The Central Drugs Standard Control Organization has issued notice for clarification of online submission of SAE reports. The CDSCO, in pursuance to implementation of the e-Governance has launched various online services through the portal “SUGAM”. In the latest phase, the development of software for online submission of SAE reports has been completed.
CDSCO clarifies that follow up reports of the already submitted SAE reports shall be continued to be submitted in offline mode. User manual and video tutorial for SAE reporting on SUGAM portal is available on CDSCO website.