A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 4
Abstract
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.
Authors and Affiliations
Budhwar Vikaas, Sunita Yadav, Manjusha Choudhary, Nitesh K
Keywords
Related Articles
- EP ID EP329065
- DOI 10.22270/ijdra.v5i4.205
- Views 125
- Downloads 0
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