New Drugs and Clinical Trial Rules (2023)
New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.
Need for new regulations:
- Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials.
- The limitations of the conventional testing process, beginning 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.
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
Technologies suggested as alternatives:
To avoid animal use for clinical trials, technologies can be used effectively which includes;
- 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.