Chapter-1 Biotechnology

United Nation Convention on Biological Diversity defines Biotechnology “any technological

application that uses biological systems, living organisms or derivatives thereof, to make or
modify products or processes for specific use”. And “Biological resources” includes genetic
resources, organisms or parts thereof, populations, or any other biotic component of
ecosystems with actual or potential use or value for humanity. India has become the world’s
12th biggest biotechnology economy having the second highest number of USFDA-approved
plants. Biotechnology will help developing countries accomplish things that they could never do

Conventional biotechnology is a biotechnology practice conducted by using simple methods

and instruments, without genetic manipulation. It has been done since thousands of years
ago to produce many kinds of products, such as beer, wine, tuak, sake, yogurt, bread, cheese,
soy sauce, tempe, tapai, and oncom.

Modern biotechnology is a biotechnology practice developed with genetic manipulation

technique, in which transfer of genetic material(transfer of gene) from one living organism to
the other occurs. Through this technique, humans can control the production according to his
desire. For examples, the production of pest and disease resistant plants, imperishable fruits,
and cattle which are able to produce more milk.

In the genetic manipulation process, organisms whose body containsforeign genes are
called transgenic organisms. They can be transgenic plants, transgenic animals, and
transgenic bacteria.

Principles of Biotechnology
1.Genetic Engineering: techniques to alter the chemistry of genetic material to introduce
into host organism and thus change the phenotype of organism

(NOTE: The genotype is a set of genes in DNA responsible for unique traits or
characteristics while the phenotype is the physical appearance or characteristic of an
organism.)

2.BIOPROCESS Engineering: Maintenance of sterile (microbial contamination-free)

ambience in chemical engineering processes to enable growth of only the desired
microbe/eukaryotic cell in large quantities for the manufacture of biotechnological
products like antibiotics, vaccines, enzymes, etc.
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Concept
In order to attain a phenotype , desired gene should be sent in to host but this gene can not
replicate by itself.so it must be integrated with recipient DNA to replicate, once it integrates with
host or recipient DNA it will reproduce itself and also transferred to future generation. This
replication of identical copies are also called as cloning.

What is Recombinant DNA?

Recombinant DNA technology is the joining together of DNA molecules from two
different species. The recombinant DNA molecule is inserted into a host organism to
produce new genetic combinations that are of value to science, medicine, agriculture,
and industry.

Steps involved in Recombinant DNA

(i) identification of DNA with desirable genes;

(ii) introduction of the identified DNA into the host;

(iii) maintenance of introduced DNA in the host and transfer of the DNA to its progeny.

Recombinant DNA Technology requires various tools like vector, host and enzymes such
as restriction enzymes, ligases, polymerases, etc.

Process involved
1.Cut the desired sequence of DNA through Enzyme called Restriction Enzyme

2.Use another Enzyme called Ligase to join DNA with plasmid(vector which can transfer
to host DNA)

3.Plasmid reaches to host DNA ,integrates and then creates multiple copies

Types of Biotechnology
Like the stripes of the rainbow, the different biotechnology applications are grouped into
seven colours or research and development areas. In this section, we highlight the most
relevant of each of them.
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• Red biotechnology: This is the health branch and responsible, according to
the Biotechnology Innovation Organization (BIO), for the development of
more than 250 vaccines and medications such as antibiotics, regenerative
therapies and the production of artificial organs.
• Green biotechnology: It is used by more than 13 million farmers worldwide
to fight pests and nourish crops and strengthen them against
microorganisms and extreme weather events, such as droughts and frosts.
• White biotechnology: The industrial branch works to improve
manufacturing processes, the development of biofuels and other
technologies to make industry more efficient and sustainable.
• Yellow biotechnology: This branch is focused on food production and, for
example, it carries out research to reduce the levels of saturated fats in
cooking oils.
• Blue biotechnology: This exploits marine resources to obtain aquaculture,
cosmetics and health care products. In addition, it is the branch most widely
used to obtain biofuels from certain microalgae.
• Grey biotechnology: Its purpose is the conservation and restoration of
contaminated natural ecosystems through, as mentioned above,
bioremediation processes.
• Gold biotechnology: Also known as bioinformatics, it is responsible for
obtaining, storing, analysing and separating biological information, especially
that related to DNA and amino acid sequences.

Applications of Biotechnology in various fields

• Applications of Biotechnology in Medicine

• Applications of Biotechnology in Agriculture
• Applications of Biotechnology in Animal Husbandry
• Application of Biotechnology in Food Processing
• Application of Biotechnology in Environment
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Applications of Biotechnology in Medicine

• Biotechnology techniques are used in medicine for diagnosis and treating

different diseases. It gives opportunities for the people to protect
themselves from dangerous diseases.
• The field of Biotechnology, genetic engineering has introduced techniques
like gene therapy, recombinant DNA technology and polymerase chain
reaction which use genes and DNA molecules to diagnose diseases and
insert new and healthy genes in the body which replace the damaged cells
• Genetic modification in mosquitoes can solve the problems of epidemic
diseases such as dengue and malaria
• Artificial insemination is the artificial introduction of semen into the
reproductive tract of a female animal. It is used extensively in breeding
animals, such as sheep and cattle
• Medical researchers believe that stem cell therapy has the potential to
dramatically change the treatment of human disease. A number of adult
stem cell therapies already exist, particularly bone marrow transplants that
are used to treat leukaemia.
• Stem cell transplantation was first used in the treatment of blood disorders
and it was a breakthrough. Conventionally known as bone marrow
transplantation, the stem cells responsible for production of the blood cells
reside in the bone marrow

Applications of Biotechnology in Agriculture

• Biotechnology has played a major role in agriculture by altering genes,

studying and cloning various crops in order to provide better quality
products of foods ultimately improving our lives.
• Hybrid Seeds, Artificial Seeds, Photosynthesis improver, Stress resistant
crops and plants, Biofertilizers, Bio-pesticides are some of the potential
applications.
• Potential advantages that biotechnology can confer across a wide range of
agricultural applications are in areas such as livestock management, storage
of agricultural products and sustaining current crop yields, while reducing
the use of fertilizers, herbicides and pesticides.
• Biotechnology offers a very promising alternative to synthetic foods and an
improvement on conventional plant-breeding technologies. Combined with
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other advanced agricultural technologies, it offers an exciting and
environmentally responsible way to meet consumer demand for sustainable
agriculture.

Applications of Biotechnology in Animal Husbandry

• The application of biotechnology in this area, in increasing production

efficiency through manipulation and control of physiological systems and
improving the health and well-being of animals, assumes great significance.
• Embryo transplantation, used with cattle, goats, pigs, and sheep, aims to
increase the number of offspring from a quality female.
• Cloning embryos to artificially produce genetic duplicates of an animal has
also become possible.
• Direct manipulation and alteration of an animal’s genetic material — genetic
engineering—has the potential to produce even more drastic changes in
animal breeding. It is believed that genetically altered pigs may one day be
able to provide compatible organs for emergency transplantation
(xenotransplantation) into humans.

Application of Biotechnology in Food Processing

• Biotechnology has a major application in the food sector.

• Bread, cheese, wine, beer, yogurt, and vinegar are all made by culturing
microorganisms and are really the oldest products of biotechnology.
• It helps in improving the edibility, texture, and storage of the food; in
preventing the attack of the food, mainly dairy, by the virus like
bacteriophage.
• Biotechnologists are also developing tests that will allow the detection of
food-contaminating microorganisms and the toxins they produce, which may
be present only in minute quantities.
• Biotechnology also has applications in the detection of mutagens
(substances that cause genetic mutations) in individual food products.
• GM crops which have been approved for use in food items in select
countries include corn, maize, soya, tomato, potato and papaya.
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• Latest innovations in biotechnology that fortify major staples with micro
nutrients like vitamin A, zinc and iron can be game changers for hunger
problem in India.

Application of Biotechnology in Environment

• Biotechnology can be used to tackle environmental issues like deforestation

and air pollution
• Biotechnology can help in finding out the level of Particulate Matter 2.5 in
the air
• Biotechnology is already providing a clean and renewable alternative to
traditional fossil fuels, the burning of which contributes to global warming.
• The benefit of environmental biotechnology helps us to avoid the use of
hazardous pollutants and wastes that affect the natural resources and the
environment.
• Biosensors, which combine a biological component (such as an enzyme) with
various electronic components to trigger a circuit when a particular type of
chemical is detected. Biosensors are capable of detecting extremely low
levels of proteins, hormones, pollutants, gases, and other molecules.

Gene Editing
Gene Editing is a type of genetic engineering in which DNA is inserted, deleted, modified or replaced
in the genome of a living organism. Unlike early genetic engineering techniques that randomly insert
genetic material into a host genome, genome editing targets the insertions to site specific locations.

CRISPR is widely considered the most precise, most cost-effective and quickest way to edit genes.

Pros:

• Most uses of genome editing have been in scientific research –for example
to investigate models of human disease.
• Genome editing has the potential to alter any DNA sequence, whether in a
bacterium, plant, animal or human being.
• It is a powerful tool that can reshape the way society deals many issues of
healthcare, food scarcity and the environment.
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• Crops and livestock (e.g. increasing yield, introducing resistance to disease
and pests, tolerance of different environmental conditions).
• Industrial biotechnology (e.g. developing ‘third generation’ biofuels and
producing chemicals, materials and pharmaceuticals).
• Biomedicine (e.g. pharmaceutical development, xenotransplantation, gene
and cell-based therapies, control of insect-borne diseases).
• Reproduction (e.g. preventing the inheritance of a disease trait).
• Engineering mosquitoes to control malaria and dengue.
• It can help fight against blood-related disorders such as haemophilia, sickle
cell anaemia, and Beta-Thalassemia.
• All such applications together can drive India’s economic growth over the
next decade to new heights.

Issues with gene-editing

• Balance Risks & Benefits: Due to the possibility of off-target effects (edits
in the wrong place creating properties different from those that were
intended) and Mosaicism (when some cells carry the edit but others do not,
leading to presence of two or more populations of cells), safety is of primary
concern.
• Application of the technique to human germline: Until now, all therapeutic
interventions in humans using genome editing have been performed in
somatic cells (i.e. only the patient gets affected, no chance of inheriting the
altered genes by the patient’s offspring). Safety concerns have been raised
regarding genome editing in human germline, where unpredictable changes
can be transmitted to following generations.
• Ecological impacts: A ‘gene drive’ can propagate a set of genes with
negative traits throughout a population which may lead to disappearance of
the whole targeted population with severe ecological consequences.
• Difficulty in regulation: The precise genetic modifications obtained through
CRISPR Cas9 technique makes it more difficult to identify a genetically
modified organism once outside the lab and also to regulate such organisms
in the market.
• At present there is no regulating body to keep a check on the practices and
applications of the technology. It may therefore lead to reduced
transparency, low quality and may also increase the unnecessary delay in
the treatment of patients.
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• Uncontrolled clinical trials: There are at present no standard norms for
standardization of norms for clinical trials for checking the efficacy of the
treatment.
• Concerns over ‘Designer Babies’: Engineering human embryos raises the
prospect of designer babies, where embryos are altered for social rather
than medical reasons e.g. to increase height or intelligence.
• The debate about gene editing has been going on for a long time now. Gene editing should be
encouraged to enhance the advancements in the field of science and improve the standard of
living of people E.g.: CRISPR technology is targeting to treat the rare disease caused by
mutation of one gene. At the same time, common guidelines need to be developed by
international communities which set the guidelines of what risks are acceptable and what are
not.

Suggestions

• India’s current regulatory architecture for approving novel treatments is

ambiguous and assigns overlapping functions to different governmental
bodies. This framework needs to be restructured to optimize trial approval
time while addressing safety requirements.
• A two-step model wherein the government works with industry and
research groups to accelerate clinical research is recommended. This model
consists of a national apex committee working in collaboration with existing
institutional ethics committees and independent accreditation agencies.
• It is envisaged that India will emerge as a significant contributor to the
world bioinformatics market and position itself as a global hub for
bioinformatics.
• Indian bioinformatics sector has numerous strengths and competitive
advantages to make the bioinformatics sector a sunrise industry of India.
• With the improvements in the IPR regime, increasing support from the
government and continuing efforts of the private sector companies, it is
very much likely that India could repeat its IT success story in bioinformatics
too.
• Much research on animal models and isolated human cells should be
conducted before any full-scale routine application in humans.

What is CRISPR-Cas9?
Chapter-1 Biotechnology
• CRISPR–Cas9 is a unique technology that enables geneticists and medical
researchers to edit parts of the genome? by removing, adding or altering
sections of the DNA?
• It is currently the simplest, most versatile and precise method of genetic
manipulation and is therefore causing a buzz in the science world.

How does it work?

• The CRISPR-Cas9 system consists of two key molecules that introduce a

change into the DNA. These are:
o an enzyme called Cas9. This acts as a pair of ‘molecular scissors’ that
can cut the two strands of DNA at a specific location in the genome
so that bits of DNA can then be added or removed.
o a piece of RNA called guide RNA (gRNA). This consists of a small
piece of pre-designed RNA sequence (about 20 bases long) located
within a longer RNA scaffold. The scaffold part binds to DNA and the
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pre-designed sequence ‘guides’ Cas9 to the right part of the genome.
This makes sure that the Cas9 enzyme cuts at the right point in the
genome.
• The guide RNA is designed to find and bind to a specific sequence in the
DNA. The guide RNA has RNA bases? that are complementary? to those of
the target DNA sequence in the genome. This means that, at least in theory,
the guide RNA will only bind to the target sequence and no other regions of
the genome.
• The Cas9 follows the guide RNA to the same location in the DNA sequence
and makes a cut across both strands of the DNA.
• At this stage the cell? recognises that the DNA is damaged and tries to
repair it.
• Scientists can use the DNA repair machinery to introduce changes to one or
more genes? in the genome of a cell of interest.

Gene Therapy
Difference between Gene therapy and Gene editing:
All concepts of Gene therapy, Gene editing and CRISPR CAS9 are interlinked. We use Gene editing
for multiple reasons like designer babies, treatment of genetic disorders, for invention of medicines
etc., if we are editing Gene for health related then its called Gene therapy. Besides there is also
difference of degree, in Gene therapy we don’t replace the Gene

In gene editing, a mutated gene is revised, removed, or replaced at the DNA level. In gene therapy,
the effect of a mutation is offset by inserting a “healthy” version of the gene, and the disease-related
genes remain in the genome. Both approaches may provide a durable benefit to patients, and both
gene therapy and gene editing, alone or in combination, may lend themselves to the development of
transformative genomic medicines.

Genes, Proteins, and DNA

The human body is made up of trillions of cells. Each cell has a copy of your genome—the total
collection of all your genes and DNA. Genes are instructions that every cell in your body uses to
make the proteins they need to function. Genes can be found in long chains of molecules called
deoxyribonucleic acids (DNA) that are twisted together into the shape of a double helix.

There are 4 DNA molecules that are identified by the letters A, T, C, and G. Combinations of these
letters make up the genetic instructions that our cells use to make proteins. Our genes can also be a
source of disease.
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Small breaks in our DNA are incredibly common and are normally uneventful. DNA breaks can
happen from sunlight, for example, or during cell divisions that happen as we grow. Our cells have
built-in DNA repair processes that constantly fix these breaks as they occur.

However, breaks are sometimes repaired incorrectly, creating what is known as a mutation.
Mutations can occur spontaneously or be passed down from our parents. Mutations can also change
how our cells function, and may lead to serious diseases such as sickle cell disease (SCD), Leber
congenital amaurosis 10 (LCA10), cancer, and many others.

Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies
can work by several mechanisms:

1.Replacing a disease-causing gene with a healthy copy of the gene

2.Inactivating a disease-causing gene that is not functioning properly

3.Introducing a new or modified gene into the body to help treat a disease

Gene therapy products are being studied to treat diseases including cancer, genetic diseases, and
infectious diseases.

Types
1. Somatic Gene Therapy: Effects will not be transferred to next generation

2.Germline Gene Therapy: Effects transferred to next generation

Challenges
Response from immune system: our immune system might not accept newly introduced gene

Mutation of undesired Gene and collateral effect

High cost for treatment of disease through Gene therapy

Delivery of desired Gene to right place

Scientists can make mistakes and it can lead to occurrence of unwanted mutations

Possibility of Bio war

Virus is used as vector and it can show toxicity

Mitochondrial Gene Therapy

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What are mitochondria?
Mitochondria are tiny rod-like structures in cells which act as power houses, generating the energy
that allows our bodies to function. Unusually, they have their own DNA, distinct from the genetic
material within the cell nucleus. Mitochondrial DNA (mtDNA) makes up about 0.1% of a cell’s total
DNA and does not affect individual characteristics such as appearance and personality.

About MRT technique: MRT techniques essentially swap a woman’s defective mitochondrial DNA
with that of a donor. The resulting embryo’s DNA will mostly come from the two parents who
supplied the egg and sperm, but a tiny proportion – a fraction of a percentage – will come from the
donor.

All cells have mitochondria, which are like power packs for the cells and create the energy that keeps
cells alive. While a child’s DNA is a mixture from both the mother and father, mitochondria are
separate “packages of genetics” that come solely from the mother.

Some people have a mitochondrial disease — a problem with the genetics in their mitochondria —
which can lead to severe, life-threatening conditions, although this is rare. One treatment for a
woman who might have one of these diseases is to replace the mitochondria in her eggs via IVF. This
can be done via a process like the one used in Greece where the DNA is taken out of the woman’s
egg and put into a donor woman’s egg once the DNA has been stripped from it, which is then
fertilized with sperm to create an embryo.

Why is it so controversial?
Some people don’t like the idea of a baby having three biological parents, and argue that
mitochondrial DNA goes some way to shaping important characteristics, such as personality. But the
scientific consensus is that swapping mitochondria is similar to changing a battery – it’s unlikely to
have much, if any, influence over a person’s behaviour.

Others have argued that the technique is unnecessary. After all, it won’t help those who have already
been born with mitochondrial diseases. Parents often don’t find out they are carriers of these
diseases until they give birth to sick children. And those who do know they could pass on a disease
have other options, such as using a donor egg. The technique is specifically for people who carry
genes for the disease, but want to have a child genetically related to them.

Another concern is that, by creating a new mix of genetic material, embryologists are creating lasting
genetic changes that will be passed down through generations, before we have a chance to find out if
they are dangerous. Some argue that this starts us on a slippery slope of germ-line editing – one that
could eventually lead to “designer babies”.

Is it ethical?
With this, a woman’s inalienable right to become a mother with her own genetic material became a
reality. However, some experts say the technique raises ethical questions and should be banned in
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cases not involving disease. The risks of the technique aren’t entirely known, though may be
considered acceptable if being used to treat mitochondrial disease.

Genome Sequencing
Genome sequencing is the process that involves deciphering the exact order of base pairs in an
individual. This “deciphering” or reading of the genome is what sequencing is all about. Costs of
sequencing differ based on the methods employed to do the reading or the accuracy stressed upon in
decoding the genome.

Need for genome sequencing:

1. Ever since the human genome was first sequenced in 2003, it opened a fresh
perspective on the link between disease and the unique genetic make -up of each
individual.
2. Nearly 10,000 diseases — including cystic fibrosis, thalassemia — are known to be the
result of a single gene malfunctioning.
3. While genes may render some insensitive to certain drugs, genome sequencing has
shown that cancer too can be understood from the viewpoint of genetics, rather than
being seen as a disease of certain organs

Genome Sequencing Initiatives by India

Genome India
Taking inspiration from the Human Genome Project, this year, the Department of Biotechnology
(DBT) initiated the ambitious “Genome India Project” (GIP) on 3rd January 2020. The GIP aims to
collect 10,000 genetic samples from citizens across India, to build a reference genome.

This project is led by the Centre for Brain Research at Bengaluru-based Indian Institute of Science,
which acts as the central coordinator between a collaboration of 20 leading institutions, each
collecting samples and conducting its own research. Institutes involved include the Indian Institute of
Science (IISc) in Bengaluru as well as several Indian Institutes of Technology (IITs). For conducting the
project, investigators in hospitals will lead the data collection through a simple blood test from
participants and the information will be added to biobanks.

Indigen Project
The IndiGen initiative was undertaken by CSIR in April 2019, which was implemented by
the CSIR-Institute of Genomics and Integrative Biology (IGIB), Delhi and CSIR-Centre for
Cellular and Molecular Biology (CCMB), Hyderabad.
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The objective is to enable genetic epidemiology and develop public health technologies
applications using population genome data.

This has enabled benchmarking the scalability of genome sequencing and computational
analysis at population scale in a defined timeline.

The ability to decode the genetic blueprint of humans through whole genome
sequencing will be a major driver for biomedical science.

IndiGen programme aims to undertake whole genome sequencing of thousands of

individuals representing diverse ethnic groups from India.

Significance

• This would aid our understanding of the nature of diseases affecting the
Indian population, and then ultimately support the development of
predictive diagnostic markers.
• This is a landmark initiative, particularly because it would bring valuable
addition to existing genome research, which has so far been limited to the
Western context
• It allows India to draw upon its tremendous genetic diversity, given the
series of large migrations historically, and thus, add greatly to the current
information about the human species.
• Through whole-genome sequencing, the plan is to build an exhaustive
catalogue of genetic variations for the Indian population. This would aid in
the designing of genome-wide association chips which will facilitate further
large-scale genetic studies in a cost-effective manner.
• It would also open new vistas for advancing next-generation personalized
medicine in the country, paving the way for predicting health and disease
outcomes and modulating treatment protocols based on the genome
sequences.
• The initiative would also support the development of targeted preventive
care, as it has the potential to help identify those population groups which
are more susceptible to various risk factors for certain diseases. For
instance, if a region shows a tendency towards a specific disease,
customized interventions can be made in the region, accordingly, leading to
more effective treatment overall.
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Cloning
Cloning is a technique scientists use to make exact genetic copies of living things. Genes, cells,
tissues, and even whole animals can all be cloned.

Types:
1. Therapeutic: In therapeutic cloning, the aim is to clone cells that make particular organs or types of
tissue

2.Reproductive: In this we actually reproduce not organ but entire being(donor) from where we got
genetic information

Methods:
1. Natural: This happens naturally when one embryo spontaneously divides into two or more
embryos, thus creating identical twins or, sometimes, triplets or even more

2.Artifical: An existing embryo is mechanically divided into two or more embryos that are then
allowed to develop naturally

3.Artifical and Donor: Through use of somatic cell of Donor.

Somatic cells are all the cells that make up an organism, but that are not sperm or egg cells. Sperm
and egg cells contain only one set of chromosomes, and when they join during fertilization, the
mother’s chromosomes merge with the father’s. Somatic cells, on the other hand, already contain two
full sets of chromosomes. To make a clone, scientists transfer the DNA from an animal’s somatic cell
into an egg cell that has had its nucleus and DNA removed. The egg develops into an embryo that
contains the same genes as the cell donor. Then the embryo is implanted into an adult female’s uterus
to grow.

Significance

• An embryo made by cloning can be turned into a stem cell factory. Stem
cells are an early form of cells that can grow into many different types of
cells and tissues. Scientists can turn them into nerve cells to fix a damaged
spinal cord or insulin-making cells to treat diabetes.
• The cloning of animals has been used in a number of different applications.
Animals have been cloned to have gene mutations that help scientists study
diseases that develop in the animals.
• Livestock like cows and pigs have been cloned to produce more milk or
meat.Example India is doing this project on Indigenous breeds
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• Cloning might one day bring back extinct species like the woolly mammoth
or giant panda.
• It overcomes the problem of immune rejection which is major concern
during organ transplantation.
• It can help in understanding process of ageing.

Issues

• Many researchers think it is worthwhile to explore the use of embryonic

stem cells as a path for treating human diseases. However, some experts are
concerned about the striking similarities between stem cells and cancer
cells. Both cell types have the ability to proliferate indefinitely and some
studies show that after 60 cycles of cell division, stem cells can accumulate
mutations that could lead to cancer. Therefore, the relationship between
stem cells and cancer cells needs to be more clearly understood if stem cells
are to be used to treat human disease.
• Researchers have observed some adverse health effects in sheep and other
mammals that have been cloned. These include an increase in birth size and
a variety of defects in vital organs, such as the liver, brain and heart.
• Another potential problem centers on the relative age of the cloned cell’s
chromosomes. As cells go through their normal rounds of division, the tips
of the chromosomes, called telomeres, shrink. Over time, the telomeres
become so short that the cell can no longer divide and, consequently, the
cell dies. This is part of the natural aging process that seems to happen in all
cell types. As a consequence, clones created from a cell taken from an adult
might have chromosomes that are already shorter than normal, which may
condemn the clones’ cells to a shorter life span. Indeed, Dolly, who was
cloned from the cell of a 6-year-old sheep, had chromosomes that were
shorter than those of other sheep her age. Dolly died when she was six
years old, about half the average sheep’s 12-year lifespan.
• Reproductive cloning would present the potential of creating a human that
is genetically identical to another person who has previously existed or who
still exists. This may conflict with long-standing religious and societal values
about human dignity, possibly infringing upon principles of individual
freedom, identity and autonomy. However, some argue that reproductive
cloning could help sterile couples fulfill their dream of parenthood. Others
see human cloning as a way to avoid passing on a deleterious g ene that runs
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in the family without having to undergo embryo screening or embryo
selection.
• Therapeutic cloning, while offering the potential for treating humans
suffering from disease or injury, would require the destruction of human
embryos in the test tube. Consequently, opponents argue that using this
technique to collect embryonic stem cells is wrong, regardless of whether
such cells are used to benefit sick or injured people.
• India does not have specific laws regarding cloning but has guidelines prohibiting
whole human cloning or reproductive cloning. India allows therapeutic cloning
and the use of embryonic stem cells for research purposes

Stem Cells

What are stem cells, and why are they important?

Stem cells have the remarkable potential to develop into many different cell types in the body during
early life and growth. In addition, in many tissues they serve as a sort of internal repair system,
dividing essentially without limit to replenish other cells as long as the person or animal is still alive.
When a stem cell divides, each new cell has the potential either to remain a stem cell or become
another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain
cell.
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Regulatory status in Iindia:

“National Guidelines for Stem Cell Research” jointly formulated by Department of Biotechnology and
the Indian Council of Medical Research was released by the Hon’ble Minister for Health & Family
Welfare on 11th October; 2017. As per the National Guidelines for Stem Cell Research (2017), at
present, there are no approved indications for stem cell therapy other than the hematopoietic stem
cell transplantation (HSCT) for hematological disorders. Accordingly, all stem cell therapy other than
the above shall be treated as investigational and conducted only in the form of a clinical trial after
obtaining necessary regulatory approvals. Use of stem cells for any other purpose outside the domain
of clinical trials will be considered unethical and hence is not permissible.

Stem cells are distinguished from other cell types by two important characteristics:
First, they are unspecialized cells capable of renewing themselves through cell division, sometimes
after long periods of inactivity.

Second, under certain physiologic or experimental conditions, they can be induced to become tissue-
or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem
cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however,
such as the pancreas and the heart, stem cells only divide under special conditions.

What are the similarities and differences between Embryonic and Adult
stem cells?
One major difference between adult and Embryonic stem cells is their different abilities in the
number and type of differentiated cell types they can become. Embryonic stem cells can become all
cell types of the body because they are pluripotent. Adult stem cells are thought to be limited to
differentiating into different cell types of their tissue of origin.

Embryonic stem cells can be grown relatively easily in culture. Adult stem cells are rare in mature
tissues, so isolating these cells from an adult tissue is challenging, and methods to expand their
numbers in cell culture have not yet been worked out. This is an important distinction, as large
numbers of cells are needed for stem cell replacement therapies.

GM Crops
GM Crops in India
According to WHO, Genetically modified organisms are the organisms in which genetic material has
been altered in a way that does not occur in natural recombination.
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All GM crops in India require approval from the Genetic Engineering Appraisal Committee (GEAC) for
use in commercial production. BT cotton is the only genetically modified crop allowed in India.
Biotech regulator recently allowed for the commercial production of GM Mustard in the
country.Several groups opposed the GEAC’s decision.

Arguments for GM Crops

1) GMOs can address challenges of food security. Biotechnology, around the world, has helped
farmers grow 311.8 million tonnes more food in the last 15 years.

2) The spectacular success of BT cotton: two billion hectares of biotech crops have been planted in
28 countries since 1996.Just as the adoption of BT cotton ensured that India transitioned into a
cotton-exporting country switching to high-yield oilseeds engineered specially for India’s semi-arid
zones can help India Reduce its dependence on imports.

At $10 billion annually, edible oil is India’s third-biggest import item after crude oil and gold. If a
farmer produces one tonne of oil, he also produces an equal quantity of cake, a by-product that is a
protein-rich feed for animals. When we import vegetable oils, we are denied a large quantity of
oilseed cake.

3) Farmers can also benefit from higher yields and income.

4) They can decrease the use of pesticides and herbicides and can protect the environment.

5) People around the world have been consuming products of biotech crops for more than 20 years.

6) GM crops can be engineered to withstand weather fluctuations and extremes.

Arguments against GM Crops

1) GM crops can cause long term consequences on human health. Ex: categorisation of glyphosate by
the World Health Organization as a “probable carcinogen”

2) GMOs are self-replicating organisms and cause genetic contamination of the environment which
cannot be reversed.

3) Its impact on the health of the people, environment, soil, groundwater or food chain is not known
yet.

4) The seed stock will also be contaminated at the molecular level.

5) It makes the farmers susceptible to the practices of MNCs and can raise the cost of cultivation and
put them in debt trap.

6) Regulation is not effective and conflict of interest is present, as field trials and safety data
generated by the company have commercial interest.
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7) The lack of transparency in the regulatory process further amplifies apprehensions. For ex refusal
of GEAC to publicly release the safety testing data

8) Recently BT cotton crop loss faced by farmers due to pest attack by the same pest it was designed
to resist. So farmers are now switching back to non BT crops.

Concerns / Challenges
Major opposition to GM cross can be stated as a trust deficit and sense of precaution. Lack of
transparency in the regulatory process and conflict of interest are the major reasons.

In India, organizations that are trying to commercialize GM crops are themselves involved in testing
their safety through field trials.

Data is also secretive. Concerns regarding loss of food biodiversity if corporate food varieties begin
to flood the markets.

The pesticide industry’s efforts to influence policymakers and regulators have obstructed reforms
globally. Their business model aims only at making profit.

Way Forward
• The technology need enabling policy to ensure their outcomes are in line with the spirit of their
promises.
• The government needs to improve infrastructure and access to funds and spur innovation.
• India needs to reform its regulatory structure to expedite approvals and make it easier to conduct
research.
• Promoting indigenous gene editing research is important to make treatments available at
affordable prices.
• Clinical trials need to be contingent on robust demonstration of safety and efficacy.
• A two-step model wherein the government works with industry and research groups to
accelerate clinical research is recommended.
• Responsible use of gene editing could be the remedy for some of India’s problems. This is India’s
chance to tailor this cutting edge tool to its own requirements and ensure affordable healthcare
to its people.

DNA Technology Regulation Bill, 2019

Key Highlights of Proposed Bill

• Purpose:
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o It allows law enforcement agencies to collect DNA samples, create DNA
profiles and special databanks for forensic-criminal investigations. It
states that all DNA data, including DNA samples, DNA profiles and
records, will be only used for identification of the person and not for any
other purpose.

• DNA profiling board:

o It creates DNA Profiling Board (DPB) that will be final authority that will
authorise creation of State-level DNA databanks, approve the methods
of collection and analysis of DNA-technologies. It makes accreditation
and regulation mandatory for DNA laboratories.

• DNA banks:
o It allows the government to set up DNA data banks across India to store
profiles. These banks will maintain a national database for identification
of victims, accused, suspects, undertrials, missing persons and
unidentified human remains.

• Penalty:
o It also empowers the government to impose jail term of up to 3 years
and fine of up to Rs. 1 lakh on those who leak information stored in such
facilities. It prescribes similar punishment for those who seek
information on DNA profiles illegally.

• Use of DNA Data:

o Under the Bill, DNA testing is allowed only in respect of matters listed in
the schedule to the Bill (such as, for offences under the Indian Penal
Code, 1860, for paternity suits, or to identify abandoned children).

• DNA Data Bank:

o The Bill provides for the establishment of a National DNA Data Bank and
regional DNA Data Banks, for every state, or two or more states.
o The National Data Bank will store DNA profiles received from DNA
laboratories and receive DNA data from the regional Banks.
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o Every Data Bank will be required to maintain indices for the following
categories of data: (i) a crime scene index, (ii) a suspects’ or undertrials’
index, (iii) an offenders’ index, (iv) a missing persons’ index, and (v) an
unknown deceased persons’ index.

• Protection of information:
o It also ensures that the data remain protected from misuse or abuse in
terms of the privacy rights of citizens.
o Under the Bill, the Board is required to ensure that all information
relating to DNA profiles with the Data Banks, laboratories and other
persons are kept confidential. DNA data may only be used for
identification of the person.
o However, the Bill allows for access to information in the Data Bank for
the purpose of a one-time keyboard search. This search allows for
information from a DNA sample to be compared with information in the
index without information from the sample being included in the index.

• Retention of DNA Data:

o The Bill states that the criteria for entry, retention or removal of the
DNA profile will be specified by regulations.
o However, the Bill provides for removal of the DNA Data of the following
persons:- (i) of a suspect if a police report is filed or court order given, (ii)
of an undertrial if a court order is given, (iii) on request, of persons who
are not a suspect, offender or undertrial from the crime scene or missing
persons’ index.
o Further, the Bill provides that information contained in the crime scene
index will be retained.

• DNA Laboratories:
o Any laboratory undertaking DNA testing is required to obtain
accreditation from the Board. The Board may revoke the accreditation
for reasons including, failure to: (i) undertake DNA testing, or (ii) comply
with the conditions attached to the accreditation. If the accreditation is
revoked, an appeal will lie before the central government or any other
authority notified by the central government.

• Obligations of DNA Laboratories:

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o Under the Bill, every DNA laboratory is required to perform various
functions, including: (i) following standards for quality assurance in
collection, storing, testing, and analysis of DNA samples, and (ii)
depositing DNA samples with the Data Bank.
o After depositing the sample for ongoing cases, the Laboratory is required
to return the biological sample to the investigating officer. In all other
cases, the sample must be destroyed and intimated to the concerned
persons.

Benefits of the Bill:

• By providing for the mandatory accreditation and regulation of DNA

laboratories, the Bill seeks to ensure that with the proposed expanded use
of this technology in the country.
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• There is also the assurance that the DNA test results are reliable and the
data remain protected from misuse or abuse in terms of the privacy rights of
our citizens.

DNA technology- significance and concerns:

• DNA analysis is an extremely useful and accurate technology in ascertaining

the identity of a person from his/her DNA sample, or establishing biological
relationships between individuals.
• A hair sample, or even bloodstains from clothes, from a scene of crime, for
example, can be matched with that of a suspect, and it can, in most cases,
be conclusively established whether the DNA in the sample belongs to the
suspected individual. As a result, DNA technology is being increasingly
relied upon in investigations of crime, identification of unidentified bodies,
or in determining parentage.
• But information from DNA samples can reveal not just how a person looks,
or what their eye colour or skin colour is, but also more intrusive
information like their allergies, or susceptibility to diseases. As a result,
there is a greater risk of information from DNA analysis getting misused.
• It is expected that the expanded use of DNA technology would result not
only in speedier justice delivery but also in increased conviction rates, which
at present is only around 30% (NCRB Statistics for 2016).

Challenges with the bill:

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• The draft statute, not only disregards the serious ethical dilemmas that are
attached to the creation of a national DNA database, but also, contrary to
established wisdom, virtually treats DNA as infallible, and as a solution to the
many problems that ail the criminal justice system.
• This Bill fatally ignores the disproportionality of the DNA bank that it seeks to
create, and the invasiveness of its purport and reach.
• It also conflates its objectives by allowing the collection of DNA evidence not only
in aid of criminal investigations but also to aid the determination of civil disputes.
• Importantly, while consent is not required before bodily substances are drawn
from a person accused and arrested for an offence punishable with either death or
imprisonment for a term exceeding seven years, in all other cases a person
refusing to part with genetic material can be compelled to do so if a Magistrate
has reasonable cause to believe that such evidence would help establish a person’s
guilt. Therefore, there’s no end to the state’s power in coercing a person to part
with her DNA.
• In Justice K.S. Puttaswamy (Retd) v. Union of India declared that the Constitution
recognizes a fundamental Right to Privacy. But, it is unclear whether the proposed
bill is compatible with the Right to Privacy or not.
• The Bill’s failure to place sufficient checks on the use of DNA evidence collected
in breach of the law makes the process altogether more frightening.
• The Schedule lists civil matters where DNA profiling can be used. This includes
“issues relating to the establishment of individual identity.” DNA testing carried
out in medical or research laboratories can be used to identify an individual. It is
unclear if the Bill intends to regulate such laboratories.
• The Bill requires the consent of the individual when DNA profiling is used in
criminal investigations and identifying missing persons. However, consent
requirements have not been specified in the case of DNA profiling for civil
matters.
• DNA laboratories are required to share DNA data with the Data Banks. It is
unclear whether DNA profiles for civil matters will also be stored in the Data
Banks. Storage of these profiles in the Data Banks may violate the right to privacy.
• DNA laboratories prepare DNA profiles and then share them with DNA Data
Banks. The Bill specifies the process by which DNA profiles may be removed from
the Data Banks. However, the Bill does not require DNA laboratories to remove
DNA profiles. It may be argued that such provisions be included in the Bill and not
left to regulations.
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Way Forward:

• DNA profiling should be undertaken exclusively for the identification of a

person and should not be used to extract any other information.
• The state must show that there exists a legitimate reason for extracting
DNA evidence and that the extent and scope of such extraction do not
disproportionately contravene a person’s right to privacy.
• To enact the law in its present form would only add a new, menacing
weapon to the state’s rapidly expanding surveillance mechanism. The
government should not allow the benefits of science and technology to be
privileged over the grave risks in allowing unrestricted access to deeply
personal material.
• Maintenance of strict confidentiality with regard to the keeping of records
of DNA profiles and their use should be considered a priority.

Bioinformatics
Bioinformatics is the application of information technology to the study of living things, usually at the
molecular level. Bioinformatics involves the use of computers to collect, organize and use biological
information to answer questions in fields like evolutionary biology.

It is an interdisciplinary field that develops methods and software tools for understanding biological
data. As an interdisciplinary field of science, bioinformatics combines computer science, statistics,
mathematics and engineering to analyze and interpret biological data. Bioinformatics has been used
for in silico analyses of biological queries using mathematical and statistical techniques.

Growth of biotechnology has accelerated particularly during the last decade due to accumulation of
vast information as a result of sequencing of genomes and solving of crystal structures. This, coupled
with advances in IT has made biotechnology increasingly dependent on computationally intensive
approaches. This has led to the emergence of a super- specialty discipline, called Bioinformatics. The
term ‘bioinformatics’ is the short form of ‘biological informatics’, just as biotechnology is the short
form of ‘biological technology’.

India’s potential and progress in Bioinformatics:

Bioinformatics is growing as an independent discipline and helping immensely to accelerate the
growth of Biotechnology. Its ultimate goal is to uncover the wealth of biological information hidden in
the mass of data and to obtain a clearer insight into the fundamental biology of organisms.
Bioinformatics has become a frontline applied science and is of vital importance to the study of new
biology, which is widely recognized as the defining scientific endeavor of the twenty-first century.
The genomic revolution has underscored the central role of bioinformatics in understanding the very
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basics of life processes. The growth in full genomic sequencing, structural genomics, proteomics,
micro-array etc. will be very slow without application of bioinformatics. In fact usefulness of these
areas to solve complex biological problems will be limited without bioinformatics and thus very high
importance to bioinformatics.

The Bioinformatics sector in India has grown rapidly as IT companies have also stepped up their focus
on the life sciences vertical. Companies like Infosys, Cognizant Technologies, HCL, MphasiS, and TCS
have made significant strides in this space. Indian Bioinformatics companies can look forward to
garnering a large chunk of the world market for bioinformatics services such as data mining, mapping
and DNA sequencing, functional genomics, proteomics and molecule design simulation. Growing
volumes of genomics data and an expanding number of participants contracting work to Indian
companies have encouraged many pharmaceutical, IT, and Biotechnology (BT) companies to enter the
bioinformatics sector. Indian IT companies such as Tata Consultancy Services (TCS), Cognizant
Technologies, Infosys, and Wipro have already set up their bioinformatics divisions. Indian
pharmaceutical companies such as GVK Biosciences, Dr. Reddy’s Laboratories, Biocon, AstraZeneca,
Ranbaxy, Biological E, and Nicholas Piramal too, are making rapid moves into the bioinformatics
arena. India is also witnessing the emergence of pure-play bioinformatics companies such as Strand
Genomics.

In India, major government organizations, such as Biotechnology Information System (BTIS) and
Department of Biotechnology (DBT) are promoting bioinformatics. DBT had identified bioinformatics
as an area of high priority during the 10thplan period(2002-2007). The Government of India is also
providing numerous tax incentives at par with IT to develop the bioinformatics sector. India has
combined its strength in biotechnology and IT to attract outsourcing contracts in bioinformatics by
building a Bio-IT park. The Bio-IT Park would be the launch pad for the bioinformatics industry as
STPs (Software Technology Parks) were for IT and position itself as a global hub for bioinformatics.
These parks would be a conglomerate of academic-industry-research initiatives, thereby opening up
new vistas for the Indian bioinformatics market and making it a sunrise industry for the future. The
Department of Biotechnology, Government of India has been working with other departments to set
up these parks, which is expected to position India in the global hub of bioinformatics. Establishment
of Bio-IT parks and new biotech policy acts as a growth catalyst for the bioinformatics sector.

Some of the achievements of India can be summed up in following

manner

• India was among the forerunners in the genomics space. The country
entered the league of the US, the UK, Canada, China and Korea by
successfully completing the Human Genome Project in 2009.
• Established in 1986, the DBT (regulatory body for biotechnology which also
takes care of bioinformatics).DBT is credited for the development of the
Biotechnology Information System network (BTISnet) in1987. India was the
first country to build such a network.
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• DBT formulated the Bioinformatics Policy of India (BPI) in 2004.
• DBT developed a mechanism aiding the exchange of information in
bioinformatics within SAARC member countries.
• India has more trained bioinformaticists than any other country in the
world.
• Double-digit growth in the bioinformatics sector.
• India among the preferred CRO and CTO locations for drug development
low-cost R&D and cheap availability of knowledge resources.

Biosimilar
Biosimilar is a biologic medical product that is almost an identical copy of an original product that is
manufactured by a different company. Biosimilars are officially approved versions of original
“innovator” products and can be manufactured when the original product’s patent
expires. Biosimilars are the generic versions of biologics medicines made from animal or plant
proteins as opposed to chemicals.

Difference between biosimilars and generics:

• Biosimilars involve developing equivalent of biological entity while generics involve

developing equivalent of a chemical entity-the Active Pharmaceutical Ingredient.
• In case of biosimilars, biological entities being some ward different (and not as it is
of replica), every organism has to be engineered to produce the same therapeutic
effect while in generics, the copies of API can be generated
• Bio-similars differ from generics – in complexity, in the manufacturing processes
and in the data needed to demonstrate similarity for approval. The structure of
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Generic Simple and well-defined whereas for Bio-similar its Complex with potential
structural variations.
• Regulatory procedure to get approval for biosimilars is complex as compared to that
of a generic.

Prospects of Biosimilars:

• The growth of the biologics market for the treatment of cancer (monoclonal
antibodies), diabetes (insulin) and many other auto-immune diseases has in
turn resulted in creating a global opportunity for biosimilars also.
• Many Indian pharma companies are now making substantial investments
into biosimilar development and production for gaining the first mover
advantage.
• In 2014, Zydus Cadila became the first company in the world to launch the
biosimilar of Adalimumab patented by the US drug major AbbVie, which is
being used to treat rheumatoid arthritis and other auto immune disorders.
• As the biologics are priced very high, it is necessary for countries to reduce
prices through biosimilars.
• The growth in the biosimilars market is welcome from a human development
standpoint because they are more affordable than biologics, the high cost of
which often puts them out of reach of many patients.
• In recent times, patents of some biologics have expired and more will expire
before 2020. So moving towards biosimilars can fill the gap.
• Targeted towards Non-communicable diseases (cancer, asthma, and
arthritis):
o There is an alarming spike across developing countries in the
prevalence of non-communicable diseases.
o Therefore, promoting the production of complex generics and
biosimilars can have a positive development impact given how
targeted they are toward treating non-communicable diseases such as
cancer, asthma, and arthritis.
• Biosimilars industry can act as a springboard for the pharma companies to
innovate, excel and earn profit
Chapter-1 Biotechnology
Challenges faced:

• The development is itself lengthy and expensive, and could cost more than
Rs 100 crore and take up to six or seven years.
• It is hard to generate investor interest if a product hits the market only after
seven years. So, India is unlikely to see startups in biosimilars, which could
also drive consolidation of some players.
• Expertise in biology is essential, and this subject does not yet have critical
mass in India. India has fewer research labs in biology than a big state in
Europe or the US. And, yet, things have improved in the last ten years, as
experience has built up in technology and regulation.

Way forward:

• Governments can support growth in this segment by clarifying the

regulatory framework for them, which is still evolving in many countries.
China is a recent example, where the government has identified biopharma,
including biosimilars, as a priority area for the country.
• India has to expand the biology research ecosystem by investing in
education and fundamental research.
• At the same time, a regulatory mechanism needs to be put in place and
appropriate monitoring needs to be done to ensure that unfair and unethical
practices are abstained from in preparation of biosimilars.

Bioplastics
• Bio-based plastics means they are developed form biomass (plants) such as
corn, sugarcane, vegetable oil or wood pulp Biodegradable plastics are those
which possess the characteristics of biodegradability and composability
• They can be converted into natural substances like water, carbon dioxide,
and compost by the action of micro-organisms in the environment.
• Bioplastics are biodegradable materials that come from renewable sources
and can be used to reduce the problem of contaminating plastic waste that
is suffocating the planet and contaminating the environment.
Chapter-1 Biotechnology
• As an alternative to plastic, the use of bioplastics is being promoted,
consisting in obtaining natural polymers from agricultural, cellulose or
potato and corn starch waste.

Types of Bioplastics

• Bioplastics can be prepared from a variety of materials like starch, sugar,

cellulose etc.
• Cellulose-based plastics are made from wood pulp and they are used for
making film based materials such as wrappers.
• Thermoplastics are starch based plastics. They are used for production of
drug capsules as starch has ability to absorb moisture.
• These represent the most widely used bioplastic, constituting about 50
percent of the bioplastics market
• Polylactic Acid (PLA) is made from the fermentation of starch from crops. It
is used for preparing computer and mobile phone casings, cups, bottles and
other packaging.
• Polyhydroxybutyrate (PHB) is used for making bank notes and car parts etc.
• Polyamide 11 (PA 11) prepared from vegetable oils is used for making oil
and gas flexible pipes, and electrical anti-termite cable sheathing etc.
• Photo-degradable plastic which degrades on exposure to light.

Positive Impact of Bioplastics

• Environment:
▪ Bioplastics are better than petro plastics in terms of fossil-fuel
consumption, greenhouse gas emissions and energy efficiency.
▪ Biodegradable plastics are easy to recycle and are non-toxic.
▪ They reduce carbon footprint
▪ They do not involve the consumption of non-renewable raw materials
▪ Their production reduces non-biodegradable waste that contaminates
the environment
• They do not contain additives that are harmful to health, such as phthalates or
bisphenol A
• They do not change the flavour or scent of the food contained
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• These are degradable, equally resistant and versatile, already used in
agriculture, textile industry, medicine and, over all, in the container and
packaging market, and biopolymers are already becoming popular in cities
throughout Europe and the United States for ecological reason.

Negative Impact of Bioplastics

• But in terms of cost and applicability, bioplastics are inferior to petro plastics.
• Bioplastic production requires almost 80% of the energy required to produce
common plastic.
• In 2009, the Central Pollution Control Board tested 10 bioplastic samples but
found only 40% cleared the test for biodegradability.
• Biggest concern about compostable plastic is it would take around 40 days to
compost during which time it would have already been ingested by several
small animal forms, with a likely injurious impact.
• Bioplastic claims biodegradability on exposure to water:-
▪ The only standards on this require that within six months, the plastic
must have disintegrated into bits smaller than 2 millimetres and that
biodegradation must have progressed so that at least 30% of the
carbon has been converted by microorganisms (such as bacteria) into
carbon dioxide.
▪ This leaves the plastic to contaminate the seas for six months and
more.
▪ And if they touch the bottom of the sea, they may not degrade at all,
because it is much colder than the 30 degrees Celsius that is their ideal
degradation temperature.
▪ According to scientists, such micro-plastics cause extreme damage to
marine life.
• People cannot differentiate bioplastics from regular plastics in the trash. In
India there is hardly any segregation of wet and dry waste so it is unlikely that
even the best bioplastics will be pulled out for treatment.
• Not all bioplastics are biodegradable
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Conclusion
Instead of revolving around plastics it’s better into alternative techniques which are more
environment friendly like composting and making people aware about the importance of waste
management and protecting the environment.

Biofuels
What are Biofuels?
Any hydrocarbon fuel that is produced from an organic matter (living or once living material) in a
short period of time (days, weeks, or even months) is considered a biofuel.

Biofuels may be solid, liquid or gaseous in nature.

1. Solid: Wood, dried plant material, and manure

2. Liquid: Bioethanol and Biodiesel
3. Gaseous: Biogas

Classification of Biofuels:
1st generation biofuels are also called conventional biofuels. They are made from things like sugar,
starch, or vegetable oil. Note that these are all food products. Any biofuel made from a feedstock that
can also be consumed as a human food is considered a first-generation biofuel.

2nd generation biofuels are produced from sustainable feedstock. The sustainability of a feedstock is
defined by its availability, its impact on greenhouse gas emissions, its impact on land use, and by its
potential to threaten the food supply. No second generation biofuel is also a food crop, though
certain food products can become second generation fuels when they are no longer useful for
consumption. Second generation biofuels are often called “advanced biofuels.”

3rd generation biofuels are biofuel derived from algae. These biofuels are given their own separate
class because of their unique production mechanism and their potential to mitigate most of the
drawbacks of 1st and 2nd generation biofuels.

4th generation biofuels In the production of these fuels, crops that are genetically engineered to take
in high amounts of carbon are grown and harvested as biomass. The crops are then converted into
fuel using second generation techniques.

Government of India initiatives to promote the use of Biofuels:

Since 2014, the Government of India has taken a number of initiatives to increase blending of
biofuels.
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1. The major interventions include administrative price mechanism for ethanol,
simplifying the procurement procedures of OMCs, amending the provisions of
Industries (Development & Regulation) Act, 1951 and enabling lignocellulosic route
for ethanol procurement.
2. The Government approved the National Policy on Biofuels -2018 in June 2018. The
policy has the objective of reaching 20% ethanol-blending and 5% biodiesel-blending
by the year 2030.
o Among other things, the policy expands the scope of feedstock for
ethanol production and has provided for incentives for production of
advanced biofuels.
3. The Government has also increased the price of C-heavy molasses-based ethano

Salient features of the National Biofuels policy 2018

• Categorisation of biofuels to enable extension of appropriate financial and

fiscal incentives under each category. The two main categories are:
o Basic Biofuels- First Generation (1G) bioethanol & biodiesel
o Advanced Biofuels – Second Generation (2G) ethanol, Municipal Solid
Waste (MSW) to drop-in fuels, third Generation (3G) biofuels, bio-
CNG etc.
• Expands the scope of raw material for ethanol production by allowing use of
Sugarcane Juice, Sugar containing materials like Sugar Beet, Sweet
Sorghum, Starch containing materials like Corn, Cassava, Damaged food
grains like wheat, broken rice, Rotten Potatoes, unfit for human
consumption for ethanol production.
• Allows use of surplus food grains for production of ethanol for blending
with petrol to ensure appropriate price to farmers during surplus. However,
it needs the approval of the National Biofuel Coordination Committee.
• Thrust on Advanced Biofuels: Viability gap funding scheme for 2G ethanol
Bio refineries of Rs.5000 crore in 6 years in addition to additional tax
incentives and higher purchase price as compared to 1G biofuels.
• Encourages setting up of supply chain mechanisms for biodiesel production
from non-edible oilseeds, used Cooking Oil, short gestation crops.
• Synergising efforts by capturing the roles and responsibilities of all the
concerned Ministries/Departments with respect to biofuels in the policy
document itself.
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Potential Benefits

• Reduce Import Dependency: The large-scale production of biofuels would

reduce import dependency on crude oil and save forex.
• Cleaner Environment: By reducing crop burning & conversion of agricultural
residues/wastes to biofuels there will be reduction in GHGs emissions and
other particulate matters.
• Municipal Solid Waste Management: It is estimated that, annually around 62
MMT of Municipal Solid Waste gets generated in India. The policy promotes
conversion of waste/plastic, MSW to drop in fuels (hydrocarbon fuels from
solid waste).
• Infrastructural Investment in Rural Areas: addition of 2G bio refineries
across the Country will spur infrastructural investment in the rural areas.
• Employment Generation: the establishment of bio-refineries would create
jobs in Plant Operations, Village Level Entrepreneurs and Supply Chain
Management.
• Additional Income to Farmers: Farmers can capitalize on agricultural
residues /waste which otherwise are burnt by them. They can sell their
surplus output to ethanol making units when price dump, thus, ensuring
appropriate price.
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Critical analysis

• Abuse of policy especially when prices of crude oil soar as farmers would
find it economically more rewarding to convert farm produce into ethanol
for doping with petrol.
• Need of improvement in technological and financial feasibility with respect
to production of biofuels. Thus, industry academic collaboration should be
enhanced in an integrated manner.
• Inadequate supply-chain infrastructure to deliver biofuels to the final
consumer. Hence, improved investment should be done in building robust
infrastructure.
• Limits on private investment: The government should also take steps to
remove policy barriers that have discouraged private investment in building
supply chains for tapping India’s huge biofuel potential.

Way Forward

• The government has set some ambitious goals for the energy sector which
include electrification of all census villages by 2019, 24×7 electricity and
175 GW of renewable energy capacity by 2022, reduction in energy
emissions intensity by 33%-35% by 2030 and producing above 40%
electricity from non-fossil fuels by 2030.
• These goals clearly exhibit the Centre’s push towards strengthening the
energy infrastructure of the country while promoting the agenda of
sustainability.
• Additionally, in the official gazette of the National Policy on Biofuels, 2018,
MNRE has also discussed the government’s five-point strategy to curb the
country’s dependency on foreign imports in the oil and gas sector.
• The strategy involves increasing domestic production, adopting biofuels and
renewables, energy efficiency norms, improvement in refinery processes
and demand substitution.
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Ethanol blending programme in India

Ethanol is a biofuel, that is, a fuel produced by processing organic matter. The auto fuels we
commonly use are mainly derived from the slow geological process of fossilization, which is why they
are also known as fossil fuels. Ethanol in India is obtained primarily from sugarcane via a fermentation
process. Ethanol is high in oxygen content, which therefore allows an engine to more thoroughly
combust fuel. It can be mixed with fuel in different quantities and can help reduce vehicular
emissions. Also, since it is plant-based, it is considered to be a renewable fuel.

The Centre had “launched pilot projects in 2001 wherein 5 percent ethanol blended petrol was
supplied to retail outlets”.Success of field trials eventually paved the way for the launching of the
Ethanol Blended Petrol (EBP) Programme in January, 2003 for sale of 5 percent ethanol blended
petrol in nine States and four UTs.Currently, 5 percent of ethanol is blended with petrol in India.The
government of India has advanced the target for 20 per cent ethanol blending in petrol (also called
E20) to 2025 from 2030. E20 will be rolled out from April 2023.The central government has also
released an expert committee report on the Roadmap for Ethanol Blending in India by 2025.The
roadmap proposes a gradual rollout of ethanol-blended fuel to achieve E10 fuel supply by April 2022
and phased rollout of E20 from April 2023 to April 2025.

Need for Ethanol blending in India:

• Ethanol has become one of the major priorities of 21st Century India.
• Mixing 20 percent ethanol in petrol holds multiple attractions for India.
• First, it can potentially reduce the auto fuel import bill by a yearly $4 billion,
or Rs 30,000 crore.
• Second, it also provides for farmers to earn extra income if they grow
produce that helps in ethanol production.
• Third, and no less important, is the fact that ethanol is less polluting than
other fuels and, per the NITI Aayog paper, “offers equivalent efficiency at
lower cost than petrol”.
• Use of ethanol-blended petrol decreases emissions such as carbon
monoxide (CO), hydrocarbons (HC) and nitrogen oxides (NOx), the expert
committee noted. Higher reductions in CO emissions were observed with
E20 fuel — 50 per cent lower in two-wheelers and 30 percent lower in four-
wheelers.
• Spelling out the opportunity for India for embracing ethanol, the paper
stresses that “availability of large arable land, rising production of
foodgrains and sugarcane leading to surpluses, availability of technology to
produce ethanol from plant-based sources, and feasibility of making vehicles
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compliant to ethanol blended petrol make E20 not only a national
imperative, but also an important strategic requirement”.
• In Europe, biofuels have been seen as a measure to reduce emissions of
greenhouse gases from road transport because they were considered CO2 -
neutral fuels once lifecycle emissions are considered.

Challenges involved:

• Less Production: Currently, domestic production of bioethanol is not

sufficient to meet the demand for bio-ethanol for blending with petrol at
Indian OMCs.
o Sugar mills, which are the key domestic suppliers of bio-ethanol to
OMCs, were able to supply only 57.6% of the total demand.
o Sugar mills do not have the financial stability to invest in biofuel
plants.
o There are also concerns among investors on the uncertainty on the
price of bioethanol in the future as the prices of both sugarcane and
bio-ethanol are set by the central government.
o Compatible vehicles: vehicles need to be produced with rubberised
parts, plastic components and elastomers compatible with E20 and
engines optimally designed for use of E20 fuel”
o The NITI Aayog paper said that two-wheelers and passenger vehicles
that are now being made in the country “are designed optimally for
E5 (5 percent ethanol blend with petrol) while rubber and plastic
components are “compatible with E10 fuel”.
• Water Footprint:While India has become one of the top producers of
ethanol but it lags top producers, the USA and Brazil, by a huge margin and
remains inefficient in terms of water usage.
o India’s water requirements for producing ethanol are not met through
rainwater and the groundwater is used for drinking and other
purposes.
o Water footprint, that is water required to produce a litre of ethanol,
includes rainwater at the root zone used by ethanol -producing plants
such as sugarcane, and surface, ground water, and fresh water
required to wash away pollutants.
• Limited Sugarcane Availability:Sugarcane is another limited resource that
affects the ethanol blending in the country.
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o In order to achieve a 20% blend rate, almost one-tenth of the existing
net sown area will have to be diverted for sugarcane production. Any
such land requirement is likely to put a stress on other crops and has
the potential to increase food prices.
o India’s biofuel policy stipulates that fuel requirements must not
compete with food requirements and that only surplus food crops
should be used for fuel production, if at all.
• Lack of Alternatives:Producing ethanol from crop residue can be a good
alternative but the annual capacity of biorefinery is still not enough to meet
the 5% petrol-ethanol blending requirement.
o Other biofuels such as Jatropha Have often proven to be
commercially unviable.
• Handling issues:Ethanol being a highly flammable liquid marks obligatory
safety and risk assessment measures during all phases of production,
storage and transportation, thus increasing the cost and risk factor.

Way forward:

• In order to introduce vehicles that are compatible the committee

recommends roll out of E20 material-compliant and E10 engine-tuned
vehicles from April 2023 and production of E20-tuned engine vehicles from
April 2025.
• The Centre must look at ways to reduce the programme’s dependence on
sugarcane.
• Alternative feedstock like agricultural waste, recycled cooking oil, provides
for more environmentally friendly bio-fuels.
• There is a need to focus on raising the non-cane contribution to the ethanol mix.
• This can be done by incentivising both public and private players to set up
second-generation ethanol facilities.
• As we progress towards higher blending of ethanol, careful monitoring and
assessment of emissions changes will be needed to make sure that emission
reduction potential can be enhanced both for regulated and unregulated
pollutants