India has released new information on compliance requirements that address both the regulations for exported drugs which went into effect yesterday October 1 and the domestic drug proposal that has been released for comments. This article will provide an overview of the changes to existing regulations and also discuss India’s motivation behind the regulations.

Exported

Manufacturers or exporters of pharmaceuticals drugs manufactured on or after October 1, 2015, have to meet serialization and reporting regulations which were recently expanded with the publication of Public Notice No. 13 (May 22, 2015). Now, starting on October 1, companies have to meet the following compliance requirements:

Serialization

Serialization of tertiary, secondary and mono-cartons has been an existing requirement for the industry. The draft notice adds additional details related to primary-level packaged products and aggregation management.

• Serialization of exported drug products at the secondary and tertiary packaging level, including serialized labels and encoding within barcodes. 
• Secondary packages must include information encoded, on a 2D Data Matrix or GS1-128 barcode, the GTIN-14, batch number, expiry date and serial number. 
• Tertiary packages must include information encoded, on a GS1-128 barcode, the GTIN, batch number, expiry date and SSCC number. 
• Primary level packed products have optional human readable printing and encoding is exempt until further notice. 
• Manufacturers are responsible for maintaining the aggregation relationships for products throughout their movement in the supply chain, although implementation details around this requirement have not been published.

Government Reporting

The Public Notice and subsequent documentation posted on the Drug Authentication and Verification Application (DAVA) portal highlight new reporting requirements for manufacturers.

• One-time registration and setup with the DAVA portal. 
• Reporting of product, batch, production and movement details for exported products to the DAVA portal via highly structured XML files. 
• Capture and reporting of aggregation relationships between secondary packages and tertiary containers. Aggregation relationships involving primary-level packaged products do not have to be reported at the present time. 

Domestic

A draft proposal for track and trace related to all pharmaceutical drugs produced for domestic use was published in June 2015. It includes serialization, labeling requirements, and reporting standards. This draft proposal, which was floated for public comment, will go into effect 180 days after final rules are published. No firm date or timetable was established for an adoption of the domestic regulations.

The draft regulations for domestic pharmaceuticals are similar to but slightly more extensive than those for exported drugs. Requirements include:

• Serialization. Unique identification, including labeling, barcoding and serial number encoding, at the primary, secondary and tertiary levels. 
• Reporting. Reporting of product (including aggregation details), batch, production and movement details for products produced for domestic consumption to the DAVA portal. 

DAVA Supports Drug Authentication

India’s stated goal is to establish end-to-end track and trace capture and reporting within DAVA in order to facilitate drug authentication. Online users will authenticate using a web-based portal and mobile users will be able to access via an SMS-based system. By providing to DAVA GTIN and serial numbers or the serial shipping container code (SSCC), Indian citizens will now have much richer information about the drugs they take including, but not limited to, the name of the drug and manufacturer, the date of expiry, and the recommended usage.

Main Takeaways and Questions

The industry has been expecting the finalization of the India government reporting requirements for exported pharmaceuticals and that day has arrived. Extensive information about products, their packaging and key events related to those products during production and initial distribution must be reported to a new reporting system. Key questions remain as to exactly how aggregation relationships are supposed to be captured, maintained and reported upon in the new compliance regime. In addition, requirements related to the reporting of product movements are still unclear until final implementation documentation is published. Finally, while primary level serialization, aggregation and reporting requirements were exempted or made optional until further notice, DGFT continues to signal their strong desire to implement these requirements for exported drugs at some point.

On the domestic pharmaceuticals front, India is beginning to lay the foundation for the establishment of a similar track and trace regime as is in place for exported pharmaceuticals. The 180-day implementation timeframe is exceedingly short for the industry to meet regardless of when the final regulation is published and primary-level serialization is a firm requirement in the domestic proposal. Key questions also remain on numerous implementation details. Many of these questions were submitted by the Organization of Pharmaceutical Producers of India (OPPI) during the comment period. So, significant changes may occur between the current draft proposal and any final regulation which is adopted.