Clinical trial process to be further streamlined: Govt
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.
Azad said the government proposed to modify the Informed Consent Form to include the socio-economic background of the person participating in the drug trial and his/her nominee`s address. Requirements and guidelines for registration of Ethics Committee would also be prescribed in the rules.
Noting that death during clinical trials has been taken very seriously by the Government, he said, "The Government has taken concrete steps to strengthen the approval procedures, monitoring mechanism for clinical trials as well as to ensure that safety, rights and well-being of persons participating in clinical trials are protected.
Azad said a number of measures have already been taken for streamlining the procedure for clinical trials including making registration of clinical trials in ICMR registry mandatory since June 15, 2009.
He said among the measures taken include setting up of 12 new Drug Advisory Committees comprising leading experts to advise the Central Drugs Standard Control Organization (CDSCO) in matters relating to approval of clinical trials and new drugs.
Six Medical Device Advisory Committees have been set up by the government and a general experts pool for medical device advisory committees has also been set up, he said.
Besides, applications of investigational new drugs (IND) which have never been earlier used on human beings are also being evaluated by the IND committee chaired by the Director General, Indian Council of Medical Research.
Azad said every approval for conducting clinical trials now includes a condition that in case of study related injury or death, applicant will provide complete medical care as well as compensation and statement to this effect should be incorporated in the consent form.