Lok Sabha Question No. 2881 (UNSTARRED), answered on 2025-12-17
Subject: Bio-safety Laboratories
Ministry: SCIENCE AND TECHNOLOGY
Asked by: Shri Tanuj Punia, Shri Balwant Baswant Wankhade, Dr. Prashant Yadaorao Padole, Dr. Dharamvira Gandhi

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE & TECHNOLOGY DEPARTMENT OF BIOTECHNOLOGY

## LOK SABHA UNSTARRED QUESTION NO. 2881 TO BE ANSWERED ON 17/12/2025

'Bio-safety Laboratories'

2881:  Shri Tanuj Punia:

Dr. Dharamvira Gandhi:

Dr. Prashant Yadaorao Padole:

Shri Balwant Baswant Wankhade:

Will the Minister of SCIENCE & TECHNOLOGY be pleased to state:

- (a)  the  details  of  the  regulatory  mechanisms  and  frameworks  established  to  ensure proper oversight of the gene-editing of crops to avoid bio-hazards;
- (b) the details of the list of Bio-safety Laboratories in the country including details of Bio-Safety Levels (BSL) for every laboratory and the crops undergoing gene-editing at each of the Bio-safety Laboratories;
- (c)  the  details  of  Lab-acquired  Infections  reported  during  the  period  2020-2025, including  the  number  of  individuals  infected,  type  of  infection  and  the  Bio-safety laboratory it occurred; and
- (d)  whether the government has granted permits to private entities to establish Biosafety Labs for gene-editing and if so, the details thereof including the name of the company and date of Government Approval?

## ANSWER

## THE MINISTER OF STATE (INDEPENDENT CHARGE) FOR THE MINISTRY OF SCIENCE AND TECHNOLOGY & EARTH SCIENCES (DR. JITENDRA SINGH)

(a) 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.

- (b) 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  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.

(c) 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,sciencecen tral.in/cgi/oai2

- (d)  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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## Annexure-1

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

|   S. N. | Institute/ Organisation                                              | Containment facility   | Crop                                                                                                       |
|---------|----------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------|
|       1 | AgriGenome Labs Pvt. Ltd, Kochi                                      | BSL-1                  | Rice, Tomato                                                                                               |
|       2 | Ahmedabad University, Ahmedabad                                      | BSL-1 and BSL-2        | Groundnut                                                                                                  |
|       3 | Ajeet Seeds Pvt. Ltd., Aurangabad                                    | BSL-1 and BSL-2        | Cotton, Okra, Brinjal, Soybean, Tomato, Tobacco                                                            |
|       4 | Anand Agricultural University, Anand                                 | BSL-1                  | Tomato                                                                                                     |
|       5 | Bhabha Atomic Research Centre, Mumbai                                | BSL-1 and BSL-2        | Banana, Rice, Soybean, Ophiorrhiza plant                                                                   |
|       6 | Bharathiar University, Coimbatore                                    | BSL-1 and BSL-2        | Salvia officinalis                                                                                         |
|       7 | Bioseed Research India, Hyderabad                                    | BSL-1 and BSL-2        | Cotton, Rice                                                                                               |
|       8 | Birla Institute of Technology &Science, Pilani                       | BSL-1 and BSL-2        | Sorghum                                                                                                    |
|       9 | BRIC-Institute of Life Sciences, Bhubaneswar                         | BSL-1 and BSL-2        | Tomato                                                                                                     |
|      10 | BRIC-National Agri-Food Biotechnology Institute , Mohali             | BSL-1 and BSL-2        | Wheat, Pea, Pearl millet                                                                                   |
|      11 | BRIC-National Institute of Plant Genome Research, New Delhi          | BSL-1 and BSL-2        | Rice, Mustard, Tomato, Chickpea, Groundnut, Cauliflower, Yellow Sarson, Ricebean                           |
|      12 | Central University of Haryana, Mahendragarh                          | BSL-1 and BSL-2        | Soybean                                                                                                    |
|      13 | Central University of Rajasthan, Ajmer                               | BSL-1 and BSL-2        | Mungbean ( Vignaradiata ), Rice                                                                            |
|      14 | College of Agriculture, Kerala Agricultural University, Vellanikkara | BSL-1                  | Banana, Rice                                                                                               |
|      15 | College of Agriculture, Kerala Agricultural University, Vellayani    | BSL-1                  | Banana                                                                                                     |
|      16 | 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                                                           |
|----|---------------------------------------------------------------------|-----------------|---------------------------------------------------------------------------|
| 17 | CSIR- Indian Institute of Integrative Medicine , Jammu              | BSL-1 and BSL-2 | Nicotianatabacum , Cannabis sativa                                        |
| 18 | CSIR-Institute of Himalayan Bioresource Technology, Palampur        | BSL-1 and BSL-2 | Gerbera ( Gerbera jamesonii Bolus), Saffron, Tea, Stevia, Potato          |
| 19 | CSIR-National Botanical Research Institute, Lucknow                 | BSL-1 and BSL-2 | Tomato                                                                    |
| 20 | CSIR-North East Institute of Science and Technology, Jorhat         | BSL-1 and BSL-2 | Rice                                                                      |
| 21 | E.I. Dupont India Pvt. Ltd., Hyderabad                              | BSL-1           | Rice                                                                      |
| 22 | Gujarat Biotechnology Research Centre, Gandhinagar                  | BSL-1 and BSL-2 | Potato                                                                    |
| 23 | Guru Gobind Singh Indraprastha University, New Delhi                | BSL-1 and BSL-2 | Rice                                                                      |
| 24 | ICAR - Indian Institute of Groundnut Research, Junagadh             | BSL-1           | Groundnut                                                                 |
| 25 | ICAR Indian Institute of Maize Research, New Delhi                  | BSL-1           | Maize                                                                     |
| 26 | ICAR-Central Citrus Research Institute, Nagpur                      | BSL-1           | Citrus aurantifolia                                                       |
| 27 | ICAR-Central Institute For Cotton Research, Nagpur                  | BSL-1           | Cotton                                                                    |
| 28 | ICAR- Central Potato Research Institute, Shimla                     | BSL-1           | Potato                                                                    |
| 29 | ICAR-Central Research Institute for Jute and Allied Fibers, Kolkata | BSL-1           | Jute, Flax                                                                |
| 30 | ICAR-Central Soil Salinity Research Institute, Karnal               | BSL-1           | Wheat, Mustard, Rice                                                      |
| 31 | ICAR-Directorate of Onion and Garlic Research, Pune                 | BSL-1           | Onion                                                                     |
| 32 | ICAR-Directorate of Rapeseed & Mustard Research, Bharatpur          | BSL-1           | Mustard                                                                   |
| 33 | ICAR-Indian Agricultural Research Institute, New Delhi              | BSL-1 and BSL-2 | Rice, Maize, Pearl millet, Foxtail millet, Finger millet, Mustard, Tomato |
| 34 | ICAR-Indian Institute of Agricultural Biotechnology, Ranchi         | BSL-1           | Soybean, Groundnut, Cotton, Sunflower, Urad bean, Rice, Maize             |
| 35 | ICAR-Indian Institute of Horticultural Research, Bangalore          | BSL-1           | Papaya, Chilli                                                            |
| 36 | ICAR-Indian Institute of Maize Research, Ludhiana                   | BSL-1 and BSL-2 | Maize                                                                     |

|   37. | ICAR-Indian Institute of Millet Research, Hyderabad                    | BSL-1           | Pearl millet, Sorghum                                                |
|-------|------------------------------------------------------------------------|-----------------|----------------------------------------------------------------------|
|    38 | ICAR-Indian Institute of Oilseeds Research, Hyderabad                  | BSL-1           | Castor, Sunflower, Sesame                                            |
|    39 | ICAR-Indian Institute of Pulses Research, Kanpur                       | BSL-1           | Grasspea (Lathyrussativus ), Pigeon pea, Urad bean, Chickpea, Lentil |
|    40 | ICAR-Indian Institute of Rice Research, Hyderabad                      | BSL-1           | Rice                                                                 |
|    41 | ICAR-Indian Institute of Soybean Research, Indore                      | BSL-1           | Soybean                                                              |
|    42 | ICAR-Indian Institute of Spices Research, Kozhikode                    | BSL-1 and BSL-2 | Ginger, Black pepper                                                 |
|    43 | ICAR-Indian Institute of Sugarcane Research, Lucknow                   | BSL-1           | Sugarcane                                                            |
|    44 | ICAR-Indian Institute of Vegetable Research, Varanasi                  | BSL-1 and BSL-2 | Chilli, Cucumber, Muskmelon, Tomato                                  |
|    45 | ICAR-Indian Institute of Wheat and Barley Research, Karnal             | BSL-1           | Wheat                                                                |
|    46 | ICAR-National Bureau of Plant Genetic Resources New Delhi              | BSL-1 and BSL-2 | Sesame, Linseed                                                      |
|    47 | ICAR-National Institute of Abiotic Stress Management, Baramati         | BSL-1 and BSL-2 | Soybean                                                              |
|    48 | ICAR-National Research Centre for Banana, Tiruchirappalli              | BSL-1           | Banana                                                               |
|    49 | ICAR-National Rice Research Institute, Cuttack                         | BSL-1 and BSL-2 | Rice                                                                 |
|    50 | ICAR-Sugarcane Breeding Institute, Coimbatore                          | BSL-1           | Sugarcane                                                            |
|    51 | ICAR-Vivekananda ParvatiyaKrishiAnushandhanSansthan, Almora            | BSL-1           | Maize                                                                |
|    52 | Indian Institute of Science and Education and Research, Tirupati       | BSL-1 and BSL-2 | Rice, Tomato, Groundnut                                              |
|    53 | Indian Institute of Science Education & Research, Pune                 | BSL-1 and BSL-2 | Potato                                                               |
|    54 | Indian Institute of Science Education and Research, Thiruvananthapuram | BSL-1           | Rice                                                                 |
|    55 | Indian Institute of Technology, Roorkee                                | BSL-1 and BSL-2 | Pea, Wheat                                                           |
|    56 | Institute of Forest genetics and Tree Breeding, Coimbatore             | BSL-1           | Eucalyptus                                                           |
|    57 | International Center for Genetic Engineering                           | BSL-1 and       | Saffron, Cotton,                                                     |

|    | and Biotechnology, New Delhi                                                           | BSL-2           | Pigeon Pea, Rice, Rice bean, Tomato                                    |
|----|----------------------------------------------------------------------------------------|-----------------|------------------------------------------------------------------------|
| 58 | International Crops Research Institute for the Semi-Arid Tropics, Patancheru           | BSL-1 and BSL-2 | Groundnut, Pearl millet, Pigeon pea, Chickpea, Sorghum, Foxtail millet |
| 59 | ITC Life Sciences & Technology Centre, ITC Ltd., Bangalore                             | BSL-1           | Eucalyptus camaldulensis , Soybean ( Glycine max ), Tobacco            |
| 60 | Jai Narain Vyas University, Jodhpur                                                    | BSL-1 and BSL-2 | Tomato                                                                 |
| 61 | Jawaharlal Nehru University, New Delhi                                                 | BSL-1 and BSL-2 | Tomato, Rice                                                           |
| 62 | Mahyco Private Limited, Mumbai                                                         | BSL-1           | Rice                                                                   |
| 63 | Metahelix Life Sciences Ltd., Bangalore                                                | BSL-1 and BSL-2 | Maize                                                                  |
| 64 | Micro CRISPR Private Limited, Valsad                                                   | BSL-1 and BSL-2 | Tomato, Wheat, Mustard, Rice, Soybean                                  |
| 65 | National Centre for Biological Sciences, Bangalore                                     | BSL-1 and BSL-2 | Rice                                                                   |
| 66 | National Institute for Plant Biotechnology, New Delhi                                  | BSL-1 and BSL-2 | Wheat, Mustard, Rice, Pigeon pea, Finger millet, Chickpea              |
| 67 | Punjab Agricultural University, Ludhiana                                               | BSL-1 and BSL-2 | Sorghum, Foxtail Millet, Wheat                                         |
| 68 | Rajagiri College of Social Sciences, Ernakulam                                         | BSL-1           | Foxtail millet                                                         |
| 69 | Regional Centre for Biotechnology, Faridabad                                           | BSL-1 and BSL-2 | Rice, Chickpea                                                         |
| 70 | Rubber Research Institute of India, Kottayam                                           | BSL-1           | Rubber                                                                 |
| 71 | Sharda University, Greater Noida                                                       | BSL-1 and BSL-2 | Mustard                                                                |
| 72 | Sher-e-Kashmir University of Agricultural Sciences and Technology of Kashmir, Srinagar | BSL-1           | Apple                                                                  |
| 73 | Siksha 'O' Anusandhan university, Bhubaneswar                                          | BSL-1 and BSL-2 | Rice                                                                   |
| 74 | South Asian University, Delhi                                                          | BSL-1 and BSL-2 | Rice                                                                   |
| 75 | SRM University, Kattankulathur                                                         | BSL-1 and BSL-2 | Tobacco                                                                |
| 76 | Tamil Nadu Agricultural University, Coimbatore                                         | BSL-1 and BSL-2 | Rice, Tomato, Brinjal, Sesame                                          |

| 77.                                                | Tata Institute for Genetics and Society, Bangalore   | BSL-1 and BSL-2   | Finger millet, Rice           |
|----------------------------------------------------|------------------------------------------------------|-------------------|-------------------------------|
| 78.                                                | The Energy and Resource Institute, New Delhi         | BSL-1             | Potato, Mustard               |
| 79. University of Agricultural Sciences, Bangalore | BSL-1                                                |                   | Potato                        |
| University of Delhi North Campus, Delhi            | BSL-1 BSL-2                                          | and               | 80. Mustard                   |
| 81. University of Delhi South Campus, New Delhi    | BSL-1 and BSL-2                                      |                   | Tomato, Rice, Papaya, Mustard |
| University of Hyderabad, Hyderabad                 | BSL-1 BSL-2                                          | and               | 82. Tomato                    |

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