India’s current track and trace regulations, the last phase of which took effect in October 2015, pertain to products manufactured in India that will be
exported to other markets. In June 2015 a draft proposal for domestic drugs was published, but no timelines have been established for the adoption
of that set of serialization, labeling, and reporting regulations.
Barcoding and Serialization: The current law requires companies to uniquely serialize drug products at the tertiary (case), secondary (saleable unit), and mono-carton packaging levels. Barcoding and serialization requirements generally follow global GS1 standards while each packaging level requires that slightly different data be captured. For example, at the secondary pack level, the GTIN, batch number, expiration date and serial number must be captured and encoded in a 2D data matrix or at GS1-128 linear barcode.
Primary-level serialization – or serializing below the “each” level - is currently optional but is expected to become a firm requirement in the future.
When it does, it will present a new set of challenges for pharmaceutical companies who will need to serialize, for instance, all of the blister cards
within a saleable unit. This will likely raise issues around how packaging is done, what materials are used, where the 2D barcodes will be placed,
Aggregation: Pharmaceutical companies must create aggregation relationships across all packaging hierarchies – including tertiary, secondary, and primary (if so encoded) - and maintain those relationships.
Reporting: India requires reporting on several events including product master data, batch pre-production and production/packaging actions. The pre-production notification alerts the DAVA portal of the intent to produce a batch and includes product code, lot number, and additional details.
When products are manufactured and packaged, product details, serialized identity across all required pack levels, and aggregation information must be
captured and configured into XML reports which are then submitted to the India Drug Authentication and Verification Application (DAVA) portal.
While the law took effect in October 2015, the DGFT has extended the deadline for aggregation management and compliance reporting, based on feedback around
the industry’s readiness. Learn more about those revised timelines, which are based in part on your company’s classification as a manufacturer of exported goods.
Exemptions: The India Directorate General of Foreign Trade (DGFT) regulations on exported products do include an exemption that allows pharmaceutical companies to instead follow the serialization laws for their export market, if they exist. However, companies must still notify India about the products they are producing, to what market they are going, and to what other law you are complying that is prompting the exemption from the DGFT law.How TraceLink Can Help
TraceLink provides a complete end-to-end India compliance solution for pharmaceutical companies and CMOs to meet the India compliance requirements that
took effect in October 2015. Master data management, serialization management, serialized operations management and compliance reporting modules are
available on the cloud platform to support your business and your supply network. Our latest integrated solution, the India Compliance module, is purpose-built
for DAVA compliance. India Compliance delivers complete compliance data management, DAVA report generation and exception management, helping companies
to reduce the time, cost, and risk associated with achieving compliance in India. Learn more about the exact capabilities included in the India Compliance module.
|Regulatory scope||Barcoding and Serialization; Aggregation; Reporting|
|Product scope||All pharmaceutical products|
|Participants||Manufacturers, wholesale distributors, dispensers|
|Next deadline||March 2016 or 2017, depending on your company's classification|
|Serial # format||GS1 standard|
|Reporting flow||Submitted to the DAVA portal|