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"As per available data, the number of serious adverse events of deaths in clinical trials reported during the last three years - 2010, 2011 and 2012 - were 668, 438 and 436, respectively," Minister for Health and Family Welfare Ghulam Nabi Azad said in a written reply to a question in the Lok Sabha.
However, deaths attributable to clinical trials were 22, 16 and 16 respectively during these three years, he said.
The minister said government has taken a number of steps to strengthen the approval procedures and monitoring mechanism for clinical trials and to ensure safety, rights and well-being of trial subjects, which includes the amendments notified in the Drugs and Cosmetics Rules, 1945.
As per the rules, the investigator conducting the trial is mandated to ascertain the death and report the same to the Drugs Controller General of India, the sponsor and the Ethics Committee within 24 hours of the occurrence.
In a bid to regulate the booming clinical trial industry in India, government had earlier this month set up four committees to monitor and ensure accountability during such tests that have seen 2,242 deaths in the past five years.
So far, there was no procedure in place to ensure accountability of this hitherto unregulated sector which is worth $500 million in India.
Azad said the expert committee while examining the event may take into consideration the reports of the investigator, the sponsor and the ethics committee.
The Drugs Controller General (India) after considering the recommendations of the expert committee shall determine the cause of death and decide the quantum of compensation to be paid by the sponsor in case of trial related death within three months of receiving the report of death.
The registration of ethics committees has been made mandatory in the drugs and cosmetics rules, specifying requirements and guidelines for registration of ethics committee.
The Supreme Court has also directed the government in January this year that clinical trials of new chemical entity shall be conducted strictly.
The government has also formed an apex committee under the chairmanship of Secretary, Department of Health & Family Welfare, with Secretary, Department of Health research-cum- Director General, Indian Council of Medical Research, and the Director General Health Services, to monitor the approval and conduct of clinical trials in the country.
The government has already constituted 12 New Drug Advisory Committees (NDAC) of leading experts mostly from the government medical colleges and institutes from all over the country, to advise the Central Drugs Standard Control Organisation (CDSCO) in matters related to approval of clinical trials and new drugs.
Registration of clinical trial in ICMR's registry has also been made mandatory and guidelines for conducting inspection of clinical trial sites and sponsor/clinical research organisations (CROs) have been prepared.
Proper procedures to analyse the reports of serious adverse events of deaths occurring during clinical trials in the country and grant of compensation in case of trial-related injury or death have also been prescribed with proper time-lines.
In reply to another question on the death of children in government hospitals during clinical trials, Azad said government is examining the reports submitted to the CDSCO.
"The government has received a notice dated 7.2.2013 from the National Human Rights Commission regarding clinical trials on 3,479 children in three government hospitals in Delhi without the consent of their guardians," he said.
The Minister said the CDSCO had constituted three committees (one for each hospital) with an outside expert, an official of CDSCO and another from the drug control department of Delhi government to investigate the matter.
"These Committees have already submitted their reports to the CDSCO which are under examination," the Minister said.
