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Journal of Pharmaceutical Research

Article

Scope and Bottlenecks in Clinical Trials of Herbal Drugs - Present Scenario
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Journal of Pharmaceutical Research

DOI: 10.18579/jpcrkc/2015/14/1/78384

Year: 2015, Volume: 14, Issue: 1, Pages: 26-32

Original Article

Scope and Bottlenecks in Clinical Trials of Herbal Drugs - Present Scenario

Kaur Ramandeep *, Gupta Vikas , Chirstopher Ajay Francis , Bansal Parveen
  • Division of Clinical Research, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, India
Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

Purpose: This communication highlights the scope of clinical trials in herbal drugs and various problems being faced by herbal drug scientists, herbal drug industry in development of new herbal products that have to undergo clinical trials in all the countries to enhance global acceptance.Social Implications: Herbal drugs have been used since ancient times as medicines for the treatment of different diseases. It is the oldest and most popular form of healthcare practice known to humanity for maintenance of health that has been practiced by the people of all the societies throughout the history of evolution. Herbal medicines are also known as "the people's medicines" because of their easy accessibility, safety, ease of availability and self medication. Particularly in countries like India, many of herbal drugs and formulations are used in different practices of treatment like Ayurveda, Siddha and Unani.Research Implications: It is expected that more than 25% of all modern medicines are directly or indirectly derived from plants sources yet the contribution of developing countries in global herbal business is very poor due to lack of quality control and standardization measures. There is lack of common standards and appropriate methods for evaluating Traditional Medicine to ensure safety, ef?cacy and quality control. This indicates the importance and requirement to develop a standard operational procedure for the standardization of herbal drugs and formulations.Original value: Quality control, quality assurance, safety and ef?cacy of herbal drugs are the bench mark in the evaluation protocols and that would play a major role in providing highly reliable and effective herbal drugs to attract international trade, thus generating returns.Approach: For this study internet search engines and various documents available for drug regulatory affairs were screened. Problems faced by different scientist groups were analyzed and compiled from internet sources.Findings: The study highlights a very good scope of clinical trials in herbal drugs. It also highlights stringent guidelines for conduct of clinical trials in herbal drugs that needs little bit relaxation by regulatory agencies.Conclusion: The conclusion drawn from this review is that presently developing countries lack the necessary guidelines for clinical trials on Ayurvedic/natural/herbal medicines. If the WHO guidelines can be adopted in developing countries to approve clinical studies without the need for stringent safety data, clinical trials on Ayurvedic medicine can be encouraged to be at par with pharmaceutical products.

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  • 01 January 2015

Year: 2015, Volume: 14, Issue: 1


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