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Introduction: Herbo-mineral formulations (Rasaushadhis) represent one of the most sophisticated branches of Ayurveda, integrating plant-based drugs with purified metals and minerals. Traditionally considered potent and fast-acting, they are widely prescribed in India. However, their global acceptance remains limited due to safety concerns, regulatory challenges, and lack of standardized evidence. Methods: A comprehensive literature review was undertaken using PubMed, Scopus, Web of Science, Google Scholar, and AYUSH Research Portal (2000–2025). Classical Ayurvedic texts (Charaka Samhita, Rasa Ratna Samucchaya, Rasatarangini) were analyzed for descriptions of safety and efficacy. Peer-reviewed studies, clinical trials, and regulatory reports on herbo-mineral formulations were included. Exclusion criteria were non-scientific sources and anecdotal claims. Data were synthesized thematically to highlight challenges and opportunities. Results: Classical texts emphasize purification (Shodhana), calcination (Marana), appropriate dosage, and Anupana (vehicle) to ensure safety. Modern research confirms therapeutic potential in chronic conditions like arthritis, diabetes, and neurological disorders. However, global concerns persist due to reports of heavy-metal toxicity, inadequate quality control, lack of Good Manufacturing Practices (GMP) adherence, and insufficient pharmacovigilance. Regulatory frameworks in the US, EU, and WHO categorize these formulations under “dietary supplements” or “traditional medicines,” imposing stringent restrictions on commercialization. On the other hand, opportunities exist in validating classical methods through advanced analytical tools (ICP-MS, XRD, TEM), developing standardized pharmacopeial monographs, integrating herbo-mineral drugs in evidence-based practice, and expanding global collaborations. Discussion: While challenges of safety perception, regulatory non-uniformity, and inadequate clinical trials hinder global acceptance, opportunities lie in translational research, GMP compliance, pharmacovigilance, and bridging traditional wisdom with modern science. Conclusion: Strategic research, regulatory harmonization, and robust safety validation can transform herbo-mineral formulations into globally recognized therapeutics, balancing tradition with modern requirements.

KEYWORDS: Ayurveda, globalization, herbo-mineral formulations, Rasaushadhi, safety