India Compliance

TraceLink’s India Compliance application generates and stores the reports of serialized product events required by India’s Directorate General of Foreign Trade.

India’s export regulations require serialization of pharmaceutical products at the secondary (saleable unit) and tertiary (case or shipper) levels. Exporters must provide compliance reports to India’s Drugs Authentication and Verification Application (DAVA) system.

TraceLink’s India Compliance application monitors TraceLink’s applications for reportable events. The India Compliance application generates reports when:

  • Product Master Data is created or updated
  • An order for a batch is placed, prior to production
  • A batch is produced
  • A batch is shipped by a manufacturer or a wholesale distributor
  • Note: To meet India’s compliance requirements, you must upload these reports to the DAVA portal
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