Our traceREADY® Label Printing module will ensure that your organization is compliant with the fast-approaching regulation on QR codes for APIs

In a bid to tackle the counterfeiting of drugs, the Central Drugs Standard Control Organization (CDSCO) in India has passed a new rule, G.S.R. 20(E), which will make it mandatory to put QR codes on Active Pharmaceutical Ingredients (APIs) containers. This new rule will be applicable from 01 January 2023. A further ruling, G.S.R. 448(E), applicable to the top 300 drug brands, will come into force on 01 May 2023.

With the impending API QR Code regulation fast approaching, now is the time for manufacturers and importers alike to ensure that they are compliant with the G.S.R. 20(E) governance that comes into effect on 01 January 2023.

The G.S.R. 20 (E) regulation requirement specifies that the
QR code must provide the following label contents:

  • Unique Product Identification Code
  • Name of the API
  • Brand name (if any)
  • Name and Address of the manufacturer
  • Batch Number
  • Batch Size
  • Date of Manufacture
  • Date of expiry or retesting
  • Serial Shipping Container Code
  • Manufacturing License Number and/or Import License Number
  • Special Storage Conditions (if any)

At Navitas Life Sciences, our NextGen enterprise-scale solution, traceREADY® Label Printing module is designed to meet the regulation and much more, to ease business operations and ensure a quicker return on investment.

traceREADY® is a ready to use solution that can be implemented within 4 weeks with no impact to current operations. Our robust label printing module can be hosted on-premise or cloud. Not only that, but it also works in unison with your existing business processes, integrating with EPCIS and ERP systems to ensure that your organization is compliant.

All of this with the added bonus of future-proofing your organization with a solution that also offers scalability should additional regulatory requirements need to be met.

traceREADY® enhances the already implemented processes and make adherence easy. traceREADY® can be extended to implement the modules from pre-manufacturing through to distribution to help pharma manufacturers achieve the required end-to-end traceability.

Benefits of implementing the traceREADY® Label Printing module to ensure your organization is QR Ready.

Designed specifically for life sciences organizations traceREADY® provides the perfect solution to improve day-to-day operations, enhancing and making consistent the product development phase, improving operational performance, and meeting the challenges of stringent regulations.

There is still time to ensure that your organization is QR Ready

For a LIVE DEMO or to learn more about traceREADY® and how you can ensure your organization’s compliance ahead of the new regulation coming into effect please click here


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