v. 15 – Q3 2020
|Market Executive Summary||
Phased implementation, starting with 2D coding through consolidation on GS1 standards to serialization and traceability based on Gvt. DB: “IVEDA” (formerly “DAVA”) for all medicines exported from India. Note that where India requirements clash with receiving market (i.e. EU), the company can apply to Pharmexcil (Pharmaceutical promotional council for India) to have their primary and secondary packs exempted from the DGFT coding (but need to still serialize pallet level and upload to the DAVA portal: SSCC number and QTY of sub-items). This will still be a problem for Canada, New Zealand, Australia, etc. because in those makets, there are currently no requirements in place and therefore, no exemption can be applied for.
DAVA Portal is being replaced by IVEDA Portal. This means pharmaceutical exporters in India will now have to implemented the Track and Trace system for maintaining the parent-child relationship in packaging levels and its uploading on the Central (IVEDA) portal from April 1, 2020.
While generally aligned to GS1 standards, recently the inclusion of QR codes outside the GS1 standard have been in discussion. See Note 9 for related links.
The Beta Version of IVEDA web portal (which will be replacing the DAVA portal) was launched on June 24, 2020. It is live now (in Beta version) at www.iveda-india.in and available to companies for data upload until July 25, 2020.
The data pertaining to all export consignments starting from June 1, 2020 pertaining to finished drug formulations must be uploaded to the Beta version of the IVEDA portal, and subsequently, on the final version.
Major Development: Implementation for Track and Trace for export of drug formulations with regard to maintaining Parent-Child relationships in packaging levels and its uploading to the Central Portal, IVEDA has been extended from April 1, 2020 to October 1, 2020 for both SSI (small scale industry) and non-SSI manufacturers.
DGFT Notification (Notification no. 13/2015-2020): The prohibition on the export of hydroxychloroquine and formulations that are made from hydroxychloroquine has been lifted as of June 18, 2020.