Free Sale Certificate (FSC) for Indian Exporters
A Free Sale Certificate confirms that your product is freely sold in India, and many importing countries ask for it before they register or clear your goods. DGFT issues it for most freely exportable goods, and CDSCO or the state licensing authority issues it for drugs, cosmetics and medical devices. We work out which one you need and file it.
What it is
A Free Sale Certificate, also called a Certificate of Free Sale or a Free Sale and Commerce Certificate, is an official statement that a product is made and lawfully sold in the exporting country. Importing countries treat it as proof that the product is not made only for export.
In India, the issuing body depends on the product. For goods not regulated under the Drugs and Cosmetics Act, 1940, Regional Authorities of the Directorate General of Foreign Trade (DGFT) issue it under paragraph 2.34 of the Handbook of Procedures 2023, on application in form ANF 2H. For items covered by the Drugs and Cosmetics Act, the application goes to the Central Drugs Standard Control Organisation (CDSCO). For notified medical devices, CDSCO guidance sends Class C and D devices to the Central Licensing Authority and Class A and B devices to the State Licensing Authority.
Who it applies to
You export general goods
Any freely exportable item, such as consumer goods, chemicals or engineering products, when the buyer’s country asks for an FSC.
You make medical devices
Makers of notified medical devices that hold a manufacturing licence under the Medical Devices Rules, 2017, and hospital items outside the Drugs and Cosmetics Act.
You export drugs or cosmetics
Manufacturers whose products fall under the Drugs and Cosmetics Act, 1940, who apply to CDSCO rather than DGFT.
Why it matters
Get your product registered abroad
Many importing regulators ask for an FSC before registering your product.
Clear customs without a hold
A missing certificate can hold a shipment at the destination port until the papers arrive.
Qualify for tenders and distributors
Foreign distributors and hospital tenders often ask for it.
Which authority issues your FSC
| Product | Issuing authority | Basis | Validity |
|---|---|---|---|
| Freely exportable goods not regulated elsewhere | DGFT Regional Authority | HBP 2023 para 2.34(b), ANF 2H | 2 years, unless otherwise specified |
| Hospital and surgical items outside the Drugs and Cosmetics Act | DGFT Regional Authority | HBP 2023 para 2.34(a), ANF 2H | 2 years, unless otherwise specified |
| Medical devices, Class C and D | CDSCO Central Licensing Authority | CDSCO FSC guidance, 2024 | Up to the validity of the manufacturing licence |
| Medical devices, Class A and B | State Licensing Authority | CDSCO FSC guidance, 2024 | Up to the validity of the manufacturing licence |
| Drugs and cosmetics | CDSCO | HBP 2023 para 2.34 note | As stated on the certificate |
Before any of this, you need an Import Export Code (IEC), because DGFT applications are filed from your IEC profile.
In practice, the route can differ even for two units on the same Faridabad industrial road. A maker of steel kitchenware asked for an FSC by a buyer in the Gulf goes to DGFT. A maker of Class C medical devices goes to CDSCO, and only after its manufacturing licence is in place.
Documents required
For a DGFT certificate
- Active IEC and DGFT portal login
- Product list with clear descriptions
- Proof of manufacture or sale in India, such as invoices
- Manufacturing licence or registration, where the product needs one
- Digital signature certificate of the authorised person
For a medical device FSC
- Cover letter with the authorised signatory’s details
- System-generated application with licence number and product list
- Bharatkosh challan for the fee
- Copy of the valid manufacturing licence
- Recently notarised undertaking on ₹100 stamp paper
From the company
- PAN and GST registration
- Company incorporation documents
- Authorisation for the person signing
How it works
Identify the right authority
We check your product against the Drugs and Cosmetics Act and the Medical Devices Rules. That tells us whether DGFT, CDSCO or the State Licensing Authority issues the FSC.
Confirm the base licences
We confirm your IEC is active and any manufacturing licence the product needs is valid.
Draft the application and file it
We draft the application and product list, prepare the undertaking where needed and file on the DGFT portal or the CDSCO medical device portal.
Answer queries and collect the certificate
We answer the authority’s queries and send you the certificate, ready for your buyer or for legalisation if needed.
Timelines
DGFT certificate: 2 years
A DGFT Free Sale and Commerce Certificate is valid for two years from issue, unless it says otherwise.
Medical device FSC: licence-linked
A CDSCO or State FSC for medical devices stays valid up to the validity of the manufacturing licence, provided no regulatory action has started.
IEC update every year
Your IEC must be updated between April and June each year. A deactivated IEC stops DGFT applications.
What happens if you ship without it
Product registration stalls
Without registration abroad, the product cannot be sold there.
Goods wait at the port
Shipments can sit at the destination port until the FSC arrives, running up demurrage.
Export-only products are refused
Here is the catch: CDSCO may refuse an FSC for a device made only for export. Get it licensed for sale in India first.
Frequently asked questions
Who issues a Free Sale Certificate in India?
It depends on the product. DGFT Regional Authorities issue the Free Sale and Commerce Certificate for freely exportable goods and for hospital items not covered by the Drugs and Cosmetics Act, under paragraph 2.34 of the Handbook of Procedures 2023. Drugs and cosmetics go to CDSCO. For medical devices, Class C and D go to the Central Licensing Authority and Class A and B to the State Licensing Authority. We confirm the right office before filing.
How long is a Free Sale Certificate valid?
A DGFT certificate is valid for two years from the date of issue, unless it states otherwise. A medical device FSC issued under CDSCO’s 2024 guidance is valid up to the validity of the manufacturing licence, as long as no regulatory action has been started against the manufacturer. Many buyers also want a recent certificate, so we plan renewals before a major tender or registration.
What is the fee for a medical device FSC?
CDSCO’s guidance sets the fee at ₹1,000 per category of medical devices, paid through Bharatkosh. The application is made online on the CDSCO medical device portal, with the challan, a copy of the manufacturing licence and a recently notarised undertaking on ₹100 stamp paper. We check the file before you pay, so nothing is filed twice.
Which form is used for a DGFT Free Sale Certificate?
Form ANF 2H, with its Annexure A, filed online on the DGFT portal from your IEC profile. The Regional Authority issues the certificate in the format of Annexure B to ANF 2H. The fee is as set in Appendix 2K. You need an active, updated IEC and a digital signature on the portal. With those in place, the filing is short.
Can I get an FSC for a product made only for export?
For medical devices, usually not. CDSCO’s guidance says the FSC may not be granted for products meant exclusively for export, because the certificate is about free sale in India. The device must be licensed for sale and distribution in India under the Medical Devices Rules, 2017. If you plan to export, get the domestic manufacturing licence first, and the FSC becomes straightforward.
Do I need an IEC to apply for a Free Sale Certificate?
Yes, for a DGFT certificate. The application is filed from your IEC profile on the DGFT portal, and the IEC must be active. IEC costs ₹500 and must be updated every year between April and June, even if nothing has changed. Exporters need an IEC to ship anyway, so most already have one. We check its status before filing.
What undertaking does CDSCO ask for?
A legal undertaking on ₹100 notarised stamp paper, stating that no action has been started against the manufacturer and that it has not been convicted for adverse events, market complaints or Not of Standard Quality reports. The notarisation must be recent. We draft the undertaking in the required wording, so you only need to sign it and get it notarised.
Does the importing country accept the FSC as issued?
Usually, but some countries also want the certificate legalised or apostilled before they accept it. The requirement comes from the importer’s regulator, not from India. Ask your buyer early what format, product wording and legalisation they need. We match the product description on the FSC to your buyer’s registration file, so the documents line up.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
| Certificate | Government fee |
|---|---|
| Medical device FSC (CDSCO / State) | ₹1,000 per category of devices |
| DGFT Free Sale and Commerce Certificate | As per Appendix 2K |
| IEC (if you do not have one) | ₹500 |
Ready to begin?
Tell us the product and the country you are shipping to, and we will get the right Free Sale Certificate issued.