The Indian Pharmacopoeia Commission 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, said the People for the Ethical Treatment of Animals (PETA) on Friday.
“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,” said PETA, welcoming the move.
PETA India, as a member of the IPC’s 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 the removal of the redundant test.
“This landmark move will prevent thousands of sensitive guinea pigs and mice from suffering and dying in this notoriously cruel and scientifically flawed test,” said PETA India Science Policy Adviser Dr. Dipti Kapoor.
In 2018, the commission had made several updates to the Indian Pharmacopoeia, 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 April 29, 2019, the proposal to remove this test from the individual monographs of human vaccines was accepted.
Upon approval from the commission’s Scientific Body, the draft amendment was opened for stakeholder comments on 20 May 2020.
Now, 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.