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

Yes. India's Ministry of Health and Family Welfare (MoHFW) mandated the Drug Barcode rule under Schedule M of the Drugs and Cosmetics Act. All pharmaceutical manufacturers selling in India must encode a DataMatrix barcode on each primary and secondary pack, capturing GTIN, batch number, expiry date, and serial number. Compliance is enforced by CDSCO (Central Drugs Standard Control Organisation). The mandate is being phased in by product category, with large manufacturers required to comply first. Non-compliance can result in rejection of consignments at state drug controller checkpoints and border control.

DCTS (Drug Coding and Tracking System) is India's national system for serialisation and track-and-trace of pharmaceutical products, operated under the Ministry of Health and Family Welfare (MoHFW). It requires manufacturers to generate unique serial numbers for each saleable unit, encode them as DataMatrix barcodes, and report supply chain events — manufacture, dispatch, receipt, and sale — to the central government portal. DCTS connects manufacturers, distributors, C&F agents, and retailers into a unified national traceability network, enabling the government to detect diversion, counterfeiting, and supply chain leakages in real time.

CDSCO (Central Drugs Standard Control Organisation) is the national regulatory authority under the Ministry of Health and Family Welfare responsible for enforcing India's drug serialisation and traceability requirements. CDSCO oversees the Drug Barcode mandate under Schedule M, issues guidance on barcode specifications, inspects manufacturing facilities for serialisation compliance, and coordinates with state drug controllers on enforcement at distribution and retail levels. Manufacturers registering new products with CDSCO are required to demonstrate Drug Barcode readiness as part of the manufacturing licence process.

Zelthy is a pharma serialisation solution provider deployed across Indian manufacturers and C&F agents for end-to-end DCTS compliance. The platform handles serial number generation and management, DataMatrix barcode encoding at pack and case level, SSCC aggregation, and automated event reporting to the MoHFW government portal. It integrates with existing ERP and packaging line systems, provides distributor and C&F agent portals for downstream supply chain event capture, and gives compliance teams real-time dashboards for DCTS status monitoring. Indian manufacturers can go live in 4–8 weeks.