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