As part of further streamlining the clinical trials sector in the country, the CDSCO has framed guidelines for reporting serious adverse events occurring during the time of trials. The move is intended to bring in uniformity in the process as at present different pharmaceutical companies and contract research organisations are using multiple and different formats and procedures to report serious adverse events.

“Though most reports adhere to Appendix XI of Schedule Y, multiple formats and missing information, including improper referencing for submission of follow-up reports have lead to difficulties in segregation and further processing of these reports by the CDSCO. Hence, this guidance document has been developed to achieve uniformity and completeness of data received by this office with respect to SAE reporting in clinical trials,” according to the draft.

The adverse event has been defined as any untoward medical occurrence (including a symptom/disease or an abnormal laboratory finding) during treatment with a pharmaceutical product in a patient or a human volunteer that does not necessarily have a relationship with the treatment being given.

“An adverse event that is associated with death, in-patient hospitalisation (in case the study was being conducted on out-patients), prolongation of hospitalisation (in case the study was being conducted on in-patients), persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise life threatening,” the draft said.

All SAEs occurring in clinical trials should be reported as per the details provided in Appendix XI of Schedule Y (Annexure I) within the applicable timeline (14 calendar days), to, the Drugs Controller General (India). Pharmaceutical company/the sponsor/CRO (Investigator in investigator-initiated studies) is responsible for reporting SAEs within the applicable timelines, it said.

“As per the regulations (Schedule Y of Drugs & Cosmetics Rules), all Unexpected SAEs (serious adverse events) have to be reported to CDSCO within 14 calendar days. Every report (both initial as well as follow-up reports) should be submitted along with a covering letter. Unexpected SAEs have to be submitted to this office as per Schedule Y of Drugs and Cosmetics Rules, 1945. The assessment report should clearly mention whether the SAE occurred is related or not related (Situations like unlikely, possibly, suspected, doubtful etc. should not be used),” draft said.