January 28, 2012, 0800 IST – Source : PharmaBizNews
The Union government’s stringent regulations on seeking informed consent and providing compensation to clinical trial victims would increase the number of volunteers and patients going for a trial in India, according to experts.
According to Dr Bhanu Priya, director and head, clinical research, G7 Synergon Life Sciences Consulting, the clause of compensation has now been insisted and therefore it is an assurance for the patients and for clinical research organizations to participate in human study and carry out the trial respectively.
Although Schedule Y of the Drugs and Cosmetics Act (D&C Act) called for compensation, Clinical Research Organizations (CROs) took up insurance policies to protect the patient in the wake of an adversity. But now with the amendment in the Act, the compensation cannot be ignored. There have been several insurance players who have chipped in to support the CROs with a dedicated policy. These include National Insurance, Oriental Insurance and Metflife, to name a few.
There is no doubt that both informed consent and compensation to victims are the two key factors which are giving the Indian volunteers and patients the confidence of participating in a clinical trial. While the former helps the volunteer or patient to understand the risks of the human study, the latter provides the much needed financial and medical support if the medicine turns fatal or reports an adverse drug reaction.
These two features will not just benefit the patients, but both informed consent and compensation for the clinical trial participants give them the option to even withdraw from a human study, Prof. SP Thyagarajan, Pro Vice Chancellor, Sri Ramachandra University, Chennai told Pharmabiz.
But Dr Krathish Bopanna, president & executive director, Semler Research Centre, begs to differ and stated that the move on compensation is a threat to the clinical research companies and we need to challenge this aspect of the law. This is primarily because there is no basis on which the compensation could be based because there are two aspects to the issue on whether it could be the test or the reference drug. Patients in a double blinded study could receive a placebo drug. We need clear cut guidelines and self regulatory norms.
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