New Delhi, Jan 13, 2015: Compensation is paid in case of death resulting from clinical trials and not in the case of non-fatal injuries sustained as a result of clinical trials. Based on a new formula, compensation can be paid to victims of clinical trials by computation of the sum of the age and health risks of the deceased. India is the first country to provide compensations in this way. An official of Drug Controller General of India (DCGI) said that since January 2013, the nominee of the subject who died due to clinical trials on experimental drugs were provided compensations in the range of Rs. 4-34 lakhs by the pharmaceutical companies. 21 number of compensations have been given out by pharmaceutical companies since January 2013.DCGI’s office has set up a patient safety cell consisting of an expert panel of pharmacologists and clinicians. This panel decides that whether death during clinical trial is caused by the trial or not. This panel has investigated more than 160 cases of death and found that 20 cases were caused by the trial. It will soon examine another 110 cases.
This effort was made by the government on account of concerns raised by health activists against pharmaceutical companies that they do not pay adequate compensation to volunteers of clinical trials who are injured during trials. A case is in the Supreme Court regarding this matter. DCGI has kept an amount of Rs. 4-74 lakhs for volunteers depending upon their age and health risks. These figures are more than what is paid to trial victims by the pharmaceutical companies. According to health ministry data, pharmaceutical companies on an average has paid Rs. 1.5-4 lakhs as compensation from 2005 to 2012.
According to the Drug Controller General of India, “this mathematical formula is based on a scientific methodology which will ensure complete transparency in the way compensation is calculated for clinical trial victims. India has taken the lead and has become a trendsetter by providing for such a formula, which will ensure rights of clinical trial victims are not compromised. ” It is the responsibility of the pharmaceutical companies and their representatives within the country to make sure that the amount determined by this formula is paid to the victim’s entitled relatives.
At the time of enrollment highest compensation is assigned to a healthy volunteer within the age groups of 17-64 years having least probability to die because of medical complications. The compensation is needed to be paid within 30 days of DCGI order by the pharmaceutical companies, though; it has option of appealing to the health Ministry against DCGI order. Less than Rs. 2 lakhs each has been paid in the 30 cases out of the 83 cases of trial-related deaths between 2005 and 2012. The data suggests that an amount of Rs. 2-4 lakhs has been given as compensation in 34 cases of trial-related deaths, Rs. 4-6 lakhs was paid to 14 families and Rs. 10 lakhs was paid in three cases.IGMPI(http://www.igmpiindia.org/)
