Opportunities, Challenges and Strategies to Develop Plant-Based Medicine or Botanical Drugs

The majority of the world's population depends heavily on traditional plants and plant products to alleviate health-related problems. The herbal tea prepared from traditional medicines or generally regarded as safe (GRAS) plants and decoctions prepared from plant mixtures are mainstay of the traditional medicines used in China, India, Sri Lanka, Nepal and other south Asian countries.  Although the use of traditional medicines and functional foods to improve health and quality of life are centuries old, the anecdotal status of traditional medicines always kept it out of the limelight.  Even today, many herbal and functional food products are sold with little or no scientific support for the health-beneficial claims.  In majority of instances, the herbal and functional food products sold in the market are examples of “get rich quick schemes”. Therefore, established efficacy, dose and toxicity of traditional medicines along with clinical efficacy are mandatory to develop them as sustainable consumer products.  The approach to develop sustainable health-promoting agricultural products consists of multiple phases.  The first phase includes the survey of folkloric knowledge pertaining to medicinal plants, selection of the plant material with anecdotal claim(s) and botanical identity, determination of whether its production can be renewable and sustainable, preparation  of decoctions as per traditional use, determination of anecdotal health claims of the selected decoctions in in vitro mechanism based bioassays and characterization of the bioactive constituents in the active decoction by using a bioassay-guided fractionation, purification and structure elucidation using spectroscopic and chemical methods.  The second phase consists of formulation and its preclinical evaluation of efficacy, dosage and toxicity by using suitable animal models.  The final phase will be adequate clinical trials, manufacturing (large scale production of plant material and extract preparation) and marketing. It is important to note that expression of bioactive compounds is a function of environmental and growth conditions that can vary from place to place.  Therefore, agricultural production of traditional plant materials become a critical factor to ensure the efficacy and hence guarantee the success of the product developed from it.  This is an opportunity for growers to implement novel methods for cultivation and production of these medicinal plants in large quantities for product development.  MOUs and contracts shall protect the interests of all parties involved and hence facilitate research and development of phytomedicines from medicinal plants at national and international levels.