Some drug manufacturing companies paid a strikingly low compensation of Rs50,000 for a life lost during their clinical trials last year, government data has suggested.
While the average cost of each life lost in drug trials was calculated at Rs2.2 lakhs last year, in 2010 the average compensation which the pharmaceutical companies paid in respect of each death stood better at Rs3.2 lakhs.
According to the data in 2011, only Pfizer has been recommended to pay maximum amount of Rs5,00,000 for a death during clinical trials. Another company VEEDA paid mere Rs50,000 as compensation for death.
According to the data, the total number of deaths in the country in 2010 and 2011 during clinical trials were 668 and 438 respectively and 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 yet to be assessed. “The payments were made by the companies based on the recommendations of the ethics committee, age of the person, disease severity, annual income etc.,” Union health minister Ghulam Nabi Azad disclosed in the Lok Sabha on Friday.
Officials in the health ministry say that the new guidelines for determining the quantum of financial compensation to be paid in cases of clinical trial related injury or death will help in better compensations.
As reported by this newspaper first, the government is in the process of finalising such guidelines which will be based on age, income, seriousness and severity of the disaease from which the subject was suffering at the time of the participation of the trial, percentage of diability in the case of injury etc.
“The government expects to finalise these guidelines soon keeping in view the rights and well-being of trial subjects,” Mr Azad added.