A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA
The present study reviews the regulations of herbal drugs in the EU, US and India and throws light upon issues
related to their clinical trials. Herbal drugs have been used for a long time in different systems of health like
Ayurveda, Yunani, Sidha and Homeopathy for treating number of diseases. It is a very difficult to perform clinical
study on herbal drugs because these drugs are a complex combination of active ingredients. It is therefore difficult to
identify the ingredient which is responsible for the therapeutic effect amongst various ingredients of herbal drugs. The
standardization of herbal drugs is also a very difficult task. In spite of all these problems are existing public interest
has increased towards herbal drugs in last 2-3 decades because of their long history of treating the disease safely. The
laws and regulations for herbal drugs are different in different countries. The WHO has stated that each country
should 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 directive
2004/24/EC in September, 2004. The main duty of HMPC is to evaluate and give authorization for herbal drugs on
the basis of their safety and efficacy. In US herbs are classified as dietary supplements after the introduction of the
Dietary 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 made
guidelines for quality enhancement of herbal substances. The present study reviews the regulations of herbal drugs in
the EU, US and India and throws light upon issues related to their clinical trials.
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