India’s DGFT published a public notice on January 5th, 2016 which extends the compliance deadline for aggregation management and compliance reporting to the DAVA portal which was originally set for October 1, 2015. NOTE: All other existing barcoding and serialization requirements are unaffected by this regulation and remain in effect. 

Current Law

The current law for manufacturers producing pharmaceutical products in India for export to other markets requires those companies to barcode and uniquely serialize, aggregate and report information about their products.

• Barcoding and Serialization: Companies must uniquely serialize drug products at the tertiary (case), secondary (saleable unit) and mono-carton packaging levels. The law also provides for primary-level serialization but this is made optional at the present time.

• Aggregation: Companies must create aggregation relationships across all packaging hierarchies, including tertiary, secondary and primary (if so encoded), and maintain those aggregation relationships.

• Compliance Reporting: When these products are manufactured and shipped, compliance information about the drug products, their serialized identity and shipment details must be captured and configured into XML reports which are submitted to the India DAVA portal. These compliance notifications include complex reports on product master data, production batch information, serialization data and shipment information.

The serialization, master data management and compliance regulations for India are highly detailed and a full description of them goes beyond the scope of this update. For any interested manufacturers or CMO/CPOs, TraceLink is available to provide a complete briefing of the regulations and how they may impact your specific supply network.

DGFT Notice and Implications

The DGFT has provided additional time for manufacturers of exported product to meet the full suite of serialization, aggregation and reporting requirements. This was based on extensive feedback from the industry, which reported significant struggles in capturing and correctly preparing all of the compliance data needed to meet India’s DAVA reporting requirements.

The DGFT notice provides for phased implementation of aggregation management and reporting requirements based on your classification as a manufacturer of exported products. There are two classifications identified in the DGFT notice: SSI Manufacturers (small manufacturers as members of the CIPI organization) and non-SSI Manufacturers (all other Indian and global manufacturers). The new deadlines established for each classification are:

Non-SSI (Large) Manufacturer

After March 31, 2016:

• Must maintain aggregation relationship across all packaging hierarchies, Tertiary, Secondary, Mono-Carton and Primary (if so encoded).

• Must perform all compliance reporting on master data, batch information, shipment data and production/serialization data for products packaged and serialized at all required levels.

SSI Manufacturer

After March 31, 2016:

• Must perform all compliance reporting on master data, batches, shipment data and serialization data at the Tertiary (case) packaging level.*

After March 31, 2017:

• Must maintain aggregation relationship across all packaging hierarchies, Tertiary, Secondary, Mono-Carton and Primary (if so encoded).

• Must perform all compliance reporting on master data, batch information, shipment data and production/serialization data for products packaged and serialized at all required level.

Grandfathering

Products with manufacturing date up to March 31, 2016:

• Both SSI and non-SSI manufacturers are exempt from compliance reporting to DAVA on these products.

Products with manufacturing date up to March 31, 2017:

• SSI manufacturers are exempt from compliance reporting to the DAVA portal on these products.*

*NOTE: The public notice has what seems to be a conflict between the Grandfathering clause for SSI manufacturers in section (vi) exempting them from all compliance reporting until April 1, 2017 and the Tertiary reporting requirement starting on April 1, 2016 as noted in section (ii/b). We believe this is intended to provide full reporting exemption for SSI manufacturers during the extended period but this awaits further clarification by DGFT.

Export Exemptions

The notice confirms that companies may apply for exemption from the serialization, aggregation and DAVA reporting requirements if the exported products are destined for a market with mandated or formally notification of intent to mandate track and trace regulations. There is still the requirement post-April 1 to report SSCC identifiers to the DAVA portal even for products that are exempt from other regulatory requirements due to export exemptions.

Key Challenges and Next Steps

The net result for multi-national and larger domestic manufacturers producing product for export is that they have a couple more months to get everything done or risk their products being held up in customs.

To successfully meet India regulations, you must have a comprehensive compliance system that tightly integrates with your serialization system, your finished goods distribution infrastructure and your compliance reporting engine. This system needs to generate, apply and capture the right product and serialization data across multiple levels of packaging for all products and shipments. It also needs to correctly and reliably generate the various compliance documents at appropriate trigger points, sending those documents in the correct XML format to the DAVA portal, all while ensuring that master data and aggregation information is updated appropriately throughout the process.

As we have seen from other regulatory regimes such as China, it takes a well-designed system and a group of experts with deep experience in serialization and compliance reporting to design an approach that will get it right. This is particularly true for pharmaceutical manufacturers and CMO/CPOs who are facing today’s complex global serialization and compliance requirements in the next few years ranging from the US and EU to South Korea and Brazil.