{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-dcgi-noc-cta-and-protocol-amendment-submissions”
},
“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.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}

Standard Operating Procedure for DCGI NOC/CTA and Protocol Amendment Submissions

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 of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO). It ensures compliance with Indian GCP (2019), New Drugs and Clinical Trials Rules, 2019, and aligns with global regulatory expectations.

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

1. CTA Submission Log (Annexure-1)
2. DCGI Query Response Log (Annexure-2)
3. Amendment Submission Log (Annexure-3)
4. 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

Annexures

Annexure-1: CTA Submission Log

Annexure-2: DCGI Query Response Log

Annexure-3: Amendment Submission Log

Annexure-4: Approval Notification Log

Revision History

For more SOPs visit: Pharma SOP