Abstract

A key point in choosing the appropriate method to guarantee the quality and safety of herbal products is to develop suitable methodology for their standardization with a sufficient degree of specificity in ensuring the desired endpoint. The unique differences in the constituents of herbal drugs create distinct challenges based on their identity, quality, and consistency of efficacy. The differentiation of conventional medicines and herbal drugs can be minimally considered from regulatory, economic, and technical perspectives. Health risks associated with herbal products are considered in three categories: extrinsic (accidental, deliberate), intrinsic (bioavailability, pharmacokinetic, pharmacodynamic), and consumer-dependent causative factors (therapeutic failure, adverse drug reaction, hypersensitivity). A change in these categories through regulation using designated approaches can minimize the health risks. Chemical fingerprinting of natural products and their ability to interact with physiological substrates of the human body are the mainstay of their therapeutic efficacy. This requires a multidisciplinary approach, involving analytical techniques and methodologies common to ethnomedicine, botany, pharmacology, pharmacotherapy, toxicology, and pharmacoepidemiology. An attempt has been made through this article to highlight the use of marker profiling of natural products with special reference to Indian herbal medicine.

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