Herbal drug safety assesment for regulatory submission: A path towards drug discovery

Chidambaram Tamilselvan

Bioscience Research Foundation, India

Scientific Tracks Abstracts: Altern Integr Med

Abstract :

Globally, herbal drugs considered to be an important alternative to modern allopathic drugs. Recently herbal products and research is very popular for the drug discovery process. Many scientist assessed medicinal products for efficacy but not in concern of safety assessments. In many countries, herbal drugs are not properly regulated and are often neither registered nor controlled by the health authorities. On the basis of health and public safety, now a days the regulatory authorities were strict in drugs safety quality evaluation at the time of submission and registration of the drugs. The World Health Organization’s (WHO) Traditional Medicine planned to focuses on promoting the safety, efficacy, and quality by expanding the knowledge base and providing guidance on regulatory and quality assurance standards. In context to this, recently evolving regulatory guidance for herbal safety testing is Good Laboratory Practices (GLP) adopted by Organization for Economic Co-operation and Development (OECD) regulatory council on mutual acceptance of data (MAD) among all countries in order to avoid the repetition of data, technical barriers to trade, further improve the protection and fulfillment of regulatory submission. Hence this will gives an imperative idea to develop directives for medical practitioners, AYUSH research sectors and end users.

Biography :

Chidambaram Tamilselvan is a humble, multi-talented and massive knowledge in the field of science. He started his career as senior research fellow funded by Department of Environment, Ministry of Environment and Forests, Government of India and also worked as principal investigator for other project funded by British Geological Survey (BGS). Then he completed his doctorate in philosophy specialization of plant protection and toxicology in University of Madras. After that he was headed department of chemistry for various contract research organizations (CRO) pioneers in the regulatory. During that period he has established several methodologies for the department of chemistry to achieve the status of OECD principles of GLP in India for the first time. He is member for several professional, regulatory and social bodies in order to contribute to science society. He published more than 45 research articles in various reputed international and national journals. He has visited more than 20 countries for the deliverance of science. He is well expertise in project development, management and troubleshooting of various techniques. With his greatest achievable more than two decade plant products experiences, he started own funded Research & Development unit as Bioscience Research Foundation and it is a largest GLP regulatory research CRO in India for all fields drugs/cometics/microbial prodcuts etc., under one umbrella. His excellence of leadership and operational of BRF it striving towards his aim to protect the environment in the context to safety and hazards products before release in to the market. His laboratory research activities execute only under the concept of total quality management throughout its life cycle with zero flaws. His life time dream is to develop a novel technology for testing and reduce herbal product manufactures encumbrances flotation in the regulatories.

E-mail: drselvan@brfchennai.com