Subsequent New Drug Approval in India - CT-16, CT-18, CT-10, CT-21, Form 30 & CT-17, CT-19, CT-20, CT-11, CT-22, CT-23, Form 29
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Subsequent New Drug Approval – Overview
For all manufacturers and importers who wish to manufacture and import a 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.
For Importers:
- Apply in CT-18 on the SUGAM portal, attach all necessary paperwork per the checklist, and pay the relevant government charge.
- IPC test letter shall be issued by CDSCO.
- Submit form CT-16 in parallel to request authorization to import ND for testing and analysis on form CT-17.
- Send the samples to the IPC labs, and once the IPC report has been acquired, submit it with the application CT-18.
- CDSCO is responsible for reviewing the application and setting up an SEC meeting for discussion and recommendations.
- After satisfying SEC recommendations and answering any questions, CDSCO will authorize the import of ND for sale or distribution on form CT-19/CT-20.
For Manufacturers:
- Apply in CT-18 on the SUGAM portal, attach all necessary paperwork per the checklist, and pay the relevant government charge.
- Fill out form CT-10 to request authorization to make ND for testing and analysis in form CT-11.
- Submit an additional Form 30 application to the state FDA for a license to manufacture ND in form 29.
- Apply in CT-21 through the SUGAM portal with the necessary paperwork listed on the checklist, plus the applicable government charge.
- CDSCO will review the application and, if necessary, ask questions. In addition, CDSCO will provide an IPC test letter.
- Send the samples to the IPC labs, and as soon as you have the IPC report, submit the application (CT-21) and gain the CT-23 permission.
- After obtaining CT-23, apply to the state FDA for form-25, which requests additional product permission.
Who Can Apply?
Eligibility criteria for the license are:
- Importers: Importers with a wholesale license are eligible to apply.
- Manufacturers: Any organisation possessing a valid mfg. copy that is registered in India. To develop an experimental novel drug under a licence in form 25 or form 28, the regulatory authority must grant the necessary regulatory clearances.
How To Apply?
The Applicant must follow the following process:
For Importers:
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Step 1: Sign in to the SUGAM portal account.
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Step 2: Go to new application submission.
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Step 3: Select CT-18 from the new drug division's drop-down menu.
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Step 4: Enter the drug's pharmaceutical information, information about the research sites, and any other pertinent material.
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Step 5: Include every document requested in CT-18.
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Step 6: Pay the fee.
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Step 7: Send your application.
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Step 1: Sign in to the SUGAM portal account.
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Step 2: Go to new application submission.
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Step 3: Select CT-21 from the new drug division's drop-down menu.
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Step 4: Enter the drug's pharmaceutical information, information about the research sites, and any other pertinent material.
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Step 5: Include every document requested in CT-21.
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Step 6: Pay the fee.
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Step 7: Send your application.
Validity
There is no validity of subsequent new drug permissions
Fee Involved
Typically, within 90 days the license processing is completed, and the applicant (manufacturers or importers) receives the license.
For Importers:
- INR 200,000 is required to apply for authorization to import a new drug (in bulk or finished form) that has already received marketing approval.
- Request for approval to import an approved new medicine for new marketing claims, new indications, new dosage forms, new administration routes, or new strengths: INR 300,000.
For manufacturers:
- INR 200,000 is required for the application for authorization to produce a new medicine (active pharmaceutical ingredient) that has previously received national approval for sale or distribution.
- Request for approval to produce a novel medicine with new indications, dosage forms, routes of administration, or strengths for sale or distribution: INR 300,000
Important Documents
A few major documents that are needed for the application are:
- CMC data (containing drug master file, manufacturer's details, batch manufacturing records of three batches, drug product details, site master file, COAs and batch stability data)
- Study reports and summaries of approved preclinical studies (PK/PD and toxicology)
- Clinical studies reports and summaries for conducted phase-I, II, and III trials
- Manufacturer and sponsor commitments and declarations.
Timeline to get
CT-17, CT-19, CT-20, CT-11, CT-22, CT-23, Form 29
from CDSCO
90
DaysEssential Tips
The main things to be kept in mind during the process of this license application preparation and submission:
- Provide phase I, II, and III clinical and preclinical data.
- Submit all administrative paperwork (GMP, FSC, CPP), failing which justification must be given.
- Three batches of COAs and stability data, along with CMC data, are needed. The most possible hindrances or problems, which could be faced during the application filling or submission process are:
- COAs from recent batches are necessary.
- Every document offered must be legitimate.
- The NDCT rule, 2019, must be properly complied with by all undertakings, ICF, IB, label, etc.
Expert Advise
CliniExperts provides sure advice to their clients-
To ensure a quick and hassle-free grant of approvals, we suggest our clients to make sure that all the paperwork is submitted according to the appropriate checklists.
Provide sufficient clinical, preclinical data. In case of any waiver, provide justification along with the supporting documents regarding this license process or documentation.
Frequently Asked Questions
When can the application of subsequent new drug permission be filed?
Subsequent new drug permissions be filed in the following cases:
- Bulk drugs already approved in the country (approved within 4 years).
- New drug (formulation) already approved in the country (approved within 4 years).
- A drug already approved and proposed to be marketed with a new indication.
- A drug already approved and proposed to be marketed as a ‘new dosage form/ new route of administration’.
- A drug already approved and proposed to be marketed as a ‘modified release dosage form’.
- A drug already approved and proposed to be marketed with additional strength.
What are the details of the approved drug required along with the application submitted for subsequent new drugs?
Approved dosage form, composition & indication are to be provided with the application.
