CDSCO issues revised Guidance Document for Export NOC of Unapproved and Approved New Drugs

CDSCO issues revised Guidance Document for Export NOC of Unapproved and Approved New Drugs

Central Drugs Standard Control Organisation (CDSCO) has released a guidance document related to  the issuance of No Objection Certificates (NOCs) for manufacturing unapproved or approved new drugs intended for export. The updated guidance, issued in May this year, includes changes particularly for unapproved fixed-dose combinations (FDCs) under the finished formulation category.
Manufacturers of unapproved formulations, including FDCs, can now submit approval from a Stringent Regulatory Authority (SRA) such as the US, EU, Canada, Japan, Australia, or Switzerland. If approval from the importing country’s National Regulatory Authority (NRA) is not available. Previously, NRA approval was mandatory.

The guidance document also extends similar flexibility to NCE batches used in research. In cases where NRA approval is unavailable, manufacturers can now submit IUPAC name details, Certificate of Analysis (CoA), and Standard Temperature and Pressure (STP) data.

It also introduces a two-step NOC process: registration at the zonal CDSCO office followed by consignment clearance at the port. Export NOCs would be valid for one year or until the approved quantity is exhausted, whichever comes first. Unused stock of formulations with less than 60% shelf life, or APIs with under three months' shelf life, must be destroyed under State Licensing Authority (SLA) supervision.

For NDPS and banned drugs, the NOC will continue to be issued on a per-order or per-consignment basis, specifying quantity and purchase order details.

Click here access the guidance document

Tags: CDSCO, Guidance Document, NOC