Drug Amendment 2022: Mandatory use of QR Code for all APIs from January 1st, 2023 and how traceREADY® can help

The Indian government has mandated the use of QR Codes by API manufacturers for all Active Pharmaceutical Ingredients (APIs) that are manufactured in India or imported, from January 1^st 2023.

Mandatory QR Code for API Medicine- What Does it Mean for you?

The Central government of India has mandated that the label of all active pharmaceutical ingredients (APIs) manufactured or imported in India should contain a Quick Response (QR) code on each level of packaging. This amendment rule is being put forward to allow effective tracking and tracing of the ingredients of the drugs, and to prevent spurious drugs from entering the market.

To find out more about the mandate and to explore ways to ensure quick compliance, we met with our expert, Santosh Narayanan BT, Senior Business Analyst, Consulting, recently.

Tell us more about your professional journey?

I Joined Navitas Life sciences in 2013. I was part of the application management services, product wing where we focused on building application for enabling in-warehouse efficiencies for manufacturing/distribution companies. Along with the company my focus since 2014 has been working towards enabling business efficiencies within the Pharma supply chain specializing in global serialization requirements.

How will the QR code for all Active Pharmaceutical Ingredients (APIs) In India help?

According to available statistics, up to 20% of drugs manufactured in India are counterfeit and, as per a government report, up to 3% of manufactured drugs are of substandard quality. The Government of India (GSR20(E)) has mandated that a QR code be affixed to all Active Pharmaceutical Ingredients (APIs) manufactured or imported to India as an effort to combat the issue of counterfeit medicines in India.

Santosh Narayanan BT

Senior Business Analyst Consulting,

Navitas Life Sciences

The inclusion of traceability at an API level prior to the formulation of drugs provides scope to extend product traceability by linking APIs to finished goods. Although at this point in time the requirement is on affixing and decoding QR codes, the extensibility of information tagged to the pharma supply chain tracing may lead to a concrete tracing structure in the future.

The regulation requirement specifies that the following information must be stored within the QR Code

• Unique product identification code
• Name of the API
• Brand name (if any)
• Name and address of the manufacturer
• Batch numbe/li>
• Batch size
• Date of manufacture
• Serial shipping container code
• Manufacturing licence number or import license number
• Special storage conditions required (if any)

What are the challenges expected in implementing the regulation?

While the efforts are a step in the right direction, compliance with the guidelines brings its own challenges. The regulations will come into effect on 01 January 2023. In order to ensure compliance, both manufacturers and importers alike are now faced with the following key considerations:

• Implementation approach - whether to invest in the existing setup or build a standalone solution
• Application scalability - An application that should adapt to future implications and regulation extensions
• Implementation timelin

It is important to devise a scaleable solution that would not only suffice current requirements, but also see through any future additions that are adapted.

How can Navitas Life Sciences aid in supporting API manufacturers meet this regulation?

With the impending requirement timeline, Navitas Life Sciences offers traceREADY^® Label Printing Module, a robust and scaleable solution, which can work hand in hand with your existing business processes in sufficing requirements as stated in GSR20(E). The validated hosted/on-premise solution can accommodate your Business specific requirement and is able to handle further upgrades in terms of regulatory requirements.

Working as an additional layer complementing established best practices, we offer uncompromising quality with practical implementation plans, not exceeding 4 weeks, to ensure the load on the business is not too heavy.

What is the Roadmap for Implementation of QR codes in API Labels?

The details are still evolving but the following steps are expected to be put into place. For an immediate compliance need the solution needs to support;

SSCC Allocation

Allocation of SSCC (Serial Shipment Container Codes) that needs to be affixed onto the outbound containers

Master Data Management

• Provision to input/import and maintain Product Master Data
• Provision to Maintain Batch Master, to link master data records with the batch information
• Provision to Link Label Details

Find the Barcode Partner

In order to include QR codes implementation, it would be ideal to partner with a company that has expertise in AIDC, GS1, hashing technology and an understanding of the pharma industry. The right partner should have the right hardware to support your needs

Barcode Parser: Parsing mechanism enabling the application scanners to scan and parse the encoded barcode data

Get regulatory-compliant technology Support for QR code Implementation

This is the most critical step in the QR code implementation. Ensure hassle free implementation of the Indian Government Drug Amendment by choosing a partner that will ensure seamless transition and regulatory compliance

Technology Support for QR code implementation

• Design dynamically the label templa
• Develop and manage API masters
• 21 CFR Part 11, EU annex 11 compliant for electronic data management
• GS1 standards compliant
• Adhere to all evolving Regulatory Needs
• Rich UI and Navigation with Multi-Device Support
• Provide customized reports when required

As the implementation rolls out, we anticipate the regulations to evolve linking up with the global best practices available within the serialization space leading to an end to end traceability. We envision the future road map would lead the manufacturers to maintain;

GS1 Company prefix

Every API manufacturer to get a GS1 Company prefix from GS1 India (for India- or a GS1 member organization). The GS1 company prefix is a unique identification key that is used to identify the trade manufacturer, items, locations and logistic units.

GLN and GTIN numbers for Trade Items

Every trade item should have a unique Global Trade Identification Number (GTIN), which is a 14-digit number generated as per GS1 guidelines. The GTIN should contain the GS1 company prefix and the product code, with an indicator digit present before and checksum added at the end.

The Global Location Numbers (GLNs) or the location identifiers are unique numbers that are specific to a manufacturing location or a sub-location within the company.

How will traceREADY^® help with QR code implementation for API manufacturers?

Navitas Life Sciences’ traceREADY^® is a device independent application that can interface with a wide variety of ERP, non-ERP, and custom solutions. Pharmaceutical industries are constantly looking for ways to ensure compliance through highly efficient and consistent processes. traceREADY^® delivers a high-quality solution for the multitude of challenges faced in the pharmaceutical industry. traceREADY^® helps to address the current unique needs of the industry like the implementation of QR codes.

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.

Why Choose traceREADY^®

• Collection of data and control of operations at the “Point of Action”
• Always stay audit ready with accurate data
• No complex middleware required for integration
• Dynamic rendering engine to configure data collection screens
• Additional system controls in real time during operations
• Reduced information latency Device>
• Connects to a range of ERP such as SAP, Oracle, etc., non-ERP products, and custom solutions
• Supports a range of Scales, Printers, and other devices within the network
• Highly scalable to handle a large number of users
• Provides adequate redundancy, reliability, and disaster recovery
• Real time information update
• 21 CFR Part 11 and Annexe-11 compliant application
• Intuitive interface, saving both time and cost of expensive ERP training
• Efficient electronic data capture and maintenance

To learn more about the traceREADY^® Label Printing module and to see if you are prepared for mandatory QR codes on APIs, please click here

To learn more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.