Quality of homeopathic medicinal products

Homeopathic medicinal product is any medicine prepared in accordance with a homeopathic manufacturing procedure described by a pharmacopoeia in official use or other officially recognized documents. Starting from variety of source materials (medicinal plants, animal and human materials, pathogens as well as minerals and chemicals), the homeopathic manufacturing procedure includes potentization or dilution of the product into different grades or potencies. Nowdays, the use of homeopathic medicines for self-healing is widespread not only in the European region but also in south Asian countries and North and South American countries. With the rapid expansion of their global market, the safety and the quality of homeopathic medicines has become a major concern for the public health. The safety of the homeopathic medicines largely depends on their quality. Two issues are decisive for the quality of homeopathic medicine: determining the authenticity and the origin of the starting materials according to the homeopathic tradition, and defining the manufacturing procedure. Because of the wide range of processing techniques and manufacturing methods in the different pharmacopoeias, the final homeopathic products may show marked variability. Second, the specific nature of homeopathic medicines have as consequence that some of the methods for quality control and some test systems that are mandatory in pharmaceutical regulation, may at times be inapplicable or irrelevant. These include identification and quantification of active substance contained in the final homeopathic product at high potency. In such cases the quality should be demonstrated by complete validation of the manufacturing and dilution process, and also by quality control of the starting material and of the least diluted source employed for potentization (e.g. mother tincture). As long as the identity and purity of starting materials and the reproducibility of the manufacturing process are given, the consistency of quality of homeopathic medicines is assured allowing their safe use.