Marketing Authorization/ New vaccine Approval - Importer in India - CT-18 & CT-19, CT-20

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Marketing Authorization/ New vaccine Approval - Importer – Overview

In order to secure marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for the importation of biologicals into India, applicants must adhere to a structured process. Initially, they are obligated to complete Form CT-18, specifically designed for importing purposes, as part of the authorization procedure. Following the submission of requisite documentation, the authority conducts a thorough review. Upon satisfactory evaluation, the CDSCO issues permission in the form of CT-19 (for Active Pharmaceutical Ingredients - API) and CT-20 (for formulation) to facilitate the importation of these products into India.

Who Can Apply?

Application for market authorization is available to importers/Indian agent of biological products already having wholesale License in Form 20B/21B.

How To Apply?

The Applicant must follow the following process:

Log in to your account using the SUGAM website.
Go to ‘Biological Division’.
Select ‘New application’.
Choose the new drug division's form CT-18 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-18.
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-19 (API) or CT-20 (Formulation).

Validity

There is a government fee of Rs. 5,00,000 for the application process.

Fee Involved

There’s no validity of the license mentioned. It remains valid for eternity unless cancelled or suspended for any reason.

Important Documents

During the documentation process, the following documents of the manufacturing company overseas should be present:

Manufacturer and sponsor commitments and declarations.
CMC data (containing drug master file, manufacturer's details, drug product details, site master file, COAs and batch stability data of three batches in which two should be of scale up size & one may be smaller).
Study reports and summaries of approved preclinical studies (PK/PD and toxicology).
Clinical studies reports and summaries for phase I, II, and III trials conducted.

Timeline to get CT-19, CT-20 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.
Send in all administrative documents (Manufacturing License, GMP), or explain if you are unable to.
Provide CMC data, including three batches of COAs, and stability information for 3 batches.

Expert Advise

The documents like DMF, SMF & other administrative documents should be apostiled/notarized.

Every document provided needs to be authentic.

NDCT rule 2019 needs to be appropriately followed by all undertakings, including ICF, IB, labels, etc.

Frequently Asked Questions

Is it permissible for an importer to advertise a new medication for a condition that has not received approval?

No. Indian Government has banned the any kind of advertising in the country unless it is related to any government national health scheme. A new medicine's importer is never allowed to advertise it for a purpose that it hasn't been approved by the CLA. The package information and advertising materials for the new drug should not contain any indication of this kind.

What likely prerequisites need to be satisfied before the importer is allowed to sell a novel medication in India?

A pharmacovigilance system must be in place for anyone wishing to import a new drug. This system should collect, process, and forward to the CLA any reports of adverse drug reactions resulting from the use of the drug in question.

Which regulatory body oversees the import of veterinary medicines for use in India?

The veterinary cell of CDSCO is responsible for approvals of the import of veterinary medicines in India.