Overview of CDSCO Test License
The CDSCO Test License, issued under Form 11 by the Central Drugs Standard Control Organization, allows the import or manufacturing of drugs and medical devices in India strictly for the purposes of examination, testing, or analysis. It is essential for R&D, formulation development, and bioequivalence studies prior to commercialization.
Advantages of Obtaining a Test License
- Legal compliance for drug/device testing in India
- Enables R&D, clinical research, and formulation studies
- Mandatory before commercial manufacturing approval
- Supports new product development and innovation
- Essential for import of unapproved drugs/devices for testing
Eligibility Criteria
- Indian pharmaceutical, biotech, or medical device companies
- Contract research organizations (CROs) or academic institutions
- Importers or manufacturers involved in drug R&D
- Must have a functional laboratory or research setup
- Need to justify the purpose of import or manufacture for testing
Documents Required
- Cover Letter with purpose of testing
- Details of product for testing (name, quantity, composition)
- Undertaking for non-commercial use
- Manufacturing License (if applicable)
- Site Master File (for domestic applicants)
- Purchase invoice or import invoice
- Authorization letter & ID proof of the applicant
Application Process
- Step 1: Prepare technical documents & justification for test use
- Step 2: Submit application in Form 11 on CDSCO SUGAM portal
- Step 3: Upload documents and make fee payment
- Step 4: Review by CDSCO Drug Inspector and technical team
- Step 5: Grant of Test License (Form 11) upon approval
Why Choose Corporate Analytica?
- Experienced CDSCO consultants for test license filings
- Assistance with SUGAM portal and document preparation
- Support for Form 11 import/manufacture licenses
- Fast turnaround time and regulatory compliance
- Pan-India service for pharma & biotech companies
Post-License Compliance
- Use strictly for R&D and non-commercial purposes
- Maintain testing records and audit trail
- Dispose unused drugs/devices as per guidelines
- Renew license for continued testing beyond validity
- Submit testing report to CDSCO if required
Frequently Asked Questions (CDSCO Test License)
Q1. What is Form 11 in CDSCO?
Form 11 is a license granted by CDSCO under the Drugs and Cosmetics Rules to import or manufacture drugs for testing and analysis—not for commercial sale.
Q2. Who needs a CDSCO Test License?
Pharmaceutical companies, CROs, academic institutions, and importers conducting R&D or testing of unapproved drugs or devices in India require this license.
Q3. How long does it take to get the license?
The CDSCO Test License is generally issued within 15–20 working days, provided all documents are complete and compliant.
Q4. Is it mandatory before clinical trials?
Yes, a test license is mandatory to legally procure or manufacture investigational drugs/devices prior to initiating clinical or analytical studies.