India tweaks coding rules for pharma exports

The implementation of India's track-and-trace system for pharma exports continues to evolve, with another amendment published this month.

The Directorate General of Foreign Trade (DGFT) issued a notice changing the way it intends to handle exports of pharmaceuticals to countries which already mandate a specific coding requirement.

The current law requires manufacturers of exported pharmaceuticals to barcode medicine packs with unique serial numbers, record the relationship between primary, secondary and tertiary packaging (aggregation) and report data to India's Drug Authentication and Verification Application (DAVA) portal.

Previously, in cases where the importing country had a specific coding requirement, the exporter was able to request exemption from India's primary and secondary packaging requirement via an application to the Drug Controller General of India (DCGI) or a nominee.

Now, companies must file exemption requests with the Pharmaceuticals Export Promotion Council of India (Pharmexcil), which will "dispose of such applications on case to case basis with prior approval of government." Tertiary packaging must comply with the DGFT requirements as before.