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THE PHARMA REVIEW (DECEMBER, 2007 - JANUARY, 2008)

Herbal Drugs Require Pharmacovigilance Study - Need and Reality

S Ponnusankar, P Venkatesh, M. Venkatesh, S. C. Mandal and Pulok Kumar Mukherjee

Abstract:

Phytotherapeutics and herbal medicinal products

Phytotherapeutic agents or phytomedicines are standardized herbal preparations consisting of complex mixtures of one or more plants which are used in most countries for the management of various diseases. One basic characteristic of phytotherapeutic agents is the fact that they normally do not possess an immediate or strong pharmacological action. For this reason, phytotherapeutic agents are not used for emergency treatment. Other characteristics of herbal medicines are their wide therapeutic use and great acceptance by the population. In contrast to modern medicines, herbal medicines are frequently used to treat chronic diseases too. So far, only handfuls of herbal formulations have been evaluated scientifically to prove their safety, potential benefits and effectiveness. The sources of raw material and the good practices of manufacturing processes are certainly the essential steps for the quality control of herbal medicines.

Medicinal agents obtained from plants and their isolated constituents have found their way into the prescription drug inventory such as atropine, colchicine, digoxin, diosgenin, ginsenosides, hypericin, hyperin, quinine, salicylates, strophanthin, taxol, vincristine, vinblastine, etc. There are only “evidence-based” medicine and “yet-to proven” medicine regardless of origin, conventionality or approach. Thus herbal medicinal products not regulated as medicines cannot be seen as alternative therapies unless they are shown to be equally effective as accepted agents.

Phytotherapeutic agents are normally marketed as standardized preparations in the form of liquid, solid (powdered extract), or viscous preparations. Solid or powdered extracts are prepared by evaporation of the solvents used in the process of extraction of the raw material. Some therapeutic agents are greatly concentrated in order to improve their therapeutic efficacy.6 In this process, it is also possible to remove, when necessary, some secondary metabolites present in the plants which may produce undesirable side effects.

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