Indian Pharmacopoeia drops ‘redundant’ toxicity test on animals for human vaccines

PT Jyothi Datta Mumbai | Updated on August 02, 2020

The move gives a lease of life to small animals

Human vaccines will no longer require an “abnormal toxicity test” done on small animals before a batch of the product is released, provided manufacturers adhered to the country’s Good Manufacturing Practices (GMP) norms.

The development follows a recent amendment to the Indian Pharmacopoeia (IP) and will give a lease of life to several guinea pigs and mice who are put through these tests. The IP is a compilation of official standards of drugs being made or marketed in India, brought out by the Indian Pharmacopoeia Commission, an autonomous institution under the Health Ministry.

Explaining why abnormal toxicity tests had been dropped in other parts of the world as well, a note from People for the Ethical Treatment of Animals (PETA) said, “In the test, animals are injected with a vaccine, and if none of them die, 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.”

Dipti Kapoor, PETA’s India Science Policy Adviser, told BusinessLine, the country had already moved in the direction of removing this toxicity test from the general requirements of the IP monographs. But the impact was missing since individual monographs still required it, and the latest IP amendment drops this requirement from individual monographs of the human vaccines as well. The move came into effect from July 22, she said, when the IP amendment was published.

Eliminating this test would not affect the safety or quality of the product being released, provided GMP norms were followed, Kapoor said, adding that these tests had already been dropped from requirements in Europe, the United States and norms outlined by the World Health Organisation.

The vaccines impacted by the move included, Diphtheria and its combination vaccines, Hepatitis A, Influenza, Rabies, Japanese Encephalitis, Typhoid, Measles-Rubella, etc, she pointed out.

Maintaining quality of drug

As a member of the IPC sub-committee on alternatives to animal experiments and as a special invitee to its expert work group that discusses vaccines and antisera for human use, PETA said, it had been calling 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 test had been discussed within the expert working group since 2016. In 2018, the Commission made several updates to the Indian Pharmacopeia, including suggestions from animal welfare groups. 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 in 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 in May 2020. As of now, the 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, the statement said.

Published on August 02, 2020

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