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Abstract

Standardization is the process of analyzing a medicinal herb so that one or more of its key constituents is present in a predefined ?standard? amount. The data behind standardization is to ensure that each dose recommended contains consistent amount of the key active ingredients that give desired therapeutic or nutritional effect. From a CRO or third party laboratory point of view, this demand could be for product registration/regulatory purposes and/or to satisfy the customer needs about product quality and efficacy. The paper discusses some of the analytical quality assurance methods developed for some plant-based dietary supplements/ Ayurvedic Indian medicines to gain entry into US and European markets and to meet required regulatory requirements.

Biography

G. Sudesh Kumar received Bachelor and Master of Science Degrees from Osmania University, Hyderabad and Ph.D. from Indian Institute of Science, Bangalore. He did his post-doctoral work at Bowling Green State University, Ohio and University of Florida, Gainesville, USA on programs related to targeted drug delivery, photopolymers and biomaterials. He has held several prominent positions and led a number of research and technology teams in ICI India, GE India Technology Center & GE Silicones at Bangalore and GE Plastics, Netherlands. He also has held senior management positions at leading Indian contract research and testing organisations like SGS India, Shriram Institute for Industrial Research and Vimta Labs. He also has 40 research publications.