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

Abstract

Purpose : This communication highlights 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 countries to enhance global acceptance. Social Implications : Herbal drugs have been used since ancient times as for treatment of different diseases. It is oldest and most popular form of healthcare practice known to humanity for maintenance of health that has been practiced by people of all societies throughout history of evolution. Herbal 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 are directly or indirectly derived from plants sources yet 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 importance and requirement to develop a standard operational procedure for standardization of herbal drugs and formulations. Original value : Quality control, quality assurance, safety and efcacy of herbal drugs are bench mark in 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 necessary guidelines for clinical trials on Ayurvedic/natural/herbal medicines. If WHO guidelines can be adopted in developing countries to approve clinical studies without need for stringent safety data, clinical trials on Ayurvedic medicine can be encouraged to be at par with pharmaceutical products.