Published: 15 Oct 2026
CDSCO Clarifies: No Separate Export NOC for Already-Approved r-DNA Drugs When Only the Export Brand Name Differs
Omega QMS Compliance Insights
Omega QMS
The Central Drugs Standard Control Organization (CDSCO) has clarified that a separate Export NOC is not required to export an already-approved r-DNA (recombinant DNA) drug when the only difference is a brand name used exclusively for export. The clarification comes in a notice dated 12 October 2026 and was listed on the CDSCO website on 14 October 2026.
If your company manufactures or exports r-DNA drug products from India, here is what the notice says, who it applies to, and what to check before you apply.
Why did CDSCO issue this clarification?
CDSCO had been receiving queries from stakeholders on whether a separate Export NOC from CDSCO is needed to export already-approved r-DNA drug products. The notice answers this for one specific scenario: the same approved product, exported under a different brand name.
CDSCO’s reasoning is that the product has already been evaluated and granted Marketing Authorization. A different export-only brand name, by itself, involves no substantive change to the product or its approved quality attributes.
What has changed?
A separate Export NOC from CDSCO is not required where a firm:
- holds a valid Marketing Authorization in Form CT-23 for a particular r-DNA drug product, and
- intends to seek product permission in Form 28-D for export of the same product.
This applies only if all three conditions are met.
The three conditions
Same product.
The product is the same as the one already authorized under the valid Marketing Authorization.
No change in approved particulars.
There is no change in the approved composition, specifications, strength, dosage form, presentation, packaging configuration, manufacturing site, manufacturing process or other critical product particulars.
Brand name is the only difference.
The only difference is a brand name proposed exclusively for export.
How to apply under the new clarification
Eligible applicants can submit the Form 28-D application for export purposes directly to the concerned State Licensing Authority (SLA) through the ONDLS portal, without first obtaining a CDSCO Export NOC.
The process then works like this:
The firm files the Form 28-D application on ONDLS with the concerned SLA.
The SLA processes the application.
The SLA forwards it to the Central Licensing Approving Authority (CLAA).
The CLAA considers and approves it under the applicable statutory and regulatory requirements.
The notice removes the Export NOC step for eligible cases, but CLAA approval is still required. Approval is not automatic.
Eligible cases vs. all other r-DNA cases
| Eligible cases (all conditions met) | All other r-DNA cases | |
|---|---|---|
| Who is covered | Firm with a valid Form CT-23 Marketing Authorization seeking Form 28-D export permission for the same product | r-DNA products or cases not covered by the clarification |
| Export NOC from CDSCO | Separate Export NOC not required | Quantity-Specific Export NOC required under the existing procedure |
| Product particulars | Unchanged; only an export-exclusive brand name differs | Any case where the conditions are not met |
| Form 28-D route | Directly to the concerned SLA via ONDLS, then forwarded to CLAA for approval | Not addressed in this notice |
Who is affected?
- Manufacturers and exporters holding a Form CT-23 Marketing Authorization for an r-DNA drug who want to export it under a different brand name.
- State Licensing Authorities and State/UT Drugs Controllers, who will receive and process these applications.
- Firms in any other r-DNA case, who must still obtain a Quantity-Specific Export NOC from CDSCO.
What businesses should keep in mind
If even one condition is not met, the case falls outside the clarification and a Quantity-Specific Export NOC is still needed.
Before applying, prepare a record showing the export product is identical to the authorized product in every approved particular, with the export-exclusive brand name as the only difference.
The notice does not define it, so any change beyond the listed attributes should be assessed carefully before you rely on the clarification.
The SLA receives your application, but the CLAA decides on it.
If your case involves any change other than the export brand name, plan for the Quantity-Specific Export NOC route.
Frequently asked questions
Is an Export NOC from CDSCO still needed for r-DNA drugs?
Yes, in cases not covered by the clarification. A Quantity-Specific Export NOC is still required under the existing procedure. It is not required only where the three conditions above are all met.
Which forms are involved?
Form CT-23 (Marketing Authorization) must be valid, and Form 28-D is the application for product permission for export purposes.
Where do I submit the Form 28-D application?
Eligible applicants submit it to the concerned State Licensing Authority through the ONDLS portal. The SLA processes it and forwards it to the CLAA for consideration and approval.
Can I change the packaging or manufacturing site and still use this route?
No. Any change in packaging configuration, manufacturing site, manufacturing process or the other listed particulars takes the case outside the clarification.
Does the notice have an effective date?
The notice does not state a separate effective date. It is dated 12 October 2026.
How Omega QMS can help
Omega QMS helps businesses navigate India’s regulatory framework, including BIS certification, customs regulations, import-export procedures, QCO compliance and CDSCO-related permissions. If you plan to apply for export permission for an r-DNA drug product, our team can help you check eligibility under this clarification, prepare your Form 28-D application, and plan the right route if you fall outside it.
Exporting an r-DNA Drug Under a Different Brand Name?
Contact Omega QMS today to discuss your export permission requirements.
Notice details
- File No.: r-DNA-15011(12)/119/2026-eoffice (E-office no. 41325)
- Subject: Clarification regarding requirement of Export NOC for already approved r-DNA products
- Dated: 12 October 2026; listed on the CDSCO website on 14 October 2026
- Issued by: Directorate General of Health Services, CDSCO
- Addressed to: All State/UT Drugs Controllers and all stakeholders
- Signed by: Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India) cum Central Licensing Authority
- Source: CDSCO official website
This article is for informational purposes only and does not constitute legal advice. Please refer to the original CDSCO notice and consult a qualified regulatory professional for your specific case.
