India takes first step to remove animals from drug-testing

Syllabus: Science and Technology- developments and their applications and effects in everyday life.

Context

An amendment to the New Drugs and Clinical Trial Rules (2023) – stopping the use of animals in research, especially in drug testing

To remove animals from drug-testing

Check whether it can treat the disease and whether it has any unintended harmful effects.
Most often used animal species: a rodent (mouse or rat), a non-rodent (canines and primates).
most drugs that cleared the animal-testing stage fail at the stage of human clinical trials – due to ‘mismatch’ between the two species – factors such as age, sex, pre-existing diseases, genetics, diet, etc influence drug reaction in humans
Instead use non-animal and human-relevant methods – including technologies like 3D organoids (millimeter-sized three-dimensional cellular structures that mimic specific organs of the body), organs-on-chip (AA-battery-sized chips lined with human cells connected to microchannels, to mimic blood flow), and advanced computational methods ( 3D bioprinter to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’), to test the safety and efficacy of new drugs.
promise to reshape drug-design and -development – can also be used to personalize drug-tests using patient-specific cells.

Challenges

Developing an organ-on-a-chip system typically requires multidisciplinary knowledge – needs focused training and human-resource building, which is lacking in the country at present – 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.
Most of the reagents, cell-culture related materials and instruments for these technologies are currently imported from the U.S., Europe, and Japan – hence opportunity to develop an end-to-end ecosystem in India exists.
There can be no ‘standard’ or ‘universal’ liver-on-a-chip to study all liver diseases – concerns about variability in the data arising from differences in lab-to-lab protocols and expertise – It is important to bring out guidelines on the minimal quality criterion and standards for these systems – Also, the current guidelines on animal testing requirements must be re-evaluated and revised, considering newer developments in cell-based and gene-editing based therapeutics.

Post Views: 61