How to remove animals from Drug Testing
Introduction:
- Animals will no longer be used in research, especially for drug testing, thanks to a change to the New Drugs and Clinical Trial Rules (2023) that the Indian government has approved. The amendment allows for the use of non-animal and human-relevant testing methods, such as 3D organoids, organs-on-chip, and powerful computational tools, to assess the efficacy and safety of innovative drugs.
Pipeline for drug development at the moment:
- Every drug that is put on the market goes through a thorough process of testing to see if it can effectively treat the ailment for which it was created and if it has any unanticipated undesirable side effects.
- Traditionally, the first step in this strategy has been to test the candidate chemical in at least two animal species, a rodent (mouse or rat) and a non-rodent, such as canines and primates.
- It’s possible that a type of lab-bred animal maintained under strict control won’t accurately represent how people react to a given medicine. Humans, on the other hand, are more complicated animals, and biological processes and their outcomes commonly differ from one individual to the next depending on things like age, sex, pre-existing conditions, genetics, food, etc.
- The infamously high failure rate of the drug development process is a clear indication of this “mismatch” between the two species.
- Despite increased investment in the pharmaceutical sector, most drugs that made it through the animal testing stage of the pipeline fail in the final round of human clinical trials.
Various test techniques:
- In the recent decades, a number of technologies have been developed employing either human or stem cells. Included in these are “organoids” or “mini-organs,” which are teeny, three-dimensional cell-based copies of particular body organs.
- Another well-liked invention is “organ-on-a-chip” technology, which uses AA battery-sized chips filled with human cells and connected to microchannels to mimic blood flow in the body.
- These gadgets capture many aspects of human physiology, including interactions between tissues and internal physiological signals.
- Researchers have also used additive manufacturing techniques for more than 20 years.
- In 2003, researchers developed the first inkjet bioprinter by modifying a standard inkjet printer. A 3D bioprinter can now “print” biological tissues using human cells and fluids as “bio-ink,” as a result of various advancements over the past ten years.
- The discovery and design of pharmaceuticals could be revolutionised by these technologies. Drug testing can be tailored using them, which is made possible by the use of patient-specific cells.
Developing the technology for organs on chips:
- One problem is the frequent need for interdisciplinary skills when developing an organ-on-a-chip system.
- To replicate cellular behaviour in the lab, one needs to have an understanding of cell biology, materials science, fluid dynamics, fluid dynamics to simulate blood flow inside the microchannels, electronics to integrate biosensors that can measure pH, oxygen, etc., engineering to design the chip, and pharmacology and toxicology to comprehend the effects of the drugs in the chip.
- It’s a highly interdisciplinary endeavour that calls both resource development and specialised training, both of which the country now lacks.
Way Forward:
- To deal with the intricacy of recreating human tissues and organs in the petri dish, researchers usually limit the amount of components needed to mimic the condition they are studying.
- It is essential to create guidelines and criteria for the systems’ minimal quality standards.
- Additionally, in view of current developments in cell- and gene-based therapies, the criteria for animal testing requirements need to be reevaluated and modified.
