Effect of Pharmacovigilance on Herbal Medicines

Authors

  • Ms. Charu Saxena
  • Geeta Rawat
  • Lovely Chaurasia

Keywords:

Pharmacovigilance, WHO, ADR, Herbal medicine

Abstract

Ayurvedic medicines play an important part in illness treatment; they originated in India and are now widely used in other countries. Pharmacovigilance is the detection, assessment, comprehension, and prevention of adverse medication reactions and complications. The importance of developing Pharmacovigilance for herbal medications is becoming more widely recognised. 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, herbal drugs are under-reported because consumers may not seek expert counsel or keep track of side effects. An ADR is a negative or noxious reaction to a marketed health product that occurs at doses that are frequently used or studied for the treatment, diagnosis, or prevention of a disease or the altering of an organic function. Plants are crucial in the creation of contemporary drugs. More than 65-70% of all current medications sold worldwide are derived or created directly or indirectly from plant components. Ephedra (Ma Huang) causes hypertension, sleeplessness, arrhythmia, and other side effects. Ginkgo biloba causes bleeding. There is an essential need to grasp the relevance of Pharmacovigilance and how it influences the product's lifecycle in India, where one or more clinical trials and other clinical research activities are taking place. In this scenario, the DCGI should move fast to improve Pharmacovigilance by incorporating Good Pharmacovigilance Practice into protocols and procedures to assist assure regulatory compliance while also improving clinical trial safety and post-marketing surveillance. Collaboration between healthcare specialists, regulatory authorities, pharmaceutical corporations, and consumers would be helpful.

Published

2019-04-10