COMPENSATION & LIABILITY FOR MERCY DEBORAH

DRUG-RELATED INJURIES IN PROFESSOR

JGLS, SPRING 2023
INDIA DPRI Elective
 LEGAL FRAMEWORK IN INDIA
I. DRUGS & COSMETICS ACT, 1940
II. DAC RULES, SCHEDULE Y, APPENDIX XII Read
III. Formulae to Determine the Quantum of Compensation
in the Cases of Clinical Trial related Serious Adverse
Events of Deaths occurring during Clinical trials (CDSCO,
2013) Read
IV. Formulae to Determine the Quantum of Compensation
in the Cases of Clinical Trial related Serious Adverse
Events of Injury Other than deaths occurring during
Clinical trials (CDSCO, 2014) Read
V. OTHER REMEDIES
 CATEGORIES OF COMPENSATION
I. DEATH-RELATED CLAIMS
II. PERMANENT INJURIES
III. TEMPORARY INJURIES
DAC RULES, 1945: RULE 122 DAB [2013]
DAC RULES, 1945, RULE 122 DAB
DAC RULES, 1945,RULE 122 DAB
DAC RULES, 1945, RULE 122 DAB
FAILURE TO COMPENSATE
DAC RULES, 1945: RULE 122 DAB
APPENDIX XII, SCHEDULE Y, DAC RULES, 1945
INC. BY GSR 30-01-2013
•INJURY [RULES 1-2]
•DEATH [RULE 3]
•FINANCIAL COMPENSATION [RULE 4]
•SPONSOR [RULE 5]
•PROCEDURE [RULE 6]
 COMPENSATION FOR DEATH OR INJURY
I. Where an injury occurs during a clinical trial but later it
is established that the injury is not related to the clinical
trial, then in such cases free medical management shall
be provided to the subject till such time it is established
that there is no causal connection between the injury
and the clinical trial [RULE 122DAB(1)]
II. Where an injury to a trial subject is proved related to
the clinical trial, then such subject shall be entitled to
financial compensation over and above any expenses
incurred on medical management of the subject. [RULE
122DAB(2)]
 COMPENSATION FOR DEATH OR INJURY
III. Where there is no permanent injury, the quantum of
compensation shall be equated with a non-permanent
injury and the subject is to be compensated for loss of
wages.[RULE 122DAB(1)]
IV. In case of death of the subject, the nominee(s) shall be
entitled to financial compensation over and above any
expenses incurred on medical management of such
subject. [APPENDIX XII, SCH. Y, DAC RULES]
 PROCEDURE FOR FINANCIAL COMPENSATION
ITEM 6, APPENDIX XII, SCHEDULE Y, DAC RULES, 1945
A. COMPENSATION FOR SAEs CAUSING DEATH
• Reporting by Investigator/Company: 24 hours
• Submission of report by EC: 14 days
• Final Report to Licensing Authority: 30 days
• Quantum of compensation: 150 days
B. COMPENSATION FOR SAEs CAUSED OTHER THAN DEATH
• Quantum of compensation: 150 days (Licensing
Authority)
• Payment of compensation: 30 days (Sponsor)
APPENDIX XII, SCHEDULE Y, DAC RULES, 1945
PROCEDURES
1. Investigator to report SAE within 24 hours to Licensing
Authority.
2. Independent Expert Committee to be constituted in to
examine and recommend to LA about cause and
compensation.
3. Sponsor and investigator to send complete report of SAE
to Ethics Committee within 14 days of event.
4. EC to forward its report to LA after due analysis within 30
days of event.
APPENDIX XII, SCHEDULE Y, DAC RULES, 1945
PROCEDURES
5. LA to forward such report to Expert Committee which
shall examine and make recommendations about the SAE
within 105 days of the events.
6. In case of death, the Expert Comm can also recommend
quantum of compensation.
7. The LA will finally decide to accept or modify the
recommendations of the Expert Comm and dispose the
matter within 150 days of the AE.