Shelf Life Extension in India - NA

ENQUIRE NOW

Facing expiring inventory that limits your ability to export vital medical products? Don't let valuable resources go to waste! CliniExperts offers a comprehensive solution for getting the Form 40 amendment letter, extending the shelf life of your export products. CliniExperts powers your success with its team of seasoned regulatory specialists with in-depth knowledge of CDSCO regulations and will guide you through the entire process, ensuring streamlined application management.

Shelf Life Extension – Overview

Manufacturers must apply for permission to extend the shelf life of their products. This is necessary to secure a shelf-life extension for export purposes. This can be done through the CDSCO following registration. The application is submitted offline. Manufacturers must physically submit the application letter. Required documents and the government fee must be included.

Who Can Apply?

Indian importers and manufacturers can apply.

How To Apply?

The Applicant must follow the following process:

The application is filled out offline. It requires physical submission of the application letter. Required documents and the government fee must be included. The application is filled out offline. It requires physical submission of the application letter. Required documents and the government fee must be included.

Users can modify the shelf life for multiple drugs in a single application, under the same RC.

Validity

Applicable till the registration certificate remains valid.

Fee Involved

USD 1800

Important Documents

To obtain this permission, a predefined checklist must be adhered to that includes the following documents:

Covering letter
Real-time and accelerated stability data for the applied drugs on Zone IV b condition

Shelf-life approval of the products from the National Regulatory Authority

Timeline to get from Central Drugs Standard Control Organisation

Days

Essential Tips

For successful re-registration of manufacturing premises and export of biologicals in India. It must adhere to CDSCO guidelines is essential. Compliance ensures proper registration of biological products. Additionally, adherence to clinical trial protocols for biologics in India is imperative. The applicant must ensure the following criteria:

Stability data for the period of the claimed shelf life. Possession of registration certificate on Form 41 from the regulatory authority in India.
Maintain consistency in the indication, strength, and dosage form of the approved product. Ensure the route of administration remains unchanged.
Ensure the accuracy of the name and address in all submitted documents. Verify details provided by the applicant or manufacturer.

Expert Advise

To obtain permission:

Applicant should ensures that The registration certificate is valid. It is the manufacturer's responsibility to verify that all regulatory documents are valid within their designated period.

Frequently Asked Questions

Is Shelf-life extension applicable for imported Products also?

Who can provide form 9?

Form 9 can be provided either by Indian agent or by manufacturer however if manufacturer is providing form 9 then it should be apostle or attested from Indian Embassy in country of origin.

Which department of CDSCO deal with application pertaining to shelf-life extension for export purpose?

Import and Registration

Shelf-life extension beyond 60 Months is allowed?

Yes.

When one can apply for an extension of the shelf life of the product for export purposes?

One can apply for an extension of the shelf life of the product for export purposes only after post-approval.

Can importers/manufacturers change the shelf life for multiple products in a single application?

Yes, importers/manufacturers can change the shelf life for multiple products.

Can shelf life be changed after the primary changes?

No, shelf life cannot be changed after primary changes.