A Blueprint guide to regulating Plant — based remedies
In this article, Foundation for Medical Research demonstrates the steps needed to be taken in order to get herbal medicines regulated the way allopathic medicine is tested and regulated.
Herbal medicines are popular worldwide. In India, plant-based remedies have been used since ages. Though India has a vast resource of these herbal remedies, often little attention is paid towards their standardization. This neglect,has led to the variability in their effect. This has become a major hurdle towards their acceptance by modern medicine
Hence for modernization of traditional medicines, it is necessary that herbal medicines should be standardized as stringently as modern medicine. Traditional Indian medicine suggests the use of guava leaf decoction (GLD) as an anti-diarrhoeal and this example has been used to demonstrate the pathway towards the process of modernization.
1. Undertaking of plant-based surveys: The legacy of indigenous knowledge has been passed on from one generation to next mostly through oral communication. Hence undertaking of surveys, will help in identifying local remedies from community and traditional healers. Numerous surveys are undertaken that list plant names, however the appropriate method of preparation and dose is not usually carefully documented.
2. Short-listing of plants based on surveys and available reports:Ecological as well as economical factors need to be considered while choosing a plant for further study. The plant to be taken up for study against a disease, preferably should not be an endangered species and should be easily available or cultivable.
3. Conducting pre-clinical screening: The shortlisted plants should be tested by undertaking laboratory and animal studies which are specific for the chosen disease. The study should not be restricted to general activities such as antimicrobial and antioxidant.
4. Identifying efficacious plant: Plant showing the most promising activity as shown through the laboratory tests and animal studies, should be selected for further study.
5. Standardization of the plant extract: Since effect shown by a plant is due to the presence of multiple compounds, modern techniques need to be employed for identification of the active combination(s). These could include metabolomics i.e. studies that decipher the metabolites in the extract based on their spectral data and link them to their activities.
6. Undertake toxicity studies: Good activity with less toxicity is the ideal combination for a medicine. Hence studies to check the toxicity of the plant extract using appropriate standard guidelines should be conducted. For example, in case of remedies for chronic diseases, long term protocols need to be followed as opposed to short term protocols.
7. Preparation of formulation and studying its stability:Development of a suitable formulation taking into consideration the shelf life of the formulation.
8. Conduct Clinical studies: In this final step, formulation is tested in clinical settings before its final manufacture and distribution.
Department of Medicinal Plants at FMR has completed steps 1 to 4 in the pathway towards the establishment of the anti-diarrhoeal guava leaf formulation. It is currently involved in standardization of the guava leaf extract using metabolomics and a proof of concept clinical trial.
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Foundation for Medical Research practices a combination of basic biomedical and translational research. Our traditional research areas are leprosy, tuberculosis, medicinal plants and water related environmental research.
If you want to know more about our research specifically in Medicinal Plants read here — http://www.fmrindia.org/medicinal-plants.html
If you want to read more about what we do, then have a look at www.fmrindia.org
