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Date: 2021-02-25 Category: Not Applicable State: Union Government Country: India

Notice issued by DCG(I) regarding implementation of SUGAM Online system for reporting of SAE's

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The Central Drugs Standard Control Organization (CDSCO) mandates online submission of Serious Adverse Event (SAE) reports via the SUGAM portal, effective March 14, 2021.
  • Physical or offline submissions of SAE reports will no longer be accepted for processing from this date.
  • Follow-up reports for SAEs already submitted can continue to be submitted offline.

Key Changes

  • Effective March 14, 2021, all new Serious Adverse Event (SAE) reports must be submitted online through the SUGAM portal (www.cdscoonline.gov.in).
  • Physical or offline submissions of new SAE reports will not be accepted after March 14, 2021.
  • This directive is based on “The New Drugs and Clinical Trials Rules, 2019”, specifically Rule 42, which outlines the reporting requirements for SAEs.
  • The SUGAM portal, launched on November 14, 2015, has been updated with software to facilitate online SAE reporting.
  • Follow-up reports of previously submitted SAE reports will continue to be accepted in offline mode.

Impact Analysis

Sponsors/CT-NOC Holders

  • Action Item: Train relevant staff on the SUGAM portal and the new SAE reporting process. Update internal SOPs to reflect the new online submission requirement.

Investigators

  • Action Item: Review the user manual and video tutorial available on the CDSCO website. Coordinate with Sponsors/CT-NOC holders to ensure seamless reporting.

Ethics Committees

  • Action Item: Update internal procedures for reviewing SAE reports submitted via the SUGAM portal. Ensure committee members are trained on accessing and reviewing online submissions.

CDSCO

  • Action Item: Monitor the SUGAM portal for performance and user feedback. Provide ongoing support and training to stakeholders as needed.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. SUGAM Portal: An e-governance portal (www.cdscoonline.gov.in) launched by CDSCO to provide online services related to drug regulation. The New Drugs and Clinical Trials Rules, 2019: A set of rules governing the regulation of new drugs and clinical trials in India. Rule 42 specifically addresses the reporting of Serious Adverse Events (SAEs). Investigator: A person responsible for the conduct of the clinical trial at a trial site. Sponsor/CT-NOC Holder: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. Ethics Committee: An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial. Serious Adverse Event (SAE): Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
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File No.CT/SAE-Misc-10/2020-Part.B F.No.CT/SAE-Misc-10/2020 Government of India Directorate General of Health Services Central Drugs Standard Control Organization (Medicines Safety Monitoring Division) FDA Bhawan, Kotla Road,New Delhi-110002. NOTICE As per “The New Drugs and Clinical Trials Rules, 2019”, Investigator, Sponsor/CT-NOC Holder and Ethics Committee shall report all Serious Adverse Events (SAE’s)to the Central Licensing Authority within a prescribed time bound manner as specified in Rule 42 of the said rules. The CDSCO, in pursuance to implementation of the e-Governance has launched various online services through the portal “SUGAM” (www.cdscoonline.gov.in) on14.11.2015. In the latest phase, the development of software for online submission of SAE reports has been completed and the stakeholders are requested to avail this facility which is intended to further reduce the time and transaction cost. Therefore, it is now decided that it will be effective from 14.03.2021, 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. User manual and video tutorial for SAE reporting on SUGAM portal is available on CDSCO website. (Dr. V.G. Somani) Drugs Controller General (India) To, All concerned stakeholders involved in Clinical Trials. Copy to: CDSCO IT cell for uploading in CDSCO website. Copy for information to: PS to JS (Drugs Regulation), Ministry of Health and Family Welfare, Nirman Bhavan, New Delhi

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