Professional Documents
Culture Documents
Paper-V Part 2
Paper-V Part 2
Paper-V Part 2
In India around 70% of the population earns its livelihood from agriculture.
It fulfills the basic need of human beings and animals.
It is an important source of raw material for many agro based industries.
India’s geographical condition is unique for agriculture because it provides many
favorable conditions.
There are plain areas, fertile soil, long growing seasons and wide variation in climatic
condition etc.
Apart from unique geographical conditions, India has been consistently making
innovative efforts by using science and technology to increase production.
SALIENT FEATURES OF INDIAN AGRICULTURE
MAJOR CROPS OF INDIA
India grows almost each and every crop. If we consider the varieties of crop grown from
Kashmir to Kanyakumari and western coast of Gujarat to extreme north eastern states of
Arunachal Pradesh, then there would be hundreds of crops.
CROPS
COMMERCIAL/PLANTATION
FOOD GRAINS HORTICULTURE
CROPS
CEREALS PULSES OILSEEDS OTHERS VEGETABLES FRUITS
Rice, Coarse Tur, Groundnut, Caster Sugarcane, Potato, Sweet Banana,
Cotton, Jute,
Mesta,
Mango,
seed, Niger seed, Coconut,
Gram, potato, Onion, Apple,
Sesamum, Tapioca,
Cereals/ Moong, Chillies, Tomato, Apricot,
Wheat Rapeseed, Mustard, Tobacco,
Millets Urad, Cauliflower, Grapes,
Linseed, Safflower, Rubber,
Lentil Brinjal Pineapple,
Sunflower, Soybean Coffee, Tea,
Walnut
Arecanut,
Spices
FOODGRAINS
The importance of foodgrains in Indian agricultural economy may be gauged from the
fact these crops occupy about two-third of total cropped area in the country.
Foograins are dominant crops in all parts of the country whether they have
subsistence or commercial agricultural economy.
On the basis of the structure of grainthe food grainsare classified as cereals and
pulses.
CEREALS
RICE:
Rice is primarily grown in plain areas like Gangetic plain, it is also grown below sea level
at Kuttanad (Kerala), hill terraces of north eastern part of India and valleys of Kashmir.
The three largest rice producing states are West Bengal, Uttar Pradesh and Andhra
Pradesh.
The other major rice producing states are Tamil Nadu, Bihar, Jharkhand,
Uttarakhand, Chhattisgarh, Punjab, Orissa, Karnataka, Assam and
Maharashtra.
It is also grown in Haryana, Madhya Pradesh, Kerala, Gujarat and Kashmir Valley.
WHEAT:
Wheat is the second most important food crop of India next to rice.
It is a Rabi or winter crop. It is sown in the beginning of winter and harvested in the
beginning of summer.
Normally (in north India) the sowingof wheat begins in the month of October-
November and harvesting is done in the month ofMarch-April.
This is the staple foodof millions of people particularly in the northern and north-
western regions of India. Some of the geographical conditions are as follows:
MILLETS:
Millets are short duration warm weather crops. These are coarse graincrops and are
used for both food and fodder.
These are Kharifcropsthough sometimes grown in rabi seasons too. These are sown in
May-August and harvested in October-November. Today millets are mostly
consumed by poor people as their staple food.
In India, lots of millet is grown and these are known by various local names.
Some of these are Jowar, Bajra, Ragi, Korra, Kodon, Kutki, Hraka, Bauti and Rajgira.
In India, Jowar, Bajra and Ragiare grown on large areas but unfortunately area
under these crops has drastically reduced over the years.
Some of the geographical conditions for growing these crops are as follows:
1. Temperature: These crops are grown where the temperature is highwhich ranges
between 270C to 320
2. Rainfall: As mentioned earlier that millets are ‘dry land crop’, therefore, rainfall
ranging from 50 to 100 cmis ideal for their cultivation. These crops are rain-fed.
3. Soil: Millets are less sensitive to soil deficiencies. They can be grown in inferior
alluvial or loamy soil.
4. Distribution: Jowar and Bajra are grown both in north and south Indiawhereas ragi
is generally concentrated in the southern India. Jowar and Bajra are grown in
Madhya Pradesh, Gujarat, Rajasthan, Maharashtra, Karanataka, Tamil Nadu, Andhra
Pradesh, Haryana and Punjab. Ragi is mostly concentrated in the southern India i.e.
Tamil Nadu, Karnataka and Andhra Pradesh. In total, coarse cereals can be found
in Rajasthan, Karnataka and Andhra Pradesh.
Jowar(sorghum), Bajra (Pearl millet/Bull Rush millet)Ragi (Finger millet/Buck
wheat) are the important millets grown in India. Though, these are known as coarse
grains, they have very high nutritional value. For example, ragi is very rich in iron,
calcium, other micro nutrients and roughage.
Maizeis a crop which is used both as food and fodder. It is a kharif crop which
requires temperature between 21°C to 27°C and grows well in old alluvial soil. In
some states like Bihar maize is grown in rabi season also. Use of modern inputs
such as HYV seeds, fertilisers and irrigation have contributed to the increasing
production of maize. Major maize-producing states are Andhra Pradesh,
Karnataka, Maharashtra, Uttar Pradesh, Bihar, Telangana and Madhya Pradesh.
PULSES
India is the largest producer as well as the consumer of pulses in the world. These are
the major source of protein in a vegetarian diet.
Pulses need less moisture and survive even in dry conditions. Being leguminous
crops, all these crops except arhar(pigeon pea)helps in restoring soil fertility by fixing
nitrogen from the air.
Therefore, these are mostlygrown in rotation with other crops. Most of these are green
manure crops Major pulse producing statesin India are Madhya Pradesh, Rajasthan,
Maharashtra, Uttar Pradesh and Karnataka.
Though gram and tur (arhar or pigeon pea/red gram) are the more important pulses,
several other pulses such as urd (black gram), mung (green gram), masur (lentil),
kulthi (horse gram), matar(peas), khersi, cow pea(black-eyed gram) and moth are also
grown. Pulses are generally fodder crops
Gram
It is the most important of all the pulses. It accounts for about 37% of the production and
about 30% of the total area of pulses in India. It is a Rabi cropwhich is sown between
September and November and is harvested between February and April. It is
either cultivated as a single crop or mixed with wheat, barley, linseed or mustard. Some
of the geographical conditions are as follows:
COMMERCIAL/CASH CROPS
Cash crops are those crops which are grown for sale either in raw form or semi processed
form. Major of them are as follows:
SUGARCANE:
Sugarcane is a Kharif crop. It is the main source of sugar, gur and khandsari.
It also provides raw material for the manufacturing of alcohol.
Bagasse, the crushed cane residue,has also multiple uses. It is used for manufacturing
of paper. It is also an efficient substitute for petroleum products and a host of
other chemical products.
A part of it is also used as fodder. Some of the geographical conditions for the growth
of sugarcane are as follows:
1. Temperature: It requires hot and humid climatewith an average temperature
of 210C to 270C.
2. Rainfall: 75-150 cmrainfall is favorable for sugarcane cultivation. Irrigation is
required in those areas where rainfall is less than the prescribed limit.
3. Soil: It can grow in a variety of soils. In fact sugarcane can tolerate any kind of soil
that can retain moisture. But deep rich loamy soilis ideal for its growth. The soil
should be rich in nitrogen, calcium and phosphorous but neither it should be too
acidic nor alkaline. Flat, plain and level pleatue is an advantage for sugarcane
cultivation because it facilitates irrigation and transportation of cane to the sugar
mills. Sugarcane cultivation requires heavy manures and fertilizers because it
exhausts the fertility of soils quickly and extensively.
4. Labour: It is a labour oriented cultivationand required cheap labour. Ample
human hands are required at every stage, i.e. sowing, hoeing, weeding, irrigation,
cutting and carrying sugarcanes to the factories.
5. Distribution: India has the largest area under sugarcane cultivation in the
world and the second largest producernext to Brazil. As far as distribution of
sugarcane cultivation in India is concerned, there are three distinct geographical
regions in the country. These regions are:
1. The Sutlej-Ganga plainfrom Punjab to Bihar containing 51% of the total area
and 60% of the country’s total production. Uttar Pradesh is the largest
producer of sugar in India.
2. The black soil belt from Maharashtra to Tamil Nadualong the eastern slopes of
the Western Ghats.
3. Coastal Andhra Pradesh and Krishna river valley.
COTTON:
Cotton is the most important fibre cropnot only of India but also of the entire world. It
not only provides raw material for cotton textile industry but also its seed is used in
Vanaspati oil industry.
The cotton seed is also used as part of fodder for milch cattle for better milk
production. Cotton is basically a kharif crop.Some of the geographical conditions are
as follows:
JUTE
OILSEEDS
Groundnut
It is the most important oilseed of India. Groundnut is grown both as kharif and Rabi
crop but 90-95% of the total area is devoted to kharif crop. It is a rainfed crop. Some of
the geographical conditions are as follows:
Soybean
Sunflower:
Sesamum (Til):
Like wheat and gram, they thrive only in cool climateof the Satluj-Ganga
plain and very small quantity is grown in the peninsular India.
They are mainly grown as rabi cropin pure or mixed form with wheat, gram and
barley.
Linseed:
Although this crop can be grown under varied geographical conditions, it prefers
cool, moist climatewith about 20oC temperature and 75 cm rainfall.
Clay loams, deep black soils and alluvial soils are best suited for its cultivation. It
can be cultivated upto a height of 800 metres above sea level.
It is a rabi-cropwhich is sown in October-November and harvested in March-April.
Castor Seed:
Castor seed plant grows into a small tree and is generally raised as a mixed crop in
tropical and sub-tropical climates.
It thrives well in areas of 200C-250C temperature and 50-75 cm rainfall.
It is grown on red sandy loams in the peninsular India and on light alluvial soils of the
Satluj-Ganga plain.
Almost the whole area of castor seed production is rainfed. It is a Kharif crop in the
north and a rabi crop in the south.
PLANTATION CROP
TEA:
1. Temperature: It requires hot and wet climate. The ideal temperature for the growth
of tea bushes and leaf varies between 200C to 300C. If temperature eitherrises above
350C or goes below 100C, it would be harmful for the growth of tea bushesand
leaves.
2. Rainfall:As mentioned above tea requires a good amount of rainfall ranging
between 150-300 cm and the annual rainfall should be well distributed throughout the
year. Long dry spell is harmful for tea.
3. Soil: Tea bush grows well in well drained, deep, friable loamy soil.
However, virgin forest soil rich in humus and iron contentare considered to be the
best soils for the tea plantation. Tea is a shade loving plant and grows better when
planted along with shady trees.
4. Labour: Cheap and efficient labouris required for tea production.
5. Distribution: Assam is the leading producerthat accounts for more than 50% of tea
production of India. Tea producing areas of Assam are the hill slopes bordering the
Brahmaputra and Surma valleys. West Bengal is the second largest producer of tea
where tea is mostly grown in the districts of Darjeeling, Siliguri, Jalpaiguri and cooch
Bihar districts. Tamil Nadu is the third largest producer where tea growing areas
are mostly restricted to Nilgiri hills.
COFFEE:
HORTICULTURE CROPS
1 b) Forests – Natural Vegetation of India:Types and distribution types
Climate, soil and topographyare the major factors that influence Natural Vegetation
of a place.
The main climatic factors arerainfall and temperature. The amount of annual
rainfall has a great bearing on the type of vegetation.
E. Alpine Forests
Sub-Alpine
Moist Alpine scrub
Dry Alpine scrub
Characteristics
Evergreen: Due to high heat and high humidity, the trees of these forests do not shed
their leaves together.
Mesosphytic:Plants adopted to neither too dry nor too wet type climate.
Less undergrowth: The sun light cannot reach the ground due to thick canopy. The
undergrowth is formed mainly of bamboos, ferns, climbers, orchids, etc.
Distribution
Western side of the Western Ghats (500 to 1370 metres above sea level).
Some regions in the Purvanchal hills.
In the Andaman and Nicobar Islands.
Timber
They are transitional forests between tropical wet evergreen forests and tropical
deciduous forests.
They are comparatively drier areas compared to tropical wet evergreen forests.
Climatic Conditions
Distribution
Western coast
Assam
Lower slopes of the Eastern Himalayas
Odisha and
Characteristics
Buttressed Trunks
The important species are laurel, rosewood, mesua, thorny bamboo – Western Ghats, white
cedar, Indian chestnut, champa, mango, etc. – Himalayan region.
Timber
Hardwood: Similar to that in tropical evergreen forests except that these forests are less dense
withmore pure stands (timber industry here is better than in evergreen forests).
Tropical Moist Deciduous Forests
Climatic Conditions
Characteristics
The trees drop their leaves during the spring and early summer when sufficient
moisture is not available.
The general appearance is bare in extreme summers (April-May).
Tropical moist deciduous forests present irregular top storey [25 to 60 m].
Heavily buttressed trees and fairly complete undergrowth.
These forests occupy a much larger area than the evergreen forests but large tracts
under these forests have been cleared for cultivation.
Distribution
Belt running along the Western Ghats surrounding the belt of evergreen forests.
A strip along the Shiwalik range including terai and bhabar from 77° E to 88° E.
Manipur and Mizoram.
Hills of eastern Madhya Pradesh and Chhattisgarh.
Chota Nagpur Plateau.
Most of Odisha.
Parts of West Bengal and
Andaman and Nicobar islands.
Timber
They can survive and grow both in fresh as well asbrackish water(The mixture of
seawater and fresh water in estuaries is called brackish water and its salinity can range
from 0.5 to 35 ppt).
Occur in and around the deltas, estuaries and creeks prone totidal influences (delta
or tidal forests).
Littoral (relating to or on the shore of the sea or a lake) forests occur at several places
along the coast.
Swamp forests are confined to the deltas of the Ganga, the Mahanadi, the Godavari,
the Krishna and the Cauvery.
Dense mangroves occur all along the coastline in sheltered estuaries, tidal creeks,
backwaters, salt marshes and mudflats. It provides useful fuel wood.
The most pronounced and the densest is theSunderban in the Ganga delta where the
predominant species is Sundri (Heriteera).
Timber
It provides hard and durable timber which is used for construction, building purposes
and making boats.
The important species found in these forests are Sundri, agar, rhizophora, screw pines,
canes and palms, etc.
Annual rainfall of 100 cm [mostly from the north-east monsoon winds in October –
December].
Mean annual temperature is about 28°C.
The mean humidity is about 75 per cent.
The growth of evergreen forests in areas of such low rainfall is a bit strange.
Characteristics
Casuarina plantation
· It resembles feathery conifer in general appearance.
· They are rapid-growing, carefree species for sites and climates as varied as coastal
sand dunes, high mountain slopes, hot humid tropics, and semi-arid regions.
· They have the ability to fix atmospheric nitrogen. It grows 15 to 25 metres in height
on an average.
Casuarina plantation
Distribution
· Casuarina is the most popular farm forestry in the states of Andhra Pradesh, Tamil
Nadu, West Bengal, Odisha, Maharashtra, Gujarat, and Karnataka.
Benefits
· Reduces damage in the event of natural calamities.
· Line planting in the coastal areas helps in controlling the wind force.
· It is also used for tourism promotion in view of its ornamental appearance.
· It provides top quality firewood.
· The wood is suitable for paper pulp and useful raw material for the manufacture of
paper for writing, printing, and wrapping.
· It is got some serious medicinal values as well.
Wasteland development
· The characteristics which make it a suitable species for wasteland development include
adaptability to wide range of habitats, fast growth, salt tolerant, drought resistant, ability to
reclaim land and stabilize sand dunes.
· Intercrops such as groundnut, cucumber, watermelons, sesamum, and pulses can also
be raised along with the plantation.
Tropical Dry Deciduous Forests
Climatic Conditions
Annual rainfall is 100-150 cm.
Characteristics
These are similar to moist deciduous forests and shed their leaves in dry season.
The major difference is that they can grow in areas of comparatively less rainfall.
They represent a transitional type – moist deciduous on the wetter side and thorn
forests on the drier side.
They have closed but uneven canopy.
The forests are composed of a mixture of a few species of deciduous trees rising up to
a height of 20 metres.
Undergrowth: Enough light reaches the ground to permit the growth of grass and
climbers.
Distribution
They occur in an irregular wide strip running from the foot of the Himalayas to
Kanniyakumari except in Rajasthan, Western Ghats and West Bengal.
The important species are teak, axlewood, rosewood, common bamboo,red sanders,
laurel, satinwood, etc.
Large tracts of this forest have been cleared for agricultural purposes.
These forests have suffer from over grazing, fire, etc.
Characteristics
Distribution
Distribution
Eastern Himalayas to the east of 88°E longitude at altitudes varying from 1000 to 2000 m.
Characteristics
Western Himalayas between 73°E and 88°E longitudes at elevations between 1000 to
2000 metres above sea level.
Some hilly regions of Arunachal Pradesh, Manipur, Naga Hills and Khasi Hills.
Timber
Chir or Chilis the most dominant tree which forms pure stands.
It providesvaluable timber for furniture, boxes and buildings.
It is also used for producing resin and turpentine.
Characteristics
Low scrub forest with small evergreen stunted trees and shrubs.
Olive, acacia modesta and pistacia are the most predominant species.
Distribution
Higher hills of Tamil Nadu and Kerala, in the Eastern Himalayan region.
Characteristics
Occurs in the temperate zone of the Himalayas between 1500 and 3300 metres.
Cover the entire length of this mountain range in Kashmir, Himachal Pradesh,
Uttarakhand, Darjeeling and Sikkim.
Characteristics
Timber
It provides fine wood which is of much use for construction, timber and railway sleepers.
Himalayan Dry Temperate Forests
Climatic Conditions
Precipitation is below 100 cm and is mostly in the form of snow.
Characteristics
Coniferous forests with xerophytic shrubs in which deodar, oak, ash, olive, etc are the main
trees.
Distribution
Such forests are found in the inner dry ranges of the Himalayas where south-west
monsoon is very feeble.
Such areas are in Ladakh, Lahul, Chamba, Kinnaur, Garhwal and Sikkim.
Alpine Forests
2 a) Biotechnology
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.
2 b) Genetic engineering
Introduction and application of genetic engineering
Genetic engineering
Genetic engineering, the artificial manipulation, modification, and recombination of DNA or
other nucleic acid molecules in order to modify an organism or population of organisms.
The term genetic engineering initially referred to various techniques used for the modification
or manipulation of organisms through the processes of heredity and reproduction. As such,
the term embraced both artificial selection and all the interventions of biomedical techniques,
among them artificial insemination, in vitro fertilization (e.g., “test-tube” babies), cloning,
and gene manipulation. In the latter part of the 20th century, however, the term came to refer
more specifically to methods of recombinant DNA technology (or gene cloning), in which
DNA molecules from two or more sources are combined either within cells or in vitro and are
then inserted into host organisms in which they are able to propagate.
The possibility for recombinant DNA technology emerged with the discovery of restriction
enzymes in 1968 by Swiss microbiologist Werner Arber. The following year American
microbiologist Hamilton O. Smith purified so-called type II restriction enzymes, which were
found to be essential to genetic engineering for their ability to cleave a specific site within the
DNA (as opposed to type I restriction enzymes, which cleave DNA at random sites). Drawing
on Smith’s work, American molecular biologist Daniel Nathans helped advance the technique
of DNA recombination in 1970–71 and demonstrated that type II enzymes could be useful in
genetic studies. Genetic engineering based on recombination was pioneered in 1973 by
American biochemists Stanley N. Cohen and Herbert W. Boyer, who were among the first to
cut DNA into fragments, rejoin different fragments, and insert the new genes into E. coli
bacteria, which then reproduced.
Process And Techniques
Most recombinant DNA technology involves the insertion of foreign genes into the plasmids
of common laboratory strains of bacteria. Plasmids are small rings of DNA; they are not part
of the bacterium’s chromosome (the main repository of the organism’s genetic information).
Nonetheless, they are capable of directing protein synthesis, and, like chromosomal DNA,
they are reproduced and passed on to the bacterium’s progeny. Thus, by incorporating foreign
DNA (for example, a mammalian gene) into a bacterium, researchers can obtain an almost
limitless number of copies of the inserted gene. Furthermore, if the inserted gene is operative
(i.e., if it directs protein synthesis), the modified bacterium will produce the protein specified
by the foreign DNA.
A subsequent generation of genetic engineering techniques that emerged in the early 21st
century centred on gene editing. Gene editing, based on a technology known as CRISPR-
Cas9, allows researchers to customize a living organism’s genetic sequence by making very
specific changes to its DNA. Gene editing has a wide array of applications, being used for the
genetic modification of crop plants and livestock and of laboratory model organisms (e.g.,
mice). The correction of genetic errors associated with disease in animals suggests that gene
editing has potential applications in gene therapy for humans.
Applications Genetic engineering
Animal Husbandry
Neither the use of animal vaccines nor adding bovine growth hormones to cows to
dramatically increase milk production can match the real excitement in animal husbandry:
transgenic animals and clones. Transgenic animals model advancements in DNA technology
in their development. The mechanism for creating one can be described in three steps:
Healthy egg cells are removed from a female of the host animal and fertilized in the
laboratory.
The desired gene from another species is identified, isolated, and cloned.
The cloned genes are injected directly into the eggs, which are then surgically
implanted in the host female, where the embryo undergoes a normal development
process.
Control of Oil Pollution
Oil spills from oil tankers either on water or water surfaces cause a major environmental
hazard. Earlier use of chemical dispersants was shown to cause major pollution in shallow
water due to their toxic nature and prolong persistence in the environment.
Various species of Pseudomonas have the property to consume available hydrocarbons from
oil and can produce active surface compounds that can emulsify oil in water and thus facili-
tate easy removal of oil. Dr. Ananda Chakrobarty has engineered a strain of Pseudomonas
aeruginosa which produces a glycolipid emulsifier that reduces the surface tension of an oil-
water interface and thus helps in removal of oil from water.
Many such genetically engineered microbes can be used by mixing with straw, which then
will be scattered over the spilled oil, the straw will first soak oily water and then the microbes
will break up the oil into non-toxic, non-polluting substances, rendering the environment
harmless.
Control of Heavy Metal Pollution
Integrated management of polluted ecosystem by the use of diverse kind of organisms which
restore the natural process in the ecosystem is called bioremediation. Application of
genetically engineered organisms, specially plants in bioremediation, to rid contaminated soil
from heavy metal toxicity has proved encouraging.
Use of Bio-Pesticides
In developing countries, about 60 to 70% of food, during harvesting and post-harvested
period is lost on account of pests. Majority of chemical pesticides, herbicides and fertilisers
cause numerous hazards, because these substances release various pollutants in the
environment. To minimise the use of chemicals and pesticides, bio-pesticides are being used.
These are compounds derived from natural biological sources like animals, plants; bacteria
and can limit the growth of pests. For example, plant-incorporated protectants (PIPs) are bio-
pesticides produced by plants through genetic manipulation.
Medicine
Genetic engineering has resulted in a series of medical products. The first two commercially
prepared products from recombinant DNA technology were insulin and human growth
hormone, both of which were cultured in the E. coli bacteria. Since then a plethora of
products have appeared on the market, including the following abbreviated list, all made in E.
coli:
In addition, a number of vaccines are now commercially prepared from recombinant hosts. At
one time vaccines were made by denaturing the disease and then injecting it into humans with
the hope that it would activate their immune system to fight future intrusions by that invader.
Unfortunately, the patient sometimes still ended up with the disease.
Agriculture
Crop plants have been and continue to be the focus of biotechnology as efforts are made to
improve yield and profitability by improving crop resistance to insects and certain herbicides
and delaying ripening (for better transport and spoilage resistance). The creation of a
transgenic plant, one that has received genes from another organism, proved more difficult
than animals. Unlike animals, finding a vector for plants proved to be difficult until the
isolation of the Ti plasmid, harvested from a tumor-inducing (Ti) bacteria found in the soil.
The plasmid is “shot” into a cell, where the plasmid readily attaches to the plant’s DNA.
Although successful in fruits and vegetables, the Ti plasmid has generated limited success in
grain crops.
Creating a crop that is resistant to a specific herbicide proved to be a success because the
herbicide eliminated weed competition from the crop plant. Researchers discovered
herbicide-resistant bacteria, isolated the genes responsible for the condition, and “shot” them
into a crop plant, which then proved to be resistant to that herbicide. Similarly, insect-
resistant plants are becoming available as researchers discover bacterial enzymes that destroy
or immobilize unwanted herbivores, and others that increase nitrogen fixation in the soil for
use by plants.
Geneticists are on the threshold of a major agricultural breakthrough. All plants need nitrogen
to grow. In fact, nitrogen is one of the three most important nutrients a plant requires.
Although the atmosphere is approximately 78 percent nitrogen, it is in a form that is unusable
to plants. However, a naturally occurring rhizobium bacterium is found in the soil and
converts atmospheric nitrogen into a form usable by plants. These nitrogen-fixing bacteria are
also found naturally occurring in the legumes of certain plants such as soybeans and peanuts.
Because they contain these unusual bacteria, they can grow in nitrogen-deficient soil that
prohibits the growth of other crop plants. Researchers hope that by isolating these bacteria,
they can identify the DNA segment that codes for nitrogen fixation, remove the segment, and
insert it into the DNA of a profitable cash crop! In so doing, the new transgenic crop plants
could live in new fringe territories, which are areas normally not suitable for their growth,
and grow in current locations without the addition of costly fertilizers.
Stem Cell Research
Stem Cell Research
Stem cells are undifferentiated, or “blank,” cells. This means they’re capable of developing
into cells that serve numerous functions in different parts of the body. Most cells in the body
are differentiated cells. These cells can only serve a specific purpose in a particular organ.
For example, red blood cells are specifically designed to carry oxygen through the blood.
All humans start out as only one cell. This cell is called a zygote, or a fertilized egg. The
zygote divides into two cells, then four cells, and so on. Eventually, the cells begin to
differentiate, taking on a certain function in a part of the body. This process is called
differentiation.
Stem cells are cells that haven’t differentiated yet. They have the ability to divide and make
an indefinite number of copies of themselves. Other cells in the body can only replicate a
limited number of times before they begin to break down. When a stem cell divides, it can
either remain a stem cell or turn into a differentiated cell, such as a muscle cell or a red blood
cell.
Potential uses of stem cells Since stem cells have the ability to turn into various other types of
cells, scientists believe that they can be useful for treating and understanding diseases.
According to the Mayo Clinic, stem cells can be used to:
Crops
Crop breeding and the introduction of GM crops for food production
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.
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
Fermentation Bioprocess
“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
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.
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
GM starter cultures
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.
Food Safety And Microbial Standards, Food Quality Standards,
Food safety and Microbial standards, Food quality standards
Food safety-Indicators of food microbial Quality and safety-Coliforms, Enterococci,
Bifidobacteria, Coliphages/Enteroviruses, predictive Microbiology/ Microbial modeling
Microbial Standards of Processed and preserved Foods
The Center for disease control (CDC) investigates each documented outbreak of food borne
disease and attempts to determine not only the specific microorganisms and foods involved
but also the events which led to the outbreak.
Indicators of Food Safety:
Microbial indicators are employed more often to assess food safety and sanitation than
quality. Ideally a food safety indicator should meet certain important criteria.
HACCP is a system that should lead to the production of microbiologically safe foods
by analyzing for the hazards of raw materials-those that may appear throughout
processing and those that may occur from consumer abuse.
It is a proactive, systematic approach to controlling food bome hazards.
Although some classic approaches to food safety rely heavily on end product testing,
the HACCP system places emphasis on the quality of all ingredients and all process
steps on the premise that safe products will result if these are properly controlled.
The system is thus designed to control organisms at the point of production and
preparation.
HACCP principles:
Although interpreted variously, the ICMSF and NACMCF view HACCP as a natural and
systematic approach to food safety and as consisting of the following seven principles:
1. Assess the hazards and risks associated with the growing, harvesting, raw materials,
ingredients, processing, manufacturing, distribution, marketing, preparation, and
consumption of the food in question.
2. Determine the CCP(s) required controlling the identified hazards.
3. Establish the critical limits that must be met at each identified CCP.
4. Establish procedures to monitor the CCP(s).
5. Establish corrective actions to be taken when there is a deviation identified by
monitoring a given CCP.
6. Establish procedures for verification that the HACCP system is working correctly.
7. Establish effective record-keeping systems that document the HACCP plan.
Coli forms:
Indirect indicators.
A coli phage assay procedure for water samples that contain five or more phases /
100ml and that can be completed in 4-6 hours is described in “Standard methods for
the examination of water and waste water”
Bifidobacteria:
Tissier (1908) identified and named as Bacillus bifidus. Later it was named as Lacto bacillus
bifidus and contently known as Bifidobacterium bifidum.
Distribution:
Found in human feces at higher lutes per gram (108 – 109 ) than E. coli (106 – 107 )
and this makes them more attractive as indicators of human fecal pollution.
By using the bifide bacteria, it is possible to determine their origin among the
following three sources: human feces, animal feces or environmental conditions.
Gavinietal (1991) devised the method to distinguish between human and animal
strains and it devides bifido bacteria into suten groups.
Human origin belong to I, III and VII.
B. adolescentis and B. longum are mount often isolated in highest numbers.
1. Grade A pasteurized milk & milk products including cultured products not over 10/ml
2. Certified raw milk not more 10/ml. Certified pasteurized milk not over 1/ml
3. Pre cooked & partially cooked frozen foods not over 10/ml
4. Crab meat not over 100/ml
5. Custard filled items not over 100/ml
The present initiative of the government seeks to meet the requirements of the food
sector and is aimed at bringing together the proposed initiatives of the Ministry of
Food Processing Industry (MoFPI), as well as related schemes proposed by other
concerned ministries like the Ministry of Agriculture, Department of Commerce,
Ministry of Health, and Department of Consumer Affairs — all of which are directly
involved in the implementation of the Food Safety and Standards Act, 2006.
The initiative has certain components.
Under the new scheme of upgradation of hygiene and quality of street food of the
Ministry, 10,000 street vendors across the nation would be identified, profiled and
steps taken to upgrade the safety and quality of their food. They would also be granted
quality certification on the basis of standards which have already been worked out by
the Ministry.
Also, 10 food streets with ethnic cuisine will be identified, under which the majority
of stakeholders would be upgraded in terms of quality and hygiene, and support will
be given for creation of infrastructure such as drainage, water supply, lighting, etc., so
that these efforts result in more hygienic and safe conditions of food preparations.
A protocol based on best international and trade standards would be prepared and
checks against the prepared protocol in HACCP certified units would be conducted.
The field protocol will be evaluated and companies graded into Platinum, Gold and
Silver categories.
National and regional industry associations would be involved in identifying units and
launching a programme for capacity building through HACCP or ISO 22000 for the
food processing units who are members of their Organisations. Under this
programme, 10,000 units could be targeted, which would be taken up, profiled and
detailed programmes drawn up for upgradation and follow-up steps launched.
Certification would be achieved within a period of 18 months.
50 food safety laboratories will be identified which would be benchmarked against
industry best practices and a plan of action drawn up for their upgradation. Steps will
be initiated to bring them up to best practice levels within the next two years.Good
Agricultural Practices (GAP) have already been identified as a thrust area for
improving traceability, hygiene and safety of food items. Across the country, 10,000
farmers would be identified (approximately 500 in each state) who would be taken in
a step by step process to achieve certification of GAP or for organic food. Viable
projects would be created so that the agri-horticultural produce from these farms is
marketed and the returns accrue to the farmers.
The current Food Safety Standards under the Prevention of Food Adulteration Act
would be reviewed in consultation with stakeholders, and revised proposals would be
drawn up for consideration of the Central Food Authority.
Along with the Quality Council of India, a brochure has been brought out on the food
safety issues faced by a housewife and safe practices required in the kitchen. The QCI
has also been roped in to introduce food safety issues in schools and proper teaching
material has been drawn up through an expert group.
In addition, the QCI is also part of a project to publish a book on Indian cuisine and
its relation to cultural aspects. Alternatively, the best few books in the area of cuisine
and food will be identified and rewarded.
To support the Indian food industry, there are certification bodies that offer solutions
to industry for certification, inspections and training.
17025:2005 (NABL) accredited laboratories in our country are offering routine to
highly specialised testing, e.g. nutritional labelling test, chemical and microbiological
test, analysis of antibiotics and pesticide residues, heavy metals, vitamin estimations
and shelf life studies.
The certification bodies offer NABCB, DAR, etc. accredited certifications for ISO
9K, 14K, 18K, 22K, HACCP, BRC Global Food & Packaging, IFS, Fami-QS, GMP+,
etc.
The MoFPI has also chalked out a three-pronged strategy to attain food safety and
quality. While coordination between the various ministries and state governments tops
the list, the other moves include a global focus on the quality of food.
Simply put, this only underscores that food safety and quality are of paramount
importance to sustain and increase the country’s food exports.
While globalisation and the removal of tariff and non-tariff barriers have brought in
international competition to the domestic markets, it has prompted the Indian food
industry to adopt strong practices of food safety and quality in order to be
competitive.
Also, it is important to note that improving food safety and quality has to be a
constant and continuous effort rather than a one-shot effort, and all stakeholders from
the government and its institutions, to the industry, spanning the entire food chain,
academic and research institutions, consumer bodies, and professionals in the field
have to be involved in it.
Awareness, or rather the creation of it, is the only solution.
The endeavour should be to include food safety and quality, as well as consumer
rights in the curriculum of schools so that future consumers will become aware of
their rights and demand the best quality food. Simultaneously, proper training
programmes for food handlers working in the processing industries in their native
language are essential
The Codex Alimentarius is the food code that has become the global food standard for
consumer foods, food producers and processors, national food regulatory agencies and
international trade practices. The code has enormous impact and its influence extends
to every continent.
The Codex Alimentarius Commission was created in 1963 by the UN Food and
Agricultural Organisation (FAO) and the World Health Organisation (WHO).
It chalked out the blueprint to develop food standards, guidelines and related texts,
such as codes of practice, under the Joint FAO/WHO Food Standards Programme.
The main purposes of this Programme are protecting health of the consumers and
ensuring fair trade practices in the food trade, and promoting coordination of all food
standards work undertaken by international governmental and non-governmental
organisations.
Ever since its creation, the Commission coordinates all of the food standards work
done by international governmental and non-governmental organisations and makes
recommendations for compliance regulations.
With the 1985 UN Resolution (39/248), the Codex became the guideline for
governments in developing and enforcing consumer protection policies around the
world. Various international trade agreements in the global food market have also
called for complying with the Codex.
Its standards have also become the benchmarks against which food regulations are
evaluated within the legal parameters of WHO agreements. The reach of the Codex,
however, has changed over the years.
The Codex system has presented a unique opportunity for all countries to join the
international community in formulating and harmonising food standards and ensuring
their global implementation.
It also allows them a role in the development of codes governing hygienic processing
practices and recommendations relating to compliance with those standards.
The Codex Alimentarius is not the only product of the Codex Alimentarius
Commission. Its scientific mission has become as influential.
It establishes the scientific standards for food quality and safety, food production,
labeling laws, food legislation and food regulations.
Its scientific reviews and science- based efforts bring together experts and specialists
from a wide range of disciplines “to ensure that its standards withstand the most
rigorous scientific scrutiny.”
The WHO and the FAO point out that the work of the Codex Alimentarius
Commission has provided a focal point for foodrelated scientific research and
investigation, and the Commission itself has become an important international
medium for the exchange of scientific information about food.
Until recently, effectiveness of food control in the Indian domestic market was found
to be severely undermined by the existence of multiple jurisdictions, and weaknesses
in surveillance, monitoring and enforcement.
Several of these food laws were enacted under different ministries in India that had
their own rules and orders, which created a perplex and sometime contradictory
environment for the food business sector.
Thus, despite a notable list of food legislations, not much could be achieved in terms
of food safety and consumers’ protection in the country.
In the second quarter of 2006, the country witnessed a new initiative of enactment of
the latest Act, ‘the Food Safety and Standards Act, 2006, under the Ministry of Health
and Family Welfare that integrates the existing eight food laws.
It brings about one statute under a single apex regulatory authority known as Food
Safety and Standards Authority of India (FSSAI) with minor revisions, while adding
the key provisions to further strengthen food safety regulation.
The Central Government notifies Food Safety and Standards Rules,2011 on May 5,
2011. This new initiative lays down science-based standards for better food quality
control.
The Act is based on international legislations, instrumentalities and Codex
Alimentarius Commission.
It is divided in 12 chapters containing 101 sections and two schedules that provide
key provisions to improve food safety in primary food from production to
consumption
It shall be the duty of the Food Authority to regulate and monitor the manufacture,
processing, distribution, sale and import of food so as to ensure safe and wholesome
food.
Without prejudice to the provisions of sub-section (1),the Food Authority may by
regulations specify
The standards and guidelines in relation to articles of food and specifying an
appropriate system for enforcing various standards notified under this Act;
The limits for use of food additives, crop contaminants, pesticide residues,
residues of veterinary drugs, heavy metals, processing aids, myco-toxins,
antibiotics and pharmacological active substances and irradiation of food;
The mechanisms and guidelines for accreditation of certification bodies
engaged in certification of food safety management systems for food
businesses;
The procedure and the enforcement of quality control in relation to any article
of food imported into India;
The procedure and guidelines for accreditation of laboratories and notification
of the accredited laboratories;
1. Endeavour to achieve an appropriate level of protection of human life and health and
the protection of consumer’s interests, including fair practices in all kinds of food
trade with reference to food safety standards and practices;
2. Carry out risk management which shall include taking into account the results of risk
assessment and other factors which in the opinion of the Food Authority are relevant
to the matter under consideration and where the conditions are relevant, in order to
achieve the general objectives of regulations;
3. Where in any specific circumstances, on the basis of assessment of available
information, the possibility of harmful effects on health is identified but scientific
uncertainty persists, provisional risk management measures necessary to ensure
appropriate level of health protection may be adopted, 21 pending further scientific
information for a more comprehensive risk assessment;
4. The measures adopted on the basis of clause
5. Shall be proportionate and no more restrictive of trade than is required to achieve
appropriate level of health protection, regard being had to technical and economic
feasibility and other factors regarded as reasonable and proper in the matter under
consideration;
6. The measures adopted shall be reviewed within a reasonable period of time,
depending on the nature of the risk to life or health being identified and the type of
scientific information needed to clarify the scientific uncertainty and to conduct a
more comprehensive risk assessment;
7. In cases where there are reasonable grounds to suspect that a food may present a risk
for human health, then, depending on the nature, seriousness and extent of that risk,
the Food Authority and the Commissioner of Food Safety shall take appropriate steps
to inform the general public of the nature of the risk to health, identifying to the
fullest extent possible the food or type of food, the risk that it may present, and the
measures which are taken or about to be taken to prevent, reduce or eliminate that
risk; and
8. Where any food which fails to comply with food safety requirements is part of a
batch, lot or consignment of food of the same class or description, it shall be
presumed until the contrary is proved, that all of the food in that batch, lot or
consignment fails to comply with those requirements.
No article of food shall contain any food additive or processing aid unless it is in
accordance with the provisions of this Act and regulations made thereunder.
Explanation– For the purposes of this section, “processing aid” means any substance
or material, not including apparatus or utensils, and not consumed as a food ingredient
by itself, used in the processing of raw materials, foods or its ingredients to fulfil a 23
certain technological purpose during treatment or processing and which may result in
the non-intentional but unavoidable presence of residues or derivatives in the final
product.
Genetically modified foods, organic foods, functional foods, proprietary foods, etc
Save as otherwise provided under this Act and regulations made thereunder, no person shall
manufacture, distribute, sell or import any novel food, genetically modified articles of food,
irradiated food, organic foods, foods for special dietary uses, functional foods,
neutraceuticals, health supplements, proprietary foods and such other articles of food which
the Central Government may notify in this behalf.
Packaging and labelling of foods
1. No person shall manufacture, distribute, sell or expose for sale or despatch or deliver
to any agent or broker for the purpose of sale, any packaged food products which are
not marked and labelled in the manner as may be specified by regulations: Provided
that the labels shall not contain any statement, claim, design or device which is false
or misleading in any particular concerning the food products contained in the package
or concerning the quantity or the nutritive value implying medicinal or therapeutic
claims or in relation to the place of origin of the said food products.
2. Every food business operator shall ensure that the labelling and presentation of food,
including their shape, appearance or packaging, the packaging materials used, the
manner in which they are arranged and the setting in which they are displayed, and
the information which is made available about them through whatever medium, does
not mislead consumers.
1. falsely represents that the foods are of a particular standard, quality, quantity or grade-
composition;
2. makes a false or misleading representation concerning the need for, or the usefulness;
3. gives to the public any guarantee of the efficacy that is not based on an adequate or
scientific justification thereof:
Provided that where a defence is raised to the effect that such guarantee is based on adequate
or scientific justification, the burden of proof of such defence shall lie on the person raising
such defence.
PROVISIONS RELATING TO IMPORT
All imports of articles of food to be subject to this Act.
No person shall import into India –
Any article of food in contravention of any other provision of this Act or of any rule or
regulation made thereunder or any other Act.
The Central Government shall, while prohibiting, restricting or otherwise regulating import
of article of food under the Foreign Trade (Development and Regulation) Act, 1992 (22 of
1992), follow the standards laid down by the Food Authority under the provisions of this Act
and the Rules and regulations made there under.
1. Every food business operator shall ensure that the articles of food satisfy the
requirements of this Act and the rules and regulations made there under at all stages
of production, processing, import, distribution and sale within the businesses under
his control.
2. No food business operator shall himself or by any person on his behalf manufacture,
store, sell or distribute any article of food
3. which is unsafe; or
4. which is misbranded or sub-standard or contains extraneous matter; or
5. for which a licence is required, except in accordance with the conditions of the
licence; or
6. which is for the time being prohibited by the Food Authority or the Central
Government or the State Government in the interest of public health; or
7. In contravention of any other provision of this Act or of any rule or regulation made
there under.
2. No food business operator shall employ any person who is suffering from infectious,
contagious or loathsome disease.
3. No food business operator shall sell or offer for sale any article of food to any vendor
unless he also gives a guarantee in writing in the form specified by regulations about
the nature and quality of such article to the vendor: Provided that a bill, cash memo,
or invoice in respect of the sale of any article of food given by a food business
operator to the vendor shall be deemed to be a guarantee under this section, even if a
guarantee in the specified form is not included in the bill, cash memo or invoice.
4. Where any food which is unsafe is part of a batch, lot or consignment of food of the
same class or description, it shall be presumed that all the food in that batch, lot or
consignment is also unsafe, unless following a detailed assessment within a specified
time, it is found that there is no evidence that the rest of the batch, lot or consignment
is unsafe.
1. The manufacturer or packer of an article of food shall be liable for such article of food
if it does not meet the requirements of this Act and the rules and regulations made
there under.
2. The wholesaler or distributor shall be liable under this Act for any article of food
which is
1. Supplied after the date of its expiry; or
2. Stored or supplied in violation of the safety instructions of the manufacturer;
or
3. Unsafe or misbranded; or
4. Unidentifiable of manufacturer from whom the article of food have been
received; or
5. Stored or handled or kept in violation of the provisions of this Act, the rules
and regulations made thereunder; or
6. received by him with knowledge of being unsafe
3. The seller shall be liable under this Act for any article of food which is
1. sold after the date of its expiry; or
2. handled or kept in unhygienic conditions; or
3. misbranded; or
4. unidentifiable of the manufacturer or the distributors from whom such articles
of food were received; or
5. received by him with knowledge of being unsafe
ANALYSIS OF FOOD
Recognition and accreditation of laboratories, research institutions and referral food
laboratory
1. The Food Authority may notify food laboratories and research institutions accredited
by National Accreditation Board for Testing and Calibration Laboratories or any other
accreditation agency for the purposes of carrying out analysis of samples by the Food
Analysts under this Act.
2. The Food Authority shall, establish or recognise by notification, one or more referral
food laboratory or laboratories to carry out the functions entrusted to the referral food
laboratory by this Act or any rules and regulations made thereunder.
3. The Food Authority may frame regulations specifying –
1. The functions of food laboratory and referral food laboratory and the local
area or areas within which such functions may be carried out;
The procedure for submission to the said laboratory of samples of articles of food for analysis
or tests, the forms of the laboratory’s reports thereon and the fees payable in respect of such
reports; and
Such other matters as may be necessary or expedient to enable the said laboratory to carry out
its functions effectively.
Recognition of organisation or agency for food safety audit
The Food Authority may recognise any organisation or agency for the purposes of food safety
audit and checking compliance with food safety management systems required under this Act
or the rules and regulations made thereunder.
OFFENCES AND PENALTIES
Penalty for selling food not of the nature or substance or quality demanded
Any person who sells to the purchaser’s prejudice any food which is not in compliance with
the provisions of this Act or the regulations made thereunder, or of the nature or substance or
quality demanded by the purchaser, shall be liable to a penalty not exceeding five lakh
rupees.
Penalty for sub-standard food
Any person who whether by himself or by any other person on his behalf manufactures for
sale or stores or sells or distributes or imports any article of food for human consumption
which is sub-standard, shall be liable to a penalty which may extend to five lakh rupees.
Penalty for misbranded food
1. Any person who whether by himself or by any other person on his behalf
manufactures for sale or stores or sells or distributes or imports any article of food for
human consumption which is misbranded, shall be liable to a penalty which may
extend to three lakh rupees.
2. The Adjudicating Officer may issue a direction to the person found guilty of an
offence under this section, for taking corrective action to rectify the mistake or such
article of food shall be destroyed.
Penalty for failure to comply with the directions of Food Safety Officer
If a food business operator or importer without reasonable ground, fails to comply with the
requirements of this Act or the rules or regulations or orders issued thereunder, as directed by
the Food Safety Officer, he shall be liable to a penalty which may extend to two lakh rupees.
Penalty for unhygienic or unsanitary processing or manufacturing of food
Any person who, whether by himself or by any other person on his behalf, manufactures or
processes any article of food for human consumption under unhygienic or unsanitary
conditions, shall be liable to a penalty which may extend to one lakh rupees
Punishment for false information
If a person, in connection with a requirement or direction under this Act, provides any
information or produces any document that the person knows is false or misleading, he shall
be punishable with imprisonment for a term which may extend to three months and also with
fine which may extend to two lakh rupees.
Punishment for carrying out a business without licence
If any person or food business operator (except the persons exempted from licensing under
sub-section (2) of section 31 of this Act), himself or by any person on his behalf who is
required to obtain licence, manufacturers, sells, stores or distributes or imports any article of
food without licence, shall be punishable with imprisonment for a term which may extend to
six months and also with a fine which may extend to five lakh rupees.
Safe drinking water is the birthright of all humankind – as much a birthright as clean
air.
The majority of the world’s population, however, does not have access to safe
drinking water. This is certainly true in most parts of Africa and Asia. Even in
relatively advanced countries such as India, safe drinking water is not readily
available, particularly in rural areas.
One reason safe drinking water is of paramount concern is that 75 percent of all
diseases in developing countries arise from polluted drinking water.
Knowledge about how to make water safe for consumption is rare in most developing
countries.
We simply must do a better job of raising public awareness and understanding about
the nature of the problem and the technologies and strategies that are available to
address it.
Background
Private industry and nongovernmental organizations role in Safe Drinking Water SUpply
Many countries – for example, India, Indonesia, Kenya, and Nepal – have active
nongovernmental organizations that involve communities in the funding and implementation
of programmes designed to transform arid and semiarid terrains into productive agricultural
regions receiving sufficient amounts of water. Such efforts should be expanded by:
Bharat Nirman
Scheme for providing safe drinking water supply through community water purification
plants in fluoride, arsenic, uranium and other heavy/toxic metals and pesticide/fertilizer
affected rural habitations in the country
The National Rural Drinking Water Programme (NRDWP) funds for supplying “safe”
water in contaminated areas are being utilized by the States as a policy mostly for
alternate safe Piped Water Supply (PWS) schemes including Multivillage schemes
(MVS) (i. e., from far away safe sources) the gestation period of such MVS projects is
about 4-5 years.
Since the rural people cannot be put to risk due to consumption of unsafe drinking
water in the interim period as also whereas all such Multi-Village Schemes carrying
safe water from far away sources cannot be planned and completed in the span of 4-5
years due to huge funds involved, hence, the Ministry of Drinking Water & Sanitation
has submitted an EFC proposal to provide community water purification plants in
fluoride, arsenic, uranium and other heavy/toxic metals and pesticide/fertilizer
affected rural habitations in the country for providing safe drinking water immediately
with an anticipated expenditure of total capital cost of Rs 3,600 crore with fund
sharing pattern of 75:25 (90:10 in case of NE, J&K) between Centre and State in
approx 20,000 habitations during the period 2014-15 to 2016-17.
Combined Water Supply Schemes are being implemented where more than one local
body, either rural or urban with a common source of water supply is involved with
financial assistance under the Minimum Needs Programme, National Rural Drinking
Water Programme and with funding from financial institutions like TUFIDCO,
TNUIFSL, NABARD and Asian Development Bank.
During 2009 – 10 combined water supply schemes have been completed to benefit
4352 rural habitations and 41 towns at a cost of Rs. 795.04 crores. Presently Board is
maintaining 422 CWSS in the state to serve 10,101 habitations benefiting populations
of 131.59 lakhs which is about 20 percent of the state population
Defluoridation and other Techniques of water purification
Defluoridation and other Techniques of water purification
Defluoridation
Defluoridation is the downward adjustment of the level of fluoride in drinking water.
Worldwide, fluoride is one of the most abundant anions present in groundwater.
Fluoride is more present in groundwater than surface water mainly due to the leaching
of minerals. Groundwater accounts for 98 percent of the earth’s potable water. An
excess of fluoride in drinking water causes dental fluorosis and skeletal fluorosis. The
World Health Organization has recommended a guideline value of 1.5 mg/L as the
concentration above which dental fluorosis is likely. Fluorosis is endemic in more
than 20 developed and developing nations.
Defluoridation of groundwater using brick powder as an adsorbent was studied in
batch process. Different parameters of adsorption, viz. effect of pH, effect of dose and
contact time were selected and optimized for the study. Feasible optimum conditions
were applied to two groundwater samples of high fluoride concentration to study the
suitability of adsorbent in field conditions. Comparison of adsorption by brick powder
was made with adsorption by commercially available activated charcoal. In the
optimum condition of pH and dose of adsorbents, the percentage defluoridation from
synthetic sample, increased from 29.8 to 54.4% for brick powder and from 47.6 to
80.4% for commercially available activated charcoal with increasing the contact time
starting from 15 to 120 min. Fluoride removal was found to be 48.73 and 56.4% from
groundwater samples having 3.14 and 1.21 mg l−1 fluoride, respectively, under the
optimized conditions. Presence of other ions in samples did not significantly affect the
deflouridation efficiency of brick powder. The optimum pH range for brick powder
was found to be 6.0–8.0 and adsorption equilibrium was found to be 60 min. These
conditions make it very suitable for use in drinking water treatment. Deflouridation
capacity of brick powder can be explained on the basis of the chemical interaction of
fluoride with the metal oxides under suitable pH conditions. The adsorption process
was found to follow first order rate mechanism as well as Freundlich isotherm.
Boiling
Boiling water is the cheapest and safest method of water purification. Water sources
and or channels of distribution may render your water unsafe. For example, parasites
and germs are things you may not see by bare eyes, but their effects can be life
threatening.
In this method, clean water should be brought to boil and left at rolling-boil for 1-3
minutes. For people living in high altitude areas, it is recommended to boil your water
for longer than water boiled at lower altitudes. This is because water boils at lower
temperatures in higher altitudes. Boiled water should be covered and left to cool
before drinking. For water drawn from wells, leave it for compounds to settle before
you filter out clean water for use.
Filtration
Filtration is one of the effective ways of purifying water and when using the right
multimedia filters it’s effective in ridding water of the compounds. This method uses
chemical and physical processes to purify water and make it safe for human
consumption. Filtration eliminates both large compounds and small, dangerous
contaminants that cause diseases with a simple and quick filtration process.. Since
filtration does not deplete all the mineral salts, water that has been filtered is
considered healthier compared to water purified using other methods. It’s one of the
effective water purification methods that utilize chemical absorption process that
effectively removes unwanted compounds from water.
Compared to reverse osmosis, filtration is considered effective when it comes to
selective elimination of much smaller molecular compounds such as chlorine and
pesticides. The other factor that makes filtration less costly is that it does not require a
lot of energy needed in distillation and reverse osmosis. It is an economic method of
water purification because little water is lost during purification.
Distillation
Distillation is a water purification method that utilizes heat to collect pure water in the
form of vapor. This method is effective by the scientific fact that water has a lower
boiling point than other contaminants and disease-causing elements found in water.
Water is subjected to a heat source until it attains its boiling point. It is then left at the
boiling point until it vaporizes. This vapor is directed into a condenser to cool. Upon
cooling, vapor is reversed into liquid water that is clean and safe for drinking. Other
substances that have a higher boiling point are left as sediments in the container.
This method is effective in removing bacteria, germs, salts and other heavy metals
such as lead, mercury and arsenic. Distillation is ideal for people who have access to
raw, untreated water. This method has both advantages and disadvantages. A notable
disadvantage is that it is a slow process of water purification. In addition, it requires a
heat source for the purification to work. Although cheap sources of energy are being
developed, distillation remains a costly process of purifying water. It is only ideal
(effective and least costly) when purifying small quantities of water (It is not ideal for
large scale, commercial or industrial purification).
Chlorination
Chlorine is a powerful chemical that has been in use for many years to treat water for
home consumption. Chlorine is an effective water purification method that kills
germs, parasites and other disease-causing organisms found in ground or tap water.
Water can be purified using chlorine tablets or liquid chlorine. As an off-the-shelf
water purification product, chlorine is cheap and effective. However, caution should
be taken when using chlorine liquid or tablets to treat drinking water. For example,
people suffering from thyroid problems should talk to a medical practitioner before
using this product. When using chlorine tablets, it is important to apply them in heated
water, as they dissolve well in water that is at 21 degree Celsius or higher. Chlorine
tablets kill all bacteria leaving your water clean and safe.
If you are looking for the best ways of treating your water, Schultz Soft Water is your
best source of advice on best water purification methods and custom solutions to your
water purification needs. Reverse osmosis is the best option, whereas filtering is good
for basic water tasks such as sediment and chlorine removal. Reverse osmosis covers
a larger spectrum of contaminant removal.
Microbial infections
Microorganisms
Microscopic organisms, commonly known as microorganisms or microbes, are found all
around us and even inside our bodies. The category ‘Microbes’ includes a massive range of
organisms including bacteria, fungi, viruses, algae, archaea and protozoa. Some of these, such
as bacteria and fungi, are well known, but others such as archaea much less so.
The vast majority of microbes on the earth pose no real threat to humans, plants or animals;
in fact they actually work alongside humans to make world go round, aiding decomposition,
decay and even helping us to digest our food. However, there are some microorganisms
which negatively impact our lives, causing illness, bad odours and damaging products and
surfaces. Some of the names we regularly hear in the media are Salmonella, E.Coli, MRSA,
Malaria and Bird flu.
common bacteria
The types of bacteria prevalent in an environment are determined by several factors.
However, bacteria are found in every habitable place on earth. They survive in soil, rocks,
oceans, volcanoes, and even arctic snow. Some have been found living in or on other
organisms including plants, animals, and humans. The common types of bacteria found in
buildings are not harmful when in low numbers. However, just like with mold, elevated
levels of bacteria particularly the gram negative type are potentially a health hazard.
Some types of bacteria in buildings are brought in with occupants and with outdoor air.
Others are human-gut-associated bacteria such as Lactobacillus, Staphylococcus and
Clostridium. These types of bacteria are most common in bathroom environment. Research
has shown that the types of bacteria in a building are also influenced by the type of
ventilation, i.e., mechanically or naturally ventilated. For example, naturally ventilated
buildings are associated with more plant- and soil-associated bacteria while mechanically
ventilated buildings are likely to be dominated by human-associated bacteria.
Virus
Virus, an infectious agent of small size and simple composition that can multiply only in
living cells of animals, plants, or bacteria. The name is from a Latin word meaning “slimy
liquid” or “poison.”
The earliest indications of the biological nature of viruses came from studies in 1892 by the
Russian scientist Dmitry I. Ivanovsky and in 1898 by the Dutch scientist Martinus W.
Beijerinck. Beijerinck first surmised that the virus under study was a new kind of infectious
agent, which he designated contagium vivum fluidum, meaning that it was a live, reproducing
organism that differed from other organisms. Both of these investigators found that a disease
of tobacco plants could be transmitted by an agent, later called tobacco mosaic virus, passing
through a minute filter that would not allow the passage of bacteria. This virus and those
subsequently isolated would not grow on an artificial medium and were not visible under the
light microscope. In independent studies in 1915 by the British investigator Frederick W.
Twort and in 1917 by the French Canadian scientist Félix H. d’Hérelle, lesions in cultures of
bacteria were discovered and attributed to an agent called bacteriophage (“eater of bacteria”),
now known to be viruses that specifically infect bacteria.
Communicable diseases
The most common diseases which are endemic in India are as follows:
Communicable Disease- Malaria:
Hepatitis A:
Hepatitis B:
Hepatitis C:
Hepatitis C is a viral disease commonly occurring after transfusion or parenteral drug
abuse.
It frequently progresses to a chronic form that is usually asymptomatic, but may
involve liver cirrhosis.
Hepatitis D:
Hepatitis E:
Person to person transmission is not possible. Leptospirosis can spread due to contact
with urine, blood or tissues from infected persons. The organisms enter the body
through the breaks in the skin or through mucous membranes.
The organisms can also be acquired by drinking contaminated water. Infection is
commonly acquired by bathing in contaminated water.
The organisms multiply in the blood and tissues of the body. Though the organism
can affect any organ of the body, the kidney and liver are commonly involved. The
incubation period is usually 10 days. It may vary from 2 to 20 days.
Brucellosis is one of the major bacterial zoonoses, and in humans is also known as
undulent fever, Malta fever or Mediterranean fever.
It is occasionally transmitted to humans by direct or indirect contact with infected
animals.
The disease may last for several days, months or occasionally, even years.
Brucellosis is both a severe human disease and a disease of animals with serious
economic consequences. Brucellosis is a recognized public health hazard that is found
the world over.
It is endemic wherever cattle, pigs, goats and sheep are raised in large numbers. The
important endemic areas for Brucellosis exist in Mediterranean zones, Europe, Central
Asia, Mexico and South America. Animal Brucellosis has been reported from
practically every state in India.
However, no statistical information is available about the extent of infection in
humans in various parts of the country.
The prevalence of human Brucellosis is difficult to estimate. Many cases remain
undiagnosed either because they are not apparent, or because physicians in many
countries are unfamiliar with the disease.
Filariasis is a major public health problem in India. There are an estimated six million
attacks of acute filarial disease per year, and at least 45 million persons currently have
one or more chronic filarial lesions.
Heavily infected areas are found in Uttar Pradesh, Bihar, Andhra Pradesh, Orissa,
Tamil Nadu, Kerala and Gujarat.
The infection is acquired from a person who has filariasis. The maximum infectivity
is when the organisms are circulating the blood.
The largest number appears in the blood at night time, and retreats from the blood
stream during the day. Their usual habitat is in the lymph nodes.
The mosquito feeds on such a person and acquires the filarial parasite. The filarial
organism is transmitted when the mosquito bites a person. The parasite is deposited
near the site of puncture.
It passes through the punctured skin or may penetrate the skin on its own and finally
reach the lymphatic system. Filariasis affects all age groups.
Non communicable diseases are the one which are of long duration and slow in
progression. As per World health organization, NCDs account for total 53% of all
deaths in India. Most of the burden is attributed by cardiovascular diseases (24%),
followed by respiratory diseases (11%), other NCDs (10%) and Injuries (10%).
According to a report presented by world economic forum and Harward School of
public health, the prevalent NCDs in India are CVDs, chronic respiratory diseases,
Diabetes, and cancer.
Cancer is one the leading cause of death in India with 28 lac cases at a point of time
and 10 lac new cases taking place very year. The burden of cancer is expected to rise
in the country due to the effects of tobacco, demographic transitions and increase in
the life expectancy.
Diabetes is another leading NCD in the nation. Estimated total number of people
suffering with diabetes is 40.9 million in India and by 2025 it is expected to increase
up-to 69.9 million. Diabetes accounts for 1.09 lakh deaths in a year.
Hypertension is a major risk factor for cardiovascular diseases. Hypertension is
directly responsible for 57% of all stroke deaths and 24% of all coronary heart disease
deaths in India. The cases of CVDs are expected to rise up to 741 lacs in 2015.
Chronic obstructive pulmonary disease is responsible for high rate of mortality and
morbidity across the world. In 2010, almost 24 million adults over the age of 40 in
India had COPD. It is expected to increase to 32 million by 2020.
The other conditions which contribute to the burden of non-communicable diseases
are mental health conditions (schizophrenia, depression & bipolar disorder) and
musculoskeletal disorders (Rheumatoid arthritis, osteoarthritis & gout).
The non-communicable diseases are emerging due to the risk factors associated with
it. The main risk factors which are associated with NCDs are tobacco use, harmful use
of alcohol, lack of physical activity and poor diet.3Table 2&3 shows the risk
factors(Behavioral & Metabolic respectively) associated with noncommunicable
diseases and their prevalence.
In addition to the above said risk factors for NCDs; Globalization and urbanization
has also contributed to its burden. It has caused the nutritional transition in the
country because of the availability of the commercial food. One another important
factor causing the rise in NCDs is change in demographic profile of the country.
A study conducted by Joy Kumar Chakma & Sanjay Gupta on“Lifestyle and Non-
Communicable Diseases: A double edged sword for future India” showed that In
India, 53% of the deaths in 2008 were due to NCDs (WHO). The cardiovascular
diseases (CVDs) alone account for 24 percent of all deaths.
The anticipated cumulative loss of national income due to NCDs mortality for India
for 2006-2015 will be USD237 billion. By 2030, this productivity loss is expected to
double. These major NCDs can be prevented through effective interventions by
undertaking the lifestyle related modifiable risk factors.
Total deaths (in thousands) caused by non-communicable diseases as per WHO
(2008) estimates are 2967.6 and 2273.8 among males and females respectively. NCD
deaths under the age of 60 years are 35.0% (Males) and 32.1% (Females).
Vaccines: Introduction to immunity
Vaccines
A vaccine is a biological preparation that improves immunity to a particular disease. A
vaccine typically contains an agent that resembles a disease-causing microorganism, and is
often made from weakened or killed forms of the microbe, its toxins or one of its surface
proteins. The agent stimulates the body’s immune system to recognize the agent as foreign,
destroy it, and “remember” it, so that the immune system can more easily recognize and
destroy any of these microorganisms that it later encounters.
Introduction to immunity
The immune system refers to a collection of cells and proteins that function to protect the
skin, respiratory passages, intestinal tract and other areas from foreign antigens, such as
microbes (organisms such as bacteria, fungi, and parasites), viruses, cancer cells, and toxins.
The immune system can be simplistically viewed as having two “lines of defense”: innate
immunity and adaptive immunity. Innate immunity represents the first line of defense to an
intruding pathogen. It is an antigen-independent (non-specific) defense mechanism that is
used by the host immediately or within hours of encountering an antigen. The innate immune
response has no immunologic memory and, therefore, it is unable to recognize or “memorize”
the same pathogen should the body be exposed to it in the future. Adaptive immunity, on the
other hand, is antigen-dependent and antigen-specific and, therefore, involves a lag time
between exposure to the antigen and maximal response. The hallmark of adaptive immunity
is the capacity for memory which enables the host to mount a more rapid and efficient
immune response upon subsequent exposure to the antigen. Innate and adaptive immunity are
not mutually exclusive mechanisms of host defense, but rather are complementary, with
defects in either system resulting in host vulnerability.
Innate immunity
The primary function of innate immunity is the recruitment of immune cells to sites of
infection and inflammation through the production of cytokines (small proteins involved in
cell-cell communication). Cytokine production leads to the release of antibodies and other
proteins and glycoproteins which activate the complement system, a biochemical cascade that
functions to identify and opsonize (coat) foreign antigens, rendering them susceptible to
phagocytosis (process by which cells engulf microbes and remove cell debris). The innate
immune response also promotes clearance of dead cells or antibody complexes and removes
foreign substances present in organs, tissues, blood and lymph. It can also activate the
adaptive immune response through a process known as antigen presentation.
Numerous cells are involved in the innate immune response such as phagocytes
(macrophages and neutrophils), dendritic cells, mast cells, basophils, eosinophils, natural
killer (NK) cells and lymphocytes (T cells). Phagocytes are sub-divided into two main cell
types: neutrophils and macrophages. Both of these cells share a similar function: to engulf
(phagocytose) microbes. In addition to their phagocytic properties, neutrophils contain
granules that, when released, assist in the elimination of pathogenic microbes. Unlike
neutrophils (which are short-lived cells), macrophages are long-lived cells that not only play
a role in phagocytosis, but are also involved in antigen presentation to T cells. Macrophages
are named according to the tissue in which they reside. For example, macrophages present in
the liver are called Kupffer cells while those present in the connective tissue are termed
histiocytes.
Adaptive immunity
Adaptive immunity develops when innate immunity is ineffective in eliminating infectious
agents and the infection is established. The primary functions of the adaptive immune
response are the recognition of specific “non-self” antigens in the presence of “self” antigens;
the generation of pathogen-specific immunologic effector pathways that eliminate specific
pathogens or pathogen-infected cells; and the development of an immunologic memory that
can quickly eliminate a specific pathogen should subsequent infections occur. The cells of the
adaptive immune system include: T cells, which are activated through the action of antigen
presenting cells (APCs), and B cells.
T cells derive from hematopoietic stem cells in bone marrow and, following migration,
mature in the thymus. These cells express a unique antigen-binding receptor on their
membrane, known as the T-cell receptor (TCR), and as previously mentioned, require the
action of APCs (usually dendritic cells, but also macrophages, B cells, fibroblasts and
epithelial cells) to recognize a specific antigen.
The surfaces of APCs express cell-surface proteins known as the major histocompatibility
complex (MHC). MHC are classified as either class I (also termed human leukocyte antigen
[HLA] A, B and C) which are found on all nucleated cells, or class II (also termed HLA, DP,
DQ and DR) which are found on only certain cells of the immune system, including
macrophages, dendritic cells and B cells. Class I MHC molecules present endogenous
(intracellular) peptides while class II molecules present exogenous (extracellular) peptides.
The MHC protein displays fragments of antigens (peptides) when a cell is infected with a
pathogen or has phagocytosed foreign proteins.
T cells are activated when they encounter an APC that has digested an antigen and is
displaying antigen fragments bound to its MHC molecules. The MHC-antigen complex
activates the TCR and the T cell secretes cytokines which further control the immune
response. This antigen presentation process stimulates T cells to differentiate into either
cytotoxic T cells (CD8+ cells) or T-helper (Th) cells (CD4+ cells). Cytotoxic T cells are
primarily involved in the destruction of cells infected by foreign agents. They are activated
by the interaction of their TCR with peptide-bound MHC class I molecules. Clonal expansion
of cytotoxic T cells produce effector cells which release perforin and granzyme (proteins that
causes lysis of target cells) and granulysin (a substance that induces apoptosis of target cells).
Upon resolution of the infection, most effector cells die and are cleared by phagocytes.
However, a few of these cells are retained as memory cells that can quickly differentiate into
effector cells upon subsequent encounters with the same antigen.
T helper (Th) cells play an important role in establishing and maximizing the immune
response. These cells have no cytotoxic or phagocytic activity, and cannot kill infected cells
or clear pathogens. However, they “mediate” the immune response by directing other cells to
perform these tasks. Th cells are activated through TCR recognition of antigen bound to class
II MHC molecules. Once activated, Th cells release cytokines that influence the activity of
many cell types, including the APCs that activate them.
Passive Immunity
Passive immunity is the transfer of antibody produced by one human or other animal to
another. Passive immunity provides protection against some infections, but this protec – tion
is temporary. The antibodies will degrade during a period of weeks to months, and the
recipient will no longer be protected. The most common form of passive immunity is that
which an infant receives from its mother. Antibodies are trans – ported across the placenta
during the last 1–2 months of pregnancy. As a result, a full-term infant will have the same
antibodies as its mother. These antibodies will protect the infant from certain diseases for up
to a year.
Protection is better against some diseases (e.g., measles, rubella, tetanus) than others (e.g.,
polio, pertussis). Many types of blood products contain antibody. Some products (e.g.,
washed or reconstituted red blood cells) contain a relatively small amount of antibody, and
some (e.g., intravenous immune globulin and plasma products) contain a large amount.
In addition to blood products used for transfusion (e.g., whole blood, red cells, and platelets)
there are three major sources of antibody used in human medicine. These are homologous
pooled human antibody, homologous human hyperimmune globulin, and heterologous
hyperimmune serum.
Homologous pooled human antibody is also known as immune globulin. It is produced by
combining (pooling) the IgG antibody fraction from thousands of adult donors in the United
States. Because it comes from many different donors, it contains antibody to many different
antigens. It is used primarily for postexposure prophylaxis for hepatitis A and measles and
treatment of certain congenital immuno – globulin deficiencies.
Active Immunity
Active immunity is stimulation of the immune system to produce antigen-specific humoral
(antibody) and cellular immunity. Unlike passive immunity, which is temporary, active
immunity usually lasts for many years, often for a lifetime.
One way to acquire active immunity is to survive infection with the disease-causing form of
the organism. In general, once persons recover from infectious diseases, they will have
lifelong immunity to that disease. The persistence of protection for many years after the
infection is known as immunologic memory. Following exposure of the immune system to an
antigen, certain cells (memory B cells) continue to circulate in the blood (and also reside in
the bone marrow) for many years. Upon reexposure to the antigen, these memory cells begin
to replicate and produce antibody very rapidly to reestablish protection.
Another way to produce active immunity is by vaccination. Vaccines interact with the
immune system and often produce an immune response similar to that produced by the
natural infection, but they do not subject the recipient to the disease and its potential
complications. Many vaccines also produce immunologic memory similar to that acquired by
having the natural disease.
Fundamental concepts in vaccination
Fundamental concepts in vaccination
Immunology and Vaccine-Preventable Diseases Immunology is a complicated subject, and a
detailed discussion of it is beyond the scope of this text. However, an understanding of the
basic function of the immune system is useful in order to understand both how vaccines work
and the basis of recommendations for their use. The description that follows is simplified.
Many excellent immunology textbooks are available to provide additional detail.
Immunity is the ability of the human body to tolerate the presence of material indigenous to
the body (“self”), and to eliminate foreign (“nonself”) material. This discriminatory ability
provides protection from infectious disease, since most microbes are identified as foreign by
the immune system. Immunity to a microbe is usually indicated by the presence of antibody
to that organism. Immunity is gener – ally specific to a single organism or group of closely
related organisms. There are two basic mechanisms for acquiring immunity, active and
passive.
Traditional methods of vaccine production ( production of DPT and Rabies vaccine)
Traditional methods of vaccine production
The first human vaccines against viruses were based using weaker or attenuated viruses to
generate immunity. The smallpox vaccine used cowpox, a poxvirus that was similar enough
to smallpox to protect against it but usually didn’t cause serious illness. Rabies was the first
virus attenuated in a lab to create a vaccine for humans.
Egg-Based Vaccines
Over the last 60 years, seasonal flu vaccines have been manufactured using fertilized
embryonic eggs. Using this method, it takes about four months to produce a batch of
vaccines for a new strain of influenza virus; from the moment the new influenza virus’
culture becomes available for vaccine manufacturing. The advantages of using embryonic
eggs to manufacture seasonal flu vaccines are that the safety and effectiveness of the vaccines
produced have been well established.
Cell-Based Vaccines
Since the mid 1990’s, newer vaccine manufacturing methods were developed. The cell-based
vaccine manufacturing process is one of such methods. The cell-based vaccine
manufacturing process uses cells from mammals to culture the influenza virus for vaccine
production. Various pharmaceutical companies use different sources of mammalian cell
cultures for the vaccine manufacturing process. Baxter Healthcare uses cells extracted from
the kidney of the African Green Monkey while companies such as Solvay Biologicals and
Novartis Vaccines use kidney cells from canines to produce seasonal flu vaccines.
Production of DPT vaccine
DPT is a class of combination vaccines against three infectious diseases in humans:
diphtheria, pertussis (whooping cough), and tetanus. The vaccine components include
diphtheria and tetanus toxoids and killed whole cells of the bacterium that causes pertussis.
Although different combinations may contain the same toxoids or antigens each vaccine may
differ substantially according to the toxoid or antigen dose, number of pertussis components
(for acellular vaccines), method of purification and inactivation of the toxins and
incorporation of adjuvants and excipients. All of these factors may have an impact on the
reactogenicity of different DTP vaccine combinations.
Diphtheria and Tetanus (DT and Td) toxoid combination: DT vaccine used for primary
immunisation and boosting in children contains 6.7-25Lf of diphtheria toxoid and 5 – 7.5 Lf
of tetanus toxoid per dose. An adult combination, Td, is used for boosting and primary
immunisation in adolescents and adults and contains a lower dose of diphtheria (less than 2
Lf/dose) but a similar dose of tetanus toxoid.
Diphtheria, Tetanus and Pertussis (DTP) combinations: Initial DTP combination
preparations contained whole-cell pertussis antigens. Concern due to common occurrence of
minor local reactions and less common severe reactions of whole-cell pertussis led to the
development of acellular vaccines and clinical trials demonstrating their efficacy in the
1980’s. Multiple acellular pertussis vaccines are now available and are referred to by the
number of acellular antigen components that they contain. Whole-cell pertussis vaccine
remains a safe, inexpensive and effective vaccine which is used in many countries because
whole cell vaccines that generate a higher level of antibody to pertussis toxin are associated
with higher vaccine efficacy.
DTP with other vaccine antigen combinations: There are many vaccine formulations
containing diphtheria and tetanus toxoids and whole cell or acellular pertussis antigens in
combination with Haemophilus influenzae type b, hepatitis B and/or inactivated polio virus to
produce quadrivalent, pentavalent and hexavalent combination vaccines.
Rabies vaccine
Pre-exposure vaccination should be offered to people at high risk of exposure to rabies, such
as laboratory staff working with rabies virus, veterinarians, animal handlers and wildlife
officers, and other individuals living in or travelling to countries or areas at risk. Travellers
with extensive outdoor exposure in rural areas – such as might occur while running,
bicycling, hiking, camping, backpacking, etc. – may be at risk, even if the duration of travel
is short. Preexposure vaccination is advisable for children living in or visiting countries or
areas at risk, where they provide an easy target for rabid animals. Pre-exposure vaccination is
also recommended for individuals travelling to isolated areas or to areas where immediate
access to appropriate medical care is limited or to countries where modern rabies vaccines are
in short supply and locally available rabies vaccines might be unsafe and/or ineffective.
Pre-exposure rabies vaccination consists of three full intramuscular (i.m.) doses of cell-
culture- or embryonated-egg-based vaccine given on days 0, 7 and 21 or 28 (a few days’
variation in the timing is not important). For adults, the vaccine should always be
administered in the deltoid area of the arm; for young children (under 1 year of age), the
anterolateral area of the thigh is recommended. Rabies vaccine should never be administered
in the gluteal area: administration in this manner will result in lower neutralizing antibody
titres.
To reduce the cost of cell-derived vaccines for pre-exposure rabies vaccination, intradermal
(i.d.) vaccination in 0.1-ml volumes on days 0, 7 and either 21 or 28 may be considered. This
method of administration is an acceptable alternative to the standard intramuscular
administration, but it is technically more demanding and requires appropriate staff training
and qualified medical supervision. Concurrent use of chloroquine can reduce the antibody
response to intradermal application of cell-culture rabies vaccines. People who are currently
receiving malaria prophylaxis or who are unable to complete the entire three-dose pre-
exposure series before starting malarial prophylaxis should therefore receive pre-exposure
vaccination by the intramuscular route.
Periodic booster injections are not recommended for general travellers. However, in the event
of exposure through the bite or scratch of an animal known or suspected to be rabid,
individuals who have previously received a complete series of pre- or post-exposure rabies
vaccine (with cell-culture or embryonated-egg vaccine) should receive two booster doses of
vaccine. Ideally, the first dose should be administered on the day of exposure and the second
3 days later. This should be combined with thorough wound treatment (see “Post-exposure
prophylaxis”, below). Rabies immunoglobulin is not required for patients who have
previously received a complete vaccination series.
Production of modern vaccines (production of Hepatitis Vaccine)
Production of modern vaccines
Live Attenuated Vaccines
Live vaccines are derived from “wild,” or disease-causing, viruses or bacteria. These wild
viruses or bacteria are attenuated, or weakened, in a laboratory, usually by repeated culturing.
For example, the measles virus used as a vaccine today was isolated from a child with
measles disease in 1954. Almost 10 years of serial passage using tissue culture media was
required to transform the wild virus into attenuated vaccine virus.
To produce an immune response, live attenuated vaccines must replicate (grow) in the
vaccinated person. A relatively small dose of virus or bacteria is administered, which
replicates in the body and creates enough of the organism to stimulate an immune response.
Anything that either damages the live organism in the vial (e.g., heat, light) or interferes with
replication of the organism in the body (circulating antibody) can cause the vaccine to be
ineffective. Although live attenuated vaccines replicate, they usually do not cause disease
such as may occur with the “wild” form of the organism. When a live attenuated vaccine does
cause “disease,” it is usually much milder than the natural disease and is referred to as an
adverse reaction.
The immune response to a live attenuated vaccine is virtu – ally identical to that produced by
a natural infection. The immune system does not differentiate between an infection with a
weakened vaccine virus and an infection with a wild virus. Live attenuated vaccines produce
immunity in most recipients with one dose, except those administered orally. However, a
small percentage of recipients do not respond to the first dose of an injected live vaccine
(such as MMR or varicella) and a second dose is recommended to provide a very high level
of immunity in the population. Live attenuated vaccines may cause severe or fatal reac – tions
as a result of uncontrolled replication (growth) of the vaccine virus. This only occurs in
persons with immunodefi – ciency (e.g., from leukemia, treatment with certain drugs, or
human immunodeficiency virus (HIV) infection).
A live attenuated vaccine virus could theoretically revert to its original pathogenic (disease-
causing) form. This is known to happen only with live (oral) polio vaccine. Active immunity
from a live attenuated vaccine may not develop because of interference from circulating
antibody to the vaccine virus. Antibody from any source (e.g., transpla – cental, transfusion)
can interfere with replication of the vaccine organism and lead to poor response or no
response to the vaccine (also known as vaccine failure). Measles vaccine virus seems to be
most sensitive to circulating antibody. Polio and rotavirus vaccine viruses are least affected.
Live attenuated vaccines are fragile and can be damaged or destroyed by heat and light. They
must be handled and stored carefully.
Inactivated Vaccines
Inactivated vaccines are produced by growing the bacterium or virus in culture media, then
inactivating it with heat and/ or chemicals (usually formalin). In the case of fractional
vaccines, the organism is further treated to purify only those components to be included in the
vaccine (e.g., the polysac – charide capsule of pneumococcus.) Inactivated vaccines are not
alive and cannot replicate. The entire dose of antigen is administered in the injection. These
vaccines cannot cause disease from infection, even in an immunodeficient person.
Inactivated antigens are less affected by circulating antibody than are live agents, so they may
be given when antibody is present in the blood (e.g., in infancy or following receipt of
antibody-containing blood products.) Inactivated vaccines always require multiple doses. In
general, the first dose does not produce protective immunity, but “primes” the immune
system. A protective immune response develops after the second or third dose. In contrast to
live vaccines, in which the immune response closely resembles natural infection, the immune
response to an inactivated vaccine is mostly humoral. Little or no cellular immunity results.
Antibody titers against inactivated antigens diminish with time. As a result, some inactivated
vaccines may require periodic supplemental doses to increase, or “boost,” antibody titers.
Currently available whole-cell inactivated vaccines are limited to inactivated whole viral
vaccines (polio, hepatitis A, and rabies). Inactivated whole virus influenza vaccine and whole
inactivated bacterial vaccines (pertussis, typhoid, cholera, and plague) are no longer available
in the United States. Fractional vaccines include subunits (hepatitis B, influenza, acellular
pertussis, human papillomavirus, anthrax) and toxoids (diphtheria, tetanus.) A subunit
vaccine for Lyme disease is no longer available in the United States.
Polysaccharide Vaccines
Polysaccharide vaccines are a unique type of inactivated subunit vaccine composed of long
chains of sugar molecules that make up the surface capsule of certain bacteria. Pure
polysaccharide vaccines are available for three diseases: pneumococcal disease,
meningococcal disease, and Salmonella Typhi.
The immune response to a pure polysaccharide vaccine is typically T-cell independent, which
means that these vaccines are able to stimulate B cells without the assistance of T-helper
cells. T-cell–independent antigens, including polysaccharide vaccines, are not consistently
immunogenic in children younger than 2 years of age. Young children do not respond
consistently to polysaccharide antigens, probably because of immaturity of the immune
system.
Repeated doses of most inactivated protein vaccines cause the antibody titer to go
progressively higher, or “boost.” This does not occur with polysaccharide antigens; repeat
doses of polysaccharide vaccines usually do not cause a booster response. Antibody induced
with polysaccharide vaccines has less functional activity than that induced by protein
antigens. This is because the predominant antibody produced in response to most
polysaccharide vaccines is IgM, and little IgG is produced.
Recombinant Vaccines
Vaccine antigens may also be produced by genetic engi – neering technology. These products
are sometimes referred to as recombinant vaccines. Four genetically engineered vaccines are
currently available in the United States. Hepatitis B and human papillomavirus (HPV)
vaccines are produced by insertion of a segment of the respective viral gene into the gene of a
yeast cell or virus. The modified yeast cell produces pure hepatitis B surface antigen or HPV
capsid protein when it grows. Live typhoid vaccine (Ty21a) is Salmonella Typhi bacteria that
have been genetically modified to not cause illness. Live attenuated influenza vaccine has
been engineered to replicate effectively in the mucosa of the nasopharynx but not in the
lungs.
Production of Hepatitis Vaccine
Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended
within 24 hours of birth with either two or three more doses given after that. This includes
those with poor immune function such as from HIV/AIDS and those born premature. It is
also recommended for health-care workers to be vaccinated. In healthy people routine
immunization results in more than 95% of people being protected.
Blood testing to verify that the vaccine has worked is recommended in those at high risk.
Additional doses may be needed in people with poor immune function but are not necessary
for most people. In those who have been exposed to the hepatitis B virus but not immunized,
hepatitis B immune globulin should be given in addition to the vaccine.The vaccine is given
by injection into a muscle.
n 1963, the American physician/geneticist Baruch Blumberg discovered what he called the
“Australia Antigen” (now called HBsAg) in the serum of an Australian Aboriginal person. In
1968, this protein was found to be part of the virus that causes “serum hepatitis” (hepatitis B)
by virologist Alfred Prince. The American microbiologist/vaccinologist Maurice Hilleman at
Merck used three treatments (pepsin, urea and formaldehyde) of blood serum together with
rigorous filtration to yield a product that could be used as a safe vaccine. Hilleman
hypothesized that he could make an HBV vaccine by injecting patients with hepatitis B
surface protein. In theory, this would be very safe, as these excess surface proteins lacked
infectious viral DNA. The immune system, recognizing the surface proteins as foreign, would
manufacture specially shaped antibodies, custom-made to bind to, and destroy, these proteins.
Then, in the future, if the patient were infected with HBV, the immune system could
promptly deploy protective antibodies, destroying the viruses before they could do any harm.
The first large-scale trials for the blood-derived vaccine were performed on gay men, in
accordance with their high-risk status. Later, Hilleman’s vaccine was falsely blamed for
igniting the AIDS epidemic. But, although the purified blood vaccine seemed questionable, it
was determined to have indeed been free of HIV. The purification process had destroyed all
viruses—including HIV. The vaccine was approved in 1981.
The blood-derived hepatitis B vaccine was withdrawn from the marketplace in 1986 when
Pablo DT Valenzuela, Research Director of Chiron Corporation, succeeded in making the
antigen in yeast and invented the world’s first recombinant vaccine. The recombinant vaccine
was developed by inserting the HBV gene that codes for the surface protein into the yeast
Saccharomyces cerevisiae. This allows the yeast to produce only the noninfectious surface
protein, without any danger of introducing actual viral DNA into the final product. This is the
vaccine still in use today.