Login Register Cart 0
Generic placeholder image

Current Drug Discovery Technologies

Editor-in-Chief

ISSN (Print): 1570-1638
ISSN (Online): 1875-6220

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Review Article

Herbal Products Regulations in a Few Countries-A Brief Overview

Author(s): Bhavana Brahmananda Bhat, Nayanabhirama Udupa and Dharmagadda Sreedhar *

Volume 16, Issue 4, 2019

Page: [368 - 371] Pages: 4

DOI: 10.2174/1570163815666181105091254

Price: $65

conference banner
Abstract

Herbal medicines have been used by mankind from time immemorial. Moreover, many modern medicines are originated from plant sources. In earlier days, patients were dependent on herbs for treatment and well-being. However, due to the advent of the industrial revolution and modern science, the scenario of treating diseases has changed over a period of time. Majority of patients started preferring allopathy medicines due to their several advantages over herbal medicines. However, due to long term treatment by allopathic medicines for chronic diseases led to side effects, patients are now drifting back to the traditional medicines. Herbal medicines have their own drawbacks, viz., lack of safety and efficacy data, standardization difficulties, not well established legislative controls and a few issues with adverse drug reactions. Drug regulations per se were always the prime focus and they are said to be dynamic. There are a few differences in regulations of herbal drugs among various countries. Regulatory authorities of countries are working to evolve the regulations to govern herbal medicines more effectively. A brief overview of the regulations related to a few developing and developed countries have been dealt here.

Keywords: Herbal medicine, regulation, adverse drug reaction, regulatory authority, plant sources, dietary supplement products.

Graphical Abstract

[1]
Dr Xiaorui ZHANG. Regulatory Situation of Herbal Medicines A worldwide Review available at www.who.int/medicinedocs/pdf/ whozip57e/whozip57e.pdf
[2]
Kelly K. History of medicineNew York: Facts on file 2009; p. 29–50.
[3]
Newman DJ, Crag GM. Natural Products as Sources of New Drugs over the Last 25 Years. J Nat Prod 2007; 70: 461-77.
[4]
Farnsworth NR, & Morris RW. Higher plants - the sleeping giant of drug development. Am J Pharm Educ 1976; 148: 46-52.
[5]
UNESCO. (2013). Report of the International Bioethics Committee on Traditional Medicine Systems and their ethical implications. SHS/EGC/IBC- 19/12/3 Rev. Paris, 8 February
[6]
Cragg GM, Newman DJ, Snader KM. Natural products in drug discovery and development. J Nat Prod 1997; 60: 52-60.
[7]
Ekor M. The growing use of herbal medicines: Issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol 2013; 4: 177.
[8]
Regulatory Situation of Herbal Medicines. A Worldwide Review (WHO/trm/98.1) Geneva: 1998. World Health Organization.
[9]
IARC Working Group on the Evaluation of Carcinogenic Risk to Humans. Some Traditional Herbal Medicines, Some Mycotoxins, Naphthalene and Styrene. Lyon (FR): International Agency for Research on Cancer; 2002. (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 82.) A, Introduction. Available from: https://www.ncbi.nlm.nih.gov/books/NBK326625/
[10]
Kasilo OMJ, Trapsida JM. Decade of African traditional medicine, 2001–2010. Afr Health Mon (Special Issue) 2011; 14: 25-31.
[11]
Raynor DK, Dickinson R, Knapp P, Long AF, Nicolson DJ. Buyer beware? Does the information provided with herbal products available over the counter enable safe use? BMC Med 2011; 9: 94.
[12]
Routledge PA. The European Herbal Medicines directive: could it have saved the lives of Romeo and Juliet? Drug Saf 2008; 31: 416-8.
[13]
Official Journal of the European Union: Directive 2004/24/EC; 31st March. 2004. Available from: http://www.eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ L: 2004:136:0085:0090:en: PDF . [Last cited on 2014 Apr 29].
[14]
Wu KM, Ghantous H, Birnkrant DB. Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States. Food Chem Toxicol 2008; 46(8): 2606-10.
[15]
North Sydney: Therapeutic Goods Administration; 2014. Australian Government Department of Health. Available from: https://www.tga.gov.au/ [Last updated on 2014 Apr 09; Last cited on 2014 Apr 29].
[16]
Malik V. editor. 23rd ed. Lucknow: Eastern Book Company; 2013. Law Relating to Drugs and Cosmetics.
[17]
Yamada Y. Traditional Herbal Medicines around the Globe: Modern Perspectives. Japanese Traditional Medicines. Proceedings of the 10th General Assembly of WFPMM, Seoul, Korea, 16-18 October 1991. Swiss Pharma 1991; 13(11a): 76-8.
[18]
Tsutani K. The evaluation of herbal medicines: An east Asian perspective. In: Lewith GT, Aldridge D, Eds. Clinical Research Methodology for Complementary Therapies. London, Sydney, Auckland: Hodder & Stockton 1993; pp. 365-93.
[19]
WHO Western Pacific Regional Office (WPRO). Communication with WHO Geneva 16 April 1996.
[20]
Wang X. Traditional Herbal Medicines around the Globe: Modern Perspectives. China: Philosophical Basis and Combining Old and New. Proceedings of the 10th General Assembly of WFPMM, Seoul, Korea, 16-18 October 1991. Swiss Pharma 1991; 13(11a): 68-72.
[21]
Drug Administration Law of the People's Republic of China, 20 September 1984.

Rights & Permissions Print Cite
Article Metrics
23
1
© 2024 Bentham Science Publishers | Privacy Policy