Overview of CDSCO Clinical Trial Approval Process in India

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Overview of CDSCO Clinical Trial Approval Process in India

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The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals, medical devices, and clinical trials. CDSCO is operated under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare, Government of India. CDSCO regulates the following: [1]

The approval of new drugs and clinical trials
The import, manufacture, distribution, and sale of drugs and medical devices
The monitoring of adverse drug reactions (ADR) and pharmacovigilance
Drug safety, effectiveness, and quality standards

The CDSCO operates under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, including amendments to the New Drugs and Clinical Trials Rules, 2019.

2. Stages of CDSCO Clinical Trial Approval in India

2.1. Pre-Submission and Feasibility

Identify the classification of the trial (global clinical trial, bioavailability/bioequivalence study, etc.)
Evaluate the regulatory requirements for new drugs or biologics
Write the protocol and trial design

2.2. Ethics Committee Approval

Preparation of clinical trial protocol, Informed Consent Document (ICD), Investigational Brochure (IB) to be submitted
Obtain approval from the registered Institutional Ethics Committee (IEC)

2.3. Application to CDSCO (Form CT-04)

Complete Form CT-04 using the SUGAM portal

Provide all necessary documents:

Clinical Trial Protocol
Investigator’s Brochure
Preclinical data
Manufacturing license for investigational product (if applicable)
EC approval
Pay the necessary fee

2.4. Regulatory Review and Response to Queries

CDSCO reviews dossier (Timelines: ~90 working days)
Respond to Regulatory Queries (RQ), if raised
DCGI will approve in writing using Form CT-06

2.5. Initiation of Trial and Site Monitoring

Trial starts when the Sponsor receives Form CT-06
Monitor for adverse events and submissions of safety reports (DSURs, SUSARs)
Submit clinical trial closure report

3. Documents Required for CDSCO Clinical Trial Submission

Cover letter
Protocol and synopsis
Investigator’s Brochure
Chemistry, Manufacturing and Controls (CMC) data
EC approval
Informed Consent Document
Case Record Forms (CRFs)
Sponsor and investigator undertakings
Previous trial data (if relevant)

5. Functions of CDSCO Relevant to Clinical Trials

Regulation of New Drugs and Clinical Trials [3]
Import and Registration of Drugs
Medical Device Regulation
Licensing and Inspection
Pharmacovigilance and Safety Monitoring
Quality Control and Standards Enforcement
Coordination with International Regulatory Agencies
Digital Regulatory Systems

Conclusion

In India, obtaining Clinical Trial approval from the CDSCO is a multi-step, regulated process that involves working together with sponsors, ethics committees, and regulatory authorities. To enable a smooth pathway for the initiation and monitoring of a clinical trial, it is essential that the trial sponsor and ethics committee maintain compliance with the NDCTR 2019, submit documentation to the CDSCO on time, and have clear lines of communication with the CDSCO.

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References

India, F. F. in. (n.d.). Central drugs standard control organization. Gov.In. Retrieved August 2, 2025, from https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/import-registration/Import_guidance_doc.pdf
Functions. (n.d.). Gov.In. Retrieved August 2, 2025, from https://cdsco.gov.in/opencms/opencms/en/About-us/Functions/