And the value is only getting cheaper going by the compensation amount paid in 2011 as against average compensation of Rs 3.2 lakh for clinincal trial-related deaths paid in 2010, according to an analysis of data provided in Parliament today by the Union Health Ministry.
The alarmingly low-level of compensation for lives lost during clinical trials in India can be credited to the fact that 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 today 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 public have been sought.
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.
In 2012, there have been 211 deaths till June during clinical trials, but the reasons of their deaths are being assessed.
A perusal of financial compensation in cases of clinical trial-related deaths in 2011 indicate that a total of Rs 35.21 lakh has been paid in 16 cases by drug firms. They ranged from a paltry Rs 50,000 to a maximum of Rs 5 lakh (still under process of payment).
In 2010, a total financial compensation of Rs 70.33 lakh was paid in 22 cases with the maximum amount being Rs 20 lakh by and a minimum amount being Rs 1.08 lakh.
