By Raj Barcode Systems
For pharmaceutical and liquor manufacturers, product integrity is the business. A single counterfeit pack, an untraceable batch or a failed audit can put patients at risk, trigger recalls and damage a brand that took decades to build. A track and trace system gives every unit a unique identity and a recorded journey, from the production line to the end customer.
This guide explains what a track and trace system is, how track and trace in the pharmaceutical industry works, which regulations to watch in 2026 and what to look for when choosing among track and trace system manufacturers in India.
A track and trace system records where a product is (tracking) and where it has been (tracing). It does this by giving each unit, carton and pallet a unique identifier, usually a serialised barcode or QR code, and capturing that identifier at every handover in the supply chain. You may also see it written as a “track n trace system”; the idea is the same.
Three building blocks make it work:
Systems can use barcodes and RFID together, depending on the product and the level of packaging. Our Track and Trace solution covers both, and our guide to how track and trace systems work goes deeper on the technology.
Track and trace in the pharmaceutical industry protects patients first, and the business second.
Fake and substandard medicines enter the market through gaps in the distribution chain. A documented trail for every pack makes it much harder for counterfeits to slip in, and makes suspect packs easier to verify.
If a batch has a quality problem, serialised records let you identify exactly which units went where, instead of recalling everything. Traceability also supports correct handling and storage records through the chain.
A track and trace system for pharmaceutical products keeps the batch, serial and movement records that regulators and customers ask for, with an audit trail you can produce quickly.
Hospitals, distributors and patients trust brands that can prove authenticity. Strong traceability becomes part of your reputation.
Rules differ by market, and they change, so always confirm current requirements with the regulator or your compliance team. The overview below reflects the broad picture.
| Market | Broad requirement | What it means for you |
|---|---|---|
| India (domestic) | Barcode or QR code on listed drug brands under the Drugs Rules, 1945; the top 300 brands were covered from 1 August 2023, with further expansion planned | Print and verify compliant codes on labels; keep batch data linked |
| India (exports) | The DGFT track and trace scheme for pharma exports was withdrawn from 1 February 2025 | Export compliance now follows the importing country’s rules |
| United States | DSCSA requires product identifiers and electronic, interoperable tracing of prescription drugs | Serialise saleable units and exchange data with trading partners |
| European Union | Falsified Medicines Directive requires a unique identifier and anti-tampering device on most prescription packs | Encode and verify 2D codes and connect to the verification system |
Sources: Business Standard on the DGFT withdrawal and WAM report on the withdrawal. The India domestic position is as described in the same announcements; check the latest Health Ministry notifications for any additions.
The practical takeaway for Indian manufacturers: the old export-specific scheme has gone, but serialisation has not. Most export destinations have their own requirements, and domestic QR and barcode rules are widening. A flexible, standards-based system (GS1 coding, aggregation and reporting) protects you whichever way the rules move. Our GS1 consulting services can help with coding structures.
Most pharma and liquor implementations follow the same flow:
Effective track and trace solutions for the pharmaceutical supply chain cover every stage, not only the packing line:
For more on our pharma offering, visit our pharmaceuticals industry page.
Follow materials, work in progress, production batches and finished goods through every stage, so any unit can be located at any time.
Every product unit receives a unique ID, linked to its batch and history. This is essential where authenticity matters most, as in pharma and liquor.
Parent-child relationships between units, cartons, cases and pallets let you scan once and identify everything inside.
Check the status and location of any product at any point in the chain, with clear reports on movement, inventory and bottlenecks.
Data flows into your ERP and warehouse systems, so records stay consistent and documentation is easier to produce. See our Mobilizing ERP solution and hardware integration with SAP and other ERP systems.
Detailed records and audit trails help you demonstrate compliance during inspections, and the system can be configured to the rules of your market.
Use barcodes where they are enough and add RFID where speed or item-level visibility pays off. Read more in our guide to RFID for inventory management.
In the liquor industry, a track and trace system helps fight illicit and spurious alcohol, protects tax revenue and keeps consumers safe. Each bottle or case carries a unique code that can be verified by distributors, enforcement teams and, in some schemes, consumers. Many Indian states run their own excise track and trace schemes, and the rules vary by state, so confirm the current requirements with the relevant excise authority before you design your system.
The same building blocks apply as in pharma: serialisation, aggregation, verification at line speed and event capture across the supply chain.
When you compare track and trace system manufacturers in India, look beyond the software demo. Ask:
Raj Barcode Systems, based in Ahmedabad, offers track and trace solutions together with hardware, integration and service, including a comprehensive hardware service pack and preventive maintenance and onsite repair.
A track and trace system turns product integrity from a promise into a provable record. For pharmaceutical and liquor manufacturers, it fights counterfeiting, speeds up recalls, supports compliance and builds trust across the supply chain. Rules differ by market and keep evolving, so choose a flexible, standards-based system and a partner who can support you after go-live.
Ready to plan your track and trace implementation? Explore our Track and Trace solution or contact our team to discuss your requirements.
It is a system that assigns a unique serialised code to each drug pack, links packs to cartons and pallets and records every movement through the supply chain. This lets manufacturers and regulators verify authenticity, locate any batch and act quickly on recalls.
It depends on the product and market. India’s Health Ministry requires barcode or QR codes on listed drug brands under the Drugs Rules, 1945, and export markets have their own serialisation rules. The DGFT export track and trace scheme was withdrawn from 1 February 2025. Check the latest notifications for your products.
Tracking follows a product forward to know where it is now. Tracing looks backward to reconstruct where it has been. A good system supports both from the same data.
They are widely used in liquor, food and beverage, chemicals, automotive and other industries that need authenticity checks, batch control or regulatory records.
Yes. A well-designed system passes serialisation, batch and movement data to your ERP and WMS, so records stay consistent. Integration should be planned from the start.
Look for serialisation and aggregation capability, GS1 standards, hardware and software under one roof, ERP integration, validation support, and strong local implementation and service.
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