Clinotek India launches awareness campaign of Registration of Ethics Committees in India

BANGALORE, India - April 10, 2013 - PRLog -- Clinical Research Industry has evolved at an enormous rate in India in the recent past. Multinational Pharmaceutical companies showed a lot of interest and outsourced huge number of clinical trials in wide range of therapeutic areas to around 100 small, medium and big Contract (Clinical) Research Organizations. As with any other fast growing industry, there were lots of non-compliance issues reported during the conduct of these trials in India. DCG(I) has also initiated 5 years Pharmacovigilance plan in India to address safety issues. During the conduct of many trials in India, biggest concern observed was related to Informed Consent. As per International and Indian guidelines, it is mandatory to obtain Informed Consent from every subject before any procedure related to a trial is initiated with the subject. It is one of the basic requirements. Unfortunately it became the most neglected aspect, as per the observed reports.

Mr. Nagendrappa. M. H, CEO of Clinotek India - Center for Advanced Clinical Research Studies, a Bangalore based Clinical Research Training Center has told that Ethics Committees can play a significant role in safeguarding the trial participants. One more reason for non-compliance in most cases was that many companies have put untrained professionals who neglected the rights, safety and wellbeing of clinical trial participants. Mr. Nagendrappa. M. H, who trains Ethics Committees has also expressed that Ethics Committees have the power to regularly monitor the progress of the site activities of the trials to safeguard the subjects. Ethics Committees are very close to the sites and can contribute much more than what is being done currently. There was also the concern about some of the members of Ethics Committees associated with Contract (Clinical) Research Organisations giving biased opinion and approval to Clinical Trial Protocols.

To discourage such companies who may be encouraged to conduct trials in an unethical manner, Drugs Controller General (India) has taken a bold step to make Ethics Committees feel much more responsible, review all the clinical trial documents and approve the protocol in an unbiased manner. Mr. Nagendrappa. M. H was very delighted to announce that this significant move after Pharmacovigilance plan and will benefit the whole clinical research industry and the trial participants can have better information and explanation related to the trial and can take an informed decision whether or not to participate in a clinical trial. Mr. Nagendrappa also appreciated another significant move by DCG(I) to nominate a committee to assess and decide the extent of compensation to be provided to trial participants in case of any trial related injury.

Clinical research industry has the potential to become one of the biggest industries in India, offering excellent business opportunities to Contract Research Organisations and also employment opportunities for Trained Clinical Research Professionals. Safety of trial participants should be considered as one of the most important considerations in any research project involving human subjects. Without the cooperation of the industry and the public, Government policies will remain only as ambitions. It is the responsibility of every professional including Ethics Committee Members in clinical research project to have better understanding of the requirements and amendments released by concerned authorities at frequent intervals to contribute in a better way in review and approval process related to clinical trial protocols. Now it is Ethics Committees turn to come forward to get adequate knowledge in ICH GCP guidelines, DCGI and Schedule 'Y' requirements before reviewing and approving / providing favorable opinion to any clinical trial protocol in India.