The document discusses compensation guidelines for injuries or deaths that occur during clinical trials in India. It outlines the following key points: 1. As per Drug and Cosmetics Rules, subjects injured during a trial are entitled to financial compensation above medical expenses to be paid by the trial sponsor. 2. An independent expert committee evaluates serious adverse events and deaths to determine the cause and compensation amount. 3. Formulas have been developed to calculate compensation for deaths based on the subject's age and health, and for disabilities based on percentage of disability. 4. Compensation for life-threatening diseases is linked to hospitalization days, and compensation for birth defects is also based on the severity of outcome and need for

1. Compensation Given In
Clinical Trail
 Presented By : Neha Singh
M.pharm 1st year
Clinical Research

2.  As per rule 122 DAB of drug and cosmetics rule
1945, in case of clinical trial related injury other
than death, the trial subject is entitled to pay for
financial compensation. The sponsor or his
representative is required to pay the financial
compensation as per the order of DCGI. As per the
rule, the financial compensation will be over and
above the expenses incurred on the medical
management of the trial subject.
 The appendix X11 of schedule Y of D&C rules
prescribes the procedure for processing the report
of the serious adverse events including the death
to arrive at the cause of death/injury to the subject
and to decide the quantum of the compensation.

3.  The independent expert committee constituted for
examination od sae of death has already devised a
formulae being followed for determining the
quantum of compensation in case of clinical trail
related death.
 Another committee was constituted in march 2014
under the chairmanship of shri R.K Jain, the
additional secretory and director general (CGHS),
ministry of health & family welfare, government of
India to deliberate and work out a formulae to be
followed to determine the quantum of
compensation in case of clinical trial related injury.

4. Compensation formulae
(clinical trial)
 As per the rule , the financial compensation will be
over and above the expenses incurred on the
medical management of the trial subject.
 In case of clinical trial related sae of death, the
DCGI will decide the quantum of compensation
after considering the recommendation of
independent expert committee constituted for the
purpose.
 The DCGI will decide the quantum of
compensation considering the report of the
investigator, sponsor, and the ethics committee .

5.  Formulae to determine the quantum
of compensation in the case of
clinical trail related serious adverse
events of injury other than deaths
occurring during clinical trial :
 The independent expert committee constituted for
examination of SAE of deaths has already devised
a formulae to determine the compensation in case
of clinical trail related death i.e.
COMPENSATION=(B*F*R)/99.37

6. Where, B = Base amount (i.e. 8 lacs)
F = Factor depending on the age of the
subject
R = Risk Factor depending on the
seriousness and severity of the disease, presence of
co-morbidity and duration of disease of the subject at
the time of enrolment in the clinical trial between a
scale of 0.5 to 4 as under ,
• Terminally ill patient (expected survival not more
than (NMT) 6 months)
• Patient with high risk (expected survival between 6
to 4 months)
• patient with moderate risk.
• patient with mild risk
• Healthy Volunteers or subject of no risk

7.  However, in case of patients whose expected mortality is 90
% or more within 30 days, a fixed amount of Rs. 2 lacs should
be given.
 The apex committee and the technical committee in its first
meeting held on 4,marcg,2014, discussed various criteria that
could be considered to determine the quantum of
compensation in clinical trial related SAE.
 The committee opened the for calculation of quantum of
compensation in such cases the guiding principle may be
linked to the criteria considered for calculation of
compensation in case of death .
 Considering the definition of SAE, following squeal other than
death are possible in a clinical trail subject , in which the
subject shall be entitled for compensation in case the SAE is
related to clinical trail.
1. A permanent disability
2. Congenital anomaly or birth defect
3. Chronic life-threating disease or
4. Reversible SAE in case it is resolved

8. 1. In case of permanent disability :
The quantum compensation in case of 100% disability
should be 90% of the compensation which would have
been due for payment to the nominee in case of death of
the subject. The quantum for less than 100% disability will
be proportional to the actual percentage disability the
subject has suffered.
Accordingly, committee arrived at the following formula:
COMPENSATION=(C*D*90)/(100*100)
Where, D= percentage disability the subject has suffered.
C=quantum of compensation which would have
been due for payment to the subject’s nominee in case of
death of the subject.

9. 2. In case of SAE causing life-threating disease :
The quantum of compensation should be linked to
the number of days of hospitalization of the subject.
The compensation per day of hospitalisation should
be equal to the wage loss. The wage loss per day
should be calculated based upon the minimum wage
of the unskilled worker.
Accordingly, the committee arrived the following
formula,
COMPENSTION=2*W*N
Where, W= minimum wage per day of the unskilled
worker(in Delhi)
N= number of days of hospitalization

10. 3. In case of SAE causing of congenital
abnormality or birth defects
 The committee opined that the congenital
abnormality or birth defects in a baby may occur
due to participation of any one or both the parents
in clinical trial. Following situations may arise due
to congenital abnormality or birth defects.
1. Still birth
2. Early death due to abnormality
3. No death but deformity which can be fully
corrected through appropriate intervention.
4. Permanent disability(mental or physical)

11.  In case of birth defects leading to (c) and (d) above
to any child, the medical management as long as
required would be provided by the sponsor or his
representative which will be over and above the
financial compensation.
Accordingly, following formula is recommended
COMPENSATION=2*W*N
Where, W = min wages per day of workers
N = no of days of hospitalization

12. Thank you