India takes first step to remove animals from drug-testing process Premium

Every drug in the market goes through a long journey of tests, each designed to check whether it can treat the disease for which it was created and whether it has any unintended harmful effects. For a long time, the first step of this process was to test the candidate molecule in at least two animal species. This could change with a new amendment passed by the Indian government.

An amendment to the New Drugs and Clinical Trial Rules (2023), recently passed by the Government of India, aims to replace the use of animals in research, especially in drug testing. The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.

Every drug in the market goes through a long journey of tests, each designed to check whether it can treat the disease for which it was created and whether it has any unintended harmful effects. For a long time, the first step of this process has been to test the candidate molecule in at least two animal species: a rodent (mouse or rat) and a non-rodent, such as canines and primates.

However, humans are more complex creatures, and biological processes and their responses often vary from person to person as well, based on factors such as age, sex, pre-existing diseases, genetics, diet, etc. – and a lab-bred animal species reared in controlled conditions may not fully capture the human response to a drug.

This ‘mismatch’ between the two species is reflected in the famously high failure-rate of the drug development process. Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials, which come towards the end of the pipeline.

The limitations of the conventional testing process, beginning with animals, have led an increasing number of researchers to focus on systems that do a better job of capturing the intricacies of human biology and predicting humans’ responses.

In the last few decades, several technologies have been developed using human cells or stem cells. These include millimetre-sized three-dimensional cellular structures that mimic specific organs of the body, called “organoids” or “mini-organs”.

Another popular technology is the “organ-on-a-chip”: they are AA-battery-sized chips lined with human cells connected to microchannels, to mimic blood flow inside the body. These  systems capture several aspects of human physiology, including tissue-tissue interactions and physical and chemical signals inside the body.