Karnataka-Biotech-Policy 2017-22 English Hires 20190828

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A

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THE B

KARNATAKA

Biotechnology
Policy 2017-2022
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 3

TABLE OF
CONTENTS
1. State of Biotechnology in Karnataka
1.1. The Prevailing Biotech Ecosystem. . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5

1.2. Achievements of the Millennium Biotech Policies. . . . . . . . . . . . . . . . . 9


1.3. Growth Potential for Biotechnology in the State. . . . . . . . . . . . . . . . . 11
2. Policy Objectives 13
3. Policy Initiatives 15
3.1. Simplify administrative and clearance processes to create an
enabling environment for the public and private sectors to invest
across the biotech value chain. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2. Realign academic and training discourses to strengthen and retain
human capital, meet evolving industry requirements and contribute
to mitigating challenges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.3. Conduct coordinated and integrated R&D with emphasis on facilitating
progress beyond the lab to address key prioritized societal issues . . . . . . 21
3.4. Invest in foundations of life sciences by creating technology platforms
and encourage more effective multi-disciplinary collaborations to
expand the scale and scope of biotechnology and its impact on the
society and economy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5. Leveraging IT and other technology (ESDM/AVGC) capabilities of the
state to encourage development of Bio-IT tools and solutions. . . . . . . . 24
3.6. Institute funding mechanisms and mentorship programmes for biotech
start-ups to stimulate innovations and discoveries that would benefit
the society and boost growth in bioeconomy. . . . . . . . . . . . . . . . . . . 25
3.7. Extending financial incentives and concessions for attracting investments
in the biotech sector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.8. Foster the development of bioeconomy by supporting research and
development (R&D) in emerging technologies. . . . . . . . . . . . . . . . . . 30
3.8.1. Bio Agriculture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.8.2. Policy Initiative: Aqua-Marine Biotechnology. . . . . . . . . . . . 33
3.8.3. Rare Diseases Management. . . . . . . . . . . . . . . . . . . . . . . 34
3.8.4. Synthetic Biology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3.8.5. Omics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.8.6. Stem cell and regenerative medicine . . . . . . . . . . . . . . . . . . 37
3.8.7. Antimicrobial Resistance. . . . . . . . . . . . . . . . . . . . . . . . . 38
3.8.8. Bio-engineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
3.8.9. Medical Devices Technology. . . . . . . . . . . . . . . . . . . . . . . 39
3.8.10. Microbiome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
KARNATAKA BIOTECHNOLOGY POLICY
4 2017-2022

ABBREVIATIONS
ABLE Association of Biotechnology-Led Enterprises
AVGC Animation, Visual effects, Gaming & Comic
BBC Bangalore Bioinnovation Centre
BFC Biotechnology Facilitation Cell
BiSEP Biotechnology Skill Enhancement Programme
CAGR Compound Annual Growth Rate
C-CAMP Centre for Cellular And Molecular Platforms
CHG Centre for Human Genetics
DLC District Level Committee
ESDM Electronics System Design & Manufacturing
FDI Foreign Direct Investment
GIFTS GoK Incubator for Tech Start-ups
HDI Human Development Index
IBAB Institute of Bioinformatics and Applied Biotechnology
IABT Institute of Agriculture Biotechnology
IGICH Indira Gandhi Institute Of Child Health Hospital
IISc Indian Institute of Science
InStem Institute for Stem Cell Biology and Regenerative Medicine
ITRI Industrial Technology Research Institute
JNCASR Jawaharlal Nehru Centre for Advanced Scientific Research
KAST Korean Academy of Science and Technology
KBITS Karnataka Biotechnology and Information Technology Services
KITVEN Fund Karnataka Information Technology Venture Capital Fund
KSTA Karnataka Science and Technology Academy
KSTePS Karnataka Science and Technology Promotion Society
KUM Karnataka Udyog Mitra
KVAFSU Karnataka Veterinary, Animal and Fisheries Sciences University
LSSSDC Life Science Sector Skill Development Council
MRI Magnetic Resonance Imaging
NAIN New-Age Incubation Network
NASSCOM National Association of Software and Services Companies
NCBS National Centre for Biological Sciences
NIB National Institute of Biologicals
NSDC National Skill Development Council
NTU Nanyang Technological University
NVEQF National Vocational Educational Quality Framework
RGUHS Rajiv Gandhi University of Health Sciences
SBCC State Biotechnology Co-ordination Committee
TBI Technology Business Incubators
UAHSS University of Agricultural and Horticultural Sciences, Shivamogga
UAS University of Agricultural Sciences
UHS University of Horticultural Sciences
VGBT Vision Group on Biotechnology
VGST Vision Group on Science and Technology
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 5

01
STATE OF
BIOTECHNOLOGY
IN KARNATAKA
KARNATAKA BIOTECHNOLOGY POLICY
6 2017-2022

1.1. THE PREVAILING BIOTECH ECOSYSTEM


1.1.1. Karnataka is the biotech capital of India underpinned by a robust
ecosystem owing to the presence of prominent educational and research
institutions as well as an array of biotech enterprises, including established
companies and promising start-ups.
Karnataka has been at the forefront of biotechnology in India and is rightly known
as the biotech capital of India. Over the years, the development of a strong
ecosystem and modern infrastructure through a proactive policy framework
enabled Karnataka to achieve sustainable development and become the flag
bearer of India’s biotechnology growth. Bengaluru, Karnataka’s science capital
and Asia’s fastest growing technopolis, has developed into an ideal base for the
biotechnology industry.
The state is home to many renowned educational and research institutes,
including the Indian Institute of Science (IISc), National Centre for Biological Sciences
(NCBS), Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Rajiv
Gandhi University of Health Sciences (RGUHS), the University of Agricultural
Sciences (UAS), Central Food Technological Research Institute (CFTRI), Defence
Food Research Laboratory (DFRL), University of Horticultural Sciences (UHS) and
others. There are several state and private universities and research institutions.
The presence of these premier institutes has contributed significantly to a surge
in R&D activities in the state, eventually translating into path-breaking innovation.
In the last two decades, the state made major investments in infrastructure
to support the expanding ecosystem, including the development of Bangalore
BioCluster, Bangalore Helix Biotechnology Park, as well as setting up of technology
incubation centres in tier 2 and 3 cities to aid the advancement of biotechnology
sector in the state.
The Karnataka government systematically built up considerable resources
and human capital to provide biotechnology companies a multi-disciplinary pool
of talented work force. The establishment of CHG, IBAB, and IABT allowed the
development of quality manpower in the fields of genetics, molecular biology
and biotechnology. The Biotechnology Finishing School (BTFS) – a first-of-its-
kind initiative in India – was launched in collaboration with the Department of
Biotechnology (DBT). Under this programme, 12 biotechnology finishing schools
were launched in the state to equip graduates and post-graduates with the
necessary employable skills to make them job-ready. This programme has
now been revamped and renamed in its second phase as Biotechnology Skill
Enhancement Programme (BiSEP). Under the renewed plan, the focus would be
on driving smart collaboration with the industry to align the skill sets of students
to industry requirements as well as focusing on developing talent in tier 2 and tier
3 cities of the state.
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 7

EXHIBIT 1

KARNATAKA’S BIOTECHNOLOGY
INFRASTRUCTURE CAPABILITIES

THE BANGALORE
HELIX INCUBATION THE BANGALORE
BIOTECHNOLOGY CENTRES BIO CLUSTER
PARK

The Bangalore Helix The government established The Bangalore Bio Cluster
Biotechnology Park comprises two biotechnology incubation comprises three major
premier academic and research centres in tier 2 cities of Mysuru institutions: National Centre
institutions such as the Institute and Dharwad to promote for Biological Sciences (NCBS),
of Bioinformatics and Applied research activities in food Institute for Stem Cell Biology &
Biotechnology (IBAB), Centre technology and agriculture, Regenerative Medicine (InStem)
for Human Genetics (CHG) respectively, and is currently and Cellular and Molecular
and Bangalore Bioinnovation developing incubation centres Platforms (C-CAMP).
Centre (BBC), a state-of-the-art in Mangaluru and Bidar for
incubation centre. aqua-marine and animal
biotechnology, respectively.

The availability of a strong research base and industry-ready manpower coupled


with government support positioned Karnataka as the preferred destination for
large global and domestic biotech investments in the country. Some of the large
biotech companies in the country such as Biocon, Syngene, Novozymes, and
Monsanto, are headquartered in the state. The state also has a thriving start-
up ecosystem, particularly Bengaluru. Currently, Karnataka’s biotech industry
comprises ~380 companies and ~194 start-ups, together forming 60% of the
biotech companies in India. The state also employs nearly 54% of the country’s
biotech workforce and contributed 35% of the total revenue generated by the
Indian biotechnology industry as of 2015-16.
KARNATAKA BIOTECHNOLOGY POLICY
8 2017-2022

EXHIBIT 2

KARNATAKA’S BIOTECHNOLOGY
ECOSYSTEM AND ECONOMIC IMPACT
RENOWNED INCUBATION CENTRES
ACADEMIC l BBC, Bengaluru
INSTITUTIONS l Agriculture Biotechnology Incubation Centre and Common
NCBS Instrumentation Facility (Agri-BTIC_CIF), Dharwad
INSTEM l Nutra - Phyto Incubation Centre & Common Instrumentation
IISC Facility (NPIC -CIF, Mysuru)
UAS l Animal Biotech Incubation Center, Bidar*
IABT l Marine Bio Incubation Center, Mangaluru*
JNCASR l UHS Bagalkot Incubation Center*
IBAB KARNATAKA'S
CHG BIOTECHNOLOGY
CFTRI PROMINENT BIOTECH COMPANIES (ILLUSTRATIVE)
UHS
ECOSYSTEM
Domestic Companies Foreign Companies
C-CAMP l Aurigene Discovery l EIDuPont India
BIO-IT CENTRE
Technologies l GE Healthcare
l Biocon l Monsanto Holdings
l Genotypic Technology l Novozymes South Asia
l Kemwell Biopharma l Quintiles Research (India)
l Metaphelix Life Sciences
l Mitra Biotech
l Richcore Lifesciences
l Stempeutics Research
l Strand Life Sciences
l Syngene International

IN 2015-16, KARNATAKA ACCOUNTED FOR

35%
OF INDIA'S BIOTECH
54%
OF INDIA'S BIOTECH
60% 7,500+
OF BIOTECH BIOTECH GRADUATES
INDUSTRY REVENUE WORKFORCE COMPANIES IN INDIA EVERY YEAR

Source: ABLE, BioSpectrum, India, ABLE-Aranca Estimates


KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 9

1.2. ACHIEVEMENTS OF THE MILLENNIUM BIOTECH


POLICY – I AND II
1.2.1. The development of biotechnology sector in Karnataka has been aptly
aided by the pragmatic policy initiatives of the state government over the years
Karnataka was the first Indian state to bring out a policy document for
biotechnology in 2001. The Millennium Biotech Policy I focused on setting up the
institutional framework required to spread awareness, attract investments and
lay the infrastructural foundations necessary for sustainable development of the
biotechnology sector. The state followed it up with the Millennium Biotechnology
Policy II in 2009 to further expand the growth and role of biotechnology in the lives
of the people, animals and the economy.
The two millennium biotech policies outlined several initiatives to strengthen
the existing infrastructure through the development of incubation and common
instrumentation facilities across Karnataka to accelerate innovation. These include
the development of BBC in Bengaluru, and agriculture, nutraceutical / phyto-
pharmaceutical technology incubators in Dharwad and Mysuru, respectively,
to facilitate the development of biotech start-ups and provide them quality
infrastructure facilities for R&D activities. Additional technology business
incubators are being considered for establishment in universities and research
institutions, across the State.
To focus on skill development, under the Millennium Biotechnology Policy II, the
state established 12 biotechnology finishing schools. These institutions contributed
to the development of industry-ready skilled workforce in biotechnology. In
the second phase, the BTFS programme is being aligned with National Skill
Development Council (NSDC) to design the course curriculum by assessing the
skill demand of the industry. The programme was renamed ‘Biotechnology Skill
Enhancement Programme (BiSEP)’ and is aimed at making students employable
or self- employable after course completion.
Other key initiatives of the two millennium biotech policies include the
establishment of premier research institutions such as the Institute of Bioinformatics
and Applied Biotechnology (IBAB), Institute of Agriculture Biotechnology (IABT) and
the Centre for Human Genetics (CHG). In recent years, the state has focused on the
development of emerging areas, including synthetic biology and genomics through
these institutions. The Government has approved a synthetic biology centre in
IBAB, allocating INR 4.2 Crore over the next three years and a Bio-IT centre at a
cost of INR 9.5 Crore over five years. Plans are also in place to leverage the existing
infrastructure of IBAB and CHG to develop this cluster as a Centre for Advanced
Genome Bioinformatics and facilitate the development of a genome databank for
the storage of DNA of patients with rare diseases, endangered species and socio-
economically important species in Karnataka. Other emerging areas, including the
medical device technology, treatment of rare diseases and marine biotechnology,
are being promoted by encouraging multidisciplinary collaboration, translational
KARNATAKA BIOTECHNOLOGY POLICY
10 2017-2022

EXHIBIT 3

ACHIEVEMENTS OF THE MILLENNIUM


BIOTECHNOLOGY POLICY I AND II

CONSTITUTION l Advice the government on policy initiaties


OF THE VISION
l Spearhead various initiatives to facilitate developmet of the biotech
GROUP ON
BIOTECHNOLOGY industry in the state
IN THE YEAR 2000 l Meet frequently to discuss progress and launch of new initiatives

Establishment of premier research institutions including


ESTABLISHMENT l IBAB (Bangaluru) - www.ibab.ac.in
OF PREMIER
l CHG (Bangaluru) - www.chg.res.in
RESEARCH
INSTITUTIONS l IABT (Dharwad) - http://google.com/a/uasd.in/iabt/home
l CFB at UHS, Bagalkot - www.uhsbagalkot.edu.in

l State of the art incubation facility - Bangalore Bioinnovation Centre


ESTABLISHMENT (BBC) in Bengaluru
OF INCUBATION
l 2 technology business incubators, viz. Agri BT IC_CIF in Dharwad and
CENTRES
NPIC_CIF in Mysuru

l Establishment of IBAB, IABT and CHG


l 12 BT finishing schools (BTFS) has been set up in the state; these
completed the first cycle of 5 years.
INDUSTRY-
l The program has now been revamped and renamed as "Biotechnology
READY HUMAN
RESOURCES Skill Enhancement Programme (BiSEP)", it has also been expanded to
include 18 institutions spread across the state.
l Promotion of enterpreneurship
l 'Young Scientists' program under the B4 program

l Setting up of KITVEN Fund III (Biotechnology), with a corpus of INR 50


BIO-VENTURE
Crores, in partnership with financial institutions. The fund is managed
FUND
by Karnataka Asset Management Company Private Limited
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 11

research and establishment of virtual centres of excellence and incubation facilities


specifically focusing on these areas.
The Karnataka government also provided a slew of fiscal incentives and
concessions to biotech companies. These include rebate on stamp duty and
exemption of entry tax, electricity duty and industrial power tariff. Additional
incentives include investment promotion subsidy; subsidy for effluent treatment
plants (ETPs); and financial support for patent registration, standardization and
certification. Furthermore, the government set up funding programmes for biotech
companies, including Bioventure Fund, Idea2PoC grants to start-ups etc.

1.3. GROWTH POTENTIAL FOR BIOTECHNOLOGY IN THE


STATE
DBT, Ministry of S&T, New Delhi, has come out with National Biotechnology
Development Strategy (2015-2020) after consulting with various stakeholders, to
achieve target & vision of US $ 100 billion by 2025.
Karnataka will play a prominent role to enable the country achieve its ambitious
goal of USD 100 billion in biotech revenues by 20251.
The biotech industry in Karnataka commands an impressive 35% market share
of the total Indian market, contributing USD 6.5 billion (INR 44,250 Crore) in 2015.
The Government of Karnataka, through various initiatives detailed under the
new biotech policy, envisions further increasing its market share and becoming a
prominent biotech destination globally. Prevalence of challenges in most sectors
will be the underlying factor to explore how biotechnology in convergence with
other sectors can perform towards making Karnataka a health and wellness state.
India has an ambitious target of becoming a USD 100 billion (INR 681,350
Crore) biotech market by 2025. Karnataka would be the dominant contributor
in achieving this. By implementing various initiatives envisaged under the new
policy, Karnataka is expected to significantly increase its market share to 40–60%
of India’s biotech industry, reaching USD 40 billion (INR 272,500 Crore) to USD 60
billion (INR 408,800 Crore) by 2025. As part of its efforts to achieve this target,
the government would continue to invest in quality foundations of science and
technology so as to attract investments and develop Karnataka as a major bio
manufacturing hub. More importantly, it would take the lead in leveraging its
IT capabilities to develop Bio-IT technologies and solutions. Additionally, in its
endeavour to become a globally competitive biotech hub and ensure international
acceptance of its biotech products, the government would focus on strengthening
its partnerships with global majors that can help accelerate innovations and
inventions in life sciences.
KARNATAKA BIOTECHNOLOGY POLICY
12 2017-2022

EXHIBIT 4

INDIA AND KARNATAKA’S BIOTECH


MARKET (2015-2025)

BioPharma
BioServices
INDIA BioAgriculture KARNATAKA
BioIndustrial
BioInformatics

0.1
0.2
USD18.6 0.8

BILLION
2015

$6.5 (INR 44,250 CRORE)


1.2 BN
(INR 126,700 CRORE)
4.2

0.4 4.8
BASE CASE

4.9 $40.0
BN (INR 272,500 CRORE)
8.0
21.8
FORECAST SCENARIOS

0.5 6.0
MODERATE CASE

USD100.0
Note: Conversion rate used USD 1 = INR 68

6.2 $50.0
2025

BILLION BN (INR 340,700 CRORE)


(INR 681,350 CRORE) 10.0
27.3

0.5 7.0
OPTIMISTIC CASE

8.0
$60.0
BN (INR 408,800 CRORE)
10.0
34.5

Source: Primary Research Based Profiling of Biotech Sector in Karnataka - KBITS,


National Biotechnology Development Strategy 2015-2020, ABLE-Aranca Estimates
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 13

02

POLICY
OBJECTIVES
KARNATAKA BIOTECHNOLOGY POLICY
14 2017-2022

T
he two Millennium policies laid the foundation for an advanced
biotechnology ecosystem in Karnataka. The third iteration in Karnataka’s
biotechnology policy seeks to provide direction and support the sustainable
development of a thriving and world-class biotech ecosystem. This would
be achieved by exploiting existing technologies and opportunities; building an elite
workforce; strategically shaping the R&D agenda to drive innovations; and using
technology to address pressing social concerns related to agriculture, health,
energy and environment. It would also offer a framework for developing essential
resources and capacities to keep pace with the global biotech revolution.
The policy outlines the following principle objectives to maximise the potential
of the state’s bio economy:
1) Simplify administrative and clearance processes to create an enabling
environment for the public and private sectors to invest across the biotech
value chain
2) Realign the academic and training discourses to strengthen and retain
human capital to meet evolving industry requirements and contribute to
mitigating challenges
3) Conduct coordinated and integrated R&D with an emphasis on facilitating
progress beyond the lab to address key prioritized societal issues
4) Invest in foundations of life sciences by creating technology platforms and
encourage more effective multi-disciplinary collaborations to expand the
scale and scope of biotechnology and its impact on the society and economy
5) Leverage IT and other technology (ESDM / AVGC) capabilities of the state to
encourage development of Bio-IT tools and solutions
6) Institute funding mechanisms and mentorship programmes for biotech
start-ups to stimulate innovations and discoveries that would benefit the
society and growth of the bioeconomy
7) Extending financial incentives and concessions for attracting investments in
the biotech sector
8) Foster the development of bioeconomy by supporting research and
development (R&D) in emerging technologies
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 15

03

POLICY
INITIATIVES
KARNATAKA BIOTECHNOLOGY POLICY
16 2017-2022

3.1. SIMPLIFY ADMINISTRATIVE AND CLEARANCE


PROCESSES TO CREATE AN ENABLING ENVIRONMENT
FOR THE PUBLIC AND PRIVATE SECTORS TO INVEST
ACROSS THE BIOTECH VALUE CHAIN
Creating an open and transparent business environment is an essential pre-
requisite for sustainable growth in industries such as biotech. Business-friendly
policies would help existing and upcoming enterprises to focus on improving
productivity and innovation. A conducive business environment is also an important
criterion for attracting investments into the state. Studies show a difference of 1%
in regulatory quality is associated with an annual difference in FDI inflow of USD
250–500 million (INR 1,700–3,400 Crore)2.
Although Karnataka is one of the largest recipients of FDI into the country, there
is scope for improving the processes for setting up and operating enterprises.
About 40% of the state’s biotech industry participants consider some scope of
improvement for the government to facilitate business3. The state government
has been working on the simplification and rationalisation of existing processes
and leveraging IT to make dissemination of information and governance more
efficient and effective.

POLICY
THE EASE OF DOING BUSINESS
IN AN ECON OMY HAS DIRECT

CONTEXT
CORRELATION TO THE INFLOW
OF INVESTMENTS

USD
1% POINT 250-500
A DIFFERENCE OF 1% POINT IN REGULATORY
MILLION
QUALITY IS ASSOCIATED WITH ANNUAL
DIFFERENCE IN FDI INVLOW OF USD 250-500
MILLION (INR 1,700-3,400 CRORE)

OF KARNATAKA'S BIOTECH INDUSTRY PARTICIPANTS

40% CONSIDER SCOPE OF IMPROVEMENT FOR THE


GOVERNMENT TO FACILITATE BUSINESS
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 17

3.1.1. Policy Initiatives/Action Points: Easing the process of setting up


and operating business in the state for biotech companies by launching a
revamped e-biz platform/interface
To improve the regulatory process for business and bring in transparency, the state,
through Karnataka Udyog Mitra (KUM), launched the revamped eBiz platform aimed at
simplifying and integrating the process of seeking approvals from various departments.
The online platform enables investors to file applications, make necessary
payments, and track status and approval of applications. This platform would also
ensure incentives available to biotech industries by the state government through
various policies are provided through the portal. It is one of the first single-window
systems to link all department approvals and make the entire process online. This
system is in addition to a comprehensive interface (E-Udyami) already developed
for investors to provide all information and support without any physical presence.
KUM established a dedicated central helpline and grievance redressal cell (which
includes representation from the Department of IT, BT and S&T) to disseminate
information to investors and ensure timely approvals and clearances. The timeline
for completing the approval process is guaranteed under the Karnataka Guarantee
of Services to Citizens Act (SAKALA Act).

3.1.2. Policy Initiatives/Action Points: Development of a central web portal


for facilitation and dissemination of information related to the state’s biotech
activities
KBITS would develop and launch a biotech-specific portal, http://itbt.karnataka.
gov.in, which would act as a gateway for enhancing knowledge and awareness
among biotechnology stakeholders in Karnataka. Relevant information related to
biotechnology infrastructure, research activities, skill development programmes,
fiscal incentives and other state-supported programmes for the development of
the sector would be accessible through the portal, which would be managed and
updated periodically by the Biotechnology Facilitation Cell (BFC).
The whole spectrum of information, including details about the biotechnology
policy, government initiatives and programmes, etc. can be accessed through the
portal. In addition, it would facilitate discussions and exchange of information
between stakeholder groups and encourage broad perspective discussions on
various biotech topics.
BFC will also expand its engagement with the civil society, interest groups
and other stakeholders by undertaking road shows, marketing and promotional
activities on social media platforms in multiple languages and on ground (through
road shows). This is done to create awareness about biotech-related programmes,
and gain public confidence and acceptance of biotech products. A science
communication strategy with the title "SCIENCE for SOCIETY” will be established.
An idea cell will also be set up within KBITS to act as an interface for biotech
companies and other stakeholders to share new ideas/recommendations with the
government.
KARNATAKA BIOTECHNOLOGY POLICY
18 2017-2022

3.2. REALIGN ACADEMIC AND TRAINING DISCOURSES


TO STRENGTHEN AND RETAIN HUMAN CAPITAL, MEET
EVOLVING INDUSTRY REQUIREMENTS AND CONTRIBUTE
TO MITIGATING CHALLENGES
Karnataka accounts for more than 5%4 of the total undergraduate enrolments in
India. About 28%4 of these enrolments are in the science stream. With 80% science
colleges in the state offering biotech courses, Karnataka produces more than
7,500 biotech graduates each year5.
The easy availability of human resources, however, should translate into
improved quality of workforce to meet evolving industry expectations and
requirements. The establishment and successful implementation of BT Finishing
Schools (BTFS) was an important step forward in developing industry-ready
graduates. The current policy emphasises building on the success of BTFS by
optimising the course structure and introducing additional initiatives to foster
R&D and entrepreneurship and ensure availability of industry-ready and skilled
manpower at different job levels.

POLICY
CONTEXT

7,500+
BIOTECH GRADUATES
PASS OUT IN KARNATAKA
80%
~80% OF POST GRADUATION
COLLEGES IN THE STATE PROVIDE
EACH YEAR BIOTECH COURSES

85%
RISE IN OVERALL
INDUSTRY SEEKS ADDITIONAL
TECHNICAL AND BUSINESS
TRAINING TO BE PROVIDED TO
GRADUATES
THE FACULTY OF A MAJORITY OF
BIOTECH INSTITUTES HAVE LIMITED
EXPOSURE TO R&D AND NEW
TECHNOLOGICAL ADVANCEMENTS
BRAIN DRAIN FROM
INDIA TO THE US IN

25%
THE LAST DECADE IMPROVEMENT OF FACULTY STANDARDS IS
TO PURSUE HIGHER
EDUCATION, VIZ.
CONSIDERED TO BE IMPORTANT BY ~25% OF
SPECIALISED INDUSTRY PARTICIPANTS TO IMPROVE THE
PROGRAMMES AND OVERALL ACADEMIC DISCOURSE IN THE STATE
DOCTORAL STUDIES
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 19

The teaching faculty at most biotech colleges has limited exposure to R&D
and new technological advancements, impacting the overall quality of academic
discourse in the state. Therefore, provision of reorientation courses and training of
faculty at senior schools and colleges would be emphasised.
Increased activities must go beyond what is in the syllabi. These could include
group discussions; learn how to learn; visits to places with ground realities (such
as agriculture fields, farm yards, human and animal health hospitals, energy
generation plants and waste recycling centres); bio-quiz competitions; creation
of science prototypes; and identification of challenges wherein life sciences/
biotechnology can play a role.

3.2.1. Policy Initiative: Develop a skilled workforce attuned to the


requirements of the industry and encourage entrepreneurship among biotech
students through the Biotechnology Skill Enhancement Programme (BiSEP)
The BTFS programme was revamped and renamed Biotechnology Skill
Enhancement Programme (BiSEP), aligning its curriculum with the National
Vocational Educational Quality Framework (NVEQF) of the NSDC (National Skill
Development Council).
The programme is aimed at bridging the gap between academic knowledge and
its application in the industry and encouraging entrepreneurship among students
enrolled under BiSEP. The programme would incorporate the following structural
modifications:
Curriculum Upgrade: BiSEP would collaborate with Life Science Sector Skill
Development Council (LSSSDC), CSIR-IICT or organisations empanelled with NSDC
while designing the course curriculum and assessing students skill sets. The
curriculum would also be tailored to incorporate the latest industry trends and
technological advances. Furthermore, the state government would constitute a
committee of experts from relevant fields of Biotechnology who would periodically
examine the syllabus in biotech institutions and suggest necessary modifications
or additions. The courses would also integrate ‘decision thinking’, data analyses
and oral/written communication skills to engage in scientific writing.
Internship Programmes: To impart industry-relevant training, the government
would enable industry-academia collaborations through on-the-job skill
development programmes under BiSEP. The programme would foster collaboration
between the industry (including startups) and institutes to offer internships
in relevant areas of expertise. This would be enabled through a mandatory
partnership by each participating BiSEP college with one or more industry players.
A programme to engage biotech industry and institutions and devise a scheme to
attract fresh graduates with better salary structure will be explored.
Incubation Centres: BiSEP colleges would be encouraged to participate in
the New Age Incubation Network (NAIN) programme — introduced under the
Startup Policy — under which institutes would be provided assistance in setting
up incubation facilities. These facilities would encourage students to start their
KARNATAKA BIOTECHNOLOGY POLICY
20 2017-2022

own entrepreneurship projects and avail initial funding under the programme. In
addition, the participating students would be provided mentorship and consultancy
services through the Virtual Incubation programme run through government-
supported incubators in the state.

3.2.2. Policy Initiative: Facilitate training and development programmes for


faculty to keep them abreast with the latest biotech technologies and trends
Faculty Development Programmes: Similar to the training programmes for
students, the teaching faculty at colleges and post-graduate institutions such as
State Agriculture Universities and Medical Colleges offering biotechnology courses
within India and, where appropriate, outside India in collaboration with leading
biotechnology institutions would be eligible for financial support for attending
faculty development programmes. The programmes will have three modules,
viz. basic, intermediary and advanced. These would be developed in association
with leading science institutions such as IISc, NCBS, InStem, IBAB, IABT, UAS and
others having expertise in particular areas of biotechnology. The modules would
be designed to enable the faculty to keep abreast with the latest technologies
and trends and help them tailor their pedagogy. The programme work would
include online course materials and short-duration training and workshops at the
aforementioned research institutions. The structure of the faculty development
programme and financing would be decided by a select committee constituting
government representatives from the Department of IT, BT, S&T, academicians
and other relevant stakeholders.
Engagement with Teachers at Schools and Pre-university Colleges: The
government, through existing programmes of Karnataka Science and Technology
Promotion Society (KSTePS) and the Vision Group on Science and Technology
(VGST) schemes such as Science Melas (public events), Lab-in-a-box programme,
Karnataka Vijnana Vidya Jagruti and other teacher training programmes, would
engage with teachers at schools and pre-university colleges to expose them to
opportunities in life sciences. They, in turn, can impart this know-how to students
to pique their interest in biotechnology.

3.2.3. Policy Initiative: Encourage fellowships and certificate programmes for


Karnataka domiciled professionals and researchers to retain skilled human
capital and provide commensurate career opportunities
Expanding enrolments under the Karnataka Science and Technology Academy
(KSTA) Fellowship Programmes: KSTA offers fellowships to meritorious students
to pursue higher education in science. This programme would be extended to
offer fellowships, specifically to students pursuing post-graduate education and
research in life sciences.
Collaborating with Foreign organizations for Internships: The state would
institute an international internship programme to support 50 young Karnataka
domiciled students to undertake internships in foreign institutions. The duration of
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 21

the internships would be three to six months, with the selected students being paid
a stipend for the duration of their internship. KBITS would pursue collaborations
with international biotech companies and administer the programme. It would
also explore partnerships with organizations such as Biopolis (Singapore), MUS-
NTU (Singapore), ITRI (Taiwan), KAST (S. Korea) and others in South East Asia.
International immersion and internship would improve study experience,
encourage exchange of ideas and knowledge and increase the number of work-
ready students with global experience.
Short-duration Training for Professionals: KBITS would collaborate with premier
institutions in the state to develop short-term specialized training programmes,
specifically for working professionals to raise their general level of competency
and skill sets. These trainings would also focus on providing specialised technical
training in key emerging technologies.
These programmes would be a collaborative effort between premier institutes,
including IBAB, CHG, InStem, IISc and industry participants. The financing required
for the initiative would be decided by a select committee constituting government
representatives from the IT, BT and S&T departments; academicians; and industry
participants.

3.3. CONDUCT COORDINATED AND INTEGRATED R&D


WITH EMPHASIS ON FACILITATING PROGRESS BEYOND
THE LAB TO ADDRESS KEY PRIORITIZED SOCIETAL ISSUES
Most innovations in biotechnology are a result of convergent, breakthrough
academic findings that evolve from basic science. Several globally successful
biotech companies benefit from the research and support of academic institutions.
Consequently, emphasis on R&D activities related to life sciences at academic and
research institutions is especially important to yield ideas and technologies that
private enterprises can leverage to develop new products and service lines and
catalyse economic and social development.
This policy would lay particular emphasis on interdisciplinary collaboration to
address the complex challenges that may often have interconnected modern
research questions. The convergence of expertise and experience from diverse
disciplines such as biology, chemistry, physics, medicine, and engineering plus
information technology would result in the development of not only the existing
knowledge library but also new technologies that address key societal challenges.
To achieve this impact, the policy would modify the existing state funding
framework to encourage beneficiary academic and research institutions to pursue
convergent research activities aimed at improving the lives of millions.

3.3.1. Policy Initiative: Continued support to academic scientists and


technologists for pursuing research activities related to life sciences
Improving Efficiency and Effectiveness of State Funding: The state provides several
KARNATAKA BIOTECHNOLOGY POLICY
22 2017-2022

grants to promote research activities. The emphasis now would be on introducing a


mechanism that promotes a more effective utilisation of funds to address societal
needs. To this effect, a share of the funding provided by the state to institutions
for research activities needs to be earmarked to pursue strategic research projects
with clear and defined outcomes, which would be put up in the public domain for
licensing and other activities. This would be applicable for all schemes driven by
the Department of IT, BT and S&T.
Promoting Interdisciplinary Research: Growth in biotechnology depends on the
convergence and collaboration of multi-agencies and disciplines to develop tools
and products with vast societal benefits. The state government would encourage
research efforts that bring together researchers/institutions and professionals
from diverse disciplines to develop innovative approaches in sequencing and
characterising specific diseases; virtualize the drug development process;
digitalise gene pool and blood banks to improve the fractionation process; These
collaborations would also focus on accelerating the commercialization of advanced
biotech products including new traits for crops, biofuels and development of tools
for assessing experimental therapies, preventives and diagnostics especially of
rare diseases, etc.

3.3.2. Policy Initiative: Initiate strategic partnerships with leading global


biotech clusters to attract investment and R&D collaboration
To increase market share in India’s biotech industry, Karnataka would enter into
strategic collaborations with leading biotech clusters around the globe. These
partnerships would be aimed at:
• Accessing biotech resources from developed clusters
• Promoting joint research work and transfer of knowledge and technologies
• Facilitating trade with leading bio economies around the globe
The state has developed strategic collaborations for academic research and
knowledge exchange programmes with Boston (Boston – Bangalore Biosciences
Beginnings - B4) and The Hague (to collaborate in the areas of technology for
elderly, security, bicycle infrastructure, human genetics and start-ups), while
partnerships with Spain and Australia are being discussed. Partnerships with other
key international players such as the UK, France, Israel, South Korea and Japan will
also be explored.

3.3.3. Policy Initiative: Development of a technology/research aggregator of


biotech ideas to easily identify strategically important technologies and foster
potential collaborations and commercialisation opportunities
Although several research projects related to life sciences are undertaken at
academic and research institutions in the state, there is limited information on
the research work conducted at these institutions. With the development of a
dynamic repository consolidating the biotech research activity in Karnataka-based
institutions, entrepreneurs, start-ups and other industry participants, investors,
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 23

collaborators would be able to identify strategically important or marketable


technologies and connect with researchers to either collaborate or license to take
the technologies to market.
The information included on this AGGREGATOR PLATFORM would include:
• Description of research
• Status of research
• Credentials of researcher/institution
The aggregation of the research on this platform would expedite the transfer of
technologies from research laboratories to the market.

3.4. INVEST IN FOUNDATIONS OF LIFE SCIENCES


BY CREATING TECHNOLOGY PLATFORMS AND
ENCOURAGE MORE EFFECTIVE MULTI-DISCIPLINARY
COLLABORATIONS TO EXPAND THE SCALE AND SCOPE OF
BIOTECHNOLOGY AND ITS IMPACT ON THE SOCIETY AND
ECONOMY
The development of biotechnology is directly related to the introduction of
new ideas and technologies in the market. To strategically shape the future of
biotechnology, collaboration with multiple disciplines is required to benefit the
broader bioeconomy. Such multi-disciplinary efforts can spawn research projects
to address key scientific challenges across areas such as agriculture, health,
environment and energy. Partnerships among government agencies, companies
and other stakeholders will be instrumental in leveraging the financial and technical
capabilities to generate solutions with a wide societal impact.

3.4.1. Policy Initiative: Collaborating with various government departments


and agencies to encourage projects that seek to provide innovative solutions
made possible by biotechnology
KBITS will actively seek to collaborate with government departments and agencies
such as the Karnataka State Bio-Fuel Development Board (KSBDB), Department
of Agriculture, Department of Health and Family Welfare, Department of Medical
Education, Department of Animal Health and Fisheries, Department of Ecology
and Environment, local municipal bodies, etc. to encourage the development of
biotechnologies that focus on improving the quality of life and addressing societal
needs. These solutions would target human health, food security, animal health
and environmental sustainability, among others.
In partnership with the relevant departments, the Department of IT, BT and
S&T will provide financial assistance to encourage pilot projects focused on
enhancing the yield of biofuels and bioenergy crops, production of enzymes
used for treatment of waste and processes (including bio-remediation and bio-
magnification), design of new therapies using stem cells and tissue engineering,
improvement in agriculture crops to increase yield and enhancement of nutritional
value.
KARNATAKA BIOTECHNOLOGY POLICY
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A “Delivery Integrator” model - similar to Department of Industrial Policy and


Promotion - to coordinate activities across the departments that biotech may
impact and critical. This will provide a platform for various state departments
(that currently work in silos/isolation) to effectively address common challenges
together and benefit the society at a faster scale.

3.4.2. Policy Initiative: Setting up a centralised biological and animal testing


facility to support preclinical trials of biopharma and bioservices companies
The government will develop a dedicated biological testing facility well-equipped
with latest technological equipment and authorized to provide certification to
product testing procedures conducted by biotech companies. Additionally, this
testing laboratory would act as a certifying authority similar to the NIB and maintain
a databank of brain, blood samples and others, which can be used by companies for
testing process. These databanks can also be used by biotech companies across
the state on a pay-per-use basis.
The laboratories will be setup in Bengaluru (at IBAB) and Bidar (as an extension
to the animal biotechnology facility being set up at the Karnataka Veterinary,
Animal and Fisheries Sciences University - KVAFSU).
The investment necessary for setting up the facilities would be decided by a
selection committee comprising government representatives from the Department
of IT, BT and S&T and industry participants.

3.5. LEVERAGING IT AND OTHER TECHNOLOGY (ESDM/


AVGC ETC., ) CAPABILITIES OF THE STATE TO ENCOURAGE
DEVELOPMENT OF BIO-IT TOOLS AND SOLUTIONS
Bio-IT is critical to modern life science research and has significantly progressed in
the last few decades. The use of computational tools to interpret large quantities
of complex data emerged essential for research and broad development of the
sector. As biotechnology continues to take advantage of increasingly large and
more complex datasets such as human genome sequencing and proteomic profiles
of cells, the ability to store, analyse, visualise and share data is a challenge. As
the IT capital of India, Karnataka can leverage its IT capabilities to address these
issues and develop interdisciplinary Bio-IT solutions. Major IT companies such as
TCS, Infosys, Wipro, IBM, and Intel have built competencies to support proteomics,
genomics, drug discovery, data analysis services and scientific data management
systems. Nonetheless, a concerted effort focused on integration of synergies
between the two domains could lead to the development of innovative solutions
and new revenue streams and accelerate development of the market.

3.5.1. Policy Initiative: Foster collaboration between the IT and BT


ecosystems to develop new solutions that will help stimulate the steps taken
to realise the potential of biological research and discoveries
IT companies collaborating with biotech institutions or developing solutions that
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 25

have utility in life sciences would be provided access to facilities and services at state
incubation centres such as BBC. Similarly, biotechnology-focussed companies will
also be hosted at the NASSCOM Startup warehouse and Mobile 10X start-up hub
and Gok Incubator for Tech Start-ups to broaden the engagement between IT and
biotech start-ups.
The Department of IT, BT and S&T will seek to expand the partnerships between
the IT and BT ecosystems by bringing together industry participants from both the
sectors to:
• Develop tools such as stem cell registry, digital genomics library and
computerisation of blood banks to address the challenges in the life
sciences domain
• Develop product lines with global relevance such as knowledge-/IT-enabled
bioservices for processing global genomics data
• Industrialise biotech research using 3D bioprinting and artificial intelligence,
among others
• Provide tertiary healthcare centres with effective technologies to develop
biotech platform
The government will also consider providing financial support to collaborative
projects with social relevance, such as developing gene banks, by establishing a
corpus fund.

3.6. INSTITUTE FUNDING MECHANISMS AND


MENTORSHIP PROGRAMMES FOR BIOTECH START-UPS
TO STIMULATE INNOVATIONS AND DISCOVERIES THAT
WOULD BENEFIT THE SOCIETY AND BOOST GROWTH IN
BIOECONOMY
A significant portion of the funding required for the biotech industry is utilised for
R&D of products and solutions. The state is home to over 200 biotech start-ups3,
with majority of them requiring access to infrastructure and funds for R&D and
product development. With new areas of research emerging, new start-ups are
expected to bloom and state funding will be a critical catalyst driving research and
allied activities.
The perceived high risk and long gestation period for biotechnology investments
limits the venture capital funding compared with start-ups in other technology
sectors receiving significantly high levels of funding in recent years. As per a KBITS
survey in 2016, only a small percentage of biotech start-ups in Karnataka received
funding from venture capitals and angel investors (9% and 7%, respectively).
For R&D, start-ups are required to leverage information from several databases
providing information on patents and legal aspects, among others. This is critical
for product development. However, these databases need to be subscribed to
annually, are expensive and lead to additional costs for companies.
A key requirement from the industry is the need to impart business skills to
scientists who are founders of start-ups and have limited exposure to business
requirements. Scientists with excellent research skills need to be equipped
KARNATAKA BIOTECHNOLOGY POLICY
26 2017-2022

with business skills, ranging from preparing business plans and fund raising to
developing sales and marketing strategies. As per the KBITS Biotech Survey
2016–17, majority of the start-ups faced difficulty in developing a business plan or
go-to-market strategy. Although these start-ups have easier access to scientific
mentorship through biotech incubation centres and life sciences institutions,
avenues to gain business mentorship and guidance are limited.
This policy will focus on addressing the funding gap by strengthening venture
capital fund and incentivising innovations that can offer solutions to long-standing
issues pertaining to the state of Karnataka. Support services such as provision to
access relevant databases will help minimise operational costs for start-ups and
enable access to mentorship cells that help hone business skills of scientists.

3.6.1. Policy Initiative: Karnataka’s biotech venture fund will effectively


contribute to meet the funding requirement of emerging biotech start-ups
Setting-up and strengthening of K Bio-Venture Fund (KITVEN III): To narrow the
funding gap, KBITS, in association with multiple state entities, set up KITVEN III - a
bioventure fund, with a size of INR 50 Crore and further increase if appropriate.
The commitment towards the current Bioventure funds comes from the following
entities:
Other enablers to the funding ecosystem:

EXHIBIT 5

FUNDING AVENUES FOR BIOTECHNOLOGY


COMPANIES IN KARNATAKA
5 CRORE DEPARTMENT OF AGRICULTURE

5CRORE KSIIDC

13CRORE KBITS
K BIO VENTURE
FUND (KITVEN III)
INR 50 CRORE

25CRORE SIDBI

IDEA2POC

FUND OF FUNDS
2CRORE OTHERS* GRAND CHALLENGES
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 27

• Funding for biotech start-ups will be complemented by other funds within


the start-up policy such as Idea2POC (fund size of up to INR 50 Lakhs),
Start-up Fund of Fund (INR 200 Crore), Grand Challenges among others.
• Technology business incubators (TBI) being set up in universities and R&D
Institutions and New Age Incubation Network (NAIN) in colleges will further
provide impetus to the biotech ecosystem in Karnataka.

3.6.2. Policy Initiative: Grand challenges focusing on biotech-led solutions to


address societal challenges in the state
Introduction of Grand Challenges: KBITS, through the Grand Challenges
Karnataka launched under the Start-up Policy of the government, will focus on
new technologies or innovations that can offer solutions to some longstanding
issues pertaining to the state of Karnataka. Grand Challenges Karnataka is aimed
at channelizing innovations for social impact and, in the process, support the
establishment and growth of start-ups. Grand Challenges around five well-defined
priority queries will be taken up in the first phase. The programme is supported by
the Karnataka Biotechnology and Information Technology Services (KBITS) as the
funding agency and IKP Knowledge Park (IKP – Hyderabad & Bangalore) as the
implementation partner.
The funding will be completed in two stages:
Phase I: Up to five innovators will receive Idea to Proof of Concept funding of up
to INR 10 lakhs for six months for prototyping and testing innovative solutions in
a real-world setting.
Phase II: After six months, the selected candidates will undergo one more round
of selection. One of them will be selected for further funding of up to INR 50 Lakhs
for 12 months to scale up the prototype.
The award agreement will be structured as a grant.
The programme will also work with the awardees for the duration of their project
and beyond to ensure project implementation and extend mentorship, resources
and networking opportunities. Through this KBITS-supported programme, IKP
and other partners will provide the winning candidates access to networks and
marketing channels to commercialise their innovations.

3.6.3. Policy Initiative: Provide access to scientific patent databases to start-


ups, incubators and academic institutions as part of the start-up booster kit
Providing access to co-shared Patent and Legal databases: As part of the Start-Up
Karnataka initiative, the government will provide start-ups access to co-shared patent
and legal databases such as Thomson Innovation and Questel patent database. This
will help biotech start-ups conducting extensive research and development and
reliant on patent data globally for supplementing research activities.
This facility will also be extended to technology business incubators (TBIs),
BiSEP and new-age incubation network (NAIN) institutions across the state.
Ready access to such expensive and relevant databases will stimulate
KARNATAKA BIOTECHNOLOGY POLICY
28 2017-2022

innovation and contribute to industry growth. It is also expected to help prevent


patent infringements, as start-ups will be able to search prior patents before filing
for patents for their innovations.

3.6.4. Policy Initiative: Provide start-ups with business advisory services


and facilitate access to private investors through a mentorship cell set up at
incubation centres
Fostering Entrepreneurship Among Research Scientists: KBITS will set up
a mentorship cell in association with the Association of Biotechnology-Led
Enterprises (ABLE) to help scientists and founders of start-ups sharpen their
business acumen and skills. The cell will comprise a committee or a pool of expert
consultants and will be run at state-run incubation centres and new-age incubation
networks. The cell is aimed at facilitating start-ups to develop:
Idea Validation: Guidance related to review of proof of concept, business idea
validation, provision of feedback will be provided by expert consultants to start-
ups.
Business Plan: Start-ups will receive support to develop an attractive business
plan entailing the market, commercial and technical feasibility for the start-up’s
idea, and will help attract relevant funding from banks, private institutions, and
venture capital funds.
Sales and Marketing Strategy: Following the successful development of
the product/solution, start-ups will receive guidance to prepare a go-to-market
strategy which will detail the sales and marketing efforts required to commercialize
the product/solution successfully and access PE/VC funding for their ventures.
Start-up/Entrepreneur Education and Training Programme: This programme is
aimed at providing education and training to start-ups and potential entrepreneurs
through short-term courses, workshops, conferences, covering a wide area of subjects
of relevance such as HR, finance, IP, management, leadership, and regulations. These
programmes can be developed in collaboration with institutes such as IIM Bengaluru.
IBAB, CHG & BBC IABT (Dharwad) and CFB@UHS (Bagalkot) can lead in
coordinating such a programme, and this, in the form of a pitch document, can help
start-ups develop a market entry strategy along with access to private equity/
venture capital funding.

3.7. DEFINITION OF BIOTECH COMPANIES AND


EXTENDING FINANCIAL INCENTIVES AND CONCESSIONS
FOR ATTRACTING INVESTMENTS IN THE BIOTECH
SECTOR
3.7.1 Definition of a Biotech Company including Startups:
A Biotech Company means and includes inter-alia a unit engaged in any of the
following activities
A. Any company (product development and/or service oriented such as
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 29

clinical research and biotech contract research organizations) / laboratory


initiating and carrying out work utilizing live cells / organisms (viruses,
bacteria, lichens, algae, fungi, plants, animals, humans) - in other words
“Living Systems” that are classified as Pro- / Eukaryotes; Plant Kingdom,
Animal Kingdom including Humans.
B. Any company / laboratory / individual working on the above with an
objective to develop via R&D a product (proteins, enzymes, lipids and other
biological molecules) or a process of benefit to the society in the areas
of Agriculture (and its relevant areas namely Horticulture, Sericulture,
Floriculture), Health, Energy and Environment.
C. Any company / laboratory engaged in Omics work (Genomics, Proteomics,
Lipidomics, Phenomics etc.), Bioinformatics, Genetic Engineering; Gene
Editing; in-vitro / in-vivo analyses to determine functions; Enzyme Catalysis
to produce products / processes.
D. Qualification of a Biotech Startup company, in addition to the applicable
terms and conditions outlined in the Startup Policy of Government of
Karnataka (http://itbt.karnataka.gov.in/), is that the Startup registered /
incorporated for not more than 4 - 7 years (depending on the nature of
work, types of living systems used- the length of its growth cycle thereof;
reagents / infrastructure required; area of application of the process /
product and other factors that may determine the time and complexity
required to proceed from one step to the next one.
E. Startups utilizing Electronics – Engineering: Fabrication work for application
in the four areas, namely, Agriculture (and relevant areas namely Horticulture,
Sericulture, Floriculture), Health, Energy and Environment would need to
justify for a 7-year qualification. Otherwise they would be qualified under 4
years or under.
Companies that can be classified in the above defined categories must register
with KBITS, Department of IT BT and S&T, Government of Karnataka as per the
terms and conditions of Biotech Policy and where applicable Start-Up Policy
framework.

3.7.2: Fiscal Incentives and Concessions:


Upon registration of Biotech Companies with KBITS, Department of IT & BT,
Government of Karnataka as outlined in section 3.7.1, the fiscal incentives and
concessions offered under the Industrial Policy 2014-19 of the Commerce &
Industries Department, Government of Karnataka (www.karnatakaindustry.gov.in)
shall be extended where applicable to the biotechnology industry and R&D centers
in the state. For the purpose of administering these incentives and concessions, the
Taluks in the state have been divided into four zones in Karnataka Industrial Policy
2014-19 and the same would be followed where applicable. The scale of fiscal
benefits and concessions available to the biotech industry under the Industrial
Policy 2014-19 varies based on the zones and the size of the enterprise (micro,
KARNATAKA BIOTECHNOLOGY POLICY
30 2017-2022

small, medium, large and mega enterprises) as per the classification of Industrial
Policy 2014-19 of the Commerce & Industries Department of Government of
Karnataka (www.karnatakaindustry.gov.in). Some of the incentives available to the
biotech sector under the Industrial Policy 2014-19 of the Commerce & Industries
Department of Government of Karnataka (www.karnatakaindustry.gov.in) include:
a. Stamp duty exemption and concessional Registration charges
b. Reimbursement of land conversion fee: 75-100% depending upon the zone
being used for set-up
c. Tax exemptions as applicable
d. Incentives for export oriented enterprises
e. Investment subsidy for setting up of effluent treatment plants (ETPs)
f. Special incentives for enterprises coming up in low HDI districts
g. Incentives for water harvesting / conservation measures
h. Incentives for energy conservation

3.7.3: Incentives from the Department of IT BT and S&T:


The incentives available from the, Department of IT BT and S&T to the companies
in the biotech sector classified under the Biotech Policy include:
a. Anchor Unit Subsidy: Available for the first two manufacturing enterprises
with a minimum employment of 50 – 100 members and a minimum green
field investment of 50 Crores
b. Reimbursement of Costs for Preparation of Project Report: Refund of
cost incurred for preparation of project report, up to a maximum of INR 1
Lakh
c. Power Tariff Concessions: A recommendation certificate from KBITS-
Department of IT BT and S&T to BESCOM to help in power tariff concession.
d. Interest subsidy (6%) for Technology up-gradation for MSMEs for a loan of
maximum of INR 50 Lakhs for 5 years
e. Standardization Certificate: Financial assistance of up to 50 % of the cost
incurred in obtaining a standards certificate such as ISO / BIS / GLP /GMP /
NABL (maximum of INR 5 Lakhs per case)
f. Patent Registration: Financial assistance towards the cost of filing and
prosecution of patent application up to a limit of INR. 2 Lakhs per Indian
Patent awarded; and for awarded international patents on a single subject
matter up to INR 10 Lakhs.
g. Marketing Incentives: Reimbursement of 30% of the actual costs incurred
for international marketing programs, subject to a maximum of INR 2 Lakhs
per year per company.

3.8. FOSTER THE DEVELOPMENT OF BIOECONOMY BY


KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 31

SUPPORTING RESEARCH AND DEVELOPMENT (R&D) IN


EMERGING TECHNOLOGIES

1 BIO AGRICULTURE
Support technologies focused on addressing biotic and abiotic
stresses in the State
2 MARINE BIOTECHNOLOGY
Leverage the rich marine biodiversity of the state
3 RARE DISEASE MANAGEMENT
Become a pioneer in diagnosis and treatment of rare diseases
through emphasis on multi-disciplinary research
4 SYNTHETIC BIOLOGY
Develop new biological parts and systems to produce complex drug
in large quantities
5 OMICS

EMERGING Drive innovation in healthcare by accelerating drub development


process/personalized medicine at reduced costs
AREAS 6 STEM CELL AND REGENERATIVE MEDICINE
Lead the next wave of development in cell therapy and regenerative
medicine
7 ANTIMICROBIAL RESISTANCE
Developing an alliance to seek innovative ways to tackle the threat
from resistance to antimicrobial drugs
8 BIO ENGINEERING
Support integration of engineering with the physical and life sciences
to develop innovative technologies and solutions
9 MEDICAL DEVICES
Provide an in digenous push to innovation in medial device
10
technology
MICROBIOME
Support activities focusing on targeted treatment and development
of altervative drugs

3.8.1. Bio Agriculture


Karnataka, with total cultivable land of 12.3 million hectares and constituting
approximately 64% of the total geographical area, is a dominant agrarian state6.
The state is also known for its dominant presence in horticulture, floriculture,
sericulture, fisheries and animal husbandry. In fact, there is no crop in India which
is not grown in Karnataka, thereby making it a representative sample of India. With
nearly 65% of the state’s population depending on agriculture as the main means of
KARNATAKA BIOTECHNOLOGY POLICY
32 2017-2022

livelihood, the state recognized the immense benefits that could be reaped out of
agricultural biotechnology and marked it as one of the most significant priorities6.
The state has made significant progress in improving the overall agricultural
productivity. However, in view of the increasing demand and decreasing resources,
there is scope for further improvement with modern technological intervention.
Karnataka, similar to several other states, faces some formidable challenges
hampering the quality of agricultural produce in the state. Approximately 74% of
the cultivable land in the state is under semi-arid tracts and prone to repeated
drought, causing crop losses up to 60%6. There is an urgent need for the adoption
of technologies such as phenomics to address this abiotic stress in tandem with
other established technologies such as genomics, molecular breeding and other
relevant ones. Apart from such abiotic stress, biotic factors such as attacks from
pests, diseases and weeds are known to reduce yield by about 35% in most crops6.
This translates into an annual crop revenue loss estimated at INR 11.4 billion.
Additionally, Karnataka has a vast coastal tract of about 1.6 lakh hectares which is
unsuitable for cultivation of crops due to high salinity. Some of these challenges can
be addressed through biotechnology as already demonstrated in other countries
and in India by adoption of Bt cotton to control cotton bollworms since 2002-036.
Across India, technological advancements in genome editing, synthetic biology
and DNA sequencing are driving new product innovation in agriculture. Additionally,
the current scope of R&D activities in transgenic research led to the generation of a
number of transgenic crops with higher productivity yield potential, prolonged shelf
life, enhanced nutrition, insect/disease resistance, moisture-stress tolerance, etc.
These technologies are anticipated to benefit agriculture and farmers and boost
biotech education and business.

Policy Initiative:
The state of Karnataka would focus on providing the necessary support to companies
operating in the agri- biotechnology segment. These steps would include:
• Allow owning or leasing of land by bio agriculture companies for performing
field trials and other agriculture related activities. Also, the process of
acquiring agriculture land by biotech companies will be streamlined. A cap
will be imposed on the size of land to be allotted to these companies along
with a mandate that it should be used only for the stipulated purposes.
Focus would be on developing biotechnology processes to tackle biotic/
abiotic stress that hampers the quality and growth of agricultural production
in the state. Some of these technologies include:
- Genetic Engineering
- Phenomics
- Marker-Assisted Selection
- Micro-propagation (Bio-based systems for maintenance and
augmentation of soil health)
- Microbe based systems for increased crop productivity
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 33

• Constitution and activation of State Biotechnology Co-ordination


Committee (SBCC) and District Level Committee (DLC) for:
- Effective co-ordination between stakeholders
- Facilitate smooth testing of biotech crops
- Promote development & deployment bio-agriculture based
technologies
• Support the functioning of the agri-biotech incubation centre set up within
the premises of the University of Agricultural Sciences, Dharwad. The
Department of IT, BT and S&T provided INR 6.5 Crore in the first phase to
establish an incubation centre that can house six or more incubatees and a
common instrumentation facility.
• Establish and support TBIs with focus on Agri and Agri-allied fields in
institutions such as UAS / UHS / UAHSS across the state.
- In collaboration with other relevant departments (Agriculture,
Horticulture, Sericulture etc.,) set up a centralized cost-effective
testing facility in a public system (SAU) for collecting test data of
new traits/events to assess value for commercial use and Biosafety
aspects
• The funding provided to K Bio Venture by the Department of Agriculture (of
INR 5 Crore) will solely be utilised to support Agri-biotech ventures in the
state

3.8.2. Policy Initiative: Aqua-Marine Biotechnology


The Indian fisheries and aquaculture plays an important role in providing
nutritional security to the food basket, enhancing export of fish and fish products
and providing employment to around 15 million people6. With a vast and diverse
aquatic resources ranging from deep seas to lakes in the mountains and around
11% of the global diversity, India has shown sustained increase in fish production,
reaching the current production level of over 10 million tonnes (which is around
4.5% of the global fish production)6.
Karnataka is one of the nine maritime states in India bestowed with rich and
varied aquatic resources, both in marine and inland sectors. These water bodies
harbour rich aquatic flora and fauna having great economic value. Rich corals,
diverse fish and a plethora of economically important aqua species along the 320-
km natural coast line represent the rich marine biodiversity of Karnataka. Fish
production in Karnataka is around 3.8 lakh tonnes, with the marine and inland
sectors contributing 60% and 40%, respectively6.
The application of biotechnological tools has the capacity to revolutionise
fisheries sector by increasing fish production and biodiversity conservation. Several
institutes in Karnataka are undertaking research activities on issues which have
relevance for field application. For instance, The Karnataka Veterinary Animal&
Fisheries Sciences University (KVAFSU) in its College of Fisheries in Mangalore
- Bangalore is undertaking research on various aspects related to control of
KARNATAKA BIOTECHNOLOGY POLICY
34 2017-2022

reproduction. Research on selective breeding and use of molecular markers,


chromosome set manipulation and sex reversal is being carried out at its centres
in Hesaraghatta and Bengaluru. Similarly, the College of Fisheries at Mangaluru is
pursuing biotechnological research on issues related to reproduction, aquatic and
fish health management and fish processing.

Policy Initiative:
The Department of IT, BT and S&T will collaborate with KVAFSU and the Directorate
of Fisheries to promote research in the field of aqua-marine biotech to increase
yield, and develop novel marine bioactive products and marine natural products.
Plans are underway to set up a centre for innovation and incubation at KVAFSU
to explore the marine ecosystem and develop products relevant to bio-energy,
pharma, nutrition, etc.
This facility would also be the primary interface for research efforts focused
on the use of molecular markers to improve stock of commercially important
and endangered species. The planned centre would also be a hub for improving
collaboration between molecular biologists, marine biologists as well as with
central research institutions such as The Central Marine Fisheries Research
Institute to develop potentially commercially exploitable technologies/findings.

3.8.3. Rare Diseases Management


An estimated 720 lakh children and adults in India are affected by a rare genetic
disorder, with Karnataka accounting for around 30–40 lakh people affected by
many diseases7. The diagnosis of a rare disease takes about seven to eight
years and entails significant out-of-pocket expenses, leading to financial
hardships for patients and their families. Moreover, there is little emphasis on
clinical research and innovations in the treatment and management of rare
diseases. To address this socially relevant challenge, Karnataka developed a
forward-looking Rare Diseases and Orphan Drugs (RDOD) Policy to emerge as
a pioneer in this area.

Policy Initiative:
The Department of IT, BT and S&T will support the Department of Health and
Family Welfare to facilitate:
• Networking between academia, research institutes such as The Centre
for Human Genetics (CHG), Rajiv Gandhi University of Health Sciences
(RGUHS), Indira Gandhi Institute of Child Health Hospital (IGICH) and
biotech industry to enable “bench to bedside” translational research for
rare diseases and other deficiencies which lie in genetic understanding.
Particular emphasis will be placed on application of genomic sciences
and other biotechnologies for effecting substantive health access for rare
diseases affected communities. This could include collaborative projects
to develop enzymes for replacement therapy and translational research
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 35

in the fields of gene editing, stem cell research and regenerative medicine
therapies for treatment of rare diseases.
• Setting up of rare disease registries for robust surveillance, data collection
and analysis for a set of prioritized rare diseases in Karnataka. Through such
registries, monitoring, documentation and evaluation of care pathways and
policies will be made possible.
• Access to genetic testing and analysis to allow for personalized and
precision treatment according to disease genotypes and phenotypes.
The funding required for promoting the research activities would be decided
by a selection committee comprising government representatives from the
Department of IT, BT & ST, Dept. of Health, Directorate of Medical Education,
hospitals and research institutions and other relevant stakeholders.

3.8.4. Synthetic Biology


The global synthetic biology market is estimated to be worth USD 5.2 billion as
of 2015 and anticipated to advance at a robust CAGR of 23% from 2015–208.
Demand from existing applications in drug & vaccine development, particularly
for bio-based polymers & bio-chemicals, are driving the market. The synthetic
biology segment gained popularity in hazardous waste clean-up initiatives through
engineered microbes. Engineered crops, through synthetic biology, would bridge
the gap between supply and demand globally. Emerging applications across novel
fields of research such as agriculture and bioremediation are expected to drive
market growth over the coming years. Synthetic biology can play a prominent role
in decreasing the demand for land, water and other valuable resources.
In India, the research activities related to synthetic biology and their application
in industries are in nascent stages. Nevertheless, in line with the global trend, India
witnessed the establishment of a few start-ups that are either providing services
or manufacturing products based on synthetic biology technology. These start-
ups are focusing on oligonucleotide, DNA fragment synthesis, butanediol (BDO)
and other synthetic biology applications using bioinformatics. Advanced synthetic
biology tools will also facilitate the fermentation processes for conversion of waste
into green products in Karnataka; a few start-ups focusing on synthetic biology are
predominantly present in Bengaluru. IBAB and BBC provide incubation facilities to
start-ups which focus on synthetic biology.

Policy Initiative:
Karnataka will leverage its existing biotechnology and information technology
infrastructure to facilitate the development of the synthetic biology segment. It
allocated INR 9.85 Crores to be utilised over five years and plans are in place to
set up a synthetic biology centre at IBAB. These funds will be spent for supporting
research activities aimed at developing products of social relevance using the
synthetic biology technology. This facility at IBAB will also be the hub for facilitating
academic-industry partnerships in the area of synthetic biology.
KARNATAKA BIOTECHNOLOGY POLICY
36 2017-2022

3.8.5. Bioinformatics - Omics


Bioinformatics, an established interdisciplinary area within the broader science &
technology domain, encompasses a systematic development and application of
IT solutions to manage biological information. Bioinformatics facilitates discovery,
development and implementation of computational algorithms and other software
tools to understand the biological processes in order to address the various
challenges faced primarily by the agriculture and healthcare sectors. Over the last
decade, bioinformatics as a segment has significantly evolved globally owing to the
increasing applications in drug discovery and biomarker development, resulting in
its rising use in drug development and clinical diagnostics.
Bioinformatics has a wide range of applications in life sciences research, including
genomics, proteomics, chemoinformatics, molecular phylogenetics and others. Of
these applications, genomics commands the largest share with more than 20% of
the bioinformatics applications developed in the last five years globally focusing
on genomics and proteomics. In the short-term, the global genomics market is
expected to gain impetus with the development of innovative technologies such as
Next Generation Sequencing (NGS), advances in cell and single molecule imaging
technologies and modelling software.
In line with the global trend, the application of genomics in India is expected to
play a key role, particularly in areas such as agriculture and personalized medicine.
Companies across industries, including cosmetics, pharmaceutical, FMCG and
agro-biotech, are increasingly focusing on genomics and require bioinformatics
applications and platforms to develop better therapeutics and products.
The evolution of new methods for high-throughput genotyping also provides
an impetus to non-invasive measurements of the fine architecture of plants and
the functional state of plant tissues. Plant Phenomics has practical applications in
agriculture, where plant breeding and agronomy can benefit significantly from the
development of new agricultural germplasm to support agricultural production.
The convergence of genetics and physiology to reveal the molecular genetic basis
of a wide range of hitherto intractable process could enable development of high-
yielding genotypes of agricultural crops adapted to future climatic conditions.

Policy Initiative:
To achieve dominance in the emerging field of omics, the government will develop
a state-of-the-art genomics infrastructure to enable Karnataka to achieve
international competency and standards. The government will leverage on the
existing infrastructure at IBAB and CHG to develop this further as a cluster for
Advanced Genome Bioinformatics-Omics.
Taking advantage of the state’s biodiversity, the government will establish a
dedicated programme for collection of floral, faunal and microbial biodiversity
to establish Karnataka’s Genome Database. Karnataka is endowed with a rich
biological diversity, which includes over 3,000 species of plants, over 500 species
of birds, 160 reptiles and 180 mammalian species. Also, with its 320-km coastline,
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 37

the state is home to nearly 500 species of fish. The Genome Database will act as
the primary storage of DNA, plant and animal tissues, including that of endangered
and socio-economically important species of Karnataka.
The government will promote large scale omics and bioinformatics projects
at IBAB to compile, integrate and intelligibly analyse the collected genomes
data through the use of modern technologies such as NGS. These projects will
enable the study of various plants, animals and microbial species, that standard
laboratory culture technique are not capable of, thereby providing valuable insights
into the biodiversity of Karnataka. The studies will in turn assist in sequencing
and characterising specific diseases and focus on biomarker studies for rapid
identification as well as treatment for human inherited and rare diseases. Also,
these studies will allow virtualizing many steps in the drug development process,
thus helping accelerate clinical trials and reduce the cost. For instance, human
genome and biological molecules will be analysed to create new information that
will play an important role in drug discovery and delivering personalized medicines
to patients. Similarly, analysing microbial genomes from soil samples can help
improve crop productivity.
The funding required for these initiatives will be decided by a selection
committee headed by the Principal Secretary - Department of IT, BT & ST,
constituting representatives from other departments such as health, agriculture,
etc. academicians and other relevant stakeholders.

3.8.6. Stem cell and regenerative medicine


Stem cell therapy and regenerative medicine is an emerging disciple that is
anticipated to revolutionise patient care in the future. Currently, there are more
than 770 regenerative medicine companies operating globally (including gene and
cell therapies), of which ~15% are based in Asia9. There have been several research
agencies and institutions in India (particularly in Karnataka) involved in stem cell
research and regenerative medicine.
These companies cumulatively raised ~US$5.2 billion in 2016, leading to
undertaking of 804 clinical trials worldwide9.

Policy Initiative:
The Department of IT, BT and S&T will support programmes in stem cell biology and
regenerative medicines with the aim of promoting basic and translational research
in view of its potential application areas. The emphasis would be on proactively
engaging with stakeholders involved in regenerative medicine and cell therapy
to develop, promote and accelerate implementation of innovative regenerative
medicine and cell therapy applications. Existing research institutions such as InStem
and CHG can be the central hubs of excellence – and would work in co-ordination
with hospital networks for promoting the field of regenerative medicine.
Additionally, the department will seek to establish a stem cell bank through
public private partnerships to provide a repository of human embryonic stem cell
KARNATAKA BIOTECHNOLOGY POLICY
38 2017-2022

lines for use in research that may lead to clinical applications. Further, the state will
seek to set up a coordination committee of experts to support the development,
communication and implementation of technical processes and manufacturing
scalability standards for gene therapy, cell therapy and other regenerative
medicines.

3.8.7. Antimicrobial Resistance


Antimicrobial resistance in disease pathogens has increasingly become a matter of
health concern globally. It is estimated 700,000 people die of resistant infections
every year. By 2020, another ~10 million lives a year and a cumulative USD100
trillion economic output are at risk due to the rise in drug-resistant infections10.
In India, antibiotic-resistant neonatal infections cause nearly 60,000 infant
deaths every year11. The magnitude of the problem has now lead to an alliance
being developed at a global stage among various stakeholders such as hospitals,
pharmaceutical and biotech companies, governments and multilateral agencies to
tackle this issue.
In India, the Ministry of Health and Family Welfare drafted a national policy for
containment of antimicrobial resistance in the country. More recently, the National
Centre for Disease Control published guidelines for treatment of antimicrobial
use in infectious diseases. Further, the central government has been encouraging
biotech start-ups to seek innovative ways to tackle the threat faced by India from
resistance to antimicrobial drugs by investing $100,000 to start an India-focused
seed fund to help groups in India compete for the UK-enabled Longitude Prize. It also
collaborated with the Finnish funding agency, Tekes, to improve competitiveness
of companies in the two countries through promoting collaboration in different
phases of the knowledge innovation chain.

Policy Initiative:
To further the efforts of tackling drug-resistant infections in Karnataka, the
Department of IT, BT and S&T will work with other government departments and
stakeholders (including hospital networks) to establish an alliance in Karnataka
against antimicrobial resistance with technological intervention where applicable.
The department will also seek to enhance multi-disciplinary collaboration and
public-private investments for:
• Identifying high-risk strains and their resistance
• Developing rapid diagnostics tests to differentiate between bacterial and
viral infections
• Discovery and development of a sustainable supply of effective new
antimicrobials
• Developing informatics tools for linking human and animal diseases
surveillance for better mapping and prediction of emerging diseases threat
• Promoting the development and uptake of genomic technologies to
improve appropriate, prompt, patient treatment
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 39

The funding required by promoting research activities and development


of solutions in this area would be decided by a select committee constituting
government representatives from the Dept. of IT, BT & ST, Dept. of Health and Family
Welfare, hospitals and research institutions, and other relevant stakeholders.

3.8.8. Bio-engineering
Bio-engineering has been behind many of the contemporary, path-breaking
healthcare solutions that are common place today such as ultrasound, MRI and
other imaging techniques as well as development of artificial hips, knees and other
prosthetic implants. As the paradigm shift from traditional schemes of healthcare
towards a more technology driven model continues unabated, the importance
of bio-engineering and bio-manufacturing to build, design and repair biological
systems quantitatively has gained more significance. Moreover, the emerging trend
of personalized medicines will continue to spur the development of innovative
healthcare solutions for curing and preventing diseases.

Policy Initiative:
To fully integrate engineering with the physical and life sciences for the larger
benefit of the society, the Department of IT, BT and S&T will encourage high-
impact research in imaging, health informatics, and other interdisciplinary areas
at the interface of biology and engineering. Of particular emphasis would be the
development of medical technologies that are low-cost, effective and accessible
to the wider society. Through the existing science and technology grants and
funding avenues of the state, necessary support will be provided for research
activities that advances knowledge of cellular and molecular disease mechanisms
into precise medical diagnostics and therapeutics.

3.8.9. Medical Devices Technology


The medical devices industry is a multiproduct industry, producing more than
14,000 different types. The Indian market for medical devices and equipment
is valued at US$4.9 billion, which is approximately ~6% of the total healthcare
market12. A rise in the number of hospitals and the increased requirement for
healthcare facilities creates a need for sophisticated devices and equipment,
which can provide accurate treatment to individuals. More so, there is a mismatch
between the design of certain technologies being imported and realities of clinical
conditions and healthcare infrastructure in the country. Thus, India has much to
gain from effective use of advanced medical technology.
The “Make in India” initiative of the Government of India identified medical
device manufacturing as a sunshine sector. The government also formulated
a draft “National Medical Device Policy-2015” to address headwinds (such as
archaic regulatory standards, sub-standard quality of India-made products, high
import dependency, Lakhs of tax incentives and unfavourable duty structure) and
encourage manufacturing in India. As a part of this policy, an autonomous body -
KARNATAKA BIOTECHNOLOGY POLICY
40 2017-2022

National Medical Devices Authority (NMDA) - is proposed to be set up with a mandate


to provide single window clearances, develop medical devices parks, benchmark
international practices, develop knowledge networks, revisit regulations, create an
enabling environment and recommend incentives to encourage manufacturing of
medical devices in India.

Policy Initiative:
In line with the plans of the centre, the state government amended the “Karnataka
Industrial Policy 2014-19” to incorporate strategies and incentives aimed at
promotion of medical devices manufacturing enterprises. These include:
• Establishing a medical devices park with comprehensive infrastructure
facilities such as common facilities, calibration, testing and quality control
through PPP mode
• Setting up a VC fund with a corpus of INR 25 Crore (with 26% contribution
from state departments) specifically for medical devices ventures
• Provision of subsidies, help with regulatory costs, incentives and grants to
build capacities, promote R&D and organise trade shows and events for
promoting medical device manufacturing
The Department of IT, BT and S&T will collaborate with the Commerce and
Industries Department for the provision and implementation of special packages
for medical devices enterprises under the Industrial Policy 2014-19.

3.8.10. Microbiome
Microbiome research has been growing on the heels of technological development
in DNA sequencing in the early 2000. Research activities in the space gained
momentum after the National Institutes of Health - a medical research agency
that is part of the U.S. Department of Health and Human Services - initiated a
study on the Human Microbiome Project (HMP) in 2007. The investments made
under this initiative (USD 215 million between 2007-14) led to generation of nearly
50,000 files of publicly available sequencing data accessed by over 75,000 users
from more than 178 countries13.
Currently at a nascent stage, the microbiome market is expected to witness
continued growth as research institutions, universities and private companies
allocate resources for advancing research in this field. Growing understanding of
the importance of microbiomes in the human body has led companies to invest
and venture into development of microbiome-based therapeutics and drugs.
Globally, the human microbiome research spending is expected to surge from
~USD 373 million in 2015 to ~USD 702 million in 202014. The growth in research
activity would be primarily driven by biotechnology companies engaged in research
and clinical trials of novel drugs and probiotic supplements based of human
microbiome research studies. Currently, there are over 55 companies around
the world working on ~106 ongoing projects (focusing on targeted treatment
and development of alternative drugs) from discovery to clinical stage15. Based
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 41

on the current research activity, it is anticipated that human microbiome based


diagnostics are likely hit the market by 2021 and drugs for treatment of diseases
such as diabetes, cancer and mental disorders by 202214.

Policy Initiative:
The Department of IT, BT and S&T will seek to promote the integrated study
of microbiomes across different ecosystems especially at premier research
institutions such as CHG, NCBS and IBAB.
The emphasis would be on mapping of human microbiome and understanding
the effects of micro-organisms on human health and a range of diseases.
Support will also be provided for development of tools to predict the function of
uncharacterised genes and enhance the understanding of chemical compounds
produced in the biological pathways of microbes. New methods and solutions
focusing on making changes in microbes to generating disease treatments and
environmental improvements will also be encouraged.
The funding required by promoting research activities in this area would be
decided by the Dept. of IT, BT & ST in collaboration with the VGBT.
KARNATAKA BIOTECHNOLOGY POLICY
42 2017-2022

REFERENCES
1 National Biotechnology Development Strategy 2015-2020
2 The Doing Business Project - World Bank Group
3 Primary Research Based Profiling of Biotech Sector in Karnataka – KBITS
4 The Sixth Report on All India Survey of Higher Education, Ministry of Human
Resource Development, Government of India
5 ABLE-Aranca Estimates
6 Report submitted by the Expert Group on Agricultural Biotechnology
7 Rare Diseases and Orphan Drug Policy (Draft), submitted by VGBT to
Secretariat of Health and Family Welfare
8 Bio-IT World - 'Synthetic Biology Market is Expected to Reach $38.7 Billion,
Globally, by 2020'
9 Annual Data Report 2016 - Alliance for Regenerative Medicine
10 Tackling Drug-resistant Infections Globally, 2016: Review on Antimicrobial
Resistance, Government of the UK and Wellcome Trust
11 The Hindu, 'Babies fall victim to antibiotic resistance', 2016
12 Karnataka Industrial Policy 2014-19 (with Amendments) - G.O. No. CI 204
SPI 2015, Dtd: 12.09.2016
13 Obama White House Archives - FACT SHEET: Announcing the National
Microbiome Initiative, May 13,2016
14 Aranca Analysis
15 Labiotech.eu - Infographic: The Microbiome Market & Research by the
Numbers
KARNATAKA BIOTECHNOLOGY POLICY
2017-2022 43
KARNATAKA BIOTECHNOLOGY POLICY
44 2017-2022

“Most of the old cities represent the past of India.


They represent history, whereas
Bengaluru represents the future that we are moulding...”

A
DI
I
Pandit Nehru on his visit to Bengaluru
N
O F
AL
A PI T
TC
THE B

For Information and Assistance, please contact

Principal Secretary to Government


Department of Information Technology, Biotechnology and Science & Technology
Government of Karnataka
6th Floor, 5th Stage, M.S. Building, Bengaluru - 560 001, Karnataka, India.
• Ph: +91-80-2228 0562 / 2226 5943 • E-mail: itbtsec@ka.gov.in
Managing Director
Karnataka Biotechnology & Information Technology Services
BMTC Building 4th Floor (TTMC ‘B’ Block-above Bus Stand)
Shanthi Nagar, Bengaluru - 560 027. India
Tel : +91-80-2223 1006 Telefax : +91-80-2272 7480
E-mail : mdkbits@gmail.com, md.ktech@ka.gov.in

Visit: http://itbt.karnataka.gov.in

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