Applying for Free Sale Certificate in India: FSC for Export

Manufacturers planning to export pharmaceuticals and other healthcare products are required to procure the Free Sale Certificate. Exporters require the FSC attesting the drug is freely marketed and sold in India without any restrictions.

Use our FSC service for a smooth application. Our support does not end with filling the FSC application. The Pharmadocx Consultants team will provide support till you successfully secure the certificate.

What is a Free Sale Certificate?

Manufacturers planning to export certain products require a Free Sale Certificate or FSC. Notably, it is an export document mandatorily demanded for certain products. This document is issued on the basis of national legislation stating that the product is freely available in the country. However, the certificate does prove the product is tested for safety and efficacy and is licensed for use in the country. The FSC is also known as the “Export Certificate” or “International Government Certificate.”  This document is issued by the national regulatory authority of the exporting country.

The FSC is issues for any commodity that is not restricted or prohibited for export. Moreover, the FSC provides the assurance the goods mentioned in the certificate are freely distributed and produced in the country that intends to export the specific drug.

Expert Tips

• A valid manufacturing license is one of the most important requirements for securing FSC
• A legal undertaking stating no market complaint or adverse event has been reported against the product is required
• The required government fee has to be paid to secure the certificate
• A manufacturer with no history of complaints against their products will easily obtain the FSC

Validation of the manufacturer

The FSC is not issued, if the manufacturer does not have a valid license. Hence, the Free Sale Certificate is a definitive proof that the manufacturer holds a valid license. Thus, the importing country can be assured the manufacturer is licensed and authorised to manufacture the drug. Moreover, the FSC validates the authenticity of the drug manufacturer. 

Mandatory document for securing permit to export to certain countries

Certain countries mandatorily demand the FSC for granting permit to import healthcare commodities into the country. Thus, exporters will have to procure this certificate to market their product in these countries.

Pro tips for smooth FSC application

There are certain prerequisites for applying for FSC:

• First and foremost, the user profile has to be linked with an Import Export Code. In case the IEC is suspended/cancelled, then you will not be able to apply for FSC.
• A valid registration cum membership certificate (RCMC) must be issued to the IEC.
• A valid digital signature certificate (DSC) has to be registered in the user’s system

Documents required for securing FSC

The following are some of the vital documents required for applying for FSC:

• Cover letter stating the applicant’s name and address that should be duly signed and stamped by the organization’s head. Additionally, the cover letter should be written on the organization’s letterhead.
• A copy of the valid manufacturing license
• A copy of the valid import export code and registration cum membership certificate
• List of products for which the FSC is being applied for
• The product permission letters for the products for which FSC is being applied for
• Letter of the concerned authority requesting for the certificate
• A notarized stamp paper stating no market complaint and adverse event reported against the product
• Copy of the authorisation letter or power of attorney, if required

The above list provides an overview of the documents required. Feel free to contact us for a detailed list of necessary documents for the application. Additionally, we will help you prepare and collate the documents as per guidelines. Our document preparation service will help you easily prepare all the necessary documents within the stipulated timeline. Furthermore, we will gladly provide a detailed checklist of documents for FSC application for easy references.

Expert Insights

• A manufacturer with a valid manufacturing license can only apply for the Free Sale Certificate.
• An undertaking stating that no action has been launched against the FSC applicant with respect to market complaints or adverse events is required. Additionally, the undertaking should state there are no not of standard quality (NSQ) reports against the product in India. This has to be submitted along with the application.
• All the documents submitted for FSC application have to comply with the FSC checklist of required documents.
• Importing countries consider FSC a definitive proof that the manufacturer holds a valid manufacturing license in India.

To start your FSC application process, simply fill out the form below and we will get back to you

Common Frequently Asked Questions on FSC