The document outlines regulations related to compensation for injury or death in clinical trials and studies involving new drugs. It stipulates the responsibilities of sponsors for medical management and financial compensation for affected subjects, detailing criteria for assessing compensation amounts based on various factors, including the severity of injury and loss of wages. The rules also establish procedures for reporting serious adverse events and calculating compensation based on defined formulas.

2. 1. Short title, commencement and applicability
2. Definitions
3. 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.
TOPICS
4.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. 1. Short title, commencement and applicability
(1) These rules may be called the New Drugs and Clinical Trials Rules, 2019.
(2) They shall come in to force from the date of their publication in the Official Gazette
,except Chapter IV which shall come in to force after one hundred and eighty days.
(3) They shall apply to all new drugs, investigational new drugs for human use, clinical trial,
bioequivalence study, bioavailability study and Ethics Committee.
2. Definitions
(1) “Clinical trial” in relation to a new drug or investigational new drug means any
systematic study of such new drug or investigational new drug in human subjects
to generate data for discovering or verifying its
(i) clinical or;
(ii) pharmacological including pharmacodynamics, pharmacokinetics or;
(iii) adverse effects,
with the objective of determining the safety, efficacy or tolerance of such new drug
or investigational new drug

4. (2) “Bioavailability study” means a study to assess the rate and extent to which the drug is
absorbed from a pharmaceutical formulation and becomes available in the systemic
circulation or availability of the drug at the site of action.
(3) “Bioequivalence study” means a study to establish the absence of a statistically
significant difference in the rate and extent of absorption of an active ingredient from a
pharmaceutical formulation in comparison to the reference formulation having the same
active ingredient when administered in the same molar dose under similar conditions.
(4) “Bioavailability and bioequivalence study centre” means a centre created or
established to undertake bioavailability study or bioequivalence study of a drug for either
clinical part or for both clinical and analytical part of such study
(5) “Medical management” means treatment and other necessary activities for providing
the medical care to complement the treatment
(6) “Adverse event” means any untoward medical occurrence (including a symptom or
disease or an abnormal laboratory finding) during treatment with an investigational drug or
a pharmaceutical product in a patient or a trial subject that does not necessarily have a
relationship with the treatment being given

5. (7) “Serious adverse event” means an untoward medical occurrence during clinical
trial resulting in death or permanent disability, or hospitalisation of the trial subject
where the trial subject is an outdoor patient or a healthy person, prolongation of
hospitalisation where the trial subject is an indoor-patient, persistent or significant
disability or incapacity, congenital anomaly, birth defect or life threatening event.

7. 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.

8. 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

9. 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

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

11. SAE Occurrence
Investigator
Within 24 hrs of occurrence report to
ECSponsor
Within 14 days of knowledge
of occurrence
Head of
Institute
DCGI
Within 30 days of receiving the report,
opinion &recommendation of
compensation
Sponsor/Representative
Pay the compensation to
subject & report to DCGI
Within 60 days of the
receipt of report
(recommendation &
financial compensation)
Within 90 days of receipt of report of SAE order will
be passed
Within 30 days
A Cases of serious adverse events of deaths
Expert
Committee
Sponsor/Representative
If SAE not related to Drug If SAE related to Drug
Within 90 days of receipt of report of SAE
order will be passed
Independent reports from
Sponsor & Investigator

12. SAE Occurrence
Investigator
Within 24 hrs of occurrence report to
ECSponsor
Within 14 days of reporting
of SAE
Head of
Institute
DCGI
Within 30 days of receiving the report,
opinion &recommendation of
compensation
Sponsor/Representative
Pay the compensation to
subject & report to DCGI
Within 60 days of the
receipt of report
(recommendation &
financial compensation)
Within 90 days of receipt of report of SAE order will
be passed
Within 30 days
A Cases of serious adverse events of permanent disability or any other injury other than deaths
Expert
Committee
(Wherever it consider
necessary)
Sponsor/Representative
If SAE not related to Drug If SAE related to Drug
Within 90 days of receipt of report of SAE
order will be passed
Independent reports from
Sponsor & Investigator

13. 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.

15. 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.

16. 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.

19. 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.

20. (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.
• 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.

21. (iii) Chronic life-threatening disease and (iv) Reversible SAE in case it is
resolved.
•Would be linked to the number of days of hospitalisation 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