PARLIAMENT QUESTION: BIO-SAFETY LABORATORIES

Ministry of Science & Technology PARLIAMENT QUESTION: BIO-SAFETY LABORATORIES प्रव तथ: 17 DEC 2025 5:12PM by PIB Delhi 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 Number of Laboratories Biosafety Facility 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 annua, Coleus forskohlii, tulasi, Cannabis sativa, sunflower, urad bean, castor, sugarcane, jute, flax, Salvia officinalis, Ophiorrhiza, 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. ****** NKR/AK Annexure-1 Institution/Organization wise containment facility, and details of crops undergoing Gene-editing S. Institute/ Organisation Containment Crop facility N. 1. AgriGenome Labs Pvt. Ltd, Kochi BSL-1 Rice, Tomato2. Ahmedabad University, Ahmedabad BSL-1 and Groundnut BSL-2 3. Ajeet Seeds Pvt. Ltd., Aurangabad BSL-1 and Cotton, Okra, Brinjal, BSL-2 Soybean, Tomato, Tobacco 4. Anand Agricultural University, Anand BSL-1 Tomato 5. Bhabha Atomic Research Centre, Mumbai BSL-1 and Banana, Rice, BSL-2 Soybean, Ophiorrhiza plant 6. Bharathiar University, Coimbatore BSL-1 and Salvia officinalis BSL-2 7. Bioseed Research India, Hyderabad BSL-1 and Cotton, Rice BSL-2 8. Birla Institute of Technology & Science, Pilani BSL-1 and Sorghum BSL-2 9. BRIC-Institute of Life Sciences, Bhubaneswar BSL-1 and Tomato BSL-2 10. BRIC-National Agri-Food Biotechnology BSL-1 and Wheat, Pea, Pearl Institute , Mohali BSL-2 millet 11. BRIC-National Institute of Plant Genome BSL-1 and Rice, Mustard, Research, New Delhi BSL-2 Tomato, Chickpea, Groundnut, Cauliflower, Yellow Sarson, Ricebean 12. Central University of Haryana, Mahendragarh BSL-1 and Soybean BSL-2 13. Central University of Rajasthan, Ajmer BSL-1 and Mungbean BSL-2 (Vignaradiata), Rice 14. College of Agriculture, Kerala Agricultural BSL-1 Banana, Rice University, Vellanikkara 15. College of Agriculture, Kerala Agricultural BSL-1 Banana University, Vellayani16. CSIR-Central Institute of Medicinal and BSL-1 Tomato, Tobacco, Aromatic Plants, Lucknow Withania somnifera, Artemisia annua, Coleus Forskohlii, Ocimum basilicum, Ocimum sanctum, Cannabis sativa 17. CSIR-Indian Institute of Integrative Medicine, BSL-1 and Nicotianatabacum, Jammu BSL-2 Cannabis sativa 18. CSIR-Institute of Himalayan Bioresource BSL-1 and Gerbera (Gerbera Technology, Palampur BSL-2 jamesonii Bolus), Saffron, Tea, Stevia, Potato 19. CSIR-National Botanical Research Institute, BSL-1 and Tomato Lucknow BSL-2 20. CSIR-North East Institute of Science and BSL-1 and Rice Technology, Jorhat BSL-2 21. E.I. Dupont India Pvt. Ltd., Hyderabad BSL-1 Rice 22. Gujarat Biotechnology Research Centre, BSL-1 and Potato Gandhinagar BSL-2 23. Guru Gobind Singh Indraprastha University, BSL-1 and Rice New Delhi BSL-2 24. ICAR - Indian Institute of Groundnut Research, BSL-1 Groundnut Junagadh 25. ICAR Indian Institute of Maize Research, New BSL-1 Maize Delhi 26. ICAR-Central Citrus Research Institute, Nagpur BSL-1 Citrus aurantifolia 27. ICAR-Central Institute For Cotton Research, BSL-1 Cotton Nagpur 28. ICAR-Central Potato Research Institute, Shimla BSL-1 Potato29. ICAR-Central Research Institute for Jute and BSL-1 Jute, Flax Allied Fibers, Kolkata 30. ICAR-Central Soil Salinity Research Institute, BSL-1 Wheat, Mustard, Rice Karnal 31. ICAR-Directorate of Onion and Garlic Research, BSL-1 Onion Pune 32. ICAR-Directorate of Rapeseed & Mustard BSL-1 Mustard Research, Bharatpur 33. ICAR-Indian Agricultural Research Institute, BSL-1 and Rice, Maize, Pearl New Delhi BSL-2 millet, Foxtail millet, Finger millet, Mustard, Tomato 34. ICAR-Indian Institute of Agricultural BSL-1 Soybean, Groundnut, Biotechnology, Ranchi Cotton, Sunflower, Urad bean, Rice, Maize 35. ICAR-Indian Institute of Horticultural Research, BSL-1 Papaya, Chilli Bangalore 36. ICAR-Indian Institute of Maize Research, BSL-1 and Maize Ludhiana BSL-2 37. ICAR-Indian Institute of Millet Research, BSL-1 Pearl millet, Hyderabad Sorghum 38. ICAR-Indian Institute of Oilseeds Research, BSL-1 Castor, Sunflower, Hyderabad Sesame 39. ICAR-Indian Institute of Pulses Research, BSL-1 Grasspea Kanpur (Lathyrussativus), Pigeon pea, Urad bean, Chickpea, Lentil 40. ICAR-Indian Institute of Rice Research, BSL-1 Rice Hyderabad 41. ICAR-Indian Institute of Soybean Research, BSL-1 Soybean Indore42. ICAR-Indian Institute of Spices Research, BSL-1 and Ginger, Black pepper Kozhikode BSL-2 43. ICAR-Indian Institute of Sugarcane Research, BSL-1 Sugarcane Lucknow 44. ICAR-Indian Institute of Vegetable Research, BSL-1 and Chilli, Cucumber, Varanasi BSL-2 Muskmelon, Tomato 45. ICAR-Indian Institute of Wheat and Barley BSL-1 Wheat Research, Karnal 46. ICAR-National Bureau of Plant Genetic BSL-1 and Sesame, Linseed Resources New Delhi BSL-2 47. ICAR-National Institute of Abiotic Stress BSL-1 and Soybean Management, Baramati BSL-2 48. ICAR-National Research Centre for Banana, BSL-1 Banana Tiruchirappalli 49. ICAR-National Rice Research Institute, Cuttack BSL-1 and Rice BSL-2 50. ICAR-Sugarcane Breeding Institute, Coimbatore BSL-1 Sugarcane 51. ICAR-Vivekananda BSL-1 Maize ParvatiyaKrishiAnushandhanSansthan, Almora 52. Indian Institute of Science and Education and BSL-1 and Rice, Tomato, Research, Tirupati BSL-2 Groundnut 53. Indian Institute of Science Education & BSL-1 and Potato Research, Pune BSL-2 54. Indian Institute of Science Education and BSL-1 Rice Research, Thiruvananthapuram 55. Indian Institute of Technology, Roorkee BSL-1 and Pea, Wheat BSL-2 56. Institute of Forest genetics and Tree Breeding, BSL-1 Eucalyptus Coimbatore57. International Center for Genetic Engineering and BSL-1 and Saffron, Cotton, Biotechnology, New Delhi BSL-2 Pigeon Pea, Rice, Rice bean, Tomato 58. International Crops Research Institute for the BSL-1 and Groundnut, Pearl Semi-Arid Tropics, Patancheru BSL-2 millet, Pigeon pea, Chickpea, Sorghum, Foxtail millet 59. ITC Life Sciences & Technology Centre, ITC BSL-1 Eucalyptus Ltd., Bangalore camaldulensis, Soybean (Glycine max), Tobacco 60. Jai Narain Vyas University, Jodhpur BSL-1 and Tomato BSL-2 61. Jawaharlal Nehru University, New Delhi BSL-1 and Tomato, Rice BSL-2 62. Mahyco Private Limited, Mumbai BSL-1 Rice 63. Metahelix Life Sciences Ltd., Bangalore BSL-1 and Maize BSL-2 64. Micro CRISPR Private Limited, Valsad BSL-1 and Tomato, Wheat, BSL-2 Mustard, Rice, Soybean 65. National Centre for Biological Sciences, BSL-1 and Rice Bangalore BSL-2 66. National Institute for Plant Biotechnology, New BSL-1 and Wheat, Mustard, Delhi BSL-2 Rice, Pigeon pea, Finger millet, Chickpea 67. Punjab Agricultural University, Ludhiana BSL-1 and Sorghum, Foxtail BSL-2 Millet, Wheat 68. Rajagiri College of Social Sciences, Ernakulam BSL-1 Foxtail millet 69. Regional Centre for Biotechnology, Faridabad BSL-1 and Rice, Chickpea BSL-270. Rubber Research Institute of India, Kottayam BSL-1 Rubber 71. Sharda University, Greater Noida BSL-1 and Mustard BSL-2 72. Sher-e-Kashmir University of Agricultural BSL-1 Apple Sciences and Technology of Kashmir, Srinagar 73. Siksha 'O' Anusandhan university, Bhubaneswar BSL-1 and Rice BSL-2 74. South Asian University, Delhi BSL-1 and Rice BSL-2 75. SRM University, Kattankulathur BSL-1 and Tobacco BSL-2 76. Tamil Nadu Agricultural University, Coimbatore BSL-1 and Rice, Tomato, BSL-2 Brinjal, Sesame 77. Tata Institute for Genetics and Society, Bangalore BSL-1 and Finger millet, Rice BSL-2 78. The Energy and Resource Institute, New Delhi BSL-1 Potato, Mustard 79. University of Agricultural Sciences, Bangalore BSL-1 Potato 80. University of Delhi North Campus, Delhi BSL-1 and Mustard BSL-2 81. University of Delhi South Campus, New Delhi BSL-1 and Tomato, Rice, BSL-2 Papaya, Mustard 82. University of Hyderabad, Hyderabad BSL-1 and Tomato BSL-2 ********** (रलीज़ आईडी: 2205351) आगंतुक पटल : 251 इस वज्ञ को इन भाषाओ ंम पढ़: Urdu , ही