India Compliance

As of 21 Feb 2021, India Compliance supports only reports intended for India's new iVEDA portal. Reports intended for the discontinued DAVA portal no longer generate but remain in the Web UI for historical purposes.

India Compliance Overview

The TraceLink India Compliance application (app) helps companies comply with the India government's serialization and reporting requirements.

Use the India Compliance app to generate reports to comply with the requirements of the India Exportation Law. The reports generated from India Compliance meet the system requirements of the Integrated Validation of Exports of Drugs from India and Its Authentication (iVEDA) portal and can be signed and uploaded to the portal.

The India Compliance app generates reports automatically when certain events occur or when a user initiates a report manually in Serialized Operations Manager. TraceLink then sends the report to the company that generated it, using an Info Exchange message.

After receiving the reports, the company can sign them and upload them to the iVEDA portal.

If the Pharmaceutical Manufacturer does not physically produce the products, they must send the reports to the CMO to sign and send to the Indian government.

The Government of India's Ministry of Commerce and Industry introduced the Foreign Trade Policy, 2015-2020, which outlines serialization requirements for products manufactured in India for export. The law in its current state places compliance responsibility on Pharmaceutical Manufacturers as the brand owner. See Paragraph 2.04 of the Foreign Trade Policy 2015-2020 for more information. The requirements address:

  • Serialization
  • Reporting
  • Product Verification

Getting Started in India Compliance

A Pharmaceutical Manufacturer or Exporter with administrator access must configure workflows to generate reports.

See Configure Event Workflows and Event Triggers for configuration details.

Some optional fields might be mandatory based on India's regulatory requirements. Download the Quick Reference Guide to view their specific required fields.

Available Functions

The table on the Search Compliance Reports screen shows the India Compliance reports that TraceLink has created. Change the reports displayed by altering any of the available search criteria.

The View Product Report Details screen displays all details associated with the specific Product report.

The View Export Tertiary Packaging Report Details screen displays all details associated with the specific Export Tertiary Packaging report. Aggregation information for the Export Tertiary Packaging reports can be viewed on the View Aggregation Hierarchy and View [Packaging Level] Pack Level screens.

The following screens display details for legacy India Compliance report types previously generated for the discontinued DAVA portal: