DTAB’s Recommendations for Labeling of Excipients

During its 90th meeting held in January, the DTAB contemplated a proposal advocating for the inclusion of excipient details on every strip of medicine.

The Health Master

March 28, 2024

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DTAB Drug Technical Advisory Board — DTAB

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Last Updated on April 9, 2024 by The Health Master

DTAB

The Drugs Technical Advisory Board (DTAB) has recently put forward a significant recommendation to the drug regulator regarding the labeling of excipients causing hypersensitivity.

This recommendation aims to address growing concerns over the lack of information about excipients in medicines, particularly for individuals with allergies or sensitivities.

Let’s delve deeper into the details of this proposal and its implications.

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Background Information

During its 90th DTAB meeting held in January, the DTAB contemplated a proposal advocating for the inclusion of excipient details on every strip of medicine.

This proposal came in response to a growing number of complaints from individuals facing allergic reactions due to certain excipients, such as parabens, commonly used as preservatives in pharmaceutical products.

Download minutes of 90th DTAB meeting

Public Concerns and Grievances

The need for this recommendation became apparent when grievances were raised about the absence of clear indications of excipient composition on medicine strips available in retail medical shops.

Many individuals, like the one who lodged the grievance, found it challenging to locate paraben-free medications for conditions like hypertension.

This issue underscores the broader problem of inadequate labeling of excipients, which can pose risks to individuals with various sensitivities.

Read and Download Minutes of all meetings of DTAB

Deliberations of Drug Consultative Committee (DCC)

The matter was further deliberated in the 61st and 62nd meetings of the Drugs Consultative Committee (DCC).

While the committee acknowledged the importance of providing excipient details, it recognized the practical challenges associated with mandating such labeling on product labels.

Consequently, the committee recommended exploring alternative methods, such as incorporating excipient details in package inserts or QR codes.

Read and Download minutes of all meetings of DCC

Recommendations and Amendments

In response to the concerns raised, the DTAB and DCC jointly recommended capturing excipient information through QR codes, especially for the top 300 brands initially.

This approach aims to strike a balance between addressing consumer needs and practical considerations faced by manufacturers.

Implications for the Pharmaceutical Industry

Implementing these recommendations would have significant implications for the pharmaceutical industry.

While enhancing transparency and consumer safety, it may also pose challenges in terms of compliance and operational adjustments for manufacturers.

However, the long-term benefits of providing comprehensive information on excipients outweigh these challenges.

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