QR code on Active Pharmaceutical Ingredients

The Indian government has mandated the inclusion of QR codes on Active Pharmaceutical Ingredients (APIs) that are manufactured in India or imported and distributed, to facilitate tracking and tracing of the products in the supply chain. The new rule will be effective from 1^st January, 2023.

QR codes on API container labels are a simple and effective solution that can be easily implemented at a nominal price, when partnered with the right persons who are experts in barcoding technology and understand the pharma industry.  The benefits are considerable, especially the significant impact it will have in making the supply chain in the Indian pharma industry more secure.

What are QR codes? What is the government mandate?

QR codes or Quick Response codes are 2D barcodes that can contain information about the product and can be scanned at any point to retrieve the information for verification.

The Gazette notification issue by the Ministry of Health and Family Welfare (MoH&FW), dated 18^th January, 2022, mentions “(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the following minimum particulars, namely:

(i) Unique product identification code, (ii) Name of the API, (iii) Brand name (if any), (iv) Name and address of the manufacturer, (v) Batch no., (vi) Batch size, (vii) Date of manufacturing, (viii) Date of expiry or retesting, (ix) Serial shipping container code, (x) Manufacturing licence no. or import licence no. (xi) Special storage conditions required (if any).”

Implementation of QR code in API Labels, what you need to know

GS1 company prefix

Each company is required to obtain a GS1 Company prefix from a GS1 member organisation. In India, the same can be obtained from GS1 India. The GS1 company prefix enables a company to create unique identification keys for each of their trade items, logistic units, locations, etc.

Create your GLN and GTIN

Each trade item and packing configuration within a trade item shall be identified by a unique Global Trade Identification Number (GTIN). This is a 14-digit number which may be generated by combining the GS1 company prefix and the product code, prefixed by an indicator digit and followed by a checksum. This needs to be generated as per GS1 guidelines.

The location identifiers or Global Location Numbers (GLNs) are unique to each location within the organisation and may be generated specific to a manufacturing location or a sub-location within each manufacturing unit as required by the company.

Select your barcode printing partner

Choosing an appropriate barcode partner (company) with expertise in AIDC technology and functional knowledge of the pharma industry and its nuances, will make the QR code implementation process smooth. Barcode printers and scanners are available from various leading OEMs and come with a wide variety of features, specifications and price ranges. The right barcode partner should be able to help choose the right hardware and suitable high-quality consumables such as labels and carbon rolls, that will meet your business needs.

Choose the right hardware and consumables

Choose the right printers for printing, depending on the label size, print volumes, connectivity needs (USB/LAN/bluetooth/wifi) and the software application to be used for label printing. The scanners may be chosen depending on the weight, physical aspects, durability, expected useful life, mobility of the scanner, range and conditions of use. A wide variety of printers and scanners are available in the market from both leading OEM brands and other economical brands allowing the user to choose based on their needs.

One may choose to print all information on plain white labels or alternatively may choose labels pre-printed with static information such as the company logo, company name, manufacturing site address, license number, etc. and may choose to only print the variable data in real time. One may choose from a wide variety of label substrates starting from the most economical paper labels to the most superior quality synthetic labels and a suitable carbon roll to print on.

Get the right software tool that is regulatory-compliant

This is the key to successful implementation of the QR code mandate. For a hassle-free printing experience, a QR code printing application specially designed for this purpose is imperative. The QR code print application should be able to do more than just printing QR codes on the labels. The key features that one needs to look for in a QR code print application are:

• Dynamically design label template, save and manage the templates specific to APIs, grade, marketing regions, customers, etc.
• Create and manage API masters, user and role masters
• Approval workflow for supervisor, QA and admin approval
• Meet the requirements for electronic data management, and is compliant with requirements for electronic system (21 CFR Part 11, EU annex 11)
• Validation in compliance with GS1 standards
• Upgradable on par with the evolving regulations (as the requirements for API is not yet clearly defined and is still evolving)
• Pull standard and customised reports as required

It is preferable to have a software tool that is 21 CFR part 11 compliant, which will allow a hassle-free regulatory audit, though it is not mandatory as per the current Indian government regulation for this mandate.

Establish process and procedures

Establish the quality process and document Standard Operating Procedures (SOP) for printing QR codes on labels. This procedure should encompass managing the workflow, managing users and passwords, approval process, data storage, backup and retrieval and others.

Plan data backup as per regulatory requirements for future reference, internal and regulatory audits as applicable and manage the database appropriately.

 Are you ready to go live?

Ensure the tool is validated, all necessary processes and procedures are in place and all relevant personnel are trained on the use of the hardware and the printing application.

Implement the process well in advance before the deadline 1st January, 2023, to sort out any teething issues that may arise during implementation.

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