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India: Germline / Embryonic

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Prohibited

Germline gene editing is banned, but specific regulation is lacking.

India’s current regulatory architecture for approving novel treatments is ambiguous and assigns overlapping functions to different governmental bodies. Human germline editing and reproductive cloning are banned by the National Guidelines for Stem Cell Research, although there are no specific and enforceable laws.

Research involving human germline gene therapy, reproductive cloning, and clinical trials involving “xenogeneic” cells—tissues or cells belonging to individuals of different species—is not allowed. However, in vitro studies—genome modifications to an embryo that will not be carried to term—are allowed. Human embryos that have undergone modification may not be developed beyond 14 days of fertilization.

Because of the legal ambiguities, human gene editing regulation in India is viewed as prime for malpractice, misuse and manipulation. The Indian Journal of Medical Ethics points out that India’s guidelines “are not legally binding and are seen as unenforceable because of the large population and lack of specific criminal laws to act as a deterrent”. The Indian Council of Medical Research is debating a law that if passed unambiguously would ban germline gene editing.

Products/Research

None

Regulatory Timeline

2019: Indian Council of Medical Research, in consultation with the Department of Biotechnology and the country’s top drug regulator, the Central Drugs Standard Control Organisation, drafts law banning germline gene editing and prohibiting the use of gene editing to induce “unnatural advantages” like enhanced physical functions or selection of particular traits to create designer babies.

2017: The third iteration of the National Guidelines for Stem Cell Research is released, banning the commercial use of stem cells by the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR).

2013: The second iteration of the National Guidelines for Stem Cell Research is released, addressing concerns from stakeholders that the original iteration lacks “statutory backing” and “legislative weight.”

2007: The first iteration of the National Guidelines for Stem Cell Research is released.

2000: Ethical Guidelines on Biomedical Research Involving Human Subjectsprohibits germline therapy.

NGO Reaction

None

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

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Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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