Become A Member

Background: The Ayurvedic Pharmacopoeia of India (API) is the legal book of standards for Ayurvedic drugs. Part I covers single drugs, and Part II covers selected compound formulations from classical texts. Most Ayurvedic medicines in commerce are compound formulations, yet their quality standards are less developed than those for single drugs. Objective: To review the structure of API standards, and to identify gaps in standards for compound formulations, using published evidence on product quality. Methods: A critical narrative review of literature on the development of the API, quality surveys and standardisation studies of compound formulations, and international guidance on herbal quality control. Results: Part I of the API comprises nine volumes with about 645 monographs on single drugs. For compound formulations, monographs typically specify composition, method of preparation, description, identity by thin-layer chromatography and general physicochemical parameters, but quantitative assays of active markers, dissolution and stability requirements are generally lacking. Evidence from the literature shows the consequences: commercial products of the same formulation differ in marker profiles and in metal content (gold 32–98 wt% in five Suvarna bhasma products), preservatives are sometimes present at high levels, heavy metals are frequently detected in over-the-counter products, and calculated shelf lives often fall short of regulatory norms. Conclusion: Compound formulation monographs should progressively include quantitative marker assays, fingerprint acceptance criteria, product-specific limits for metals and contaminants, dissolution or disintegration tests where relevant, and stability-linked specifications.