India gives small pharmacos extension on DAVA compliance

India has amended the implementation period for the Drug Authentication and Verification Application (DAVA) once again.

In a notice dated January 5, India's Directorate General of Foreign Trade (DGFT) has confirmed that smaller drugmakers have been given a one-year extension on various requirements, such as uploading of track-and-trace data to the DAVA portal.

Specifically, the notice refers to the parent-child relationship (aggregation) data between primary, second and tertiary packaging. Maintaining parent-child data for primary and secondary packaging and uploading it to the DAVA was deemed optional in guidance issued last year by the DGFT for all pharma exporters.

Now however, the DGFT has set a date of March 31, 2017 for small scale industry (SSI) companies and March 31, 2016, for larger companies.  Any product manufactured before those dates is exempted from the requirements.

The DAVA system applies to pharma manufacturers who wish to export drugs to other countries, and envisages the printing of a barcodes onto the primary pack, secondary and tertiary packaging  - incorporating a 14-digit global trade identification number (GTIN) plus the batch number, expiry date and a unique serial number.  Adding the codes to the primary packaging is exempted until further notice by the DGFT.