The Planning Commission will soon create a central fund that would be operated only to compensate clinical trial participants in the event of injury during the course of a human study.
The creation of such a fund is seen to be a major support for the clinical research industry. It is a positive move in the right direction as the government has now turned around to recognize the need to chip in financial assistance for patient compensation, Prof. Ranjit Roy Chaudhury, chairman of expert committee on clinical trials told Pharmabiz on the sidelines of the 7th ISCR annual conference.
The funds will not cover any compensation coming under academic research and pharma related drug development activities. It will only be provided to human studies which have been approved by the Technical Review Committee (TRC) constituted under Directorate General of Health Services and therefore it does not dilute the focus of compensation.
“The quantum of funds is not known but definitely it is not a prohibitive allocation for the Planning Commission to set aside. Now we have to ensure that the process of compensating the participants during a trial is implemented properly,” he added.
The need to compensate clinical trials participants will only see them to agree in participating in human studies. Moreover, they would also be assured that in case of an injury, their medical needs would be taken care over and above a compensation. In fact, JIPMER in Pondicherry and the Institute of Liver and Biliary Sciences, New Delhi have begun to compensate its doctors in hospitals if they were injured with surgical and injectable instruments but not patients for clinical trials. Therefore, the funding coming in from the Planning Commission for patients’ compensation costs is seen to be an encouraging start in India’s clinical research regulation, said Prof. Roy.
Further, Prof. Roy was certain that by the end of 2014, the clinical research regulations could be enforced in total. “The formation of the ethics committee was a simple process but the accreditation of sites was seen to take some time. This is where state regulatory authorities need to be associated to audit facilities in their region,” he noted.
Use of information technology and legal framework were the crux of the recommendations which needed considerable coordination, said Prof. Roy adding that the country was facing the challenges of high cost of treatment and poor access to drugs.
“The clinical trial component of the healthcare industry was down on its knees and this is where transparency in human studies is seen to be much wanted. The current scene indicated dismay for clinical research industry. The clinical research organizations are closing down and the reality is that drug research is going away from India. All this has happened because of poor confidence on the sector. Since the government gave a free hand to formulate the recommendations which is now being put in place, the future is hopeful if the sector works to get its house in order and get on to provide credibility in quality research and adhere to ethical practices,” said Prof. Roy.
This is where the concept of ‘Health India’ comes into force, said Prof. Roy adding that drug research should become a national priority.