Marketing Authorization in India - Application in Form CT-18 & Approval in Form CT-19 (API), CT-20 (Formulation)
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Marketing Authorization – Overview
For all importers who wish to market new API or New Drug formulations for retail or distribution, a license is mandatory from the zonal FDA and CDSCO. To receive CDSCO's approval, this process is necessary.
- Apply in CT-18 together with the necessary paperwork listed on the checklist, the government fee, and the SUGAM portal.
- CDSCO must send out an IPC test letter. In parallel, fill out form CT-16 to request authorization to import ND for testing and analysis on form CT-17.
- Send the samples to the IPC labs, and as soon as you have the IPC report, submit the report on the Sugam portal to CDSCO.
- To analyze and make suggestions, CDSCO will examine the application and schedule an SEC meeting.
- After satisfying SEC advice and answering any questions, CDSCO will authorize the import of ND for sale or distribution on form CT-19/CT-20. Typically, within 90 days, the license processing is completed, and the applicant receives the license.
Who Can Apply?
Importers with a valid wholesale license (Form 20B/21B) are eligible to apply.
How To Apply?
The Applicant must follow the following process:
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Access your account on the SUGAM portal.
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Go to new application submission.
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Select form CT-18 under the new drug division.
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Enter the drugs details of the medicine, information about the trial sites, and any other pertinent material.
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Include all the documents that are requested in CT-18.
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Pay the fee.
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Submit the application. Follow up on any questions the CDSCO may have and obtain the approval in form CT-19(API)/CT-20(Formulation) after that.
Validity
There’s no validity of the license. It remains valid for eternity.
Fee Involved
INR 500,000 per drug/strength (Drug Formulation/ API that is not approved in India)
Important Documents
The essential documents needed to acquire licenses are as follows:
- CMC Data (including Site Master File, Drug Master File, COA's & Stability data of 3 batches, Manufacturers details, Drug details)
- Study Reports & Summaries of Appropriate Pre-clinical Studies (Toxicity & PK/PD studies)
- Clinical Studies Reports & Summaries for Conducted Phase-I, II, III trials.
- Undertakings & declarations from manufacturer, sponsor.
Timeline to get
Approval in Form CT-19 (API), CT-20 (Formulation)
from Central Drugs Standard Control Organisation
90
DAYSEssential Tips
The main considerations that need to be made while preparing and submitting this license application are:
- Provide phase I, II, and III clinical and pre-clinical data.
- Submit all administrative paperwork (GMP, FSC, CPP), failing which justification must be given.
- Stability information and CMC data, including 3 batches of COAs, are needed.
Expert Advise
COAs from recent batches are necessary.
Each document offered must be legitimate.
The NDCT rule, 2019, must be properly complied with by all undertakings, ICF, IB, label, etc.
Related Services
Frequently Asked Questions
Is it legal for an importer to promote a novel medicine for an unapproved medical indication?
No. The importer of a new medicine is never permitted to promote it for a use that has not received CLA approval. No such indication should be stated in the new drug's package information or advertising materials.
What probable conditions must be met before the importer can bring a new medicine into India for sale?
Anyone planning to import or produce a new drug for sale or distribution must have a pharmacovigilance system in place for gathering, processing, and forwarding any reports of adverse drug reactions resulting from the use of the drug they are planning to import, manufacture, or market domestically to the CLA.
Which department oversees importing veterinary medications for use in India?
CDSCO's veterinary cell.