The Union health ministry has said that total number of deaths related
to clinical trials during three years from 2010 were 54 while the
casualties and injuries during the year of 2013 were still to be
assessed.
In a written reply in the Lok Sabah recently, Health
Minister Ghulam Nabi Azad said the number of deaths related to clinical
trials in the year 2010, 2011 and 2012 were 22, 16 and 16 respectively
as per the available data. “The reports of Serious Adverse Events (SAEs)
of injuries and deaths, received in the current year 2013 are under
examination. Compensations have been paid in 21 cases of deaths related
to clinical trial in 2010 and in all cases in 2011 and 2012. In one case
of 2010, the compensation remained unpaid as whereabouts of the legal
heir could not be traced by the investigator and his team in spite of
their best efforts,” he said
The Minister also gave details of
the steps taken by the government to strengthen the approval procedure
for clinical trials, monitoring mechanism and payment of compensation to
ensure that safety, rights and well-being of clinical trial subjects
are protected.
“In light of the Supreme Court Order dated
21.10.2013, it has been decided that for all clinical trials, in
addition to the requirement of obtaining written informed consent,
audio-visual recording of the informed consent process of each trial
subject, including the procedure of providing information to the subject
and his/her understanding on such consent, is also required to be done
while adhering to the principle of confidentiality. This is applicable
to the new subjects to be enrolled in all clinical trials including
Global Clinical Trials,” the Minister said.
“The Drugs and
Cosmetics Rules, 1945 have been amended vide Gazette Notification G.S.R.
53 (E) dated 30-01-2013 specifying procedures to analyze 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. . The Drugs and Cosmetics Rules, 1945 have
been amended vide Gazette Notification G.S.R. 63(E) dated 01-02-2013
specifying various conditions for conduct of clinical trials, authority
for conducting clinical trial inspections and actions in case of
non-compliance. Another amendment was done vide Gazette Notification
G.S.R No. 72(E) Dated 08.02.13 making registration of the Ethics
Committees mandatory and specifying requirements and guidelines for
registration of Ethics Committee,” he added.
Source: Pharmabiz
