Background & Rules

Global clinical trial means any clinical trial which is conducted as part of a clinical development of a drug in more than one country. 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 New Drugs and Clinical Trials Rules, 2019. The specific Rules are-

• Rule 21- Application for permission to conduct clinical trial of a new drug or investigational new drug
• Rule 22- Grant of permission to conduct clinical trial.
• Rule 23- Permission to conduct clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India.
• Rule 24- Permission to conduct clinical trial of a new drug already approved outside India.
• Rule 25- Conditions of permission for conduct of clinical trial.
• Rule 26- Validity period of permission to initiate a clinical trial.
• Rule 27- Post-trial access of investigational new drug or new drug
• Rule 28- Academic clinical trial
• Rule 29- Inspection of premises relating to clinical trial.
• Rule 30- Suspension or cancellation of permission to conduct clinical trial.

• 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. CT-04), review, approval and follow-up until end of study as per Schedule New Drugs and Clinical Trials Rules, 2019. 

  Review and approval of Test License applications (CT-16) 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.)

GCT Processes  

•     Guidelines Document
• Guidance on Clinical Trial Inspection
•     Sugam User Manual
•     FAQ
•     Checklist Documents