A study to evaluate ayurveda product labels for their compliance as per drug and cosmetic rules 1945, rule 161(B)

Abstract

Background: Product labels are considered as clinical instruction manual which plays a vital role in providing information to the prescriber and end-user at a glance. As Ayurvedic drugs fall under the purview of the Drugs and Cosmetics Act, 1940, a set of quality criteria-based information is required to be displayed on the labels of Ayurvedic product containers marketed in India. Aim and Objective: In the present study, containers of different Ayurvedic products dispensed at Government hospitals and sold at private pharmacies in Bangalore were selected and checked for their compliance with labeling guidelines as mentioned in Drugs and Cosmetic Act 1940. Results: Among 150 selected products, 78 products were classical preparations and 72 were proprietary medicines. Among the fourteen criteria derived from labeling guidelines mentioned in drugs and cosmetic act, all the 150 products were following the standard guidelines with respect to the six basic criteria like name and address of the manufacture, net weight of the formulation, batch number, license number, date of manufacture and mentioning of the word Ayurvedic medicine. Conclusion: Even though majority of the labels of Ayurvedic drug containers fulfilled the requirements, a good number of Ayurvedic products are still not in accordance with the regulatory requirements in providing label information. Following a strict compliance in some labeling specifications like providing complete details of ingredient with their net weight in metric system, displaying the caution warning for formulations containing schedule E 1 drugs, providing the expiry date, and citing the reference from authentic texts in case of classical formulations is still lacking.