Online submission of SAE reports through SUGAM portal

Online submission of SAE reports through SUGAM portal

The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame. CDSCO, through the SUGAM portal, started the process of electronic submissions of clinical trial applications. Electronic submissions make the submission process hassle-free. It also enables the easy tracking of applications. The latest development in the space of e-governance is the launch of a software for the online submission of SAE reports. On February 25, 2021, CDSCO released a notice requesting all stakeholders involved in clinical trials for the online submission of SAE reports through the SUGAM portal ( from March 14, 2021. CDSCO will not accept physical/offline files of SAE reports for processing from March 14, 2021. The online submission of SAE reports is expected to reduce the time and transaction cost. To enable a smooth transition to the online platform, CDSCO has developed a user manual and video tutorial, which is now available on the CDSCO website. To report SAE on the SUGAM portal, the sponsor will have to follow a set of steps to fill up the database and for proper linking of data. All steps have been explained in the user manual with the help of screenshots for ease of understanding. It should be noted that the follow-up reports of SAE reports which are already submitted can be continued to be submitted in offline mode.

Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

FORM MD-24 is an application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device.

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

The clinical performance evaluation shall be initiated within a period of one year from the date of grant of permission.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

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