Out of the 436 deaths in 2012, 16 were caused due to the clinical trials, he said. Rest of the deaths might have been disease-related in the cases of terminally ill patients suffering from cancer, cardio-vascular diseases and AIDS or due to side effects of drugs administered during the trial.
Azad said compensation is paid in cases of deaths and injury which are attributable to clinical trials.
The Drugs and Cosmetics Rules, 1945 have been amended specifying the procedures to analyse the reports of serious adverse events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines, he added.
—Indo-Asian News Service spc/vd/dg
- NHRC issues notice to the Centre on allegations of illegal clinical trials on 3479 children in Delhi hospital (kractivist.wordpress.com)
- Six cases of irregularities in clinical trials in India (vancouverdesi.com)
- 16 direct deaths in 2012 due to clinical trials, says Govt (thehindu.com)