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The regulation and oversight of gene‑editingin crops in India are guided by a comprehensive biosafety framework established under the Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro‑organisms/Genetically Engineered Organisms or Cells, 1989 (the “Rules, 1989”), which notified under the Environment (Protection) Act, 1986 (EPA). The Ministry of Environment, Forests and Climate Change (MoEF&CC) administer the EPA.

Development of gene‑edited (GEd) plants is conducted under strict contained‑laboratory conditions until the plants are shown to be free of exogenously introduced DNA. During this phase, Institutional Biosafety Committees (IBSCs) exercise regulatory oversight, with information reported to the Review Committee on Genetic Manipulation (RCGM).

The regulatory oversight of GEd plant R&D is guided by the following:

1). Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017

2). Handbook for Institutional Biosafety Committees (IBSC), 2020

3). The notification regarding the exemption of site-directed nuclease (SDN)-1 and SDN-2 categories of genome edited plants, which are free from exogenous introduced DNA, from the provisions of Rules 7 to 11 (both inclusive) of the Rules, 1989 of the Environment (Protection) Act, 1986 issued by the MoEF&CC vide O.M. F. No. C -12013/3/2020-CS-III dated 30 March 2022. Furthermore, the subsequent development, evaluation, and release of a genome‑edited plant as a new variety or hybrid shall be governed in accordance with all other applicable laws, acts, and regulations.

4). Pursuant to the mentioned notification the Department of Biotechnology (DBT), Ministry of Science and Technology (MoST) notified following guidelines and Standard Operating Procedures (SOPs) for research and development of gene-edited plants in India.

i). Guidelines for the Safety Assessment of Genome Edited Plants, 2022

ii). Standard Operating Procedures (SOPs) for Regulatory Review of Genome Edited Plants under SDN-1 and SDN-2 Categories, 2022

In line with the regulation, investigators who have produced GEd plants free of exogenous DNA and wish to move them out of containment must submit the lab‑generated regulatory data to their IBSC seeking exemption from Rules 7‑11 of the Rules, 1989. After satisfactory review by the IBSC and acceptance of the minutes of the meeting of the IBSC by the RCGM, the IBSC conveys the exemption decision to the applicant. This mechanism aligns with international practice by distinguishing gene‑edited plants lacking foreign DNA from conventional genetically engineered plants while maintaining biosafety oversight.

Category wise numbers of Biosafety Laboratories (BSL) registered with DBT is placed below.

Level of Biosafety Facility Number of Laboratories
BSL-1 Laboratories of this type are deemed to be at the lowest risk level. They are utilized for the study of non‑pathogenic microorganisms that present only a minimal hazard to healthy adults. In such environments, standard microbiological practices together with basic personal protective equipment (including lab coats and, where necessary, gloves), hand‑washing facilities, and easily cleanable work surfaces are required.
BSL-2 750 nos.
BSL-3 89 nos.
BSL-4 01 nos.

 

The crops currently being gene‑edited in these laboratories include, a wide range of species such as cotton, rice, sorghum, mung bean, banana, gerbera, saffron, tea, stevia, potato, onion, mustard, maize, pearl millet, foxtail millet, finger millet, ginger, chilli, cucumber, muskmelon, wheat, eucalyptus, pigeon pea, rice bean, groundnut, chickpea, soybean, tobacco, cauliflower, yellow sarson, rubber, apple, brinjal, sesame, papaya,ashwagandha, Artemisia annuaColeus forskohlii, tulasi, Cannabis sativa, sunflower, urad bean, castor, sugarcane, jute, flax, Salvia officinalisOphiorrhiza, citrus, grass pea, lentil, black pepper, okra, and tomato. Institution wise containment facilities and details of crops undergoing gene-editing is placed as Annexure-1.

During the period 2020-2025, one incidence of lab-acquired infectionhas been reported. A doctoral student of National Centre for Cell Sciences, Pune was exposed occupationally to vaccinia virus in a biosafety level 2 (BSL-2) laboratory. Compete details of this occupational incidence is available in a public domain at https://nccs.sciencecentral.in/990/#:~:text=Atom%20RSS%201.0%20RSS%202.0,sciencecentral.in/cgi/oai2

All organizations including private entities are required to constitute and register IBSC with DBT before commencing research and development activities involving genetic engineering including gene-editing.
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NKR/AK

Annexure-1

Institution/Organization wise containment facility, and details of crops undergoing Gene-editing

S.

N.

Institute/ Organisation Containment facility Crop
AgriGenome Labs Pvt. Ltd, Kochi BSL-1 Rice, Tomato
Ahmedabad University, Ahmedabad BSL-1 and BSL-2 Groundnut
Ajeet Seeds Pvt. Ltd., Aurangabad BSL-1 and BSL-2 Cotton, Okra, Brinjal, Soybean, Tomato, Tobacco
Anand Agricultural University, Anand BSL-1 Tomato
Bhabha Atomic Research Centre, Mumbai BSL-1 and BSL-2 Banana, Rice, Soybean, Ophiorrhiza plant
Bharathiar University, Coimbatore BSL-1 and BSL-2 Salvia officinalis
Bioseed Research India, Hyderabad BSL-1 and BSL-2 Cotton, Rice
Birla Institute of Technology & Science, Pilani BSL-1 and BSL-2 Sorghum
BRIC-Institute of Life Sciences, Bhubaneswar BSL-1 and BSL-2 Tomato
BRIC-National Agri-Food Biotechnology Institute , Mohali BSL-1 and BSL-2 Wheat, Pea, Pearl millet
BRIC-National Institute of Plant Genome Research, New Delhi BSL-1 and BSL-2 Rice, Mustard, Tomato, Chickpea, Groundnut, Cauliflower, Yellow Sarson, Ricebean
Central University of Haryana, Mahendragarh BSL-1 and BSL-2 Soybean
Central University of Rajasthan, Ajmer BSL-1 and BSL-2 Mungbean (Vignaradiata), Rice
College of Agriculture, Kerala Agricultural University, Vellanikkara BSL-1 Banana, Rice
College of Agriculture, Kerala Agricultural University, Vellayani BSL-1 Banana
CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow BSL-1 Tomato, Tobacco, Withania somnifera, Artemisia annua, Coleus Forskohlii,

Ocimum basilicum, Ocimum sanctum, Cannabis sativa

CSIR-Indian Institute of Integrative Medicine, Jammu BSL-1 and BSL-2 NicotianatabacumCannabis sativa
CSIR-Institute of Himalayan Bioresource Technology, Palampur BSL-1 and BSL-2 Gerbera (Gerbera jamesonii Bolus), Saffron, Tea, Stevia,

Potato

CSIR-National Botanical Research Institute, Lucknow BSL-1 and BSL-2 Tomato
CSIR-North East Institute of Science and Technology, Jorhat BSL-1 and BSL-2 Rice
E.I. Dupont India Pvt. Ltd., Hyderabad BSL-1 Rice
Gujarat Biotechnology Research Centre, Gandhinagar BSL-1 and BSL-2 Potato
Guru Gobind Singh Indraprastha University, New Delhi BSL-1 and BSL-2 Rice
ICAR – Indian Institute of Groundnut Research, Junagadh BSL-1 Groundnut
ICAR Indian Institute of Maize Research, New Delhi BSL-1 Maize
ICAR-Central Citrus Research Institute, Nagpur BSL-1 Citrus aurantifolia
ICAR-Central Institute For Cotton Research, Nagpur BSL-1 Cotton
ICAR-Central Potato Research Institute, Shimla BSL-1 Potato
ICAR-Central Research Institute for Jute and Allied Fibers, Kolkata BSL-1 Jute, Flax
ICAR-Central Soil Salinity Research Institute, Karnal BSL-1 Wheat, Mustard, Rice
ICAR-Directorate of Onion and Garlic Research, Pune BSL-1 Onion
ICAR-Directorate of Rapeseed & Mustard Research, Bharatpur BSL-1 Mustard
ICAR-Indian Agricultural Research Institute, New Delhi BSL-1 and BSL-2 Rice, Maize, Pearl millet, Foxtail millet, Finger millet, Mustard, Tomato
ICAR-Indian Institute of Agricultural Biotechnology, Ranchi BSL-1 Soybean, Groundnut, Cotton, Sunflower, Urad bean, Rice, Maize
ICAR-Indian Institute of Horticultural Research, Bangalore BSL-1 Papaya, Chilli
ICAR-Indian Institute of Maize Research, Ludhiana BSL-1 and BSL-2 Maize
ICAR-Indian Institute of Millet Research, Hyderabad BSL-1 Pearl millet, Sorghum
ICAR-Indian Institute of Oilseeds Research, Hyderabad BSL-1 Castor, Sunflower, Sesame
ICAR-Indian Institute of Pulses Research, Kanpur BSL-1 Grasspea (Lathyrussativus), Pigeon pea, Urad bean, Chickpea, Lentil
ICAR-Indian Institute of Rice Research, Hyderabad BSL-1 Rice
ICAR-Indian Institute of Soybean Research, Indore BSL-1 Soybean
ICAR-Indian Institute of Spices Research, Kozhikode BSL-1 and BSL-2 Ginger, Black pepper
ICAR-Indian Institute of Sugarcane Research, Lucknow BSL-1 Sugarcane
ICAR-Indian Institute of Vegetable Research, Varanasi BSL-1 and BSL-2 Chilli, Cucumber, Muskmelon, Tomato
ICAR-Indian Institute of Wheat and Barley Research, Karnal BSL-1 Wheat
ICAR-National Bureau of Plant Genetic Resources New Delhi BSL-1 and BSL-2 Sesame, Linseed
ICAR-National Institute of Abiotic Stress Management, Baramati BSL-1 and BSL-2 Soybean
ICAR-National Research Centre for Banana, Tiruchirappalli BSL-1 Banana
ICAR-National Rice Research Institute, Cuttack BSL-1 and BSL-2 Rice
ICAR-Sugarcane Breeding Institute, Coimbatore BSL-1 Sugarcane
ICAR-Vivekananda ParvatiyaKrishiAnushandhanSansthan, Almora BSL-1 Maize
Indian Institute of Science and Education and Research, Tirupati BSL-1 and BSL-2 Rice, Tomato, Groundnut
Indian Institute of Science Education & Research, Pune BSL-1 and BSL-2 Potato
Indian Institute of Science Education and Research, Thiruvananthapuram BSL-1 Rice
Indian Institute of Technology, Roorkee BSL-1 and BSL-2 Pea, Wheat
Institute of Forest genetics and Tree Breeding, Coimbatore BSL-1 Eucalyptus
International Center for Genetic Engineering and Biotechnology, New Delhi BSL-1 and BSL-2 Saffron, Cotton, Pigeon Pea, Rice, Rice bean, Tomato
International Crops Research Institute for the Semi-Arid Tropics, Patancheru BSL-1 and BSL-2 Groundnut, Pearl millet, Pigeon pea, Chickpea, Sorghum, Foxtail millet
ITC Life Sciences & Technology Centre, ITC Ltd., Bangalore BSL-1 Eucalyptus camaldulensis, Soybean (Glycine max), Tobacco
Jai Narain Vyas University, Jodhpur BSL-1 and BSL-2 Tomato
Jawaharlal Nehru University, New Delhi BSL-1 and BSL-2 Tomato, Rice
Mahyco Private Limited, Mumbai BSL-1 Rice
Metahelix Life Sciences Ltd., Bangalore BSL-1 and BSL-2 Maize
Micro CRISPR Private Limited, Valsad BSL-1 and BSL-2 Tomato, Wheat, Mustard, Rice, Soybean
National Centre for Biological Sciences, Bangalore BSL-1 and BSL-2 Rice
National Institute for Plant Biotechnology, New Delhi BSL-1 and BSL-2 Wheat, Mustard, Rice, Pigeon pea, Finger millet, Chickpea
Punjab Agricultural University, Ludhiana BSL-1 and BSL-2 Sorghum, Foxtail Millet, Wheat
Rajagiri College of Social Sciences, Ernakulam BSL-1 Foxtail millet
Regional Centre for Biotechnology, Faridabad BSL-1 and BSL-2 Rice, Chickpea
Rubber Research Institute of India, Kottayam BSL-1 Rubber
Sharda University, Greater Noida BSL-1 and BSL-2 Mustard
Sher-e-Kashmir University of Agricultural Sciences and Technology of Kashmir, Srinagar BSL-1 Apple
Siksha ‘O’ Anusandhan university, Bhubaneswar BSL-1 and BSL-2 Rice
South Asian University, Delhi BSL-1 and BSL-2 Rice
SRM University, Kattankulathur BSL-1 and BSL-2 Tobacco
Tamil Nadu Agricultural University, Coimbatore BSL-1 and BSL-2 Rice, Tomato, Brinjal, Sesame
Tata Institute for Genetics and Society, Bangalore BSL-1 and BSL-2 Finger millet, Rice
The Energy and Resource Institute, New Delhi BSL-1 Potato, Mustard
University of Agricultural Sciences, Bangalore BSL-1 Potato
University of Delhi North Campus, Delhi BSL-1 and BSL-2 Mustard
University of Delhi South Campus, New Delhi BSL-1 and BSL-2 Tomato, Rice, Papaya, Mustard
University of Hyderabad, Hyderabad BSL-1 and BSL-2 Tomato
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