4. The Centre for Advanced Research in Clinical Medicine research where human capacity will be Pharmacology in Traditional Medicine at T.N. developed and strengthened. The aims of this Medical College, Mumbai carried out studies on Centre will be validation of safety and therapeutic mechanism of action of Pterocarpus marsupium, efficacy, study mechanism of action of herbal clinical and experimental evaluation of ACTM001 remedies and conduct clinical trials besides in diarrheoa and ACTM 002 for wound healing. collection and dissemination of information on Pterocarpus marsupium showed protection against medicinal plants of Western Ghats and their damage, increase in insulin secretion, reduction in cultivation / conservation. Survey on usage, MDA formation with Streptozotocin and increased availability and utility of TRM / Formulations in angiogenesis but with no insulinomimetic activity Belgaum region and evaluation of plants used in at tested concentrations. There was dose Ayurveda / Siddha for anti-oxidant activity and a dependent increase in PBMC proliferation in normal cross-sectional study on the status of Reproductive volunteers, and the same effect is being studied in and Child Health and Practice of Traditional diabetic patients. There was also dose dependent Medicine in Belgaum District are other activities increase in polymorphonuclear phagocytosis and contemplated. Already a database has been inhibition of TPA induced oxidative burst. Viability created for medicinal plants of the Western Ghats. assays on rat insulinoma cells (RIN) cells showed It is also proposed to undertake studies on no viability upto 10 mg/ml but an increase in cell pharmacoepidemiology and phytochemistry, set up numbers as compared to control at certain a Museum for the medicinal plants of the Western concentrations. ACTM 001, a combination of Ghats and undertake cultivation of some of them. Cyperus rotundus, Zingiber officinale and syzigium cummini was tried in diarrhea which could have an The Council has also brought out two volumes impact on public health. Cyperus rotundus inhibited of “Quality Standards of Indian Medicinal Plants and bacterial translocation, but with no antibacterial four volumes of “Reviews on Indian medicinal effects. Zingiber officinale inhibited bacterial Plants”. translocation and also exerted antibacterial effects. Further areas to be explored would include The wound healing action of ACTM 002, a Adverse Drug Reactions due to herbal drugs, “Classical” formulation used for would healing was Natraceuticals (Herbal Health Foods) and validated. Ayurvedic parameters to assess genetically modified foods, IPR issues / Indigenous response to medication, effect in diabetic patients, knowledge, Academia-Industry collaboration. The rate of wound healing, and bioassay guided expanded network would involve Department of standardization with respect to active markers were AYUSH (earlier ISM & H) for Clinical trials, carried out. Training Courses were held on use of preparation of Pharmacopoeia and quality drugs, research methodology in traditional system to DBT for bioconservation and Gene Banks, CSIR increase expertise in protocol designing. for Standardisation, quality Control and formulations, The Regional Medical Research Centre at ICAR for agrotechnology and Department of Belgaum for traditional medicine research was Chemicals/Fertilisers for database and export of conceptualized in 1983, and land was allotted in plant drugs. The objectives of this network would 1984 and finally initiated during this plan period. This be to generate trained manpower, identify/ centre will address the regional health problems in strengthen clinical trial centres, and referral centres the state of Karnataka and also establish a National for crude drugs, and conduct regular training Centre to promote collaborative research between programmes for trial designing and related ethics. practitioners of Modern Medicine and Traditional The Golden Triangle partnership under a system of medicine. The mission is to provide cost- tripartite Agreement, is among the Department of effective quality healthcare through the traditional AYUSH, CSIR and ICMR to develop formulations / systems of Medicine. The mandate is to plant based drugs for identified diseases. While scientifically validate the claims of Traditional the Department of AUSH will give technical Medicine to provide evidence for global acceptance guidance regarding formulations to be used, CSIR and to set up a Centre of excellence in Traditional will carry out the pre-clinical studies on these 6 ICMR’s Annual Report 1999-2000. 118
  • 5. formulations and ICMR will conduct the clinical would soon be legislated through a bill for Promotion trials. The objectives of the program are given and Regulation of Biomedical Research. The below: recognized Indian Systems of Medicine are Ayurveda, Siddha and Unani, which use herbs and 1. To develop safe and effective standardized minerals in the formulations. Many of the drugs Ayurvedic products for the identified disease used in Modern Medicine also have been derived conditions. from medicinal plants but are marketed only after 2. To develop new Ayurvedic and plant based such drugs have undergone safety and efficacy products effective in disease conditions of evaluation in animals and human subjects in that national / global importance. order as per regulatory requirements. Since the traditional formulations used in the traditional way 3. To develop mechanism to make products for traditional use are time tested, their safety and affordable in the domestic market. efficacy for validation could be straightaway evaluated through human trials provided, there are 4. To use appropriate technologies for no reports of toxicity and the use is for not more development of single and polyherbal products than three months. If large Phase III clinical trials to make it globally acceptable. have to be undertaken then limited toxicity studies 5. To develop potential patentable products. for 4 – 6 weeks in 2 species of animals should be undertaken. This concept of ward to lab strategy The fourteen areas of priority under this known as reverse pharmacology, was incorporated partnership will be Rasayana, Joint disorders, in the ethical guidelines for clinical trials using herbal Memory disorders, Menopausal syndrome, medicines. The Drugs Controller General of India Bronchial allergy, Fertility and infertility, Cardiac has accepted these guidelines, which are now disorders (cardioprotective & anti-atherosclerosis), incorporated in the Drugs & Cosmetics Act Sleep disorders, Irritable Bowel Syndrome, Vison amendment of 2002. disorders, Urolithiasis and Benign Prostate Hypertrophy (BPH), Malaria / Filaria / Leishmaniasis, With this vision in mind the Council wishes to Diabetes and Bhasma toxicity. restore the glory to the Traditional Medical heritage of the country and utilize the revitalized knowledge With regard to regulation of the plant drugs to improve the health of the suffering millions of the ICMR has brought out ethical guidelines which country through a joint scientific effort. 119