NEW DELHI—A controversial and obsolete animal test for batch testing human vaccines has been abolished by the Indian Pharmacopoeia Commission in what is being hailed by Humane Society International/India as a landmark decision. Deletion of the Abnormal Toxicity Test from the Indian Pharmacopoeia will spare the lives of hundreds of thousands of animals nationwide every year. The decision was announced following the draft notification published for public consultation in May. HSI/India, a member of the IPC’s Expert Committee has been in dialogue with the IPC, vaccine manufacturers and scientists to remove ATT which is in accordance with the World Health Organisation guidelines which deleted the test in November 2018.
Alokparna Sengupta, managing director of HSI/India, said: “This is a landmark decision by the Ministry of Health and Family Welfare and the IPC, and represents a progressive stride in joining some of the most scientifically advanced countries in the world that have also deleted the obsolete Abnormal Toxicity Test. This is the first vital step towards consigning animal testing for vaccines to the history books, and we hope that an equally forward-thinking vision will be applied to similarly obsolete animal tests for veterinary vaccines too.
“As a global player of ever-growing significance in worldwide vaccine manufacturing, India needs to be at the forefront of innovation and compliance with the highest international standards. As well as being inhumane, animal tests are increasingly recognized to be poor at replicating results in human, prone to excessive variability, and highly costly.”
The ATT was originally developed in the 1950s to detect external contaminants in vaccines and has remained the de facto gold standard despite mounting scientific evidence questioning its reliability and value. The introduction of “good manufacturing practices” and the use of stringent quality control measures, now mean that omission the test does not compromise the safety of the products. The IPC has previously granted waivers on the ATT for companies able to demonstrate good manufacturing practices and adequate consistency of production, but now the test will be completely deleted.
With support from the Bill & Melinda Gates Foundation, Humane Society International is working across the globe with vaccine safety authorities, industry and stakeholders in an effort to eliminate or replace redundant animal testing from regulations for human and veterinary products. HSI has facilitated extensive stakeholder engagement in India to help bring about this monumental step sparing countless animal lives while ensuring vaccine safety and availability.
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