Avdhesh Kumar¹, Dr. M. P. Venkatesh², T.M. Pramod Kumar²

 Paper Index :

 ¹M.Pharm, Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS University, Mysuru- 570015

²Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysuru- 570015

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Abstract

Herbal medicine has been practiced for centuries in many countries butthe legalityof herbal medicines varies from country to country. In certain countries herbal medicines are well-established, but they are not used under legal claim instead they are regarded under food and therapeutic claim. Developing countries, however, often have a great number of traditionally used herbal medicines and much folk-knowledge about them, but have hardly any legislative criteria to establish these traditionally used herbal medicines as part of the drug legislation. The herbal medicine sector is in a dilemma. Some practitioners would like to continue to practice as they do now, with no further regulation, and accept that their practice is based on tradition and personal experience rather than empirical science. The logical consequence of adopting this form of practice is that we should take a precautionary approach in order to ensure public safety. This article presentsoverview of regulatory challenges of herbal medicine in world and regulation, types of documents for herbal medicine in Russia.This work clearly gives the overview of the herbal drug registration requirements in Russia and also about the marketing authorization procedure and timelines involve.

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