Takshashila Issue Brief - GM Mustard Offers a Chance to Relook at India’s Gene Editing Governance
Late last month, the Genetic Engineering Appraisal Committee (GEAC) approved the environmental release of a transgenic mustard hybrid called Dhara Mustard Hybrid-11 (GM Mustard) for seed production and testing before its commercial release. The commercial cultivation of GM Mustard will begin after four years from the date of this approval, subject to further approvals from the GEAC. The GEAC has also directed that field studies on the effects of GM Mustard on honey bees and other pollinators be carried out simultaneously post the environmental release.
This is the first time that a genetically modified food crop has received approval for environmental release in India, after the rollback of Bt. Brinjal in the past. As of now, Bt. Cotton is the only approved crop allowed for commercial cultivation in India. GM Mustard is expected to help farmers by increasing the productivity and profitability of mustard cultivation. It is also expected to boost edible oil production in the country.
Meanwhile, the Supreme Court is also hearing a challenge to the decision of GEAC approving GM Mustard. The Court has suggested to the Union Government that it maintains the status quo on the cultivation of GM Mustard, and the success of GM Mustard is dependent on the outcome of the case.
The use of genetic engineering technologies, which offer immense benefits but is accompanied by significant risks, has faced national and international opposition. The GEAC has so far given its approval for commercial use to only one non-food crop, i.e Bt. Cotton. This reflects low levels of adaptation of genetic engineering technology in India.
As far as the regulatory framework for genetically modified organisms (GMOs) in India is concerned, the Department of Biotechnology has released the draft Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment in 2020. However, we are still waiting to see a finalised version of the guidelines. India needs to follow a pragmatic regulatory approach guided by its national interest, irrespective of parochial counter-narratives.
Governing Gene Editing
In Governing Gene Editing: Policy Framework, we argue that research in gene editing, especially using cost-effective technologies like CRISPR-Cas9 is critical for India’s biotech sector. An enabling regulatory framework that allows the technology to grow will help India navigate its food security and healthcare problems. Given that it is a highly technical field, scientists must be at the forefront of designing the regulations and considering the ethical implications, other stakeholders must also be consulted.
To this end, we propose an analytical model for policymaking and a three-level framework. In the chart below, various gene editing applications are classified based on their scientific and ethical risks into 3 distinct categories: fundamental R&D, commercial R&D, and commercialisation.
Based on the risk levels of each of these categories, a layered approach to regulation as depicted below must be followed for the respective gene editing application:
At the laboratory stage, research in the lab is free to be conducted as long as compliance with standards is met. In the trials stage, clinical or open field trials can be conducted with prior approval from the relevant agency. And finally, in the public stage, the government must independently verify that the relevant product meets safety and disclosure standards before commercial use is allowed.
The three-level framework is only the beginning. A forward-looking regulatory framework that takes into account scientific and ethical considerations is a first step towards harnessing India’s genetic resources and technical capacity.
Compiled by Shrikrishna Upadhyaya, with inputs from Shambhavi Naik.
November 14, 2022.
Further Material:
Takshashila Policy Brief - Governing Gene Editing: An Analytical Framework by Shambhavi Naik, Anirudh Kanisetti, Ajay Patri, and Madhav Chandavarkar
Takshashila Discussion SlideDoc - Gene Drives in Infectious Diseases - A Risk Assessment by Shambhavi Naik
Chinese gene-edited baby row rekindles need for guidelines in India by Shambhavi Naik
Gene Editing Tech Needs Enabling Policies to Be Useful in India by Shambhavi Naik
Should India move towards germline gene editing aka genetically modified babies? by Shambhavi Naik
