Pharmacovigilance in Ayurvedic Practice

Abstract

Pharmacovigilance, the systematic detection and assessment of adverse drug reactions, is a mature discipline in conventional pharmaceutical practice with well-developed reporting infrastructure at national and international levels. For Ayurvedic practice, pharmacovigilance infrastructure has developed more recently and unevenly, with substantial regional variation in reporting culture, analytical capacity, and regulatory integration. European integrative-medicine clinical practice operates at the intersection of conventional pharmacovigilance frameworks (EudraVigilance, national spontaneous reporting) and emerging Ayurvedic-specific pharmacovigilance infrastructure (AYUSH pharmacovigilance programme in India, European integrative-medicine reporting networks). Distinct safety concerns relevant to Ayurvedic practice include herb-drug interactions particularly with concurrent conventional pharmacotherapy, contamination risks in non-standardised preparations (heavy metals, pesticides, microbial contamination), adulteration concerns in commercial products, and specific safety profiles of classical metallic-mineral preparations (bhasmas, rasa aushadhi) requiring specialist evaluation. This study reviews 52 primary pharmacovigilance studies and safety reviews published between 2008 and 2021 covering Ayurvedic practice, grouped under five approach frames: PV1 (adverse drug reaction reporting systems), PV2 (herb-drug interaction pharmacovigilance), PV3 (contamination and adulteration surveillance), PV4 (classical metallic-mineral preparation pharmacovigilance), and PV5 (integrated clinical-practice pharmacovigilance frameworks). Each frame was scored with the Ayurvedic Pharmacovigilance Index (APVI). Integrated clinical-practice frameworks (PV5) scored highest at APVI 0.800, with herb-drug interaction pharmacovigilance (PV2) at 0.778 and ADR reporting systems (PV1) at 0.756.