CDSCO revises export NOC guidance document for new drug formulations

The CDSCO has updated its guidelines for issuing export NOCs for new drug formulations, including relaxations for FDCs, research-oriented drug batches, and SRA approvals

The Central Drugs Standard Control Organisation (CDSCO) has revised its guidance document for issuing no-objection certificates (NOCs) for the manufacture of approved or unapproved new drugs intended exclusively for export. 

 

The updated framework, previously notified in May this year, introduces relaxations for fixed-dose combinations (FDCs) and research-oriented drug batches.

 

As part of the revised document, manufacturers of unapproved FDCs will now be allowed to submit regulatory approvals from Stringent Regulatory Authorities (SRAs) such as the United States (US), European Union (EU), Canada, Australia and Japan as an alternative to approvals from the National Regulatory Authority (NRA) of the importing country. 

   

Earlier, an NRA approval was mandatory for unapproved FDCs, new drugs under the Narcotic Drugs and Psychotropic Substances (NDPS) category, and banned drugs.

 

The updated guideline also permits the submission of SRA approvals in cases where NRA clearance of the importing country is not available, easing the regulatory burden on Indian pharmaceutical exporters catering to international markets with more advanced drug oversight systems.

 

The revised guidance also entails discontinuation of quantity and purchase order (PO)-specific NOCs for all classes of drugs, except for NDPS and banned drugs. 

 

The apex regulatory body also clarified that exporters of New Chemical Entity (NCE) batches for research purposes can now submit International Union of Pure and Applied Chemistry (IUPAC) names, and standard temperature and pressure (STP) data, if NRA approval of the importing country is not available.

 

The previous document provided this option to NCE batches for clinical trials and Abbreviated New Drug Applications (ANDAS), but did not elaborate on providing the same for other NCE research activities.

 

In May this year, the CDSCO formalised a two-step process for securing export NOCs, with the first step involving a one-time registration at the CDSCO zonal office, submission of legal documents, manufacturing licenses, reconciliation data, and regulatory approvals. 

 

The second step entailed clearance of consignments at the port office through online submission of export documents.

 

Each NOC will be valid for one year or until the approved export quantity is exhausted, whichever comes first. The CDSCO has also set a seven-day timeline for NOC issuance under the new system.

 

The revised guidance document for issuance of NOC for manufacture of unapproved and new drugs comes after the CDSCO had centralised this process in July last year.

 

These powers were earlier delegated to State and Union Territory (UT) Licensing Authorities, before the apex drug regulator had withdrawn them over complaints of non-compliance of rules in issuing export NOCs.

 

The CDSCO had also asked states to hand over all NOCs issued from August 20, 2018 to May 14, 2024 to it.