The Central Drugs Standard Control Organization (CDSCO) has directed all stakeholders involved in clinical trials (CT) for online submission of serious adverse event (SAE) reports through SUGAM portal (www.cdscoonline.gov.in) to reduce time and transaction cost.
In order to implement e-governance effectively, the CDSCO has
launched various online services through the SUGAM portal (www.cdscoonline.gov.in) on November 14, 2015.
In the latest phase, the development of software for online submission of SAE reports has been completed and stakeholders are requested to avail this facility towards effective time management and optimize transaction cost.
“It has now been decided that the same will be effective from March 14, 2021 and from this date physical / offline files of SAE reports may not be accepted for processing. However, follow up reports of the already submitted SAE reports shall be continued to be submitted in offline mode,” according to Drugs Controller General of India Dr V G Somani.
As per “The New Drugs and Clinical Trials Rules, 2019”, investigator, sponsor / CT-NOC Holder and ethics committee shall report all SAE’s to the Central Licensing Authority (CLA) within a prescribed time bound manner as specified in Rule 42 of the said rules.
SUGAM is an e-Governance system to discharge various functions performed by CDSCO under the Drugs and Cosmetics (D&C) Act, 1940.
The software system developed is an online web portal where applicants can apply for NOCs, licenses, registration certificates, permissions and approvals.
It provides an online interface for applicants to track their applications, respond to queries and download the permissions issued by CDSCO.
It also enables CDSCO officials to process the applications online and generate the permissions online and generate MIS reports.
It contains step-by-step guidance to the applicants of the SUGAM portal with screenshots of the workflow for various application submissions.
Following sections which are detailed in Sugam are User Registration and Login, Applicant Dashboard, Managing Sub login Accounts, Form Submission for various processes and Post Approval Changes.
Applications were made in hard copy dossier format to various divisions in CDSCO before the Sugam portal was introduced.
The timelines for granting permissions or approvals for applications were almost three times more than what is there in the current scenario.