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The new Indian Plants Protection Bill And the Gene Revolution. 
Dr. A.D.Damodaran



1.           As part of  discharging India's obligations under TRIPS, the new Bill giving effective protection for newly bred plant varieties has been passed by both houses of parliament and this has in turn also received the assent of the president. In other words, from now onwards  the Intellectual Property Rights aspects of the newly developed plant breeds in India will be governed by the concerned clauses of the above Bill, be they developed by the conventional hybridization techniques, nuclear techniques or newly emerging by the state-of-art biotechnological techniques.India implemented the celebrated Green Revolution and equipped herself self sufficient in food under the overall IP umbrella of a ' plants not  patentable' legal frame work. If India has to implement a Gene Revolution to meet the huge additional food demand by the quarter of the century, this program will have to be regulated for IPR compatibility as per clauses enlisted in the Bill.

2.            A quick review of the world patents literature indicates that there are already over 150 patents granted under the keyword "genetically modified plants", the last one being even as late as this month ! When viewed that India is yet to have her own contributions in this area of agricultural research, one can understand the vast Technology Gap existing in this field , whatever be her ability to understand and appreciate the intricacies of this newly emerging knowledge-product revolution.

3.            Importantly enough , though through the connivance of allegedly unscrupulous traders, the Indian farmer has already tasted the flavour of the Bt cotton ; undoubtedly the legal violation must be curbed and punished, but then there cannot be undue delay in solving the problem as well. The estimated cotton crop losses are estimated at Rs 1,300 crores  and according to senior agricultural scientists like Vinay Kumar, Vice Chancellor of Haryana Agricultural University, a situation has reached where there is no alternative to the introduction of Bt cotton. The Indian scientific-bureaucratic-legal structures will have to bear the brunt and come clean at the earliest in line with the writings on the wall and that of the international scenario.

4.            Patentmatics.com wishes to highlight the issues connected with this impending Gene Revolution and as part of this , we give below the following article from Business Line, November 23,2001.

Genetically modified plants -- Biological intervention, the answer 
Ashok Chaudhury 

GENETICALLY modified (GM) or transgenic plants will play an important role in Indian agriculture. The situation unquestionably calls for an integrated approach for sustainable agricultural development, as no single option will provide an answer. One of the solutions, scientists agree globally, is biotechnological intervention, which can play a vital role in not only increasing the crop yield but also improving the nutritional quality. 

Plant breeders have been improving traditional crop varieties through hybridisation of diverse germplasm and selection for better performing varieties. However, self-incompatibility and species barrier has been a limiting factor in many crop plant improvement programmes. With the advent of molecular biology and genetic engineering techniques, it is now possible to isolate, clone and transfer genes of agronomic importance across species. This technique has not only enabled precise transfer of one or two genes from one species to another but also hastens the over-all process of crop improvement. Recent innovations in biotechnology have led to a revolution in modern agriculture worldwide. 

Adopting adequate strategies for harnessing biotechnology research will ensure increased production of foodgrains, both quantitatively and qualitatively, as well as milk and animal products. There is a definitive need for biotechnological intervention in Indian agriculture. Numerous field trials of transgenic plants worldwide for increased crop production through insect resistance, herbicide tolerance, nutritional improvement, oil quality and plants as a factory for edible vaccines are being conducted. 

The Green Revolution, ushered in the late 1960s, has certainly transformed the country from a state of foodgrain importing to that of self-sufficiency. However, with our burgeoning population, the achievements of the Green Revolution are proving to be insufficient to feed our teeming millions. Injurious farm practices that are commonly in use have damaged the cultivated land through water and wind erosion, compaction, salinisation, and water logging. The extent of the forest reserve is a sad mismatch between desirable levels and the actual ground reality. Over-tillage rapidly depletes prime agricultural lands. Very little quality land is available to increase the area under farm production today. 

It is, therefore, not surprising that India would need to import an estimated 45 million tonnes of 
foodgrains to meet the basic requirements of food by 2030. There is a little doubt that agricultural research will have to be rejuvenated to meet the increasing demands of farm production. To achieve this, there will have to be a paradigm shift from the methodologies of the 1970s and 1980s. Radical changes will have to be made in the very thought processes that go into planning for the needs of the new century. Conservative and obsolete policies drawn for an older era will have to give way to realistic measures that reflect the urgency of the demand for availing technological breakthroughs that are available to us. The success of the Green Revolution of the earlier decades will now have to be repeated through a Gene Revolution. 

In addition to increasing the total useful biomass in plants, improving or creating resistance to insects, pests, and microbes, value-addition to crops through suitable alteration of carbohydrate profile, addition of specific amino acids and vitamins, modification of fatty acid profile to meet the dietary requirements of humans and animals, elimination of certain biosynthesised products harmful to animals, enhancing the shelf-life of fruits and vegetables, and enhancing production of certain metabolites are some of the options that have been made possible by successfully employing biotechnology tools. 

Vaccines can now be efficiently administered to the needy population through their incorporation in a common fruit such as banana. 

While pursuing greater productivity, we need to redesign the crop and be able to add value to the farm produce so as to make agriculture more rewarding to farmers. A revitalised Indian agriculture can be the engine of growth in the new millennium, and biotechnology might be the best fuel for this. When deployed sensibly and with responsibility, biotechnology can be a major benefit to our society. 
Several protest groups are confusing farmers and consumers alike on the inherent social, ethical and environmental risks being posed by genetic modifications and consuming foods from such modified plants. One should not forget that every human activity has inherent risks. Be it the use of electricity, nuclear power or even the use of new drugs and vaccines, or driving a car or flying in an airplane, all have certain perceived and real risks. Public acceptance of these risks is driven by the perception of the risk rather than the physical reality. Deadly chemicals continue to be manufactured even after the Bhopal leakage, and nuclear power plants using radioactive material churn out megawatts of power, despite the Chernobyl debacle. 

It is interesting to note that in 1996 the acreage under transgenic plants was 1.7 million hectares, in 1999 over 45 countries from the US to China, including Canada, Argentina, Brazil, and India, had planted transgenic crops on over 39.9 million hectares while in 2000 more than 44.2 million hectares were planted. Exhibiting thereby, more than 25-fold increase in total area under transgenic crops worldwide. The global market for GM products has grown rapidly from $75 million in 1995 to $2.1-2.3 billion in 1999, crossed $3 billion in 2000 and is expected to reach $8 billion by 2005. 

Globally, over 3,647 field trials of GM crops were conducted, of which 796 were in Western Europe and the rest in the US, Canada, Latin America and Asia. Genetically modified foods worth billions of dollars, ranging from cheese to tomato and soybean, are being consumed in all these countries (besides Japan and Australia), and there has not been even one report of adverse effects either to human health or to an animal from the use of such products. 

Recently, some protest groups have been claiming that the transgenic plants generated have antibiotic resistance markers which are highly toxic and may cause allergenicity in people consuming GM food thereof. The presence of a suitable marker is necessary to facilitate the detection of genetically modified plant tissue during development. These genes have no intentional function in the genetically modified organism or in any products derived from it. Marker genes in genetically modified plants are almost exclusively of two types: Genes conferring antibiotic resistance and those conferring herbicide tolerance. The most widely used selectable marker is a bacterial gene for neomycin phospho transferase (NPTII), an enzyme that inactivates a number of related aminogycosidic antibiotics including kanamycin. After the introduction of constructs containing the NPTll gene into plant cells, kanamycin is applied to kill non-transformed tissue. Transformed cells expressing NPTII gene are protected from the effects of the antibiotic and, using appropriate plant tissue culture media transgenic plants are regenerated. Extensive experimentation to demonstrate that the potential for compromising the efficacy of kanamycin or neomycin for therapeutic use in humans or animals by consuming the food and feed products derived from GM plants is effectively negligible owing to the following reasons: 

The transfer of the NPTll gene from GM plant to gut microflora is extremely unlikely because there is no evidence that such transfer can occur. This conclusion is supported by studies, which demonstrate that horizontal gene transfer from plants to microbes did not occur under a variety of test conditions. 
The expression of the NPTll gene in GM plant is under the control of a plant-specific promoter, which is not expected to function in bacteria. 

Even if expressed in intestinal bacteria, antibiotic therapy would not be compromised, as the co-factors necessary for the enzyme to inactivate kanamycin and neomycin are not present at the required concentration range in the gut. The NPTII protein would be rapidly degraded in the gut. 
The ideal situation would be to develop strategies to remove a selectable marker from a transgenic plant before commercialisation. However, now strategies have been developed to generate marker-free transgenic plants which rely on high transformation efficiencies and which will allow the removal of the selectable marker gene by several methods. Numerous companies engaged in seed/agricultural biotechnology have a major role to play by keeping up their research efforts as also by disseminating information about the same. They need to soften their stand on royalty issues. 
The relation between research institutes and industry needs to be strengthened for realising full commercial benefits through clear economic analysis of the benefits of adopting of the transgenic crops. The role of the media must be one of balanced reporting that is based on scientific data rather than on sensationalism. They should elaborate on giving technically correct information rather than on sensational reporting. 

The mainstream population will have to be necessarily involved and duly communicated to without hype or false hope. Scientists who are developing genetically modified crops and the new opportunities that they foster are the fountainhead of evolving knowledge and hold primary responsibility for its effective dissemination. 

Policy-makers, administrators, legislators, judiciary, industry, farmers, and the media will each have to play an active role in safeguarding societys interests by their participative decision-making. We should not be swayed by the European stand of resisting GM crops, in India our priorities are altogether different.