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Ayurveda GCP Guidelines: Need for freedom from RCT ascendancy in favor of whole system approach

Journal of Ayurveda and Integrative Medicine
Publication Date
  • Editorial
  • Medicine


As a result of the significant interest and growth in Ayurveda, Siddha, and Unani (ASU) medicines and other aspects of the Traditional Medicine (TM) sector, the Department of Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH), Government of India, is planning to introduce a regulation for Good Clinical Practices (GCP) under Schedule T of the Drugs and Cosmetics Act, 1940. Guidelines are being drafted for the evaluation of ASU medicines and other TM, to encourage Research and Development (R and D) activities in the sector.[12] The purpose of the guidelines is to develop methodologies for research and evaluation; to improve the quality and value of research; to provide appropriate evaluation methods to facilitate the development of regulation and registration in ASU medicines and other TM in a phased manner; and to help promote a better understanding of ASU medicines and other TM. These guidelines are intended to serve as a reference source for research scientists, registered medical practitioners, manufacturers, and health authorities. This exercise initiated by the Department of AYUSH is timely and commendable. However, the proposed guidelines seem to have been drawn up on the basis of Western biomedical approaches, including randomized controlled trials, as necessary evidence. These are mainly related to evaluation of New Chemical Entities (NCE). They appear to be largely based on the standard GCP guidelines previously proposed by the Central Drugs Standard Control Organization[3] and need more attention to the special needs of the ASU sector. In fact, we need to evolve appropriate guidelines based on the basic principles of Ayurveda where due weightage is given to empirical evidence. The black box approach, pragmatic trials, and the whole system approach of Ayurveda needs to be maintained rather than accepting reductionist methods of treating any symptom or disease condition in isolation. Although safety and quality assurance should not be compromised, the new guidelines need to be revised in light

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