2012: 211 people died in six months during clinical trials in India
As many as 211 people died between January and June 2012 due to serious adverse events (SAE) during clinical trials.
NEW DELHI: As many as 211 people died between January and June 2012 due to serious adverse events (SAE) during clinical trials. Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects.
Union health minister Ghulam Nabi Azad said on Friday that the deaths could be related to diseases such as cancer or administration of drugs and their side-effects. In 2011, 438 cases of SAE were reported, of which 16 were found to be due to clinical trials. The previous year, 668 cases of SAE were reported, of which 22 were caused due to the trials.
The Union health ministry says approval for conducting clinical trials now includes a condition in the consent form that in case of a study-related injury or death, the applicant will provide medical care and pay compensation. All trials are now compulsorily registered with the Indian Council of Medical Research.
Union health minister Ghulam Nabi Azad said on Friday that the deaths could be related to diseases such as cancer or administration of drugs and their side-effects. In 2011, 438 cases of SAE were reported, of which 16 were found to be due to clinical trials. The previous year, 668 cases of SAE were reported, of which 22 were caused due to the trials.
The Union health ministry says approval for conducting clinical trials now includes a condition in the consent form that in case of a study-related injury or death, the applicant will provide medical care and pay compensation. All trials are now compulsorily registered with the Indian Council of Medical Research.
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