DTAB advocates Bar Codes and QR Codes on Vaccine Products

The DTAB recommendation extends the tracking mechanism to not only vaccine products but also to another products

March 11, 2024

Table of Contents

Last Updated on March 21, 2024 by The Health Master

Vaccine

In the fast-evolving landscape of healthcare, the Drugs Technical Advisory Board (DTAB) has recently put forth a crucial recommendation that could revolutionize the way we monitor and trace vaccine products.

The proposal suggests affixing bar codes or quick response (QR) codes on all vaccine products as part of the benchmarking maturity levels required under the upcoming World Health Organisation (WHO) Global Benchmarking of vaccines.

Let’s delve into the details and implications of this significant move.

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1. DTAB’s Recommendation

The article kicks off by introducing the primary recommendation made by the DTAB – the implementation of bar codes or QR codes on vaccine products.

This sets the stage for understanding the context and the driving force behind this proposal.

2. WHO Global Benchmarking of Vaccines

Delving into the WHO Global Benchmarking of vaccines, we explore the process of assessing National Regulatory Authority (NRA) based on Global Benchmarking Tools (GBT).

The article explains the importance of this benchmarking for the Indian drug regulator and its preparations for the upcoming assessment.

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3. Tracking Mechanism Extension

The DTAB recommendation extends the tracking mechanism to not only vaccine products but also to antimicrobials, narcotic, and psychotropic substances.

This section highlights the phased implementation plan for this extension.

4. Previous WHO NRA Assessment

To provide context, the article touches upon the last NRA assessment carried out by WHO in 2017, emphasizing the need for a new assessment and preparation for the WHO prequalification programme.

5. Marketing Surveillance and Control

Detailing one of the crucial functions audited by the WHO NRA assessment team – marketing surveillance and control.

The article explains the significance of legal provisions for placing a product’s unique identification number (UIN) on its outer packaging.

6. Maturity Level 4 Standards

Exploring the requirements of Maturity Level 4 under GBT, the article focuses on the need for legal provisions or regulations for affixing UIN on the outer packaging of each vaccine product.

7. Process at DTAB

This section provides insights into the DTAB meeting held in January, shedding light on the board’s observation and agreement on the proposal to affix bar codes or QR codes on vaccine products.

8. Implementation Monitoring

The article discusses the DTAB’s recommendation regarding the monitoring of the implementation of QR codes for the top 300 brands in the states, emphasizing the importance of vigilance in this process.

9. Government Mandate on QR Codes

Highlighting a government mandate implemented in August 2023, which requires the affixing of QR codes on labels of 300 brands, including seven vaccine brands.

10. List of 300 Brands with QR Codes

Providing specifics on the list of 300 brands, including notable vaccine brands such as Pfizer’s Prevnar 13 and GlaxoSmithkline Pharma’s Varilrix, among others.

11. Fulfilling Global Benchmarking

Delving into the requirement of fulfilling sub-indicator 1.05 of the function “Marketing Surveillance and Control” under Global Benchmarking Tools for Maturity Level 4, emphasizing the need for legal provisions for affixing unique identification numbers on outer packaging.

12. Implications for Manufacturers

This section explores the implications of the recommendation for manufacturers, as specified in Schedule H2, to print or affix bar codes or QR codes on primary packaging labels.

13. The Role of QR Codes in Authentication

Highlighting the role of QR codes in authentication, the article underscores the importance of data or information legible with software applications to facilitate authentication.

14. Inclusion of Vaccine Brands in QR Code Mandate

Discussing the inclusion of vaccine brands in the QR code mandate and how it aligns with the broader goals of the DTAB and WHO.

15. Future Steps and Conclusion

Wrapping up the article, this section outlines the future steps in the implementation process and concludes with a summary of the key takeaways from the DTAB’s recommendation.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.