CURRENT REGULATORY PERSPECTIVE OF HERBAL DRUGS

The current challenging aspect of herbal medicine or traditional system is maintenance of quality, safety and efficacy issues. As there is a global recognition for the herbal drugs as an healing aids, the demand for these traditional system have been increased drastically from 19th century to 21st century. As the main challenge of this herbal medicine / drugs is maintenance of DNA finger printing, phytochemical and therapeutic uniformity, lack of Good clinical practices, standard operating protocols, no proper protocols or guidelines on pharmacokinetic and pharmacodynamic issues , no standardisation protocols, no control on residual limits (Pesticide residues, Microbe residues, heavy metal residues, solvent residues and teratogenicity). In order to meet this challenges the regulatory agencies EMEA, ICH AYUSH, WHO, USFDA trying to bring these herbal therapies/drugs under regulatory pipeline under the NDA approval process. In order to meet these current challenges, the Indian Herbal Pharmacopoeia has published 40 monographs monitored by Indian Drugs Manufacturers Association (IDMA). The current review focuses on the current trends in herbal drug safety monitoring and regulatory aspects of Herbal therapeutics.