CDSCO moves towards online SAE reporting system

India’s Central Drugs Standard Control Organisation (CDSCO) has released a notice informing sponsors that they will soon be required to file Serious Adverse Event (SAE) reports electronically via the Sugam online portal from 14 March.

Following the Indian government’s implementation of The New Drugs and Clinical Trials Rules, 2019, SAEs are required to be reported to the Central Licensing Authority (CLA). SAE reporting is subject to time-based requirements that determine the period within which they should be submitted by the investigator to the CLA. The move to an online reporting system will help facilitate investigators, sponsors and ethics committee’s in carrying out their reporting duties.

This development is also aimed at reducing the time and transaction costs of managing SAE reports. Whilst physical reports may no longer be accepted once the new system is fully operational, companies can still provide physical follow-ups for events that are already in the system.

Resources such as a user manual to help users acclimatise with the new reporting system can be found on the CDSCO website.

To read the notice in full, click here.