The good clinical practice (GCP) guidelines given by the department of Ayush addresses a long felt need for proper conduct of clinical trials on Ayurveda, Siddha and Unani (ASU) treatments and therapies.
The guidelines provided are framed based on CDSCO manuscript on Good Clinical Practice Guidelines (2001) for Clinical Trials on Pharmaceutical Products. They must have to be followed for conducting all ASU medicine research in India at all phases of drug development, whether preceding or succeeding the product registration in India.
With the advent of Drugs & Cosmetics Rule 158 B in August 2010, the necessity of evidence of efficacy for licensing of patent or proprietary ASU medicine was made mandatory which in turn resulted in the evolution of present guidelines of Good Clinical Practice.
Proper Conduct of clinical trials and generating critical evidence on the basis of these guidelines would help the world believe the potential scope of ASU therapies in scientific language and challenge the questions posed due to lack of proof and validation. Immense prospects thus lie in-front of all the stakeholders to embrace the guidelines as a means for conducting scientific and quality clinical research for authentic outcomes.
The Good Clinical Practice guidelines are intended to assist the researchers and institutions in following a methodical way of good clinical practice while performing trials on humans for ISM medicines. Regularized manufacturing practices and an established system of scientific documentation relating to safety of products are the two fundamental requirements of ISM sector which are not in place since long.
The Good Clinical Practice is a set of guidelines which cover the design, conduct, audit, analysis, termination, documentation and reporting of the clinical trials involving human subjects. The basic principle of Good Clinical Practice is that in research involving humans, the interest of science and society should never be given priority over issues relating to the well being of the study subjects.
The purpose of this 114-page document is to see that clinical studies on humans in ASU systems are in harmony with ethical and scientific standards and safety aspects and rights of trial participants are properly safeguarded.
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