INDIA—In a significant move, the Indian Pharmacopoeia Commission (IPC) has made a progressive amendment and waived off the Target Animal Batch Safety Test (TABST) in the Indian Pharmacopoeia, effective 1st July 2024.  

The TABST, a non-specific safety test for veterinary vaccines, typically involves the administration of vaccine overdose to animals to test that every batch of vaccine produced is safe for a specific species. However, multiple studies have proved that the method lacks specificity and is prone to producing false results. The IPC’s decision to waive the TABST will reduce the number of animals subjected to unnecessary testing and underscores the supportive atmosphere of the regulators and industry to steer away from obsolete animal-based testing.

By recognizing the shortfalls of the TABST and allowing the test to be waived, India is a step closer to aligning itself with international veterinary vaccine testing standards, joining Brazil, Europe, Canada, the US, Japan, and others.  

Alokparna Sengupta, managing director at Humane Society International/India said: “We are delighted at the recent waiver of the TABST. This reaffirms India’s commitment towards eliminating obsolete animal tests for batch release testing of vaccines. We have been working on this with both IPC and the industry since 2020 and we believe that such collaboration is pivotal in this decision. We look forward to facilitating further advancements in other areas of safety testing of vaccines as well.” 

This waiver follows a series of progressive decisions by the IPC. Back in 2018, the Rabbit Pyrogen Test was replaced with the Bacterial Endotoxin Test (BET), followed by the inclusion of the Monocyte Activation Test in 2018 and removal of the Abnormal Toxicity Test for almost all human vaccines in 2020 from Indian Pharmacopoeia monographs. 

Over the last five years, HSI/India’s Research & Toxicology department has been working with the Government of India, the veterinary industry and associated interest holders to promote the development and use of advanced non-animal methodologies. This positive step by the IPC will save countless animal lives whilst enhancing veterinary vaccine safety. 

ENDS

Media contact: Shaili Shah: 993059100: sshah@hsi.org