Genome editing technology has great potential in biology, including human and animal health, as well as in the agriculture and allied sectors. Since its invention in 2012, genome technology has globally revolutionised the medical and agricultural sectors.  

In India, various public and private institutions develop improved crop varieties. Key laboratories of the ICAR and DBT have already developed rice varieties that require less water, and bananas bio-fortified with beta-carotene (precursor of Vitamin A) using this technology. Other public and private institutions have products in the R&D pipeline with various traits related to disease resistance, climate change resilience and enhanced nutrition.  

However, scientists were eagerly waiting for a positive sign favouring genome-edited crops, as witnessed in various other countries like Argentina, the US, Japan, China, the UK and others.  

The Centre, in its Office Memorandum of March 30, 2022, exempted plants falling under the categories of SDN1 and SDN2 from the certain provisions of the EPA Rules, 1989, which governs the regulatory and biosafety of genetically modified organisms (GMOs) in the country. This is a decisive step appreciated by the researchers all over the country as India embarks on a path not to regulate SDN1 and SDN2 genome-edited plants from being regulated as GMOs.   

This would lead to accelerated development of crop varieties with different improved traits, particularly to impart resistance to devastating plant diseases and fight climate change and malnutrition and would help realize the government’s dream of ‘per drop more crop’ and doubling farmers’ income in the near future.  

What are SDN1 and SDN2 plants 

Unlike the Genetically Modified Organisms (GMO) technology, CRISPR-based genome editing is a versatile tool that generates functional mutation(s) in the recipient genome at specific target sites. Depending on the type of approach, the three types of genomic changes can be distinguished. 

While (Site-Directed Nuclease) SDN1 introduces changes in the DNA (host genome) through small insertions/deletions without the addition of exogenous DNA as a template, SDN2 uses a small DNA template to generate a specific desired change. Both approaches yield plants free from foreign DNA and remain indistinguishable from the conventionally bred crop varieties.   

On the contrary, SDN3 inserts larger DNA elements or a full-length gene of foreign origin using a similar approach as SDN2, as typical of GMO development. In simple words, genome editing through SDN1 and SDN2 means tweaking a gene already present in the plant – plants own or native genes.  

SDN 1 and SDN2 types of genome editing are currently being used in Indian labs to breed new crops imparting traits, including resistance to diseases, drought, salinity stresses, and improving nutritional quality through bio-fortification.  

Global advances in Genome Editing 

While the world is already ahead in adopting this technology, which is now a billion-dollar industry, we are happy that finally, India has arrived there. It is the right time for us to appreciate and recognize the efforts of Indian regulators and policy planners, including coordinated efforts among MOEF&CC, MOA&FW, DBT and ICAR.  

Several countries, through genome editing, have either developed or approved the commercial cultivation of some vegetables, fruits, oilseeds, cereals and pulses such as gamma-aminobutyric acid (GABA) tomato, high oleic canola and soybean, non-browning apple, mushroom and reduced black spot potato. These crops are either disease-resistant or bio-fortified with better nutritional qualities.  

India’s forte in genome editing 

The ICAR and the Government of India’s Department of Biotechnology (DBT) have initiated mega programs using genome editing for crop improvement in the recent past. It includes nutritionally enriched bananas, high yielding and biofortified rice, citrus resistance to greening, herbicide-tolerant maize and pigeon pea, banana resistance to Panama disease, climate-resilient wheat, drought and salinity tolerant rice, mustard with improved nutrition, high oleic soyabean and quality millets.  

Moreover, DBT proposed establishing a Centre of Excellence and launching a Mission Programme on Improved Crop Varieties through genome editing. NABI was among the first in India to use CRISPR technology to develop beta-carotene enriched bananas for preventing Vitamin-A deficiency-related disease. Several ICAR & DBT institutes, ICGEB and CSIR institutes are also using this technology for enhancing abiotic stress tolerance, disease resistance and nutritional quality in various crops. 

Awaiting Guideline on genome editing:  

The government decision on SDN1 and SDN2 category genome-edited plants recognises the potential of genome editing technology in agriculture. It paves the way for MOEF to approve and notify the Guidelines on Genome Edited Plant drafted by the Department of Biotechnology, pending with MOEF&CC since early 2020. 

The recent policy would allow an exit of SDN1/SDN2 categories of genome-edited plants free from transgene/foreign gene from the additional norms of the GMO regulatory system. In summary, it’s not a biosafety exemption per se. Still, the genome-edited SDN1/SDN2 category plants will be absolved from the cumbersome GMO regulatory system after evaluation of molecular data by IBSC/RCGM under EPA Rules 1989 and subsequently regulated under the Seed Act of Ministry of Agriculture and farmers welfare- a unique duel regulatory system ensuring biosafety and benefits of technology for the interest of smallholder growers.  

In 2006, the MOEF&CC took a similar decision on the recommendation of the task force on rDNA drugs under the chairmanship of Dr RA Mashelkar to allow the exit of rDNA pharma products from the GMO regulatory system after primary evaluation by IBC/RCGM, subsequently regulated under Drug Comptroller General of India (DCGI).   

Light at the end of the tunnel  

After a decade of policy uncertainty and extended consultations, we see the light at the end of the tunnel. There is a ray of hope among researchers, students and scholars, and we have much to be delivered in crop varieties for the welfare of farmers and consumers.  

However, the optimism of the system moving at a rapid pace ahead, providing enormous benefits, particularly to the smallholder farmers, must be geared to secure technology access, provide an intellectual property framework, align with liked-minded countries, secure trade and social acceptance. Scientists need to fully harness the benefits of genome editing for the welfare of farmers and the country.  

(The authors work for South Asia Biotechnology Centre, Jodhpur)   

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