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International Journal Of Drug Regulatory Affairs
Year : 2023, Volume : 11, Issue : 4
First page : ( 52) Last page : ( 66)
Print ISSN : 2321-7162. Online ISSN : 2321-6794.
Article DOI : 10.22270/ijdra.v11i4.632

Overview of good manufacturing practices requirements for herbal medicines in India and Europe

Ram Kanchan H., Kothari Lokesh P., Mundada Atish S.

Department of Regulatory Affairs, SNJB's Shriman Sureshdada College of Pharmacy, Chandwad, 423101, Nashik, Maharashtra, India

Online Published on 29 March, 2024.

Abstract

Over the past three decades, the usage of herbal medicines and supplements has grown significantly, with at least 80% of people turning to them for some aspect of primary healthcare. Although the efficacy of many herbal products has been proved, therapies utilising these compounds have showed promising potential. Since safety is still a major concern when using herbal remedies, it is crucial that the proper regulatory agencies put in place the necessary safeguards to protect public health by ensuring that all herbal medications are secure and of high enough quality. In addition to outlining some significant difficulties in conducting an efficient safety review of herbal medicinal products, this review examines toxicity-related issues and significant safety concerns resulting from their use. Good Manufacturing Practices are designed to promote human health and, as a result, quality of life. Ensure the applicability of the principles offered and demonstrate the advantages resulting from this applicability in order to accomplish the objectives specified.

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Keywords

Herbal medicines, Safety, AYUSH, Drug and cosmetics Act 1940, Good manufacturing practices, Guidelines.

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