Dr Vijay Paranjape (Ph. D) is the Vice President of Life Science Advisory, Sathguru Management Consultants, Hyderabad and is a Visiting Fellow  at the Global Development, CALS, Cornell University, USA. Dr Paranjape is an experienced seed Industry professional with over 35 years of academic, techno-commercial, and international development experience with focus on Agricultural Biotechnology. In his current role at Sathguru management consultants, he advises seed industry clients on research strategy, portfolio optimization, entry strategy, IP strategy, competitive assessment, and technical due diligence for M&A.  Partnering with Cornell University, he has also been advising and overseeing activities associated with USAID funded Bt eggplant project in Bangladesh, focusing primarily on technology development, commercialization, scientific outreach, and product stewardship. Prior to joining Sathguru he was associated with Monsanto for about 17 years where he provided leadership as well as contributed towards different phases of plant biotech product development pipeline starting from gene discovery to product development, intellectual property protection, quality management systems, seed regulatory compliance and product stewardship to enable delivery of high quality of seeds to farmers. He has a Ph. D in molecular biology from Jawaharlal Nehru University, New Delhi. He was a post-doctoral research fellow at Imperial College, London and Washington State University, Pullman, USA.

Q1: Tell us your experience with farmers growing Bt Brinjal in Bangladesh. How have their socio-economic life changed?

A:Eggplant (brinjal) is an extremely popular vegetable in Bangladesh and a critical source of income for small, resource-poor farmers. Eggplant is grown by an estimated 150,000 farmers on ~50,000 hectares. Eggplant cultivation in Bangladesh is exposed to the threats of eggplant fruit and shoot borer (EFSB) that causes more than 60% loss in yield, forcing farmers to spray expensive and toxic insecticides more than 80 times each growing season to try and control the pest. This frequent application of insecticides results in very high pesticide residue levels on the fruit, kills beneficial insects, exposes farm workers to hazards, and pollutes the local environment.

The India-based Maharashtra Hybrid Seed Company (Mahyco) developed an eggplant expressing Cry1Ac (EE-1) for control of the eggplant fruit and shoot borer (EFSB). As part of USAID funded South Asia Eggplant Improvement Partnership project, Mahyco, Sathguru Management Consultants and Cornell University, EE-1 event was provided pro bono to the Bangladesh Agricultural Research Institute (BARI), who bred it into local farmer preferred public varieties. The Bangladesh government granted approval for the release of four public varieties developed by BARI in 2013. In the seven years since Bt eggplant was first approved, the number of farmers growing it has progressively increased to well over 60,000 in the 2020-21 season. The actual number of farmers growing Bt eggplant is likely to be larger as some farmers use seeds they saved from the previous season or share seeds with other farmers. The four Bt eggplant varieties currently available cover only a limited eggplant growing area and many farmers still do not have access to the technology.

The reasons for the high rate of adoption are clear: Farmers have benefited from the technology by getting higher yields and savings due to the reduced use of pesticides to control the eggplant fruit and shoot borer (EFSB). Reduced use of pesticides also provides health benefits to the farmers. Independent studies conducted in the last few years show that farmers are realising a six-fold increase in their net returns, earning $2,151/ha as compared to $357/ha for non-Bt eggplant, and are saving at least 60% on pesticide cost compared to non-Bt eggplant farmers. Further decreases in insecticide use and increases in environmental benefits will occur as growers gain more experience with EFSB-resistant brinjal. Bt eggplant has proven to be far superior to its non-Bt counterparts with negligible fruit infestations compared to 45% in the non-Bt eggplants. Further, the technology has been able to bring in a 41% reduction in toxicity of pesticides applied. The technology has also witnessed an increased labor use or harvesting, grading, and packaging of Bt eggplant because of increased yield. The key motivation factors among farmers for shifting to Bt eggplant from traditional eggplant included potentiality of higher marketable yield, lesser insect (EFSB) infestation and better price. Having benefited from the technology, farmers now want the Bt technology in higher yielding, agronomically superior, wilt-tolerant and widely adapted varieties to achieve broader adoption of Bt eggplant in Bangladesh.

Bangladesh has gained by the release of publicly developed varieties that met the needs of the small farmers. In India, too, ten public Bt brinjal varieties were developed by public institutions, but in 2010 a moratorium on their use was implemented. If they had been approved, it could have made the technology affordable to small farmers in India.

Q2: After the success of Bt Brinjal, when do you think blight resistant potato and golden rice are set to be introduced in Bangladesh and how will it impact the farmers?

A:The Golden Rice which is still under review in Bangladesh was created at the International Rice Research Institute (IRRI) in Los Baños, Philippines. Researchers bred beta-carotene genes into a rice variety named dhan 29, which is grown widely during the dry season in Bangladesh and contributes about 14% to the national harvest. When Dhan 29 Golden Rice was planted at multiple locations, researchers at the Bangladesh Rice Research Institute (BRRI) in Gazipur found no new farming challenges and no significant differences in quality—except for the presence of vitamin A. BRRI submitted data to the Bangladeshi Ministry of Environment, Forest, and Climate Change in November 2017. The Biosafety Core Committee of the National Committee on Biosafety has since been reviewing environmental risks. BRRI is now awaiting approval from National Committee on Biosafety. If approved, Bangladesh could be the first country to cultivate genetically modified rice.  Widespread adoption of golden rice would be incredibly valuable for Bangladesh and benefits from its cultivation would be associated with increased farmer productivity as well as  positive health effects and reduction in per unit cost of rice production.

Late blight is the most serious potato disease worldwide, caused by the water mold, Phytophthora infestans, that destroys leaves, stems, and tubers. The disease spreads very quickly and can result in total crop loss. To protect crops, farmers spray heavy concentrations of fungicide which increases input costs and labour and increases potential risks to the population and environment. The Feed the Future Biotechnology Potato Partnership is finding effective alternatives to fighting late blight through biotechnology. Michigan State University in partnership with U.S. based Simplot Plant Sciences and USAID plans to develop and bring to market a three-resistance gene (3R-gene) late blight resistant potato in farmer-preferred varieties in Bangladesh. The late blight resistant potato is expected to improve livelihoods of smallholder farmers by reducing input costs, increasing yields and yield stability, and reducing the exposure to chemical fungicides which are harmful to human and environmental health. The genetically modified potatoes will undergo multi-year, multi-location field trials in both target countries to collect the necessary data in order to apply for regulatory approval and be commercialized. The project expects that farmers in Bangladesh can begin to see the benefits of this technology in their fields in five-ten years.

Q3: India allowed Bt Cotton in 2002 and the nation is struggling to get an NOC for Bt Brinjal field trials even after 19 years, how far behind is India now when compared to countries like Bangladesh, Canada, and USA? 

A:India went ahead with the release of Bt cotton, primarily because it’s not a food crop and is not directly consumed whereas the country has been dragging its feet far too long for commercialization or even providing NOCs for field trials of food crops like brinjal, mustard or even of next generation of Bt cotton that provides better resistance to insect pests and selected herbicides. The Indian regulatory framework is a robust one however, there are far too many pressure groups who either lack the scientific basis of the Biotech or genetic modification of crops or feign ignorance due to one reason or other best known to them. It will not be fair to compare India and developed countries like USA and Canada who are way ahead as far as the acceptance of genetic modification (GM) technologies and their wider acceptance in these countries from the perspectives of scientists, farmers, and end consumers whether it be for maize, soybean, sugar beet, potato, squash, oilseed etc. USA and Canada are also treating gene editing technologies (gene editing of the host plant, no introduction of foreign genetic material) as safe and treat them differently than Genetic modification technologies (incorporation of foreign genes into host plant).

When we compare India to Bangladesh, Bangladesh is doing well as far as the commercialization of GM crops is concerned. Bangladesh commercialized Bt brinjal in 2013 and is working towards releasing golden rice, late-blight resistant potato and GM cotton. The commercialization of Bt eggplant has been made possible by a strong push from the government despite opposition from various pressure groups. Ironically, the technology for commercialization has been transferred from Indian company to Bangladesh. Indian public sector developed ten varieties of Bt Brinjal as total indigenous development effort that has been denied to resource poor farmers in India. Varietal release by the public sector has created a significant impact in Bangladesh for small farmers to gain access to affordable seeds.  The speed at which the Indian Government is moving for commercialization of GM crops does not augur well for Indian farming community as the threats from current and emerging pests are enormous and cannot be met by conventional means. Therefore, if India must be in the league of countries like USA and Canada or even Bangladesh, the government needs to start believing in the scientific evidence for commercialization of GM crops in the country, including but not limited to Bt Brinjal.

Q4: What would be your suggestion to de-bottleneck the regulatory process in India to get approval on the next GM crops? 

A:The regulatory protocols in India are as well-defined and stringent as anywhere else in the world, however, the major challenge the government faces are from the various pressure groups who have practically no stake in believing the scientific evidence for the safety of GM crops. The government is also at fault for not respecting the recommendations made by the scientific committees comprised of experts drawn from various fields across the country. The government needs to abide by the advice of scientists/scientific institutions for taking a call on the commercialization of GM crops and not be pressured by activists/politicians. An overcautious Ministry of Environment and Ministry of Agriculture influenced by a small section of NGOs opposed to technology, projecting their opinion as  ‘public opinion’ rather than scientific data (performance, safety) accepted by DBT for technology approval is killing the innovative approach among few seed companies of India who are spending millions of dollars to develop the safe products for the farming community and end consumers only to see it scuttled by unscientific opinions. These companies are now looking for markets outside of India!  Further, a lengthy approval process seeking resubmission of the data from local experiments that too not customized but the entire set forces the innovators to waste time and money instead of recognizing what has been accepted by other approvers in different countries. A model similar to ISO or other quality standards or even what we have adopted for the release of COVID-19 vaccines within a year recently can be taken up for commercialization of GM crops. After all, the novel tools and technologies are for the benefit of society at large whether it be for medical science or agricultural/food sciences; if it has proven to be safe within the given regulatory framework, it should be made accessible to its users.

The GM product developers also need to take some blame for not creating enough publicity right from product development and ‘pre-launch’ stages about both the limitations and benefits of the technology that resulted in confusions among the users who would likely to be on the safer side and not use the product unless they are fully aware of the benefits and limitations. They need to invest in stronger communication and policy advocacy efforts. There is also a lack of clarity on who is the approver – GEAC is the appraisal committee but does not have the authority to “approve”. GEAC gives permission for trials but states deny it. Further, the lack of inter-ministerial coordination, too many players to play spoilsport (agriculture being the state subject and each state imposes their power based on whims and fancy) coupled with the lack of political will for approval of GM crops was the biggest hurdle for the commercialization of Bt brinjal in India.  This makes it tough for an applicant to explain the technology multiple times to new experts.

There is also one major bottleneck that requires states’ NOC for conducting environmental toxicity assessment involving approval from multiple stakeholders making it impossible for applicants to do desired number of trials in different states. This can be done away and once the environmental toxicity studies have been completed, they need not be repeated for the same technology. There is also a lack of a clarity for study requirements – the guidelines for stacked (multiple traits) products are yet to be formalised.

There is a need in India for an independent authority that is free from political influence and should have the clear guidelines and authority for appraisal and approval for commercialization of GM crops. This should follow the model that USA, Canada and Australia have adopted and should be free from socio-political and not be influenced by pressure groups like so-called environmental activists and/or NGOs. This should be supported by clear timelines for approval process and the decision of same authority should be accepted by all the states without any contradictory signals from central and state governments. Removing these bottlenecks will help India become one of the leading adopters of the new tools and technologies benefiting farmers of the country as well as ensuring food safety and security.

Q5: What are your views on gene editing? How do you think it will revolutionize the agriculture sector and the food basket?

A:Gene editing has the potential to reshape agriculture. It has become a powerful tool in plant genomics research that can accelerate crop improvement and food production. With the discovery of novel and better enzymes and improved delivery methods of gene editing, the application potentials of CRISPR/Cas9-based crop improvement have been enhanced. It not only facilitates newer varieties to be produced quicker by cutting down on time, labor and costs compared to genetic modification but also will aid to develop high yielding, nutrient rich, disease resistant, herbicide tolerant and other abiotic stress tolerant varieties of crops and can significantly reduce input costs of farmers. Combining artificial intelligence and gene editing together could empower researchers to design plants with desired traits suitable for local conditions. In recent years there are multiple reports, including from India, that have shown successful application of genome editing in crop improvement.

Department of Biotechnology, Ministry of Science & Technology has recently released a comprehensive draft document on regulatory framework and guidelines for risk assessment of gene edited crops. This is a significant development and may pave the way for utilizing gene edited crops in India. However, the draft guidelines proposed by DBT takes the process-driven approach rather than a more desirable product-centric approach, where the novelty of the characteristics in the gene edited plants is evaluated. US and other developed countries take the product-centric approach to deregulate gene edited crops. The draft guidelines also propose a tiered regulatory approval process. Plants whose genome has been minimally modified (SDN-1), would have to conform that only the targeted genome is edited and rule out any significant off-types. Plants whose cells have few or several base pair edits (SDN-2) will have to undergo trait efficacy trials and would be assessed for equivalence with similar non-edited varieties. However, plants with large DNA changes (SDN-3) will be treated similarly to genetically modified crops. Once the proposed framework is tested and few gene-edited crops get approved, regulators would certainly review and move towards a product-centric approach.

Genome editing in crops can significantly speed up the progress of breeding programs. It could drive the development of traits in new crops and allow improvements in yield and pest resistance, adaptation to climate change, and industrial and pharmaceutical applications. Hence it is time a widely acceptable regulatory approval process is in place at the earliest to revolutionize the agriculture sector. India must follow the regulatory systems of countries that are large producers and exporters of agricultural produce.

Disclaimer: The opinion expressed above are solely that of the author and does not represent the opinion of any institution or entity he is affiliated to or referred to in this interview.