Abstract

The Food and Drug Administration has mandated that all pharmaceutical products should have an expiration date (or shelf life), mentioned directly on the container label since 1979. The notion of shelf life was introduced to Ayurveda, Siddha, and Unani medications in the year 2005. In view of this, a number of research works have been published regarding the shelf life assessment of varied Ayurvedic formulations and their modified dosage forms. However, lots of variations have been observed in the estimated shelf life of the same dosage form in the different studies undertaken. Owing to this, the presented article aims to compile and critically appraise both published and unpublished literature on shelf life, considering both classical and scientific concepts. An extensive search was performed in various online databases, websites as well as search engines including Google Scholar, PubMed, ScopeMed, Dhara Online, etc., to screen the available published literature. The search criterion was using the words “Shelf life”, “Saveeryata avadhi”, “stability study”, “real-time stability study”, and “expiry date” in relation to the Ayurvedic formulations. On reviewing the accessible literature, it was found that only 49 researches are there that reported the shelf life of Ayurvedic formulations, corresponding with the norms laid down in the recent version of the 2016 Gazette Notification while a majority of the studies do not comply. The calculated shelf life was found less in 54.68 % and more in 35.93 % and exact equal in only 4.68 % formulations in comparison to the prescribed values. Upon reviewing the available literature, the authors believe that determining shelf life for Ayurvedic formulations is a challenging task. Limiting shelf life to certain duration in absence of a range may be misleading. Although this current attempt is a preliminary one, more in-depth research is needed to determine the changes in stability periods and the underlying rationale for these changes due to different attributes. Moreover, there is a lack of indistinct specifications for the shelf life of many dosage forms. Hence, estimation, validation, and then incorporation of the shelf life of new dosage forms to Gazette are also the need of the moment.