India: Genome editing stays stuck in a rut

In the beginning of 2020, India’s Department of Biotechnology (DBT) released the much-awaited draft guidelines on regulation and risk assessment of genome-edited organisms. Genome editing technologies such as CRISPR hold potential for many sectors of the Indian economy, where agriculture assumes prominence in the mostly agrarian society.

Since the advent of disruptive genome editing technologies in 2013, the US and China have made great leaps in therapeutics and agriculture. But, before taking the plunge in India, the draft guidelines remain open for discussions. It also inspires a revisit to the country’s editing experiments since 2013.

Lack of original research

Sadly, the agri-biotech timeline reveals a stark image for gene-editing technology. Although Indian scientists have published voluminous papers on the topic, talent remains limited to assessment and review of the original research undertaken across the globe. Likewise, Indian agri-biotech labs remain devoid of original research work, except for a patent filed by ICGEB using the CRISPR scissors to yield herbicide tolerant maize varieties.

So, why the need to move forward and promote the genome editing efforts? Genome editing tool such as CRISPR-Cas is a simple two-component system that allows researchers to precisely edit any sequence in the genome of an organism. Scientists can achieve precise and cost-effective editing of any genome by guide RNA, which recognises the target sequence, and the CRISPR-associated endonuclease (Cas) that cuts the targeted sequence.

This is a very efficient method of making site-specific mutations contrary to the random mutation caused by conventional chemical or radiation technology. In nature, bacteria usages the CRISPR system to protect themselves from invading viruses. From research to commercial applications, the CRISPR can now be deployed in all types of organisms such as plant and animal species, as well as to humans. It has countless applications.

In 2018, non-browning mushrooms with extended shelf life made way to the US markets, while nutritionally enhanced high oleic soybean was planted on a large area. Moreover, corn with altered starch composition, resistance to northern blight, and potatoes with reduced black spot have also been approved. Brazil declared genome-edited hornless cows as conventional animals.

Chinese feats

Correspondingly, in China, glyphosate-tolerant maize, rice, and pigeon pea secured approval. In November 2018, a controversial Chinese researcher claimed to have created genome-edited twins resistant to HIV infection. Not only the lessons from abroad underline the benefits of tech, but the Indian story of Bt cotton is an in-house legend. When the genome of ordinary cotton was edited through genetic modification, it acquired unique abilities to maintain plant health by disturbing the predatory insect’s gut.

Bt cotton plants not only became capable of protecting themselves but also benefited farmers with higher incomes. With a small nick in the genome, the use of insecticides was vastly reduced. But the Bt cotton success remains confined to the cotton fields and the Indian scientific competencies remain unexploited. Scientists in premier genome editing labs such as ICAR, CSIR & DBT are all striving for survival in the absence of large-scale project funds to advance genome editing in agriculture.

Lack of direction

Almost eight years of shying away from the genome editing technology, which is helping developed nations feed their populations better, has restrained the Indian potential. Bt brinjal stands under a moratorium while Bangladesh has already approved, grown and commercialised the crop.

Currently, the fate of dozens of genome edited products such as maize, rice and banana under research and development hangs in the balance. Lack of succinct policies and strategic direction, coupled with rickety regulatory environment, hampers progress in the filed. The current regulations on genome-edited organisms and, to no small extent the proposed draft adopts a process-driven approach. Alternatively, the US and other developed countries’ approach involves product-trigger, where the novelty of the characteristic being imparted to the edited organism is evaluated on a case-by-case basis. Yet, the draft guidelines proposed by DBT take the process-driven approach further instead of a more desirable product-centric approach.

Contrastingly, the process-driven guidelines do not prescribe any safety tests for any possible unwanted changes resulting from chemical or radiation-induced mutations. The guidelines also leave grey areas for the categorization of edited products under Group I and Group II categories. Additionally, the guideline is silent on cisgenic products developed under Group III category.

Regulatory imperatives

Instead of categorisation of technologies, the draft guideline on genome editing should be about the concepts, and should distinguish products based on their characteristics. Moreover, the guideline excludes genome-edited microorganisms and thus, fermentation products, which has myriad applications as biopesticides, biofertilizer and biostimulants.

Once the discussions on guidelines culminate, they will begin the eager wait to witness the possible rectifications accepted by DBT. Hope we do not produce another rickety regulatory guideline that drains the biotech jet and slows down the leap to a new and sustainable future.