India regulations to implement a Track and Trace system for export of pharmaceuticals and drug consignments were introduced as a phased programme to address counterfeit and ineffective product recall challenges under the control of the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry from 2011.
Core features are:
- Product Item serialisation and aggregate level to pallet
- Track & Trace reporting to Government Database: DAVA (Drugs Authentication and Verification Application)
- All exported drugs are in scope (Rx and OTC)
- Specific requirements on use of the Pack Level indicator (1st character of the GTIN-14 that are narrower than the GS1 standard)
These requirements pose a challenge for EU-FMD requirements in relation to the treatment of GTINs and OTC products.
SecurMed has issued information on the identification of Indian Coding of packs with guidance on how to identify the packs in comparison with EU FMD compliant packs. The MHRA, is expected to issue further information for the wholesale community.