Executive Summary:
This document summarizes the Indian government's response to concerns regarding the release of gene-edited rice varieties, specifically DRR Dhan 100 and Pusa DST Rice 1. It clarifies the regulatory framework, safety assessments, intellectual property rights considerations, and consultations undertaken. The response addresses questions raised in Lok Sabha Unstarred Question No. 1398 on July 29, 2025.
Key Points / Main Content:
Regulatory Framework and Safety Assessments:
* The Ministry of Environment, Forest and Climate Change (MoEFCC) exempted SDN1 and SDN2 genome-edited crops without foreign DNA from GM regulations via OM F.NO. C1201332020CSIII dated March 30, 2022.
* The Department of Biotechnology (DBT) issued safety assessment guidelines for genome-edited plants in 2022 (OM No. File No. PID1501112022PPBDBT dated 17.05.2022) and standard operating procedures for SDN1 and SDN2 categories (OM No. File No. PID1501112022PPBDBT dated 04.10.2022).
* The Review Committee on Genetic Manipulation (RCGM) confirmed the exemption of these rice lines from further biosafety regulations after reviewing data submitted by Institutional Biosafety Committees (IBSCs) in its 258th meeting on May 30, 2023.
* India follows rigorous biosafety regulations for gene-edited plants, ensuring no foreign genes/nucleotides are present in the final product.
Intellectual Property Rights (IPR):
* DRR Dhan 100 Kamala and Pusa Rice DST1 were developed using CRISPR-Cas technology, which is under IP protection.
* Inventors provided Freedom to Operate (FTO) for research purposes.
* The seeds will be accessible to Indian farmers like normal crop varieties, with no affordability or accessibility issues anticipated.
Consultations:
* Extensive consultations were held with stakeholders by the Indian Council of Agricultural Research, Department of Biotechnology, and National Academy of Agricultural Sciences.
* The rice varieties were discussed in various forums, including conferences, meetings, seminars, farmers' fairs, and industry meets.
Oversight and Monitoring:
* Regulatory bodies (IBSC and RCGM) critically examine data to ensure the absence of foreign genes and scrutinize mutation stability and phenotype robustness.
* Varieties were independently tested at over 50 locations each by the ICAR-All India Coordinated Research Project on Rice during 2023 and 2024.
Impact Analysis:
State Governments, Farmer Groups, Scientific Institutions:
* Impact: Informed about the development and regulatory processes of gene-edited rice varieties through consultations and open forums.
* Action Required: Continue participating in discussions and providing feedback on gene-edited crops.
Indian Farmers:
* Impact: Will have access to gene-edited rice varieties (DRR Dhan 100 Kamala and Pusa Rice DST1) seeds at an affordable price, similar to conventional varieties.
* Action Required: Adopt the new varieties as appropriate for their farming needs.
Regulatory Bodies (IBSC, RCGM):
* Impact: Responsible for the rigorous safety assessment and regulatory oversight of gene-edited crops.
* Action Required: Continue to critically examine data, ensure the absence of foreign genes, and scrutinize mutation stability and phenotype robustness per established guidelines.
Key Entities Referenced
Ministry of Agriculture and Farmers Welfare: The Indian government ministry responsible for agricultural research, education, and farmer welfare.
DRR Dhan 100: A gene-edited rice variety that has undergone safety assessments for release.
Pusa DST Rice 1: A gene-edited rice variety that has undergone safety assessments for release.
SiteDirected Nuclease1 (SDN1): A category of gene editing that is exempt from rigorous biosafety regulation.
SiteDirected Nuclease2 (SDN2): A category of gene editing that is exempt from rigorous biosafety regulation.
Department of Biotechnology (DBT): A department under the Ministry of Science and Technology, Govt. of India, that issued guidelines for the safety assessment of genome-edited plants.
Review Committee on Genetic Manipulation (RCGM): A committee under the DBT that confirms exemptions for genome-edited rice lines from further biosafety regulations.
Indian Council of Agricultural Research (ICAR): An autonomous organisation under the Department of Agricultural Research and Education (DARE), Ministry of Agriculture and Farmers Welfare, Government of India.
GOVERNMENT OF INDIA
MINISTRY OF AGRICULTURE AND FARMERS WELFARE
DEPARTMENT OF AGRICULTURAL RESEARCH & EDUCATION
LOK SABHA
UNSTARRED QUESTION NO. 1398
TO BE ANSWERED ON 29TH JULY, 2025
RELEASE OF GENE EDITED RICE VARIETIES
1398. SHRI SASIKANTH SENTHIL:
Will the Minister of AGRICULTURE AND FARMERS WELFARE कृषि और ककसान कल्याण
मंत्री be pleased to state:
(a) whether the Government is aware of concerns raised regarding the adequacy of safety
assessments conducted for the release of gene edited rice varieties such as DRR Dhan 100 and
Pusa DST Rice 1, if so, the details thereof;
(b) whether the exemption of SDN-1 and SDN-2 categories of gene editing from rigorous
biosafety regulation aligns with established scientific and international biosafety standards;
(c) whether any assessment has been made regarding the Intellectual Property Rights (IPR)
implications of CRISPR based technologies and their potential impact on affordability and
accessibility for Indian Farmers;
(d) whether consultations were held with State governments, farmer groups, and scientific
institutions regarding biodiversity concerns and potential ecological risk, if so, the outcomes of
such consultations; and
(e) the details of measures being taken to strengthen regulatory oversight, promote
independent testing and ensure public transparency in the approval and monitoring of gene
edited crops in India?
ANSWER
THE MINISTER OF STATE FOR AGRICULTURE AND FARMERS WELFARE
कृषि और ककसान कल्याण राज्य मंत्री (SHRI BHAGIRATH CHOUDHARY)
(a) & (b): Yes, DRR Dhan 100 and Pusa DST Rice 1 have been approved under the provision
of Ministry of Environment, Forest and Climate Change (MoEF&CC), Govt. of India exempted the
Site-Directed Nuclease-1(SDN1) and Site-Directed Nuclease-2 (SDN2) genome edited crop free
of exogenous introduced DNA from GM regulation rules (Rules 7-11 of Rules 1989) vide OM
F.NO. C-12013/3/2020-CS-III dated 30 March, 2022. Further, the Department of Biotechnology
(DBT), Ministry of Science and Technology, Govt. of India issued the Guidelines for the Safety
Assessment of Genome Edited Plants, 2022 vide OM No. File No. PID-15011/1/2022-PPB-DBT
dated 17.05.2022 and “Standard Operating Procedures for Regulatory Review of Genome Edited
Plants under SDN-1 and SDN-2 Categories” vide OM No. File No. PID-15011/1/2022-PPB-DBT
dated 04.10.2022. The detailed dossier of relevant data generated during development of these
varieties was submitted to Review Committee on Genetic Manipulation (RCGM), DBT by
Institutional Biosafety Committees (IBSCs). The RCGM in its 258th meeting held on 30 May 2023
confirmed the exemption for the genome edited rice lines from further biosafety regulations.
1(c): The genome edited varieties DRR Dhan 100 (Kamala) and Pusa Rice DST1 have been
developed from public sector bred parent varieties BPT 5204 and MTU 1010, respectively
through indigenous efforts.
Since these varieties have been developed using CRISPR/Cas genome editing technology
which is under IP protection, the inventors have provided Freedom to Operate (FTO) provision
for using genome editing technology for research purpose.
There is no issue of bearing on the affordability and accessibility of Indian Farmers. Seeds
of these varieties will be accessible to them as a normal variety of crop.
(d): The wider consultations on genome edited plant varieties were held with stakeholders by
Indian Council of Agricultural Research, Department of Biotechnology and National Academy of
Agricultural Sciences in open forums before notification of the guidelines and procedures for
genome edited plant varieties in India. These two rice varieties have been discussed and
deliberated in conferences, meetings, seminars, farmers’ fairs and industry meets.
(e): As covered under responses (a), India follows one of the most robust and rigorous biosafety
regulations for development and testing of gene edited plant varieties through SDN-1 and SDN-
2 technologies of genome editing. The GM regulatory bodies, IBSC and RCGM, examine the
data very critically to ensure that end product does not have any footprint of foreign
genes/nucleotides, and follows global standard of non-GM products. These regulatory bodies
also scrutinize the stability of mutations created by gene editing tools, and the robustness of
phenotype. The exemption is given only after these biosafety regulatory bodies examine and
clear the application as per guidelines of RCGM, DBT, Government of India. Further, these
varieties were tested independently at more than 50 locations each at the centres of ICAR-All
India Coordinated Research Project on Rice during 2023 and 2024.
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