The Global Clinical Trial (GCT) Division functions under the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare, Government of India.  The Division is responsible for the scientific and regulatory evaluation, approval, monitoring, and oversight of Global Clinical Trials conducted in India in accordance with the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019, as amended from time to time, and the applicable Good Clinical Practice (GCP) Guidelines. A Global Clinical Trial (GCT) global clinical trial means any clinical trial which is conducted as part of a clinical development of a drug in more than one country. 

The major functions of the GCT Division include:

• Processing and scientific review of Clinical Trial Applications submitted through the SUGAM Portal in the prescribed forms i.e. Form CT-04 for grant of permission to conduct Global Clinical Trials under the New Drugs and Clinical Trials (NDCT) Rules, 2019, and other related statutory applications.

• Review of protocol amendments, Investigator's Brochure, Informed Consent Documents, Case Report Forms, and other essential trial documents.

• Processing applications related to addition or deletion of clinical trial sites, investigators, changes in protocol, import of investigational medicinal products.

• Coordinating with the Subject Expert Committees (SECs) for scientific deliberation and evaluation of proposals related to Global Clinical Trials.

• Monitoring regulatory compliance throughout the conduct of the trial, including review of Development Safety Update Reports (DSURs), annual status reports, protocol deviations, and final Clinical Study Reports (CSRs).

• Conducting regulatory inspections of clinical trial sites to verify compliance with Good Clinical Practice (GCP) and applicable regulatory requirements.

• Processing applications related to academic clinical trials, post-trial access, and other clinical research activities as provided under the NDCT Rules.

• Contributing to the development of regulatory policies and guidance documents, facilitating stakeholder engagement, and strengthening India's clinical research regulatory framework.

GCT Processes  

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