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Ayurvedic Medicine: drug research and development, critical issues

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Research and development of new drugs is a complicated endeavor. Although there are thousands of ayurvedic drugs available, only very few are explored properly in such a way, that western doctors are aware of the findings and will prescibe the formulations. There are many barriers for ayurvedic drugs to take, before these can enter foreign markets. Among others issues such as purity, quality control, GMP, toxicology, production and characterization have to be taken into consideration. Furthermore, preclinical mechanistical work, and phase I, II and III studies are needed. Thus,also for Indian traditional medicines, guidelines of standardization, manufacture and quality control as well as scientifically rigorous R&D is required. The upside for conducting such research coulld be significant, The total sales' value of a drug such as Taxol, derived from the tree Taxus baccata was US$ 2.3 billion in 2000. Ayurvedic medicine can provide novel impulses into international drug development. However, bioprospecting, the search for economically valuable herbal products by pharmaceutical companies up to 2010 has not been overly successful.

So far so good

Various intersting biological active molecules have come out of Ayurvedic tradition including Rauwolfia alkaloids for hypertension, Holarrhena alkaloids in Amoebiasis, Guggulsterons as hypolipidemic agents, Mucuna pruriens for Parkinson’s disease and piperidines as bioavailability enhancers, to mention a few. However, the acceptance within the western wold of ayurvedic preparations is very low, due to a variety of reasons. But there is a promise to deliver!

But a promise to deliver 

Ayurvedic herbs may hold a promise for many western diseases and clinical problems, such as cancer, diabetes and other chronic disases. [1][2] But knowledge about putative side effects is scant. [3][4] 

Research into ayurvedic medicine using modern methods is relative young, and started in the 60s of last century. [4] But to date less then 100 clinical trials have been published in this field. The development of insight what is needed to bring ayurvedic drugs to the western market is slow, and much expertise needed in this field is difficult to find.

Slowly, slowly animal models as well as cell culture screening tests are introduced in the analysis of the mechanism of action of ayurvedic drugs. [6] [7][8][9][10]

Pyhtochemical characterization is needed, as well as the pharmacology properties. [11] [12][13]

One main issue for all herbs used in auyrveda is to check whether these herbal formulations are free of heavy metals. [14] Toxicological studies in specific animal models are required before entering clinical trials. [15]Hepatotoxicity for instance is an issue in herbals. [16]

If clinical trials are published, the selected medical journals are not really main stream journals. [17][18][19][20][21][22][21][22] Some of the studies appeared in local Indian journals, or journals with a very low impact factor. [25][26][27][28][29] Other studies only focussed on surrogate parameters.[30][18][19][27][34] Furthermore, interactions studies are very few. [35] 

Clinical studies are few, and mostly not following a respected RCT methodology. [36] [37] And only very few studies reached respectible journals. [38] But these studies were mainly pilot trials. Basically there are only three ayurvedic preparations of outstanding quality and supported with sufficient clinical data to take serious: Bacopa for cognition,[39][40][41] Boswellia for colitis and reuma [42][43][44][45] and Mucuna for Parkinson.[46][38]

Thus there is are still main hurdles for ayurvedic medicines to take, before these preparations are to enter the western medical world.  

 

Other relevant Sources 

‘WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine’ and ‘WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants’

Rao Yogeshwar, Technology Network and Business Development Division, CSIR, New Delhi 

Patwardhan Bhushan (2000). Ayurveda: The Designer Medicine. Indian Drugs 37( 5): 213-227 

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