India – Export

v. 13 – 2020/01

Market Executive Summary Phased implementation, starting with 2D coding through consolidation on GS1 standards to serialisation and traceability based on Gvt DB: “IVEDA” (formerly “DAVA”) for all medicines exported from India.

Note that where India requirements clash with receiving market – for example 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 serialise 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 markets 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 implement the Track and Trace system for maintaining the parent-child relationship in packaging levels and its uploading on the Central (IVEDA) portal from 01 April 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.

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 has been extended from 01 Apr 2020 to 01 Octo 2020 for both SSI (small scale industry) and non-SSI manufacturers.

Key Dates
  • 01 April 2020: The director of Foreign Trade announced that the date for implementation of the Track and Trace is now extended to 01 Oct 2020.
  • Jul 2019: The date for implementation of Track and Trace for export of drug formulation with respect to maintaining parent-child relationship in packaging levels and uploading on Central Portal has (been extended to 01.04.2020 for both SSI and non-SSI manufactured drugs.
  • 01 April 2016: Data reporting to DAVA portal (including aggregation) for larger manufacturers only (non SSI “Small Scale Industry” manufactured drugs
  • 01 Jan 2013: Requirement for manufacturer to mark medicinal products at secondary and tertiary level (primary level is optional).
  • 01 Oct 2011: Requirement on manufacturers to mark medicinal products at tertiary level.