New Delhi: Over the years, using animals to test drug safety before human trials has been one of the most contentious dilemmas in pharmaceutical research-a fraught intersection of scientific necessity and ethical responsibility.
However, confrontations that once defied resolution are now within reach, thanks to modern scientific breakthroughs, coupled with added benefits of cost efficacy, reduced timelines and better predictability.
Non-animal methods (NAM) -such as organ-on-a-chip, in vitro systems, and AI-enabled in silico models-have emerged as groundbreaking alternatives that spare animals from testing, while enhancing the accuracy and predictive power of preclinical results.
Perhaps with newer modalities such as biologics, biosimilars, Prof. Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois, USA, stresses that animal toxicology studies are increasingly becoming irrelevant, as the real clinical differences they reveal are minimal.
Constraints with conventional approach
According to Prof. Niazi, animal testing often falls short for biologic drugs, as humans and animals share very few receptors in common. Biosimilars, engineered with precise receptor-targeting mechanisms, expose this limitation.
Whereas if an innovator can demonstrate near-identical similarity between a biosimilar and its reference molecule using advanced analytical methods, he says, ‘the need for extensive animal studies can often be avoided.
For industry, Deepak Sapra, CEO of API & Services at Dr. Reddy’s Laboratories Ltd, argues that this shift reduces the cost burden on preclinical studies, enhances early-stage decision-making with more accurate screening, while accelerating trial timelines.
Prof. Niazi notes that such advancements bring substantial cost savings.
In US-based studies, the cost of preclinical research could drop from $100 million to roughly $10 million.
In India, the potential cost benefits are still unclear due to limited data and insufficient empirical analysis.
Ethics evolution
Anchored in the principle of the 3Rs-Replacement, Reduction and Refinement-these non-animal methods are gaining a positive traction across regulated markets such the TIC and Europe.
However, the transition has been decades in the making. First proposed as early as 1959, the idea encountered sustained regulatory resistance. Prof. Niazi recalls years of institutional reluctance, a stance that only began to shift last year when the US Food and Drug Administration unveiled a transformative plan to gradually phase out the use of animals in drug testing.
Meanwhile, the ever expanding European regulatory framework embraced the advancements, a little before with its “Roadmap towards ultimately phasing out animal testing for chemical safety assessments.”
In India, the central regulatory agency -CDSCO- begun the churn in its latest guidelines for developing and manufacturing biosimilars notified in May 2025.
While the draft proposal remains under consideration, senior regulatory officials told ET Pharma that the rules are in the “final stages of review,” without specifying a timeline.
Earlier, ET Pharma also reported that regulators are considering multiple NAM approaches for cell and gene therapies.
Advancing adoption
A recent report, “Landscape Analysis on Alternatives to Animal Testing for Drug Development in India”, places India in a early stages of adoption of such methods and suggest a gradual upgrade with capability support from the government.
The report calls for establishing ‘Centres of Excellence’ (CoEs) to support workforce training across the country and a central agency for validation, standardisation, and integration of NAMs into regulatory review and submissions.
Deepak Sapra told ETPharma that, presently the use of NAMs is uneven and remains at varying degrees of maturity. However at his company the drugmaker has already explored “in silico models, organoids, and endotoxin/pyrogen testing.”
“Dr. Reddy’s is actively integrating NAMs across early toxicology studies, mechanistic investigations, and selected species workflows,” he said adding that, “the company is also working to expand adoption among industry peers by sharing the benefits achieved through their use.”
Notably, the Hyderabad based pharma major is planning to head an industry consortium with Sun Pharma, Torrent, Cipla and several other domestic giants to create “structured channels for regulatory engagement.”
Small molecules struggle
While the shift toward non-animal methods seems inevitable for modalities such as biologics and stem cell therapies, Prof. Niazi notes that for small-molecule drugs-where delivery mechanisms remain uncertain-animal studies will likely continue. However, a gradual transition could be planned, with decisions made on a case-by-case basis.
Source : Economictimes
