GLOBAL MARKET ACCESS

Free Sale Certificate for Exports

Prove your product's regulatory compliance to international buyers. We facilitate FSC issuance from CDSCO (Medical/Drugs), State FDA, and DGFT for seamless export registration.

FSC Eligibility Check

Determine the correct issuing body.

What is a Free Sale Certificate?

A Free Sale Certificate (FSC), also known as a Certificate of Free Sale (CFS), is a document issued by a national regulatory authority. It certifies that the product listed is manufactured in accordance with local laws, is freely sold in the domestic market of the exporting country (India), and is safe for human use.

Importing countries require this document to register the product with their own Health Ministry or Drug Controller before allowing import. It acts as a primary proof of quality and regulatory standing.

Jurisdiction

Who Issues Your Certificate?

The authority depends on the nature of your product.

CDSCO (Central)

For Medical Devices & New Drugs: Issued by the Central Licensing Authority via the SUGAM portal for Class C & D devices and new drug molecules.

State Licensing Authority

For Generic Drugs & Cosmetics: Issued by the State FDA where the manufacturing unit is located. Required for Class A & B medical devices as well.

DGFT (Regional)

For General Goods: Issued for items not covered under the Drugs & Cosmetics Act (Engineering goods, consumer products, etc.).

Note on Ayush

For Herbal, Ayurvedic, and Unani products, the FSC is issued by the Ministry of AYUSH or the respective State AYUSH Department.

Required Documentation

To obtain an FSC, you must prove that you hold a valid license to manufacture and sell the product in India.

  • Manufacturing LicenseValid license copy (Form 25/28) listing the products.
  • Product ListList of products for which FSC is required, matching the license.
  • GMP CertificateGood Manufacturing Practice certificate (often mandatory).
  • Market StandingProof of domestic sales (Invoices) to show “Free Sale”.

Attestation Services

An FSC issued in India is often not valid abroad until it is legalized. We handle the full chain:

1Notary Public
2Home Department / SDM
3MEA Apostille
4Embassy Legalization
Workflow

How to Obtain FSC

1

Prepare

Collate Manufacturing License, Product List, and applicable fees.

2

Apply

File online on SUGAM (CDSCO) or submit to the respective State Authority.

3

Scrutiny

Drug Inspector verifies license validity and product approval status.

Grant

FSC issued. Validity usually aligns with the Manufacturing License.

Service Charges

FSC Issuance

Per Certificate Application

Request Quote

Based on Authority & Product

  • Authority Identification
  • Document Review
  • Online/Offline Filing
  • Liaison with Drug Inspector
  • Query Resolution
Start Process

Why CloudDesk for Free-Sale-Certificates?

An FSC isn't just a letter; it's a verification of your domestic compliance. CloudDesk ensures your Indian licenses are the foundation for your global sales.

1. Dual-Authority Navigation (DGFT vs. CDSCO)

Exporters often apply to the wrong department. If it's a Medical Device or Drug, you need CDSCO (Central Drugs Standard Control Organization). If it's an Engineering or General Item, you need DGFT. CloudDesk routes your application to the correct authority, preventing months of jurisdictional delays.

2. Product-to-License Mapping

To get an FSC, you must prove you have a Manufacturing License or an FSSAI/LMPC license for that specific product in India. CloudDesk performs a Compliance Audit to ensure your domestic licenses cover the exact technical name and specifications mentioned in your export order.

3. Authentication & Apostille Services

Many countries (like those in the Hague Convention) won't accept a simple FSC; they need it Apostilled by the Ministry of External Affairs (MEA). CloudDesk provides the FSC + Apostille combo, handling the physical movement of documents between departments.

4. "Commerce Certificate" for Non-Regulated Items

For items that don't fall under a specific regulatory body (like textiles or furniture), we obtain a Certificate of Commerce from the DGFT. This serves as the equivalent of an FSC, reassuring your foreign buyer that the product is a standard "article of commerce" in India.

Frequently Asked Questions

What is a Free Sale Certificate (FSC)?

It is a government-issued certificate confirming that the product is manufactured in India and is "free to be sold" in the Indian domestic market. It's proof that the product is safe and legally compliant at its source.

Which products definitely need an FSC?

Medical Devices, Pharmaceuticals, Cosmetics, and Food products are the most common. However, some countries now require it for Pesticides, Toys, and Electronics as well.

Is a Certificate of Origin (COO) the same as an FSC?

No. A COO only says where the product was made. An FSC says the product is safe/legal for sale in the country of origin. You usually need both for high-stakes exports.

How long is an FSC valid?

In 2026, an FSC is typically valid for 2 years from the date of issue, or until the expiry of your manufacturing license—whichever is earlier.

Can a "Merchant Exporter" apply for an FSC?

Yes, but with a catch. You must provide a No Objection Certificate (NOC) and a copy of the manufacturing license from the actual manufacturer. CloudDesk manages this tripartite documentation.

What documents are needed for a DGFT FSC?

(1) Valid IEC, (2) Manufacturing License from a State/Central authority, (3) List of products to be certified, and (4) Self-declaration that the product is not banned or restricted in India.

My buyer is asking for an FSC for "Medical Devices." Where do I go?

You must apply to the CDSCO (Sugam Portal). Under the Medical Device Rules (MDR) 2017/2026, this requires a valid "Form MD-5" or "MD-9" manufacturing license.

Can I get one FSC for 100 different products?

Yes. You can list multiple products in a single application, provided they fall under the same manufacturing license. This saves you significant application fees.