The last two decades has seen a significant increase in the use of herbal medicines. Plant materials are employed throughout the industrialized and developing world as home remedies, over-the-counter (OTC) drugs and ingredients for the pharmaceutical industry. As a result of WHO’s promotion of traditional medicine, countries have been seeking the assistance of the organization in identifying safe and effective herbal medicines for use in National Health Care systems. The World Health Assembly in its resolutions of 1978, 1987 and 1989 has emphasized the need to ensure the quality of medicinal plant products by using modern control techniques and applying suitable standards. Deliberations on the regulation of herbal medicines that were part of the Fourth and Fifth International Conferences of Drug Regulatory Authorities in 1986 and 1989 were concerned with the commercial exploitation of traditional medicines through OTC products. This was followed by model guidelines prepared by WHO to define basic criteria for the evaluation, safety and efficacy of herbal medicines.

Quality control and standardization of herbal drugs involves several steps. These take into consideration all aspects that contribute to their quality right from the source and quality of raw material, subsequent manufacturing operations, analytical methods of evaluating the potency up to clinical evaluations where needed. WHO guidelines for the quality control of herbal drugs encompasses various physicochemical, biological and analytical evaluation techniques. These processes and procedures include the following quality indication parameters: