Cited by 259Complementary and Alternative Medicine StudiesPhytochemistry Medicinal Plant ApplicationsMedicinal Plant Research

Challenges and guidelines for clinical trial of herbal drugs

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Ahmad, Sayeed, Parveen, Abida, Parveen, Bushra, Parveen, Rabea·2015·Journal of Pharmacy And Bioallied Sciences

Abstract

World Health Organization (WHO) has defined herbal medicines as finished labeled medicinal product that contain an active ingredient, aerial, or underground parts of the plant or other plant material or combinations. According to a report of WHO, about 80% of the world population is reported to rely on traditional medicine for their primary health care needs. Even in the developed countries, complementary or alternative medicine is gaining popularity. A report of a global survey on national policy on traditional medicine and regulation of herbal medicines indicated that about 50 countries including China, Japan, and Germany already have their national policy and laws on regulations of traditional medicines. Herbal drugs possess a long history of its use and better patient tolerance. These are cheaper and easily available in countries like India due to rich agro culture conditions. However, reckless utilization of resources threatens the sustainability of several plant species. Traditional medicines are governed by the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. In 1959, the Government of India amended the Drugs and Cosmetics Act to include drugs that are derived from traditional Indian medicine. In 1993, the guidelines for the safety and efficacy of herbal medicines developed by an expert committee directed that the procedures laid down by the office of the Drug Controller General of India for allopathic drugs should be followed for all traditional and herbal products to enter into clinical trials for any therapeutic condition. However, there are certain loop holes in the clinical trials of herbal drugs as the lack of stringent bylaws and regulations. Hence, a deep insight of important challenges and major regulatory guidelines for clinical trial of herbal drugs and botanicals is discussed in the present communication. There is lack of scientific evidence to evaluate safety and efficacy of herbal drugs. The quality of the trial drug has to be tested for batch-to-batch uniformity of the active constituents. It is very difficult to have active and control groups with identical color, smell and taste of the herbal drug, which cannot be imitated while manufacturing a placebo. These challenges can be reduced or overcome by applying most recent methodologies and guidelines for clinical trials. Since the quality control of herbal medicines is complicated and difficult, relevant and appropriate requirements should be established for the assessment of safety and efficacy for different categorized herbal medicines to reduce cost and expenditure. And, efforts should be made for the integration of traditional medicine into national healthcare systems. 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.

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  1. [1]Mills S Lewith GT Jonas WB Walach H Clinical Research in Complementary Therapies: Principles, Problems and Solutions 2003 Elsevier Science Churchill Livingstone 211 27
  2. [8]Leung PC Machin D Day S Green S Textbook of Clinical Trials 2004 1st ed John Wiley and Sons Chichester 63 84
  3. [23]BBC News. Can Herbal Medicine Combat Aids? Wednesday, 15 March, 2006, 13:10 GMT Last accessed on 2013 Apr 16 Available from: http://www.newsvote.bbc.co.uk/mpapps/pagetools/print/newsbbccouk/2/hi/Africa/4793106.stm
  4. [28]World Health Organization. Regulatory Situation of Herbal Medicines. A Worldwide Review 1998 Geneva World Health Organization
  5. [32]World Health Organization. Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review. WHO/EDM/TRM/2001 2001 Geneva World Health Organization

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Authors
Ahmad, S., Parveen, A., Parveen, B., & Parveen, R.
Affiliations
  • Jamia Hamdard (IN)
  • Fortis Escorts Heart Institute (IN)
Corresponding author
Ahmad, Sayeed
Venue
Journal of Pharmacy And Bioallied Sciences
Published
2015
Volume
7
Issue
4
Pages
329
ISSN
0975-7406 (ISSN-L)
OpenAlex
W2233625034
Cited by
259
References
32
Citations by year
2026: 24 · 2025: 50 · 2024: 48 · 2023: 26 · 2022: 20 · 2021: 35 · 2020: 18 · 2019: 13 · 2018: 13 · 2017: 7 · 2016: 5
FWCI
2.00
Type
journal article
Language
en
Open access
Licence
cc-by-nc-sa
Locations
  • Journal of Pharmacy And Bioallied Sciences (publishedVersion, cc-by-nc-sa)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-sa)
  • PubMed Central (publishedVersion, cc-by-nc-sa)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Phytochemistry Medicinal Plant Applications
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Medicinal Plant Research
Keywords
herbal drugs, regulatory guidelines, traditional medicine regulation, herbal medicine quality control

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