Gene Editing is a type of genetic engineering in which DNA is inserted, deleted, modified or replaced in the genome of a living organism. Unlike early genetic engineering techniques that randomly insert genetic material into a host genome, genome editing targets the insertions to site specific locations.
CRISPR is widely considered the most precise, most cost-effective and quickest way to edit genes.
- Most uses of genome editing have been in scientific research –for example to investigate models of human disease.
- Genome editing has the potential to alter any DNA sequence, whether in a bacterium, plant, animal or human being.
- It is a powerful tool that can reshape the way society deals many issues of healthcare, food scarcity and the environment.
- Crops and livestock (e.g. increasing yield, introducing resistance to disease and pests, tolerance of different environmental conditions).
- Industrial biotechnology (e.g. developing ‘third generation’ biofuels and producing chemicals, materials and pharmaceuticals).
- Biomedicine (e.g. pharmaceutical development, xenotransplantation, gene and cell-based therapies, control of insect-borne diseases).
- Reproduction (e.g. preventing the inheritance of a disease trait).
- Engineering mosquitoes to control malaria and dengue.
- It can help fight against blood-related disorders such as haemophilia, sickle cell anaemia, and Beta-Thalassemia.
- All such applications together can drive India’s economic growth over the next decade to new heights.
Issues with gene-editing
- Balance Risks & Benefits: Due to the possibility of off-target effects (edits in the wrong place creating properties different from those that were intended) and Mosaicism (when some cells carry the edit but others do not, leading to presence of two or more populations of cells), safety is of primary concern.
- Application of the technique to human germline: Until now, all therapeutic interventions in humans using genome editing have been performed in somatic cells (i.e. only the patient gets affected, no chance of inheriting the altered genes by the patient’s offspring). Safety concerns have been raised regarding genome editing in human germline, where unpredictable changes can be transmitted to following generations.
- Ecological impacts: A ‘gene drive’ can propagate a set of genes with negative traits throughout a population which may lead to disappearance of the whole targeted population with severe ecological consequences.
- Difficulty in regulation: The precise genetic modifications obtained through CRISPR Cas9 technique makes it more difficult to identify a genetically modified organism once outside the lab and also to regulate such organisms in the market.
- At present there is no regulating body to keep a check on the practices and applications of the technology. It may therefore lead to reduced transparency, low quality and may also increase the unnecessary delay in the treatment of patients.
- Uncontrolled clinical trials: There are at present no standard norms for standardisation of norms for clinical trials for checking the efficacy of the treatment.
- Concerns over ‘Designer Babies’: Engineering human embryos raises the prospect of designer babies, where embryos are altered for social rather than medical reasons e.g. to increase height or intelligence.
The debate about gene editing has been going on for a long time now. Gene editing should be encouraged to enhance the advancements in the field of science and improve the standard of living of people E.g.: CRISPR technology is targeting to treat the rare disease caused by mutation of one gene. At the same time, common guidelines need to be developed by international communities which set the guidelines of what risks are acceptable and what are not.
- India’s current regulatory architecture for approving novel treatments is ambiguous and assigns overlapping functions to different governmental bodies. This framework needs to be restructured to optimize trial approval time while addressing safety requirements.
- A two-step model wherein the government works with industry and research groups to accelerate clinical research is recommended. This model consists of a national apex committee working in collaboration with existing institutional ethics committees and independent accreditation agencies.
- It is envisaged that India will emerge as a significant contributor to the world bioinformatics market and position itself as a global hub for bioinformatics.
- Indian bioinformatics sector has numerous strengths and competitive advantages to make the bioinformatics sector a sunrise industry of India.
- With the improvements in the IPR regime, increasing support from the government and continuing efforts of the private sector companies, it is very much likely that India could repeat its IT success story in bioinformatics too.
- Much research on animal models and isolated human cells should be conducted before any full-scale routine application in humans.