The Pharma Serialisation and Traceability Platform

Pharmaceutical traceability is the ability to track and verify the identity, location, and status of a drug product at every point in the supply chain — from manufacturing through distribution to the point of dispensing. It encompasses serialisation (assigning unique identifiers to each saleable unit), aggregation (linking individual units to cases and pallets), and verification (confirming authenticity and supply chain integrity at dispensing or border control). Traceability is mandated by regulations including the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD).

Pharmaceutical serialisation is the process of assigning a globally unique identifier — typically a 2D barcode conforming to GS1 standards — to each individual saleable unit of a drug product. The identifier encodes product GTIN, batch number, expiry date, and serial number. Serialisation enables product verification at the point of dispensing, supports market withdrawal and recall at the unit level, and is a regulatory requirement in major markets including the US (DSCSA), EU (FMD), and markets across Asia-Pacific and the Middle East.

Key traceability regulations include: the US Drug Supply Chain Security Act (DSCSA), which requires unit-level serialisation and electronic interoperability across the supply chain; the EU Falsified Medicines Directive (FMD/Directive 2011/62/EU), which mandates unique identifiers and anti-tampering devices with verification at point of dispensing; and national regulations in markets including India (Schedule H2), Brazil (ANVISA), Saudi Arabia (SFDA), China (NMPA), and others. Each market has specific requirements for serialisation format, aggregation, verification, and reporting.

Yes, for products in Schedule H2 of the Drugs Rules, 1945. Under Rule 96(5)–(7), amended by G.S.R. 506(E) in 2026, manufacturers of specified drug formulations must affix a Bar Code or QR Code on packaging, storing nine mandated data elements including a unique product code, batch number, and expiry date. This is a product- and batch-level requirement, not per-unit serialisation: India has not mandated unit-level serial numbers domestically, unlike DSCSA in the US or FMD in the EU. Schedule H2 originally covered about 300 named brands from 2023; the 2026 amendment expanded coverage to all vaccines, antimicrobials, anticancer, and NDPS drugs, phased in from 1 July 2027 (antimicrobials from 2028).

Schedule H2 is a product- and batch-level requirement: a QR or barcode on packaging carrying nine mandated data elements, not a unique serial number per unit. DSCSA (US) and the EU Falsified Medicines Directive require unit-level serialisation, meaning every individual saleable pack gets its own unique serial number, plus aggregation and event reporting across the supply chain. India has not mandated unit-level serialisation domestically. A manufacturer selling in both India and export markets typically needs both: batch-level QR/barcode compliance for Schedule H2 and unit-level serialisation for DSCSA/FMD markets.

CDSCO (Central Drugs Standard Control Organisation) issues implementation guidance on the QR code requirements, but day-to-day enforcement sits with State Licensing Authorities under the existing Drugs Rules, 1945 framework. G.S.R. 506(E), the 2026 amendment that expanded Schedule H2, created no new penalty clause or inspecting authority, so it inherits the same risk-based inspection, stop-production-order, and licence-cancellation powers State Licensing Authorities already use.

Zelthy generates batch-encoded, GS1-aligned QR and DataMatrix codes carrying all nine Schedule H2 data elements, and manages the packaging-line and artwork changes needed to print them across primary or secondary packaging. The same platform extends to unit-level serialisation and aggregation for manufacturers that also need DSCSA or EU FMD compliance for export markets, so Indian and export compliance run on one system rather than two.