New Delhi: With 11 deaths reported every week during clinical trials in the last three years, government today said there have been 211 such deaths this year till June.
While 668 deaths were reported in 2010 and 438 in 2011, out of these, deaths attributed only "to clinical trials" were 22 and 16 respectively.
In a written reply to a question in the Lok Sabha, Minister for Health and Family Welfare Ghulam Nabi Azad said a total of 1,954 persons died from 2009 till June 2012 due to "serious adverse events of death" in clinical trials.
He said the serious adverse events of death may occur during clinical trials due to various reasons, which could be attributed to deaths relating to diseases like cancer or administration of drug on critical or terminally ill patients or side-effects or unrelated causes.
Azad, however, said deaths "attributed to clinical trials" in 2010 and 2011 after they were studied were only 22 and 16 respectively.
"The scrutiny of cases pertaining to the year 2012 is in process," the Minister said.
The Minister said compensation has been paid in all the cases pertaining to 2010, except in one case where the whereabouts of the legal heir could not be ascertained.
In respect of cases pertaining to 2011, compensation has been paid in 15 cases and in the remaining one case, issue of payment has been taken.
To a question if the recent data released by WHO shows consistently high mortality rates in clinical trials, Azad said, "The WHO has denied existence of any WHO report regarding deaths in clinical trials in India in the past few years."
He claimed that the Health Ministry has taken a number of measures to strengthen the provisions for regulating the conduct of clinical trials in the country.
Listing out steps taken to bring in transparency in the system of approving new drugs, Azad said registration of clinical trials in the Clinical Trial Registry of the Indian Council of Medical Research (ICMR) has been made mandatory since June 2009.
He said that a Committee/Core panel of experts has been set up to advice on matters relating to regulatory approval of clinical trials for investigational new drugs and another panel of experts - Cellular Biology Based Therapeutic Drugs Evaluation Committee (CBTDEC) has been set up to advice on matters of regulatory pathways leading to approval of clinical trials.
He said 12 new Drug Advisory Committees and six Medical Device Advisory Committees have been set up by the government. Besides, a general expert’s pool for medical device advisory committees has also been set up.
Azad said every approval/permission 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 for the injury or death and statement to this effect should be incorporated for the informed consent form.
Further, in case of such injury or death, the details of compensation provided should be intimated to the office of the Drugs Controller General (India), he said, adding that the draft rules containing provisions for payment of compensation by sponsor for injury or death of trial subjects have been notified.
Guidelines for conducting inspection of clinical trial sites and sponsor CROs have been prepared, Azad said.
After uproar over 33 drugs approved in the country during 2008-2010 without carrying out clinical trials on Indian population, government had set up a three-member expert committee to examine the validity of the scientific and statutory basis adopted for approval of new drugs, which is yet to submit its report.
The committee was formed after a Parliamentary Standing Committee on Health on the functioning of the Central Drugs Standard Control Organisation (CDSCO) said that many opinions of experts were actually written by the invisible hands of drug manufacturers.