The Central Drugs Standard Control Organisation (‘CDSCO’), has issued a revised Guidance Document on Export NOC with a list of alternate documents that may be submitted by applicants while filling the integrated registration form (“IRF”), in case the National Regulatory Authority (“NRA) Approval issued by the importing country is not available.
Key Highlights:
As per the revised Guidance Document, following documents can be submitted in place of NRA approval :
For Active Pharmaceutical Ingredient (API):
- Approved New Drugs in India: The Approval status as issued by CDSCO may be submitted.
- Unapproved APIs in India: The API / Bulk drug’s Pharmacopeial status in IP/USP/BP/JP/EP may be submitted.
- Unapproved API of NDPS category in India & Banned API in India: NRA approval of the importing country is mandatory to submit.
For Finished Formulation (FF):
- Approved New Drugs in India: the approval status as issued by CDSCO may be submitted.
- Unapproved Formulation in India: Approval status in SRA Country (United States/ European Union Member States/ Canada/ Japan/Australia/Switzerland)/Importing country may be submitted.
- 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.
For R & D Batches:
- 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.
- Formulation: Approval status of any SRA Country (United States/ European Union Member States/ Canada/ Japan/Australia/Switzerland) and (or) Importing country may be submitted.
For NCE Batches:
- NCE –Batches for Clinical trials, DMF/ANDA filings: The firm is required to submit IUPAC name details, COA & STP.
In case of third country exports, all the above requirements are applicable to destination country/end use country.
Source: Central Drugs Standard Control Organisation
