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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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Overview of CDSCO Clinical Trial Approval Process in India
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.
1. Stakeholders and Roles in CDSCO Approval
| Stakeholder | Role in Clinical Trials |
|---|---|
| CDSCO | Regulatory authority for trial approval and inspection |
| Ethics Committee (EC) | Reviews and approves trial protocols and patient safety measures |
| DCGI (Drugs Controller General of India) | Grants permission for new drugs and biologicals |
| Sponsor | Responsible for trial design, funding, and compliance |
| CRO (Contract Research Organization) | Manages and monitors clinical trial operations on behalf of the sponsor |
| Investigator | Conducts trial at the site and ensures protocol adherence |
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)
4. CDSCO Timelines For Clinical Trial Approval
| Approval Stage | Estimated Timeline |
|---|---|
| Ethics Committee Review | 30–60 days |
| CDSCO Review & DCGI Approval | 90 working days (standard) |
| Site initiation after approval | Within 30 days post-approval |
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
- (N.d.). Researchgate.net. Retrieved August 2, 2025, from https://www.researchgate.net/profile/Brahmaiah-Bonthagarala/publication/318815195_Regulatory_process_and_ethics_for_clinical_
- Functions. (n.d.). Gov.In. Retrieved August 2, 2025, from https://cdsco.gov.in/opencms/opencms/en/About-us/Functions/