Approaches for the development of single plant based standardized formulations

In comparison to the western medicines, the use of natural products for health & healing can be traced back for at least 5000 years. There are more than 85,000 plant species, that have been documented for medical use globally and out of these more that 10 percent are used in the officially recognized, time tested Indian Traditional systems of medicine namely, Ayurveda, Unani, Siddha and Homoeopathy. According to a World Health Organization (WHO) estimate, as high as 80% of the population in developing countries depend on traditional and herbal medicines as their primary source of health care. In the last one decade there has been an exponential growth in the consumption of herbal medicine. It is getting popularized in developing as well as in developed countries, primarily due to the consumer driven “ back to nature” movement and lesser side effects attributed to botanicals. Worldwide sales of medicinal plants, crude extracts and finished products amounted at 23 billion US dollars in 2002. With an annual growth rate of 5–15% as projected by the World Bank, the current market size is about 60 billion US dollars per annum. One of the major challenges we face is the standardization of biological materials from natural sources. New technologies to modernize traditional herbs into mainstream pharmaceutical products are being evaluated with the ultimate goal of maximizing the opportunities and overcoming the challenges of standardization and proving the time tested biological activities. The scientific proof and clinical validation of these herbal formulations require a rigorous approach that includes chemical standardization, biological assays, animal models, and clinical trials for proof of safety and efficacy. In the presentation, our approach at IIIM, Jammu, of developing globally acceptable single plant based, standardized botanical formulations with proven safety and efficacy would be illustrated through three case studies on Vitex negundo (Liv-1), a hepatoprotective, Withania somnifera, an immunomodulator/adaptogen and RJM-1195 a tnf-α inhibitor (anti-rheumatoid arthritis agent).