Clarification regarding requirement of Export NOC for already approved r-DNA products.

The Central Drugs Standard Control Organization (CDSCO) has issued a clarification regarding the requirement of Export NOC for already approved r-DNA drug products. The notice specifies that firms possessing a valid Marketing Authorization in Form CT-23 for an r-DNA product may directly apply for product permission in Form 28-D for export purposes without obtaining a separate Export NOC from CDSCO.   This exemption is applicable only when the export product remains identical to the approved product in terms of composition, specifications, strength, dosage form, presentation, packaging configuration, manufacturing site, manufacturing process, and other critical quality attributes.   A different brand name intended exclusively for export will not necessitate an Export NOC. Applications may be submitted through the ONDLS portal to the concerned State Licensing Authority and processed as per applicable regulatory requirements.