New Drug Approval in India - Application in Form CT-21 & Approval in Form CT-22 (API)/Form CT-23 (Formulation)
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New Drug Approval – Overview
For all manufacturers who wish to manufacture 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.
- Fill out form CT-10 to request authorization to manufacture ND for testing and analysis in form CT-11.
- Submit a second Form 30 application to the state FDA for a license to manufacture ND (Form 29).
- Submit your CT-21 application via the SUGAM portal with the necessary supporting documentation and the applicable government charge.
- CDSCO will review the application and, may raise queries if it is not satisfied. In addition, CDSCO will provide an IPC test letter.
- Submit your samples to IPC labs & once the IPC report is received, submit the application via form CT-21, to receive approval in CT-22 (API)/CT-23 (Formulation).
- Once CT-22/CT-23 has been secured, submit Form 25 to the state FDA to request additional product approval. Typically, within 90 days the license processing is completed, and manufacturers receive the license.
Who Can Apply?
To develop an experimental novel medicine, a firm must obtain the necessary regulatory clearances from the regulatory body. This applies to any company registered in India with a valid copy of a manufacturing license in Form 25 or Form 28.
How To Apply?
The Applicant must follow the following process:
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Sign in to your SUGAM portal account.
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Submit “new application”.
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Select CT-21 from the new drug division's drop-down menu.
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Enter the drug's pharmaceutical information, information about the research sites, and any other pertinent information.
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Submit all documents requested in CT-21.
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Pay the eligible fees.
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Submit completed application.
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Follow up on any CDSCO questions and obtain the form CT-22/CT-23 approval later.
Validity
There’s no validity of the license mentioned. It remains valid for eternity.
Fee Involved
INR 50,000 for each drug (medicine formulation/API not authorized in India) is charged as the government fee.
Important Documents
The essential documents needed to be submitted for the license 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
Approval in Form CT-22 (API)/Form CT-23 (Formulation)
from Central Drugs Standard Control Organization
90
DAYSEssential Tips
The primary considerations that need to be made while preparing and submitting this license application:
- Provide enough phase I, II, and III clinical and preclinical data.
- Submit all administrative paperwork (GMP, FSC, CPP), failing which justification must be given.
- Submit three batches of COAs and stability data, along with CMC data.
The most likely obstacles or issues that can be easily avoided by manufacturers when filling out or applying:
- COAs must be from recent batches.
- Each document submitted must be legitimate.
- The NDCT rule, 2019, must be properly complied with by all undertakings, ICF, IB, label, etc.
Expert Advise
It takes a lot of work to obtain CT-23, which also requires other permissions (CT-11) and licenses (Form-29).
Both the Central Licensing Authority and the State Licensing Authority are involved in this.
To ensure a quick and hassle-free grant of approvals, we suggest our clients make sure that all the paperwork is submitted according to the appropriate checklists.
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Frequently Asked Questions
I do not currently manufacture any drugs. For the first time, I wish to manufacture new medications in my facility. How do I move forward?
In this situation, the individual or group that has built a manufacturing facility may apply to CDSCO for authorization to produce new drugs for sale and distribution. He must, however, also apply for a manufacturing license under the Drugs and Cosmetics Rules, 1945 by applying to the relevant State Licensing Authority.
Is it legal for a company to sell a new medicine for an unapproved medical indication?
No. A new medicine cannot be marketed by the manufacturer for a medical condition that has not received CLA approval. No such indication should be stated in the new drug's package information or advertising materials.
Can I apply for a new therapeutic molecule that hasn't received national approval but simply needs its API (bulk drug) approved?
No. An application for permission to manufacture a new drug for sale or distribution in the form of an active pharmaceutical ingredient with a novel drug molecule that has not previously received national approval must be submitted in addition to the application for permission to manufacture the novel drug's pharmaceutical formulation, which is necessary for the novel drug's safety and efficacy to be assessed.