ADVERSE DRUG REACTION MONITORING IN THE AYUSH SYSTEM: A REVIEW OF PHARMACOVIGILANCE PRACTICES, FRAMEWORKS, AND ASSESSMENT SCALES

AYUSH system of medicine consists of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy is an ancient and well established system of healthcare in India. Its relevance was reiterated during the COVID-19 pandemic, where ASU (Ayurveda, Siddha, Unani) drugs were found beneficial in prevention, management and treatment of postCOVID complications. However, ASU drugs, like all pharmacologically active substances, are not free of adverse effects and their perception as intrinsically safe has often delayed the setting up of safety monitoring systems. Pharmacovigilance (PV) the science of detecting, assessing and preventing adverse effects or adverse reactions to medicines is crucial to safeguarding patients receiving these therapies. India’s pharmacovigilance infrastructure is expanding through initiatives like the Pharmacovigilance Program of India (PvPI) and the National Pharmacovigilance Program for ASU&H Drugs, but remains in its early stages compared to established drug monitoring systems. The major challenge is the chronic underreporting of ADRS due to the lack of knowledge of reporting tools among practitioners, underreporting by patients, the absence of a standardized system of causality assessment, and the polyherbal, multi-ingredients nature of many of the ASU preparations making it difficult to attribute a reaction to a causative agent. ADR is known to be a cause of hospitalization and causality assessment is particularly difficult when multiple medicines are used concomitantly. The review discusses the present status of ADR monitoring in AYUSH system, regulatory framework available for it and causality, severity and preventability assessment scales such as WHO-UMC, Naranjo and Hartwig scales used or adaptable for ASU drug safety evaluation. Pharmacovigilance in AYUSH needs to be strengthened for ensuring patient safety and confidence in traditional Indian medicine.