The Central Drugs Standard Control Organization (CDSCO) on October 12, 2026, issued a clarification regarding the requirement of an Export NOC for Already Approved r-DNA Products.
The following has been stated: -
•This notice issued by the CDSCO clarifies that a separate Export NOC is not required for firms holding a valid Marketing Authorization in Form CT-23 for an r-DNA drug product when applying for export permission in Form 28-D.
•This exemption applies only if the product, its composition, specifications, strength, dosage form, packaging, manufacturing site, and process remain identical to the approved version.
•The sole permissible change is using a brand name proposed exclusively for export purposes. Eligible applicants can directly submit an application for product permission in Form 28-D to the concerned State Licensing Authority without obtaining a separate NOC from CDSCO.
•The application will subsequently be processed and forwarded to the Central Licensing Approving Authority for final approval under applicable statutory regulations.
The detailed notification is given in the document below.
[Notification No.: r-DNA-15011(12)/119/2026-eoffice (E-office no. 41325)]
