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Biotechnology and its dimensions

The remarkable march of India into the world of biosciences and technological advances began in 1986. That year,
the then Prime Minister of the country, late Rajiv Gandhi accepted the vision that unless India created a separate
Department for Biotechnology, within the Ministry of Science and Technology, Government of India the country
would not progress to the desired extent. This was because many of our macro-economic issues of growth were
subsumed within that science’s development. That decision has made India one of the first countries to have a
separate department for this stream of science and technology.
In 1982, after detailed deliberations with the scientific community, and on the basis of recommendations by the then
Scientific Advisory Committee to the Cabinet, a National Biotechnology Board (NBTB) was constituted by the
Government to identify priority areas and evolve long term perspective for Biotechnology in India. It was also
responsible for fostering programmes and strengthening indigenous capabilities in this newly emerging discipline.
A separate Department of Biotechnology (DBT) was finally set up in February, 1986 and the NBTB selected Dr S
Ramachandran as the first Secretary of the department. The DBT constituted a ten member Scientific Advisory
Committee (SAC) with heads of various scientific agencies and a seven member Standing Advisory Committee for
North America SAC (0) to ensure that the Department kept abreast of global developments in the field of
Biotechnology.
There were many serious challenges at the start. First, there were inter-departmental conflicts with no department
willing to part with its earlier responsibilities to a new but specialised body. The second most important problem was
the “tendency of Indian scientists to publish only in national journals” because publishing in international and solidly
peer-reviewed journals took too long. Third, the industry could not be persuaded early to join hands as
governmental procedures took too long. The fourth major obstacle was procuring scientific equipment and reagents
and other vital necessities for lab research. In those days in the country, not too many people were working on
biosciences. The department had therefore to focus on
1. Developing human resources
2. Creation of appropriate infrastructure
3. Research and development
4. Creating a regulatory framework
The first autonomous institute, the National Institute of Immunology which was set up in 1981 was brought under
the wings of DBT. Soon after, it was joined by the National Facility for Animal Tissue and Cell Culture of Pune formed
in 1986 which was later christened the National Centre for Cell Science.
The late 1990s and early 2000 saw many other institutes like The National Institute for Plant Genome Research
(NIPGR), the National Brain Research Centre (NBRC) followed, the Centre for DNA Fingerprinting & Diagnostics,
Institute of Bioresources and Sustainable Development and the Institute of Life Sciences take shape. Subsequently,
several other prominent institutes like Translational Health Science and Technology Institute (THISTI), Institute for
Stem Cell Biology and Regenerative Medicine (INstem), National Agri-Food Biotechnology Institute (NABI) at Mohali,
and National Institute of Biomedical Genomics (NIBMG) at Kalyani in West Bengal were established.
There is also renewed effort on social aspects such as health care, food and agriculture, energy and environmental
security. International collaborations have become more strategic, with better reach and breadth and industry
partnerships are growing.

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Importance of Biotechnology for India

Biotechnology has a promising future. In future biotechnology will be accredited for some revolutionary technology.
Recent advances in bioenergy, bioremediation, synthetic biology, DNA computers, virtual cell, genomics, proteomics,
bioinformatics and bio-nanotechnology have made biotechnology even more powerful. Recent discovery of
conduction of electricity by DNA and its behavior as a superconductor has opened a new realm in modern science. In
future biotechnology will have profound impact in world economy. Biotechnology is a golden tool to solve some of
the key global problems like global epidemic, fatal diseases, global warming, rising petroleum fuel crisis and above all
poverty.
One of the major scientific revolutions of the twentieth century was the breaking of the genetic code and the
development of tools that enable scientists to probe the molecules of life with incredible precision. Now, in the
twenty-first century, these developments in biology are being married with the use of ever-increasing computer
power to help us face the challenges that the new century brings. Bioinformatics is the name given to the new
discipline that has emerged at the interface of biology and computing.
Huge amount of genetic data (DNA, RNA, amino acid and protein sequences) of various organisms, form bacteria to
humans, being generated worldwide is stored in a computer database. Specialized software programs are used to
find, visualize, and analyze the information, and most importantly, communicate it to other people. Various
computer tools are used to predict protein structure which is a valuable information for development of vaccines,
diagnostic tools as well as more effective drugs.
Bioinformatics can help in easy and early detection of various diseases like cancer, diabetes and many more with the
help of microarray chips (microarrays are miniature arrays of gene fragments attached to glass slides). Bioinformatics
also helps scientists to construct phylogenetic tree based on molecular biology and ultimately contribute in the study
of evolution. Computer simulations model such things as population dynamics, or calculate the cumulative genetic
health of a breeding pool (in agriculture) or endangered population (in conservation). One very exciting potential of
this field is that entire DNA sequences or genomes of endangered species can be preserved.
Biotechnology can deliver the next wave of technological change that can be as radical and even more pervasive
than that brought about by IT. Employment generation, intellectual wealth creation, expanding entrepreneurial
opportunities, augmenting industrial growth are a few of the compelling factors that warrant a focused approach for
this sector.

Initiatives
1. Innovation:
Basic and translational research in key biological processes and new materials will be supported as innovation for
tomorrow. Access to the knowledge generated will be improved by supporting knowledge and social networks
among stakeholders so that those with appropriate skills can convert the research output into useful products and
processes.Research to promote innovation must be supported increasingly on a cooperative rather than a
competitive basis. This requires effective communication among science agencies, research institutions, academia
and industry
To promote India as a hub of innovation, a network of relevant stakeholders should be developed. Public investment
should be used as a catalyst to promote such clustering and networking as this can lead to enhanced creativity by
sharing of expertise, resources and infrastructure. Availability of human resource would be ensured at each phase of
the product cycle.
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2. Strengthening technology transfer capacity

It is proposed to create several national/regional technology transfer cells (TTC’s) over the next 5 years to provide
high caliber, specialized and comprehensive technology transfer services. The services would include: evaluating
technology and identifying potential commercial uses, developing and executing and intellectual property protection
strategies identifying potential licensees and negotiating licenses. Each TTC would service a cluster of institutions in a
region or a large city. Optimal delivery of services by the TTCs requires professionals with background in industry and
science, wide networks, an external focus and high level licensing skills. The best practices for effective technology
transfer will be benchmarked.
The skills of existing technology transfer professionals will be upgraded by a combination of specialized training
courses, including linking to important programs redesigning the incentives and career paths for posting.
Scientists and other innovators shall be equipped with a better understanding of markets and commercialization
pathways, the process of technology transfer, the strategy of protecting intellectual property rights and industrial
licensing.
3. Fiscal and trade policy initiatives
Biotechnology firms are by far the most research intensive among major industries. On an average the biotechnology
sector invests 20-30 % of its operating costs in R&D or technology outsourcing. Government support, fiscal
incentives and tax benefits are therefore critical to this sector. These measures will also help to capitalize on the
inherent cost effectiveness of the Indian biotech enterprise. The suggested interventions include:
Exemption of import duties on key R&D, contract manufacturing / clinical trial equipment and duty credit for R&D
consumer goods to enable small and medium entrepreneurs to reduce the high capital cost of conducting research.

Biotechnology Parks & Incubators

Establishing biotechnology parks for the growth of the biotechnology industry is essential either through public-
private alliance or public/private sponsorships. With its large human resource in molecular biology, microbiology,
biochemical engineering, synthetic organic chemistry, chemical engineering and allied branches of engineering and
strong institutional base at the universities, CSIR, ICMR and ICAR, India is well placed to support a number of biotech
parks.
Biotechnology Parks can provide a viable mechanism for licensing new technologies to upcoming biotech companies
to start new ventures and to achieve early stage value enhancement of the technology with minimum financial
inputs. These biotech parks facilitate the lab to land transfer of the technologies by serving as an impetus for
entrepreneurship through partnership among innovators from universities, R&D institutions and industry.
Basic minimum components for parks should include research laboratories for product development, multi-purpose
pilot facility for manufacturing and process development, quality control and validation of technologies, common
effluent treatment plant, a GLP Animal House, a recognized human resource training centre, administrative support
centre etc.
The biotech parks should be located so as to be easily accessible for all the stakeholders, tenants, academia with
connecting roads, water and power supply and should also attract less administrative clearances from the
government.
Regulatory Mechanisms
It is important that biotechnology is used for the social benefit of India and for economic development. To fulfill this
vision, it has to be ensured that research and application in biotechnology is guided by a process of decision-making
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that safeguards both human health and the environment with adherence to the highest ethical standards. There is
consensus that existing legislation, backed by science based assessment procedures clearly articulates rules and
regulations that can efficiently fulfill this vision.
Choices are required to be made that reflect an adequate balance between benefit, safety, access and the interest of
consumers and farmers. It is also important that biotechnology products that are required for social and economic
good are produced speedily and at the lowest cost. A scientific, rigorous, transparent, efficient, predictable, and
consistent regulatory mechanism for biosafety evaluation and release system/protocol is an essential for achieving
these multiple goals.
Public Communication and Participation
Biotechnology today has become as important as traditional plant and animal breeding have been in the past. At the
same time, it raises a number of difficult economic, social, ethical, environmental and political issues that constitute
major challenges for the human society. The reception of biotech products by the public has been rather mixed. In
general biopharmaceutical products seem to be better accepted than transgenic crops.
Clearly it is no longer possible to assume automatic public acceptance of new products and processes that promise
public and commercial benefits. Public perception and opinion have a significant influence on the direction and
funding of biotechnology research. Hence there is a need to work actively and transparently to inform and engage
the civic society in decision-making, and to maintain a relationship of trust and confidence. The government and the
industry must actively promote access to information on the benefits and risks in a balanced manner.
To achieve this goal, several enabling factors already exist: a sound biosafety regulatory system; well respected
appellate and judicial system for redressal of grievances; cadre of willing and able scientists for effective and
accurate communication of information; a large body of extension personnel in agriculture, fisheries, veterinary and
human health sectors; large NGO network spread across the country; and an effective and independent mass media
Key Institutions
National institute of immunology
The National Institute of Immunology (NII) is committed to advanced research addressing the basic mechanisms
involved in body’s defence to identify modalities for manipulation of the immune system to provide protection
against diseases and understand mechanisms that can be used to target disease processes for intervention. The
institute’s research thrust areas under immunology and related disciplines cluster in four main themes, namely,
infection and immunity, molecular design, gene regulation and reproduction and development, where cutting edge
research in modern biology is being carried out.
National Center for Cell Sciences, Pune
The National Centre for Cell Science is a National Level, Biotechnology, Tissue Engineering and Tissue Banking
research center located at Savitribai Phule Pune University, in Pune. The institute formerly known as “National
Facility for Animal Tissue and Cell Culture”, is one of the premier research centers in India, which works on cell-
culture, cell-repository, immunology, chromatin-remodelling.
Center for DNA fingerprinting and diagnostics
The Centre for DNA Fingerprinting and Diagnostics (CDFD) is a Biotechnology research centre, located in Hyderabad,
operated by the Department of Biotechnology, Ministry of Science and Technology, Government of India. CDFD is
Sun Microsystems Centre of Excellence in Medical Bio-informatics, supported with a strong bioinformatics facility,
and is the India node of the EMBnet. In addition, DNA fingerprinting and diagnostics services provided by the centre

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support some of the activities. The centre utilises the Combined DNA Index System for DNA profile Matching. The
CDFD and the U.S. FBI had signed an MoU early this year for the acquisition of CODIS.
CDFD receives funding from other agencies like the Wellcome Trust on specific collaborative projects. The Centre is
recognised by the University of Hyderabad and Manipal University for pursuing doctor of philosophy in Life Sciences.
Research at CDFD has focused largely on molecular epidemiology of bacterial pathogens, structural genetics,
molecular genetics, bioinformatics and computational biology

Institute for Life Sciences

The Institute of Life Sciences (ILS), an autonomous institute has been brought under the fold of the Department of
Biotechnology, Government of India in August 2002. The institute is located in close proximity to other research
institutions at Bhubaneswar. The institute was earlier established on February 11, 1989 and was under the
administrative and financial control of Department of Science and Technology, Government of Orissa.
The mandate of ILS is to undertake basic and translational research in frontier areas of life sciences. The research
interests of the faculty are in three major areas: (a) Infectious Disease Biology, (b) Gene Function and Regulation and
(c) Translation Research and Technology Development. In addition, new collaborations with industry have been
established to tap commercial potential of laboratory science.

Research and Development Initiatives

With a billion-plus mouths to feed, and counting, crop biotechnology has to be a natural winner in priority terms for
a country like India, especially in the era of climate change, degradation of farmlands, increased soil salinity, due to
drop in groundwater as well as pollution of surface water sources, more frequent droughts and so on.
Advances in gene discovery and genomics have led to the identification of several novel genes that provide excellent
opportunities for effectively tackling problems of biotic/abiotic stresses, for enhancement of crop productivity, and
for improvement of their nutritional quality.
These scientific advances can facilitate us in accelerating pre-breeding germplasm enhancement for eventual crop
improvement through effective molecular breeding. Along with pursuing basic research, genome sequencing and
genomic studies for identification of useful genes, QTLs & validation of their function; developing transgenic crops
and crop improvement through marker aided selection for tackling various abiotic & biotic stresses and quality traits
are high priority in the agriculture biotechnology programme of the department.
Major ongoing programmes:
1. Wheat Genome Sequencing Programme
2. Rice Functional Genomics
3. Crop Biofortification and quality improvement programme
4. National Plant Gene Repository at NIPGR, New Delhi
5. Next Generation Challenge Programme on Chickpea Genomics,
6. Network project – From QTL to Variety- Marker Assisted Breeding of Rice with Major QTLs for Drought, Flooding
and Salt Tolerance,
7. Root Development and Nutrition, germination, Characterisation and Use of EMS Induced Mutants of Upland
Variety Nagina-22 for Functional Genomics of Rice,
8. Identification of Candidate Genes for Enhanced Water Use Efficiency in Rice through Activation Tagging, Metabolic
Engineering programme,
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9. Four Programme support for State Agricultural Universities,

10. Accelerated Crop Improvement Programme to bring important traits into high yielding varieties of Rice, Wheat,
Chick pea, soybean, cotton, mustard and Maize.
11. Besides, nearly 300 ongoing R&D projects have been supported by the department during last 3 to 5 years.
Several research leads have been obtained and these are being pursued further.

Basic research has been a major thrust area under Plant Biotechnology with special emphasis on signal transduction,
root and floral differentiation, host pathogen interaction etc. Application of genomic tools to study both structural
and functional genomics under the Solanaceae Genome Initiative. Thrust has also been on forestry, horticulture and
plantation crops, fruits & vegetables including application of tissue culture for regeneration of high quality
economically important plant species, their field demonstration, and validation of proven technology; germplasm
characterization and their improvement of crops through molecular biology tools. Focus is also on major horticulture
crops including apple with focus on, 1) Creating A genomics platform for Apple research in India and 2) Improvement
of Apple through biotechnological interventions.
Studies are also supported on Forestry network focussing on Genetic improvement of Eucalyptus through mapping
and tagging of QTL genes for two industrially important traits like adventious rooting capacity and wood property.
Under saffron network focus is on developing a tissue culture protocol for corm production of desired size, develop
in vitro microplants for cormlet production and develop complete agro technology for use of cormlets of small size;
characterization of microflora of rhizosphere associated with Saffron crop to develop consortia of beneficial
microbes; for genetic improvement of Saffron and functional genomics approaches in understanding the regulation
of synthesis and accumulation of appocarotenoids.

Animal Biotechnology
Livestock sector plays an important role in the economy of our country. The contribution of this sector in national
economy was approximately 3.9% in 2011-12. India ranks first in the world in milk production with an estimated
production of 132.4 million tonnes in 2012-13. India is also third largest egg-producer in the world, over 69.7 billion
eggs were produced in 2012-13.
DBT supports R & D programmes for development of affordable new generation vaccines and diagnostics against a
plethora of animal diseases. The emphasis is to suffix “C” to the R & D programmes to make way for the
‘commercialization’ of the developed leads, products and processes. A thrust in this direction is given through multi-
faceted approaches such as collaborative translational research, consolidation of existing projects with potential
leads and generation of network programmes around major animal disease of national importance

Aquaculture and Marine Biotechnology

1. Development of diagnostics and vaccines for major diseases in aquaculture
2. Development of culture technology in non-traditional species and front-line demonstrations to prove techno-
economic viability of aquaculture production system
3. Improved aspects on new feed development, fish nutrition, breeding and reproduction, health and sanitation,
post-harvest, value addition for enhancement of aquaculture productivity
4. Development of in vitro tissue/ cell culture system in various aquaculture species

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5. Marine pharmaceuticals, biomaterials, bio-adhesives, bio-flocculent, bio-surfactants, medical implants,

biopolymers, bio-plastics, Novel enzymes, Biosensors and Bioremediation
6. Fish transgenics for therapeutic and ornamentals
7. Marine extremophiles
8. Molecular biology of Indian aquaculture species, identification of useful genes for transgenesis work including
genomics & proteomics studies
9. Programme support/ Centre of excellence in Aquaculture & Marine Biotechnology
10. Training support in Molecular Biology for Fisheries Professionals
11. Computer Simulation model for Aquaculture system

Seri biotechnology
The DBT has established a Centre of Excellence in Genetics and Genomics of Silkworm at CDFD, Hyderabad.
Transgenic lines of silkworm resistant to baculovirus (BmNPV) have been generated through RNAi technology. The
transgenic lines are being transferred to sericulture centres for controlled trials after necessary clearance from
RCGM. Analysis of immune transcriptome of bacteria-challenged wild silkmoth, Antheraea mylitta led to the
identification of a number of potential immune-related genes.
Eleven potential silkworm (Bombyx mori) lines tolerant to BmNPV varying from 27 per cent to 67 per cent have been
developed through DNA-marker assisted breeding jointly at Seribiotech Research Laboratory (SBRL), Bangalore and
Andhra Pradesh State Sericulture Research and Development Institute (APSSR&DI), Hindupur. The selected lines are
at BC-5 F-9 generation and are being further taken up for field trials.
A programme on comparative genetic analysis of sex chromosomes and sex determining genes in silkmoths has been
continued at CDFD, Hyderabad. Two novel genes predicted to be involved in the silkworm sex determination, were
identified using various biochemical and molecular procedures. Their validation is in progress. W-derived gene Bmz1
has been analysed for its involvement in sex determination.

Human Genetics
Human genetics is the study of inheritance as it occurs in human beings. Human genetics encompasses a variety of
overlapping fields including: classical genetics, cytogenetics, molecular genetics, biochemical genetics, genomics,
population genetics, developmental genetics, clinical genetics, and genetic counseling.
Genes can be the common factor of the qualities of most human-inherited traits. Study of human genetics can be
useful as it can answer questions about human nature, understand the diseases and development of effective
disease treatment, and understand genetics of human life. This article describes only basic features of human
genetics; for the genetics of disorders please see: medical genetics.

Stem Cell Research

Stem cells and regenerative medicine has emerged as a new and most exciting field of life science in view of its
potential clinical applications. The classical definition of a stem cell requires that it possess two properties:
1. Self-renewal: the ability to go through numerous cycles of cell division while maintaining the undifferentiated
state.
2. Potency: the capacity to differentiate into specialised cell types.

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The ability of stem cells to self-renew and give rise to subsequent generations with variable degrees of
differentiation capacities, offers significant potential for generation of tissues that can potentially replace diseased
and damaged areas in the body, with minimal risk of rejection and side effects. Keeping in view the therapeutic
applications of these cells, the DBT has identified this area as one of its thrust areas since 2001.
The overall aim is to promote basic, early and late translational research in the area of stem cell and regenerative
medicine in the country. The road map for stem cell research has been broadly categorized into: basic research; pre-
clinical and clinical research; industry-academia partnership programme, capacity building; and formulation of an
appropriate regulatory framework.
An institute of “Stem Cell Research and Regenerative Medicine” has been established at Bangalore. CMC-DBT Centre
for Stem Cell Research CSCR at CMC, Vellore is a translational unit of inStem, Bangalore. National Apex Committee
for Stem Cell Research and Therapy (NAC-SCRT) has been established by the Government.

Bioengineering
Bioengineering is a multi-disciplinary field of research which involves application of engineering techniques for basic
understandings and development of innovative technologies for improved quality of life. The Department of
Biotechnology has taken an endeavor to apply principles and techniques of allied quantitative sciences such as
physics, mathematics, chemistry, computer sciences and engineering in the domain of biological sciences to
effectively address the biomedical challenges.
The main scope of this program is to foster and support innovative ideas in fields of Biomaterials for various
therapeutic/biomedical applications, Bio-instruments/Bio-medical devices and implants, Bio-medical sensors, Bio-
imaging for improved diagnostics/existing medical equipment, Tissue engineering and other allied areas. The central
concern at DBT is improving the quality of life and to that end, bioengineering is a crucial field of activity.
Implantable device for multifunction prosthesis hand control has been fabricated successfully. The implantable
device pickup and transmit electromyographic signals transcutaneously. An auxiliary device placed over the skin
receives the transmitted signal and also supply electrical power by electromagnetic induction. The signal
transmission uses a digital packet radio network to provide high reliability of the EMG signal. The final design and
fabrication of the circuits for implantation completed and miniature electronics with power and data transmitter
accomplished. The prototype testing in animal models are under process.
Mannequin-based training simulator specifically for detection of different types of heart attacks or AMI (Acute
Myocardial Infarction) has been developed to train the cardiologists (trainer). The researchers have developed an
interactable (hardware) mannequin, with software simulated Cardiovascular System incorporating parameters like
radial artery pulse measurement, ECG determination, BP measurement, heart sound, injection of life-saving drugs
etc that can be programmed by the trainer.
Fiberoptic Laser Raman spectrometer has been standardized to develop and evaluate fiberoptic probes designs for
the diagnosis of oral precancers (erythtoplakia, leukoplakia and OSMF) and cancers in the clinical setting. Non-
invasive, hand-held, compact and wireless technology based easy-to-use device for display of ECG signals for
monitoring chest pains devised successfully. The technology has been combined with mobile phone technology using
GPRS.
A low cost biosensor for rapid detection of Salmonella typhi has been developed by surface modification of nylon
membrane & polyacrylonitrile fibre (PAN) with an aim to use them as solid matrices for ELISA/FIA. A digital and plug-

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based microfluidic system is being developed to study the aggregation kinetics of the β-amyloid peptides towards
understanding the cause of neurodegenerative disease like Alzheimer.
Calibration-free pulse oximeter has been successfully developed for non-invasive measurement of oxygen saturation
in arterial blood. A couple of novel algorithms has been designed for computation of oxygen saturation and method
is independent of source intensity, detector sensitivity, coloration of skin of patient or volume of intervening tissue.
Three prototypes have been developed and field testing is underway.
Robotic wheelchair to provide comfort or to give independence of mobility to physically challenged persons has
been designed successfully. Prototypes of two models have been developed: a low cost one and an advanced one.
The most important feature of the advanced version is its autonomous navigational capability in user’s residence and
office.
Microparticle-based dual drug delivery system for the treatment of lung cancer has been extrapolated as a
therapeutic option for solid tumors. A model drug, ampicillin along with an anti-cancer drug has been incorporated
within the delivery vehicle for the study of release kinetics and bioactivity on various lung cancer cell lines.

Tissue Engineering
An animal model of physical injuries in the goat successfully demonstrated utilizing the autologous chondrocyte
culture. Tissue engineered osteochondral grafts developed and tested successfully in vitroin terms of gene
expression, biochemistry and biomechanics. Significant efforts also undertaken modifying tissue engineered cartilage
system to develop in vitro disease models of Osteoarthritis.
The silk fibroin proteins isolated from domesticated mulberry, Bombyx mori and wild non-mulberry; Antheraea
mylitta silkworms have been exploited to develop multilayer 2D films for controlled drug release. The study
envisages the versatile and tunable properties of silk making them exciting candidates for the tissue engineering and
biotechnological applications.

Environmental Biotechnology
Scientists at IGIB are exploring the rich microbial diversity of India and developing biotechnological applications using
this resource to address issues pertaining to the environment and energy crisis. Different areas that are being
pursued are:
1. Microbial diversity and its exploration
2. Hydrogen and bio-plastic from waste
3. Waste water treatment using microbes
4. Metagenomics
Microbes which survive in extreme environments make enzymes tolerant to physical stress. Many of these are
difficult to isolate and culture in the laboratory. At IGIB, metagenomic libraries made from samples collected from
various ecological niches in different geographical regions of India are being screened for functional clones
expressing novel biocatalysts, bioactive compounds and pathways.
Hydrogen has emerged as a clean fuel for the future. IGIB scientists have analyzed metabolic and genomic databases
of microbes have been analyzed in order to identify microbes which can collectively provide the biochemical route to
production of hydrogen and environment friendly plastics.
IGIB has been involved in screening of pollutants against biodegradative enzymes, development of biosensors for
monitoring pollutants and using microbial consortia for treatment of alkaline waste water generated from industries.
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Industrial Biotechechnology
India is among the top 12 biotech destinations in the world and ranks second in Asia, after China. The Indian biotech
industry is likely to experience significant growth on the back of increasing economic prosperity, health
consciousness and a billion-plus population base. Current estimates value the industry at US$ 7 billion in FY15, which
is expected to grow at 30.46 per cent Compound Annual Growth Rate (CAGR) to US$ 100 billion by FY25.
The sector is divided into five major segments: bio-pharma, bio-services, bio-agri, bio-industrial and bio-informatics.
Biotechnology industry’s growth in India is primarily driven by vaccines and recombinant therapeutics. Going
forward, India also has the potential to become a major producer of transgenic rice and several Genetically Modified
(GM) or engineered vegetables.
The Government of India has taken several initiatives including a biotechnology industry partnership program to
develop new technologies and launched a National Rural Healthcare Mission to boost healthcare spending. As per
the 12th Five-Year Plan, the government aims to spend US$ 3.7 billion on biotechnology compared to US$ 1.1 billion
in the 11th Five-Year Plan to accelerate the pace of research, innovation and development. In addition, the
Department of Biotechnology (DBT) has designed the National Biotechnology Development Strategy (NBDS) to
strengthen the industry’s human resources and infrastructure while promoting growth and trade. Furthermore, the
Government has allowed 100 per cent Foreign Direct Investment (FDI) through the automatic route for
manufacturers of drugs and pharmaceuticals.

Emission mode project on stem cell biology

The Institute for Stem Cell Biology and Regenerative Medicine (inStem), is a state-of-the-art research institute in
Bangalore, India, dedicated to the study of stem cell and regenerative biology.
An autonomous institute funded by the Dept of Biotechnology, Govt. of India, inStem emphasizes collaborative
research in stem cell biology. inStem’s mandate to allow this cross-disciplinary, multi-pronged approach to research,
straddles the divide between clinical and laboratory research in stem cell biology. In trying to answer intractable and
challenging questions that face the field, inStem seeks to rewrite the paradigm of the research institute: without
barriers and across disciplines.
Research at inStem, encompasses a wide range of topics in stem cell biology: from questions about the fundamental
mechanisms that control differentiation and renewal, to clinical studies on the impact of stem cells on recovery from
stroke/injury. The institute is also home to the Wadhwani Centre, a generous philanthropic donation dedicated to
the study of stem cell biology of the nervous system as well as cardiomyopathies. inStem’s fast-growing, young and
enthusiastic atmosphere ensures that its work is at the very forefront of science.
Research at inStem is well-supported, with access to facilities at both NCBS and Centre for Cellular and Molecular
Platforms (C-CAMP). Together these three institutions serve as part of the Bangalore Biocluster. inStem is also the
umbrella organization for three initiatives: inStem itself, the Center for Stem Cell Research (CSCR) located at CMC
Vellore, and an Extramural Program in Stem Cell Research (EPiSTEM), a funding initiative for support of stem cell
research nationwide. Strategically placed in the biotechnology hub of India with access to world-class research and
facilities, inStem is perfectly positioned to take its place as a leader in stem cell biology and regenerative medicine
research.
Apart from this, inStem has established collaborative programs with iCeMS, Kyoto, Japan, with Cambridge University
(chemical biology of cancer), with IFOM, Milan, with Stempeutics (for research in mesenchymal stem cells) and with
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MacLaughlin Research Institute, Montana USA (to collaborate on generation of mouse models for study of
development and disease).
Jointly with CIRM (California Institute of Regenerative medicine, California), inStem funds collaborative projects that
seek to understand stem cells and their future role in human disease.

Problems and issues of biotechnology

There are four main societal concerns in the biotechnology field. Biotechnology is the use of living systems and
organisms to develop or make products, or any technological application that uses biological systems, living
organisms or derivatives thereof, to make or modify products or processes for specific use. New tools and products
developed by biotechnologists are useful in research, agriculture, industry and the clinic.

Societal Concerns With Biotechnology

1. Harm to the environment – This concern is perhaps the most widely cited by those opposed to GMOs. It is very
difficult to predict what will happen in an ecosystem where a new organism has been introduced, whether
genetically modified or not.
2. Bioterrorism – Governments are worried that terrorists will use biotechnology to create new Superbugs, infectious
viruses, or toxins, for which we have no cures.
3. Laboratory/production safety – It’s hard to protect oneself if you don’t know what you’re working with. Some new
technologies, usually nonbiologicals such as nanoparticles make commercial production lines before they have been
sufficiently tested for safety. There is also concern about technician safety in laboratories, even under secured
conditions, when working with organisms of unknown virulence.
4. Ethical issues – Besides the age-old debate over whether cloning genes is sacrilegious, innumerable ethical
questions arise over the appropriateness of licensing genetic inventions and other IP issues. In addition, the
construction of genes from scratch (the first artificial gene was actually synthesized in 1970) means we might
someday be able to create life from a chemical soup which will most certainly go against the ethical or religious
beliefs of a significant number of people.

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Genetic engineering,

also called genetic modification or genetic manipulation, is the direct manipulation of an organism's genes using
biotechnology.Genetic engineering involves the techniques to alter the chemistry of genetic material (DNA and RNA)
and thus change the phenotype of the host organism.Asexual reproduction preserves the genetic information, while
sexual reproduction permits variation.Traditional hybridisation procedures used in plant and animal breeding, very
often lead to inclusion and multiplication of undesirable genes along with the desired genes.The techniques of
genetic engineering which include creation of recombinant DNA, use of gene cloning and gene transfer, overcome
this limitation and allows us to isolate and introduce only one or a set of desirable genes without introducing
undesirable genes into the target organism.

There are three basic steps in genetically modifying an organism

 identification of DNA with desirable genes;

 introduction of the identified DNA into the host;
 maintenance of introduced DNA in the host and transfer of the DNA to its progeny.

CLONING:

Cloning is the process of producing genetically identical individuals of an organism either naturally or artificially. In
nature, many organisms produce clones through asexual reproduction. the process of generating a genetically
identical copy of a cell or an organism. Cloning happens often in nature—for example, when a cell replicates itself
asexually without any genetic alteration or recombination. Prokaryotic organisms (organisms lacking a cell nucleus)
such as bacteria create genetically identical duplicates of themselves using binary fission or budding. In eukaryotic
organisms (organisms possessing a cell nucleus) such as humans, all the cells that undergo mitosis, such as skin cells
and cells lining the gastrointestinal tract, are clones; the only exceptions are gametes (eggs and sperm), which
undergo meiosis and genetic recombination.
Advancements in the field of molecular biology led to the development of techniques that allowed scientists to
manipulate cells and to detect chemical markers that signal changes within cells. With the advent of recombinant
DNA technology in the 1970s, it became possible for scientists to create transgenic clones—clones with genomes
containing pieces of DNA from other organisms. Beginning in the 1980s mammals such as sheep were cloned from
early and partially differentiated embryonic cells.
In 1996 British developmental biologist Ian Wilmut generated a cloned sheep, named Dolly, by means of nuclear
transfer involving an enucleated embryo and a differentiated cell nucleus. This technique, which was later refined

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and became known as somatic cell nuclear transfer (SCNT), represented an extraordinary advance in the science of
cloning, because it resulted in the creation of a genetically identical clone of an already grown sheep. It also
indicated that it was possible for the DNA in differentiated somatic (body) cells to revert to an undifferentiated
embryonic stage, thereby reestablishing pluripotency—the potential of an embryonic cell to grow into any one of
the numerous different types of mature body cells that make up a complete organism. The realization that the DNA
of somatic cells could be reprogrammed to a pluripotent state significantly impacted research into therapeutic
cloning and the development of stem cell therapies.
SCNT is a laboratory technique for creating an ovum with donor nucleus. In it, nucleus containing the organism’s
DNA of somatic cell (a body cell other than sperm or egg cell) is removed and rest of cell discarded. The nucleus of
somatic cell is then inserted into enucleated egg cell which reprograms somatic cell nucleus by the host cell. The egg,
now containing nucleus of somatic cell, is stimulated with a shock and will begin to divide forming blastocyst (an
early stage embryo with about 100 cells) with almost identical DNA to original organism. It can be used in embryonic
stem cell research, regenerative medicine i.e. “therapeutic cloning.” It can also be used as first step in process of
reproductive cloning.
APPLICATIONS OF SCNT:
Stem cell research- Somatic cell nuclear transplantation is being used in stem cell research. These cells are deemed
to have a pluripotent potential because they have the ability to give rise to all of the tissues found in an adult
organism. This could be used in therapies or disease research. This allows stem cells to create any cell type, which
could then be transplanted to replace damaged or destroyed cells.
Organ transplants- Another application of SCNT stem cell research to generate tissues or even organs for transplant
into the specific patient. The resulting cells would be genetically identical to the somatic cell donor, thus avoiding
any complications from immune system rejection.
Therapeutic applications- SCNT have ample scope of success in therapy and curing diseases. It can be used to treat
diseases like diabetes, Parkinson’s disease etc. In 2014, the New York Stem Cell Foundation was successful in
creating SCNT stem cells derived from adult somatic cells. One of these lines of stem cells was derived from the
donor cells of a type 1 diabetic. These insulin producing cells could be used for replacement therapy in diabetics,
demonstrating real SCNT stem cell therapeutic potential.
Reproductive cloning- Somatic Cell Nuclear Transfer technique is currently the basis for cloning animals (such as the
famous Dolly the sheep), and has been theoretically proposed as a possible way to clone humans. But there are
moral and ethical objections against reproductive cloning. In 2018, the first successful cloning of primates using
somatic cell nuclear transfer, (the same method as Dolly the sheep), was successfully done with the birth of two live
female clones .
Preservation of endangered species- Interspecies nuclear transfer (iSCNT) is a means of somatic cell nuclear transfer
used to facilitate the rescue of endangered species, or even to restore species after their extinction.

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SURROGACY PROTECTION ACT

The Surrogacy (Regulation) Bill, 2019 was introduced by the Minister of Health and Family Welfare, Dr. Harsh
Vardhan in Lok Sabha on July 15, 2019. The Bill defines surrogacy as a practice where a woman gives birth to a child
for an intending couple with the intention to hand over the child after the birth to the intending couple.

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Regulation of surrogacy: The Bill prohibits commercial surrogacy, but allows altruistic surrogacy. Altruistic surrogacy
involves no monetary compensation to the surrogate mother other than the medical expenses and insurance
coverage during the pregnancy. Commercial surrogacy includes surrogacy or its related procedures undertaken for a
monetary benefit or reward (in cash or kind) exceeding the basic medical expenses and insurance coverage.

Purposes for which surrogacy is permitted: Surrogacy is permitted when it is: (i) for intending couples who suffer
from proven infertility; (ii) altruistic; (iii) not for commercial purposes; (iv) not for producing children for sale,
prostitution or other forms of exploitation; and (v) for any condition or disease specified through regulations.
Eligibility criteria for intending couple: The intending couple should have a ‘certificate of essentiality’ and a
‘certificate of eligibility’ issued by the appropriate authority.
A certificate of essentiality will be issued upon fulfilment of the following conditions: (i) a certificate of proven
infertility of one or both members of the intending couple from a District Medical Board; (ii) an order of parentage
and custody of the surrogate child passed by a Magistrate’s court; and (iii) insurance coverage for a period of 16
months covering postpartum delivery complications for the surrogate.
The certificate of eligibility to the intending couple is issued upon fulfilment of the following conditions: (i) the
couple being Indian citizens and married for at least five years; (ii) between 23 to 50 years old (wife) and 26 to 55
years old (husband); (iii) they do not have any surviving child (biological, adopted or surrogate); this would not
include a child who is mentally or physically challenged or suffers from life threatening disorder or fatal illness; and
(iv) other conditions that may be specified by regulations.
Eligibility criteria for surrogate mother: To obtain a certificate of eligibility from the appropriate authority, the
surrogate mother has to be: (i) a close relative of the intending couple; (ii) a married woman having a child of her
own; (iii) 25 to 35 years old; (iv) a surrogate only once in her lifetime; and (v) possess a certificate of medical and
psychological fitness for surrogacy. Further, the surrogate mother cannot provide her own gametes for surrogacy.

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Appropriate authority: The central and state governments shall appoint one or more appropriate authorities within
90 days of the Bill becoming an Act. The functions of the appropriate authority include; (i) granting, suspending or
cancelling registration of surrogacy clinics; (ii) enforcing standards for surrogacy clinics; (iii) investigating and taking
action against breach of the provisions of the Bill; (iv) recommending modifications to the rules and regulations.
Registration of surrogacy clinics: Surrogacy clinics cannot undertake surrogacy related procedures unless they are
registered by the appropriate authority. Clinics must apply for registration within a period of 60 days from the date
of appointment of the appropriate authority.
National and State Surrogacy Boards: The central and the state governments shall constitute the National Surrogacy
Board (NSB) and the State Surrogacy Boards (SSB), respectively. Functions of the NSB include, (i) advising the central
government on policy matters relating to surrogacy; (ii) laying down the code of conduct of surrogacy clinics; and (iii)
supervising the functioning of SSBs.
Parentage and abortion of surrogate child: A child born out of a surrogacy procedure will be deemed to be the
biological child of the intending couple. An abortion of the surrogate child requires the written consent of the
surrogate mother and the authorisation of the appropriate authority. This authorisation must be compliant with the
Medical Termination of Pregnancy Act, 1971. Further, the surrogate mother will have an option to withdraw from
surrogacy before the embryo is implanted in her womb.
Offences and penalties: The offences under the Bill include: (i) undertaking or advertising commercial surrogacy; (ii)
exploiting the surrogate mother; (iii) abandoning, exploiting or disowning a surrogate child; and (iv) selling or
importing human embryo or gametes for surrogacy. The penalty for such offences is imprisonment up to 10 years
and a fine up to 10 lakh rupees. The Bill specifies a range of offences and penalties for other contraventions of the
provisions of the Bill.
IN-VITRO FERILIZATON:
In vitro fertilization (IVF) is a complex series of procedures used to help with fertility or prevent genetic problems
and assist with the conception of a child.
During IVF, mature eggs are collected (retrieved) from ovaries and fertilized by sperm in a lab. Then the fertilized egg
(embryo) or eggs (embryos) are transferred to a uterus. One full cycle of IVF takes about three weeks. Sometimes
these steps are split into different parts and the process can take longer.
IVF is the most effective form of assisted reproductive technology. The procedure can be done using your own eggs
and your partner's sperm. Or IVF may involve eggs, sperm or embryos from a known or anonymous donor. In some
cases, a gestational carrier — a woman who has an embryo implanted in her uterus — might be used.
chances of having a healthy baby using IVF depend on many factors, such as your age and the cause of infertility. In
addition, IVF can be time-consuming, expensive and invasive. If more than one embryo is transferred to your uterus,
IVF can result in a pregnancy with more than one fetus (multiple pregnancy).
The IVF technique was developed in the United Kingdom by Doctors Patrick Steptoe and Robert Edwards. The
world's first "test-tube baby", Louise Brown, was born as a result of this technique on July 25, 1978 amid intense
controversy over the safety and morality of the procedure. India's first successful IVF to produce "Durga" alias
Kanupriya Agarwal-second test tube baby in the world-was performed by Dr. Subhash Mukhopadhyay on October 3,
1978. Both these events caused public debate, criticism and even social professional ostracism of those involved in
initiating life outside the body. Besides these obstacles the techniques of IVF has survived as a method of choice for
treating some type of infertility.
Currently, IVF success rates have improved dramatically and IVF is used by heterosexual and homosexual couples
experiencing infertility as well as single women pursuing parenthood. IVF is now an established technique for
treating some forms of infertility, yet it remains ethically controversial.
In-vitro Fertilization is an assisted reproductive technology (ART) commonly referred to as IVF. IVF is the process of
fertilization by extracting eggs, retrieving a sperm sample and then manually combining an egg and sperm in a

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laboratory dish. The embryo(s) is then transferred to the uterus. Other forms of ART include gamete intrafallopian
transfer (GIFT) and zygote intrafallopian transfer (ZIFT).
IVF Cycle
It consists- Egg Retrieval: A minor surgical procedure in which a doctor obtains eggs from the follicles of the ovaries.
Donor Insemination: It is placed sperm directly inside the vagina at the cervix or inside the uterus (called Intrauterine
Insemination or IUI). Donor insemination was previously called Artificial Insemination.
Embryo Development: When the sperm successfully fertilizes the egg, an embryo forms and begins to grow. When
the embryo is 2 to 3 days old it at the ‘cleavage stage’; at 5 to 6 days old, it is called a ‘blastocyst’.
Embryo Transfer: Fertilized eggs (embryos) are placed back into the woman’s uterus or fallopian tube through the
cervix.
Treat Different Types of Infertility
IVF can be used to Treat Infertility of Different Types such as-
Blocked or damaged fallopian tubes.
Male factor infertility including decreased sperm count or sperm motility.
Women with ovulation disorders, premature ovarian failure and uterine fibroids.
Women who have had their fallopian tubes removed.
Individuals with a genetic disorder.
Unexplained infertility.

GENETICALLY MODIFIED CROPS:

Genetically modified crops (GM crops) are plants used in agriculture, the DNA of which has been modified using
genetic engineering techniques. More than 10% of the world’s crop lands are planted with GM crops. In most cases,
the aim is to introduce a new trait to the plant which does not occur naturally in the species like resistance to certain
pests, diseases, environmental conditions, herbicides etc. Genetic Modification is also done to increase nutritional
value, bioremediation and for other purposes like production of pharmaceutical agents, biofuels etc.

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SUPPORTING STATEMENTS:

The proponents, argue that the GM technologies have been around for about 15 years and they have been in use
across the world including in countries such as Brazil and China. During a visit to India in March 2005, Norman
Borlaug – widely regarded as the father of the Green Revolution – supported producing genetically modified (GM)
food to eradicate hunger from the world. “It is better to die eating GM food instead of dying of hunger,” said the
Nobel laureate, who passed away in 2009.

Former prime minister, Manmohan Singh, saw biotechnology as key to food security and warned against succumbing
to “unscientific prejudices”.

“The concerns over their (GM crops) perceived risks should be addressed by following internationally accepted
procedures for assessing safety parameters. ICAR, which is involved in developing useful products and technologies
in this field, must contribute to the public discourse and provide clarity on this sensitive issue,” – President Pranab
Mukerjee.

Indian intelligence agency names anti-GM groups such as Greenpeace India and Gene Campaign as one of the many
“anti-national” foreign-funded NGOs hampering India’s economic progress.

Agriculture scientists from research institutions including IARI, ICAR and various Universities demanding “field trials”
for GM crops, arguing that “confined field trials are essential for the evaluation of productivity performance as well
as food and environmental safety assessment”.

A group of prominent scientists had met under ‘father of green revolution’ MS Swaminathan at National Academy of
Agricultural Sciences ( NASA) and issued a 15-point resolution in favour of GM crops.

“A brinjal crop normally requires up to 30 sprays of insecticides. This goes into the human consumption indirectly. If
we grow and consume Bt brinjal, we will consume some of the genes that have been built into the seeds to make the
crop pest- and herbicide-resistant. Ultimately, we have to see which of the two is less harmful for consumption” –
S.S. Gosal, Director of Research, Punjab Agriculture University.

STATEMENTS AGAINST GM-CROPS:

Organisations such as Greenpeace argue that the GM crops don’t yield better results, but push the farmers into
debt. They lose their sovereign right over seeds as they are forced to buy GM seeds and technologies from
multinational corporations. The increasing incidence of suicide by farmers cultivating Bt cotton is cited as an example
of the perils of GM crops in a country such as India. Besides the suspect merits of GM crops, what the opponents
also say is that once they are released into the environment, it’s irreversible.

GEAC:

Genetic Engineering Appraisal Committee (GEAC)

The Committee shall function as a Statutory Body under the Ministry of Environment & Forests for approval of
activities involving large-scale use of hazardous living microorganisms and recombinants in research and industrial
production from the environmental angle as per the provisions of rules 1989.

 The Committee shall also be responsible for approval of proposal relating to release of genetically
engineered organisms and products into the environment including experimental field trials as per the
provisions of Rules, 1989.

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 The Committee shall be responsible for approval of proposals involving the use of living modified organism
falling in the risk category Ill and above in the manufacture/import of recombinant Pharma products or
where the end product of the recombinant Pharma products per se is a living modified organism.
 The Committee may co-opt other members/experts to the GEAC in accordance with the provisions of
Section 4, para 3 of the Rules, 1989 as necessary.
 The Committee may also appoint subgroups/sub-committees/expert committee to undertake specific
activities related to compliance of biosafety.
 One third members of the GEAC will constitute the quorum for convening the meeting.
 The members of the GEAC will be required to sign a ‘Statement of Declaration of Independence’ and
‘Statement of Confidentiality’ (as per enclosed proforma).
 The Committee shall function for a period of three year from the date of issue of this notification.
 With the approval of the Chairman GEAC, if required, representative of other Ministries and other experts
may be invited as ‘Special Invitees’ to participate in the meeting of the GEAC depending on the issues to be
discussed.

Major companies interested in Genetically Modified crops in India include Monsanto India, Mahyco and BASF. The
industry body — Association of Biotech Led Enterprises- Agriculture Group (ABLE-AG) wants a progressive push to
the march of GM technology in India.

CONTROVERSIES:

 2002 – Bt cotton introduced in India.

 2006 – Activists filed a PIL against GM crops in the Supreme Court.
 2010 – The then environmental minister Jairam Ramesh blocked the release of Bt Brinjal until further notice
owing to a lack of consensus among scientists and opposition from brinjal-growing states. No objection
certificates from states were made mandatory for field trials.
 2012 – Parliamentary standing committee on agriculture, in its 37th report asked for an end to all GM field
trials in the country.
 2013 July – New crop trials have been effectively on hold since late 2012, after a supreme court-appointed
expert panel recommended suspension for 10 years until regulatory and monitoring systems could be
strengthened. Though the SC panel suggested moratorium on GM trails, there was no official verdict from
the Supreme Court on this issue.
 2013 July – Environment minister Jayanthi Natarajan put on hold all trials following SC panel suggestions.
 2014 – Her successor, Veerappa Moili cleared the way for trails. (NB: Two of Manmohan Singh’s own
environment ministers had stalled GM trials earlier, but Veerappa Moily took an opposite stand and the
process of approving the one-acre field trials restarted.)
 2014 March – GEAC (UPA government) approved field trials for 11 crops, including maize, rice, sorghum,
wheat, groundnut and cotton.
 2014 July – 21 new varities of genetically modified (GM) crops such as rice, wheat, maize and cotton have
been approved for field trials by the NDA government in July 2014. The Genetic Engineering Appraisal
Committee (GEAC) — consisting mostly of bio-technology supporters — rejected just one out of the 28
proposals up for consideration. Six proposals were rejected for want of more information.
 2016: GEAC gave green signal to GM Mustard for field trial, but SC stayed the order and sought public
opinion on the same.

There are as many as 20 GM crops already undergoing trails at various stages.

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INTELLECTUAL PROPERTY RIGHTS:

Intellectual property rights (IPR) are the rights given to persons over the creations of their minds: inventions, literary
and artistic works, and symbols, names and images used in commerce. They usually give the creator an exclusive
right over the use of his/her creation for a certain period of time.

These rights are outlined in Article 27 of the Universal Declaration of Human Rights, which provides for the right to
benefit from the protection of moral and material interests resulting from authorship of scientific, literary or artistic
productions.

The importance of intellectual property was first recognized in the Paris Convention for the Protection of Industrial
Property (1883) and the Berne Convention for the Protection of Literary and Artistic Works (1886). Both treaties are
administered by the World Intellectual Property Organization (WIPO).

Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and
symbols, names and images used in commerce.

IP is protected in law by, for example, patents, copyright and trademarks, which enable people to earn recognition or
financial benefit from what they invent or create. By striking the right balance between the interests of innovators
and the wider public interest, the IP system aims to foster an environment in which creativity and innovation can
flourish.

1. COPYRIGHT
Copyright is a legal term used to describe the rights that creators have over their literary and artistic works.
Works covered by copyright range from books, music, paintings, sculpture and films, to computer programs,
databases, advertisements, maps and technical drawings.
2. PATENTS
A patent is an exclusive right granted for an invention. Generally speaking, a patent provides the patent
owner with the right to decide how - or whether - the invention can be used by others. In exchange for this
right, the patent owner makes technical information about the invention publicly available in the published
patent document.
3. TRADEMARK
A trademark is a sign capable of distinguishing the goods or services of one enterprise from those of other
enterprises. Trademarks date back to ancient times when artisans used to put their signature or "mark" on
their products.
4. INDUSTRIAL DESIGNS
An industrial design constitutes the ornamental or aesthetic aspect of an article. A design may consist of
three-dimensional features, such as the shape or surface of an article, or of two-dimensional features, such
as patterns, lines or color.
5. GEOGRAPHICAL INDICATIONS
Geographical indications and appellations of origin are signs used on goods that have a specific geographical
origin and possess qualities, a reputation or characteristics that are essentially attributable to that place of
origin. Most commonly, a geographical indication includes the name of the place of origin of the goods.
6. TRADE SECRETS
Trade secrets are IP rights on confidential information which may be sold or licensed. The unauthorized
acquisition, use or disclosure of such secret information in a manner contrary to honest commercial
practices by others is regarded as an unfair practice and a violation of the trade secret protection.
need of IPR?

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The progress and well-being of humanity rest on its capacity to create and invent new works in the areas of
technology and culture.
 Encourages innovation:
The legal protection of new creations encourages the commitment of additional resources for further
innovation.
 Economic growth:
The promotion and protection of intellectual property spurs economic growth, creates new jobs and
industries, and enhances the quality and enjoyment of life.
 Safeguard the rights of creators:
IPR is required to safeguard creators and other producers of their intellectual commodity, goods and services
by granting them certain time-limited rights to control the use made of the manufactured goods.
 It promotes innovation and creativity and ensures ease of doing business.
 It facilitates the transfer of technology in the form of foreign direct investment, joint ventures and
licensing.

INDIA AND IPR:

 India is a member of the World Trade Organisation and committed to the Agreement on Trade Related
Aspects of Intellectual Property (TRIPS Agreement).
 India is also a member of World Intellectual Property Organization, a body responsible for the promotion of
the protection of intellectual property rights throughout the world.
 India is also a member of the following important WIPO-administered International Treaties and
Conventions relating to IPRs.
 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of
Patent Procedure
 Paris Convention for the Protection of Industrial Property
 Convention Establishing the World Intellectual Property Organization
 Berne Convention for the Protection of Literary and Artistic Works
 Patent Cooperation Treaty
 Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks- Madrid
Protocol
 Washington Treaty on Intellectual Property in respect of Integrated Circuits
 Nairobi Treaty on the Protection of the Olympic Symbol
 Convention for the Protection of Producers of Phonograms Against Unauthorized Duplication of Their
Phonograms
 Marrakesh Treaty to facilitate Access to Published Works by Visually Impaired Persons and Persons with
Print Disabilities.

National IPR Policy

 The National Intellectual Property Rights (IPR) Policy 2016 was adopted in May 2016 as a vision document to
guide future development of IPRs in the country.
 It’s clarion call is “Creative India; Innovative India”.
 It encompasses and brings to a single platform all IPRs, taking into account all inter-linkages and thus aims to
create and exploit synergies between all forms of intellectual property (IP), concerned statutes and agencies.
 It sets in place an institutional mechanism for implementation, monitoring and review. It aims to incorporate
and adapt global best practices to the Indian scenario.
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 Department of Industrial Policy & Promotion (DIPP), Ministry of Commerce, Government of India, has been
appointed as the nodal department to coordinate, guide and oversee the implementation and future
development of IPRs in India.
 The ‘Cell for IPR Promotion & Management (CIPAM)’, setup under the aegis of DIPP, is to be the single point
of reference for implementation of the objectives of the National IPR Policy.
 India’s IPR regime is in compliance with the WTO's agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS).

Objectives

 IPR Awareness: Outreach and Promotion - To create public awareness about the economic, social and
cultural benefits of IPRs among all sections of society.
 Generation of IPRs - To stimulate the generation of IPRs.
 Legal and Legislative Framework - To have strong and effective IPR laws, which balance the interests of rights
owners with larger public interest.
 Administration and Management - To modernize and strengthen service-oriented IPR administration.
 Commercialization of IPRs - Get value for IPRs through commercialization.
 Enforcement and Adjudication - To strengthen the enforcement and adjudicatory mechanisms for combating
IPR infringements.
 Human Capital Development - To strengthen and expand human resources, institutions and capacities for
teaching, training, research and skill building in IPRs.

Achievements under new IPR policy

 Improvement in GII Ranking: India’s rank in the Global Innovation Index (GII) issued by WIPO has improved
from 81st in 2015 to 52nd place in 2019.
 Strengthening of institutional mechanism regarding IP protection and promotion.
 Clearing Backlog/ Reducing Pendency in IP applications: Augmentation of technical manpower by the
government, has resulted in drastic reduction in pendency in IP applications.
 Automatic issuance of electronically generated patent and trademark certificates has also been introduced.
 Increase in Patent and trademark Filings: Patent filings have increased by nearly 7% in the first 8 months of
2018-19 vis-à-vis the corresponding period of 2017-18. Trademark filings have increased by nearly 28% in
this duration.
 IP Process Re-engineering Patent Rules, 2003 have been amended to streamline processes and make them
more user friendly. Revamped Trade Marks Rules have been notified in 2017.
 Creating IPR Awareness: IPR Awareness programs have been conducted in academic institutions, including
rural schools through satellite communication, and for industry, police, customs and judiciary.
 Technology and Innovation Support Centres (TISCs): In conjunction with WIPO, TISCs have been established
in various institutions across different states.

Issues in India’s IPR regime

 Section 3(d) of the Indian Patent Act 1970 (as amended in 2005) does not allow patent to be granted to
inventions involving new forms of a known substance unless it differs significantly in properties with regard
to efficacy.
 This means that the Indian Patent Act does not allow evergreening of patents.

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 This has been a cause of concern to the pharma companies. Section 3(d) was instrumental in the Indian
Patent Office (IPO) rejecting the patent for Novartis’ drug Glivec (imatinib mesylate).
 Issue of Compulsory licencing (CL): CL is problematic for foreign investors who bring technology as they are
concerned about the misuse of CL to replicate their products. It has been impacting India-EU FTA
negotiations.
 CL is the grant of permission by the government to entities to use, manufacture, import or sell a patented
invention without the patent-owner’s consent. Patents Act in India deals with CL.
 CL is permitted under the WTO’s TRIPS (IPR) Agreement provided conditions such as ‘national emergencies,
other circumstances of extreme urgency and anti-competitive practices’ are fulfilled.
 India continues to remain on the United States Trade Representative's (USTR’s) ‘Priority Watch List’ for
alleged violations of intellectual property rights (IPR).
 In its latest Special 301 report released by the United States Trade Representative (USTR), the US termed
India as “one of the world’s most challenging major economies" with respect to protection and enforcement
of IP.
 Data Exclusivity: Foreign investors and MNCs allege that Indian law does not protect against unfair
commercial use of test data or other data submitted to the government during the application for market
approval of pharmaceutical or agro-chemical products. For this they demand a Data Exclusivity law.
 Enforcement of the Copyright act is weak, and piracy of copyrighted materials is widespread.

*****

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