CDSCO says approved r-DNA products need no separate export NOC for an export brand

What changed

The Central Drugs Standard Control Organization (CDSCO) has issued a notice clarifying the export NOC requirement for already approved r-DNA products, file r-DNA-15011(12)/119/2026. The file name dates it 12 October 2026 and the CDSCO public notices page lists it on 14 October 2026. CDSCO says it acted because stakeholders kept asking whether a separate export NOC was needed for r-DNA products that are already approved in India.

The notice says that where a firm holds a valid marketing authorisation in Form CT-23 for an r-DNA drug product, and seeks a product permission in Form 28-D for export of the same product, a separate export NOC from CDSCO is not required. Three conditions apply:

1. The product is the same as the one authorised under the marketing authorisation.
2. There is no change in the approved composition, specifications, strength, dosage form, presentation, packaging configuration, manufacturing site, manufacturing process or other critical particulars.
3. The only difference is a brand name proposed exclusively for export.

Eligible firms apply for the Form 28-D export permission through the ONDLS portal to the State Licensing Authority, which processes it and forwards it to the Central Licensing Approving Authority. For all other r-DNA products and cases, the firm must obtain a quantity-specific export NOC from CDSCO under the existing procedure.

Who it affects

• Indian manufacturers of recombinant biologics, such as recombinant proteins and biosimilars, that sell the same approved product abroad under a different brand.
• Hospitals, licensed importers, tender agencies and NGOs that source these products from India and see an export brand on the pack.
• Exporters that place approved r-DNA products into destination-specific presentations, since those changes keep the NOC step.

What it means for buyers

For a product identical to the Indian approved product, one regulatory step falls away when the manufacturer registers an export brand. That can shorten the time before a new export brand is first available, although the Form 28-D permission is still needed.

The notice is narrow. A change in pack configuration, presentation or manufacturing site keeps the quantity-specific NOC, and that NOC is issued per quantity, so repeat or larger orders may need a new one. Buyers who ask for a destination-specific pack should expect the longer route.

The notice was read directly from the CDSCO website. It does not change the cold-chain, quality release or destination import rules for these products. No law firm commentary on the notice was found when this update was written.

What to do now

1. Ask the manufacturer whether the product holds a Form CT-23 marketing authorisation in India and whether the export version differs only in brand name.
2. If you need a different presentation or pack configuration, ask how long the quantity-specific NOC will take and build it into the lead time.
3. Check that the export brand name matches what your own regulator has registered or approved, so labels and import documents agree.
4. Keep quantities stable where a quantity-specific NOC applies, since changes may need a new application.

For more on how Indian export approvals work, see Indian export rules buyers should know.