Good Clinical Practice :- The guidelines relating to good clinical practice (GCP) published by the department of Ayush necessitates a long cherished need to guide the course of clinical trials on Ayurveda, Siddha and Unani (ASU) treatments and therapies.
These guidelines are transpired based on CDSCO document on GCP Guidelines (2001) for Clinical Trials on Pharmaceutical Products. They entrust upon carrying out all ASU medicine research in India at all stages of novel drug development, whether earlier or later to product registration in India.
With the enforcement of Drugs & Cosmetics Rule 158 B since August 2010, the obligation of proof of effectiveness for licensing of patent or proprietary ASU medicine has paved the way for the development of current guidelines of Good Clinical Practice.
Performing clinical trials and producing the proof on the basis of these guidelines would help believe the world about the prospective scale of ASU remedies in scientific jargon and tackle the questions of lack of facts and substantiation. Plethora of opportunities thus lies in front of the stakeholders to embrace the guidelines as a tool for encouraging scientific and reliable clinical research for plausible outcomes.
The GCP guidelines are likely to assist the researchers and institutions in following a customary way of good clinical practice while carrying out human trials for ISM medicines. The Standard manufacturing practices and a well laid system of technical documentation of safety of products are two fundamental necessities of ISM sector was prominently missing for a long time.
The GCP is a set of guidelines to the industry which includes the design, conduct, audit, analysis, reporting, termination, and documentation of the clinical studies relating to human subjects. The elemental precept of GCP is that in investigations on man, the concern of science and society should never be given a priority over considerations pertaining to the well being of the human volunteers participating in the clinical trial.
The intention of this 114-page manuscript is to persuade that clinical studies in ASU systems are conducted in agreement with ethical and scientific standards and safety issues and rights of study subjects are protected at all stages of trial conduct.