As per data available with the Drugs Controller General (India), the number of Serious Adverse Events (SAEs) of death including those related and not related to clinical trial reported between January, 2012 and December, 2014 is as follows:
Year
|
Nos. of SAEs where death was reported.
|
Nos. where death established to be related to Clinical Trial.
|
2012
|
436
|
16
|
2013
|
590*
|
46
|
2014
|
443a
|
22
|
2015
|
162
|
These relate to current year and relativity has not been examined as yet.
|
* - out of 590 reports, 534 reports of SAEs of death have been examined so far.
a - out of 443 reports, 345 reports of SAEs of death have been examined so far
The Drugs Controller General (India) has granted permission for 241 global clinical trial application(s) from January, 2012 to May, 2015. These clinical trials relate to medicine(s) of different therapeutic categories including anti-diabetes, anti-cancer, anti-arthritis, anti-asthma, anti-HIV, etc.
The Health Minister, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.Courtesy: pib.nic.in
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