Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document outlining the procedure for manufacturers to obtain a No Objection Certificate (NOC) for the manufacture of unapproved or approved new drugs exclusively for export purposes.

Manufacturers holding valid licenses in Form 25, Form 28, or Form 28-D (including loan licenses) can apply for an Export NOC through zonal CDSCO offices. The process has two distinct steps:

Step I: One-time Online registration process with zonal office

• Applicant must fill an Integration Registration Form (IRF) before the grant of Export NOC which needs to be verified by the concerned zonal office and the NOC will be issued within 7 working days which will be valid for 1 year.
• The following documents needs to be submitted along with the application:
  • Export NOC Form/IRF
  • Legal Undertakings
  • Valid manufacturing license copy (Form 25/28/28-D and loan license)
  • Reconciliation data of previous NOCs
  • NRA approval status of importing country or alternate supporting documents based on drug type.
  • In case NRA approval of the importing country is not available, the following documents may be submitted-

A. For Active Pharmaceutical Ingredients (API)-

1. 1. Approved drugs – Approval status by CDSCO may be submitted.
   2. Unapproved API – The API / Bulk drug’s Pharmacopeial status in IP/USP/BP/JP/EP may be submitted
   3. Unapproved API of NDPS category in India & Banned API in India: NRA approval of the importing country is mandatory to submit.

B. Finished Formulation (FF):

1. 1. Approved New Drugs in India: In case of Approved New Drugs (FF) approval status as issued by CDSCO may be submitted.
   2. Unapproved Formulation in India: Approval status in SRA Country (United States/ European Union Member States/ Canada/ Japan/Australia/Switzerland)/Importing country may be submitted.
   3. Unapproved (fixed dose combination) FDC in India, Unapproved NDPS Drugs in India & Banned Drugs in India: NRA approval of the importing country is mandatory to submit.

C. R & D Batches:

1. 1. API: The API / Bulk drug’s Pharmacopeial status in IP/USP/BP/JP/EP may be submitted. Further, if formulation of the said API is approved in SRA country (United States/ European Union Member States/ Canada/ Japan/Australia/Switzerland) &(or) Importing country &(or) India may be submitted.
   2. Formulation: Approval status of any SRA Country (United States/ European Union Member States/ Canada/ Japan/Australia/Switzerland) and (or) Importing country may be submitted

D. NCE Batches:

1. 1. NCE –Batches for Clinical trials, DMF/ANDA filings: The firm is required to submit IUPAC name details, COA & STP.

Step II: Procedure for release of consignment at port office

After getting a NOC applicant have to submit details at the time of release of an consignment which will be verified by the concerned port office.

All the necessary details will be submitted in online mode.

• Documents Required at Port Office:
  • Valid Export NOC (auto-fetched)
  • Reconciliation details for exported quantity
  • Certificate of Analysis (COA)/Batch Release Certificate
  • Purchase Order/Export Invoice/Shipping Bill details
  • Product label
  • Export license from State Licensing Authority