Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Serious Adverse Event

  • Processing of reports of  SAE cases (i.e. Appendix-XI), review, approval for payment of compensation in cases of related cases as per Schedule Y, Rule 122 DAB under Drugs & Cosmetics Rules 1945) 

  • Handling of Parliament questions and RTI queries related to SAEs. 

  • Conduct of GCP Inspections based on the documents / information submitted for reporting of SAEs etc. 

  • Review & action taken in respect to GCP inspection reports (Show-cause notice, response of show-cause notice, warning, debarment, suspension etc.) 

  • Data-base management (receipts/files/other misc. data including Related  and not related orders, maintenance of guard files, parliament questions answered etc.)

Currently there is no data is available.

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  • Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2024 2024-Jan-12
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  • Details of clinical trial Permissions of Year 2021 2023-Mar-15
  • Details of clinical trial Permissions of Year 2022 2023-Mar-15
  • Details of Importers whose permissions have been suspended / cancelled 2020 2023-Mar-15
  • Details of Importers whose permissions have been suspended / cancelled 2021 2023-Mar-15
  • Details of Importers whose permissions have been suspended / cancelled 2022 2023-Mar-15
  • Details of Manufacturers whose permissions have been suspended / cancelled 2020 2023-Mar-15
  • Details of Manufacturers whose permissions have been suspended / cancelled 2021 2023-Mar-15
  • Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2020 2023-Mar-15
  • Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2021 2023-Mar-15
  • Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2023 2023-Jan-20
  • Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2022 2022-Feb-17
  • SOP Guidance for import of vaccine by private sector or any person 2021-May-04
  • Month wise Tentative schedule of SEC (Vaccine) meetings of the year 2021 2021-Jan-01
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  • Notice regarding Online application for Human Vaccines on Sugam 2017-Feb-06
  • Presentation for Rabies Vaccine 2016-Sep-08
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