Adverse drug reactions and pharmacovigilance of herbal medicines in India

Abstract

The use of Ayurvedic medicines is popular in India and in recent times has become accepted in other countries. This paper discusses, in brief, the Ayurvedic concepts of adverse reactions to medicines, the need for pharmacovigilance of Ayurvedic medicines, challenges in introducing pharmacovigilance in Ayurveda, and some recommendations to successfully implementing these activities. Pharmacovigilance is the science and practice related to the detection, assessment, understanding, and prevention of adverse effects of drugs or any other possible drug-related problems. The objective of the present article is to review the recent trends and challenges posed in the practice of pharmacovigilance of herbal drugs, especially in the Indian context and to shed light on the importance of pharmacovigilance practice in establishing and maintenance of rational use of these drugs. There is increasing awareness of the need to develop pharmacovigilance for herbal medicines. Applying standard pharmacovigilance techniques (WHO guidelines) presents additional challenges, related to the ways in which herbal medicines are regulated, used, named, and perceived. Proper reporting of suspected adverse drug reactions to herbal medicines is currently the main method of detection. However, there is under-reporting for herbal medicines, since users do not seek professional advice about their use of such products, or report adverse effects. Herbal medicine practitioners are not recognized as reporters to spontaneous reporting schemes. Several other conventional pharmacovigilance tools, such as prescription-event monitoring and the use of computerized health record databases, are currently of little use for evaluating the safety of herbal medicines although modified methods have been developed. This process of pharmacovigilance of herbals in India has come a long way since its initiation. The promotion of the systematic and rational use of drugs requires the reporting of adverse events possibly caused by herbal and traditional medicines also