India

India Domestic Supply – Proposed

v. 1.1 – 04/17/16

Serialization Model Track and Trace
Governing Body Ministry of Health & Family Welfare (MoHFW)
Compliance Date TBD

  • 16 March 2017 Public Notice issued indicating that a program for barcoding similar to that for export requirements
  • Public comments due by 15 April 2017
Randomization Requirements TBD
Data Repositories TBD
Aggregation Requirements TBD
Primary Package Data Carrier TBD
Primary Package HRI TBD
Logistics Unit Data Carrier TBD
Logistics Unit HRI TBD
Additional Notes

India Export

v. 2.05 – 05/06/17

Serialization Model Track and Trace
Governing Body Directorate General of Foreign Trade (DGFT)
Compliance Date
  • Primary Pack – TBD
  • Intermediate Package (excluding mono carton, which is optional) and Logistics Regultaion in effect
Randomization Requirements No
Data Repositories
  • Non-SSI manufacturers to report secondary and tertiary packs data to DAVA starting April 1, 2016; SSI by April 1, 2017
  • Also required to submit DAVA implementation readiness form to DAVA Support
  • Full Parent-Child relationship submissions per below timing (see “Aggregation Requirements”)
  • DAVA portal requires indicator digit assignments 0,1,2,3,5 for primary; secondary (inner, second, outermost); tertiary pack levels
Aggregation Requirements Yes, all three (3) levels:

  • By April 1, 2016 for non-SSI manufacturers
  • By April 1, 2017 for SSI manufacturers
Primary Package Data Carrier (Optional) GS1 Data Matrix encoded with GTIN, Serial Number, Lot, and Expiry Date–defined as in the packaging in direct contact with the drug
Primary Package HRI (Optional) GS1 Data Matrix encoded with GTIN, Serial Number, Lot, and Expiry Date–defined as in the packaging in direct contact with the drug
Logistics Unit Data Carrier GS1-128 encoded with GTIN, Lot, and Expiry Date (SSCC-18 also recommended)
Logistics Unit HRI Not specified
Additional Notes