The Centre is planning to further modify the newly added clause 122 DAB of the Drugs and Cosmetic (D&C) Rules, 1945 to further relax the norms on compensation in the case of injury or death during the clinical trials. The timeline for reporting the serious adverse events will also be modified in line with the international practices.
This is being done in accordance with the recommendations by a technical committee set up by the Ministry of Health and in the wake of apprehensions raised by different stakeholders, after the Government introduced the rule and added an appendix in Schedule Y. The Apex Committee set up by the Ministry and headed by the Secretary, in the wake of a Supreme Court direction, has forwarded the changes and many of them were cleared by the Drug Technical Advisory Board (DTAB).
As per the clause (1) of rule 122 DAB, in the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required. The clause will be changed to specify that medical management will be provided in case the injury is due to clinical trial related activities only, as the free medical management may create undue influence for patient to enrol in a clinical trial.
Regarding the clause (2) of rule 122 DAB, the DTAB recommended that a qualifying clause may be further added in the sub-rule that in case there is no permanent injury, the quantum of compensation shall commensurate with the inconvenience, loss of wages and transportation.
Apart from modification in the compensation rules, the timeline for reporting the serious adverse events will also be changed. The requirements of sponsor and investigator to report the serious adverse events after due analysis in 10 days will be changed to 14 days while the timeline to be followed by the Ethics Committee to forward the reports along with their opinion on quantum of compensation will be 30 days, instead of 21 days stipulated now.
The independent expert committee will be given 60 days to examine the adverse events of death and recommend to the DCGI about the cause of death. At present, it is required to report to DCGI within 30 days.
The timelines for the DCGI to determine the cause of the injury or death and decide the quantum of compensation will be two months while there will not be any change in the timeline to pay the compensation (30 days).
This is being done in accordance with the recommendations by a technical committee set up by the Ministry of Health and in the wake of apprehensions raised by different stakeholders, after the Government introduced the rule and added an appendix in Schedule Y. The Apex Committee set up by the Ministry and headed by the Secretary, in the wake of a Supreme Court direction, has forwarded the changes and many of them were cleared by the Drug Technical Advisory Board (DTAB).
As per the clause (1) of rule 122 DAB, in the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required. The clause will be changed to specify that medical management will be provided in case the injury is due to clinical trial related activities only, as the free medical management may create undue influence for patient to enrol in a clinical trial.
Regarding the clause (2) of rule 122 DAB, the DTAB recommended that a qualifying clause may be further added in the sub-rule that in case there is no permanent injury, the quantum of compensation shall commensurate with the inconvenience, loss of wages and transportation.
Apart from modification in the compensation rules, the timeline for reporting the serious adverse events will also be changed. The requirements of sponsor and investigator to report the serious adverse events after due analysis in 10 days will be changed to 14 days while the timeline to be followed by the Ethics Committee to forward the reports along with their opinion on quantum of compensation will be 30 days, instead of 21 days stipulated now.
The independent expert committee will be given 60 days to examine the adverse events of death and recommend to the DCGI about the cause of death. At present, it is required to report to DCGI within 30 days.
The timelines for the DCGI to determine the cause of the injury or death and decide the quantum of compensation will be two months while there will not be any change in the timeline to pay the compensation (30 days).
Source:Pharmabiz
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