Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Atul Chouhan, Kapil Choudhary 

Abstract: Ayurvedic medicines play an important part in illness treatment; they originated in India and are now widely used in other countries. Pharmacovigilance is concerned with the detection, assessment, comprehension, and prevention of adverse medication reactions and associated difficulties. The world is becoming more aware of the importance of developing pharmacovigilance for herbal medications. Using normal pharmacovigilance methodologies (WHO standards) introduces new issues linked to how herbal medications are controlled, used, identified, and perceived. The primary approach of detection is now correct reporting of possible adverse medication responses to herbal medicines. However, there is under-reporting for herbal medications since individuals do not seek expert counsel or record side effects. An ADR is described as a detrimental or noxious reaction to a marketed health product that occurs at dosages routinely used or evaluated for the treatment, diagnosis, or prevention of a disease or the alteration of an organic function. Plants are crucial in the creation of contemporary medications. More than 65-70 percent of current medications sold throughout the world are derived or created directly or indirectly from plant sources. Ginkgo biloba causes bleeding, Ephedra (Ma Huang) causes hypertension, sleeplessness, arrhythmia, and other side effects. With one or more clinical trials and other clinical research activities being undertaken in India, there is an urgent need to comprehend the significance of pharmacovigilance and how it affects the product's lifecycle. In this case, the DCGI should respond immediately to improve pharmacovigilance by incorporating Good Pharmacovigilance Practice into processes and procedures to assist assure regulatory compliance, as well as to improve clinical trial safety and postmarketing surveillance. When healthcare experts, regulatory agencies, pharmaceutical firms, and consumers cooperate, it will be beneficial.

Keywords: Herbal medicine, ADR, Pharmacovigilance, WHO.