Global Clinical Trial

Background & Rules

Global Clinical Trial means any clinical trial which is conducted as part of multi-national clinical development of a drug. Clinical Trial means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug.

No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21.

 

RULES GOVERNING CLINICAL TRIALS

The clinical trials are conducted in accordance with the Drugs and Cosmetics Rules. The specific Rules are-

  1. Rule 122 DA – Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;

 

  1. Rule 122 DAB – Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;

 

  • Rule 122DAC - Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance;

 

  1. Rule122 DD – Requirements and guidelines for registration of Ethics Committee;

 

  1. Rule122 E – Definition of new drug;

 

  1. Schedule Y - Detailed guidelines and requirements for conduct of clinical trial and approval of new drug

 

  • Good Clinical Practice Guidelines issued by CDSCO, Directorate General of Health Services, Govt. of India

 

The Handbook for applicants and reviewer of clinical trials in India has been published by ICMR with CDSCO to provide clarity, enhance transparency, and facilitate understanding of review process.

Functionalities of Global Clinical Trials Division.

 

  • Processing of applications received for conduct of Global Clinical Trials (i.e. Form 44), review, approval and follow-up until end of study as per Schedule Y, Rule 122 DA, 122 DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945)

 

  • Review and approval of Test License applications (Form 12) to import the Investigational Medicinal Products (IMP) for Global Clinical Trials.

 

  • Review of notification for Non-interventional/Observational/Academic/Investigator Initiated Trials.

 

  • Review and approval of post approval changes applications like Major protocol amendments &change in sponsors/applicant etc.

 

  • Review of notifications like Minor protocol amendments, Investigator’s Brochure (IB), Informed Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Reports (DSUR), site additions/deletions, Change in Principal investigators/Co-investigators, Clinical Trial Agreements, Ethics committee approval of PI sites, Annual Status Reports, End of clinical trial notifications& Clinical Study Reports (CSR) etc.

 

  • Handling of complaints, parliament questions and RTI queries related to Global clinical trials.

 

  • Handling/Monitoring of GCP Inspections based on the trial monitoring documents like PSURs, ASRs, complaints received etc.

 

  • Review & action taken in respect to GCP inspection reports received from Inspection Team/Zonal Offices (Show-cause notice, response of show-cause notice, warning, debarment, suspension etc.)

 

  • Data-base management (receipts/files/other misc. data including permissions generated, maintenance of guard files of query/approvals, parliament questions answered, CSR etc.)
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 List of approved Clinical Trial Sites and Investigators 2019-Dec-02 1932 KB
2 List of approved Clinical Trial Sites & Investigators for Global Clinical Trials 2019-Dec-02 347 KB
3 Notice regarding human vacine appliation through SUGAM online Portal of CDSCO 2017-Dec-26 584KB
4 Notice Order regarding SUGAM ONLINE Dated 01.12.2016 2016-Nov-01 260KB
5 Notice Order regarding SUGAM ONLINE 2016-Oct-05 259KB
6 Notice for Online Clinical Trial Application and Monitoring System (OCTAMS) 2015-Sep-09 52KB
7 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
8 Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Jul-28 210KB
9 Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs 2014-Jul-03 152KB
10 Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time 2014-Jul-03 158KB
11 Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT 2014-Jul-03 151KB
12 Office Order dated 03.07.2014 - Placebo Controlled Trials 2014-Jul-03 174KB
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 - Approval of academic CT 2014-Jul-03 146KB
15 Office Order dated 03.07.2014 - Clinical Trial on Medical Device 2014-Jul-03 164KB
16 Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage 2014-Jul-03 164KB
17 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM 2014-Feb-17 211 KB
18 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
19 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
20 Notice-dated 11.12.2012: Advisory notice on Clinical Trial 2012-Dec-11 1,240Kb
21 Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration) 2012-Aug-29 297KB
22 Advisory notice on clinical trial 2012-Feb-17 1273 KB
23 Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices 2012-Feb-17 1292 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