GMP for Botanicals: Regulatory and Quality Issues on Phytomedicines

The concept of Good Manufacturing Practices (GMP) is well known to the pharmaceutical industry of the world, which finds expressions in many countries in regulations, codes and guides. In the era of revolution in herbal medicines throughout the world, the need of the day is the implementation of GMP in the production of botanicals, including the production of medicinal products from natural resources. Besides the widespread use of phytomedicines in developing countries for their historical and cultural reasons, concurrently alternative and complimentary medicine has been included in the developed countries too for their potential therapeutic efficacy. Thus the plant drugs are used throughout the world as home remedies, over-the counter drug products and also as raw materials for the pharmaceutical industries and thereby represent a substantial proportion of the global medicines market. To combat the worldwide demand of the herbal medicines, the maintenance of GMP is by. This is required right from the cultivation of herbal drugs in the field to the preparation of its different formulations either with the crude power or with the extract or with some purified components made there from. Thus strict control on each and every step of the different aspects of herbal medicines production like cultivation, collection, storage, extraction, formulation, processing, standardization, quality control and packaging etc. have to be taken for the development of herbal drugs of uniform quality. Proper documentation of each and every step from the cultivation to formulations including specification of all the stages involved therein today has global importance. To retain the quality in a phyto-pharmaceutical, it must be ensured that the co-existing materials are also taken care of instead of carrying out a quantitative extraction of what might generally be considered to be the active constituents.