Quality, Safety, and Efficacy of Herbal Products through Regulatory Harmonization

Abstract

Quality of herbal medicines is a great concern to consumers and regulators throughout the world. The quality of herbal medicines mainly depends on regulatory requirements of respective countries. To probe the role of regulatory standards and their harmonization in improving quality, safety, and efficacy, legislation on herbal medicines of different countries was analyzed. Results show that different countries have been changing and upgrading quality requirements over the last few years, and those who have no legislation presently have started framing suitable legislation. Like other countries, India has also adopted prudent measures to improve the quality of herbal medicines. Though there is a general trend to incorporate stringent measures worldwide, there is little initiative to harmonize regulations, which is essential for providing quality herbal medicines globally.