Effect of Pharmacovigilance on Herbal Medicines

Abstract

Ayurvedic Medicines has major role in treatment of disease, this is originated from India and now it is accepted in other countries. Pharmacovigilance is related to detection, assessment, understanding and prevention of adverse drug reaction of drug and any other problems. There is increasing awareness in the world is needful to develop pharmacovigilance for herbal medicines. By applying standard pharmacovigilance techniques (WHO guidelines) presents additional challenges, related to the ways in which herbal medicines are regulated, used, named, and perceived. Correct reporting of suspected adverse drug reactions to herbal medicines is currently the main method of detection. But, there is under-reporting for herbal medicines, since users do not seek professional advice about their use of such products, or report adverse effects. An ADR is defined as a harmful or noxious reaction and unintended response to a marketed health product, which occurs at doses normally, used or tested for the treatment, diagnosis or prevention of a disease or the modification of an organic function. Plants have an important role in the development of modern medicines. More than 65-70% of modern medicines in the world marketed are directly or indirectly derived or developed from plant products. Herbal drug having adverse effect are Ginkgo biloba it causes Bleeding, Ephedra (Ma Huang) causes Hypertension, insomnia, arrhythmia, etc. With one and more clinical trials and other clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the lifecycle of the product. According to this situation, the DCGI should act quickly to improve pharmacovigilance so as to integrate Good Pharmacovigilance Practice into the processes and procedures to help ensure regulatory compliance and should enhance clinical trial safety and post marketing surveillance. It will be useful when healthcare professionals, regulatory authorities, pharmaceutical companies and the consumers are participated.