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


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

Review Article

Herbal Health Products Quality through Stability Studies: A Global Regulatory Concern

Author(s): Gulshan Bansal, Ishtdeep Kaur and Jasmeen Kaur

Volume 4 , Issue 1 , 2017

Page: [26 - 35] Pages: 10

DOI: 10.2174/2213476X03666160712233727

Price: $65


Herbal medicinal products are widely used for treatment of almost all human ailments in traditional systems of medicines. These are consumed not only as medicinal products but also as dietary supplement products to improve one's health. So, both types of these herbal products can be collectively termed as herbal health products. Growing demand of these health products in global market has raised issues on the quality and safety of herbal materials and finished products. The phytochemical complexity, and uncertainty about phytochemicals responsible for therapeutic effects of a herbal product are the most prominent challenging problems in deriving the criteria for evaluation of its quality. A practical approach to assess quality of a herbal product is evaluation of its stability during the proposed storage/shelf time. Regulatory agencies in various countries across the globe have recommended guidelines for establishing and ensuring quality, safety and efficacy of herbal products. The present review deals with the guidelines issued by drugs regulatory agencies of different countries or group of countries, and compiled those to understand the extent of coherence or agreement among various guidelines on the quality attributes of herbal products.

Keywords: Herbal health product, quality, stability, regulation, guidelines.

Graphical Abstract

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