Draft rules have been released for regulating phyto –pharmaceuticals or plant-based drugs in India. The rules will update the country’s Drugs & Cosmetics Rules. They will cover processed and unprocessed materials from plants, as well as plant extracts in a dosage form that are designed for consumption by humans or animals. However, the regulations will not cover parenteral drugs. Among the requirements will be information about the plants’ growth conditions and harvest, as well as information about the quality of the plant, such as total ash, acid, insecticide and heavy metal content, as well as microbial load. Also required will be information about extracts, formulation, stability, safety, pharmacovigilence and animal toxicity.

Source: pharmabiz.com