Concept of biotechnology

The term ‘Biotechnology’ may sound futuristic, but it is nearly as old as civilization itself. We have begun growing crops and raising animals 10,000 years ago to provide a stable supply of food and clothing. We have been using the biological processes of microorganisms for 6,000 years to make useful food products such as bread, cheese and to preserve dairy products. The term ‘biotechnology’ has been used to signify activities relating to biological process and technologies. Traditional biotechnology and its development processes were entirely experiential. It was aimed at understanding the mechanisms for improving every activity from farming to food processing. Early farmers selected particular plants to grow crops and saved their seeds for the following season. Over the years, they bred the varieties of seeds they found best and learned how to grow them more efficiently through techniques of irrigation and weed control. The process of choosing certain seeds for their expressed characteristics and learning how to irrigate and rotate the crops was the genesis of earlier days of biotechnology.

The expression ‘modern biotechnology’ can be differentiated form traditional use of biological process which was commonly termed as classical biotechnology. Even though biotechnology has been in practice for thousands of years, the technological explosion occurred only in the twentieth century. Various branches of science like physics, chemistry, engineering, computer application and information technology helped revolutionise the development of life sciences and it ultimately resulted in the evolution of modern biotechnology. Unlike classical biotechnology, modern biotechnology operates at the molecular level of life. It is modern in the sense that the techniques are applied mainly to cells and Molecules. Life at the molecular level is the same among every species from humans to bacterium. Every living thing on earth is built with molecules which are similar and there exists hardly any difference among humans, fishes, trees, worms and bacterium at molecular level. Only the deoxyribonucleic acid (DNA) coding is different among various species and it ultimately makes every living thing what it is.

The term biotechnology for the purpose of understanding can be divided in to two ‘bio’ and ‘technology’. ‘Bio’ means the use of biological processes and ‘technology’ means to solve problems or make useful products.  Biotechnology is a collection of many different technologies. It is a highly multidisciplinary subject. It involves the contribution of scientists from various fields like biology, chemistry, engineers, statisticians, mathematicians, and information technology. It also involves contributions from financial, legal, and managerial experts. It is a rapidly growing technological terrain, recognised by its significant contribution to life science research like the agricultural, medical and pharmaceutical sectors. In order to have a better understanding of the major issues raised by biotechnology, we must have some grasp of what biotechnology and bioscience are. The concepts and jargons frequently used in biotechnology are not familiar to legal researchers. This chapter makes an attempt to familiarise the common concepts and terminologies used in biotechnology for the better understanding of legal issues relating to biotechnology and research data protection.

The simple definition of ‘biotechnology’ is the commercialization of cell biology”. Biotechnology is an umbrella term that covers various techniques for using he properties of living organisms to make products or provide services. The Convention on Biological Diversity (CBD) defines biotechnology as: “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products for specific use.” This definition includes medical and industrial applications as well as many of the tools and techniques that are common in agriculture and food production.

The developments of modern biotechnology

The era of modern biotechnology is believed to have started with the discovery of the microscope. The path of genetic manipulation can be said to have started in 1665 when the English scientist Robert Hook published a review of some observations he had made while peering through a microscope. He saw tiny spaces surrounded by walls while he was observing samples of cork. He is the one who coined the word “cell.” Ten years later Anton van Leeuwenhoek designed the microscope with magnifying power as great as 270 times. He was the first person to observe and describe micro-organisms which he called “very little animalcules”. He was also the first person to observe the “bacteria” which according to him were twenty five times smaller than the blood cells. He also discovered the presence of sperms in semen in human and other animals.

Even though cells were found everywhere from plants to animals, nobody came up with the idea that the cells were fundamental to life. More than 70 years later, two Germen biologists Matthias Schleiden and Theodore Schwann introduced the cell theory which says that all living organism are made of cells. According to them cells are the basic structural and functional units of a living organisms. The research on cells further led to the discovery of deoxyribonucleic acid (DNA) which is believed to be the heart of life. The area of biotechnology developed as a result of man’s increasing desire to know the mechanisms that maintain living organisms.

The landmark moment in the history of science occurred on April 25, 1953 when James D. Watson and Francis Crick published “A Structure for Deoxyribose Nucleic Acid” in the journal, Nature. Watson and Crick, along with their colleague Maurice Wilkins, received the 1962 Nobel Prize in physiology and medicine for “their discoveries concerning the molecular structure of nucleic acids and its significance for information transfer in living material.

The discovery of double helix DNA structure was a huge controversy during that period. In fact the crystallographer Rosalind Franklin, who generated the legendary “photograph 51” using the X-ray diffraction photo, was the first one to reveal DNA’s double-helix structure. The controversy was that the Rosalind Franklin’s X-ray crystallography image, “photo”, was shown to Watson and Crick without her knowledge and consent. The image which actually indicated the doublehelix structure of DNA, was not the discovery of Watson and Crick which earned them the Nobel Prize. They could not have proposed their celebrated structure of the DNA without access to the experimental results obtained by Rosalind Franklin, particularly her crucial X-ray diffraction photograph. She was known as the dark lady of DNA.

The major development in medical biotechnology was the discovery and development of antibiotics. The first antibiotic was ‘moldy soybean curd’ used by the Chinese almost 2,500 years ago to treat skin infections. The Sudanese-Nubian civilization of Africa used a form of the same micro organism which created tetracycline as an antibiotic as early as 350 B.C.41 The traces of tetracycline have been found in human skeletal remains of ancient Sudanese Nubia. The distribution of tetracycline in bones was only understandable after exposure to tetracyclinecontaining materials in the diet of these ancient people. In the middle ages in Europe, tinctures made from plant extracts or cheese curds were used to ward off infection. The tetracycline as a large family of generic antibiotics was discovered as natural products by Benjamin Minge Duggar in 1948.

 

Biotechnology in agriculture

For about 10,000 years , farmers have been improving wild plants and animals through the selection and breeding of desirable characteristics. This breeding has resulted in the domesticated plants and animals that are commonly used in crop and livestock agriculture. In the twentieth century, breeding became more sophisticated, as the traits that breeders select for include increased yield, disease and pest resistance, drought resistance and enhanced flavor. Traits are passed from one generation to the next through genes, which are made of DNA. All living things—including the fruits, vegetables and meat that we eat—contain genes that tell cells how to function. Recently, scientists have learned enough to begin to identify and work with the genes (DNA) that are responsible for traits.

Agricultural biotechnology is a collection of scientific techniques used to improve plants, animals and microorganisms. Based on an understanding of DNA, scientists have developed solutions to increase agricultural productivity. Starting from the ability to identify genes that may confer advantages on certain crops, and the ability to work with such characteristics very precisely, biotechnology enhances breeders’ ability to make improvements in crops and livestock. Biotechnology enables improvements that are not possible with traditional crossing of related species alone.

Technological aspects of agricultural biotechnology

Genetic engineering

Scientists have learned how to move genes from one organism to another. This has been called genetic modification (GM), genetic engineering (GE) or genetic improvement (GI). Regardless of the name, the process allows the transfer of useful characteristics (such as resistance to a disease) into a plant, animal or microorganism by inserting genes (DNA) from another organism. Virtually all crops improved with transferred DNA (often called GM crops or GMOs) to date have been developed to aid farmers to increase productivity by reducing crop damage from weeds, diseases or insects.

Molecular markers

Traditional breeding involves selection of individual plants or animals based on visible or measurable traits. By examining the DNA of an organism, scientists can use molecular markers to select plants or animals that possess a desirable gene, even in the absence of a visible trait. Thus, breeding is more precise and efficient. For example, the International Institute of Tropical Agriculture has used molecular markers to obtain cowpea resistant to bruchid (a beetle), disease-resistant white yam and cassava resistant to Cassava Mosaic Disease, among others. Another use of molecular markers is to identify undesirable genes that can be eliminated in future generations.

Molecular diagnostics

Molecular diagnostics are methods to detect genes or gene products that are very precise and specific. Molecular diagnostics are used in agriculture to more accurately diagnose crop/livestock diseases.

Vaccines

Biotechnology-derived vaccines are used in livestock and humans. They may be cheaper, better and/or safer than traditional vaccines. They are also stable at room temperature, and do not need refrigerated storage; this is an important advantage for smallholders in tropical countries. Some are new vaccines, which offer protection for the first time against some infectious illnesses. For example, in the Philippines, biotechnology has been used to develop an improved vaccine to protect cattle and water buffalo against hemorrhagic septicemia, a leading cause of death for both species.

Tissue culture

Tissue culture is the regeneration of plants in the laboratory from disease-free plant parts. This technique allows for the reproduction of disease-free planting material for crops. Examples of crops produced using tissue culture include citrus, pineapples, avocados, mangoes, bananas, coffee and papaya.

Biofertilizers

Biofertilizers are defined as preparations containing living cells or latent cells of efficient strains of microorganisms that help crop plants’ uptake of nutrients by their interactions in the rhizosphere when applied through seed or soil.  They accelerate certain microbial processes in the soil which augment the extent of availability of nutrients in a form easily assimilated by plants.

Very often microorganisms are not as efficient in natural surroundings as one would expect them to be and therefore artificially multiplied cultures of efficient selected microorganisms play a vital role in accelerating the microbial processes in soil.

Use of biofertilizers is one of the important components of integrated nutrient management, as they are cost effective and renewable source of plant nutrients to supplement the chemical fertilizers for sustainable agriculture. Several microorganisms and their association with crop plants are being exploited in the production of biofertilizers. They can be grouped in different ways based on their nature and function.

Different types of biofertilizers 

Rhizobium

Rhizobium is a soil habitat bacterium, which can able to colonize the legume roots and fixes the atmospheric nitrogen symbiotically. The morphology and physiology of Rhizobium will vary from free-living condition to the bacteroid of nodules. They are the most efficient biofertilizer as per the quantity of nitrogen fixed concerned. They have seven genera and highly specific to form nodule in legumes, referred as cross inoculation group.

Rhizobium inoculant was first made in USA and commercialized by private enterprise in 1930s and the strange situation at that time has been chronicled by Fred.

Initially, due to absence of efficient bradyrhizobial strains in soil, soybean inoculation at that time resulted in bumper crops but incessant inoculation during the last four decades by US farmers has resulted in the build up of a plethora of inefficient strains in soil whose replacement by efficient strains of bradyrhizobia has become an insurmountable problem.

Azotobacter            

Of the several species of Azotobacter, A. chroococcum happens to be the dominant inhabitant in arable soils capable of fixing N2 (2-15 mg N2 fixed /g of carbon source) in culture media.

The bacterium produces abundant slime which helps in soil aggregation. The numbers of A. chroococcum in Indian soils rarely exceeds 105/g soil due to lack of organic matter and the presence of antagonistic microorganisms in soil.

Azospirillum

Azospirillum lipoferum and A. brasilense (Spirillum lipoferum in earlier literature) are primary inhabitants of soil, the rhizosphere and intercellular spaces of root cortex of graminaceous plants.

They perform the associative symbiotic relation with the graminaceous plants.   The bacteria of Genus Azospirillum are  N2 fixing organisms isolated from the root and above ground parts of a variety of crop plants. They are Gram negative, Vibrio or Spirillum having abundant accumulation of polybetahydroxybutyrate (70 %) in cytoplasm.

Five species of Azospirillum have been described to date A. brasilense, A.lipoferum, A.amazonense, A.halopraeferens and A.irakense.  The organism proliferates under both anaerobic and aerobic conditions but it is preferentially micro-aerophilic in the presence or absence of combined nitrogen in the medium.

Cyanobacteria

Both free-living as well as symbiotic cyanobacteria (blue green algae) have been harnessed in rice cultivation in India. A composite culture of BGA having heterocystous Nostoc, Anabaena, Aulosira etc. is given as primary inoculum in trays, polythene lined pots and later mass multiplied in the field for application as soil based flakes to the rice growing field at the rate of 10 kg/ha. The final product is not free from extraneous contaminants and not very often monitored for checking the presence of desiredalgal flora.

Once so much publicized as a biofertilizer for the rice crop, it has not presently attracted the attention of rice growers all over India except pockets in the Southern States, notably Tamil Nadu. The benefits due to algalization could be to the extent of 20-30 kg N/ha under ideal conditions but the labour oriented methodology for the preparation of BGA biofertilizer is in itself a limitation. Quality control measures are not usually followed except perhaps for random checking for the presence of desired species qualitatively.

Azolla  Azolla is a free-floating water fern that floats in water and fixes atmospheric nitrogen in association with nitrogen fixing blue green alga Anabaena azollae. Azolla fronds consist of sporophyte with a floating rhizome and small overlapping bi-lobed leaves and roots. Rice growing areas in South East Asia and other third World countries have recently been evincing increased interest in the use of the symbiotic N2 fixing water fern Azolla either as an alternate nitrogen sources or as a supplement to commercial nitrogen fertilizers. Azolla is used as biofertilizer for wetland rice and it is known to contribute 40-60 kg N/ha per rice crop.

Food bio technology

• Biotechnology is defined in accordance with the Convention on Biological Diversity, i.e. “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”
• Biotechnology as applied to food processing in most developing countries makes use of microbial inoculants to enhance properties such as the taste, aroma, shelf-life, texture and nutritional value of foods.
• The process whereby micro-organisms and their enzymes bring about these desirable changes in food materials is known as fermentation.
• Fermentation processing is also widely applied in the production of microbial cultures, enzymes, flavours, fragrances, food additives and a range of other high value-added products.
• These high value products are increasingly produced in more technologically advanced developing countries for use in their food and non-food processing applications.
• Many of these high value products are also imported by developing countries for use in their food-processing applications.

Agriculture & Food Biotechnology

• Biotechnology is necessary to maintain our agriculture competitive and remunerative and to achieve nutrition security in the face of major challenges such as
• Declining per capita availability of arable land;
• Lower productivity of crops, livestock and fisheries, heavy production losses due to biotic (insects pests, weeds) and abiotic (salinity, drought, alkalinity) stresses
• Heavy postharvest crop damage and declining availability of water as an agricultural input.
• Investment in agricultural related biotechnology has resulted in significantly enhanced R&D capability and institutional building over the years.
• However, progress has been rather slow in converting the research leads into usable products.
• Uncertainties regarding IPR management and regulatory requirements, poor understanding of risk assessment and lack of effective management and commercialization strategies have been significant impediments. India owns very few genes of applied value.
• The majority of the genes under use about 40 are currently held by MNCs and have been received under material transfer agreements for R&D purpose without clarity on the potential for commercialization.
• The spectrum of biotechnology application in agriculture is very wide and includes
• Generation of improved crops, animals, plants of agro forestry importance;
• Microbes;
• Use of molecular markers to tag genes of interest;
• Accelerating of breeding through marker assisted selection;
• Fingerprinting of cultivars, land raises, germplasm stocks;
• DNA based diagnostics for pests / pathogens of crops, farm animals and fish;
• Assessment and monitoring of bio diversity;
• In vitro mass multiplication of elite planting material;
• Embryo transfer technology for animal breeding; food and feed biotechnology.
• Plants and animals are being used for the production of therapeutically or industrially useful products, the emphasis being on improving efficiency and lowering the cost of production.
• However, emphasis should not be on edible vaccines for which use in real life condition is difficult.
• Nutrition and balanced diet are emerging to be important health promotional strategies.
• Biotechnology has a critical role in developing and processing value added products of enhanced nutritive quality and providing tools for ensuring and monitoring food quality and safety.
• It has been estimated that if Biofertilizers were used to substitute only 25% of chemical fertilizers on just 50% of India’s crops the potential would be 2,35,000 MT.
• Today about 13,000 MT of Biofertilizers are used – only 0.36% of the total fertilizer use. The projected production target by 2011 is roughly around 50,000 23 MT.
• Biopesticides have fared slightly better with 2.5% share of the total pesticide market of 2700 crores and an annual growth rate of 10-15 %.
• In spite of the obvious advantages, several constraints have limited their wider usage such as products of inconsistent quality, short shelf life, sensitivity to drought, temperature, and agronomic conditions.

CURRENT USE, RESEARCH AND IMPENDING DEVELOPMENT OF FOODS PRODUCED THROUGH MODERN BIOTECHNOLOGY

Foods produced through modern biotechnology can be categorized as follows:

1. Foods consisting of or containing living/viable organisms, e.g. maize.
2. Foods derived from or containing ingredients derived from GMOs, e.g. flour, food protein products, or oil from GM soybeans.
3. Foods containing single ingredients or additives produced by GM microorganisms (GMMs), e.g. colours, vitamins and essential amino acids.
4. Foods containing ingredients processed by enzymes produced through GMMs, e.g. high-fructose corn syrup produced from starch, using the enzyme glucose isomerase (product of a GMM).

Crops

Crop breeding and the introduction of GM crops for food production

• Conventional breeding, especially of crops, livestock and fish, focuses principally on increased productivity, increased resistance to diseases and pests, and enhanced quality with respect to nutrition and food processing.
• Advances in cellular genetics and cell biology methods in the 1960s contributed to the so-called ‘green revolution’ that significantly increased varieties of staple food crops containing traits for higher yield and resistance to diseases and pests in a number of both developed and developing countries.
• A key driver of the green revolution was to improve the potential to provide sufficient food for all.
• The intensification and expansion of agriculture brought about by these methods and agricultural systems have, however, also resulted in new forms of health and environmental risks through, for example, increased use of agrochemicals and intensified cultivation resulting in soil erosion.
• Various transformation methods are used to transfer recombinant DNA into recipient species to produce a GMO.
• For plants, these include transformation mediated by Agrobacterium tumefaciens (a common soil bacterium that contains genetic elements for infection of plants) and biolistics shooting recombinant DNA placed on microparticles into recipient cells.
• The methods used in the transformation of various animal species include microinjection, electroporation and germ-line cells.
• The success rate of transformations in animals tends to be lower than in plants, and to vary from species to species, thus requiring the use of many animals.
• Genetic modification is often faster than conventional breeding techniques, as stable expression of a trait is achieved using far fewer breeding generations.
• It also allows a more precise alteration of an organism than conventional methods of breeding, as it enables the selection and transfer of a specific gene of interest.
• However, with the present technology, in many cases it leads to random insertion in the host genome, and consequently may have unintended developmental or physiological effects.
• However, such effects can also occur in conventional breeding and the selection process used in modern biotechnology aims to eliminate such unintended effects to establish a stable and beneficial trait.

Livestock and fish

• In terms of food production, the application of modern biotechnology to livestock falls into two main areas: animal production and human nutrition.
• Many of the applications discussed below are in the early stages of R&D.

Fish

• The projected increasing demand for fish suggests that GM fish may become important in both developed and developing countries.
• Enhanced-growth Atlantic salmon containing a growth hormone gene from Chinook salmon is likely to be the first GM animal on the food market.
• These fish grow 3–5 times faster than their non-transgenic counterparts, to reduce production time and increase food availability.
• At least eight other farmed fish species have been genetically modified for growth enhancement. Other fish in which genes for growth hormones have been experimentally introduced include grass carp, rainbow trout, tilapia and catfish.
• In all cases, the growth-hormone genes are of fish origin.

Livestock and poultry

• Foods derived from GM livestock and poultry are far from commercial use.
• Several growth enhancing novel genes have been introduced into pigs that have also affected the quality of the meat, i.e. the meat is more lean and tender.
• This research was initiated over a decade ago, but owing to some morphological and physiological effects developed by the pigs, these have not been commercialized. Many modifications to milk have been proposed that either add new proteins to milk or manipulate endogenous proteins.
• Recently, researchers from New Zealand developed GM cows that produce milk with increased levels of casein protein. Use of such protein-rich milk would increase the efficiency of cheese production.
• Other work aims to reduce the lactose content of milk, with the intent of making milk available to the population of milk-intolerant individuals.

Microorganisms

Microorganisms as foods

• Currently, there are no known commercial products containing live genetically modified microorganisms (GMMs) on the market.
• In the United Kingdom, GM yeast for beer production has been approved since 1993, but the product was never intended to be commercialized.
• Other microorganisms used in foods (which are in the R&D phase) include starter fermentation cultures for various foods (bakery and brewing), and lactic acid bacteria in cheese.
• R&D is also aimed at minimizing infections by pathogenic microorganisms and improving nutritional value and flavour.
• Attempts have been made to genetically modify ruminant microorganisms for protecting livestock from poisonous feed components.
• Microorganisms improved by modern biotechnology are also under development in the field of probiotics, which are live microorganisms that, when consumed in adequate amounts as part of food, confer a health benefit on the host.

Food and nutrition

• R&D would be focused on:
• Development of biotechnology tools for evaluating food safety, development of rapid diagnostic kits for detection of various food borne pathogens
• Development of analogical methods for detection of genetically modified foods and products derived there from;
• Development of nutraceuticals / health food supplements/ functional foods for holistic health;
• Development of pre-cooked, ready-to-eat, nutritionally fortified food for school going children;
• Development of suitable pro-biotics for therapeutic purposes and development of bio food additives.
• It is proposed to set up (under the auspices of Department of Biotechnology) an autonomous institute for nutritional biology and food biotechnology (2006).

Biofertilizers and biopesticides

• Priorities would include screening of elite strains of micros-organisms and / or productions of super-strains, better understanding of the dynamics of symbiotic nitrogen fixation, process optimization for fermentor – based technologies, improved shelf life, better quality standards, setting up accredited quality control laboratories and standardization of GMP guidelines.
• Integrated nutrient management system would be further strengthened.

Fermentation Bioprocess

• The fermentation bioprocess is the major biotechnological application in food processing. It is often one step in a sequence of food-processing operations, which may include cleaning, size reduction, soaking and cooking.
• Fermentation bioprocessing makes use of microbial inoculants for enhancing properties such as the taste, aroma, shelf-life, safety, texture and nutritional value of foods.
• Microbes associated with the raw food material and the processing environment serve as inoculants in spontaneous fermentations, while inoculants containing high concentrations of live micro-organisms, referred to as starter cultures, are used to initiate and accelerate the rate of fermentation processes in non-spontaneous or controlled fermentation processes.
• Microbial starter cultures vary widely in quality and purity.

1. Spontaneous inoculation of fermentation processes

• In many developing countries, fermented foods are produced primarily at the household and village level, using spontaneous methods of inoculation.
• Spontaneous fermentations are largely uncontrolled.
• A natural selection process, however, evolves in many of these processes which eventually results in the predominance of a particular type or group of micro-organisms in the fermentation medium

2. “Appropriate” starter cultures as inoculants of fermentation processes

• “Appropriate” starter cultures are widely applied as inoculants across the fermented food sector, from the household to industrial level in low-income and lower-middle-income economies.
• These starter cultures are generally produced using a backslopping process which makes use of samples of a previous batch of a fermented product as inoculants

3. Defined starter cultures as inoculants of fermentation processes

• Few defined starter cultures have been developed for use as inoculants in commercial fermentation processes in developing countries.
• Nevertheless, the past ten years have witnessed the development and application of laboratory-selected and pre-cultured starter cultures in food fermentations in a few developing countries.
• “Defined starter cultures” consist of single or mixed strains of micro-organisms. They may incorporate adjunct culture preparations that serve a food-safety and preservative function.
• Adjunct cultures do not necessarily produce fermentation acids or modify texture or flavour, but are included in the defined culture owing to their ability to inhibit pathogenic or spoilage organisms.
• Their inhibitory activity is due to the production of one or several substances such as hydrogen peroxide, organic acids, diacetyl and bacteriocins.

4. Defined starter cultures developed using the diagnostic tools of advanced biotechnologies

• The use of DNA-based diagnostic techniques for strain differentiation can allow for the tailoring of starter cultures to yield products with specific flavours and/or textures.
• Random amplified polymorphic DNA (RAPD) techniques have been applied in, for example, Thailand, in the molecular typing of bacterial strains and correlating the findings of these studies to flavour development during the production of the fermented pork sausage, nham.
• The results of these analyses led to the development of three different defined starter cultures which are currently used for the commercial production of products having different flavour characteristics

5. GM starter cultures

• To date, no commercial GM micro-organisms that would be consumed as living organisms exist.
• Products of industrial GM producer organisms are, however, widely used in food processing and no major safety concerns have been raised against them.
• Rennet which is widely used as a starter in cheese production across the globe is produced using GM bacteria.

Food additives and processing aids

• Enzymes, amino acids, vitamins, organic acids, polyunsaturated fatty acids and certain complex carbohydrates and flavouring agents used in food formulations are currently produced using GM micro-organisms

National Agri-Food Biotechnology Institute (NABI)

• National Agri-Food Biotechnology Institute (NABI) is the first Agri-Food Biotechnology Institute, established in India on 18th February 2010.
• The institute aims at catalysing the transformation of Agri – food sector in India.
• The institute has the vision to be a nodal organization for knowledge generation and translational science leading to value added products based on Agri-food biotech innovations.
• The main research focus of NABI is to harness biotechnological tools in the area of Agriculture Biotechnology, Food and Nutritional Biotechnology so as to provide sustainable and novel solutions towards quality food and nutrition.
• Activities undertaken at NABI under different areas includes,

1. Agricultural Biotechnology
2. Food and Nutritional Biotechnology
3. Human Resource Development
4. Meeting and Courses
5. Technology Transfer and Outreach

• The institute has developed strong linkages with National and International organizations and industries.
• The institute is part of agri-food cluster in the “Knowledge City” of Mohali (Punjab) along with its neighboring institutes.

Efforts of government in promoting biotechnology in the country

DBT and Biotech parks

The remarkable march of India into the world of biosciences and technological advances began in 1986. That year, government of india accepted the vision that unless India created a separate Department for Biotechnology, within the Ministry of Science and Technology, Government of India the country would not progress to the desired extent. This was because many of our macro-economic issues of growth were subsumed within that science’s development.

That decision has made India one of the first countries to have a separate department for this stream of science and technology. However the initiation of deliberations to establish the department started much earlier In 1982, after detailed deliberations with the scientific community, and on the basis of recommendations by the then Scientific Advisory Committee to the Cabinet, a National Biotechnology Board (NBTB) was constituted by the Government to identify priority areas and evolve long term perspective for Biotechnology in India. It was also responsible for fostering programmes and strengthening indigenous capabilities in this newly emerging discipline.

BioPharma Mission

India needs to take firm steps quickly towards achieving its target of $100 billion Biotech Industry by 2025 and capturing 5% of the Global Biopharmaceutical market share if Indian biopharmaceuticals Industry needs to be globally competitive over the next decade. The health standards of India’s population can be transformed only through affordable product development. Therefore, there is an immediate need to consolidate efforts to promote product discovery, translational research and early stage manufacturing in the country to ensure inclusive innovation.

Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT) Ministry of Science & Technology has initiated the Mission Program entitled “Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals – Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation” (“Program”).Biotechnology Industry Research Assistance Council (BIRAC) setup by DBT is the implementing Agency of i3 Program through a dedicated Program Management Unit (PMU). The National Biopharma Mission has been approved by the Cabinet for implementation in May 2017 with a total cost US$ 250 million which is co-funded World Bank 50%.  This Mission is designed in a manner in which it addresses the key components of the Vision outlined in the National Missions like “Make in India” and “Start up India” and also aims to take forward the commitments made by DBT in the National Biotechnology Development Strategy.

Biotech-KISAN scheme

Biotech-KISAN scheme is a farmer centric scheme for farmers, developed by and with farmers. It is a Pan-India program, following a hub-and spoke model and stimulates entrepreneurship and innovation in farmers and empowers women. The Biotech- KISAN Hubs are expected to fulfil the technology requirement to generate agriculture and bio-resource related jobs and better livelihood ensuring biotechnological benefits to small and marginal farmers. Biotech-KISAN also has unique a feature to identify and promote local farm leadership in both genders. Such leadership helps to develop sciencebased farming besides facilitating transfer of knowledge. So far a total of eight Biotech-KISAN Hubs in different Agro-climatic Zones have been supported.

 

Government Initiatives To Boost Up “Make In India” Campaign In Biotechnology Sector

Patent protection

Apart from Pharmaceutical sectors, biotechnology innovations and research are instrumental in health care systems, agricultural industry, polymers & materials sectors, etc. Research & development in this area is relatively time consuming and involves huge investment with risk involved with the outcome. To promote such results much more importance is affixed with respect to patenting the inventions in said field, and enabling the growing research sector to monetarily sustain itself.

The Indian Patent Office (IPO) has issued draft guidelines on examination of biotechnology patent applications. The guidelines detail illustrative examples on various facets of patentability of biotechnology related inventions, including novelty, inventive step, industrial application, sufficiency of disclosure, clarity of claims and biodiversity related issues. The patentability of biotechnology related inventions particularly genetic engineering has also been discussed. The details of wording of claims, clarity, support and sufficiency of the disclosure are provided. However, for better understanding of the issues related to novelty and inventive step, a preliminary discussion of claims of biotechnology related inventions are covered. These include the polynucleotides or gene sequences, polypeptides or protein sequences, vectors, gene libraries, host cells, micro-organisms and stem cells plants and animals tissue culture, pharmaceutical or vaccine compositions comprising micro-organisms, proteins, polynucleotides and antibodies or antigen binding fragments thereof monoclonal or polyclonal.

In order to help the patent seekers, a Biotechnology Patent Facilitation Cell (BPFC)  has been catering to the need of promotion of biotech research by:

• creating awareness and understanding among biologists and biotechnologists, relating to patents and the challenges and opportunities in this area
• providing patenting facilities to biologists and biotechnologists in the country for filing Indian and foreign patents on a sustained basis.
• keeping a watch on development in the area of IPR and make important issues known to policy makers, bio-scientists, biotech industry, etc.

Another government authority working for the same cause is the Council of Scientific and Industrial research (CSIR) which has moved from their earlier mantra of “publish or perish” to “patent or perish”. The Indian Government has under its “Science and Technology Policy” also highlighted that Innovative fiscal measures are planned and strategies for attracting higher levels of investments both public and private in science and technological development and Development of technologies that add value to India’s indigenous resources would be Supported and the Indian share in the global herbal product market would be increased.

Department of Biotechnology (DBT) constituted under the Ministry of Science and Technology is the nodal agency for policy, promotion of R&D, international cooperation and manufacturing activities. Together with DBT, Genetic Engineering and Approval Committee (GEAC) constituted under Ministry of Environment and Forests (MoEF) is the leading regulatory body in the area of Biotechnology in India. Several committees have also been constituted under the said ministries to regulate the activities involving handling, manufacture, storage, testing, and release of genetic modified materials in India. These committees have statutory authority. Most of the committee members are from the scientific community and staff of DBT and MoEF. DBT appoints the members to the committees. The GEAC is supposed to be assisted by the State Biotechnology Coordination Committees (SBCC) and District Level Committees.