The proposal has been put in public domain for comments
The Indian Pharmacopoeia Commission (IPC), responsible for setting standards for drugs, has proposed ending animal test — Abnormal Toxicity Test (ATT) — for human vaccines. The Draft Amendment in Human Vaccine Monograph has been opened for public comments through mid-July.
The proposal, out forth by the IPC in its scientific body meeting on February 22, 2020, was put in the public domain for comments on June 1.
IPC is an autonomous institution under the Ministry of Health and Family Welfare that sets standards for all drugs that are manufactured, sold and consumed in India.
“These monographs are part of the Indian Pharmacoepeia that prescibe standards for a vaccine. Earlier, there was a waiver for ATT on a case-to-case basis. But now, the test has been removed for 33 vaccines where ATT was mandatory earlier,” Alokparna Sengupta, managing director, Humane Society International / India, an international animal welfare organisation, told Down to Earth.
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 against its reliability and value.
“ATT is an obsolete test which does not contribute to the quality control of the vaccine. We welcome the Government of India’s move to delete it. India, being a major manufacturer of vaccines, will get rid of the redundancy. The vaccine industry also wants it to be removed as it is resource-intensive,” Sengupta added.
The minutes of the IPC meeting, released on June 1, showed that ATT removal has been proposed for the following vaccines: Diphtheria, tetanus and pertussis (whole cell), hepatitis B (rDNA) and haemophilus influenza, Japanese encephalitis, measles and rubella, mumps, meningococcal, plague, rabies, typhoid and yellow fever.
The European Union and United States pharmacopeia deleted the ATT on the World Health Organisation’s recommendations in November 2018, according to Sengupta.
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