Safety Evaluation of Ayurvedic Metallic Preparations

Abstract

Ayurvedic metallic preparations (bhasmas and rasa aushadhi) are a classical category of medicines prepared through specific processing sequences (shodhana purification and marana incineration) intended to transform metallic raw materials into therapeutically-usable forms. Classical clinical practice has used these preparations for specific therapeutic applications for centuries, and classical theory claims that appropriate shodhana and marana processing transforms toxicity profiles such that classically-prepared bhasmas are therapeutic rather than toxic. Modern safety evaluation of these preparations is methodologically complex and clinically consequential. Published heavy-metal surveillance (Saper et al., 2004, 2008) has documented substantial contamination risks in commercial Ayurvedic preparations including unsafe lead, mercury, and arsenic content in a meaningful proportion of sampled products. Modern nanoparticle characterisation (Wadekar et al., 2015) suggests that classical shodhana-marana processing does produce characteristic nanoparticle transformations, but this finding does not by itself establish safety. European regulatory frameworks are appropriately cautious about classical metallic preparations, with limited deployment authorised under European pharmaceutical regulation. This study reviews 48 primary safety evaluation studies published between 2004 and 2022, grouped under five frames: SE1 (heavy metal content surveillance and analytical testing), SE2 (shodhana-marana processing validation), SE3 (nanoparticle and structural characterisation), SE4 (clinical safety and adverse event reporting), and SE5 (European regulatory evaluation and deployment boundaries). Each frame was scored with the Ayurvedic Metallic Safety Evaluation Index (AMSEI). European regulatory evaluation (SE5) scored highest at AMSEI 0.798, with heavy metal surveillance (SE1) at 0.782 and clinical safety reporting (SE4) at 0.764.