Test License to Manufacture Drug in India
Quick Answer
A Test License to Manufacture Drug in India is issued in Form 29 under the Drugs and Cosmetics Rules, 1945. To apply, a manufacturer submits Form 30 to the State Drug Licensing Authority (SDLA) along with a ₹500 fee per product. For new drugs or unapproved APIs, manufacturers must first get CDSCO permission using CT-10, CT-12, or CT-13 before applying to the state FDA. The license is valid for one year and typically takes 15–20 working days to obtain. It is required to legally manufacture small test batches for generating chemistry, manufacturing, and control (CMC) data needed for full regulatory approval.
What is a Test License to Manufacture Drug in India?
Before a pharmaceutical company can launch a new drug or formulation in India, it needs real data — data that proves the drug works and is safe to make. This data is called Chemistry, Manufacturing, and Control (CMC) data. To generate this data, manufacturers need to produce a few small trial batches.
But here’s the problem: you cannot legally manufacture even a test batch without a proper license. That’s exactly where a Test License (Form 29) comes in.
Under Part VIII of the Drugs and Cosmetics Rules, 1945, the State Drug Licensing Authority (SDLA) has the authority to grant a test license to eligible manufacturers. This license allows you to produce limited quantities of a drug solely for testing, analysis, and regulatory submissions — not for commercial sale.
For Test Batches Only
The license covers only small-quantity manufacturing for generating CMC, BA/BE, or clinical trial data. No commercial production allowed.
State-Level Authorization
The license is issued by your State Food and Drug Administration (FDA), not CDSCO directly — though CDSCO permission is needed for new drugs.
Valid for 1 Year
The Form 29 test license is valid for one year from the date of issue. It can be renewed if manufacturing trials are still ongoing.
Mandatory for New Drugs
Without this license, you cannot legally run test batches needed for NDA, ANDA, or clinical trial approvals in India.
Who Can Apply for a Test License?
Not everyone qualifies. The Drugs and Cosmetics Rules lay out clear eligibility criteria. Here’s who can apply:
Licensed Drug Manufacturers
Any company holding a valid Form 25 (manufacturing license) or Form 28 (restricted license) issued by the State Licensing Authority can apply.
DSIR-Registered R&D Units
Research and development units that are registered with the Department of Scientific and Industrial Research (DSIR) are eligible even without a Form 25/28 manufacturing license.
Pharma Startups & New Entrants
New pharma companies that have set up a manufacturing facility and are in the process of getting approvals can apply if they already hold a Form 25/28 license.
Important Note: If you are applying for a test batch of a New Drug (as defined under the New Drugs and Clinical Trials Rules, 2019), you must first obtain CDSCO permission via Form CT-10, CT-12, or CT-13 before applying to the State FDA.
Government Forms Explained: Form 29, Form 30, CT-10, CT-12, CT-13
This is where most people get confused. Let’s break it down clearly — what each form is, who files it, and what you receive in return.
| Form | What It Is | Who Files It | Issued By | Output |
|---|---|---|---|---|
| Form 30 | Application for test license to manufacture drug | Manufacturer / R&D unit | — | Filed with State FDA |
| Form 29 | The actual Test License issued by State FDA | — | State Drug Licensing Authority (SDLA) | License Granted |
| CT-10 | Application to CDSCO for permission to manufacture a New Drug / Investigational New Drug for trials or analysis | Manufacturer / Sponsor | — | Filed at NSWS Portal |
| CT-11 | Permission issued by CDSCO after reviewing CT-10 | — | CDSCO (Central Licensing Authority) | Permission Granted |
| CT-12 | Application to manufacture formulation using unapproved API for test or clinical trial | Formulation manufacturer | — | Filed at NSWS Portal |
| CT-13 | Application to manufacture unapproved API for development or clinical trial | API manufacturer | — | Filed at NSWS Portal |
Old Drug vs. New Drug: Which Path Applies to You?
This is the most critical distinction. Your application route depends entirely on whether you’re manufacturing a drug that’s already approved in India or a brand-new one.
Old Drug (Already Approved in India)
Apply directly to your State Drug Licensing Authority in Form 30. Receive license in Form 29. No CDSCO step needed.
New Drug / Unapproved API
First apply to CDSCO via NSWS portal using CT-10 (for new drug test batch), CT-12 (for formulation with unapproved API), or CT-13 (for API manufacturer). After receiving CT-11 permission from CDSCO, then apply to State FDA in Form 30 to get Form 29.
Required Documents for Test License Application
Missing even one document can delay your approval by weeks. Here’s a complete checklist of what you need when applying in Form 30:
Copy of valid manufacturing license (Form 25 / Form 28) OR DSIR registration certificate for R&D units
Duly filled and signed Form 30 application
Testing Protocol / Manufacturing Protocol for the proposed test batch
Specification Sheet of the drug product (quality standards)
Undertaking letter with justification for the quantity of samples to be manufactured
Government fee challan — ₹500 per product
Site Master File (SMF) or Plant Master File showing GMP compliance
Qualified Person (QP) / Technical Staff details and qualification proof
List of equipment and facilities at the manufacturing site
CDSCO CT-11 permission (only for New Drugs — obtained before applying to State FDA)
Authorization letter from the company's signing authority
Drug Master File (DMF) or API source details (for formulations)
2024 Update: Since January 16, 2024, all CT-10, CT-12, and CT-13 applications must be submitted only through the National Single Window System (NSWS) portal. CDSCO no longer accepts physical or SUGAM-only submissions for these forms.
Our Process
Step-by-Step Process to Get a Test License in India
Follow these steps in the correct order. Skipping a step or filing out of sequence is the #1 reason for delays and rejections.
Path A: For Old / Already Approved Drugs
Confirm Drug Status
Verify that the drug is already approved in India. Check CDSCO's approved drug list. If the drug is unapproved or new, follow Path B instead.
Prepare All Documents
Gather your Form 25/28 license, testing protocol, specification sheet, undertaking letter, and fee challan. Ensure all documents are current and properly signed.
File Form 30 on ONDLS Portal
Submit your application on the Online Drug Licensing System (ONDLS) portal for your respective state. Upload all documents and pay the ₹500 government fee online.
State FDA Review & Inspection
The State Licensing Authority reviews your application. An inspector may visit your manufacturing site to verify GMP compliance and facilities.
Respond to Queries (If Any)
The authority may raise queries or request additional information. Respond promptly with complete answers to avoid further delays.
Receive Form 29 Test License
Once approved, your Form 29 Test License is issued. You may now legally manufacture test batches for a period of one year.
Path B: For New Drugs / Unapproved APIs
Identify Your CT Form
Determine which CDSCO form applies: CT-10 if you're the new drug/IND manufacturer, CT-12 if you're manufacturing a formulation using an unapproved API, or CT-13 if you're the API manufacturer making an unapproved bulk drug for formulation development.
Register on NSWS Portal
Create an account on the National Single Window System (NSWS) portal (nsws.gov.in). Since January 16, 2024, all CT-10/CT-12/CT-13 applications must go through NSWS only.
Submit CT-10 / CT-12 / CT-13 Application
Upload all required documents including the drug dossier, manufacturing protocol, site master file, and testing parameters. Pay the applicable CDSCO government fee.
CDSCO Review & CT-11 Permission
CDSCO reviews your application. They may raise queries. Once satisfied, CDSCO issues CT-11 permission (or the relevant approval form) granting permission to manufacture the test batch.
Apply to State FDA in Form 30
With your CT-11 permission in hand, now submit Form 30 to your State Drug Licensing Authority on the ONDLS portal. Include all required documents plus a copy of the CDSCO permission.
State Inspection & Form 29 Issuance
After State FDA review and possible site inspection, your Form 29 Test License is issued. You can now begin test batch manufacturing.
Timeline & Government Fees
Document Preparation
3–7 days to compile all documents, protocols, and fee challans.
Form 30 Submission
Application filed on ONDLS portal. Acknowledgment received immediately.
SLA Review / Queries
State FDA may raise queries. Prompt replies are critical here.
Form 29 Issued
License granted within 15–20 working days of complete submission.
| Application Type | Fee |
|---|---|
| Form 30 (State FDA) | ₹500 per product |
| CT-10 (CDSCO — New Drug) | As per CDSCO schedule (varies) |
| CT-12 / CT-13 (CDSCO) | As per CDSCO schedule (varies) |
| License Renewal | ₹500 per product (Form 30 re-application) |
Real-World Case Study: How a Pharma Startup Unlocked Its Test License in 38 Days
A US-based startup with a Class II surgical robotic system had been in development for 26 months before engaging TraccGlobal. Their existing documentation was scattered across multiple engineering tools, Google Drive folders, and email threads. When they started preparing their 510(k) submission, they discovered their design inputs had never been formally approved, their verification testing lacked approved protocols (tests were run before protocols were written), and there was no formal design review record for any development stage.
TraccGlobal conducted a full DHF gap assessment, mapped all existing documentation to FDA requirements, identified 34 specific gaps, and executed a structured remediation plan over 11 weeks. We rebuilt the traceability matrix from scratch, facilitated retroactive design reviews with proper documentation, drafted missing verification protocols retrospectively with objective evidence, and reorganized the entire DHF into an eQMS-structured format ready for FDA review.
38
Days to License
0
Rejections After Engagement
₹500
State Fee Paid
100%
First-Time Approval
Common Mistakes That Delay Test License Approvals
Based on hundreds of pharmaceutical license applications, these are the most frequent — and easily avoidable — errors:
Filing Form 30 Before Getting CDSCO CT-11 (For New Drugs)
State FDAs will outright reject Form 30 if the CDSCO permission is missing for new drugs. Always get CT-11 first, then file Form 30.
Outdated or Missing Manufacturing License Copy
Submitting an expired Form 25/28 license or missing the DSIR certificate is a very common document error that leads to immediate query letters.
Vague Testing Protocol
A generic or incomplete testing protocol is not acceptable. The protocol must mention specific parameters, methods, and testing locations in detail.
Using SUGAM Portal for CT-10/CT-12/CT-13 Applications (Post Jan 2024)
Since January 16, 2024, these applications must go through the NSWS portal. CDSCO will not accept them on the old SUGAM portal. Many applicants are still unaware of this change.
Not Responding to CDSCO / State FDA Queries on Time
Queries have a response deadline. Missing it means your application is abandoned and you must start over. Always track and respond within the stipulated time.
Confusing CT-12 and CT-13
CT-12 is for the formulation manufacturer; CT-13 is for the API manufacturer. Filing the wrong form wastes weeks. Both may be needed if different entities are involved in API and formulation production.
Why Choose TraccGlobal for Your Drug Test License?
Navigating India’s pharmaceutical regulatory system can be complex, especially when two different authorities (CDSCO and State FDA) are both involved. Here’s why pharmaceutical companies and R&D startups trust TraccGlobal for their regulatory needs:
End-to-End Handling
From document preparation to CT-10/CT-12/CT-13 filing to Form 30 submission — we handle every step, so you focus on your R&D.
Faster Turnaround
Our established CDSCO relationships and deep knowledge of state FDA requirements mean fewer queries and faster approvals.
Zero-Error Documentation
Every application goes through multi-level review before submission, dramatically reducing the chance of rejection or query-based delays.
Real-Time Application Tracking
Know exactly where your application stands at all times. We provide regular status updates and respond to queries on your behalf.
All India Coverage
Whether your facility is in Maharashtra, Gujarat, Telangana, Himachal Pradesh, or any other state, we handle applications across all state FDAs.
Startup-Friendly Guidance
New to pharma regulatory in India? Our team explains every step clearly, helping you understand what you're filing and why.
Frequently Asked Questions (FAQs)
These are the most commonly asked questions about the test license to manufacture drug in India, based on real user queries and Google’s “People Also Ask” data.
What is a Test License to Manufacture Drug in India?
A Test License (issued in Form 29) is a legal authorization under the Drugs and Cosmetics Rules, 1945 that permits a pharmaceutical manufacturer or R&D unit to produce small quantities of a drug solely for testing, analysis, and generating CMC (Chemistry, Manufacturing, and Control) data. It is not a license for commercial production. The manufacturer applies using Form 30 and the license is granted by the State Drug Licensing Authority (SDLA). For new drugs, prior CDSCO permission (CT-11) is also required.
What is the difference between Form 29 and Form 30 in drug licensing?
Form 30 is the application form that a manufacturer submits to the State Drug Licensing Authority to request a test license. Form 29 is the actual test license document issued by the SDLA after approving the Form 30 application. Think of Form 30 as your application and Form 29 as the approval certificate you receive.
What is the difference between CT-10, CT-12, and CT-13?
CT-10 is filed by a manufacturer/sponsor seeking CDSCO permission to manufacture a New Drug or Investigational New Drug for clinical trials, BA/BE studies, or test & analysis. The resulting permission is CT-11. CT-12 is specifically for a formulation manufacturer who wants to manufacture a drug formulation using an unapproved API for test/analysis or clinical trial purposes. CT-13 is for an API manufacturer who wants to manufacture an unapproved active pharmaceutical ingredient to be used in development of a formulation. If both an API and formulation manufacturer are different entities, CT-13 (for the API maker) and CT-12 (for the formulation maker) may both be needed.
How long is a test license (Form 29) valid?
A Form 29 Test License is valid for one year from the date of issuance, as specified under Part VIII of the Drugs and Cosmetics Rules, 1945. If you need to continue manufacturing test batches beyond one year, you must apply for renewal by resubmitting Form 30 along with the applicable fee.
What is the government fee for a test license in India?
The government fee for applying for a test license under Form 30 is ₹500 per product. This fee is paid to the State Drug Licensing Authority when submitting the Form 30 application. Additional CDSCO fees may apply if you also need to file CT-10, CT-12, or CT-13 forms for new drugs.
How many days does it take to get a Test License (Form 29)?
For an already approved (old) drug, the Form 29 test license is typically granted within 15–20 working days of complete application submission to the State FDA. For new drugs requiring CDSCO permission first (CT-10/CT-12/CT-13), the total timeline can be 45–90 days depending on CDSCO’s review and query resolution time.
Can a pharma startup with DSIR registration apply for a test license?
Yes. R&D units registered with the Department of Scientific and Industrial Research (DSIR) are eligible to apply for a test license even if they don’t hold a Form 25/28 manufacturing license. They need to submit a copy of their valid DSIR registration certificate in place of the manufacturing license when filing Form 30.
Which portal is used for CT-10, CT-12, CT-13 applications in 2025–26?
From January 16, 2024 onwards, all CT-10, CT-12, and CT-13 applications must be submitted exclusively through the National Single Window System (NSWS) portal (nsws.gov.in). CDSCO no longer accepts these applications through the SUGAM portal or in physical form. This change is effective as of 2025–26.
Is Form 29 required for manufacturing drugs in a contract manufacturing setup?
Yes, if the contract manufacturing organization (CMO) does not have the specific drug in its existing manufacturing license, a test license (Form 29) may be required to produce test batches for the principal manufacturer. The CMO must hold a valid Form 25/28 license and the drug must be within the permitted category of that license or covered by the Form 29 test batch authorization.
Ready to Get Your Test License?
Whether you need Form 30 for an old drug or CT-10/CT-12/CT-13 + Form 30 for a new drug, our regulatory experts will guide you through every step — fast, error-free, and compliant.