Replying to a Calling Attention Motion on the issue in Rajya Sabha, Health and Family Welfare Minister Ghulam Nabi Azad said the government proposed to strengthen the rules by incorporating certain new provisions soon.
He said the proposed Committee of Experts would give its recommendations for compensation in case of injury or death during clinical trials to the Drug Controller of India (DCGI), to decide the final amount within three months.
The Minister said the proposals include that "in case of injury, the sponsor will provide medical care to the person concerned as long as required" and "there would be specific provision in Rules for payment of compensation to the affected persons/their nominees for trial related injuries/death".
Azad said the investigator shall report all serious adverse events, including death, to the DCGI as well as sponsor company and Ethics Committee within 24 hours of occurrence.
The Minister also assured the members that the government was seized of the sensitive matter and was taking steps to further streamline the procedure for clinical trials.
He said as per available data, the number of Serious Adverse Events (SAEs) of deaths in clinical trials reported during 2010, 2011 and up to June 2012 are 668, 438 and 211 respectively. He, however, said the SAEs of death due to clinical trials were 22 and 16 in 2010 and 2011 respectively.
During the discussion initiated by P Rajeeve (CPI-M), members expressed concern over the increased deaths during such trials.
