M A I N   N E W S

Clinical trials claimed 436 lives in 2012
Tribune News Service

New Delhi, February 22
Close on the heels of fresh notifications in the Drugs and Cosmetics Rules to regulate the clinical trial sector better in India, the government today informed the Lok Sabha that 436 deaths occurred during such trials over the past year.

So far, it was known that 211 persons had died in 2012 on account of serious adverse events during the clinical trials of drugs and medical devices in the country. The death toll has doubled by the end of 2012.

Shocking revelation Not a single case of death has been investigated yet and no compensation has been paid to any victim's family The death toll in drug trials in the country stands at 1,542 over the past three years It was 668 in 2010 where only 22 cases were attributed to deaths on account of clinical trials In 2011, 438 deaths happened in drug trials, but companies paid compensation to just 16 persons The Health Ministry had changed the procedures governing compensation and said the Drug Controller General of India will now be the final authority to determine compensation

What is more shocking is that not a single case of death has been investigated yet and no compensation has been paid to any victim’s family. “The cases of 2012 are under examination,” the Health Ministry said in a written answer in the Lok Sabha today.

With this admission, the death toll in drug trials in India stands at 1,542 over the past three years. It was 668 in 2010 where only 22 cases were attributed to deaths on account of clinical trials and the rest were attributed to previous medical history of the trial participants. In 2011, 438 deaths happened in the drug trials with the companies paying compensation to just 16 persons after admitting that they died due to complications arising from clinical trials.

Last year 436 deaths were recorded during clinical trials and compensation is yet to be paid with the government still examining how many deaths occurred due to trials.

“Serious adverse events of deaths may occur during clinical trials due to various reasons. The deaths could be due to life threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, stroke and other serious diseases which the participant of drug trial could be suffering from in the past. They could also be due to side effects of drugs administered to participants during clinical trials. Such deaths have to be investigated to arrive at a connection if any,” the ministry says.

Earlier this month, the ministry had changed the procedures governing compensation and said the Drug Controller General of India will now be the final authority to determine compensation in cases of death and injury during drug trials. So far, pharma firms have themselves been investigating deaths and paying compensation.

The government has also changed the rules to mandate pre-registration of the ethics committees of each medical institute that wants to conduct a clinical trial in future. The practice hitherto is to register such committees on need basis.

The moves follow grant of low compensation by pharma firms sponsoring drug trials to families of those who died during such procedures. Fresenius, a sponsor of clinical trial of Paclitaxel Nanoparticle, paid Rs 50,000 each in two deaths caused. Veeda paid Rs 50,000 for a life lost during the clinical trial of its product MP 102/Placebo in 2011 in India.

Different companies continued to pay different compensations. The government is now in the process of fixing minimum compensation in cases of deaths and injuries during drug trials.