ANIMAL
AND DRUG TESTING – POLITY
News:
India takes first step to
remove animals from drug-testing process
What
is in the news?
● Recently,
an amendment to the New Drugs and Clinical Trial Rules (2023) was passed by the
Government with the aim of stopping the use of animals in research, especially
in drug testing.
Key
provisions of the New Drugs and Clinical Trial Rules (2023):
● The
amendment authorizes researchers to use non-animal and human-relevant methods
like 3D organoids, organs-on-chip, and advanced computational methods, to test
the safety and efficacy of new drugs.
Reasons
for the removal of animals from drug testing:
1. No response
up to the human level:
● 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.
2. High failure
rate:
● This
‘mismatch’ between the two species is reflected in the 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.
3. Test in
human biological system:
● The
limitations of the conventional testing process, which begin 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.
Alternative
testing methods:
1.
Organoids:
● Organoids are three-dimensional cellular
structures that emulate specific organs of the body.
● These
miniature organs, developed from human cells or stem cells, provide a more
accurate representation of human physiology, enabling researchers to study drug
interactions in a human context.
2. 3D
Bioprinting:
● 3D
bioprinting technology enables the creation of complex human tissues and organs
using patient-specific cells.
● This
advancement allows for the development of personalized drug testing approaches,
catering to individual variations in biology.
3. 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.
Challenges:
1.
Poor research material:
● Most
of the reagents, cell-culture related materials and instruments are currently
imported from the U.S., Europe, and Japan.
2. Differences
in results:
● Variability
in the data arising from differences in lab-to-lab protocols and expertise.
● For
example, One lab may create a system with only liver cells, while another lab
attempting to study the immune system and liver may also incorporate immune
cells in its liver-on-a-chip.
3. Experts
shortage:
● Developing
and implementing technologies like organoids and organs-on-chip demand diverse
expertise, ranging from cell biology and materials science to electronics and
pharmacology.
World
Wide regulation:
1.
European union:
● In
2021, the European Union passed a resolution on an action plan to facilitate
transition towards technologies that don’t use animals in research, regulatory
testing, and education.
2. USA:
● The
U.S. passed the FDA Modernization Act 2.0 in December 2022, allowing
researchers to use these systems to test the safety and efficacy of new drugs.
3. Canada:
● In
June 2023, Canada amended its Environmental Protection Act to replace, reduce
or refine the use of vertebrate animals in toxicity testing.
WAY
FORWARD:
1.
Multidisciplinary training:
● India
must invest in multidisciplinary training and resource-building to bridge
existing knowledge gaps.
2. Standardization
of drug test:
● Clear
guidelines and quality criteria are essential to ensure reliable and comparable
results across different labs.
● Regulatory
bodies must adapt to the advancements in cell-based and gene-editing-based
therapeutics.
3. Resources
localisation:
● To
establish a self-sufficient ecosystem, India should focus on developing a
robust infrastructure in areas like cell culture, material science, and
electronics.