A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA

Abstract

The present study reviews the regulations of herbal drugs in the EU, US and India and throws light upon issuesrelated to their clinical trials. Herbal drugs have been used for a long time in different systems of health likeAyurveda, Yunani, Sidha and Homeopathy for treating number of diseases. It is a very difficult to perform clinicalstudy on herbal drugs because these drugs are a complex combination of active ingredients. It is therefore difficult toidentify the ingredient which is responsible for the therapeutic effect amongst various ingredients of herbal drugs. Thestandardization of herbal drugs is also a very difficult task. In spite of all these problems are existing public interesthas increased towards herbal drugs in last 2-3 decades because of their long history of treating the disease safely. Thelaws and regulations for herbal drugs are different in different countries. The WHO has stated that each countryshould have a system to regulate herbal drugs in their territory. In the EU the committee on herbal medicinal products(HMPC) which part of the EMA was established under regulation (EC) No. 726/2004 and European directive2004/24/EC in September, 2004. The main duty of HMPC is to evaluate and give authorization for herbal drugs onthe basis of their safety and efficacy. In US herbs are classified as dietary supplements after the introduction of theDietary Supplement Health and Education Act (DSHEA) in1994. In US herbal drugs are categorized into two types,first is OTC herbal drugs and drugs which required NDA approval. In India the Department of AYUSH has madeguidelines for quality enhancement of herbal substances. The present study reviews the regulations of herbal drugs inthe EU, US and India and throws light upon issues related to their clinical trials.