Re-registration in India - Form 40 & Form 41

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Are you a foreign manufacturer who wishes to import or renew their import license for sale in the Indian market? Your one-stop shop for successfully and quickly handling the crucial Form 41 licensing process is CliniExperts. Get in touch with us right now to arrange a free consultation and go over how we can assist you with getting your license.

Re-registration – Overview

It is necessary for the applicant to register with the SUGAM portal to obtain the renewed Registration Certificate 9 months before the expiry of the original registration certificate.

The application should be submitted using Form 40, along with all the required documents.
The necessary application fee should be paid.
Applications must be accompanied by certain forms (called undertakings) listed in Schedule D-I and D-II.
The required documents must be submitted in accordance with the Drugs and Cosmetics Act and Rules. The purpose of this service is to help with the submission of Form 40 applications to CDSCO to get a renewal of the registration certificate issued on Form 41 (license for import of medications into India) in accordance with CDCSO, India.

Who Can Apply?

Renewal applications are only available to importers.

Registration in India – Form 40 & Form 41

How To Apply?

The Applicant must follow the following process:

Selection of authorized Indian Agent
Generation of SUGAM credentials
Applying for a Registration Certificate in Form 40 by filling in an online form, uploading documents in PDF formats
Submitting the Government fee.
Submission of Application

Validity

The registration certificate will be valid for three years. Post this, it should be renewed again by following the same process.

Fee Involved

The following fees and forms must be submitted, along with the undertakings required under Schedule D(I) for the registration of manufacturing facilities and Schedule D(II) for the registration of pharmaceuticals:

A registration cost of USD 10,000 (or the equivalent amount in Indian currency) for the manufacturing premises.
A registration fee of USD 5,000 (or its equivalent in Indian currency) for one drug and an additional USD 5,000 (or its equivalent in Indian currency) for each additional drug, provided that the production location stays the same. Fees must be paid using a Challan at the Bank of Baroda, located at Kasturba Gandhi Marg, New Delhi 110 001, or at any other bank that the authorities may occasionally notify.

Important Documents

The application for renewal of registration or re-registration must be made nine months before the expiration of the Registration Certificate. In addition to regulatory documentary compliance such as Form 40, the following documents are required:

Wholesale license and/or manufacturing license.
Drug master file
Site master file

Free sale certificate/Certificate of Pharmaceutical Product
Good Manufacturing Practice Certificate
Power of attorney

Timeline to get Form 41 from Central Drugs Standard Control Organisation

Months

Essential Tips

Clinical trial protocols for drugs in India should be followed, as well as CDSCO criteria for Drugs product registration, to successfully get a registration certificate for their manufacturing facilities and to import and utilize drugs in India. Additionally, the applicant needs to make sure of the following:

At the time of application, stability data spanning at least six months is available.
The supporting paperwork for an application needs to be apostilled or notarized.
The authorized product's indication, strength, dosage form, and administration method shouldn't be altered.
The applicant's or manufacturer's submitted documents must contain accurate name and address information.

Expert Advise

According to the experts:

The company needs to confirm that the manufacturing site for which they are applying has never before received a registration certificate.

The manufacturer is responsible for verifying that all regulatory documents are still valid. The product samples that are sent to the government laboratory for testing ought to be in adequate numbers and well within the product's shelf life.

Frequently Asked Questions

Should someone obtain a registration certificate for Drugs that are going to be transported from India to other nations but will not be sold or distributed there?

No, in situations where only transportation is required, a registration certificate is not required.

How long will the registration certificate be valid if the address of the manufacturing site using Form 41 and the firm's constitution both change?

After the date of the modification, the registration certificate will still be valid for three months. Applying for the required new registration certificate at the new address is required.

What are the main obstacles to the registration of drugs in India?

The complicated regulatory environment, strict documentation requirements, controlling expenses and time restrictions, guaranteeing compliance with Indian biotech product rules, and accurate interpretation of guidelines are some of the major obstacles in the Drugs medication registration process.