Bt-Crops

Biosafety of Bt-Crops Safe Transition

Introduction

Insect pest management in agriculture is important to safeguard crop yields and productivity. A large number of chemical insecticides that effectively control insect pests have been proven to be harmful to human health and environment. There is a need to reduce the dependence on pesticides by using safer alternatives to manage insect pests. Many insecticidal proteins and molecules are available in nature, which are effective against agriculturally important pests but innocuous to mammals, beneficial insects and other organisms. Insecticidal proteins present in the soil borne bacterium, Bacillus thuringiensis (Bt), which has demonstrated its efficacy as a spray formulation in agriculture over the past five decades, have been

expressed in many crop species with positive results (Kumar et al., 1996). Bt-transgenic crop species (cotton, corn, rice, tomato and potato) have been commercialized with substantial benefits to the farmers (Kumar 2003). Bt crops were cultivated in an area of 32.1 million hectares out of the global transgenic area of 102.0 million hectares in 2006 (James 2006).

Bacillus thuringiensis

Bt is a gram-positive, aerobic, endospore-forming bacterium belonging to morphological group I along with Bacillus cereus, Bacillus anthracis and Bacillus laterosporus. All these bacteria have endospores. Bt, however, is recognized by its parasporal body (known as the crystal) that is proteinaceous in nature (see figure above) and which possesses insecticidal properties. The parasporal body comprises of crystals varying in size, shape and morphology. The crystals are tightly packed with proteins called protoxins or-endotoxins. There are many subspecies and serotypes of Bt with a range of well-characterized insecticidal proteins or Bt toxins (-endotoxins). At present it has been estimated that over 60,000 isolates of Bt are being maintained in culture collections worldwide. Known Bt toxins kill subsets of insects among the Lepidoptera, Coleoptera, Diptera and nematodes. The host range of Bt has expanded considerably in recent years due to extensive screening programs. Currently more than 140 different genes encoding Bt toxins have been cloned.

Mode of action

The Bt toxins exert their toxicity by forming pores in the larval midgut epithelial membranes. Initially the protoxins are activated in the midgut by trypsin-like proteases to toxins (see figure below). The active toxins bind to specific receptors located on the apical brush border membrane of the columnar cells. Binding is followed by insertion of the toxin into the apical membrane leading to pore formation (see figure below). The formation of toxin-induced pores in the columnar cell apical membrane allows rapid fluxes of ions. Different studies revealed that the pores are K+ selective, permeable to cations, anions or permeable to small solutes like sucrose,

irrespective of the charge. It appears that the toxin forms or activates a relatively large aqueous channel in the membrane. The disruption of gut integrity results in the death of the insect from starvation or septicemia.

Applications of Bt

The first practical application of Bt dates back to 1938 when it was sold as 'Sporeine' in France for the control of European corn borer. The growing realization that organic insecticides are deleterious to the environment and human health spurred a renewed interest in Bt in the 1960s, which led to the introduction of viable Bt biopesticides like Thuricide and Dipel. Bt is the most popular biological control agent with worldwide sales of about $100 million. Bt spray formulations comprise 5% of total global pesticide market. The use of conventional Bt biopesticides, however, was found to have limitations like narrow specificity, short shelf life, low potency, lack of systemic activity, and the presence of viable spores. An elegant and most effective delivery system for Bt toxins is the transgenic plant. The major benefits of this system are economic, environmental, and qualitative. In addition to the reduced input cost to

the farmer, the transgenic plants provide season-long protection independent of weather conditions, effective control of burrowing insects difficult to reach with sprays and control at all of the stages of insect development. The important feature of such a system is that only insects infesting the crop are exposed to the toxin.

Introduction and expression of Bt genes in crop plants conferred significant protection against target pests. The first transgenic Bt-crops viz., cotton, corn and potato were commercialized in USA in 1995 and 1996. Currently more than a dozen countries cultivate Bt-crops. Bt-cotton was permitted for commercial cultivation in India in 2002. Biosafety Safety of Bt toxins in terms of toxicity and allergenicity towards mammals and other non-target organisms is well documented (Glare and O'Callaghan, 2000). The salient features are: Lack of receptors that bind to Bt toxins and instant degradation of Bt toxins in human digestive system make them innocuous to human beings. Community exposure to Bt toxins/spray formulations over a period of six decades has not resulted in any adverse effects. Lack of homology to any allergenic protein/epitope sequences makes Bt toxins non-allergenic. Consumption of foods derived from Bt corn, potato, tomato and rice over the past one decade has not led to any adverse effects in the populations. Consumption of foods derived from Bt corn, potato, tomato and rice over the past one decade has not led to any adverse effects in the populations. Federation of Animal Societies of USA (2001) observed that Bt crop products (corn) fed to chicken-broilers, chicken-layers, catfish, swine, sheep, lactating dairy cattle and beef cattle did not show any adverse effects on growth, performance, observed health of the animals and composition of meal, milk, eggs, etc., Dairy cows fed with corn and Bt-corn did not exhibit any significant differences in lactation and ruminal fermentation Bt, Bt-sprays, Bt-crops and Bt-crop products are safe to non-target organisms such as soil microorganisms (protozoa and fungi) collembola, molluscs, crustaceans, spiders, aquatic insects, predators, parasitoids, arthropods, honey bees, lady bird beetles, earthworms, salamanders, bird species, small and large mammals, etc. Benefits of Bt-crops The International Service for the Acquisition of Agri-biotech Applications (ISAAA) conducted a detailed survey of the Bt-cotton cultivation, adoption and performance in eight countries (USA, Australia, China, India, Mexico, Argentina, South Africa and Indonesia) in 2002 (James, 2002). All the countries that have introduced Bt cotton have derived significant and multiple benefits. These include increases in yield, decreased production costs, a reduction of at least 50% in insecticide applications resulting in substantial environmental and health benefits to small producers, and significant economic and social benefits. In a recent study at Indian Institute of Management (Ahmedabad), Gandhi and Namboodiri (2006) observed that cotton farmers in major cotton-growing states such as Gujarat, Maharashtra, Andhra Pradesh and Tamil Nadu were benefited significantly. On a global basis, the benefits from the deployment of Bt cotton between 1998 and 2001 were estimated to be $1.7 billion. Surveys conducted among small resource-poor farmers in developing countries, mainly in China and South Africa, revealed that Bt cotton contributed to reduction in poverty by increasing incomes of small farmers. The environmental benefits of cultivating pest-resistant transgenic crops are more profound and invisible. These are enumerated below: Reduction in use of pesticides: The estimated total savings of insecticides on Bt cotton in 2001 was of the order of 10,627 MT, which is equivalent to 13% of the 81,200 MT of all insecticides used on cotton globally in 2001. Fewer insecticides in aquifers and the environment: The substantial decrease in insecticides associated with the cultivation of Bt cotton has led to significant decrease in insecticide run off into watersheds, aquifers, soils and generally into the environment. More widespread global cultivation of Bt-cotton will further improve the water quality. Reduced farmer exposure to insecticides and improvement of human health: Substitution of the chemical insecticides with Bt cotton has clearly reduced the risks to farm workers and to others in the farm community who may be exposed to the former’s toxicity. These effects are particularly important in developing countries where modern application techniques are neither always adopted nor available for use. Increased populations of beneficial insects: The global use of broad spectrum insecticides on cotton has adversely affected and decreased the populations of non-target species including the arthropod natural enemies that can provide effective control of non-lepidopteran pests. Various studies confirmed that the arthropod natural enemy populations in Bt cotton are greater than in non-Bt cotton. In addition to reducing the number of sprays for the bollworm/budworm complex, Bt cotton has also reduced the number of sprays for other insects such as thrips and aphids. This effect has been attributed to higher populations of beneficial predators and parasitic insects that are eliminated by insecticide sprays. Reduced risk for wildlife: Reduction in the use of insecticides, many of which are highly toxic to wildlife will reduce the risks to mammals, birds, bees, fish and other organisms. Many birds are dependent on insects for food and their elimination through the use of insecticides deprives birds of their food source. Reduced fuel and raw material consumption and decreased pollution: Lowering the demand for insecticides through the use of Bt cotton reduces tractor fuel usage as a result of reduction in number of sprays, which in turn reduces air pollution. For example, in the Hebei Province of China, where adoption of Bt cotton increased dramatically from its introduction in 1997 to 97% in 2001, farmers have noticed a substantial improvement from the chronic air, soil and water pollution levels prior to the introduction of Bt cotton in 1997, caused by the intensive spraying of cotton with insecticides. The ecological benefits of cultivating Bt-crops were recently documented in a comprehensive manner by Sanvido et al. (2006). According to this study cultivation of Bt corn and Bt cotton resulted in significant environmental benefits. In conclusion, Bt crops are safe and beneficial to farmers, human society, non-target organisms, biodiversity and environment in general. References Dale, P. J., Clarke, B. and Fontes, E. M. G. 2002. Potential for the environmental impact of transgenic crops. Nature Biotechnology. 20: 567-574. Gandhi, V. P. and Namboodiri, N. V. 2006. The adoption and economics of Bt-cotton in India. W.P. No. 2006-09-04, IIM, Ahmedabad Glare, T. R. and O'Callaghan, M. 2000. Bacillus thuringiensis: Biology, Ecology and Safety. John Wiley, Chichester. James, C. 2002. Global review of commercialized transgenic crops: 2001. Feature: Bt-cotton. ISAAA Brief No. 26, ISAAA, Ithaca. James, C. 2006. Global status of commercialized Biotech/GM crops. ISAAA Brief No. 35, ISAAA, Ithaca. Kumar, P. A., Sharma, R. P. and Malik,. V. S. 1996. Insecticidal proteins of Bacillus thuringiensis. Advances in Applied Microbiology. 42:1-43. Kumar, P. A. 2003. Insect pest-resistant transgenic crops. In: Advances in Microbial Control of Insect Pests, Upadhyay, R. K. Ed. pp. 71-82. Kluwer Academic, New York. Sanvido O, Stark M, Romeis J and Bigler F, 2006. Ecological benefits of genetically modified crops. Swiss Expert Committee on Biosafety, Federal Department of Economic Affairs, Switzerland.

DNA Banking Genetic Interest

DNA Banking Genetic Interest

Low Cost, Generic Molecular Markers for Breeding and Research

The enormous diversity of world's flora and fauna has been the mainstay of human survival and well being. Genetic resources, comprising useful living organisms, fulfil our basic needs of food, shelter and clothing; provide valuable medicines, spices and materials for industrial products; and help in maintaining and ameliorating the environment. Genes available in wild plants and animals are being constantly used by breeders to improve yield, quality and nutritional value of crops and farm animals. India is fortunate to have a high and varied diversity of flora. The country possesses 11.9% of the recorded

world's plants including 49,219 higher plant species. India is homeland of 167 cultivated species and 329 wild relatives of crop plants. It has about 30,000 to 50,000 indigenous land races of cultivated plants. Over the last about 30 years, increasing concern is being expressed over the loss of biodiversity due to human and natural factors. Consequently, worldwide efforts are being made towards conservation of wild and cultivated genetic resources. There are two approaches to plant genetic resources conservation: In-situ conservation which refers to the maintenance of plant populations in the habitat where they naturally occur and evolve. Biosphere reserves and heritage sites are examples of in-situ conservation strategy. Ex-situ conservation is done outside the natural habitat or outside the production area, in facilities called genebanks, specially created for this purpose. Methods of ex-situ conservation include storage of seeds in genebanks at subzero temperatures, maintaining in vitro cultures under slow growing conditions and immersion of tissues, embryos or seeds in liquid nitrogen (cryopreservation), or maintenance of whole plants in field genebanks.

DNA banking

Another form of biological resource that offers tremendous opportunities of practical and academic value is the DNA. In fact, the concept of DNA as a genebank resource has emerged out of the revolution in genomic information brought about by the analysis of DNA extracted from numerous plant species in laboratories across the world. DNA may also be available as amplification products of polymerase chain reaction based experiments. Other biotechnology experiments require construction of DNA libraries, i.e. collection of segments of DNA containing several copies of the part of genome. These include clones of cDNA, cosmid, PAC (plasmid-derived artificial chromosomes), BAC (bacterial artificial chromosomes), YAC (yeast artificial chromosomes) etc. All these DNA forms are being envisioned as an important resource since the DNA can be utilized for several applications, viz. characterizing the source material, understanding genetic and evolutionary relationships between taxa, functional analysis of genes, comparative genomics and plant breeding. Thus, while so far DNA samples have been accumulating in molecular biology and biotechnology laboratories as a spin-off of ongoing projects, the realization of its vast potential has prompted the consideration of DNA collections as a genetic resource. DNA bank is a particular type of genetic resource bank that preserves and distributes the DNA samples and provides associated information.It must be mentioned here that at present we do not have technology to raise plants from DNA, and DNA banks cannot replace conventional seed genebanks, in vitro repositories or cryobanks. Hence, DNA banking is considered a complementary conservation strategy that together with other conservation strategies leads to an optimum and sustainable use of genetic diversity.

DNA storage

DNA is generally extracted from young growing leaves but can also be obtained from seeds in genebanks and herbarium specimens. The quality of DNA extracted depends upon the condition of the specimen before storage, the storage environment and the duration of storage. Standard protocols are available for DNA extraction, which involve removal of other cellular components while maintaining the integrity of DNA. The protocols need to be suitably modified for different species. Commercial DNA extraction kits, though expensive, are highly efficient in yielding good quality DNA. DNA is a highly stable molecule; degradation kinetics models suggest that fully hydrated DNA kept at room temperature takes about 10,000 years to depolymerise into small fragments. However, degradation due to presence of endonucleases and other cellular components in the extracted DNA can considerably hasten the process of degradation. With increasing fragmentation of DNA template, it's utility for providing useful information decreases progressively. Studies suggest that purified DNA dissolved in buffer, stores well up to 1-2 years at 40C, 4-7 years at -180 C and more than 4 years when stored at -800 C. It has been found that purification procedures used to remove degrading agents and PCR inhibitors may shear the DNA and also remove proteins that stabilized DNA tertiary structure. Long-term stability of extracted DNA is not fully studied. However, when dried, the extracted DNA shows greater stability. An alternative approach is to store cells and tissues rather than purified DNA, which avoids the uncertainties about the stability of DNA. Further, stored cells and tissues have added advantage of providing a continuous supply of DNA and enabling biochemical and molecular studies of living cells. In any case, it is not recommended that a DNA extract will exist in a bank without the original plant sample from which it has been extracted. Depending upon the available facilities, the reference sample may be in the form of a live plant in field repository, a propagule conserved in a genebank which can be recovered into a full plant, or a herbarium specimen.

DNA banks around the world

While DNA extraction is a routine activity of numerous laboratories working in diverse areas of genetics, biochemistry, molecular biology and biotechnology, DNA banking is not widespread. A recent worldwide survey by International Plant Genetic Resources Institute (now Bioversity International) revealed that of the 274 respondents from 77 countries, 51 (21%) stored DNA while the rest did not. The survey revealed that the majority of institutes do not store DNA due to budget constraints, insufficient infrastructure and lack of trained human resources. However, more than half of the above respondents indicated that they would consider DNA storage if the above constraints are removed. Some of the major plant DNA banks already operational in different parts of the world are:

1. Australian Plant DNA Bank, Lismore, Australia (http://www.biobank.com) 2. DNA bank, Instituo de Pesquisas, Jardim Botanico de Rio deJaneiro, Brazi (http://www.jbrj.gov.br/pesquisa/div_molecular/bancodna/sobre_ing.html ) 3. Missouri Botanical Garden, Missouri, USA (http://www.welbcenter.org/dna_banking.html) 4. Royal Botanic Gardens, Kew, Surrey, Great Britain (http://www.kew.org/data/dnaBank/homepage.html) 5. South African National Biodiversity Institute DNA Bank, Kirstenbosch, South Africa (http://www.sanbi.org/frames/researchfram.html)

The DNA Bank at Royal Botanical Gardens, Kew (U.K) contains nearly 23,000 samples of plant genomic DNA stored at -800 C. The bank has a large collection of orchid DNA samples and samples of rare and endangered species. The DNA extraction protocol includes a standard CTAB-chloroform extraction with ethanol precipitation and washing, followed by cleaning with caesium chloride/ethidium bromide gradient. The samples are clean enough to be stable at ambient temperature for several days, and for about 10 years under -800 C storage. The Missouri Botanical Garden stores dried samples of plant material, usually young leaves, in a walk-in freezer maintained at -200 C. The International Rice Genome Sequencing Project is a consortium of 10 countries devoted to sequencing, functional analysis of genes and isolation of genes for important agronomic traits in rice. The DNA bank of National Institute of Agrobiological Sciences (Ibaraki, Japan) preserves, manages and provides access to the materials generated by the project for use of researchers throughout the world.

Opportunities for DNA banks

There are a number of areas in which DNA banks could make an impact in the near future. Most promising possibilities in this context are:

Germplasm characterization and management: Detailed characterization of germplasm using a combination of phenotypic and molecular markers improves genebank management in several ways. It allows 1) detection of gaps in collections, identification of duplicates and redundancy, 2) provides valuable knowledge about molecular diversity, genetic and evolutionary relationships, and 3) allows identification of unique genotypes of special importance to genebanks and breeders. Marker-assisted selection: An important new role for genebanks having DNA samples of germplasms is the application of molecular techniques to identify genes controlling specific traits in collections of cultivated species and wild relatives DNA barcoding: Global efforts are underway to produce DNA barcodes of all the plant species on earth. DNA banks would greatly facilitate such efforts by providing the required species DNA and thus avoiding the need for undertaking expensive and time- consuming collection trips of depleting rare herbarium specimens. Exchange of genetic resources: It will be a lot easier to exchange genetic resources as DNA samples, rather than seed or vegetative propagules. Transboundary movement of seed and other planting material requires time consuming inspection and certification for freedom from pests and diseases. Exchanging DNA samples, on the other hand, avoids the need for time consuming and costly certification procedures.

A novel method of DNA distribution has been developed recently whereby DNA clones or PCR products are pasted directly on the pages of books for distribution to users. The National Institute of Agrobiological Sciences, Japan in collaboration with RIKEN Institute, Japan has constructed a DNA book for rice containing 32,000 clones. The DNA can be extracted from the paper and analysed for various purposes.DNA banking could constitute a complementary conservation strategy for safeguarding the genetic diversity of a crop's genepool, especially if combined with in vitro conservation or

cryopreservation. DNA banks can also serve as back up or safety duplicates of the physical seed, field or in vitro collections, in case of catastrophic losses.

Limitations of DNA banks

Though holding lot of promise and potential for future compilation, management, storage and referencing of earths genetic resources DNA Banking is faced with its own set of limitations. Methodologies: Several species with high concentrations of polysaccharides, proteins, tannins and lipids in cells pose problems in extraction of DNA of acceptable purity. Relatively short life span of DNA is another limitation necessitating frequent replacement of DNA samples. Plant recovery: DNA banking cannot be considered as a substitute for conventional conservation strategies since technologies for regeneration of plants from stored DNA have not been developed so far. Resource and policy: The cost of establishing and operating a DNA laboratory can be quite prohibitive for some genebanks due to resource limitations. The ready availability of DNA extraction chemicals and other consumables, liquid nitrogen and unlimited power supply may be a problem at some locations. It is obvious that the use of marker technologies in genebank management requires significant additional funding and policy support. Intellectual property rights: Material Transfer Agreements (MTA) which regulate the usage and intellectual property rights (IPRs) of material transferred are specially designed for exchange of seed or vegetative propagules and do not consider IPR issues in the event of exchange of DNA samples. Given the concerns in the developing world about the protection of rights on its biodiversity, there is a need for adequate safeguards against the infringement of IPRs while exchanging DNA samples.

Conclusions

It is envisaged that DNA banks would develop as strategic components of genebanks providing basic information for improved genebank management and facilitating germplasm characterization and utilization. They would serve as a reference basis for evolutionary and comparative genomics studies and DNA barcoding. This, however, will require a proactive approach involving policy and financial support for not only establishment and operation of DNA banks, but for capacity building in molecular biology, genomics, bioinformatics, modern genetic resources management and Web-based networking tools.

Indian Biotech Market Panorama

Panorama

The Indian biotechnology sector is projected to cross the US $ 2 billion mark during 2006-07. Although this answers for only a little more than 1% share of the global biotech pie, the encouraging sign is that the sector is riding on a healthy growth rate of over 35% annually over the last five years. The prognosis is good and consensus among industry leaders and policy makers is that, with proper fiscal and policy initiatives, the sector could easily scale the US $ 25 billion figure by 2015

There are today about 300 biotech companies in India with the top 10 accounting for 50% of the revenue generated, and R&D investment of the top five exceeding US $ 300 million. Geographically, the biotech companies have developed in three major clusters across the country. The largest in terms of revenue generated is the western cluster (Ahmedabad, Aurangabad, Mumbai and Pune), followed by the southern cluster (Bangalore, Chennai and Hyderabad) and the northern cluster (Delhi, Gurgaon and Noida). Exports stood at Rs 2,001 crores and contributed to 42.17% of the total business with bio-pharma products currently contributing to 73.15% of the exports. Domestic business accounted for Rs 2,744 crores. The key opportunity segments are: bio-pharmaceutical (vaccines, therapeutics, diagnostics) bio-agri (transgenics, biofertilizers, biopesticides) bio-industry, bio-informatics and bio-services (R&D, clinical trials, and manufacturing on contract). The bio-agri segment registered the highest growth rate during the year at 154%, followed by bio-services (54.6%), bio-industry (34.55%), bio-pharma (30%) and bio-informatics (25%).

Several factors have contributed to the current upbeat feeling about India's biotech sector. Among the strengths we can count are our wealth of biodiversity; a sizeable English-speaking scientific workforc, robust IT base, reasonably good infrastructure network, well-positioned pharma industry, strong MNC presence, and a large, diverse, therapy-naïve population with varying gene pool.             The Government, both at the centre and in the states, has provided several fiscal and other incentives to the sector in terms of tax holidays, capital subsidies, creation of biotech parks, special economic zones, incubators etc. Besides the Department of Biotechnology (DBT), which is the major supporter of R&D related to biotechnology, the Department of Science & Technology

(DST), Council of Scientific & Industrial Research (CSIR), Indian Council of Agricultural Research (ICAR), and Indian Council of Medical Research (ICMR), all fund public sector research in life sciences and biotechnology Private firms can approach DST's Technology Development Board (http://www.tdbindia.org/), which offers soft loans with minimum interest, DBT's Small Business Innovation Research Initiative (http://dbtindia.nic.in/SBIRI/SIBRI_main-F.html), which funds early/late stage research, or CSIR's New Millennium Indian Technology Leadership Initiative program (http://www.csir.res.in/csir/external/heads/collaborations/NM.pdf) that was set up to boost public-private partnerships. India's IPR regime has become fully TRIPS compliant to promote innovation. A single-window biotech regulatory authority is on the anvil to ensure a science-based efficient process.

Indian biotech companies have not only been resourceful in leveraging various financing opportunities from both domestic and international sources but also proactive in establishing and maintaining collaborations and partnerships in India and abroad. They have also aimed to become competitive by patenting products and technologies on a global basis.

However, much still needs to be done if India is to assume its rightful role in the global bioeconomy. The draft National Biotechnology Development Strategy (prepared by DBT after nearly two years of consultations with all stakeholders) has identified a number of issues that require urgent attention in the quest to create a favorable and enabling environment for enterprise creation and private sector development. Some of the issues that need to be urgently translated into policies and actions are: a) creating a pool of technologically skilled human resource in adequate numbers; b) capacity building in areas such as IPR management, technology transfer and clinical trials etc.; c) creating institutions with a new ethos for seamless conversion of knowledge into products and processes; d) greater support to industry, specially small and medium sector enterprises; e) putting in place a world class regulatory system and ensuring adequate training for regulatory personnel.

In short, we need to build a culture of innovation and enterprise from the bottom up with complementary help from top down.

Agri Biotechnology

Agri Biotechnology

Agribiotechnology - Harvesting the Potential
The agriculture biotechnology space has grown in the past five years as witnessed in increasing number of private sector and public sector projects. The investment in the sector has also shifted to some extent from purely application-oriented research to a mix of basic and applied research. Birth of several biotechnology companies who are catering to and providing specialized research services to seed companies who lack in-house research facilities demonstrates the growing opportunities agribiotechnology.

  After its introduction in India in 2002, the acreage under Bollgard cotton expanded from 72,000 acres to projected 14 million acres in the 2007 planting season. The annual increment in acreage in the 2005 to 2006 season has shown a 177% increase with enhanced yields at a minimum of 45% over non-technology products. This has led to an overall cotton production increase by 13263K quintals of seed cotton, additional

 2730K bales of lint, additional income for the farmers from the crop and its byproducts such as cotton  oil and feed, and associated savings in farm labor costs. These trends have been witnessed in the next  growing season as well. This surpasses all previous adoption rates for any product.

 Bollgard cotton has demonstrated significant benefits as a result of adoption of appropriate technology  by Indian farmers. Other technology products being developed include insect tolerant rice, eggplant, okra, pigeonpea and many other crops. The second generation products reflect the ability to address more complex traits such as abiotic stresses like drought and salinity.

The realization that agriculture will benefit significantly with the use of molecular tools in addition to genetically enhanced crops is also leading to greater investments in high-throughput molecular marker/diagnostic facilities.

Assured by a well defined and stringent regulatory system, private sector companies look to the coming years with optimism for biotechnology products. With a few more success stories like the Bollgard cotton, the Indian agribiotechnology sector is set to fly high.
 

New and Emerging Transgenic Crops

India had realized several years back that to sharply increase food, feed and fiber production from the current level, use of biotechnology is imperative. Several institutions under the Indian Council of Agricultural Research and Council for Scientific and Industrial Research are actively applying biotechnological tools to enhance productivity and quality of agricultural crops. Besides, a number of institutions, notably state agricultural universities, traditional universities and other R&D organizations are funded by DBT through extramural grants to support research on transgenic crops.

          The commercial cultivation of transgenic cotton, field evaluation of mustard for heterosis breeding, development of Bt eggplant and protein-rich potato has yielded very encouraging results. Acreage under Bt cotton cultivation doubled in 2003 and stood at 3.8 million ha in 2006 in comparison to China's acreage of 3.5 million ha thus moving India to the fifth position in global ranking ahead of both China and Paraguay. The major states growing Bt cotton presently in order of area coverage are Maharashtra, Andhra Pradesh, Gujarat, Madhya Pradesh, Karnataka and Tamil Nadu

  Pulses are important ingredients of Indian food and the country accounts for 90% and 73% of world's pigeonpea and chickpea production respectively. Therefore, priority is being given for developing transgenic pulse crops resistant to pod borer and other biotic stresses. In other crops such as rice, potato, eggplant, tomato, sorghum, and cauliflower, transgenics are being developed on a fast track in both public and private sector institutions.

Majority of developments in crop biotechnology are presently being carried out by public sector institutions. Some private sector organizations, in collaboration with MNCs, are making efforts to develop and commercialize transgenics. The Bt strategy has been predominantly targeted by institutions for insect-pest resistance in several crops. Efforts are also being made by public sector institutions to develop major crops

DNA Markers based Purity Certificates for Basmati Exports

Basmati rice is a very special type of aromatic rice known world over for their extra long grains, and pleasant and distinct aroma. Traditional Basmati rice is not only in great demand in the domestic markets, but is also seen in the menu of connoisseurs worldwide creating a staggering billion-dollar export market. Authentic Basmati rice cultivation is confined to Indo-Gangetic regions of the Indian sub-continent.

Consumer preference for Traditional Basmati label not only yields high returns but even attracts duty exemption in some markets.

Evolved Basmati varieties developed by breeders to adopt intensive cultivation fell short of quality traits of Traditional Basmati and hence fetch a fractional profit. With the presence of relatively inferior non-aromatic long grain rice varieties, it is difficult to differentiate genuine traditional Basmati from pretenders. Importing countries gradually lose interest in adulterated consignments thereby hurting Basmati trade. Thus, to protect the interests of consumers and trade, precise identification of genuine Basmati rice samples and devaluation of adulterated samples becomes vital. Till recently, there was no established high throughput protocol to do so

Researchers at Centre for DNA Fingerprinting and Diagnostics (CDFD) at Hyderabad have developed a capillary electrophoresis based methodology along with a multiplex microsatellite marker assay for detection as well as quantification of adulteration in Basmati rice samples. The single-tube assay generates variety-specific allele profiles that can detect adulteration from 1% upwards. The protocol also incorporates a quantitative-competitive PCR based analysis for quantification of adulteration. Accuracy of quantification has been shown to be ±1.5%.

Purity certificates based on DNA tests are issued to export samples. This accomplishment showcases how advancement in Indian biotechnology has contributed to maintaining the quality of Basmati, the pride and heritage of the country.

Biofuels

Biofuels

Breathing New Fire

Self sufficiency in energy requirement is critical to the success of any growing economy. With increasing energy consumption, dependence on fossil fuels will necessarily have to be reduced. Being the fifth largest energy consumer, India imported nearly 70% of its crude oil requirement (90 million tonnes) during 2003-04. Estimates indicate that this figure would rise to 95% by 2030

India has rich biomass resources which can be converted into renewable energy. The Planning Commission, Govt. of India, has launched an ambitious National Mission on Biodiesel to be implemented by a number of government agencies and coordinated by the Ministry of Rural Development. The Mission focuses on the cultivation of the physic nut, Jatropha curcas, a shrubby plant of the castor family. The seed contains 30-40% oil and can be mixed with diesel after trans-esterification. Initially Jatropha cultivation will be demonstrated on 0.4 m ha of wasteland area across the country. The entire cost economics is dependant on the productivity, quality and performance of the raw material. The Government is also discussing a National Biofuel Policy.

DBT has been entrusted through a micro-mission with the task of developing technologies that convert fiber, starch and sugar from woody plants and agricultural wastes into useful biofuel products. The thrust is on developing ethanol using lignocellulosic waste as raw material, identifying recombinant microbial stains for enhanced ethanol recovery, producing high quality raw material for biodiesel production and developing the enzymatic trans-esterfication process for more efficient conversion of oil to biodiesel. For the first time, a systematic scientific survey, characterization and collection of superior accessions of J.curcas from across the country has been taken up. More than 1500 accessions have been collected and characterized. Nurseries have been established at 12 locations for providing quality planting material to the National Mission. Nearly 0.8 million quality plantlets have been planted over an area of 300ha. A special focus is being given to crop improvement and on genes involved in oil biosynthesis. Other 'petro-crops' being investigated include Karanja (Pongamia pinnata), toothbrush tree (Salvadora persica) and Mahua (Madhuca indica) 

With continued policy support and vigorous technology, biofuels could very soon be breathing new fire.

Indian Biotech Industry

Biotech Industry

Indian Biotech Industry: Regional spread
The Indian biotechnology industry is well spread across the length and breadth of the country. Several states such as Andhra Pradesh, Himachal Pradesh, Kerala, Tamil Nadu, Uttaranchal, Uttar Pradesh, and Rajasthan among others have adopted biotech policies and established biotech parks to promote the industry.

Bioclusters
There are over 300 companies that are into the biotech business across the country and another 140 companies that supply technology products to these biotech companies. 

Regional distribution of Biotech Revenue 

 The Southern biocluster is housed mostly in and around Bangalore, Hyderabad and Chennai. The heterogenous nature of the Southern cluster, which has companies ranging from the bioagri to bioinformatics to bioindustrial, has made it an attractive destination for companies to set shop here. The Western cluster is centered around Aurangabad, Ahmedabad, Mumbai and Pune, while companies in the North are primarily located in Delhi-Gurgoan-Noida region

Biotech Parks in India
Lucknow - Health Care, Agriculture, Environment, Industrial Applications, Energy Andhra Pradesh - Development and scale-up of bioprocesses and technologies Karnataka - Drugs and Pharma Punjab - Agribusiness and Certification of Export Goods Kerala - Traditional Medicines Himachal Pradesh - Medicinal and Aromatic Plants, Horticulture

 

Revenue Share. 

The Biocluster in the western region is the largest in terms of the revenue generated in financial year 2006 with companies like Serum Institute of India, Venkateshwara Hatcheries and Mahyco-Monsanto leading the way. In fact the Western region is the topper for the fourth year in a row with companies from the region grossing $718 million (Rs. 3234.42 crores) which is half of the national biotech share.

 The southern region continues to be second accounting for 36 percent of the industry revenues; they generated $526 million (Rs. 2367 crores) in FY 06. The prominent companies in this region include Biocon and Rasi Seeds, among others. Companies in the North generated a total revenue of $200 million (Rs. 919.46 crores) and contributed to 14 percent of industry revenues. Panacea Biotec, Eli Lilly and Ranbaxy are some of the major players from the North region.

Special Economic Zones in India

These are engines for economic growth supported by quality infrastructure and an attractive fiscal package with minimum possible regulations. They are expected to trigger a large flow of foreign and domestic investment for building infrastructure and increasing productive capacity thereby leading to generation of additional economic activity and creation of employment opportunities. The incentives and facilities offered to the units in SEZs include:-

Duty free import/domestic procurement of goods for development, operation and maintenance of SEZ units 00% Income Tax exemption on export income for SEZ units under Section 10AA of the Income Tax Act for first 5 years, 50% for next 5 years thereafter and 50% of the ploughed back export profit for next 5 years Exemption from minimum alternate tax under section 115JB of the Income Tax Act External commercial borrowing by SEZ units up to US $ 500 million in a year without any maturity restriction through recognized banking channels Exemption from Central Sales Tax and Service Tax Single window clearance for Central and State level approvals Biotech Companies in Biotech Parks allowed 5 year time-frame to meet export obligation norms under the SEZ scheme

India's Intellectual Property Regime Promotes Innovation

Fully TRIPS compliant patent regime provides for product patent protection in all fields of technology Patenting of new microbes and parts thereof (e.g. novel genes, constructs, vectors etc.) is possible Procedures simplified to make the system efficient and user-friendly IP Offices in Chennai, Delhi, Kolkata and Mumbai fully modernized and operational; website of IP offices (www.ipindia.nic.in) launched; online search facilities available through connectivity to international databases IP administration continuously upgraded vis-à-vis WIPO, EPO, JPO, Korean Patent Office, etc. Intellectual Property Appellate Board set up in Chennai to ensure speedy disposal of appeals against decisions of Registrar of Trade Marks New regime encourages investment in R&D from local sources as well as from abroad through joint ventures

Government to set up Biotech Industry R&D Assistance Council

Global experience indicates that innovation in biotechnology occurs in small and medium size enterprises (SMEs) with large industries then taking up manufacturing and marketing activities. However, for India to fulfill its potential and emerge as a strong global player in biotech sector, government's role as champion and catalyst is critical in ushering in an ecosystem that encourages innovation, competitiveness, investment and enterprise development. Public-private partnership is critical to the success of innovation. A seamless interface between academia and industry is essential.

       To stimulate and enhance innovation capabilities of the industry sector and to promote and sustain academia-industry interaction, the Government of India has envisaged the creation of Biotechnology Industry Research & Development Assistance Council (BIRAC). The council is expected to assist industry through a range of services. These are intended to 

access key resources and new technologies

offer testing and validation facilities

offer timely financial assistance

facilitate and promote industrial research through technology transfer and intellectual property management, technology acquisition and technology forecasting

In addition, a special cell would be designed to addresses the needs of training and capacity building of SMEs.

Health Biotech Sector

Health Care Health Biotech Sector - A Defining Moment Health Biotech Sector - A Defining Moment The first ever, independent survey of 21 homegrown health biotech firms in India (Frew SE, Rezaie R, Sammut SM, Ray M, Daar AS and Singer PA. 2007. India's health biotech sector at a crossroads. Nature Biotechnology 25 (4): 403-417, April 2007) has revealed that they are not only headed for future growth but also, in some cases, for developing innovative products for world markets. The interview based study found that while policies and support of the government and the expertise and efficiencies of the private sector have each contributed to the development of this sector, it is the creativity and astute management of the firms themselves that has been a crucial element of success. Lessons learnt The study provides the following valuable lessons for all developing countries wishing to strengthen their health innovation systems and for individual companies planning to develop or enhance their biotech capacity. Many local firms started small with one or a few familiar products and/or services to generate early revenues, and leveraged early success for later growth Firms have been resourceful in exploring various financial opportunities from both domestic and international sources, without having to surrender much equity Successful firms have proactively established and maintained collaborations and partnerships with both public and private organizations in India and abroad Firms are aiming to become more competitive by patenting their products and technologies globally. At the national level, they have been able to capitalize on the domestic policy of emphasizing process patenting over product patenting to build strong capabilities on generics manufacturing Successful Indian firms have been able to establish and maintain favourable reputations internationally Barriers to success However, the survey also pointed out several obstacles that are hindering the development of the health biotech sector: Delays in commercialization caused by multiple regulatory agencies Shortage of advanced training programmes and scarcity of qualified personnel Overall lack of public-private collaionboration Few Indian academics show entrepreneurial ambition in biotech Dearth of financial resources and burdening bureaucracy Lack of national prioritization diverts focus from domestic health needs High cost associated with domestic distribution

Recommendations for development
On the basis of the study, the authors made six recommendations to
encourage continued growth of the sector:

• Harmonize pharmaceutical regulatory system into one regulatory agency and ensure adequate training for regulatory personnel
• Increase training programmes in advance biotech through a single agency for science mentoring and guidance
• Ensure translation of initiatives in the draft Biotech Strategy into policies that increase effective public-private collaboration and encourage academic scientists to pursue entrepreneurial ventures to commercial research
• Create a favourable and enabling financial environment for enterprise creation and private sector development, including early stage research and product development
• Identify national priorities for public health and use a targeted funding approach to ensure development of products and services that address local health needs
• Improve public health infrastructure and/or give incentives to private firms to develop innovative distribution strategies

The findings of this survey will be of interest to biotech firms across the globe seeking partnerships with Indian firms, venture capitalists seeking investment opportunities, foundations interested in global health solutions and developing world governments seeking ideas about successful innovation strategies.

SPECIAL SUPPLEMENT

BOSTONMay 6-9, 2007
BIOPHARMA SECTOR IN THE COUNTRY

India: A New Hub for Clinical Research

Large, diverse and therapy-naïve population with varying gene pool

Low trial cost per unit patient

Suitable legislation in place

Clinical research extended to chronic diseases (e.g cardio, nephro, neuro, joints, reproduction etc.)

World Class Clinical Research Training and Translational Centres

Large number of CROs for initiating collaborative multinational trials

Clinical trial units coming up in medical colleges and pharma units