In the last four years, 2,031 people died in India as a result of Serious Adverse Events (SAEs) caused during drug trials but only about 1 per cent cases received any compensation, information disclosed by the office of the Drug Controller-General of India has revealed.
The figures of SAE-related deaths for 2008, 2009, 2010 and 2011 are 288, 637, 668 and 438. However, compensation was provided only in 22 cases of deaths and that too only in 2010, according to information available with the DCG (I).
No compensation was paid for 2008 and 2009 and the data for 2011 has yet to be compiled.
The information was provided by the DCG (I) in response to a Right to Information query filed by Indore-based medical rights activist Anand Rai.
The reason for such a small number of cases receiving compensation is simple: Pharma companies conducting clinical trials pay compensation only in cases where it is established that the death was caused as a result of the trials and not merely during the trial.
“But it is the companies themselves that decide whether a death was caused due to the trials or not. So there is a conflict of interest there as the companies want to pay compensation in the lowest possible number of cases,” says Dr. Rai, who founded the Clinical Trial Victim Association of Madhya Pradesh.
“We believe all cases of SAE-related deaths should receive compensation. We have filed a petition in the Supreme Court on the matter,” says Dr. Rai.
Dr. Rai also asked for the SAE-related death figures for the year 2012 and for details of the trial sites/hospitals where the 2,031 deaths occurred and their State-wise location, but the DCG (I) said it did not maintain such data.
However, on an appeal by the petitioner, the CIC on Friday directed the DCG (I) to provide the State-wise trial site details by August 15, 2012.
The CIC also directed the DCG(I) to provide the petitioner with figures for SAE-related deaths till January 2012. The DCG(I) told the Commission the data up to January 2012 had not been compiled as it was compiled four to six months after the end of the calendar years.
On this, Information Commissioner Shailesh Gandhi said data should be available on a monthly basis.
“The Commission feels such data should be available every month,” Mr. Gandhi noted in the order, passed on Friday.
