India: Gene Drives

Limited Research, No Clear Regulations

Regulatory status of gene drives has not been determined.

Worldwide, gene drive regulations are in flux. Gene drives are being developed using transgenic technology (GMOs) that contain foreign genes, as well as gene editing, including CRISPR (synthetic gene drives), which do not, complicating regulatory oversight as gene editing and GMOs are often regulated differently.

India has not determined the regulatory status of gene drives.

Products/Research

None

Regulatory Timeline

None

NGO Reaction

None

Additional Resources

Genetic Literacy Project’s FAQ on gene editing

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.

Africa

Therapeutic / Stem Cell

Germline / Embryonic

Argentina

Therapeutic / Stem Cell

Germline / Embryonic

Australia

Therapeutic / Stem Cell

Germline / Embryonic

Brazil

Therapeutic / Stem Cell

Germline / Embryonic

Canada

Therapeutic / Stem Cell

Germline / Embryonic

Central America

Therapeutic / Stem Cell

Germline / Embryonic

Chile

Therapeutic / Stem Cell

Germline / Embryonic

China

Therapeutic / Stem Cell

Germline / Embryonic

Colombia

Therapeutic / Stem Cell

Germline / Embryonic

Ecuador

Therapeutic / Stem Cell

Germline / Embryonic

European Union

Therapeutic / Stem Cell

Germline / Embryonic

India

Therapeutic / Stem Cell

Germline / Embryonic

Israel

Therapeutic / Stem Cell

Germline / Embryonic

Japan

Therapeutic / Stem Cell

Germline / Embryonic

Mexico

Therapeutic / Stem Cell

Germline / Embryonic

New Zealand

Therapeutic / Stem Cell

Germline / Embryonic

Norway

Therapeutic / Stem Cell

Germline / Embryonic

Paraguay

Therapeutic / Stem Cell

Germline / Embryonic

Russia

Therapeutic / Stem Cell

Germline / Embryonic

Southeast Asia

Therapeutic / Stem Cell

Germline / Embryonic

Ukraine

Therapeutic / Stem Cell

Germline / Embryonic

United Kingdom

Therapeutic / Stem Cell

Germline / Embryonic

United States

Therapeutic / Stem Cell

Germline / Embryonic

Uruguay

Therapeutic / Stem Cell

Germline / Embryonic

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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

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

Swipe right/left if all columns aren't visible

Country / Region	Therapeutic	Germline	Human Rating
Japan	8	8	8
Brazil	4	0	2
Canada	4	0	2
Russia	10	5	7.5
Argentina	5	1	3
Israel	8	2	5
Australia	4	0	2
China	8	4	6
US	4	0	2
Chile	4	1	2.5
New Zealand	4	0	2
Ukraine	10	5	7.5
Central America	1	1	1
Paraguay	1	1	1
Uruguay	1	1	1
India	4	0	2
UK	4	4	4
Mexico	8	0	4
EU	4	0	2

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

Africa

Gene Drives

Argentina

Gene Drives

Australia

Gene Drives

Brazil

Gene Drives

Canada

Gene Drives

Central America

Gene Drives

Chile

Gene Drives

China

Gene Drives

Colombia

Gene Drives

Ecuador

Gene Drives

European Union

Gene Drives

India

Gene Drives

Israel

Gene Drives

Japan

Gene Drives

Mexico

Gene Drives

New Zealand

Gene Drives

Norway

Gene Drives

Paraguay

Gene Drives

Russia

Gene Drives

Southeast Asia

Gene Drives

Ukraine

Gene Drives

United Kingdom

Gene Drives

United States

Gene Drives

Uruguay

Gene Drives

Gene Drive 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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

Lightly Regulated: Gene drives regulated through existing biotechnology laws.

*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.

Gene Drives:

Genetic engineering technology used to transmit a characteristic throughout a wild population. For example, it can be used to develop mosquitoes that only have female offspring. If released into the wild, these mosquitoes would breed with wild malaria-carrying mosquitoes and over time would eliminate the population. Scientists are interested in using this technology to help eradicate disease-carrying insects and control invasive species, but questions about how gene drives will be directed and controlled are still being fleshed out.

Rating by Country / Region
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Country / Region	Gene Drives	Gene Drive Rating
Japan	1	1
Brazil	8	8
Canada	8	8
Russia	1	1
Argentina	1	1
Israel	1	1
Australia	4	4
China	1	1
US	4	4
Chile	1	1
New Zealand	4	4
Ukraine	1	1
Central America	1	1
Paraguay	1	1
Uruguay	1	1
India	1	1
UK	2	2
Mexico	1	1
EU	2	2

Regulations of gene editing and new breeding techniques (NBTs) worldwide are quickly evolving. Click on a country or region for more information on its regulatory status, what crops are approved or in development, and reactions from regional NGOs. The Gene Editing Index ratings represent their current status and will be updated as new regulations are approved.

Africa

Crops / Food

Animals

Argentina

Crops / Food

Animals

Australia

Crops / Food

Animals

Brazil

Crops / Food

Animals

Canada

Crops / Food

Animals

Central America

Crops / Food

Animals

Chile

Crops / Food

Animals

China

Crops / Food

Animals

Colombia

Crops / Food

Animals

Cuba

Crops / Food

Ecuador

Crops / Food

Animals

European Union

Crops / Food

Animals

India

Crops / Food

Animals

Israel

Crops / Food

Animals

Japan

Crops / Food

Animals

Mexico

Crops / Food

Animals

New Zealand

Crops / Food

Animals

Norway

Crops / Food

Animals

Paraguay

Crops / Food

Animals

Russia

Crops / Food

Animals

Southeast Asia

Crops / Food

Animals

Ukraine

Crops / Food

Animals

United Kingdom

Crops / Food

Animals

United States

Crops / Food

Animals

Uruguay

Crops / Food

Animals

Agriculture 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.

Ratings Guide

Regulation Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.

*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:

Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.

Animals:

Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

4

0 Rating by Country / Region
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Swipe right/left if all columns aren't visible

Country / Region	Food / Crops	Animals	Ag Rating
Ecuador	10	10	10
Norway	6	6	6
Africa	5	5	5
Japan	8	8	8
Brazil	10	10	10
Canada	8	8	8
Russia	5	5	5
Argentina	10	10	10
Israel	10	5	7.5
Australia	8	8	8
Switzerland	5	5	5
China	5	5	5
US	10	4	7
Chile	10	1	5.5
New Zealand	4	4	4
Ukraine	1	1	1
Central America	6	6	6
Paraguay	10	10	10
Uruguay	6	6	6
India	6	6	6
UK	2	2	2
Mexico	1	1	1
EU	2	2	2
Colombia	10	1	5.5

Country / Region	Crops / Food Rating
Australia^	4
Canada*	4
Chile^	4
Costa Rica^	4
Israel^	4
Japan*	4
Philippines*	4
United States*	4
Argentina^	3
Bangladesh^	3
Brazil*	3
China*	3
Colombia*	3
Ecuador	3
Ghana^	3
Honduras	3
India^	3
Indonesia	3
Kenya^	3
Malawi^	3
Nigeria^	3
Pakistan	3
Paraguay	3
Uruguay	3
Cuba^	2
Guatamala	2
El Salvador	2
European Union^	2
Norway	2
South Africa^	2
South Korea^	2
Switzerland^	2
United Kingdom^	2
Bolivia	1
Mexico	1
New Zealand	1
Peru	1
Russia	0

Approved Gene Edited / NBT Crops
Current list of foods developed by New Breeding Techniques that are approved for sale.

Product	Description	Country	Company
Waxy corn	Corn with high starch content developed using CRISPR.	Approved: Japan (2024)	Corteva Agriscience
Non-browning lettuce	GreenVenus Non-browning romaine lettuce.	Approved: United States (2024)	Intrexon
Slick-coat cattle	PRLR-SLICK cattle Cows developed using CRISPR to grow short hair, which results in improved heat tolerance, which allows them to gain weight more easily.	Approved: United States (2024)	Acceligen
Fungal resistant wheat	Edit approved that confer resistance to a common fungal infection called powdery mildew that can be applied to different varieties.	Approved: China (2024)	Suzhou, Chinese Academy of Sciences
Mustard greens	Conscious Greens Milder, less bitter mustard green developed using CRISPR-Cas12a.	Approved, available: United States (2023)	Pairwise
Non-browning banana	Banana developed using CRISPR to slow the browning process for prolonged shelf-life.	Approved: Philippines (2023)	Tropic Biosciences
Seabream	Red Seabream Fish developed using CRISPR disabling a gene suppressing muscle growth, allowing the fish to grow larger.	Approved, available: Japan (2021)	Regional Fish Institute
GABA tomato	Sicilian Rouge Tomato edited using CRISPR to contain more GABA, a compound in tomato fruits and known to lower blood pressure.	Approved, available: Japan (2021)	Sanantech Seed
Fast growing pufferfish	Tiger Pufferfish Fish developed using CRISPR disrupting a gene controlling appetite, allowing the fish to eat more and grow faster.	Approved, available: Japan (2021)	Regional Fish Institute
High-oleic soybean oil	Calyno Soybean oil with fewer saturated fats and zero trans fats, developed using a gene-editing technique called TALENs.	Approved, available: United States (2019)	Calyxt
Non-browning mushroom	White Button Mushroom Non-browning mushroom developed using a gene-editing technique called TALENs.	Approved: United States (2016)	Pennsylvania State University
Non-browning apple	Arctic Apple Non-browning apple (multiple varieties) developed with RNA interference, a more traditional New Breeding Technique (NBT). Varieties include Golden, Granny, Fuji, Gala, Honey.	Approved, available: Canada (2017) Approved, available: United States (2015)	Okanagan Specialty Fruits
Non-browning potato	White Russet Potato Non-browning, blight protection, lowered sugars, and low acrylamide potato developed with RNA interference.	Approved, available: United States (2015) Available: Canada (2015)	Simplot
Rapeseed/Canola	Developed to be herbicide-tolerant canola using oligonnucleotide-direct mutagenesis (ODM).	Approved: United States (2014) Canada (2013)	Cibus

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:

(1) Cartagena Protocol on Biosafety [https://bch.cbd.int/protocol/]

Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.

(2) Product v process

Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.