Perspectives in Clinical Research

REGULATORY
Year
: 2013  |  Volume : 4  |  Issue : 4  |  Page : 199--203

Injury and death in clinical trials and compensation: Rule 122 DAB


Ravindra B Ghooi 
 Scientia Clinical Services, Pune, Maharashtra, India

Correspondence Address:
Ravindra B Ghooi
G 801, Rohan Nilay (1), Aundh, Pune - 411 007, Maharashtra
India

Three amendments to the drugs and cosmetics rules were published in quick succession in 2013. These addressed the issues of compensation of injury and death in clinical trials in addition to the role and registration of Ethics Committees. Of the three, the first and the third make an impact on the clinical research activities in India. The second amendment has codified the conduct of clinical trials, putting together rules, which appeared in different sections of Schedule Y. The first amendment deals with the compensation for injuries and deaths taking place during clinical trials while the third deals with registration of Ethics Committees. Despite the long delay in the issue of compensation rules, there appears significant room for improvement. The most problematic are conditions of injury and death in which compensation has to be paid. When compared with other countries, the Indian rules seem unduly harsh on sponsors and are at significant variance with those in UK. The rules are very generous toward subjects and compensation is likely to become an alternative to insurance in terminally ill subjects. The implementation of these rules will make clinical trials in India more expensive and hurt the industry that is already struggling through other handicaps. There is an urgent need to make the the environment more industry friendly to attract more clinical work.


How to cite this article:
Ghooi RB. Injury and death in clinical trials and compensation: Rule 122 DAB.Perspect Clin Res 2013;4:199-203


How to cite this URL:
Ghooi RB. Injury and death in clinical trials and compensation: Rule 122 DAB. Perspect Clin Res [serial online] 2013 [cited 2019 Nov 13 ];4:199-203
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2013;volume=4;issue=4;spage=199;epage=203;aulast=Ghooi;type=0