Compensation to the Injured patients in Clinical Trails

1. NEW DRUGS AND CLINICAL TRIALS,2019
CHAPTER VI
&
SEVENTH SCHEDULE
Prepared by: Sri Harsha Chennapragada

2. CHAPTER VI-
COMPENSATION
39.Compensation in case of injury or death in clinical trial or BA/BE
study of new drug or investigational new drug.
40. Medical Management in clinical trial or BA/BE study of new drug or
investigational new drug
41. Consideration of injury or death or permanent disability to be
related to clinical trial or BA/BE Study
42. Procedure for compensation in case of injury or death during
clinical trial, BA/BE Study
43. Medical management and compensation for injury or death
Seventh Schedule:– Formulae to determine the quantum of
compensation in the cases of clinical trial related injury or death
1. Formula in case of clinical trial related death
2. Formula in case of clinical trial related injury (other than death)

3. Rule 39.
Compensation in case
of injury or death in
clinical trial or
bioavailability
bioequivalence study
of new drug or
investigational new
drug
 In any death/permanent disability/injury, financial compensation
should be provided by the sponsor/representative to the subject /
Subject’s legal heir (as appropriate). This shall be in addition to any
expense incurred on subject’s medical management.
 In the event of an injury, not being permanent in nature, the
quantum of compensation shall be commensurate with the loss of
wages of the subject as provided in the Seventh Schedule.
 The sponsor or its representative shall give an undertaking along
with the application for clinical trial permission to the DCGI to
provide compensation for which subjects are entitled to
compensation.
 If fails to provide financial compensation, the DCGI after giving an
opportunity of being heard , suspend or cancel the permission to
conduct clinical trial or BA/BE study for appropriate period

4. Rule 40. Medical
Management in
clinical trial or
bioavailability and
bioequivalence study
of new drug or
investigational new
drug
 Medical management to the injured subject shall be provided as
long as required as per the opinion of investigator or till such time
it is established that the injury is not related, as the case may be,
whichever is earlier
 The sponsor or the person who has obtained permission from the
DCGI is responsible for medical management of injured subjects.
 If Fails to provide medical management to the subject , after
affording an opportunity of being heard suspend or cancel/restrict
the sponsor including its representative/ other action as
considered appropriate

5. Rule 41.
Consideration of
injury or death or
permanent disability
to be related to
clinical trial or
bioavailability and
bioequivalence study
 Adverse effect of the investigational product
 Violation of the approved protocol/scientific
misconduct/negligence by the sponsor or his representative or the
investigator
 Failure of investigational product/ rescue medication should not be
provided to the subject as per clinical trial protocol.
 Not providing the required standard care in case the subject under
the placebo-controlled trial.
 AE due to concomitant medication excluding standard care.
 AE on a child in-utero

6. 42. Procedure for compensation in case of injury or
death during clinical trial, bioavailability and
bioequivalence study

9. 43. Medical
management and
compensation for
injury or death relating
to biomedical and
health research
overseen by an Ethics
Committee for
biomedical and health
research as referred to
in Chapter IV
 Overseen by an Ethics Committee for clinical trials as referred to in
Chapter IV/ accordance with the National Ethical Guidelines for
Biomedical and Health Research Involving Human Participants
specified by the Indian Council of Medical Research from time to
time.

10. SEVENTH SCHEDULE
Formulae to determine the quantum of compensation in the cases of clinical
trial related injury or death

11.  1. Formula in case of clinical trial related death:
Compensation = (B x F x R) / 99.37
Where,
B = Base amount (i.e. 8 lacs)
F = Factor depending on the age of the trial subject as per Annexure 1 (based on
Workmen Compensation Act)
R = Risk Factor depending on the seriousness and severity of the disease, presence of
co-morbidity and duration of disease of the trial subject at the time of enrolment in
the clinical trial.

14. RISK FACTOR (R)
 1. Risk factor shall be divided in a scale of 0.50 ,1.0, 2.0 , 3.0 & 4.0
 2. In case of patients whose expected mortality is 90% or more
within 30 days, a fixed amount of 2 lakh may be given.
 3. The five grade of the scale is divided as below:
(1) 0.5 terminally ill patient (expected survival not more than (NMT) 6
months)
(2) 1.0 Patient with high risk (expected survival between 6 to
24months
(3) 2.0 Patient with moderate risk
(4) 3.0 Patient with mild risk
(5) 4.0 Healthy Volunteers or trial subject of no risk

15. 2. Formula in case of
clinical trial related
injury (other than
death):
1. The quantum of compensation in case of Clinical Trial related SAE
should not exceed the quantum of compensation which would have
been due for payment in Case of death of the trial subject since the
loss of life is the maximum injury possible.
2. Following are the possible injury other than death are possible in
clinical trial subject:
(i) A permanent disability:
• The quantum of compensation in case of 100% disability shall be 90%
of the compensation which would have been due for payment to the
nominee (s) in case of death of the trial subject.
The quantum for less than 100% disability will be proportional to the
actual percentage disability the trial subject has suffered
Compensation = (C x D x 90) / (100 x 100)
W h e r e :
D = Percentage disability the trial subject has suffered.
C = Quantum of Compensation which would have been due for
payment to the trial subject's nominees) in case of death of the trial
subject.

16. (ii) Congenital anomaly or birth defect:
1. Participation of anyone or both the parent in clinical trial.
2. Following situations may arise due to congenital anomaly or birth defect.
(a) Still birth
(b) Early death due to anomaly
(c) No death but deformity which can be fully corrected through appropriate
intervention
(d) Permanent disability (mental or physical).
 The compensation in such cases would be a lump sum amount such that if that
amount is kept by way of fixed deposit or alike, it shall bring a monthly interest
amount which is approximately equivalent to half of minimum wage of the
unskilled worker (in Delhi).
 Quantum of compensation in such cases of SAE shall be half of the base amount
as per formula for determining the compensation for SAE resulting into death(B X
F X R).
 In case of birth defect leading to sub-clause (c) and (d) of this clause to any child,
the medical management as long as required shall be provided by the Sponsor or
his representative which will be over and above the financial compensation.

17. (iii) Chronic life-threatening disease and (iv)
Reversible SAE in case it is resolved
 Would be linked to the number of days of hospitalization of the trial subject.
 The compensation per day of hospitalization shall be equal to the wage loss.
 The wage loss per day shall be calculated based upon the minimum wage of the
unskilled worker (in Delhi).
Compensation = 2 X W X N.
Where,
W = Minimum wage per day of the unskilled worker (in Delhi)
N = Number of days of hospitalization

18. The Subsequent slides summarize the changes
brought in by the New Drugs and Clinical trial
rules,2019.
A comparison with previous regulatory
requirement(Chapter vi) is presented in tabular
form

19. Section/Rule/Subject New requirement/Understanding Previous requirement
Chapter vi-Compensation
Death Cases
Sponsor and Investigator to forward their reports
on SAE death case after due analysis of CLA, Head
of Institution with in 14 days of the knowledge of
occurrence of SAE Death
Sponsor and Investigator to forward their
reports on SAE death case after due analysis to
Licensing Authority, Head of Institution with in
14 days of the occurrence of SAE Death
EC to forward their reports on SAE death case
after due analysis along with their opinion on
financial compensation to CLA, with in 30 days of
receiving the report of the SAE Of death from
investigator
EC to forward their reports on SAE death case
after due analysis along with their opinion on
financial compensation to licencing authority,
with in 30 days of occurrence of the serious
adverse event of death
Expert Committee to provide their
recommendations to CLA with in 60 days from
receipt of the report of SAE Of death
Expert Committee to provide their
recommendations to CLA with in 105 days of
occurrence of the adverse event
CLA to pass order to sponsor with in 90 days of
receipt of the report of SAE
Licensing Authority to pass order to sponsor
with in 150 days of occurrence of SAE
Sponsor or its representative shall pay
compensation with in 30 days of receipt of such
order from CLA
Same timelines as earlier

20. SECTION/RULE
/SUBJECT
NEW REQUIREMENT/UNDERSTANDING PREVIOUS REQUIREMENT
Chapter vi-Compensation
Injury Cases
Sponsor and investigator to forward their reports on SAE
case after due analysis to CLA, Chairperson of EC, Head of
institution with in 14 days of the reporting of SAE.
Sponsor and investigator to forward their reports on SAE case
after due analysis to Licensing Authority, Chairperson of EC,
Head of institution with in 14 days of occurrence of SAE.
Ethics Committee to forward their reports on SAE after due
analysis along with their opinion on financial compensation,
with in 30 days of receiving the report of the Serious adverse
Event
Ethics Committee to forward their reports on SAE after due
analysis along with their opinion on financial compensation
to licensing authority, with in 30 days of occurrence of the
Serious adverse Event
CLA may constitute an expert committee to examine the
case and provide their recommendations to CLA. The
Committee shall provide its recommendation with in 60 days
of receipt of the report of SAE.
The Licencing authority shall have the option to constitute an
independence ethics Committee, wherever considered
necessary to examine such serious adverse events of injury,
which will recommend to the licensing authority for arriving
at the cause considered necessary, to examine such serious
adverse events of injury and also the quantum of
compensation in case of clinical trial injury
CLA to pass orders to sponsor with in 90 days of receipt of
report of the SAE
Licensing authority to pass orders to sponsor with in 150
days of occurrence of SAE
Sponsor or its representative shall pay compensation with in
30 days of receipt of such order from CLA
Same timelines as earlier