Shelf Life of Ayurvedic Dosage Forms in Regulatory Perspectives

Abstract

Ayurveda is an ancient (since 1000 B.C.) system of traditional medicine in India. It is not only practised in India even practiced globally as a complementary and alternative medicine system. Ayurveda defined enormous formulations belongs to different Bheshaj Kalpana (dosage forms) out of which Svarasa (juice), Kalka (paste), Shruta/Kvatha (decoction), Sheeta/Hima (cold infusion) and Phanta (hot infusion) can be considered as basic/primary dosage forms and few other dosage forms e.g. Churna (powder), Vati (tablet/pills), Tail/Ghrita (medicated Oils/Clarified butter), Asava and Arishta (self-generated alcoholic preparations) and Avaleha (electuary/semisolid confectionary) considered as secondary dosage forms derived from primary dosage forms. The Saviryta Avadhi (shelf life) of the basic dosage forms are considered as 03 hrs while the shelf life of derived dosage forms is varied as the later mentioned formulations comprises complicated specified Ayurvedic medicine processing and inclusion of natural preservatives also. In the current scenario, the amendment of Rule No. 161-B of Drugs and Cosmetic Act 1940, specify the maximum shelf life or date of expiry; unless otherwise determined on the basis of scientific data of an Ayurveda medicine defined under clause (a) of section 3 of the Act. This rule also stated that the Ayurvedic medicine defined under clause (h) of section 3 of the Drugs and Cosmetic Act 1940, the scientific data based shelf life based on the Real-time stability studies of medicines should be derived in accordance with the guidelines prescribed in Ayurvedic Pharmacopeia of India Part I, Vol III.