CDSCO Drug Approval Process – How to Register a Drug in India (Step-by-Step Guide)
CDSCO Drug Approval Process: The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority of India responsible for approving drugs, medical devices, and clinical trials.
For pharmaceutical manufacturers, importers, and marketers aiming to introduce a drug into the Indian market, navigating the CDSCO Drug Approval Process is essential.
Also Read: EMA Drug Approval Process – A Complete Guide to Centralized, DCP, and MRP Pathways
This guide about CDSCO Drug Approval Process provides a comprehensive look at every stage—from application types and submission formats to approval timelines and post-approval obligations.
🏢 What is CDSCO?
The CDSCO functions under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Headquartered in New Delhi, it works in coordination with State Licensing Authorities (SLAs) to regulate drug quality, safety, and efficacy throughout the country.
📦 Types of Drug Approvals Under CDSCO
CDSCO oversees various types of drug approvals, including:
- New Drug Approval (NDA): Required for drugs not approved in India or with new claims.
- Clinical Trial Permission: For conducting human trials in India.
- Import Registration: For importing drugs into India via Form 10 and Form 11.
- Fixed Dose Combinations (FDCs): New combinations of approved or unapproved drugs.
📝 Step-by-Step CDSCO Drug Approval Process
1. Determine the Category
Check whether the product is a new drug, FDC, or a biologic.
For new drugs, CDSCO’s approval is mandatory before market entry.
2. Prepare the Application
| Form | Use |
|---|---|
| Form 44 | New drug applications |
| Form CT-04 | Clinical trial permissions |
| Form 10 | License to import a drug |
| Form 11 | For testing and research (non-commercial) |
3. Dossier Submission (CTD/eCTD)
Submissions must follow the Common Technical Document (CTD) format:
- Module 1: Regional (India-specific)
- Module 2: Summary and overviews
- Module 3: Quality data
- Module 4: Non-clinical studies
- Module 5: Clinical study reports
Certain categories also use eCTD via SUGAM portal.
4. Review by Subject Expert Committee (SEC)
Scientific reviews are conducted by domain-specific SEC panels to evaluate safety, efficacy, and data integrity.
5. Approval or Query Letter
If everything is in order, CDSCO issues approval via Form 46.
Otherwise, a query letter requesting additional data is shared.
⏱️ Timeline for CDSCO Drug Approval Process
| Application Type | Approx. Time |
|---|---|
| New Drug + Clinical Trials | 9–12 months |
| Import Registration | 6–9 months |
| Fixed Dose Combination | 4–6 months |
| Clinical Trial only | 3–6 months |
💰 Fees & Charges
| Application Type | Form | Fee (INR) |
|---|---|---|
| New Drug | Form 44 | ₹2,50,000 (per strength) |
| Import License | Form 10 | ₹10,000 per product |
| Registration Certificate | Form 41 | ₹1,50,000 |
📦 Post-Approval Responsibilities
- Submit PSURs (Periodic Safety Update Reports)
- Follow CDSCO’s labeling and packaging rules
- Notify any variation (major or minor)
- Maintain updated site master files (for imports)
⚖️ Regulatory Bodies & Portals
- CDSCO – National authority
- DCGI – Head of CDSCO
- SUGAM Portal – Online submission platform
- SLAs – State-level drug license authorities
⚠️ Common Deficiencies in Submissions
- Non-compliance with CTD format
- Incomplete site master file for imports
- Inadequate or outdated trial data
- Missing justification for product claims
🌍 CDSCO vs EMA vs USFDA
| Feature | CDSCO | EMA | USFDA |
|---|---|---|---|
| Region | India | Europe (EU/EEA) | USA |
| Review Timeline | 6–12 months | 12–14 months | 10–12 months |
| eCTD Acceptance | Partial (SUGAM) | Mandatory | Mandatory |
| Review Authority | SEC + CDSCO | CHMP | CDER/CBER |
❓ FAQ – CDSCO Drug Approval Process
Q1. Is CDSCO approval mandatory before clinical trials in India?
Yes, Form CT-04 is required before human trials.
Q2. Can foreign companies apply for CDSCO registration?
Yes, but they must appoint an Indian agent or importer.
Q3. What is the submission format required?
CDSCO follows CTD format, and SUGAM supports eCTD.
Q4. Can US-approved drugs be directly marketed in India?
No, CDSCO approval is required for all drugs sold in India.
Q5. How long does import registration take?
It typically takes 6–9 months.
✅ Final Thoughts: CDSCO Drug Approval Process
India is one of the world’s fastest-growing pharmaceutical markets.
A thorough understanding of the CDSCO Drug Approval Process is essential for timely market access.
Whether you’re filing for a new drug, an import registration, or a clinical trial, accurate documentation and regulatory strategy are key to success.