Context: 

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-highlights of the Amendment:

• 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.
• These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.

Why has the Government removed animals from drug testing?

• 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 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, 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.

Clinical Trials module in India:

• Scientists subject every drug to a lengthy series of tests to determine its efficacy in treating the intended disease and to assess its potential harmful effects.
• The first step of the process for drug testing involves 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, – and a lab-bred animal species reared in controlled conditions may not fully capture the human response to a drug.

Technologies suggested as alternatives:

To avoid the use of animals in clinical trials, one can effectively employ technologies.

• Technologies 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”.
• ‘Organ-on-a-chip’ Technology: These are AA-battery-sized chips lined with human cells connected to micro channels, 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.
• USING 3D Bioprinter: Bio printers are used to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.
  • Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.

Challenges:

• Developing an organ-on-a-chip system: It typically requires multidisciplinary knowledge and expertise in cell biology to recreate the cellular behaviour in the lab.
  • Materials science to find the right material to ensure that the chip does not interfere with biological processes.
  • Fluid dynamics to mimic blood flow inside the microchannels; electronics to integrate biosensors that can measure pH, oxygen etc. in the chip; engineering to design the chip; and pharmacology and toxicology to interpret action of the drugs in the chips.
• Resources for research and development: Currently, the U.S., Europe, and Japan supply most of the reagents, cell-culture related materials, and instruments.
  • There is a huge gap and opportunity in several diverse areas related to cell culture, material science and electronics, to develop an end-to-end ecosystem in India.
• 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.
  • It means there can be no ‘standard’ or ‘universal’ liver-on-a-chip to study all liver diseases.

Way Forward:

• There is a need  for multi-stakeholders involving members of industry, academia, government, and regulatory bodies, on the topic of implementing new human-based technologies.
• To enable this crosstalk between different disciplines, technology developers in academia and industry have proposed creating a ‘Centre for Excellence’ in India to bring together scientists and others with a wide range of expertise to build preclinical human models.

• Authorities must re-evaluate and revise the current guidelines on animal testing requirements, considering newer developments in cell-based and gene-editing-based therapeutics.
• It’s a truly interdisciplinary endeavour and needs focused training and human-resource building, which is lacking in the country at present.

FAQs about the Removal of Animals from Drug Testing and Implementation of Human-Based Technologies:

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