The value of the herbal medicine market size was USD 71.19 billion globally in 2016 and is expected to grow even more in the near future. The main obstacle to the growth of herbal medicine is its quality control. The scientific validation by standardization, evaluation of purity, and demonstration of its efficacy in animal models and in humans will increase the trust of users and increase its acceptability. There are various guidelines available for standardization of herbal medicines. Globally each country has its own rules and regulations. In the USA, guidelines for botanical drugs have been revised in 2016. The phytopharma guidelines also came in existence in India in 2015. The scientific validation of herbal drugs requires information regarding pharmacognostic description like taxonomic classification and quality specifications in which heavy metals, ash, and impurity data are important. The herbal medicines which are already used in human do not require any animal studies but if there are any changes in method of extraction and formulation then animal safety data is essential. The toxicity studies in two species are minimally required. The clinical trials are necessary to demonstrate its efficacy for newer drugs. The phase I clinical studies are conducted to assess the maximum tolerated dose of medicine and its safety. The proof of concept and confirmatory clinical trials should be conducted as randomized placebo control trials and as per good clinical practice norms. The regulatory requirements of herbal drugs for clinical trials and marketing permission may be abbreviated, modified or relaxed based on adequate evidence from market or research published in peer-reviewed journals. The current book chapter will discuss the requirements of herbal drugs and practical issue in scientific validation of herbal medicines.
Source: Herbal Medicine in India pp 573-579