Following the amendment in the Drugs & Cosmetics (D&C) Rules, inserting a Rule 122DAB empowering the DCGI to determine the quantum of compensation in clinical trial related injuries and deaths in the country, the Central Drugs Standard Control Organisation (CDSCO) has introduced a system of pre-screening of Serious Adverse Events (SAEs) reports at the time of receiving these reports by the CDSCO.

This system of preliminary screening to determine the acceptability of the SAE report has come into effect from February 18, 2013. The main objective of introducing this system is to streamline the submission of reports of SAEs.

The pre-screening system or the preliminary scrutiny of the SAE reports will be done by CDSCO officers based on laid down checklist. During the preliminary examination, the CDSCO officers will scrutinize the SAE reports to ensure that it contains all the required administrative as well as technical information in proper manner as per the checklist. If SAE reports are not submitted in accordance with the format and the checklist, it will not be accepted by CDSCO for further examination.

Once a report of SAE is accepted, the information in the report will be reviewed by CDSCO as per the specified procedures. The sponsor or his representative conducting clinical trials in India are requested to prepare the SAE reports for submission to CDSCO as per appendix-XI of schedule-Y of D&C Rules and as per the checklist.

The SAE reports must be submitted with proper binding, indexing and page number. Without indexing of page number, no SAE report will be accepted. The reports of SAEs of deaths should be prepared and submitted in red cover and the reports of SAE of injury other than deaths should be prepared and submitted in blue cover. Other SAE reports should be prepared and submitted in white cover.

Earlier, the government had amended the D&C Rules, specifying the detail procedures for analysis of SAEs including deaths occurring during clinical trial to arrive at the cause of death/ injury to the subject, as the case may be, and to determine the quantum of compensation, if any to be paid by the sponsor or his representative whosoever have obtained permission from CDSCO in a time bound manner.

As per the provisions, each SAE including death is required to be examined and decision regarding causality of death and quantum of compensation, if any, is required to be taken by CDSCO in a time bound manner as per the procedure specified in Appendix XII of schedule Y.

As per Appendix XII the Investigator shall report all serious and unexpected adverse events to the CDSCO, the Sponsor or his representative whosoever had obtained permission from the CDSCO for conduct of the clinical trial and the Ethics Committee, within twenty four hours of their occurrence.

In case of serious adverse events of death, the reports shall be examined by an independent Expert Committee constituted by DCG(I) to determine if the cause of death is due to following reasons, which are considered as clinical trial related death and gives its recommendation to CDSCO. In case of clinical trial related death the committee shall also recommend the quantum of compensation to be paid by the sponsor or his representative, to CDSCO.