• 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 inserts genetic material into a host genome, genome editing targets the insertions to site specific locations.

Opportunities due to gene editing :-

• The clustered, regularly interspaced, short palindromic repeats, or CRISPR/CRISPR-associated protein 9 (Cas9) (CRISPR-Cas9) system has revolutionised genetic manipulations and made gene editing simpler, faster and easily accessible to most laboratories.
  1. The technique has gained considerable traction recently to repair defective genes for potential therapeutic applications.
  2. Targeted gene correction has the potential to treat many different  diseases, including clotting disorders such as hemophilia A and B, muscular dystrophy, cystic fibrosis, Fabry disease, Hurler and Hunter syndromes and so on.
  3. It has made gene editing simpler, faster and easily accessible to most laboratories.
• 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).
• It can help fight against blood-related disorders such as haemophilia, sickle cell anaemia, and Beta-Thalassemia.

Ethical challenges :-

• Bioethicists expressed concern over the clinical application of such research. These are still early days in a new frontier of genome engineering. 
• Bioethicists fear abuse of gene editing, not just by misguided governments but also by the private sector preying on a parent’s desire to create a perfect child.
• There is growing fear that the gene-editing system is being prematurely rushed for clinical use.
• There are various ethical and technical issues involved with gene editing.
• It can create unforeseen changes in the genome which are undesirable.
• It has also been ethically questioned whether editing gene to create babies that parents desires would make them more like commodities.
• Bioethicists and researchers generally believe that human genome editing for reproductive purposes should not be attempted at this time. In addition, there are concerns with manipulating human embryos for own interest. Many people have moral and religious objections to the use of human embryos for research.
• Safety:- Due to the possibility of off-target effects (edits in the wrong place) and mosaicism (when some cells carry the edit but others do not), safety is of primary concern
• Informed Consent
  1. Some people worry that it is impossible to obtain informed consent for germline therapy because the patients affected by the edits are the embryo and future generations.
  2. Researchers and bioethicists also worry about the possibility of obtaining truly informed consent from prospective parents as long as the risks of germline therapy are unknown.
• Justice and Equity
  1. As with many new technologies, there is concern that genome editing will only be accessible to the wealthy and will increase existing disparities in access to health care and other interventions.
  2. Some worry that taken to its extreme, germline editing could create classes of individuals defined by the quality of their engineered genome.

Way forward:-

• 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.
• The technology need enabling policy to ensure their outcomes are in line with the spirit of their promises.
• The government needs to improve infrastructure and access to funds and spur innovation
• India needs to reform its regulatory structure to expedite approvals and make it easier to conduct research