Regulatory Provisions for Introducing Phytopharmaceutical Drugs in Indian Market

Plants have been recognized as a very useful and important source of drugs, since time immemorial. However, in the present day, context, usefulness of plants has been questioned, on the grounds of quality control, lack of clinical trials, etc. Historically, plant drugs listed in "Official books" under "Schedule I" of the Drugs and Cosmetics Act, 1940, were accepted for marketing in India, without any need for clinical trials. However, such drugs, although marketed in India, could not be marketed as "drugs" in countries like USA, EU, Japan, China, etc., wherein these drugs failed to meet the same standards of quality, consistency and clinical evidence, as chemical drugs. Thus, several Indian "drugs" were introduced in US market as "dietary supplements". This article discusses the concept of "phytopharmaceuticals", as introduced by amendment in the Indian Act, in 2015. The legal provisions related to Ayurvedic, Siddha and Unani drugs, in India, are traced out. Recent developments in Indian act, pertaining to phytopharmaceuticals, have been traced out, and compared with those in other countries, such as USA, EU, Japan, China, etc. The recent amendments in Indian act have paved the way towards introduction of "phytopharmaceuticals", meeting the same standards of quality, safety and efficacy, as for chemical drugs, and have brought the quality, safety and efficacy standards for plant-based drugs, at par with those for chemical drugs. It is hoped that this will help in introducing plant -based drugs in several regulated markets.