Test License to Manufacture Drug in India - Form 30, Form 29 & CT-10, CT-12, CT-13
Need permission to manufacture a small quantity of samples for generating chemistry, manufacturing, and control data for further regulatory approvals? CliniExperts' professionals have the expertise and will provide end-to-end practical, and technical solutions in securing a test license for manufacturers seeking Form 29, Form 30.
Test License for Drug Manufacturers – Overview
A manufacturer must apply for regulatory approval. If they wish to manufacture a small quantity of samples for generating chemistry, manufacturing, and control data. The State Drug Licensing Authority grants the test license to the manufacturer. The applicant must file an application in Form 30 to the state Food and Drug Administration (FDA) to apply for the test license. During the application process, the manufacturer must also submit the necessary documents. They should pay the required government fees. A common platform called the ONDLS portal is available for the whole of India for applications and approvals of drug licenses. It takes about 15 – 20 days to receive the license.
Who Can Apply?
A manufacturer with a Forms 25 and 28 manufacturing license can apply for a test license. R&D units having DSIR can also apply. This is to manufacture test batches. Used for generating chemistry, manufacturing, and control data for further regulatory approvals.
How To Apply?
The Applicant must follow the following process:
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The applicant must file an application in Form 30 to the state Food and Drug Administration (FDA) for the test license. Additionally, a common platform called the ONDLS portal is available. It is used in the whole of India for applications and approvals of drug licenses.
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Test License in Form 29: The manufacturer can apply on State Specific Portal and/or ONDLS portal via Form 30. The regulatory authority will issue the test license within 15-20 working days.
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A manufacturer should submit an offline application for the phytopharmaceutical drug for a Test License No Objection Certificate. It should be submitted to the CDSCO HQ. The manufacturer can use Form CT-10, CT-12, or CT-13 for the application.
Validity
The test license's validity would be three years from the date of issue.
Fee Involved
The applicant who wishes to apply must pay INR 500 per product during the application process.Important Documents
The following documents are mandatory while submitting an application for a test license:
- Form 30
- A copy of the manufacturing license or a copy of the Department of Scientific and Industrial Research (DSIR) certificate
- Testing protocol
- Specification sheet of the product
Timeline to get
CT-10, CT-12, CT-13
from Central Drugs Standard Control Organisation
15 to 20
WORKING DAYSEssential Tips
The manufacturer applying for the test license must ensure these essentials are followed:
- A clear justification of the sample quantity to be manufactured should be given.
- The documents must mention all the tests and sample quantity to be used for testing purposes.
- Documents not signed correctly or a mismatch in sample quantity. It can cause roadblocks during the application process.
Expert Advise
The manufacturer must ensure that:
The documents presented during the application process are as per the checklist
The justification of the sample quantity is mentioned
The tests and sample quantity to be used for testing purposes must be mentioned.
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Frequently Asked Questions
Why are manufacturers required to obtain a test license in Form 29?
A test license issued in form 29 is required to manufacture the test batches for generating chemistry, manufacturing, and control data for further regulatory approvals.
How can manufacturers apply for the test license?
The manufacturers can apply for a test license by applying in Form 30.
How much fee is the applicant required to pay during the application process?
The applicant who wishes to apply for a test license must pay INR 500 per product during the application process of Form 29.
What documents are mandatory to be submitted during the application process?
During the application process for a test license, the applicant must supply the following documents: o Copy of manufacturing license or copy of DSIR certificate o Undertakings and justification of quantity of samples to be imported o Testing Protocol o Specification Sheet of the product
Who is the regulatory authority for Form 30?
The State Drug Licensing Authority is the concerned authority for approval of Form 30.