Understanding Regulations for Gene-Edited Crops in India

1. Which law governs gene-edited crops in India?

Gene-edited crops and genetically modified organisms (GMOs) in India are regulated under the Rules, 1989, framed under the Environment (Protection) Act, 1986. These rules are administered by the Ministry of Environment, Forest and Climate Change (MoEF&CC). Any research, import, export, or commercial use of such organisms must comply with these regulations.

2. What is the latest regulatory change regarding gene-edited crops?

In March 2022, the MoEF&CC announced a significant policy change: crops developed using SDN1 and SDN2 gene-editing techniques are exempt from Rules 7 to 11 of the 1989 Rules—provided they do not contain any foreign DNA. This exemption simplifies field trials and accelerates the development of gene-edited crops in India.

3. What are SDN1 and SDN2 categories in gene editing?

SDN1: Involves small edits within a plant’s own DNA, such as deleting or disabling a specific gene.
SDN2: Uses a repair template for precise edits but still does not introduce any foreign genetic material.
Both categories differ from traditional GMOs because no external DNA is inserted into the plant genome.

4. Why is this regulatory exemption important?

The exemption streamlines approval and testing for gene-edited crops aimed at improving yield, nutritional value, and climate resilience. Researchers can now move their innovations from the laboratory to field trials with fewer bureaucratic hurdles, promoting faster agricultural innovation.

5. What guidelines are used to assess gene-edited plants?

The “Guidelines for the Safety Assessment of Genome Edited Plants, 2022”, issued by the Department of Biotechnology (DBT), outline the safety protocols for evaluating gene-edited crops. These guidelines ensure that all plants, including exempted ones, meet environmental and public health safety standards.

6. Which government bodies are involved in the approval process?

• RCGM – Review Committee on Genetic Manipulation: conducts scientific safety assessments
• GEAC – Genetic Engineering Appraisal Committee: provides final environmental and risk approvals
• MoEF&CC – Ministry of Environment, Forest and Climate Change: issues policy notifications and oversees legal compliance
• FSSAI – Food Safety and Standards Authority of India: ensures food safety clearance
• Ministry of Agriculture: grants approval for large-scale cultivation and distribution

7. What were Rules 7 to 11 about?

Rules 7 to 11 under the 1989 framework dealt with the approval process, risk management, monitoring, and reporting requirements for genetically modified organisms. The 2022 exemption for SDN1 and SDN2 crops reduces paperwork and accelerates project implementation.

8. Are safety checks still required for SDN1 and SDN2 crops?

Yes. Even with relaxed regulatory requirements, all gene-edited crops must undergo detailed biosafety assessments and field evaluations under the 2022 guidelines before being approved for commercial release.

9. What benefits will farmers and researchers gain from this change?

This regulatory shift allows for faster field trials, improved access to climate-resilient and nutrient-rich seeds, and stronger support for sustainable farming. Both public and private research institutions can now innovate more efficiently, benefiting farmers with advanced crop varieties.

10. Are crops with foreign DNA still restricted?

Yes. Only crops without foreign genes—those classified under SDN1 and SDN2—are eligible for regulatory exemption. Crops containing foreign DNA, such as SDN3 or transgenic varieties, remain under full regulatory supervision and must meet all GMO-related approval requirements.