Manuscript Number : GISRRJ203611

A Mini Review on Challenges in Regulatory, Development and Clinical Development for Herbal Product

Authors(2) :-Sruthi Bhat, Vishwanath Guddadar

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. Different challenges and regulatory guidelines discussed for the clinical trial of herbal drugs will be useful for various industries for considering it before going ahead for clinical trial of their product. This mini review explore the various country herbal drug clinical trial procedures and potential.

Authors and Affiliations

Sruthi Bhat
Param Bhakti healthcare & Research in affiliation with Param Healthcare & IT Services, Iselin, New Jersey USA
Vishwanath Guddadar
Param Bhakti healthcare & Research in affiliation with Param Healthcare & IT Services, Iselin, New Jersey USA

Herbal Drugs, Clinical Trials, Regulatory

  1. Bhatt P, Fnu G, Bhatia D, Shahid A, Sutariya V. Nanodelivery of Resveratrol-Loaded PLGA Nanoparticles for Age-Related Macular Degeneration. AAPS PharmSciTech. 2020; 21(8):291.
  2. Tandel H, Bhatt P, Jain K, Shahiwala A, Misra A. In-Vitro and In-Vivo Tools in Emerging Drug Delivery Scenario: Challenges and Updates.In: Misra ASA, editor. In-vitro and in-vivo tools in drug delivery research for optimum clinical outcomes. Boca Raton: CRC Press; 2018.
  3. Chaudhary R, Chandrashekharan M, Mishra S. Embryotoxicity and teratogenicity studies of an ayurvedic ontraceptives-pippalyadi vati. J Ethnopharmacol. 2001; 74: 189-93.
  4. Mills S. Herbal medicine. In: Lewith GT, Jonas WB, Walach H, editors. Clinical Research in Complementary herapies: Principles, Problems and Solutions. Elsevier Science: 2003; p. 211–27.
  5. Howard KL, Orlinsky DE, Perilstein J. Contribution of therapist's to patient's experiences in psychotherapy: a components of variance model for analyzing process data. J Consult Clin Psychol. 1976; 44: 520–6.
  6. Mills S. Clinical Research in Complementary Therapies: Principles, Problems and Solutions. In: Lewith GT, Jonas WB, Walach H, editors. Elsevier Science: Churchill Livingstone; 2003. pp. 211–27.
  7. Bansal D, Hota D, Chakrabarti A. Research methodological issues in evaluating herbal interventions. J Clin Trial. 2010;2:15–21.
  8. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993;328:246–52.
  9. Geneva, Switzerland: 2014. [Last cited on 2014 Apr 29]. Convention on International Trade in Endangered Species of Wild Fauna and Flora. Available from: http://www.cites.org/eng/disc/what.php
  10. Geneva: WHO Library Cataloguing-in-Publication Data, World Health Organization; 2005. [Last cited on 2014 Apr 29]. Guidelines on the Registration of Traditionally used Herbal Products, Department of Health, Republic of Philippines, Report of a WHO Global Survey. Available from: http://www.apps.who.int/medicinedocs/pdf/s7916e/s7916e.pdf
  11. Food and Drug Administration. Rockville: U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER): Guidance for Industry, Botanical Drug Products Online Resource. 2004. [Last cited on 2014 Apr 29]. Available from: http://www.fda.gov/cder/guidance/index.htm 
  12. Official Journal of the European Union: Directive 2004/24/EC; 31st March. 2004. [Last cited on 2014 Apr 29]. Available from: http://www.eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ: L: 2004:136:0085:0090:en: PDF .

Publication Details

Published in : Volume 3 | Issue 6 | November-December 2020
Date of Publication : 2020-12-30
License:  This work is licensed under a Creative Commons Attribution 4.0 International License.
Page(s) : 50-54
Manuscript Number : GISRRJ203611
Publisher : Technoscience Academy

ISSN : 2582-0095

Cite This Article :

Sruthi Bhat, Vishwanath Guddadar, "A Mini Review on Challenges in Regulatory, Development and Clinical Development for Herbal Product", Gyanshauryam, International Scientific Refereed Research Journal (GISRRJ), ISSN : 2582-0095, Volume 3, Issue 6, pp.50-54, November-December.2020
URL : https://gisrrj.com/GISRRJ203611

Article Preview