The Central Drugs Standard Control Organization (CDSCO) has moved to tighten up requirements for reporting serious adverse events (SAEs) that occur during clinical trials conducted in India.
The draft guidance for industry issued by the CDSCO, part of the Drugs Controller General (India), is an attempt to reiterate and standardise the existing requirements for SAE reporting from clinical trials included in Appendix XI of India’s Schedule Y regulations.
It comes amid persistent concerns that ethical and other standards for clinical trials in India have not kept pace with the rapid growth in outsourcing of drug development to the country.
As the CDSCO notes in its draft guidance on Reporting Serious Adverse Events Occurring In Clinical Trials, which was published on 11 May with a 15-day comment period, pharmaceutical companies and contract research organisations (CROs) operating in India currently use a number of different formats and procedures for reporting SAEs to the CDSCO.
Although most of these reports comply with Appendix XI of the Schedule Y regulations, “multiple formats and missing information, including improper referencing for submission of follow-up reports, have led to difficulties in segregation and further processing of these reports by this office”, the CDSCO says.
In response, the organisation put together the guidance document with the aim of achieving “uniformity and completeness of data received by this office with respect to SAE reporting in clinical trials”.
Among the specifications in the draft guidance are that:
- All unexpected SAEs must be reported to the CDSCO within 14 calendar days, as per the Schedule Y regulations.
- Each SAE report (both initial and follow-up) needs to be filed with a covering letter following the template set out in Annex II of the draft guidance.
- The report must include a causality assessment by the trial investigator and the medical monitor of the sponsor/CRO, stating clearly whether or not the SAE that occurred is related to the pharmaceutical product under investigation.
- It must also include details of any compensation provided for injury or death in the trial; in cases where no compensation is paid, the SAE report should explain the reasons for not doing so.