Non-Animal Testing Methods (NAMs)
Non-animal testing methods/New Approach Methodologies (NAMs) assess drug safety, efficacy and quality using biological (in vitro/ex vivo) and computational (in silico) tools. Examples include organ-on-chip, stem cell organoids (used to link Zika to microcephaly), human blood cell assays replacing rabbit pyrogen tests, and AI models predicting toxicity/arrhythmias. New Drugs and Clinical Trials (Amendment) Rules, 2023 permit human-relevant NAMs. Traditional animal testing approves only 10–14% Phase I candidates; a report cites >50% time reduction and ~70–90% cost cuts in India; NAM centres exist in US/EU/Japan. Ethical issues cite animal suffering, Kant’s imperative, Singer’s “speciesism” and utilitarian limits.
The Hindu

