[last updated: 06 May 2021]
In January 2020, the Indian government published Draft Document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment, in order to seek comment on the proposed policy pertaining to genome editing through a public consultation exercise.[1] Issued by the Department of Biotechnology, of the Ministry of Science and Technology, the document is based on the biosafety regulatory framework established under ‘Manufacture, use, import, export and storage of hazardous microorganisms/ genetically engineered organisms or cells, Rules 1989 (Rules 1989) under Environment (Protection) Act (EPA), 1986’, and clarifies up front that ‘[t]he definition of gene technology under Rules 1989 covers genome editing, process and product.’ In this course, the draft explicitly applies to both genome-edited plants, animals, and human cells in one sweep of the proposed biosafety rules.
The document proposes the ‘tiered approach for the risk assessment of genome edited products / organisms’ described in the tabel below.
Table: Proposed tiered approach for the risk assessment of genome edited products / organisms in India.[1]
| Proposed group of genome edited products / organisms | Proposed risk assessment process |
| Genome Editing Group I: Single or few base pair edits/deletions/insertions leading to least complexity (Phenotype/Genotype). Changes leading to knockdown/knock-out of protein/RNA that result in a new trait which may be familiar with prior knowledge. Chances of off-target effects. | [The] following biosafety concerns should be addressed for G[enome] Ed[ited] Group I organisms: · Changes resulting in altered expression/ activity of native protein. · Presence of vector/components used in the editing process. · Confirmation of intended Trait efficacy. · Confirmation of Phenotypic equivalence. · Changes leading to protein with new/altered functions. In rare cases, single base pair mutation(s) might result in the introduction of novel trait (e.g., Herbicide tolerance) which might pose additional biosafety concerns. The G[enome] Ed[ited] cells/organisms falling under Group I would be assessed mainly to confirm targeted edit(s) as well as absence of any biologically significant off-target genomic changes. Also, they would be subjected to phenotypic equivalence analysis on case-by-case basis. |
| Genome Editing Group II: Several base pair edits leading to certain degree of complexity in Phenotype/ Genotype (leading to improvement of an existing attribute or creation of a new attribute). Changes leading to gain of function with a new protein or RNA. May or may not be familiar with prior knowledge. Chances of off-target effects. | [T]he following additional biosafety concerns should be addressed considering increased potential of offtarget effects: · Insertion of exogenous DNA sequence leading to: o Altered expression of gene. o Deletion/knockout of gene expression. o Modification of amino acid sequence of a native protein. · Insertion of allelic sequences having prior knowledge. · Introduction of foreign gene with novel trait(s). The G[enome] Ed[ited] cells/organisms falling under Group II would be assessed to confirm targeted edit(s) as well as absence of any biologically significant off-target genomic changes. Also, they would be assessed for phenotypic equivalence and trait efficacy through appropriate contained and/or confined field trials. |
| Genome Editing Group III: Insertion of foreign gene/DNA sequence leading to high degree of complexity in Phenotype/Genotype (leading to creation of a new attribute, new metabolic pathways, etc.). Changes leading to gain of function with new protein or RNA. May not have prior knowledge. Chances of off-target effects. | The data requirement and biosafety assessment level would increase with the increase in the complexity of the modification. Nevertheless, regulatory approval for the G[enome] Ed[ited] cell/organism will depend on biosafety assessment on a case-by-case basis. Group III G[enome] Ed[ited] cells/organisms harbouring large or foreign DNA in the recipient cell/organism genome, may represent similar biosafety concerns as that of genetically engineered (GE) cells/organisms with typical foreign gene insertion(s). Therefore, all the biosafety data requirements which are prescribed in existing food and environmental safety guidelines specific for GE. cells/organisms on case-by-case basis where foreign genes are inserted, would be envisaged. |
The Draft Document received a number of critical comments both as part of its public consultation, and in the scientific and trade press; Schmidt et al. note that ‘there is no differentiation between the health risks of off-target mutations in somatic cells for human therapeutics versus plant cells where deleterious effects are eliminated by crossing and pose no ethical issues.’ (Schmidt, et al., 2020). The authors furthermore highlight the immense bureaucratic burden of the proposed measures, under which ‘any market authorization will require review by no less than three agencies: the Institutional Biosafety Committee, the Ministry of Agriculture & Farmers’ Welfare, and the Food Safety and Standards Authority of India.’
[1] Government of India (January 2020): Draft Document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment (accessed: 7th March 2023)
[last updated: 06 May 2021]
2023 REIMAGINE EUROPA
CONTACT ⋅ PRIVACY POLICY
