India open to global bid to avoid animal trials for new drugs

A central government official, who asked not to be named, said there are now global conversations around tweaking this approach

India’s medicines regulator is examining the feasibility of decreasing reliance on animal studies in drug trials, according to people familiar with the matter, who said the plan aligns with a global shift towards alternative testing methods, driven by scientific, ethical and other concerns regarding animal studies.

Animal testing is a decades-old practice and typically occurs during preclinical research, forming a crucial bridge between laboratory discoveries and human trials.

Animal testing is a decades-old practice and typically occurs during preclinical research, forming a crucial bridge between laboratory discoveries and human trials. Before any new drug reaches human subjects, researchers first test it in at least two different animal species—usually mice or rats, followed by larger mammals like dogs or primates.

A central government official, who asked not to be named, said there are now global conversations around tweaking this approach. “The entire system of drug trials and regulatory framework is undergoing transformation worldwide, and India is no exception. While completely eliminating animal models may not be feasible, the global focus is on reducing dependence on animal studies,” said this person.

A decision on this, however, may not come soon. “Use of animals for research in biosciences is being re-looked at; however, the thought is at nascent stages as far as Indian drugs regulatory system is concerned. It will take some time before any decision is taken in this regard, particularly on what alternative modes are going to be followed.”

The topic featured prominently at the recently concluded 19th International Conference of Drug Regulatory Authorities in India. A Union health ministry statement noted that presentations explored alternative testing methods.

“The presentations advocated establishing robust regulatory frameworks for Advanced Therapy Medicinal Products, while raising awareness and creating opportunities for replacing, reducing and refining reliance on animal studies, alongside providing information on WHO prequalification of IVDs,” the statement read.

IVD refers to in-vitro diagnostics, a process in which the safety and reaction of certain elements on humans can be tested in a lab environment, by using tissues.

Alternative methods include IVD, organs-on-a-chip technology, computational and mathematical models, and human clinical research.

A March 2024 article in Pharmacological Reviews, titled “Protecting Human and Animal Health: The Road from Animal Models to New Approach Methods,” highlighted growing concerns about using animals in drug and chemical research for safety assessment and cited efforts for the scientific community to adopt the “3Rs” approach—replace, reduce and refine animal testing—while developing new approach methods (NAMs), which include laboratory techniques that use human cells and computer modelling.

“Although progress has been made in several areas, complete replacement of animal models with new approach methods is not yet attainable,” the article noted.