The good clinical practice (GCP) guidelines issued by the department of Ayush fulfil a long felt need to guide the direction of clinical trials on Ayurveda, Siddha and Unani (ASU) remedies and therapies.
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.
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.
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 GCP guidelines are expected to facilitate the researchers and institutions in adopting a standard way of good clinical practice while conducting human trials for ISM medicines. Standardized manufacturing practices and a system of scientific documentation of safety of products are two basic requirements of ISM sector was lacking for a long time.
The main reason for this trend is the unorganized character of this industry consisting of mostly small and tiny units spread across the country. The objective of this set of guidelines now is to encourage clinical studies in ASU systems in accordance with scientific standards and safety aspects protecting the rights of participants. Adhering to methodical documentation of trials is expected to bring credibility to the efforts of persons and institutions involved in the trials which was lacking for want of any ASU-specific guiding document. The guidelines are considered significant as validation of safety and efficacy using scientific and evidence-based methodologies is needed for the purpose of universal acceptability of these products amongst practitioners and end users.
Indian Ayurveda industry is not able to fully cash in on the growing international demand for its products as these countries are insisting on safety of these products, standardisation of raw materials and dosage forms as in the case of modern medicine. In a situation like this, Ayurveda industry need to realize this position and cooperate with the government in implementing basic regulatory reforms if it has to grow into a science based modern industry.
But, the attempt to modernise this industry was getting delayed because of the objections raised by several members of this sector. The move to introduce clinical trials is also being objected to by a section of this industry on the ground that it is not necessary for traditional medicines especially for the ones which are already established in the market for years. This argument of the ISM units is not acceptable to the international market and the regulatory authorities there.
In fact, the regulatory authorities of the developed countries are willing to accept the fact that many diseases can be cured and prevented with ayurvedic drugs but they insist on documented evidence to support this contention. It seems that most of the units in the ISM sector have realized this fact and are now willing to adopt GCP guidelines and other reforms. Such a positive change in the approach should help this sector to grow much faster in the coming years.
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 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.