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Pharmaceutical & Healthcare

DGFT & CDSCO Pharma Export Track and Trace Solutions

Indian pharmaceutical exporters must serialise, aggregate and report every export consignment. We build that system for you - code generation, line-level printing and verification, aggregation, and automated regulatory upload - engineered around the packing lines, printers and ERP you already run.

Serialisation at Every Level

Unique, GS1-compliant codes applied and verified from primary pack through carton, shipper and pallet.

Automated Regulatory Upload

Export data files generated, validated and submitted to the government portal without manual re-keying.

Line-Ready Hardware Integration

Printers, cameras, scanners and reject systems supplied, installed and integrated on your existing lines.

Plant-Fit Engineering

Designed around your line speed, carton format, SKU matrix and existing ERP environment.

Export Compliance, Built Around Your Plant

Every formulation plant runs a different line speed, carton format and ERP setup. We engineer the serialisation layer to fit yours instead of forcing a licensed product template onto your operation.

Serialisation at Every Level
Unique, GS1-compliant codes applied and verified from primary pack through carton, shipper and pallet.
Automated Regulatory Upload
Export data files generated, validated and submitted to the government portal without manual re-keying.
Line-Ready Hardware Integration
Printers, cameras, scanners and reject systems supplied, installed and integrated on your existing lines.

Our DGFT & CDSCO Pharma Export Track and Trace Solutions

A complete export track and trace capability - code management, line integration, regulatory reporting and partner data exchange - delivered as one engineered solution and supported after go-live.

1. Serialisation & Unique Code Management
Generate, secure and manage every unique identifier your export markets require, with full lifecycle control from allocation through commissioning to decommissioning.

Key Capabilities:

GS1-compliant GTIN, serial, batch and expiry encoding in GS1 DataMatrix
Secure code generation and vaulting with guaranteed non-duplication
Market-specific formats for India export, US DSCSA, EU FMD and GCC requirements
Full code status lifecycle: allocated, commissioned, shipped, decommissioned
2. Packaging Line Integration & Aggregation
We integrate directly into your existing packing lines so serialisation runs at production speed, with parent-child aggregation captured automatically rather than reconstructed afterwards.

Key Capabilities:

Print-and-apply, thermal inkjet and laser coder integration on running lines
Camera-based code verification with automatic rejection of unreadable packs
Carton to shipper to pallet aggregation with full parent-child hierarchy
Batch reconciliation covering codes commissioned, rejected and destroyed
3. Regulatory Reporting & Portal Upload
The compliance step most exporters underestimate. We automate file preparation, validation and submission so your regulatory team stops assembling spreadsheets before every shipment.

Key Capabilities:

Automated generation of export data files in the prescribed format
Serial data mapped to invoice, shipping bill and consignment records
Submission logs, acknowledgement capture and structured exception handling
Audit-ready archives with configurable retention and rapid retrieval
4. ERP, CMO & Partner Data Exchange
Serialisation only works when it matches the rest of your business. We connect the system to your ERP and to the contract manufacturers and packers producing on your behalf.

Key Capabilities:

SAP, Oracle, Navision and Tally integration for batch, order and dispatch data
Onboarding of CMOs and third-party packers with controlled code allocation
EPCIS-based data exchange with importers, distributors and 3PL partners
Role-based access, electronic signatures and full change-control logging

Technologies That Power Our Solutions

Industrially hardened technologies selected for your line conditions and product mix - not a fixed stack applied identically to every client.

Machine Vision & Optical Character Verification
High-speed cameras confirm that every printed code is present, readable and correctly graded before the pack leaves the line.

Applications:

Code grade verification Print quality inspection Aggregation validation Reject confirmation
Industrial IoT & Line Controllers
Controllers and sensors synchronise printing, inspection and rejection with actual line movement, at production speed.

Applications:

Printer triggering Pack detection Reject actuation Line event capture
Secure Data Platforms (On-Premise or Private Cloud)
Your serial number repository and EPCIS event store, deployed wherever your data governance policy requires it to sit.

Applications:

Code vaulting EPCIS event storage Portal submission Disaster recovery
Blockchain-Backed Audit Trail
An optional tamper-evident ledger for organisations that need cryptographic proof of event integrity across multiple partners.

Applications:

Immutable event logs Partner data integrity Dispute resolution Provenance evidence

Industry Success Stories

Representative outcomes from pharmaceutical export deployments. Figures below are indicative ranges typical of this solution type and should be confirmed against your own baseline before publication.

Formulation Exporters
Multi-line oral solid dosage plants shipping to both regulated and semi-regulated markets.

Results Achieved:

Serialisation coverage extended across all export SKUs
60-75% reduction in manual compliance documentation effort
Batch release cycle shortened by two to four days
Contract Manufacturers (CMO / CDMO)
Sites serialising on behalf of multiple brand owners with differing destination market requirements.

Results Achieved:

Multiple brand owners handled on shared packing lines
50-70% faster onboarding of a new customer's serialisation requirement
Code duplication incidents eliminated post-deployment
API & Intermediate Manufacturers
API units meeting QR code and traceability obligations on drums, containers and intermediate packs.

Results Achieved:

QR coding applied across all dispatched containers
40-60% reduction in dispatch documentation errors
Trace-back time reduced from days to minutes

Key Performance Indicators

The measures a QA head and a regulatory affairs lead actually care about. Targets below are design goals we engineer towards and agree with you in writing before deployment.

Code Read Rate on Line
Share of printed codes successfully verified by the vision system at full production speed.
Target: >99.5% | How we get there: Engineered through print head selection, substrate testing and lighting design.
Serialisation Reconciliation Accuracy
Match between codes generated, commissioned, rejected and dispatched for every batch.
Target: 100% | How we get there: Achieved through automated reconciliation rather than manual code accounting.
Regulatory File Submission Success
Export data files accepted by the portal on first submission without rework.
Target: >98% | How we get there: Typically three to five times fewer resubmissions than manual file preparation.
Line Speed Impact
Output reduction caused by adding serialisation to an existing packing line.
Target: <3% | How we get there: Minimised through in-line integration design and pre-deployment line trials.

How We Deliver

Every deployment follows the same disciplined sequence, so you know exactly what happens and when.

1
Step 1: Requirement Study & Line Assessment
We survey each packing line, review your SKU and destination market matrix, and document the exact compliance obligations that apply to your exports.
2
Step 2: Solution Design & Hardware Selection
Architecture, printer and camera selection, and every integration point are documented and signed off before any procurement begins.
3
Step 3: Pilot on a Single Line
We deploy on one line against defined acceptance criteria, so performance is proven on your own product before you commit to a full rollout.
4
Step 4: Rollout, Validation & Support
Remaining lines are commissioned, audit documentation is prepared, and the system moves into an agreed AMC with defined response times.

Why Choose Our DGFT & CDSCO Pharma Export Track and Trace Solutions?

Four reasons Indian pharmaceutical exporters choose an engineered solution over a licensed serialisation product.

Regulation-Led, Not Feature-Led
We start from the specific obligation you must meet and build backwards, so nothing in the system exists purely to look good in a demonstration.
One Accountable Partner
Software, hardware, installation, integration and support come from a single team - no gap between a software vendor and a hardware supplier when read rates drop.
Deployed Where Your Policy Requires
On-premise, private cloud or hybrid, with documented data residency and clear source code and data ownership terms.
Built to Survive an Audit
Change control, electronic signatures, access logs and retention rules are designed in from day one, not retrofitted after an observation.

Ready to Make Your Export Lines Compliant?

Book a requirement discussion with our engineering team. We will review your packing lines, SKU matrix and export markets, then come back with a scoped approach, a hardware outline and an indicative timeline.

Frequently Asked Questions (FAQs)

It is the Government of India requirement that pharmaceutical products exported from India carry unique, machine-readable identifiers, and that the corresponding serialisation data be uploaded to the designated government portal. In practice it means barcoding at primary, secondary and tertiary packaging levels, aggregation linking those levels together, and structured data submission tied to your export documentation.

It is custom-built. We are a solution development and systems integration company, not a SaaS vendor. Every deployment begins with a requirement study of your lines, SKUs and export markets, and the system is engineered to that specification. Hardware selection, line integration, installation and post-deployment support are all part of the project scope.

Yes. We scope, supply, install and integrate the coding and inspection hardware as part of the project, and we take responsibility for read-rate performance on your line - not only for the software layer sitting above it.

In the large majority of cases, yes. We carry out a line assessment first to confirm available space, line speed, pack substrate and control interfaces, then design the integration around the equipment you already own.

CMOs and packers are onboarded as controlled participants. Codes are allocated to them under your authority, their commissioning and aggregation events flow back into your central repository, and you retain a single reconciled view across every site producing on your behalf.

We routinely integrate with SAP, Oracle, Microsoft Dynamics and Navision, and Tally, as well as in-house and legacy systems. Where a standard connector does not exist, we build the interface as part of the project rather than asking you to change your ERP.

Yes. On-premise, private cloud and hybrid deployments are all supported. Many pharmaceutical exporters require serialisation data to remain inside their own infrastructure, and the architecture is designed to accommodate that from the outset.

A single-line pilot is usually commissioned within eight to twelve weeks of requirement sign-off, with multi-line rollout following in phases. The precise timeline depends on line count, SKU complexity, hardware lead times and your validation requirements, and it is agreed in writing before work begins.

Yes. Code and event structures follow GS1 standards, and market-specific formats and reporting profiles are configured per destination, so a single system can serve several export markets without parallel deployments.

The system moves into an agreed support arrangement covering defined response times, preventive maintenance of coding and vision hardware, regulatory format updates and change requests. Support scope, SLA and escalation path are documented as part of the contract.