@article{Budhwar_Yadav_Choudhary_Nitesh_2017, title={A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA}, volume={5}, url={https://ijdra.com/index.php/journal/article/view/205}, DOI={10.22270/ijdra.v5i4.205}, abstractNote={<p>The present study reviews the regulations of herbal drugs in the EU, US and India and throws light upon issues<br>related to their clinical trials. Herbal drugs have been used for a long time in different systems of health like<br>Ayurveda, Yunani, Sidha and Homeopathy for treating number of diseases. It is a very difficult to perform clinical<br>study on herbal drugs because these drugs are a complex combination of active ingredients. It is therefore difficult to<br>identify the ingredient which is responsible for the therapeutic effect amongst various ingredients of herbal drugs. The<br>standardization of herbal drugs is also a very difficult task. In spite of all these problems are existing public interest<br>has increased towards herbal drugs in last 2-3 decades because of their long history of treating the disease safely. The<br>laws and regulations for herbal drugs are different in different countries. The WHO has stated that each country<br>should have a system to regulate herbal drugs in their territory. In the EU the committee on herbal medicinal products<br>(HMPC) which part of the EMA was established under regulation (EC) No. 726/2004 and European directive<br>2004/24/EC in September, 2004. The main duty of HMPC is to evaluate and give authorization for herbal drugs on<br>the basis of their safety and efficacy. In US herbs are classified as dietary supplements after the introduction of the<br>Dietary Supplement Health and Education Act (DSHEA) in1994. In US herbal drugs are categorized into two types,<br>first is OTC herbal drugs and drugs which required NDA approval. In India the Department of AYUSH has made<br>guidelines for quality enhancement of herbal substances. The present study reviews the regulations of herbal drugs in<br>the EU, US and India and throws light upon issues related to their clinical trials.<br>&nbsp;</p&gt;}, number={4}, journal={International Journal of Drug Regulatory Affairs}, author={Budhwar, Vikaas and Yadav, Sunita and Choudhary, Manjusha and Nitesh, ,}, year={2017}, month={Dec.}, pages={8-17} }