“Phytopharmaceutical drug” includes 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."
Phytopharmaceutical Drugs is a new drug category included in the year 2015 by the amendment in the Drug & Cosmetic Act 1940 and Rules 1945.