ABSTRACT
Phytopharmaceuticals retain the holistic nature of plant extracts and use a combination of compounds, while isolated purified compounds are single, well-defined substances with known pharmacological effects. Both approaches have their place in pharmacology and medicine, and their use depends on the specific therapeutic goals and the type of medicine or treatment being developed or practiced. In cases when phytopharmaceuticals are not included in the AYUSH textbook, these are equally considered as a new drug, and the regulatory rule is similar to that of new drugs. Any relaxation in regulatory standards should be clearly defined, transparent, and communicated to all relevant stakeholders, including manufacturers, healthcare professionals, and the public. The primary goal is to maintain public health and safety while addressing specific circumstances that may warrant regulatory flexibility. The specific details of any relaxation in the regulatory process would depend on the laws and regulations of the country or region in question. This chapter discusses the regulations, data requirements, and the approval procedures.
