IPC waves off TABST in Indian Pharmacopoeia

Last Updated on October 9, 2024 by The Health Master

IPC

The Indian veterinary vaccine landscape has undergone a significant shift with the Indian Pharmacopoeia Commission’s (IPC) progressive move to waive off the Target Animal Batch Safety Test (TABST).

This decision, effective July 1, 2024, marks a positive step towards minimizing unnecessary animal testing and aligning India with international best practices.

What was the TABST and why is it being phased out?

Previously, the TABST served as a non-specific safety test for veterinary vaccines.

It involved administering an excessive dose of the vaccine to animals to assess its safety for a specific species within each production batch. However, research has consistently highlighted the limitations of this method.

The TABST:

• Lacks Specificity: It fails to pinpoint specific safety concerns within a vaccine batch.
• Produces False Results: The high dosage employed can lead to misleading outcomes.

Benefits of Eliminating the TABST

The IPC’s decision to waive off the TABST offers a multitude of advantages:

• Reduced Animal Testing: This amendment significantly reduces the number of animals subjected to unnecessary and potentially stressful testing procedures.
• Modernization of Testing Practices: India takes a step closer to adopting more advanced and reliable non-animal testing methodologies.
• Alignment with Global Standards: This move positions India alongside leading nations like Brazil, Europe, Canada, the US, and Japan, who have already eliminated the TABST.

Collaboration for Progress

Alokparna Sengupta, MD, of Humane Society International/India (HSI/India), lauded the decision, emphasizing India’s commitment to phasing out outdated animal testing practices.
HSI/India has actively collaborated with the IPC and the veterinary industry since 2020 to advocate for this change.

This collaborative effort underscores the critical role of stakeholder engagement in driving positive advancements.

A History of Progressive Decisions

The elimination of the TABST builds upon a series of progressive actions taken by the IPC in recent years:

• 2018: Replacement of the Rabbit Pyrogen Test with the Bacterial Endotoxin Test (BET)
• 2018: Inclusion of the Monocyte Activation Test
• 2020: Removal of the Abnormal Toxicity Test for most human vaccines from Indian Pharmacopoeia monographs

The Road Ahead

HSI/India’s unwavering efforts, focusing on research and toxicology, have been instrumental in advocating for the development and implementation of sophisticated non-animal testing methods alongside the Government of India, the veterinary industry, and relevant stakeholders.

This positive step by the IPC not only spares countless animals from unnecessary procedures but also paves the way for enhanced veterinary vaccine safety through modern testing practices.

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.

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