India DGFT Provides New Update on Compliance Requirements

Based on feedback that the India Directorate General of Foreign Trade (DGFT) received following their April draft notice, they have published updated compliance requirements for serialization and reporting of exported pharmaceuticals. Below is an overview of the changes to existing regulations.

Primary level serialization 

• This pertains to the actual unit within the saleable package
• Requirements set but enforcement postponed again
• Human readable is optional until further notification
• 2D data matrix w/ serialization data is exempt until further notification

Aggregation

• Required at packaging between Tertiary-Secondary-Primary
• Required to maintain above relationship for movement in the supply chain (no additional details provided)
• Tertiary–Secondary will be enforced; Secondary–Primary is optional until further notification
• No specific dates noted for Aggregation requirements, but reporting on Aggregation required starting 10/1/15

Reporting

• Requirement confirmed for both serialization and aggregation but delayed until 10/1/15
• Serialization and aggregation data will be reported to a central portal
• Drugs manufactured prior to 10/1/15 are grandfathered in and exempt from reporting requirements

Exemptions

• As before, a company can request an exemption if exporting to another country with serialization requirements
• However, Tertiary (case) packaging will still need to maintain an India-specified barcode in addition to any required by the target export country

Details on data management, the reporting process, and exemptions will follow in a subsequent guidance.

The full notice can be read here.