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Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)


ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

Regulatory and Quality Aspects of Herbal Drugs

Author(s): Reena Hooda, Deepti Pandita*, Poonam Kumari and Viney Lather

Volume 4 , Issue 2 , 2017

Page: [107 - 113] Pages: 7

DOI: 10.2174/2213476X04666170619092022

Price: $65


Background: Herbal drugs obtained from medicinal plants are used by a majority of the people because of their safety and less side effects, but it is not completely true that herbal products do not have any side effects or toxic effects, they do carry risks. Regulatory authorities of different countries regulate the quality and standard of herbal drugs on the basis of problems associated with them such as herb-drug interaction, side effects, toxicity and adverse effects. The International Drug Monitoring Program of World Health Organization (WHO) has made certain guidelines for herbal drugs evaluation and quality control analysis. The WHO has done various efforts for the improvement of herbal drugs in the context of their safety and efficacy. The herbal drug toxicity arises when the drug is used without proper indications, in large doses, or with other drugs, for longer duration without consultation of a physician, and manufactured appropriately.

Objectives: This mini review has been written to discuss the current status of regulatory and quality aspects of herbal drugs. The regulatory guidelines of herbal drugs need to be improved along with the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) guidelines.

Discussion: In the field of herbal drugs, various parameters/guidelines regarding their safety and efficacy, in manufacturing and selling have been controlled thoroughly by the regulatory authorities. However, improvements should be done w.r.t. rules and regulations of herbal drugs, particularly in the case of collection, cultivation and toxic effects of herbs.

Keywords: Herbal drugs, safety and efficacy, regulatory authority, WHO guidelines, toxicity, adverse effects, drug interactions.

Graphical Abstract

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