Quality control and standardisation of phytomedicines – From cultivation of medicinal plants to its clinical application

In the recent years with ever growing commercialization in the field of herbal medicines, there has been an instant demand for quality control of the drugs used in this system. The studies on the identity, purity and quality of the genuine drug will enhance information in checking the adulteration. A set of standards would not doubt be detterent on substitution and adulteration and also an aid both for 'Drug law Enforcement' as well as for Safety Assessment of the Finished Herbal Products.

In the present paper an attempt has been made for a sequential study of the Quality Control of Phytomedicines starting from -Selection of Medicinal Plants, Good Agricultural Practices (GAP), Cultivation, Good Field Collection Practices (GFCP), Organized and Unorganized Drugs, Source and Period of Collection, Identification and authentication, Storage, Chemical Standardisation, Assay, Good Manufacturing Practices (GMP), Pre Clinical studies up to Clinical Approach, with special reference to maintain Standardisation at each and every stage.

Besides above protocols, this study deals with approaches towards establishing the Safety & Quality starting from preliminary examination of a medicinal plant, its morpho-anatomical, pharmacognostic, physicochemical and analytical parameters, foreign organic matter, pesticide residue, radioactive and microbial contamination, chemical assay, finger printing of different extractives using modern extractors, Chromatographic and Spectroscopic techniques, phytochemical screening, quantitative analysis of inorganic constituents and standardisation with special reference to marker compounds in plant species and their fingerprinting along with its modern perspectives.

Different stages, i.e Quality Control Studies of Raw medicinal plant, Controlled Studies on Method of Processing, Quality Control Studies of Finished Phytomedicines and Standardisation Proceedures at each stage from birth of the medicinal plant up to clinical application of herbal medicine have been described. An emphasis has been given on the protocols which are required for Registration of phytomedicines. An example is cited with standardisation and quality control studies of Salvadora persica carried out in our laboratories.