Victory! Indian Pharmacopoeia Commission Removes Deadly Animal Test

For Immediate Release:

22 July 2020


Dipti M Kapoor; [email protected]

Hiraj Laljani; [email protected]

Appeal From PETA India Prompts Removal of ‘Abnormal Toxicity Test’ on Guinea Pigs and Mice From Human Vaccine Monographs

New Delhi – Today, thanks in part to People for the Ethical Treatment of Animals (PETA) India, Indian Pharmacopeia Commission and industry stakeholders, the Indian Pharmacopoeia Commission (IPC) has removed the “abnormal toxicity test” from the human vaccine monographs of the Indian Pharmacopoeia – the official compilation of approved tests for drugs manufactured and marketed in India. The group welcomes this long-awaited positive and progressive move that will spare the lives of thousands of animals every year.

In the test, animals are injected with a vaccine, and if none of them dies, the batch is deemed safe. Animals who don’t die during the experiment are killed afterwards. Extensive reviews of historical data from the abnormal toxicity test have shown that compliance with good manufacturing practices is superior to the use of animals for controlling and detecting batch contamination.

PETA India – as a member of the IPC subcommittee on alternatives to animal experiments and as a special invitee to its expert work group that discusses vaccines and antisera for human use – has long been advocating for the removal of this redundant test, as it does not provide any value in the quality control of drugs or contribute to patient safety, although it does harm animals.

The removal of this redundant test has been discussed within the expert working group since 2016. In 2018, the commission made several updates to the Indian Pharmacopeia, incorporating several suggestions made by PETA India. It also included provisions for companies with certified good manufacturing practices to waive this test for human vaccines, upon approval by the National Regulatory Agency.

At the IPC’s seventh group meeting of experts on 29 April 2019, the proposal to remove this test from the individual monographs of human vaccines was accepted – and upon approval from the commission’s Scientific Body, the draft amendment was opened for stakeholder comments on 20 May 2020. Now – effective immediately – this test is no longer required before the batch release of any human vaccines, as per the Amendment List-06 to IP 2018, published by the commission.

“This landmark move will prevent thousands of sensitive guinea pigs and mice from suffering and dying in this notoriously cruel and scientifically flawed test,” says PETA India Science Policy Adviser Dr Dipti Kapoor. “The future of science is animal-free, and PETA India will keep working to ensure that all remaining animal experiments are replaced with modern, humane methods.”

PETA India – whose motto reads, in part, that “animals are not ours to experiment on” and which opposes speciesism, a human-supremacist worldview – notes that the vast physiological differences between humans and other species mean that the results of animal experiments are often misleading.

For more information, please visit