The department of Ayush has issued good clinical practice (GCP) guidelines for clinical trials in Ayurveda, Siddha and Unani (ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice while conducting the ASU clinical trials.

The guidelines are addressed to investigators and all those, who are interested, concerned, involved and affected with the conduct of clinical trials on ASU drugs. These are timely in view of the focus being given for scientific validation and for promoting evidence-based use of ASU treatments and are meant for voluntary use, not linked with any provisions of Drugs & Cosmetics (D&C) Act, 1940, and the rules thereunder.

The GCP is a set of guidelines which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject.

It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine under investigation are properly documented. The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated.

The objective of this 114-page log document is to encourage that clinical studies in ASU systems are undertaken in accordance with ethical and scientific standards and safety aspects and rights of participants are protected. Adhering to methodical documentation of trials will help bringing credibility to the efforts of persons and institutions involved in the process, which otherwise was lacking for want of any ASU-specific guiding document.

The guidelines are significant as although the ASU systems are known for their long history of safe and effective use, yet validation of safety and efficacy using scientific and evidence-based methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners and satisfaction of end users in the products.

The arguments of having long standing in the medical practice or market are often unconvincing and there has been persistent and increasing demand of documented proof of clinical safety and efficacy of ASU medicine. In this perspective, the clinical trials in ASU systems need to be guided on the principle of ‘Good Clinical Practice’. Researchers, sponsors and drug manufacturers, therefore, have to be well versed with the standard scientific procedures that are required to be followed while conducting clinical trials with ASU interventions to achieve objective and reproducible results.

These guidelines are formulated based on CDSCO Document on GCP Guidelines (2001) for Clinical Trials on Pharmaceutical Products. They should be followed for carrying out all ASU medicine research in India at all stages of drug development, whether prior or subsequent to product registration in India.

With the introduction of Drugs & Cosmetics Rule 158 B since August 2010, the requirement of proof of effectiveness for licensing of patent or proprietary ASU medicine has necessitated the development of present guidelines of Good Clinical Practice. However, these guidelines are for voluntary use by the researchers interested in taking up clinical trials by using ASU medicine. Conducting clinical trials and generating evidence on the basis of these guidelines would help convincing the world about the potential scope of ASU remedies in scientific parlance and address the questions of lack of evidence and validation. Immense opportunities thus lie ahead for the stakeholders to adopt the guidelines as a tool for promoting scientific and quality clinical research for credible outcomes.

The guidelines fulfill a long felt need to guide the direction of clinical trials on ASU remedies and therapies.