Procedure for payment of financial compensation

THE PROCEDURE FOR REPORTING SAE TO THE LICENSING AUTHORITY (DCGI) IN INDIA VARIES FOR CASE OF DEATH AND FOR CASE OTHER THAN DEATH


(A) the investigator shall report all serious and unexpected adverse events to the 

• Licensing Authority as defined under clause(b) of rule 21, the sponsor or his REPRESENTATIVE
• The sponsor of his representative whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial
• Ethics Committee that accorded approval to the study protocol,

Within 24 hours of their occurrence as per Appendix XI

IN CASE OF SAE OF DEATH
(B ) (i) the cases of serious adverse events of deaths shall be examined as under

• An independent expert committee shall be constituted by the Licensing Authority as defined under rule 21 (b) to examine cases and recommend to the licencing authority for the purpose of arriving at the cause of death and quantum of compensation in case of clinical trial related death.

• The Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conducting thd clinical trial, and the investigator shall forward their reports on SAE of death after due analysis to 

1. (a) Chairman of the Ethics committee
2. (b) Chairman of the Expert committee 
3. (c) with a copy of the report to licensing authority as defined under rule 21 (b) and 
4. (d) the head of the institution where the trial has been conducted

With in 10 calendar days from the occurrence of the SAE

• The ethics committee shall forward it's report on serious adverse event of death after due analysis along with its opinion on financial compensation, if any , to be paid by the Sponsor to his representative, whosoever had obtained permission from Licencing authority within 21 calendar days of the occurrence of SAE.

• The expert committee shall examine the report of SAE of death and give it's recommendations to the Licensing Authority for the purpose of arriving at the cause of the adverse event within 30 days of receiving the report from ethics committee while examining the event, may tak into consideration, the reports of the Investigator,  sponsor or his representative whosoever had obtained permission from the Licensing Authority for conducting the clinical trial.

• In case of clinical trial related death, the expert committee shall also recommend the quantum of compensation to be paid by the Sponsor of his representative whosoever had obtained permission from the Licensing Authority as defined under rule 21(b) for conducting the clinical trial

• The licensing authority shall consider the recommendations of the Expert committee and shall determine the cause of death and pass orders as deemed necessary.

• In case of clinical trial related death, the Licensing Authority, after considering the recommendations of the expert committee, shall decide the quantum of compensation to be paid by the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conducting the clinical trial and shall pass orders as deemed necessary within three months of receiving the report of the serious adverse event.

IN CASE OF SAE OTHER THAN THAT OF DEATH

• The Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conducting thd clinical trial, and the investigator shall forward their reports on SAE  after due analysis to 

1. (a) Chairman of the Ethics committee
2. (B) licensing authority as defined under rule 21 (b) and 
3. (d) the head of the institution where the trial has been conducted

     Within 10 calendar days of occurrence of the SAE

• The ethics committee shall forward it's report on serious adverse event after due analysis along with its opinion on financial compensation, if any , to be paid by the Sponsor to his representative, whosoever had obtained permission from Licencing authority within 21 calendar days of the occurrence of SAE.

• The licensing authority shall determine the cause of injury and pass orders as deemed necessary. The licensing authority shall have the option to constitute an independent expert committee, wherever considered necessary, to examine such serious adverse Events of injury,  which will recommend to the licencing authority for arriving at the cause of the injury and also the quantum of compensation in case of clinical trial related injury to be paid by the Sponsor or his representative whosoever had obtained permission from the Licensing 6 as defined under rule 21 (b) for conducting the clinical trial.

• In case of clinical trial related injury the licensing authority shall decide the quantum of compensation to be paid by the Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial and shall pass the order as deemed necessary within three months of receiving the report of the SAE.

APPLICABLE FOR ANY SAE

The Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial shall pay the compensation in case of clinical trial related injury or death as per the order of the licensing authority as defined under rule 21 (b) within 30 days of receipt of this order.