What Is a Neutral Code? Export Codes for Medical Devices and Drugs

Your overseas buyer has asked for a neutral code on the export consignment, and the shipment cannot leave until it is printed on the packs. In India the route to that code now depends on what you make. Medical device manufacturers generate it on CDSCO’s online portal against their manufacturing licence; drug exporters apply with an export NOC file. Medfins International handles both.

What a neutral code is

A neutral code is a code granted for products manufactured in India for export, which is printed on the export packaging. Exporters usually need one because the foreign buyer has asked for it: CDSCO’s checklist for drugs expects a letter from the buyer stating that requirement. For drugs, CDSCO’s checklist calls the general version a special code; the term neutral code appears in its narcotics checklist and in the medical device notices.

Medical devices: the code is now generated online

CDSCO moved neutral code requests for medical devices onto its Online System for Medical Devices at cdscomdonline.gov.in, as reported by Medical Dialogues in February 2024. The process then changed again:

• CDSCO public notice MED/52/2024-eoffice-Part (1), dated 9 April 2025, provides a system auto-generated neutral code for export purposes.
• It is available to manufacturers holding a valid manufacturing licence, through an option in the approved licence on the manufacturer’s dashboard.
• From the implementation date, the earlier issuance of neutral codes by the Central Licensing Authority is non-functional.

In practice there is no separate application file for a device neutral code. The code hangs off your approved licence, so the licence must be valid and must cover the products you are exporting. If it does not, the licence needs amending first through the CDSCO manufacturing licence process.

Drugs: a special code with the export NOC

For finished formulations and bulk drugs, CDSCO’s special code checklist asks for these documents, tagged serially:

1. Application for Export NOC on company letterhead, duly signed.
2. Valid export order on the foreign buyer’s letterhead, stating the quantity and name of the drug.
3. A letter from the foreign buyer on its letterhead stating the specific requirement for a special code number.
4. Copy of the valid manufacturing licence issued by the State Licensing Authority.
5. Copy of the product permission, or the NOC for export of the specific product.
6. Prototype packing material (labels, cartons, leaflets, blister foil) showing the code.
7. For banned drugs, a valid registration certificate from the importing country’s Ministry of Health.

For narcotic drugs and psychotropic substances the checklist adds a neutral code from the State Licensing Authority and an NOC from the importing country’s regulator for the drug carrying the neutral or special code.

Neutral code, Free Sale Certificate and export NOC are different documents

• Neutral code: an identifier printed on export packs.
• Free Sale Certificate: confirms a licensed device is freely sold in India. CDSCO guidance says it may not be granted for products made only for export.
• Export NOC (drugs): permission to export a specific product.

Importing countries usually ask for more than one of these, plus their own registration. None of them replaces the registration in the destination market.

Where this goes wrong

Using the old route for devices. Since the April 2025 notice, issuance by the Central Licensing Authority is non-functional. Requests sent outside the portal do not move.

A licence that does not cover the product. The device code is generated from the approved licence. A product missing from that licence cannot be given a code until the licence is amended.

No buyer letter for drugs. The drug checklist expects the foreign buyer to state the special code requirement on its own letterhead. An export order alone is not enough.

Packaging prototypes without the code. The drug checklist asks for labels and cartons that already show the code. Artwork prepared without it sends the file back.

Frequently asked questions

Sources: CDSCO public notice MED/52/2024-eoffice-Part (1), 9 April 2025; CDSCO checklist for special code for export of drugs; Medical Dialogues, 21 February 2024. Need the code for your next consignment? Talk to our team.