Decision-oriented Quality Assurance of Herbal Medicines: An Integrated Framework for Authentication, Standardization, and Safety

Haritha Ramadas; Adithya Murali C.K; Shahana U

Decision-oriented Quality Assurance of Herbal Medicines: An Integrated Framework for Authentication, Standardization, and Safety

Author(s)	Ms. Haritha Ramadas, Ms. Adithya Murali C.K, Ms. Shahana U
Country	India
Abstract	Herbal medicines are made up of many different chemical and biological substances, so their quality can change depending on the plant’s identity, where it is grown, climate, harvesting stage, processing, storage, and manufacturing methods. Because of this complexity, their quality cannot be checked by testing only one compound or using one method(1,2). Traditional methods are used to identify the correct plant, while chemical, physical, chromatographic, and spectroscopic tests, along with DNA-based identification and contaminant testing, are used together to make sure the herbal medicine is safe, pure, and of good quality.(1–4) This critical review aims to provide a decision-making framework in which five quality control questions pertain to different levels of evidence. HPTLC and HPLC fingerprints offer routine approaches to chemical profiling and marker analysis, whereas more comprehensive analyses of chemical compounds can be achieved by means of LC–MS, GC–MS and NMR. Botanical identification by DNA barcoding is orthogonal to establishing chemical quality control and safety (3–7). Metabolomics, chemometrics, hyperspectral imaging, machine learning and new portable spectroscopy techniques are also discussed with regard to their potentials and limitations, opportunities for validation and regulatory relevance (8–11). Unlike many previous reviews, this article integrates information on analytical technologies according to the specific quality control decisions rather than presenting an inventory of relevant approaches. Emphasis is placed on the need to interpret findings in the context of particular quality attributes because any single technology or combination of methods may not be suitable for all stages of manufacturing (1–4). Particular areas of research include the need for reference materials and spectral and DNA databases, opportunities for external validation of metabolite identification and machine learning algorithms, the importance of establishing inter-laboratory reproducibility and comparable acceptance criteria, and regulatory relevance of different analytical technologies for authentication (4,8–11).
Keywords	Herbal medicines; quality assurance; authentication; standardization; adulteration; HPTLC; HPLC; DNA barcoding; metabolomics; chemometrics; machine learning; regulatory quality control.
Field	Medical / Pharmacy
Published In	Volume 8, Issue 5, September-October 2026
Published On	2026-09-17

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Decision-oriented Quality Assurance of Herbal Medicines: An Integrated Framework for Authentication, Standardization, and Safety

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