The average cost of each life lost in drug trials in India's booming and largely unregulated clinical trial industry was a meagre Rs 2.2 lakh last year. A year prior to that the average compensation which the pharmaceutical companies paid so far in respect of each death came out to a slightly better Rs 3.2 lakh. Though the total number of deaths in the country in 2010 and 2011 during clinical trials were 668 and 438 respectively,the Serious Adverse Events (SAEs) of death attributed only to clinical trials of drugs were found to be in 22 and 16 cases in these respective years. Till June 2012 there have been 211 deaths during clinical trials,but the reasons of their deaths are being assessed. The strikingly low-level of compensation for lives lost during clinical trials in India can be credited to the fact that the government is yet to frame rules for compensation in such cases under the existing drug regulation laws in the country. By its own admission,the government said in Parliament on Friday that there were no such rules in place and it was in the process of finalising them. Health Minister Ghulam Nabi Azad said the government is in the process of finalising such guidelines and expects to do so soon. The government expects to finalise these guidelines soon keeping in view the rights and well-being of trial subjects, Azad said,in a written reply to a question in Lok Sabha. The minister said draft guidelines for determining the quantum of financial compensation to be paid in cases of clinical trial related injury or death have been prepared and comments from the public have been sought. He said there were no such rules in place at present.
