CDSCO Clarifies Export NOC Requirements for Already Approved r-DNA Drug Products

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, has reportedly issued a clarification concerning Export No Objection Certificate (NOC) requirements for already approved recombinant DNA (r-DNA) drug products intended for export from India.

According to the supplied notice summary, eligible firms holding a valid Marketing Authorization in Form CT-23 may apply for export product permission in Form 28-D without obtaining a separate Export NOC, provided the proposed export product remains identical to the approved product in all critical respects and only the export brand name differs.

1. Background of the CDSCO Clarification

The clarification addresses stakeholder queries about whether a separate Export NOC is necessary when a firm already holds a valid Marketing Authorization in Form CT-23 for an r-DNA drug product and intends to obtain product permission in Form 28-D for export purposes.

The situation concerns products that have already received Marketing Authorization in India and are proposed for export under a different brand name, without changes to their approved critical attributes.

2. Key Regulatory Clarification

According to the supplied notice details, a firm holding a valid Marketing Authorization in Form CT-23 may directly apply for export product permission in Form 28-D without first obtaining a separate Export NOC from CDSCO when all specified conditions are met.

• The existing Marketing Authorization must be valid.
• The proposed export product must be identical to the authorized product.
• Approved composition, specifications and strength must remain unchanged.
• Dosage form, presentation and packaging configuration must remain unchanged.
• The manufacturing site and manufacturing process must remain unchanged.
• No other critical product particulars may change.
• The proposed export brand name must be the only difference.

This is a conditional clarification, not a general exemption from Export NOC requirements for every r-DNA drug product.

3. Conditions for Applying Without a Separate Export NOC

Product identity and composition

The proposed export product must be the same product as the one already authorized, and its approved composition must remain unchanged.

Specifications and strength

Relevant approved specifications and strength must remain consistent with the existing authorization.

Dosage form, presentation and packaging

The dosage form, presentation and packaging configuration must meet the conditions stated in the clarification. Proposed variations should be assessed separately.

Manufacturing site and process

The manufacturing site and manufacturing process must remain unchanged under the stated conditions. A change in either should not automatically be treated as eligible for the exemption.

Export brand name

The proposed brand name must be intended exclusively for export and must be the sole difference from the already approved product.

4. Form 28-D Application Procedure Through ONDLS

Eligible applicants may follow the applicable procedure for export product permission through the Online National Drugs Licensing System (ONDLS), subject to confirmation of current official requirements.

1. Verify the Marketing Authorization: Confirm that the r-DNA drug product holds a valid Marketing Authorization in Form CT-23.
2. Compare the products: Review composition, specifications, strength, dosage form, presentation, packaging configuration, manufacturing site, process and other critical particulars.
3. Confirm the brand-name difference: Document that the export brand name is the only difference.
4. Prepare the application: Compile the required product details, authorization information and supporting documents for the applicable Form 28-D application.
5. Submit through ONDLS: According to the supplied notice summary, submit the application to the concerned State Licensing Authority (SLA) through the prescribed procedure.
6. Regulatory processing: The application is processed by the concerned SLA and forwarded to the Central Licensing Approving Authority (CLAA) for consideration and approval, as applicable.

Applicants should confirm the current portal workflow, required documents and authority responsibilities before submission.

5. When Is a Separate Export NOC Still Required?

The clarification does not establish a blanket exemption for all r-DNA drug exports. According to the supplied notice details, other r-DNA products or cases that do not satisfy the specified conditions continue to require a quantity-specific Export NOC from CDSCO under the applicable procedure.

A separate regulatory assessment is particularly important where there are changes to:

• Composition or specifications
• Strength or dosage form
• Presentation or packaging configuration
• Manufacturing site or manufacturing process
• Other critical product particulars

Companies should not assume that a different export brand name alone guarantees eligibility. The full set of conditions must be satisfied.

6. Compliance Checklist for Pharmaceutical Exporters

Before submitting an application, regulatory affairs teams should verify the following:

• A valid Marketing Authorization in Form CT-23 is available.
• The proposed export product is identical to the authorized product.
• Composition and specifications remain unchanged.
• Strength, dosage form and presentation remain unchanged.
• Packaging configuration remains unchanged.
• Manufacturing site and process remain unchanged.
• No other critical product particulars have changed.
• The export brand name is the sole difference.
• Required Form 28-D application documents are prepared.
• The appropriate regulatory pathway is confirmed for cases outside the exemption.

This checklist is a practical compliance aid and does not replace applicable statutory requirements or a product-specific regulatory assessment.

7. Regulatory Implications for Pharmaceutical Manufacturers and Exporters

Simplified export permission process

Eligible firms may proceed with the applicable Form 28-D application without the additional step of obtaining a separate Export NOC.

Reduced regulatory duplication

Where the product has already been authorized and its approved attributes remain unchanged, the clarification may reduce an additional regulatory step associated solely with a different export brand name.

Improved export planning

Manufacturers can assess proposed export branding and documentation requirements earlier, supporting coordination between commercial, quality and regulatory affairs teams.

Continued compliance obligations

The exemption applies only to eligible cases. Companies must continue to meet applicable export permission requirements and should not interpret the clarification as automatic product approval or a waiver of all regulatory obligations.

8. How ACPL Can Support Pharmaceutical Regulatory Compliance

Accredited Consultants Pvt. Ltd. (ACPL) provides regulatory consultancy support for pharmaceutical companies navigating product approvals, documentation and compliance requirements.

Depending on the product and applicable regulatory pathway, ACPL can assist with:

• Regulatory pathway assessment
• Review of existing product authorization and proposed export changes
• Regulatory documentation and dossier review
• Application preparation and submission support
• Regulatory query coordination
• Export-related regulatory compliance guidance

A product-specific assessment can help companies determine whether their proposed export application appears to meet the stated conditions or requires further regulatory review.

9. Frequently Asked Questions

Is a separate Export NOC required for every approved r-DNA drug product?

Not necessarily. According to the supplied clarification, eligible products may proceed directly with the applicable Form 28-D application without a separate Export NOC, provided all stated conditions are met. Other cases may continue to require a quantity-specific Export NOC.

Can an approved r-DNA drug be exported under a different brand name?

The described exemption may apply when the export brand name is the only difference and the product remains identical in all specified critical respects. Applicable product permission requirements must still be fulfilled.

What is Form CT-23 in this context?

The supplied regulatory update identifies Form CT-23 as the existing Marketing Authorization for the approved r-DNA drug product.

What is Form 28-D used for in this update?

The supplied notice summary identifies Form 28-D as the form for applying for product permission for export purposes under the described procedure.

Where should eligible applicants submit the application?

According to the supplied summary, the application is submitted through ONDLS to the concerned State Licensing Authority for processing and subsequent consideration by the Central Licensing Approving Authority, as applicable.

What happens if the manufacturing site or composition changes?

Such a change falls outside the stated conditions for the described exemption. The company should obtain a product-specific regulatory assessment and confirm the applicable approval and Export NOC requirements.

Conclusion

The CDSCO clarification dated 12 October 2026, as described in the supplied regulatory update, may simplify the export product permission process for already approved r-DNA drug products when the proposed export brand name is the only difference and all specified product attributes remain unchanged.

Pharmaceutical manufacturers and exporters should review their existing authorization, proposed export product and application documents before relying on the exemption. Cases outside the stated conditions may continue to require a quantity-specific Export NOC under the applicable procedure.

Reference: CDSCO Notice No. r-DNA-15011(12)/119/2026-eoffice (E-office No. 41325), dated 12 October 2026. Verify the original notice before publication.

Disclaimer: This article is for general regulatory information and does not constitute legal or regulatory approval advice. Requirements depend on applicable legislation, official directions and product-specific circumstances.