CDSCO revises export NOC rules for new drugs; sets one-year validity

New CDSCO rules set one-year validity for export NOCs, fix seven-day timeline, and simplify process for unapproved and approved drugs meant solely for export

The country’s apex drugs regulator has revised the procedure to issue export no objection certificate (NOC) for manufacture of approved and unapproved new drugs solely for export purposes.

 

According to the Central Drugs Standard Control Organisation (CDSCO), the export NOC will now have one-year validity from the date of registration or exhaustion of the sanctioned amount, whichever is earlier. The revised document also fixes the timeline for issuance of the NOC to seven days.

 

There will be a two-step process to apply for the export NOC.

 

The first would include a one-time online registration, submission of export NOC form, legal undertakings, copy of manufacturing license and reconciliation data.

   

The second step would be the procedure for release of consignment at the port office, including submission of documents online. 

 

The revised guidelines, however, discontinue quantity specific and purchase order specific NOCs except for Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs.

 

For the issuance of export NOC for NDPS drugs and banned drugs, a quantity-specific and purchase order-specific NOC will be issued for each order or consignment

 

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were earlier delegated to State and Union Territory (UT) Licensing Authorities, before the apex drug regulator had withdrawn them over complaint of non-compliance of rules in issuing export NOC’s

 

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