ABSTRACT

Dear Reader,

“Phytopharmaceutical drug” includes a purified and standardised fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include administration by parenteral route as specified in Rule 122 (eb) of the Drugs & Cosmetics (D&C) Govt. of India”. The data requirements have been specified in the Appendix IB of Schedule Y & GMP manufacturing as per Schedule M (part VI) of D&C Rules. Clinical trials for phytopharmaceutical drugs is to be conducted as per applicable rules and guidelines for a new drug.”