Compensation to clinical trial volunteers
The adverse events in clinical trials and the compensation thereafter has been a topic of debate since long.
One of our honourable members of parliament Kumari Sailaja in Rajya Sabha asked a question about
"(a) whether it is a fact that Pharmaceutical companies do not always compensate volunteers of clinical trials for their sufferings;
(b) if so, the details thereof;
(c) the details of compensation paid during the last two years to the volunteers; and
(d) the steps being taken by Government to safeguard the volunteers from the risks they face?"
(b) if so, the details thereof;
(c) the details of compensation paid during the last two years to the volunteers; and
(d) the steps being taken by Government to safeguard the volunteers from the risks they face?"
The answer by honourable Minister of Health and Family Welfare revealed
the details of compensation paid in clinical trial related cases of SAEs of deaths. The data is being reproduced for your information.
|
SN
|
Name
of the Sponsor
|
Drug
Name
|
Compensation
amount
|
|
2013
| |||
|
1.
|
M/s Johnson
& Johnson
|
Epoetin Alfa
|
Rs. 4,00,000
|
|
2.
|
M/s Fortis Escorts Heart
Hospital
|
Taxus element
(Xience Prime)
|
Rs. 16,00,000
|
|
3.
|
M/s Fortis Escorts Heart
Hospital
|
Taxus element
|
Rs. 8,00,000
|
|
4.
|
M/s Reliance
Life Science
|
Bevacizumab
|
Rs. 5,16,600/-
|
|
5.
|
M/s Reliance Life Science
|
Bevacizumab
|
Rs. 5,45,700/-
|
|
6.
|
M/s Reliance Life Science
|
R-TPR-017 (Rituximab)
|
Rs.
10, 91,400/-
|
|
7.
|
M/s Boehringer Ingelheim
|
Afatinib
|
Rs. 5,16,600/-
|
|
8.
|
M/s PPD
|
KIACTATM
|
Rs. 20,07,900/-
|
|
9.
|
M/s Fortis
|
Drug eluting stent (Xience Prime)
|
Rs. 8,00,000/-
|
|
10.
|
M/s Fortis
|
Drug eluting stent (Taxus Element)
|
Rs. 8,00,000/-
|
|
11.
|
M/s Amgen
|
Darbepoetin
|
Rs. 4,00,000/-
|
|
12.
|
M/s Astellas
|
Tacrolimus
|
Rs. 34,10,200/-
|
|
13.
|
M/s Max Neeman
|
Drug Eluting Stent
|
Rs.
9,24,600/-
|
|
14.
|
M/s Piramal
|
PL225B
|
Rs. 8,20,600/-
|
|
15.
|
M/s Amgen
|
Darbepoetin alfa
|
Rs. 5, 74,400/-
|
|
16.
|
M/s Fortis
|
Drug Eluting stent
|
Rs.
21,82,800/-
|
|
17.
|
M/s Reliance Life Science
|
Bevacizumab
|
Rs.
5,45,700
|
|
18.
|
M/s Roche
|
Gemicitabin
|
Rs. 6,43,300/-
|
|
19.
|
M/s Quest Life Sciences
|
Doxorubicin
|
Rs. 13,64,200/-
|
|
20.
|
M/s Amgen
|
Darbepoetin Alfa
|
Rs. 4,00,000/-
|
|
21.
|
M/s Reliance
|
R-TPR-023
|
Rs. 6,16,242
|
|
22.
|
M/s
George Clinical India Pvt Ltd.
|
Aleglitazar
|
Rs.1,00,000
|
|
23.
|
M/s Biocon
|
Bmab200
|
Rs. 2, 79,635
|
|
24.
|
M/s Biogen
|
PEGylated Interferon
Beta-1a (BIIBo17)
|
Rs. 3,00,000
|
|
25.
|
M/s OncoRx
|
Lucanthone or Placebo
|
Rs. 6,00,000
|
|
26.
|
M/s Reliance
|
R-TPR-017
|
Rs. 15,00,000
|
|
27.
|
M/s Piramal
|
P276-00
|
Rs. 1,65,606
|
|
28.
|
M/s Roche
|
Bevacizumab
|
Rs. 4,15,000
|
|
29.
|
M/s Quintiles
|
DU-176b
|
Rs. 1,34,000
|
|
30.
|
M/s Quintiles
|
DU-176b
|
Rs. 5,00,000
|
|
31.
|
M/s GSK
|
Ofatumumab + Fludarabine
|
Rs. 3,98,000
|
|
2014
| |||
|
32.
|
M/s Amgen
|
AMG 386 vs Placebo
|
Rs. 4,14,330
|
|
33.
|
M/s Novartis
|
Enalapril/CLCZ696/Placebo
|
Rs. 9,52,078
|
The data retrieved from: http://164.100.47.234/question/annex/234/Au906.docx
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