Union Ministry's Latest Notification Mandate Pharmaceutical Serialization Under Drug Rules, 1945

(in rule 96, after sub-rule (4))

As per the sub-rule (5), every API (Bulk Drug) imported/manufactured in India must bear a QR code on its label at each level of packaging. The QR code will store multiple set of data to facilitate smooth tracking. Pharma Manufacturers are expected to comply with the mandate by January 2023 leaving only few months to plan and execute.

How can O4S help you?

O4S can help Pharmaceutical Manufacturers speedify implementation of QR code printing on their packaging with the help of its serialization software and wide partner network at one-time minimal CAPEX. Our SaaS-based solution allow faster deployment even in geographically dispersed manufacturing units with 100% precision. We are expert in the Serialization Software industry serving prominent brands such as ITC, PepsiCo, Coca Cola, Honeywell, AkzoNobel, Mahindra, Polycab, Orient Electric Essilor, NATCO Pharma, Mondelez, among others.

How can Manufacturers Track & Trace Pharma Products ?

  • Serialize product, record and report transactions to iVEDA in a single platform.

  • Leverage O4S's platform to easily integrate with CMOs, 3PLs, and facilitate accurate data exchange to meet compliance standards.

  • Use Single-tenant architect to exercises complete control over systems.

  • Access global platform for compliance data management and reporting.

Serialization Solutions Capabilites

Advanced Configuration

IoT encrypted serialization solution are capable of generating serial formats to suit all compliances. Encodes packages with manufacturing, expiration date, lot code, Unique Identification (UID) code, GTIN, and a 2D matrix code and a GSI-DataMatrix symbol.

Data Management

All the transactions history are safely recorded and maintained in respositories accessible by authorized personnels only.

Plug & Play

Manufacturers can sit back and relax with our plug and play module that allows quick, efficicent deployment at low cost.

Real-Time Tracking

Manufacturers can monitor transactions on a real-time basis via Dashboard view.

No Additonal Hardware

Our solution can work with most of the scanners available in market. Just scan and activate serial numbers.

Related Applications

O4S Impact

0
Million Blisters Packs and Vials serialized
0 +
Reduction in Revenue Losses due to ageing
0 %
Traceability Supply Chain uptil Consumption

Case Study

Pharmaceutical Manufacturer Tackled Counterfeiting Via Product Serialisation

A leading pharmaceutical company wanted to solve one of the most dreaded pharma industry challenge i.e., the counterfeiting problem of prescription drugs.

Solution

O4S’s serialization software assigned Unique Digital Identities (UID) in form of QR code to every blister and empowered consumers to authenticate their purchases by scanning
0 Million
Blisters serialized
0
Minimum scans per day
0 +
Unique customers engaged in the system

FAQs

It is just a matter of weeks with zero flaws and faster compliance with ongoing regulations. Moreover, the solution is flexible enough to adapt to changing regulations.
To address the question correctly, we would like you to share a few pointers such as Production Volume, Packaging Material, and Level of Packaging, among other pieces of information to understand the Capital Expenditure required to integrate our solution with your existing systems. Moreover, it is noteworthy to understand that our solution is designed to facilitate faster implementation with the lowest one-time Capital Expenditure.
No, you do not require separate infrastructure. We are capable of integrating serialization with the existing production line. Either industrial printers are integrated with the production line or manual labels are pasted on the product/packaging which is later activated.
Manufacturers can access serialization or related information via dashboard view (Web widget or mobile app) at any time. He just needs to log in with credentials that are restricted to only authorized personnel.
Yes, we offer easy and pocket-friendly integration with existing ERPs, CMOs, and 3PLs.
O4S’s UID is already very secure as they are randomly generated and continuously audited. However, if you are keen on adding more security features then we can do it for you through our partners.

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O4S raises Series A investment. To be announced soon. Read More