With as many as 2,868 deaths during clinical trials from 2005 to 2012, only 89 have been attributed directly to such trials and compensation paid only in 45 cases so far, the Rajya Sabha was today informed. Last year, 436 people died during clinical trials but only 16 of these were attributed directly to the trials. Compensation was paid in only two of the 16 cases. While Novartis gave Rs 2.5 lakh in one case, Sun paid Rs 50,000 as interim payment in the other, Health and Family Welfare Minister Ghulam Nabi Azad said in a written reply. In a bid to regulate the booming clinical trial industry, the government had earlier this month set up four committees to monitor and ensure accountability during the tests that have seen 2,242 deaths in past five years. So far, there is no procedure in place to ensure accountability of this hitherto unregulated sector which is worth USD 500 million in India. Azad said detailed requirements of reporting of serious adverse events including deaths in clinical trials in a time-bound manner were incorporated in the Drugs and Cosmetics Rules through amendments in Schedule 'Y'. "Serious adverse events including deaths may occur during clinical trials.
However, all such deaths may not be attributable to the clinical trials. They could be disease- related in the cases of critically or terminally ill patients suffering from cancer, cardiovascular diseases, AIDS, etc or due to side effects of drugs administered during the course of the trial or due to other unforeseen reasons," he said. In 2011, all 16 such cases of clinical trial-related deaths were paid compensation ranging from Rs 50,000 to Rs 5 lakh, while 22 of the 23 such cases in 2010 were paid compensation from Rs 1.08 lakh to Rs 20 lakh. Compensation of Rs 1.5 lakh in one case is yet unpaid as the whereabouts of the legal heirs of the deceased could not be located. While there have been five deaths related to clinical trials in 2005, two in 2006 and four in 2007, no compensation has been paid in any of these cases. In 2008, there were eight trial-related deaths but compensation of Rs 2.5 lakh to Rs 10 lakh was paid in only three cases. Compensation of Rs 1-2.80 lakh was paid in three of 16 such deaths during clinical trials in 2009. Azad said as per available data, the number of deaths during clinical trials in 2005 was 128 and five of these deaths were attributable to the trials, while 137 people died in 2006 during such trials and only two of these deaths were attributed directly to these tests. In 2007, there were 136 deaths during clinical trials and four of them were attributable directly to such trials while of the 288 deaths in 2008, only eight were attributed. Of the 637 deaths during clinical trials in 2009, 16 were attributed directly to the trials and only 22 of the 668 deaths during such trials were attributed in 2010. In 2011, there were 438 deaths during clinical trials and 16 of the deaths were found to be due to these trials.