Manufacture formulation of unapproved API for test or analysis or CT or BA or BE (CT-12, 14) in India - Form 30 & Form 29
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Manufacture formulation of unapproved API for test or analysis or CT or BA or BE (CT-12, 14) – Overview
A CT-14 license is essential for manufacturers aiming to create formulations using unapproved Active Pharmaceutical Ingredients (APIs) exclusively for Clinical Trials (CT), analysis, or Bioavailability/Bioequivalence (BA/BE) studies. Here's the process for both integrated and separated API and formulation manufacturers:
For Integrated API and Formulation Manufacturers:
- Submit Form CT-12: Complete Form CT-12 for using an unapproved API in CT, BA/BE studies, or analysis.
- CLA Approval: Essential for Central Licensing Authority (CLA) approval, as detailed in Form CT-14, for new drug manufacturing.
- API Manufacturer's Role: The API manufacturer must apply via Form CT-13 to acquire permission in Form CT-15, allowing them to supply the unapproved API.
- State FDA License: Obtain Form 30 from the State FDA (SFDA) for a manufacturing license dedicated to testing and examination purposes.
For Separated API and Formulation Manufacturers:
- Complete CT-12 Application: For producing an investigational new drug using an unapproved API in CT, BA/BE studies, or analysis, complete a CT-12 application.
- Seek CLA Permission: This application is vital for obtaining CLA permission, as specified in Form CT-14, for manufacturing the investigational new drug.
- API Manufacturer's Role: The API manufacturer must apply through Form CT-13 to secure permission in Form CT-15, enabling them to supply the unapproved API.
- SFDA License: Obtain Form 30 from the State FDA (SFDA) to secure a manufacturing license exclusively for testing and analytical purposes.
Who Can Apply?
A manufacturer holding either a Manufacturing License in Form-25/28/29 issued by SLA, a copy of Form 37 issued by SLA, DSIR approval for formulations, or a copy of approval for a BA/BE centre is eligible to apply for the license
How To Apply?
The Applicant must follow the following process:
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Access the Sugam Portal and log in to your account.
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Navigate to the "Submit new application" section. ·
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Select "Test License" and then proceed to choose "Form CT-12." ·
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Provide the pharmaceutical information for the drug, specify the details of the sites involved in the study, and complete all other relevant sections as indicated.
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Attach all the necessary documents as outlined in CT-12. ·
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Make the required government fee payment. ·
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Then click on “Submit” and apply. ·
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Keep track of any potential inquiries or requests for clarification from the CDSCO and subsequently obtain approval in the form of CT-14.
Validity
The time frame for obtaining the license is approximately 90 days and the duration of validity is three years from the date of issuance unless the authority suspends or cancels it.
Fee Involved
The cost for obtaining the license is INR 5000 per product.Important Documents
The essential documents needed to acquire licenses are as follows:
- A breakdown of the utilization of each drug, outlining the nature of tests and the quantity required for each test. This breakdown should be signed and stamped by a competent authority, specifically applicable to both bulk drugs and finished formulations for R&D purposes.
- Package inserts or technical literature, or a concise technical description of the drugs.
- Copies of Manufacturing Licenses in Forms-25/28/29 issued by SLA, or a copy of Form-37 issued by SLA, and/or DSIR approval in the case of formulations, and/or copies of approvals for BA/BE centres.
- An inventory of manufacturing equipment, analytical facilities, SOPs, proposed STPs, and specifications.
Timeline to get
Form 29
from Central Drugs Standard Control Organisation
90
DAYSEssential Tips
Kindly submit the required documents following the provided checklist to ensure that there is no rejection of application or delay. These are potential obstacles that individuals may encounter during the license application process:
- Licenses that have expired. ·
- Lack of comprehensive CMC and administrative information.
Expert Advise
Please provide valid & attested Administrative documents as per the checklist.
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Frequently Asked Questions
Where should I submit my application to seek permission for manufacturing a new drug or investigational new drug solely for the purpose of examination, testing, and analysis, without involving CT or BA/BE studies in human subjects?
You should submit this application to the relevant Zonal/ Sub-zonal offices of CDSCO.
Where should I send my application to request permission to manufacture a new drug or investigational new drug solely intended for CT or BA/BE studies?
You need to submit this application to the CDSCO Headquarters, which is located at FDA Bhavan in New Delhi. This should be done in conjunction with your application for permission to carry out the CT or BA/BE study, depending on your specific circumstances.
What should I do if a new drug, produced under Form CT-11, CT-14, or CT-15, reaches its expiration date?
If a new drug, manufactured for the purpose of CT or BA/BE studies, or for examination, testing, and analysis, is damaged, left unused, or is determined to be of substandard quality, or has surpassed its specified shelf life, it must be disposed of, and the corresponding actions should be documented.