Standardization of Herbal Medicine Through Biotechnology: Ensuring Consistency and Efficacy of Phytopharmaceuticals

Background: Herbal medicine still faces batch-to-batch inconsistency arising from variation in botanical identity, growing conditions, harvest time and post-harvest processing, which compromises the reproducibility of clinical trials and delays the registration of phytopharmaceuticals. Objective: This narrative review aimed to summarise the contribution of biotechnological approaches to the standardization of herbal medicine during 2020 to 2026. Methods: Literature was retrieved from Scite.ai, PubMed, ScienceDirect, MDPI, Frontiers and Google Scholar using combined keywords of herbal standardization, DNA barcoding, chromatographic fingerprint, metabolomics, plant tissue culture, hairy root, chemometrics and artificial intelligence; fifty articles published between 2020 and 2026 with traceable DOIs were included. Results: Five complementary biotechnological pillars were identified, namely molecular authentication of raw material, controlled biomass supply through in vitro culture, process control through elicitation and bioreactor cultivation, chemical profiling based on fingerprinting and metabolomics, and data modelling using chemometrics and artificial intelligence. Integration of these pillars shifts the point of quality control from end-product testing to control along the entire production chain. Conclusion: Biotechnology can secure the consistency and efficacy of phytopharmaceuticals, but incomplete reference barcode databases, the shift of secondary metabolism in dedifferentiated cells, the cost of bioreactor scale-up and the absence of a regulatory framework recognising in vitro-derived biomass as an official raw material remain to be resolved.