PHYTO-PHARMACEUTICAL DEFINITION UNDER DRUG REGULATIONS, INDIA NEEDS AN URGENT REVIEW

Dear Reader, An Amendment to the Drugs and Cosmetics Regulations to permit scientifically developed plant based leads as drugs named “phytopharmaceuticals”, was notified for the first time in November 2015. This regulation has now been further amended and revised to put it under new drug definitions and provided more provisions for greater clarity in 2019. However, having championed these regulations (as part of the Indian Pharmacopoeia Commission's Expert Committee on Herbals) for nearly a decade a greater number of drugs should have come out through this route given the scientific capability of the Indian drug sector and academia. However, the only information in the public domain as on date is the approval for conducting human clinical trials of a plant based lead for testing the protective or curative potency of Coculous hirsutus against SARS – CoV-2 given by the Drugs Controller General of India. A purified fraction of the stem of this plant commonly called broom creeper has been tested for sinnococculine markers as the lead drug candidate.