October 16, 2019,

All pharmaceutical companies who intend to import Active Pharmaceutical Ingredients (API) can import without any categorization henceforth.  However, all API import must have Drug Master File (DMF) or Active Substance Master File (ASMF).

The DMF /ASMF should be directly sent or made available in electronic copy to Director, Drug Evaluation and Research. The DMF or ASMF is required to obtain import permit.

Thank you for your usual co-operation.