HUMANE Society International/India has lauded the Indian Pharmacopoeia Commission for proposing to end a controversial and obsolete animal test ‘Abnormal Toxicity Test’ for human vaccines. If implemented, the deletion of the Abnormal Toxicity Test (ATT) from the Indian Pharmacopoeia will spare the lives of hundreds of thousands of animals nationwide every year while ensuring vaccine safety and availability. The decision deliberated upon during the IPC’s Scientific Committee meeting, follows dialogue between the IPC, vaccine manufacturers and scientists from HSI/India, and is in accordance with the World Health Organisation recommendation to delete the test in November 2018.
Humane Society International/India has facilitated extensive stakeholder engagement in India to help bring about this monumental step. HSI 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.
Alokparna Sengupta, managing director of HSI/India, said, “We welcome this first step by the Ministry of Health and Family Welfare and the IPC. This is an opportune moment for India to join some of the most scientifically advanced countries in the world that have also deleted the obsolete Abnormal Toxicity Test. We are sure there will be wide-scale acceptance of this deletion and India will be able to make a landmark decision on this.”
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 of 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 has been proposed for deletion.