Pharmacovigilance in Ayurveda – Concept and Regulations

Abstract

Background: The Indian system of medicine has its origin in India and has been practiced since centuries in India and its neighbouring South East Asian countries. Mostly the practice of this system of medicine is believed to be the safest form of therapy, however, incidences of adverse drug reactions owing to the consumption of traditional drugs led to the origin of pharmacovigilance of Ayurvedic drugs. The Concept of Pharmacovigilance: Pharmacovigilance is the science of detection, understanding, assessment and prevention of adverse drug reactions and related untoward effects. Concepts and Regulations of Pharmacovigilance in Ayurveda: Given the current scenario of the usage of the traditional and alternative medicine at a global scale, it becomes imperative to ensure the safety of the patients consuming these medications. This makes the science of pharmacovigilance, a significant domain in the field of medicine and public health as well. Nevertheless, the adverse drug reaction of traditional Ayurvedic medicine may range from trivial effects to serious fatal outcomes leading to the death of a patient. Furthermore, the application of the principles of pharmacovigilance in the realm of Ayurveda is a challenging job owing to several of the inherent characteristic features associated with such a science. Albeit recent researches are based on in-vivo and/or in-vitro trials of many herbal preparations, however, the science of Ayurveda is the science of ages and is transmitted from generation to generation. During the recent past considering the significance of pharmacovigilance in Ayurveda and other indigenous systems of medicine, a national pharmacovigilance unit of ASU (Ayurveda, Unani and Siddha) systems of medicine has been initiated at Gujrat Ayurveda University in the year 2008.

Origin, History and Development of Pharmacovigilance Through Ages

“…Pharmacovigilance is the science of detection, understanding, assessment and prevention of adverse [1] drug reactions and related unfortunate effects. The objective of pharmacovigilance is to identify, analyse and understand adverse effects or any other specific drug-related problems that are not limited to chemical drugs, but also to herbal, conventional and complementary medicines, biological medicines, vaccines, blood products and medical devices, and to prevent them.…”