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“headline”: “SOP for DCGI NOC/CTA and Protocol Amendment Submissions”,
“description”: “This SOP provides step-by-step procedures for obtaining DCGI No Objection Certificate (NOC), Clinical Trial Application (CTA) approvals, and submitting protocol amendments in compliance with CDSCO and Indian GCP guidelines.”,
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Published on 25/12/2025
Standard Operating Procedure for DCGI NOC/CTA and Protocol Amendment Submissions
| SOP No. | CR/OPS/143/2025 |
| Supersedes | NA |
| Page No. | X of Y |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define procedures for submitting Clinical Trial Applications (CTAs), obtaining No Objection Certificates (NOCs), and managing protocol amendments with the Drugs Controller General
Scope
This SOP applies to sponsors, CROs, investigators, and regulatory affairs staff involved in clinical trials conducted in India. It covers preparation, submission, tracking, and approval of initial CTAs, NOCs, and protocol amendments, along with responsibilities for documentation and archiving.
Responsibilities
- Sponsor: Prepares and submits complete dossiers for DCGI approvals.
- Regulatory Affairs: Manages submission to SUGAM portal, ensures timelines, and communicates with CDSCO.
- CRO: Provides operational and documentation support for regulatory submissions.
- Investigator: Ensures site-level documentation is aligned with approved protocols.
- QA: Reviews submission packages for accuracy and compliance.
Accountability
The Sponsor’s Regulatory Affairs Head is accountable for all submissions and amendments to DCGI and ensuring adherence to timelines.
Procedure
1. Preparation of CTA/NOC Dossier
1.1 Compile documents: protocol, IB, IMPD, investigator CVs, ethics approvals.
1.2 Submit electronically via SUGAM portal.
1.3 Record submission in CTA Submission Log (Annexure-1).
2. DCGI Review Process
2.1 Monitor application status via SUGAM.
2.2 Respond to DCGI queries within stipulated timelines.
2.3 Record in DCGI Query Response Log (Annexure-2).
3. Protocol Amendment Submissions
3.1 Identify substantial vs. non-substantial amendments.
3.2 Submit substantial amendments to DCGI with justification.
3.3 Track approval in Amendment Submission Log (Annexure-3).
4. Approval and Communication
4.1 Notify investigators and sites upon DCGI approval.
4.2 Archive approval letters in TMF.
4.3 Record in Approval Notification Log (Annexure-4).
5. Archiving
5.1 Archive all CTA/NOC/protocol amendment documentation in TMF and ISF.
5.2 Maintain inspection readiness for DCGI audits.
Abbreviations
- SOP: Standard Operating Procedure
- CTA: Clinical Trial Application
- NOC: No Objection Certificate
- DCGI: Drugs Controller General of India
- CDSCO: Central Drugs Standard Control Organization
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- ISF: Investigator Site File
Documents
- CTA Submission Log (Annexure-1)
- DCGI Query Response Log (Annexure-2)
- Amendment Submission Log (Annexure-3)
- Approval Notification Log (Annexure-4)
References
- CDSCO – Central Drugs Standard Control Organization
- New Drugs and Clinical Trials Rules, 2019
- ICH GCP Guidelines
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Regulatory Affairs Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: CTA Submission Log
| Date | Protocol ID | Submitted By | Status |
|---|---|---|---|
| 01/09/2025 | CTA-2025-01 | Reg Affairs | Submitted |
Annexure-2: DCGI Query Response Log
| Date | Query | Response Submitted | Submitted By | Status |
|---|---|---|---|---|
| 05/09/2025 | Safety Clarification | Yes | Reg Affairs | Resolved |
Annexure-3: Amendment Submission Log
| Date | Amendment Type | Protocol ID | Submitted By | Status |
|---|---|---|---|---|
| 10/09/2025 | Substantial | CTA-2025-01 | Reg Affairs | Approved |
Annexure-4: Approval Notification Log
| Date | Protocol ID | Approval Notification Sent To | Sent By | Status |
|---|---|---|---|---|
| 15/09/2025 | CTA-2025-01 | Investigator | Sponsor | Completed |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP