Status of research, regulations and challenges for genetically modified crops in India

ABSTRACT

A large number of genetically modified (GM) crops, including both food and non-food crops carrying novel traits have been developed and released for commercial agriculture production. Soybean, maize, canola and cotton for the traits insect resistance and herbicide tolerance are the main crops under commercial cultivation worldwide. In addition, many other GM crops are under development and not yet released commercially. Food and Agriculture Organization (FAO) in its report, the State of Food Security and Nutrition in the World 2017, highlights the severity of food security and malnourishment problem in most of the Asian and developing countries. GM crops could be an option for nutrients enhancement and yield increase in major crops and solve the problem of malnourishment and food security. India has progressed tremendously in GM crops research, evaluation and monitoring in last two decades but regulatory system impeded gravely due to lack of coordination and common stand on GM technology across different governments, ministries and departments. The increasing cultivation of genetically modified crops has raised a wide range of concerns with respect to food safety, environmental effects and socio-economic issues. Here, we discussed the current status of GM crops research, regulatory framework, and challenges involved with transgenic plants research in India.

1. INTRODUCTION

India has experienced Green Revolution in wheat and rice during 1970s which makes us self-sufficient in food grains production. The situation has changed significantly in 21st century due to climate change and increasing population pressure. World hunger is on the rise again and eliminating hunger and malnutrition by 2030 will be challenging and it will be achieved by sustainable agriculture and collective efforts by all the stakeholders (FAO, IFAD, UNICEF, WFP and WHO 2017). The conventional technologies will not be able to meet the food and nutrition requirements. Advancement in modern biology, especially biotechnology and molecular biology, offer many advantages when applied in conjunction with the traditional plant breeding techniques. The scientific and technological advances in these areas have progressed at a remarkable pace during the last decade at the global level. GM crops are produced by transfer of genes between organisms for specific traits using laboratory techniques. Plants derived from this method are called GMOs (Genetically Modified Organisms) or genetically engineered or transgenic plants. Researchers have attempted various approaches for preparing genetically engineered crops in last three decades and the first transgenic fruit crop developed and commercialized successfully was the well‐known ‘Flavr Savr’ tomato (Bruening and Lyons 2000) which had been modified to contain reduced levels of the cell wall softening enzyme polygalacturonase (Smith et al. 1988). After this, several other GM food and non-food crops have been developed and commercialized worldwide. These include pest resistant cotton, maize, canola (mainly Bt or Bacillus thuringiensis), herbicide glyphosate resistant soybean, cotton and viral disease resistant potatoes, papaya and squash (FAO 2012). In addition to this many other GM crops are under development and field trials, and not yet released commercially with the traits of phytoremediation, biofortification and production of pharmaceuticals (Shahid et al. 2016).

Development of genetically modified crops expressing a variety of novel traits such as insect resistance, disease resistance, herbicide tolerance, improved nutritional quality etc have led to large scale cultivation of GM crops and as per latest update about 18 million farmers in 28 countries have planted GM crops on 181.5 million hectares in 2014 which shows increase of 3–4 % over previous year 2013 (Lucht 2015). GM crops that have been commercialized in the past twenty years include tomato, corn, soybean, cotton, canola, rice, potato, squash, melon and papaya of which soybean, corn, cotton, and canola are of major importance due to its wide cultivation and integral part of agricultural economy in several countries. The United States of America, Argentina and Canada are the major producers and exporters of GM crops and products (James 2010). Argentina, Brazil, China and India are the largest developing-country producers of transgenic crops (James 2015). Substantial social, economic and environmental benefits are being realized worldwide by cultivating GM crops but many farmers and people in some countries are not convinced with GMOs. Most arguments for and against transgenic plants are about their outcomes and impacts, whether on farmers, on health and the environment, or on economic performance. Climate change and food crisis are some of the major issues concerning scientists and policy makers worldwide. Food crisis is growing at an alarming rate as it is getting difficult to keep pace in agriculture production with the rate of population growth; therefore, scientists are looking for modern biotechnology to provide food security (Trivedi et al. 2016).

Journey for development and commercialization of GM crops was not so smooth as compared to many other technological advancements and developments in several other scientific fields. Huge debate is going on since its introduction and commercialization and faced many demonstrations and protests by NGOs, farmers and general public, and bans by many governments in worldwide. USA, Canada and Japan had commercialized several food and non-food GMOs and accepted well by the public largely except little sporadic opposition to some specific GM food. There is some confusion about GM foods, their safety and labelling of genetically modified foods among Americans. Recently, the majority of Americans supported strongly for the labelling of foods that have been genetically modified. They want to know that what they are eating, GM or non-GM? and all the food stuffs should be labelled properly about the presence of GMOs (The New York Times 2013; PBS News 2014). There is a strong opposition of GM foods in UK and entire Europe but UK Government is trying hard to convince the people about safety of GMOs and its urgent need to feed about one billion hungry people in developing nations. GMOs are only allowed to use for restricted non-food purposes in UK and Europe. Recently, environment secretary of UK made public appeal and asked the public to support genetically modified food (The Guardian 2013). Latin American countries mainly Argentina and Brazil adopted GMOs more vigorously with little resistance from the general people. Brazil and Argentina have recorded significantly large areas under GM since last 10 years. About 10 Latin American countries had approved GM crops, out of total 29 countries in 2011 and about half of all developing country GMO-adopters are Latin American (Katovich 2012). GM food debate reached to developing world from developed world after commercialization of first GM crops about 20 years back in USA. Almost the same group is fighting against the spread of GMOs in Africa who had poised strong opposition in Europe. Few NGOs and local civil society groups are resisting against GM banana developed in Uganda against banana leaf wilt. They have an argument that banana leaf wilt can be controlled by some other early available methods and the transgenic technology is still not proven to be safe (The Independent 2015).

Although many scientific researchers have showed that genetically engineered foods are safe but India is still waiting for its first GM food to be commercialized. Deregulation on Bt brinjal has been put on hold in 2010 by imposing moratorium while Bt cotton has been deregulated in 2002 in India. Many GM crops, food and non-food crops both are still in laboratory or in limited field trials level and ready for commercialization amid strong protests by some farmers associated with NGOs about its safety on human health and effects on biodiversity. Ideological beliefs, political reasons and lack of scientific knowledge are the major reasons for resistance to GMOs in many developing countries while psychology, emotions and politics are some of the reasons for opposition to adopt GMOs in developed countries.

Biotechnology industry in India has registered 15.08 % growth in 2012–2013 (ABLE INDIA 2013) while agricultural biotechnology is the third largest sector in Indian biotech industry (Business Standard 2013). This industry is considered as one of the key sector which will contribute to the socio-economic growth of the country. Several state governments are making sincere efforts to create a favorable environment to attract entrepreneurs to set up their units and leverage on the vast talent pool and rich biodiversities in the respective states. The infrastructure for research and development on genetically engineered crops is expanding every year. Government of India took major initiative in order to strengthen the infrastructure on biotechnology through Department of Biotechnology (DBT) under Ministry of Science and Technology. DBT funded numerous research projects on GM crops research and development which includes various universities and research institutions in every corner of India. Indian Council of Agricultural Research (ICAR) has sponsored project for research on genetic manipulation of 14 crops and functional genomics of 7 crops (Mishra and Shukla 2013). India has a comprehensive bio-safety regulatory system in place and pursuing aggressive research on genetically engineered crops. As many as seven Biotechnology Parks and Incubation Centres were established by DBT, Govt. of India (DBT, Government of India 2017) in different states have immense role in research, development and commercialization of GM crops in India and helping in translating biotechnology research to reach to Indian farmers. Many private companies also invested enormously on research and development of transgenic crops. Now, without any doubt GMOs are an integral part of many agricultural based commodities in every corner of the world, adding billions of dollars per year to the global economy, and being major income source for developed and developing countries including India.

2. STATUS OF GM CROPS IN INDIA

Genetically engineered cotton (popularly known as Bt cotton) for insect resistance has been released for commercial cultivation in India during 2002 by GEAC (Genetic Engineering Approval Committee), Government of India (GOI) and it has turn out to be a paradigm shift in Indian GM crop research, its deregulation and even for cotton industry in India. Cultivation and production of Bt cotton has grown exponentially since then and India has become second largest producer of cotton and leading exporter in the world (Choudhary and Gaur 2010). The GEAC cleared Bt brinjal for commercialization in October 2009 but following concerns raised by some farmers, anti-GM activists and scientists, the Government of India officially announced moratorium on 9 February 2010, and then Environment & Forest Minister Mr. Jairam Ramesh mentioned that there is no overriding urgency to introduce Bt brinjal in India and also reiterated that the government had only imposed a moratorium on the release of transgenic brinjal hybrid, and not a permanent ban (MoEF 2010). The report “Cultivation of Genetically Modified Food Crops – Prospects and Effects” prepared by the Parliamentary Standing Committee on Agriculture and tabled in Lok Sabha on 9th Aug, 2012 concluded that “GM crops are just not the right solution for our country” after raising various concerns over the potential and actual impacts of GM crops to our food, farming, health and environment (Lok Sabha 2012). This committee also emphasized that the government should not promote the views of the biotechnology and seed industry and in fact, Bt cotton has not improved the socio economic condition of cotton farmers in the country but further deteriorated especially in the rainfed areas of the country after consulting various stakeholders across the country.

Food grain production in India has increased to 241 million tonnes in 2010–2011 as compared to only 51 million tonnes in 1950 (Parwez 2013). India is largely an agricultural economy where almost 70 % of the working population is dependent on agricultural sector for employment and subsistence and the condition of farmers are very pathetic despite all these achievements. The story of Bt cotton producers are not so rosy as reported by several scientists and that too, if there is no clear evidence as yet that GM crops can actually increase yields then there is no urgent need to go ahead for commercialization of GM crops in India and need to develop new policy for ensuring food security in future without compromising the safety of human and livestock health and jeopardising the vast biodiversity (Chaturvedi 2012). The process of development, its potential benefits and deregulation of Bt Brinjal in India is the most debated issue till now. Recently, the GEAC (Genetic Engineering Appraisal Committee, since July 22, 2010) on July 18, 2014 has given approval for limited experimental field trials of GM rice, brinjal, mustard, cotton and chickpea for the sole purpose of generating biosafety data (The Hindu 2014). The current Modi government is a supporter of GM crops and former Environment Minister Mr Prakash Javadekar advocated his views and told to Reuters in February 2015 that “Field trials are already on because our mandate is to find out a scientific review, a scientific evaluation” (Reuters 2015). Recently, the GEAC recommended for commercial cultivation of GM mustard for clearance to Environment Minister (Indian Express 2017) but final decision is still pending. Present Indian Government is showing some interest to change the course on GM field testing and allowed for field trials of few GM crops last year but several State Governments are still not ready to embrace this technology (Kumar 2015). The Economic Survey for 2015–16, raised the safety concerns related to genetically modified (GM) and hybrid seeds and mentioned for more debate and tests so that their introduction is facilitated in the next few months. This survey also mentioned that the regulatory process needs to be evolved to address safety concerns of GM crops (The Hindu 2016). There is urgent need to improve agricultural productivity to ensure food and nutrition security for rapidly growing population. Thus, India should embrace GM technology to develop higher yield crops that are resistant to pests or grow well in droughts or harsh environments. Although, India is moving very slow to adopt this technology but resuming field trials for few crops indicates some bright future for several scientists working on transgenic crops research, evaluation and production (Kumar 2015).

Substantial increase in cotton production and improved socio-economic conditions of cotton growers in different states of India over the years after deregulation of Bt cotton is telling entirely different story. Promoters and many scientists advocating GM crops commercialization are emphasizing on this fact again and again. Transgenic Bt cotton has been commercialized in 2002, moratorium on Bt Brinjal in 2010 and many GM crops still in laboratory or containment facility indicates careful slacken progress and enormous gap amongst farmers, scientists and policy makers in India. Farmers growing Bt cotton have been benefiting largely and their socio-economic conditions has changed positively. As per an estimate, approximately 7.2 million farmers cultivated Bt cotton on 10.8 m ha equivalent to 93 per cent of India’s total 11.6 m ha cotton in the season of 2012 (James 2012). Approximate 40 million bales of cotton was produced in 2014 in India and becomes the world’s leading producer of cotton in 2014 after 13 years of deregulation and commercial release of Bt cotton in India (Choudhary and Gaur 2015).

A number of GM crops or transgenic crops carrying novel traits have been developed and released for commercial agriculture production with the rapid advances in biotechnology. GM crops are in different stages of development in many institutes in India since last two decades with a variety of traits. Under Networking project on Transgenic in crops, ICAR scientists are involved in research, monitoring of field trials and regulatory evaluation of GM crops (Meridian Institute 2003). More than 20 crops are under various stages of research and field trials for genetic modification in India, namely Cotton, Rice, Wheat, Maize, Brinjal, Potato, Sorghum, Mustard, Groundnut, Cauliflower, Okra, Chickpea, Pigeon pea, Castor, Sugarcane etc. for the traits insect resistance, herbicide tolerance, drought tolerance, salinity tolerance, virus resistance, quantitative traits (yield increase), nutrition improvement etc. (Mishra and Shukla 2013; FAO 2014; Gupta and Ahuja 2016) (Table 1). Current status of GM crops entered into the GMO regulatory system in India is summarized in Table 1. Few events of cotton, brinjal, mustard, maize and chickpea are in final stages of field trials and ready to be released commercially. The increasing cultivation of transgenic crops has raised several issues with respect to food safety, environmental effects, socio-economic issues and ethical issues. From the food and health perspective, the main concerns are related to possible toxicity and allergenicity of GM foods and products. Concerns about environmental risks of GM crops include the impact of introgression of the transgenes into the natural landscape, impact of gene flow, effect on non-target organisms, evolution of pest resistance and loss of biodiversity.

TABLE 1.

Status of GM crops entered into the GMO regulatory system in India.

S. No.	Crop	Trait	Event/Gene	Developer	Institutional Type	Status
1.	Cotton	Insect Resistance	MON531/cry1Ac	Monsanto	Private	Approved for environmental release
2.	Cotton	Insect Resistance	MON15958/cry1Ac	Monsanto	Private	Approved for environmental release
3.	Cotton	Insect Resistance	Event GFM/cry1Ac-cry1Ab	Nath Seeds	Private	Approved for environmental release
4.	Cotton	Insect Resistance	Event 1/cry1Ac	JK Agri Genetics	Private	Approved for environmental release
5.	Cotton	Insect Resistance	BNLA-601/cry1Ac	ICAR-CICR, Nagpur, UAS, Dharwad	Public	Approved for environmental release
6.	Cotton	Insect Resistance	MLS-9124/cry1Ac	Metahelix	Private	Approved for environmental release
7.	Cotton	Insect Resistance & Herbicide Tolerance	MON15985 x MON88913	Mahyco	Private	Confined field trials for BRL-II
8.	Cotton	Insect Resistance	cry1F gene, cry1Ac gene	ICAR-CICR, Nagpur	Public	Event selection trials
9.	Cotton	Insect Resistance	cry1Ac gene in G. arboretum; cry1Ac gene in G. barbadense; cry1Ac gene in G. herbaceum cv. Jayadhar; cry1Ac and cry1F genes in G. hirsutum	UAS, Dharwad	Public	Event selection trials
10.	Cotton	Insect Resistance & Herbicide Tolerance	MON 15985 x COT102 (BGIII), MON 15985 x COT102 x MON 88913 (BGIII RRF), COT102	Monsanto	Private	BRL-I trials
11.	Cotton	Virus Resistance	cp gene of TSV	Mahyco	Private	Confined field trials for event selection
12.	Cotton	Herbicide Tolerance	cp4epsps gene	Mahyco	Private	Confined field trials
13.	Cotton	Herbicide Tolerance	GHB614/2mEPSPS	Bayer Bioscience	Private	BRL-II trials
14.	Cotton	Insect Resistance	Event 281–24-236 & Event 3006–210-23/cry1F & cry1Ac	Dow Agroscience	Private	BRL-II trials
15.	Cotton	Water Use Efficiency and Nitrogen Use Efficiency	ipt and AlaAt gene	Mahyco	Private	Confined field trials for event selection
16.	Cotton	Insect Resistance & Herbicide Tolerance	GHB119 (Cry2Ae/PAT) x T304-40 (Cry1Ab/PAT) x GHB614 (2mEPSPS) x Cot102 (vip3A)	Bayer Bioscience	Private	Confined field trials for BRL-I
17.	Cotton	Herbicide Tolerance	synthetic EPSPS gene	Metahelix	Private	Application for event selection trials is under investigation
18.	Cotton	Insect Resistance	cry1Ac gene	Metahelix	Private	Application for event selection trials is under investigation
19.	Brinjal	Insect Resistance	EE-1	Mahyco/TNAU/UASD/IIVR	Public-Private	Moratorium
20.	Brinjal	Insect Resistance	Event-142/cry1Fa1	Bejo Sheetal	Private	BRL-II trials
21.	Brinjal	Insect Resistance	cry1Fa1, cry2Aa, stacked cry1Fa1 and cry2Aa	Global Transgenes	Private	Event selection trials
22.	Brinjal	Insect Resistance	ANK-19 event/Cry1Fa1 gene	Ankur Seeds	Private	BRL-I trials
23.	Brinjal	Insect Resistance	Cry1Fa1 gene	Rasi Seeds	Private	Event selection trials
24.	Mustard	Agronomic Performance	Event bn 3.6 and modbs 2.99/barnase, barstar and bar genes	CGMCP, University of Delhi	Public	Recommended by GEAC for environmental release but kept pending for further review
25.	Maize	Insect Resistance	MON89034	Monsanto	Private	BRL-I trials
26.	Maize	Herbicide Tolerance	NK603	Monsanto	Private	BRL-II trials
27.	Maize	Insect Resistance	MON 89034 x NK603	Monsanto	Private	Confined field trials
28.	Maize	Herbicide Tolerance & Insect Resistance	TC1507/cry1F, TC1507 (DAS-01507–1)	Dow Agro Sciences	Private	Confined field trials for BRL-I
29.	Maize	Herbicide Tolerance & Insect Resistance	TC1507xNK603	Pioneer Overseas Corporation	Private	BRL-II trials
30.	Maize	Herbicide Tolerance & Insect Resistance	TC15017xMON810xNK603	Pioneer Overseas Corporation	Private	BRL-I trials
31.	Maize	Insect Resistance & Herbicide Tolerance	Bt11, GA21 and Bt11 x GA21	Syngenta Biosciences	Private	Confined field trials
32.	Maize	Insect Resistance & Herbicide Tolerance	TC1507 x MON 810 x NK 603 (DAS-01570–1 x MON-00810–6 x MON-00603–6)/cry1F, cry1Ab and cp4epsps genes	Pioneer Hi-Bred	Private	BRL-I trials
33.	Maize	Herbicide Tolerance	cp4epsps	Metahelix	Private	Confined field trials for event selection
34.	Maize	Insect Resistance & Herbicide Tolerance	cry1F and synthetic EPSPS gene	Metahelix	Private	Application for event selection trials is under investigation
35.	Maize	Insect Resistance & Herbicide Tolerance	cry1Ab and synthetic EPSPS gene	Metahelix	Private	Application for event selection trials is under investigation
36.	Wheat	Salt Tolerance	OsNHX1 gene	Mahyco	Private	Confined field trials for event selection
37.	Wheat	Herbicide tolerance	event MON 71800/cp4epsps gene	Mahyco	Private	Confined field trials
38.	Cauliflower	Insect Resistance	Event CFE4	Sungro Seeds	Private	Confined field trials
39.	Okra	Insect Resistance	cry1Ac gene	Mahyco, Sungro Seeds	Private	Confined field trials
40.	Potato	Reduced Cold Induced Sweetening	KChipInvRNAi-2214	CPRI, Shimla	Public	BRL-I trials
41.	Potato	Agronomic Performance	GA20 Oxidase 1gene	CPRS – CPRI, Jalandhar	Public	Confined field trials for event selection
42.	Potato	Fungal Resistance	RB gene	CPRI, Shimla	Public	Event selection trials
43.	Groundnut	Drought Tolerance	rd29A gene (DREB1A)	ICRISAT, Hyderabad	Private	Confined field trials for event selection
44.	Rice	Insect Resistance and Herbicide Tolerance	dual Bt (Cry1Ab & Cry1Ca) and bar genes, Cry1Ab & Cry1Ca and Cry 2 Ad gene	Bayer Biosciences	Private	Confined field trials for event selection
45.	Rice	-	-	BASF	Private	Elite event selection trials
46.	Rice	Nutritional Enhancement	ferritin gene	Department of Botany, University College of Science, University of Calcutta	Public	Event selection trials
47.	Rice	Salt Tolerant	OSnhx1 gene	Mahyco	Private	Event selection trials
48.	Rice	Water use efficiency	ipt gene	Mahyco	Private	Event selection trials
49.	Rice	Nitrogen use efficiency	AlaAt gene	Mahyco	Private	Event selection trials
50.	Rice	Insect Resistance	cry1Ab (DG) gene	Devgen Seeds & Crop Technology	Private	Event selection trials
51.	Rice	Drought and Salinity tolerance and Nutrition stress	-	Bioseed Research	Private	Confined field trials for elite event selection
52.	Rice	Insect Resistance	cry2Aa2	Rasi Seeds	Private	Confined field trials for event selection
53.	Rice	Drought and Salinity tolerance	B6 and C15/gly I and gly II	Bioseed Research	Private	BRL-I trials
54.	Rice	Drought Tolerance	T I-3 and T I-5/DREB, LEA-11, LEA-20 and LEA-21/lea	Bioseed Research	Private	BRL-I trials
55.	Rice	Hybrid Rice SPT Maintainer	Os-MSCA1, Zm-AA1,DsRed2	Pioneer Overseas Corporation	Private	Confined field trials for event selection
56.	Rice	Insect Resistance	Cry1Ab and Cry2Ad genes, Cry1C and Cry1Ab genes	Pioneer Overseas Corporation	Private	Event selection trials
57.	Rice	Insect Resistance	cry1Ab and cry1Ac, cry1Ab	Metahelix	Private	Confined field trials for Event selection
58.	Rice	Insect Resistance	JKOsE081/cry2Ax1 JKOsE016/cry1Ac JKOsE081xE016/cry2Ax1 and cry1Ac	JK Agri Genetics	Private	BRL-I trials
59.	Rice	Herbicide Tolerance	event OS_A17314/cp4epsps gene	Mahyco	Private	BRL-I trials
60.	Golden Rice	Nutritional Enhancement	GR-2	ICAR-IIRR Hyderabad, IARI New Delhi, TNAU Coimbatore	Public	Confined field trials
61.	Chickpea	Insect Resistance	-	AAU Jorhat	Public	Confined field trials
62.	Chickpea	Insect Resistance	SSL-3/cry1Ac	Sungro Seeds	Private	Confined field trials
63.	Chickpea	Insect Resistance	SSL-6/cry2Aa	Sungro Seeds	Private	BRL-I trials
64.	Chickpea	Insect Resistance	cry1Ac/cry1Aabc	ICAR-IIPR, Kanpur	Public	Confined field trials for event selection
65.	Pigeonpea	Insect Resistance	cry1Ac/cry1Aabc	ICAR-IIPR, Kanpur	Public	Confined field trials for event selection
66.	Sorghum	Insect Resistance, Drought and Salinity Tolerance	Event-4/19	ICAR-IIMR, Hyderabad	Public	Confined field trials
67.	Sorghum	Drought Tolerance	-	CRIDA, Hyderabad	Public	Event selection trials
68.	Castor	Insect resistance	Cry1EC and Cry1Aa genes	ICAR-IIOR, Hyderabad	Public	Confined field trials for event selection
69.	Sugarcane	Insect Resistance	cry1Ac gene	Sugarcane Research Institute, UPCSUR, Shahjahanpur	Public	Confined field trials for event selection

Source: Compiled from GEAC meetings minute, geacindia.gov.in, nbpgr.ernet.in, Mishra & Shukla, 2013 and Choudhary et al., 2014

3. REGULATIONS

India is a signatory of Cartagena Protocol on Biosafety and established Biosafety Clearing House (MoEF&CC 2017) and other institutions required to assess biosafety issues associated with GM crops. Cartagena Protocol on Biosafety describes biosaftey regulations for LMOs in detail and suggests the biosafety requirements for GM crops research and its role during commercialization and deregulation process. In India, regulation for biotechnology products was started in 1982 when The National Biotechnology Board was established for forming biotechnology safety guidelines to undertake biotech research in laboratory (Chaturvedi 2004). Later on, National Biotechnology Board was converted into Department of Biotechnology (DBT) under the Ministry of Science and Technology in 1986 (Sharma et al. 2003). Biodiversity conservation and environment protection comes under MoEF by the Government of India (Allocation of Business) Rules 1961. MoEF initiated the regulation of genetically modified organisms and their products under the existing Environmental Protection Act 1986 (EPA 1986), which was enacted by the Parliament of India in 1986 (Kolady and Herring 2014). After this, MoEF drafted and notified ‘the rules for the manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells in 1989ʹ referred as the EPA Rules 1989 under ‘hazardous substances’ section of the EPA 1986 (MoEF Notification 1989).

The regulation of all activities related to GMOs and products derived from GMOs in India is governed by Rules, 1989 under the provisions of the Environment Protection Act (EPA), 1986 through the Ministry of Environment, Forest and Climate Change (MoEF&CC) (MoEF and BCIL, New Delhi 2015). Multi-tiered regulatory framework to assess and ensure biosafety of GM crops work under the MoEF&CC and Department of Biotechnology (DBT) of Ministry of Science and Technology, Government of India through six competent authorities: The Recombinant DNA Advisory Committee (RDAC), The Review Committee on Genetic Manipulation (RCGM), The Genetic Engineering Appraisal Committee (GEAC), Institutional Bio-safety Committees (IBSC), State Biotechnology Coordination Committees (SBCC) and District Level Committees (DLC) (Mishra and Shukla 2013; MoEF and BCIL, New Delhi 2015) (Figure 1). The roles and functions of each of these committees have been elaborated in the Rules 1989. The Genetic Engineering Appraisal Committee (GEAC) is the highest body constituted in the Ministry of Environment, Forest and Climate Change under ‘Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989ʹ, under the Environment Protection Act, 1986. GEAC acts as a statutory body in India for review and approval from environmental angle of activities involving large scale use of GMOs and their products in research and development, industrial production, environmental release and field application (MoEF&CC 2016). Three important legislations enacted by the Parliament of India for regulation of GM crops development, environmental release and approval for commercialization. These included the Environment Protection Act 1986 administered by MoEF&CC, the Seed Act 1966 & the Seeds (Control) Order by Ministry of Agriculture and the Food Safety and Standard Act 2006 under the Ministry of Health and Family Welfare (Choudhary et al. 2014).

FIGURE 1.

Regulatory framework for GM crops in India.

India has ratified the Cartagena Protocol in 2003 which requires a setting up of a regulatory body. Currently, the GEAC under the Ministry of Environment, Forests and Climate Change is responsible for approval of genetically modified products in India. Government of India is in the process of establishing Biotechnology Regulatory Authority of India (BRAI) for quicker realization of modern biotechnology products to Indian farmers (PIB, Government of India 2011). This new authority will be able to made efficient single window system for GM crops research, safety issues and regulatory measures. The Biotechnology Regulatory Authority of India (BRAI) bill was introduced in Lok Sabha in 2013 to set up an independent regulatory authority for regulation of organisms and products of modern biotechnology including GMOs (PRS Legislative Research 2013). This BRAI will regulate the research, transport, import, containment, environmental release, manufacture, and use of all biotechnology products and all the approval will be granted through a multi-level process of assessment undertaken by scientific experts (Lok Sabha 2013). Presently, the BRAI bill has been lapsed (PRS Legislative Research 2013) and expected to be produced again after substantial revisions under current government.

4. CHALLENGES AND WAY FORWARD

Rapid research, development and commercialization of GM crops in past few years has also generated considerable concerns with regard to their potential impacts on the environment, biodiversity and consequently on the human and animal health. Biosafety concerns, impact on environment and ethical issues are some of the major challenges for GM crops research and deregulation in entire world including India. Several news articles, reports, and documentaries have been published by media on safety of GMOs on regular basis. Ecological risk assessment of transgenic crops, issue of gene flow, development of secondary pest resistance and ecological risks involved with pollen flow are some of the issues which should be addressed before release of any GM crop for open field trials and commercialization (Craig et al. 2008). Biosafety issues should be addressed at all the stages of development and release of GM crops on a case-to-case basis. It is essential to have robust biosafety guidelines to evaluate the GM crops and need to be addressed at all the stages of development and release of transgenic crops. Since, many transgenic crops are being developed and released for open field trials and commercial cultivation regularly; concerns have been raised about the potential risks associated with their impact on environment, biological diversity and human health. Assessments of environmental risk of GMOs have been performed extensively worldwide during the last decade and extensive risk assessment framework has been formulated. There are many important traits introduced into plants and urgent need to address their impact on agriculture and agricultural practices in several countries. Gene flow from GM crops, factors affecting gene flow, consequences of gene flow and transfer of traits to wild weedy relatives from genetically engineered crops must be explored extensively before release of any crop for commercialization. Many environmental issues related to genetically modified crops have been studied and discussed by scientists and policy makers thoroughly since the release of first transgenic crop for commercial cultivation in 1980s. These include effects of transgenic crops on biodiversity, gene flow, out-crossing, invasiveness, weediness, horizontal gene transfer, effect on non-target organisms, and evolution of virulent strains of pests and impact on soil microorganisms (Tsatsakis et al. 2017). However, many issues are still being debated because the potential long term cumulative effects are difficult to predict (Bhalla et al. 2007). Horizontal gene transfer is one the biggest concerns among all the ethical issues related to GMOs. Novel gene in an organism could be a source of potential harm to the human health or the environment (Prakash et al. 2011). Introduced gene from GM crops may confer a novel trait in another organism such as the transfer of antibiotic resistance genes to a pathogen has the potential to compromise human or animal therapy (Bennett et al., 2004).

There is relatively very little research has been conducted on the long-term effects on human health and environment because GMO technology has been available for such a short period of time. The greatest danger lies not in the effects that we have studied, but in those which we cannot anticipate at this point. Some new proteins which have never been ingested before by humans are now part of the foods that people consume every day and their potential effects on the human health are as of yet unknown. The use of transgenic plants or genetically modified organisms is a practice still in its infancy. The long-term effects of this technology are yet to be seen, and thus we must proceed with caution as we develop our practices and guidelines. Well planned, systematic research, development, exchange and commercialization of transgenic crops after addressing all the concerns pertaining to the environment followed by regular post-release monitoring to evaluate the long-term impacts would be required to sustain the biodiversity and to harness the benefits of genetically modified crops.

Current research and development in crop biotechnology in India is focused on the development of biotech food, feed and fiber crops that can contribute to higher and more stable yields and also enhanced nutrition. Rice being the major staple food, the research on genomics of rice is being pursued aggressively for conferring biotic and abiotic stress. Field trials with Bt rice are already underway. Nutritional quality improvement and reduction of post harvest losses particularly in fruits and vegetables through delayed ripening gene is also a major research area. Several transgenic crops developed by public sector are already in field trials and 85 different plant species for various traits are under different stages of experiments for the development of genetically engineered crops in India (Warrier and Pande 2016). After commercial release of Bt Cotton in 2002, there was rapid increase in research on Bt technology and as a result different foreign genes were deployed in Brinjal, Cabbage, Cauliflower, Tomato, Lady’s finger, Rice, Corn and Groundnut for many beneficial traits (Mishra and Shukla 2013; Warrier and Pande 2016). These crops are being evaluated under confined field trials except Bt brinjal which is facing moratorium as of now. Political leaders, scientists as well as technocrats in India have noticed these opportunities, and they are now routinely endorsing the potential contributions that biotechnology - including transgenic crops - might make to agricultural productivity, growth and poverty reduction in the years ahead. Many top leaders in India have endorsed the value of agribiotechnology in general, and treasury resources have even been allocated to promote GM crop research within India’s national agricultural research system. But there are also few expert opinions and a report on GM crops by parliamentary standing committee recommends that introducing transgenics in agriculture is not a sustainable way forward to achieve a food security in coming years in India (Chaturvedi 2012). Critics of GM crops were able to work within India’s open and democratic political system to push for a precautious or even a preventive approach toward GM crops instead, especially in the area of biosafety policy. Urbanization and industrial growth diminishes the available arable land rapidly. Increasing the agricultural productivity by second green revolution can only solve the problem of food and nutrition security in India.

Requirement of NOCs from State Governments to conduct field trials of GM crops, illegal cultivation of HT cotton and resistance developed by pink boll worm to Bt cotton are important challenges for GM crops during and post deregulation process. GEAC has introduced the requirement of NOC (No Objection Certificate) from the State Governments to conduct field trials since agriculture is state subject. Many State Governments have declined to issue NOC despite of approval of GEAC. Government is working to establish the Notified Field Trial Sites (NFTS) in all agro-climatic regions to resolve this issue of NOC requirements. Meanwhile, GEAC in its 130th meeting in August 2016 has exempted the NOC requirements from State Governments for Event Selection Trials (ESTs) (GEAC, MoEF&CC 2016). Few reports emerged about illegal cultivation of herbicide-tolerant (HT) cotton in the States of Telangana and Andhra Pradesh (Times of India 2018). GEAC has not approved any HT cotton event for commercial use. DBT constituted a Field Inspection and Scientific Evaluation Committee (FISEC) to examine the extent of illegal cultivation of HT cotton in India (GEAC, MoEF&CC 2018). Though respective State Governments have been advised to take required action but the necessary guidelines and precautionary measures will be issued after FISEC report submission. Development of resistance by pink boll worm to BGI and BGII cotton pose a serious challenge to researchers and regulators about application of GM technology in agriculture. Several incidence of damage to bolls and yield loss in Bt cotton have been reported from Gujarat in last few years (Kranthi 2015). Bt cotton Bollgard-II contains cry1Ac & cry2Ab gene for effective control of pest. Planting a refuge crop around the cotton crop could delay the resistance as suggested by regulators and scientists. It is imperative to develop new product for farmers affected with pink boll worm resistance and also remind us that GM technology is not the very effective solution for all agricultural problems.

Despite several challenges, the futures of genetically modified crops look promising in India. Many developing countries, especially the Asian countries are expected to plant GM crops next 2–3 years. Currently, many genetically engineered crops are in final stages of development in India and scientists are looking towards government anxiously for policy change and approval for commercialization. GM crops is not a panacea but they have the potential for achieving food security targets and make a substantial contribution for poverty alleviation in developing world by increasing crop productivity on limited resources. The world will have to produce 70% more food, feed and biomass on about the same area of land by 2050 (FAO 2009). Increasing population, urbanization, income and dietary preferences in developing countries requires extraordinary steps to intensify agriculture production to meet the growing demand by substantially increasing crop yield and optimizing the use of input resources (Choudhary et al. 2014).

5. CONCLUSION

The wide advantages of transgenic crops for a society to solve food security or nutrition security issues have been well established. Many added benefits such as higher nutritional value, herbicide tolerance, virus resistance, tolerance to various abiotic stresses, increase the shelf life of a fruit and thus, can account for a good market for farmers. There is an urgent need for India to carry on its GM crop research program to sustain its food and nutrition security targets. Debate on GM crops about safe or unsafe will never end although there is hardly any substantial scientific evidence against safety of GM foods. Surprisingly, few public sector intuitions also showed their concerns for GM foods. Intuitions funded by GOI should follow same broad policies of Indian Government and must show their strength with the government to fight poverty and malnutrition. This valid point is raised due to opposite views of the members of Technical Expert Committee appointed by the Supreme Court of India for Safety and Guidelines for GM crop research and make recommendations for future of GM crop research in India. Although, this is a fact that India does not have basic infrastructure and stringent guidelines for GM crop research and risk assessment but taking in to account India,s urgent need, we cannot halt this program. Ideally, India must continue on its research on GM crop and its deregulation along with building basic infrastructure facilities and preparing stringent biosafety and marketing guidelines. Although portals like GEAC, IGMORIS (Indian GMO Research Information System), Biosafety Clearing House are doing their role for assessing biosafety and their regulation of GM crops but there is an urgent need to build a single window system and online portal for assessment, control, regulations and approval of GM crops. It should become mandatory for every company and public sector institutions to register themselves with this portal whenever they develop any event for transgenic development and starting their field trials before submitting for approval. Every new transgenic event under development must show their registry number and date of registry with a website or online portal specifically designed to obtain approval in any country for marketing. This portal should also contain publication list associated with the development of any specific genetically modified crop so that any individual who have an interest in any GM crop development event can get all the details at single place along with its current status. This type of portal will be very useful and public friendly for making positive effects among people at large for GM food research, safety of GM foods and its present status.

Acknowledgments

The authors would like to thank the support and encouragement received from Maj. Gen. K.K. Ohri, Pro Vice-Chancellor, Amity University Lucknow Campus and Mr. Aseem Chauhan, Chairperson, Amity Lucknow, for providing necessary facilities and assistances.