Abstract The safety and effectiveness of a product are greatly influenced by its stability. Ayurvedic, Siddha, and Unani (ASU) medicine includes single-herb or polyherbal formulations with or without mineral medications and/or drug ingredients derived from animals. Pharmaceutical products have currently undergoing stability testing in accordance with the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The First Schedule of the Drugs and Cosmetics Act, 1940 includes a concept of shelf life and stability study. According to Rule No. 161-B of the Drugs & Cosmetics Act 1940 and Rules 1945, a person applying for a license or renewing an existing license for the manufacturing of patent & proprietary ASU medicines must provide the scientific data based shelf life or date of expiry of the medicine based on the Real-time stability tests to the State licensing authority. The Ayurvedic Pharmacopoeia of India (API), Part I, Vol. VIII, specifies the guideline for stability testing and shelf life determination for both new and old Ayurvedic Siddha and Unani medicines. Stability tests should be performed on the dosage form contained in the container and closure system that are intended for marketing. At least three primary batches should be the subject of formal stability studies. For accelerated long-term study, the recommended storage conditions are 400 C ± 20 C / 75 % RH ±5 % RH for at least 6 months, and for long-term study, the recommended storage conditions are 300 ± 20 / 60 % RH ± 5% RH for at least 12 months. A product is considered to be stable if “no significant change” occurs at any time of testing.
Keywords Stability, Shelf life, Ayurveda, Unani, Siddha, Drugs & Cosmetic Act, 1940 and Rules, 1945.