Marketing Authorization for Manufacturers of Biological Products in India - CT-21 & CT-22, CT-23

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If you are looking to manufacture Biologicals in India, CliniExperts is your one-stop shop for handling the crucial licensing process successfully. Our dedicated team of seasoned regulatory specialists, who have over ten years of experience have mastered the subtleties of the typical obstacles and how to overcome them. We guide you through each stage to ensure a smooth road offering.

Marketing Authorization for Manufacturers of Biological Products – Overview

To help obtain a marketing authorization license from the Central Drugs Standard Control Organization (CDSCO) to manufacture biological products in India. To obtain an authorization license, applicants must fill out form CT-21. Following the completion of the documentation, the authority will issue a license on forms CT-22 (API) and CT-23 (formulation) for manufacturing products in India.

Who Can Apply?

Biological product manufacturers with existing valid license on Form 25/Form 28/ Form 28 D may apply for market Authorization.

How To Apply?

The Applicant must follow the following process:

Log in to your account using the SUGAM website.
Go to ‘Biological Division’.
Go to ‘New application’.
Choose the new drug division's form CT-21 as applicable to you.
Add the medication's pharmaceutical specifics, trial location details, and any other relevant information.
Add every document that is asked for in CT-21.
Pay the application fee.

Submit application form. After that, if the CDSCO has any questions, you may have to answer them or produce the relevant documents and get the approval in form CT-22 (API) or CT-23 (Formulation).

Validity

The license mentioned has no validity. Unless it is cancelled or suspended for any reason, it is perpetually valid.

Fee Involved

The application process carries a government charge of Rs. 5,00,000.

Important Documents

The following documents should be present during the documentation process:

Declarations and commitments from manufacturers and sponsors.
CMC data (including a master file for the drug, a manufacturer's file for the drug product, a site master file, a certificate of analysis (COA) and batch stability data for three batches).

Summaries of study reports of preclinical research that have been approved (PK/PD and toxicity).
Reports and summaries of clinical investigations related to phase I, II, and III trials.

Timeline to get CT-22, CT-23 from Central Drugs Standard Control Organisation

Days

Essential Tips

The primary considerations that need to be made while preparing and submitting this license application are:

Provide clinical and pre-clinical data for phases I, II, and III.
Provide all the necessary documentation in the correct format (Manufacturing License, GMP), or explain if you are unable to.
Provide stability data and CMC data, including three batches of COAs.

Expert Advise

For a rapid and smooth receipt of the license, ensure the following, as advised by our experts:

NDCT rule 2019 must be adequately adhered to by all projects, such as labelling, IB, and ICF.

Each document that is submitted must be genuine.

All the documents should be in line to checklist provided in the SUGAM application.

Frequently Asked Questions

Manual sign and stamp will be accepted or not?

Digital signature on the Form CT-18/CT-21 is mandatory.

Whether Marketing Registration Certificate issued in the name of Brand?

No. Marketing Authorization issued by the authority in the generic name.

Who can apply for grant of permission to import and market a new drug?

Any person/ organization having a valid wholesale license for sale and distribution of drugs under the Drugs and Cosmetics Rules, 1945 can make application to CLA for grant of permission to import the new drug.

Is an importer or manufacturer allowed to market a new drug for unapproved indication?

No. Under any circumstances, the manufacturer or importer of new drug cannot market a new drug for an indication not approved by CLA. No such indication should be mentioned in the package insert/ promotional literature of the new drug.

Whether notarized GMP/CoPP/Mfg Lic required?

All the certificate such as GMP/CoPP/Mfg Lic required to be notarized.

I don't manufacture any medications right now. I want my facility to produce new drugs for the first time. How can I proceed?

In this case, the person or organization that constructed the manufacturing facility may apply to CDSCO for permission to manufacture novel medications for retail and distribution. However, in accordance with the Drugs and Cosmetics Rules, 1945, he must further apply to the appropriate State Licensing Authority for a manufacturing license.

Can a business legally market a novel medication for a condition that hasn't been approved by the FDA?

No. The producer is not allowed to commercialize a new medication for a medical condition for which it has not acquired CLA approval. The package information and advertising materials for the new drug should not contain any indication of this kind.