The Central Drugs Standard Control Organization (CDSCO) has issued a clarification stating that pharmaceutical companies may not need a separate Export No Objection Certificate (NOC) for certain already approved recombinant DNA (r-DNA) drug products intended for export.
According to the notice, when a company holds a valid Marketing Authorization in Form CT-23 for a particular r-DNA drug product and seeks product permission in Form 28-D for export purposes for the same product, a separate Export NOC from CDSCO will not be required, provided specified conditions are fulfilled.
The exemption applies only when the product is identical to the product already covered by the valid Marketing Authorization. There must be no change in its approved composition, specifications, strength, dosage form, presentation, packaging configuration, manufacturing site, manufacturing process or other critical product particulars. The only difference permitted under this clarification is the brand name proposed exclusively for export.
CDSCO stated that the product has already undergone evaluation and received Marketing Authorization. Therefore, introducing a different brand name solely for export purposes, without making substantive changes to the product or its approved quality attributes, will not by itself necessitate a separate Export NOC from the central regulator.
Eligible applicants may directly submit an application for product permission in Form 28-D for export purposes through the Online National Drugs Licensing System (ONDLS) portal to the concerned State Licensing Authority (SLA). The application will subsequently be processed by the concerned authority and forwarded to the Central Licensing Approving Authority (CLAA) for consideration and approval in accordance with applicable statutory and regulatory requirements.
The notice also makes clear that the relaxation is limited to cases in which the product's identity and approved quality attributes remain unchanged and the proposed export-specific brand name is the sole difference from the already authorized product. For all other r-DNA products or cases not covered by this clarification, companies will continue to be required to obtain a quantity-specific Export NOC from CDSCO under the existing regulatory procedure.
The clarification is expected to provide greater procedural clarity for pharmaceutical companies exporting already approved r-DNA drug products under different brand names. However, it does not remove the requirement to obtain the applicable export product permission or comply with other regulatory requirements.
