Challenges and opportunities in standardization of homeopathic drugs and dilutions

Abstract

Homoeopathy is a widely used holistic system of medicine. Since its inception, it has faced dissension on scientific grounds. Further, a vast variety of the source materials including plants, animals, minerals, microorganisms and even body secretions from patients put forth the challenge of standardization and quality control for homeopathic medicines. The quality of the homeopathic medicines depends on the production and collection of raw materials. Homeopathic pharmacopoeias throughout the world prescribe microscopy, physicochemical, instrumental, chromatography and biological analysis for standardization of homeopathic medicines. These methods prescribed in pharmacopoeias do not narrate the quantification of any active ingredients which are responsible for biological activity. Different pharmacopoeias specify disparate methods of preparation and extents of dilutions for mother tinctures. Homeopathic medicines include ultrahigh dilutions which practically do not contain any active ingredients and there is a dearth of methods for their standardization. To assure the end users regarding quality, efficacy, and safety, current methods of standardization of homeopathic drugs need to be upgraded to include sensitive and relevant biological assays. It has become necessary to speculate standard parameters to ensure batch-to-batch uniformity and reproducibility in its therapeutic action. Hence, this review summarizes the challenges related to standardization of homeopathic drugs and emphasizes on their in vitro and in vivo biological testing for standardization. As a representative class of the most widely prescribed homeopathic drugs, here the anti-inflammatory homeopathic medicines have been highlighted.