A survey of the labeling information provided for ayurvedic drugs marketed in India
Authors
Supriya Bhalerao
Department of Clinical Pharmacology, TNMC and BYL Nair Ch. Hospital, Mumbai 400 008, India
Renuka Munshi
Department of Clinical Pharmacology, TNMC and BYL Nair Ch. Hospital, Mumbai 400 008, India
Prajakta Tilve
Department of Clinical Pharmacology, TNMC and BYL Nair Ch. Hospital, Mumbai 400 008, India
Dipti Kumbhar
Department of Clinical Pharmacology, TNMC and BYL Nair Ch. Hospital, Mumbai 400 008, India
Keywords:
Ayurvedic drug container labels, classical formulations, proprietary formulations, Drug and Cosmetic Act 1945
Abstract
Ayurvedic drugs fall under the purview of the Drugs and Cosmetics Act, 1940 and labels on Ayurvedic drug containers need to comply with the requirements specified in this Act (Part XVII, 161). The present survey was conducted to evaluate whether Ayurvedic drug labels were in compliance with the Drugs and Cosmetics Act, 1940 with respect to their contents.
Materials and Methods:
Ayurvedic drugs container labels at three Ayurvedic pharmacies were selected based on the convenience sampling method. Their contents were checked against a set of quality criteria given in the Act. The results are expressed as percentages.
Results:
Basic manufacturing details were present on all the 190 labels reviewed (101 classical and 89 proprietary formulations). References from authoritative books as specified in the 1st Schedule of the Act were mentioned on 90% of labels of the 101 classical formulations reviewed. Fifty-five percent (n = 56) labels of classical drugs and 79 (88%) labels of proprietary drugs provided an ingredient list. Although 20 (20%) of classical formulations and 13 (15%) of proprietary formulations labels mentioned the Cautions/Warnings, only one language (either English or Hindi) was used.
Conclusion:
Ayurvedic drug container labels were not compliant with most of the requirements specified in the Act.
Keywords: Ayurvedic drug container labels, classical formulations, proprietary formulations, Drug and Cosmetic Act 1945
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