Approaches and Challenges in Developing Quality Control Parameters for Herbal Drugs

Herbs have been used as medicines from ancient times in the world. In the present scenario, awareness and acceptability towards herbal medicines have been raised tremendously due to their easy availability and few or no side effects. Unfortunately, due to the lack of stringent regulatory guidelines for herbal drugs, standard quality degradation may be associated with these herbal medicines through either intentional or unintentional adulterations, spurious drugs, the substitution of drugs with other drugs, etc. Hence, it becomes mandatory to control the quality standards of herbal medicines as they are being used for the betterment of human health. Improvements in various domains of herbal medicine have helped developed countries, such as USA, UK, Australia and European countries, adopt this ancient and enriched medicinal system leading to the “Herbal Renaissance”. Herbal medicines, however, are associated with a number of shortcomings such as quality assurance, safety, efficacy, purity, lack of appropriate standardization parameters, lack of accepted research methodology and toxicity studies. Despite the availability of numerous traditional quality control methods (e.g., thermal methods, HPTLC, HPLC, SFC) for herbal medicines, owing to the lacunae, there is a prerequisite for newer approaches in fostering quality parameters of herbal drugs. Chromatographic and spectral fingerprinting, DNA fingerprinting and metabolomics can be used as newer approaches to the authentication and standardisation of medicinal botanicals. Currently, the computational In-Silico technique for standardization of phytochemicals is in trend because of the number of pros like less time consumption, fast, and improved efficiency of the entire process with excellent reproducibility.

Keywords: Adulterations, DNA fingerprinting, Herbal medicines, In-silico, Quality-control.