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Use of Animals In Drug Testing UPSC NOTE

 


Current drug-development pipeline

  • For a long time, the first step of the 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.

  • A lab-bred animal species reared in controlled conditions may not fully capture the human response to a drug.

    • 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.

  • 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.

Alternative testing modes

  • 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.

  • Researchers have also used additive manufacturing techniques for more than two decades. 

  • In 2003, researchers developed the first inkjet bioprinter by modifying a standard inkjet printer.

  • Several innovations in the last decade now allow a 3D bioprinter to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.

  • These systems promise to reshape drug-design and -development. 

  • Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.

Status of regulations worldwide

  • How global regulatory frameworks are designed will play an important role in determining whether researchers will adopt non-animal methods to test the effect and potential side-effects of new drug candidates.

  • 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. 

  • The U.S. passed the FDA Modernization Act 2.0 in December 2022, allowing researchers to use new technology systems to test the safety and efficacy of new drugs.

  • In the same month, South Korea introduced a Bill called ‘Vitalization of Development, Dissemination, and Use of Alternatives to Animal Testing Methods’. 

  • In June 2023, Canada amended its Environmental Protection Act to replace, reduce or refine the use of vertebrate animals in toxicity testing.

  • In March 2023, the Indian government embraced these systems in the drug-development pipeline by amending the New Drugs and Clinical Trials Rules 2019.

    • It did so after inviting comments from the people and in consultation with the Drug Technical Advisory Board, the statutory body that advises Central and State governments on drug-related technical matters.

Challenges

  • Developing an organ-on-a-chip system typically requires multidisciplinary knowledge. 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; 

    • Pharmacology and toxicology to interpret action of the drugs in the chips.

  • It’s a truly interdisciplinary endeavour and needs focused training and human-resource building, which is lacking in the country at present.

  • Another important problem concerns the resources needed for research.

  • Most of the reagents, cell-culture related materials and instruments for these technologies are currently imported from the U.S., Europe, and Japan.

  • There exists a huge gap and hence opportunity in several diverse areas related to cell culture, material science and electronics, to develop an end-to-end ecosystem in India.

  • To manage the complexity of recreating human tissues and organs in the petri dish, researchers often minimise the number of components required to simulate the disease being investigated. 

  • This means, for example, there can be no ‘standard’ or ‘universal’ liver-on-a-chip to study all liver diseases.

  • So regulators sometimes express concerns about variability in the data arising from differences in lab-to-lab protocols and expertise.

Way forward

  • We need to create one or more institutes like the Wyss Institute in Boston, which is a dedicated centre that focuses on innovations that emulate human biology.

  • To enable the crosstalk between different disciplines, technology developers in academia and industry have proposed creating a ‘Centre for Excellence’ in India, akin to the Wyss Institute, to bring together scientists and others with a wide range of expertise to build preclinical human models.

  • It is important to bring out guidelines on the minimal quality criterion and standards for these systems.

  • The current guidelines on animal testing requirements must be re-evaluated and revised, considering newer developments in cell-based and gene-editing based therapeutics.

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Learnerz IAS | Concept oriented UPSC Classes in Malayalam: Use of Animals In Drug Testing UPSC NOTE
Use of Animals In Drug Testing UPSC NOTE
Learnerz IAS | Concept oriented UPSC Classes in Malayalam
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