Central Drugs Standard Control Organization

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

Serious Adverse Event

About SAE

Functionalities

  • 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.)

Processes

Currently there is no data is available.

Organogram

SAE Organo New

Guideline

S.no Title Release Date Download Pdf Pdf Size
1 GCP Inspection Checklist16 2018-Feb-09 261kb
S.no Title Release Date Download Pdf Pdf Size
1 Submission of PSUR 2018-Feb-09 529kb
2 System of Pre-screening for submission of reports of SAEs to CDSCO 2017-Feb-17 255 KB
3 Draft Guidance For Industry On Requirement Of Chemical & Pharmaceutical Information Including Stability Study Data Before Approval Of Clinical Trials / BE Studies 2017-Feb-17 2599 KB
4 Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Deaths Occuring During Clinical Trials 2017-Feb-17 310 KB
5 Panel of Experts for examination of reports of Serious Adverse Events (SAEs) of Deaths 2017-Feb-17 667 KB
6 System for the Pre - Screening of the applications for registration of Ethics Committee 2017-Feb-17 206 KB
7 Monitoring of Clinical Trials - regarding 2017-Feb-17 397 KB
8 GCP inspection Checklist 2017-Feb-17 261 KB
9 Good Clinical Practice Guidelines 2017-Feb-17 1074 KB
10 Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Injury other than Deaths Occuring During Clinical Trials 2014-Feb-17 368 KB
11 Draft Guidelines on Audio-Visual Recording of Informed Consent Process In Clinical Trial 2014-Feb-17 434 KB
12 DCG(I) approved Clinical Trial registered in Clinical Trial Jan 2013 2013-Feb-17 99 KB
13 Registration of Clinical Trials ( 26 Jul 2012 ) 2012-Feb-17 369 KB
14 New Drugs Recommended by NDAC for marketing authorization in India without Local Clinical Trial (Till August 2012) 2012-Feb-17 166 KB
15 Guidance on Clinical Trial Inspection ( 26 Jul 2012 ) 2012-Feb-17 492 KB
16 Details of Global Clinical trial approved in 2012 2012-Feb-17 926 KB
S.no Title Release Date Download Pdf Pdf Size
1 Draft Guidelines on Good Clinical Practices 2024-Sep-12 3315 KB
2 Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19 2020-Mar-30 602 KB
3 List of approved Clinical Trial Sites and Investigators 2019-Dec-02 1932 KB
4 List of approved Clinical Trial Sites & Investigators for Global Clinical Trials 2019-Dec-02 347 KB
5 Notice regarding human vacine appliation through SUGAM online Portal of CDSCO 2017-Dec-26 584KB
6 Notice Order regarding SUGAM ONLINE Dated 01.12.2016 2016-Nov-01 260KB
7 Notice Order regarding SUGAM ONLINE 2016-Oct-05 259KB
8 Notice for Online Clinical Trial Application and Monitoring System (OCTAMS) 2015-Sep-09 52KB
9 Office Order dated 05.09.2014 reg. Information required in respect of Conduct of the Clinical Trial of New Drugs and GCT in India 2014-Sep-05 503KB
10 Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Jul-28 210KB
11 Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time 2014-Jul-03 158KB
12 Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs 2014-Jul-03 152KB
13 Office Order dated 03.07.2014 - Providing Ancillary Care to the Clinical Trial subjects 2014-Jul-03 156KB
14 Office Order dated 03.07.2014 - Placebo Controlled Trials 2014-Jul-03 174KB
15 Office Order dated 03.07.2014 - Approval of academic CT 2014-Jul-03 146KB
16 Office Order dated 03.07.2014 - Clinical Trial on Medical Device 2014-Jul-03 164KB
17 Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage 2014-Jul-03 164KB
18 Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT 2014-Jul-03 151KB
19 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Feb-17 211 KB
20 Audio -Video Recording of Informed Consent Process of All New Subjects in Clinical Trials- Administrative Orders Monitoring of Clinical Trials - regarding 2013-Feb-17 733 KB
21 Order Dated 06.02.2013: "System for supervision Clinical trials on new Chemical entities in the light of direction of Hon'ble Supreme Court of India" 2013-Feb-06 739KB
22 Notice-dated 11.12.2012: Advisory notice on Clinical Trial 2012-Dec-11 1,240Kb
23 Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration) 2012-Aug-29 297KB
24 Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices 2012-Feb-17 1292 KB
25 Advisory notice on clinical trial 2012-Feb-17 1273 KB
S.no Title Release Date Download Pdf Pdf Size
1 G.S.R.227(E) 19 March 2019 2019-Mar-21 2458 KB
2 Extension of Expert Committee 2018-Feb-09 667kb