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Biotechnology Policy in India

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 CHAPTER
10

Biotechnology Policy in India

ALOK CHANDRA SAMAL1 AND PIYAL BHATTACHARYA2*

1
Department of Environmental Science, University of Kalyani, West Bengal-741 235, India
2
Department of Environmental Science, Kanchrapara College, West Bengal-743 145, India
*Corresponding Author - Email: piyal_green@yahoo.co.in

ABSTRACT

The ‘Biotechnology’ can be broadly defined as the technological applications of biological processes.
Biotechnologists utilize living organisms or their body parts to develop a new product or a process which
can improve the environment and/or quality of life. The diverse applications of biotechnology are
implemented in agriculture, medicine, energy, industry, and environment sectors. People used to practice
traditional biotechnological processes for centuries to yield bread, alcohol, wine, beer, fermented milk
products, and medicines. The arenas of today’s biotechnology comprise genomics, recombinant DNA
technology, proteomics and bioinformatics. In recent time agriculture, healthcare, social wellbeing, and
environmental management industries have contributed well to the global economy by employing
biotechnological measures. In India several socio-economical aspects like conservation of bioresources,
and ensuring safety of products, and processes, etc, are required to be dealt in an efficient manner in order
to utilize the benefits of biotechnological innovations. For the last few years biotechnology has induced a
new challenge to the sustainable laws and regulations worldwide. Thus there is an urgent necessity for
drafting as well as implementing a well defined ‘Biotechnology Policy’ in national and international levels.
The said policy framework should be a resultant of wide consultation with all stakeholders of
biotechnology field– researchers, educationists, regulators, policy makers and representatives of society, for
accomplishing the full potential of the social and economic wellbeing of our country. India has already
framed its biotechnology policy under the aegis of the Department of Biotechnology (DBT) by aggregating
the state biotechnology policies.

KEYWORDS: Biotechnology, policy, national biotechnolgy policy

 Biotechnology Policy in India
1. INTRODUCTION
For the last two decades the Indian biotechnology sector has witnessed a sharp increase in the
R&D and its application in various sectors like agriculture, medicine, industries and environment.
Being a rich biodiversity country biotechnology in India offers great opportunities by utilizing the
bioresources for the social and economic development of its people. Renewable resource induced
advanced products and services increase production efficiency of various industrial processes in a
sustainable manner. The Indian agriculture sector is continually facing the great challenge to meet
the demand of India’s exponential population growth with falling per capita cropland. In this
scenario biotechnology has shown the potential to sweep over this challenge while ensuring the
livelihood security of the country’s large farming population. The advancement of biotechnology
as a successful industry confronts many challenges related to research and development, creation
of investment capital, technology transfer and technology absorption, patentability and
intellectual property, affordability in pricing, regulatory issues, and public confidence.
Sustainable innovation technology and facilitating technology have to be efficiently amalgamated
to create a balance in the biotechnology policy. In India several socio-economical aspects like
conservation of bioresources, and ensuring safety of products, and processes, etc, are required to
be dealt in an efficient manner in order to utilize the benefits of biotechnological innovations. The
government and industrial sectors should come forward to deliver the advancement and benefits
of modern biotechnology to the countrymen by making provision for proper education and
protection of the public interests. The adaptation of new applications of biotechnology would
require clear demonstration of its value to all its stakeholders.
India’s ‘National Science and Technology Policy’ and the ‘Vision Statement on Biotechnology’
have emphasized significant interventions in the public and private sectors to promote benefits of
life sciences, especially biotechnology. In the last few years we have witnessed remarkable
progress in R&D, generation of human resource and development of necessary infrastructure. In
order to be competitive throughout the world biotechnological innovations have to be of
prominent degree, and the product patenting measure will enhance such initiatives. But, higher
investments and an effective functioning mechanism of the innovation will then be required to
fulfill such objectives. New opportunities and the potential economic, environmental, health and
social benefits are hypothesized to induce betterment in the government policy, public awareness,
education, scientific, technological, legal, and institutional frameworks. Access to the benefits of
medicinal and agricultural biotechnology by people is of high concern. A well designed public
good research thus should be supported which only can make provision for reaching the
unreached. Researches for ‘public good’ as well as researches ‘for profit’ should strengthen each
other for greater technological empowerment. This can be achieved by executing substantial roles
through various public institutions as well as industries. India’s ‘National Biotechnology
Development Strategy’ addresses previous accomplishments and makes provision for the future
framework within which strategies and specific actions to promote biotechnology can be taken.
The above said policy framework is the resultant of wide consultation with all stakeholders–
scientists, educationists, regulators, representatives of society, and others who have reported their
consensus. Issues such as human resource development, academic and industrial interface,
infrastructure development, laboratory and manufacturing, promotion of industry and trade,
creation of biotechnology parks and incubators, regulatory mechanisms, creation of public
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education and awareness, etc, are primarily focused. Agriculture and food biotechnology,
industrial biotechnology, therapeutic and medical biotechnology, regenerative and genomic
medicine, diagnostic biotechnology, bio-engineering, nano-biotechnology, bioinformatics and IT-
enabled biotechnology, clinical biotechnology, manufacturing and bio-processing, research
services, bioresources, environment, intellectual property right and patent law, etc are selected as
priority areas whose pathways of progress have been outlined in the policy. Several state
governments of India have already notified biotechnology policy for their territory. At the same
time the ‘National Biotechnology Development Strategy’ will blueprint an integrated 10-year road
map with clear directions and destinations. This would generate investment in different areas of
biotechnology sector which would ultimately make betterment of the social and economic
wellbeing of our country.
2. NATIONAL BIOTECHNOLOGY POLICY OF INDIA
For the development of agricultural biotechnology sector India initiated to establish a policy and a
regulation system during 1980s. At present the country is observing serious changes in all
biotechnology sectors. Enactment of the Rules for the Manufacture, Use, Import, Export and
Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989 under
the Environment Protection Act, 1986 (EPA) was the pioneer legislation related to agricultural
biotechnology in India. The EPA (1986) and the Rules (1989) are still seen to regulate the
pending parliamentary approval of the Biotech Regulatory Authority of India (BRAI), India’s
Biotech Policy, and regulatory mechanisms. The development of India’s Biotech Policy can be
categorized in three stages:
a) Policy and regulatory establishment during 1989−2002 when Bt cotton was approved for
commercialization;
b) Policy developments during 2003−2010 when the Ministry of Environment and Forest
(MoEF) imposed a moratorium on Bt brinjal; and
c) Policy debates since 2010, during which Bt brinjal and BRAI are under suspension.

The Indian biotechnology sector is growing steadily, and thus the policy and regulation on
biotechnology are needed to be developed, and also to be updated periodically. Bt cotton was
approved for commercialization in 2002, there after some noteworthy actions like ‘Biosafety
Protocol’ ratification (2003), ‘Report on the Application of Agri-Biotech’ (2004) by MoEF and
Ministry of Agriculture, approval for a ‘National Biotech Development Strategy’ (2007), etc were
taken up. Establishment of an autonomous, statutory, and professionally-led ‘National
Biotechnology Regulatory Authority’ (NBRA) as a first national biotech authority was
recommended by the Report (2004). The proposed NBRA was designed to have two separate
wings−one addressing food and agri-biotech, while the other dealing with medical and
pharmaceutical biotechnology. The NBRA was bestowed the task for generating the necessary
public, professional, and commercial confidence in the science-based regulatory mechanism in
India. In 2005, the Department of Biotechnology (DBT) drafted the ‘National Biotechnology
Development Strategy’ by elaborating a 10-year vision and action plan of biotechnology in India.
The Strategy would incorporate multi-stakeholder consultations to achieve its goals by focusing
all relevant issues of the biotechnology community. Establishment of the National Biotechnology
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 Biotechnology Policy in India
Regulatory Authority (NBRA) with separate divisions for agricultural products/transgenic crops,
pharmaceuticals/drugs, industrial products, and transgenic food/feed and transgenic animal/aqua
culture was recommended by the Strategy (2005) for regulatory mechanisms. In 2007, this
strategy was approved by the Government of India.

India’s biotechnology regulatory governance is relatively independent, but, is governed by the

three ministries- Ministry of Science and Technology, Ministry of Environment, Forest and
Climate Change, and Ministry of Agriculture. Some risk-management institutions within or
outside of these ministries also regulate the sector (Figure 1). There are also several different
bodies to manage biotechnology sector in individual states of India. Some states in India are
interested in accepting the benefits of biotechnological applications while some other states are
still cautious to this new-age technology. Thus, the biotechnology policy and associated
regulations differ with states.

Figure 1: Biotechnology regulatory mechanism in India

3. STRATEGIES FOR DEVELOPING BIOTECHNOLOGY POLICY IN INDIA
The DBT, Government of India, announced the ‘National Biotechnology Development Strategy’
in 2007. The implementation of Biotechnology Strategy (2007) has provided an insight into the
enormous opportunities. The current ‘National Biotechnology Development Strategy:
2015−2020’ of India aims to establish India as a world-class manufacturing hub of bio-products.
It intends to launch a major mission, backed with significant investments, for the creation of new
biotech products; create a strong infrastructure for R&D and commercialization, and empower
India’s human resources scientifically and technologically. The new strategy would seamlessly
build on the earlier strategy (2007) to accelerate the pace of growth of biotechnology sector at par

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 Progress of Biotechnology in India
with global requirements. Research in all areas of basic and interdisciplinary sciences using
modern biotechnology would be supported by the DBT. Emphasis would be on generation of
biotech products, processes and technologies to enhance efficiency, productivity, safety and
cost‐effectiveness of agriculture, food and nutritional security; affordable health and wellness;
environmental safety; clean energy and biofuel; and bio‐manufacturing.
The renewed mission is to:
 Provide impetus to utilizing the knowledge and tools to the advantage of humanity,
 Launch a major well directed mission backed with significant investment for generation
of new biotech products,
 Empower scientifically and technologically India’s incomparable human resources,
 Create a strong infrastructure for R&D and commercialization, and
 Establish India as a world class bio-manufacturing hub.
The ten guiding principles of the ‘National Biotechnology Development Strategy: 2015−2020’
are as follows:
 Building a skilled workforce and leadership,
 Revitalizing the knowledge environment at par with the growing bio-economy,
 Enhancing research opportunities in basic, disciplinary and inter-disciplinary sciences,
 Encouraging use-inspired discovery research,
 Focussing on biotechnology tools for inclusive development,
 Nurturing innovation, translational capacity and entrepreneurship,
 Ensuring a transparent, efficient and globally best regulatory system and communication
strategy,
 Biotechnology cooperation by fostering global and national alliances,
 Strengthening institutional capacity with redesigned governance models, and
 Creating a matrix of measurement of processes as well as outcome.
The above key elements would be implemented in collaboration and partnership with other
ministries, departments of state governments and international agencies towards achieving the
following goals:
 Making India ready to meet the challenge of achieving US$100 billion by 2025,
 Launching four major missions: Healthcare, Food and Nutrition, Clean Energy and
Education,
 Creating a technology development and translation network across the country (5 new
clusters, 40 biotech incubators, 150 TTOs, and 20 bio-connect centers) with global
partnership, and
 Strategic and focused investment in building the ‘human capital’ by creating a ‘Life
Sciences and Biotechnology Education Council’.
Based on industry analysis of the biotech sector and inputs from experts, the following thrust
areas are selected for concentration:
 Diagnostics
 Therapeutics
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 Biotechnology Policy in India
 Pharmacogenomics
 Bioinformatics
 Agriculture biotechnology
 Industrial biotechnology
 Marine biotechnology
 Forest and Environment-focused biotechnology
 Research in all related areas of biotechnology
4. BIOTECHNOLOGY POLICY OF DIFFERENT STATES OF INDIA
4.1 Andhra Pradesh:
The Andhra Pradesh government wants the private sector to play an active role in developing the
biotechnology industry in the state. The government would act as a facilitator and a catalyst in
this development process. Realizing the utility of this industry, the government has announced its
policy for the promotion of biotech units in the state. The major objectives of the ‘Biotechnology
Policy’ of Andhra Pradesh are:
 To take up a detailed inventory of the bioresources in the state with the help of
universities, research institutes, NGOs and private agencies,
 To promote conservation of biodiversity and sustainable exploitation of bioresources,
 To develop high quality infrastructure with the required support services for
manufacturing units by setting up specialized biotech parks in various parts of the state,
and,
 To facilitate the flow of venture capital funds and bank credit to biotech companies.
4.2 Arunachal Pradesh:
The biotechnology industries of the state are eligible for benefits under the ‘North-East Industrial
and Investment Promotion Policy’ (NEIIPP), 2007 as recommended by the Ministry of
Commerce and Industry, Government of India. In 2009−10, the DBT set up the ‘North Eastern
Region-Biotechnology Programme Management Cell’ (NER-BPMC) through Biotech
Consortium India Limited (BCIL) for coordination and monitoring of biotechnology programs in
the North Eastern States of India as part of its commitment towards the promotion of
biotechnology activities in the North Eastern Region.
4.3 Assam:
Assam is one of the 34 biodiversity hotspots in the world with abundance of natural resources and
bioresources. The state may get tremendous economic benefits through commercialization of
bioresources through modern biotechnology. The ‘State Biotechnology Policy’ for Assam was
drafted to fulfill the aims of state biotechnology policy. The Guwahati Biotech Park, established
in 2008, is a registered society with main objective to provide self employment to the
unemployed and additional work for the underemployed. Also to stimulate the economy of
Assam through a focused and comprehensive approach on a few, selected sectors to encourage
new groups of entrepreneurs to start diversified business units in the region. The major areas of
R&D effort will include information technology based drug discovery, herbal and tribal medicine,

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plant tissue culture and micro propagation, food processing, bioinformatics, biodiesel, tea
biotechnology, crop sciences, floriculture, horticulture, etc.
4.4 Bihar:
The vision of Bihar government on biotechnology is to use revolutionary tools provided by
biotechnology to help converge the state’s diverse bioresources to useful products and process
accessible to the people of Bihar for economic development, employment generation and women
empowerment. The chosen thrust areas are Agricultural/Horticultural Biotechnology,
Biotechnology & Forestry, Microbial Biotechnology, Aquatic Biotechnology, Animal/ Dairy
Biotechnology, Environmental Biotechnology, Biotechnology and Public Health, and Industrial
Biotechnology. The government has chalked out an efficient action plan as well as various
economical and technological incentive strategies.
4.5 Chhattisgarh:
The ‘Biotechnology Policy’ of Chhattisgarh aimed to enable the communities of Chhattisgarh,
who are the custodians of bioresources heritage, to get the optimal advantages of their natural,
bio-cultural and bio-knowledge heritage in a sustainable manner. The other main objectives are as
follows:
 To create an environment where benefits of bioresources are not dissipated, but available
to their natural custodians, whether individually or as a community, and to involve in this
enterprise all stakeholders, including knowledge professionals, entrepreneurs and
technology leaders;
 To contribute 5% of the biotechnology output of India by 2012;
 To achieve substantial productivity gains and substantial reduction of risks to livelihood
and environment in sectors relating to agriculture, forestry, animal husbandry and health,
with the ultimate objective for ensuring food security and protection of the environment;
 To institutionalize major capabilities in biotechnology research and development in
general with particular focus on the indigenous knowledge systems and their applications
in furthering socio-economic growth;
 To facilitate an environment for research through development of infrastructure, and
acknowledgement through appropriate incentives;
 To leverage convergence between various fields of related disciplines and provide
benefits to society at large;
 To facilitate growth of an industry through provisions of high quality infrastructure with
the required support services for production including facilitation of flow of venture
capital and bank credit;
 To address issues such as Intellectual Property Rights, biosafety, bio-surveillance and
bioethics.
4.6 Goa:
The government of Goa is keen to facilitate accelerated development of biotechnology utilizing
the natural, scientific, human and other resources in the state and the region by providing the
required policy support keeping in view the unique requirements of the sector. Keeping in view

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the strengths and advantages of the state, the ‘Biotechnology Policy’ was drafted to concentrate
on the development of the following sectors:
a. Agriculture [Mass propagation of locally important horticulture and medicinal plant
species, Mushroom cultivation, biofertilizers and biopesticides, Organic farming,
transgenic crops, etc]
b. Healthcare [Vaccines, Therapeutics, Diagnostics, Drug delivery systems, Isolation of
bioactive molecules from native herbs, Contract research and manufacturing, Animal
healthcare products]
c. Industrial biotechnology [Fermentation of beverages, bakery and dairy products,
Probiotics, Nutraceuticals and health food supplements, Bioenergy, etc]
d. Environmental biotechnology [Bioremediation, Phytoremediation, Bio-waste conversion
and management, etc]
e. Bioresources utilization [Inventorization, mapping, molecular characterization and
bioprospecting, etc]
f. Bioinformatics [Genomics, proteomics, drug designing, data mining, etc]
g. Bio-services [Contract research, Contract manufacturing, Bioinstrumentation, etc]
h. Marine biotechnology [Isolation and cultivation of elite marine organisms for value
added products, etc]
4.7 Gujarat:
With a view to providing focused attention on the subject and addressing the global developments
and their cascading effect, the government of Gujarat has decided to lay down the ‘Biotechnology
Policy’ of the state for 2016-2021. Various incentives (like capital subsidy, registration/ stamp
duty concession, incentives on power tariff and electrical duty, subsidy on interest, VAT/ GST/
CST incentives, etc) are proposed for setting up biotechnology units in the state.
4.8 Haryana:
The ‘Biotechnology Policy’ of Haryana (2002) has chosen 7 sectors to flourish with the help of
biotechnology: agriculture and horticulture, animal husbandry, food and agro processing, health,
educational and industrial training, human resource development and bioinformatics. Special
incentives have also been declared on biotech industries.
4.9 Himachal Pradesh:
The ‘Biotechnology Policy’ of Himachal Pradesh (2014) aimed to convert Himachal Pradesh into
a prosperous Himalayan Bio-business Hub with biotechnology as one of the engines of growth
through scientific and technological empowerment of human resource for enhancing efficiency,
productivity, cost effective products, processes and technologies. The strategies to achieve the
above said goals are as follows:
 Scientific and technological empowerment of human resource for enhancing efficiency,
productivity, cost-effective products, processes and technologies;
 Identification of areas for sustainably harnessing the rich bioresources available in the
state;

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 Ensuring an effective scientific base and make strategic investments in R&D to support
biotechnology innovation and economic development;
 Patenting of research findings using effective patenting regimes;
 Supporting infrastructure for up scaling the research for commercial production;
 Outline a number of incentives for setting up of enterprises based on local resources and
commercialization of research base;
 Promotion of industries for manufacture of end products based on bioresources;
 Conservation of bioresources of the state.
4.10 Jammu and Kashmir:
The ‘Biodiversity and Biotechnology Policy’ (2010) of Jammu and Kashmir state was aimed to
boost industrial and employment scenario. The selected priority areas for bio-products
development are essential oil products, herbal drugs, cut flowers, leather, potable water, dry and
wet fruit, carpets, sericulture, silk and products thereof. The operational mechanism for
implementing the policy is drafted as follows: Documentation; Policy, rules and regulations for
Sustainable Use and Equitable Distribution; Conservation measures for biodiversity with special
reference to important crops of Jammu and Kashmir; Creation of regional gene centers in eco
parks; Commercial Utilization of Bioresources; Identification of the biotech sectors;
Identification of biotechnologies and policies; Awareness programs and dialogue; Establishing
industry for products and employment; and Public Private Partnership. The state government has
categorized the role of different institutes of the state in developing biotech products depending
on their area of expertise.
4.11 Jharkhand:
The ‘Industrial Policy’ (2012) drafted by the Jharkhand government has provision for supplying
land and other necessary infrastructural facilities to the industries based on biotechnology.
4.12 Karnataka:
The objectives of the ‘Millennium Biotech Policy’ (2001) by the state government are:
 To spread awareness about the investment opportunities in biotechnology, genomics,
bioinformatics, biofuels, contract research, etc, to the entrepreneurial community.
 To sustain and maintain the present pre-eminent position of Karnataka and Bangalore in
the field of biotechnology.
 To outline a set of incentives and concessions for the biotechnology industry to attract
investments to the State.
 To provide specific infrastructure as well as enhance human resources for the
development of biotechnology.
 To encourage the growth of bioinformatics in Karnataka.
 To provide an appropriate institutional framework to achieve all these objectives.
The identified areas where the State has opportunities are: genomics, biofuel and contract
research. Several fiscal incentives are also applicable in setting up biotech industries in the State.
Biotech Parks, Biotech Corridors, Centre for Human Genetics, Institute for Agri-biotechnology,
K-Ganga are some specific infrastructure for the development of biotechnology in Karnataka.
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The ‘State Biotechnology Coordination Committee’ has taken up Single Window strategy in
clearing all projects of the biotechnology industry.
4.13 Kerala:
The ‘Biotechnology Policy’ (2003) is designed to catalyze the development and application of
biotechnology, taking advantage of the State’s resources and emphasizing its specific needs while
meeting global requirements. The Policy is aimed to ensure the rapid exploitation of pipeline
technologies and opportunities available in the State to products and processes and to promote the
sustained build-up of an elite knowledge cadre and knowledge base through the strengthening and
creation of educational and R&D institutions, establishing infrastructure and putting in place
administrative, regulatory, legal and financial framework conducive for investment and growth of
biotechnology enterprises, for the economic development and human welfare. To achieve the
Kerala vision in Biotechnology, ensure hassle-free implementation and provide sustained
leadership and resources, the following two major initiatives will be undertaken to create: (i)
Kerala Biotechnology Board and (ii) Kerala Biotechnology Commission. The Biotechnology
Board will organize a corpus of Rs. 100 crores to create infrastructure in biotechnology including
Biotechnology Parks by collecting a Biotech Development Fund from the stake holding
Departments of Industry, Health, Agriculture, Forest, etc. The contribution of each department
will be in conformity with the anticipated benefits. In addition a Biotechnology Development
Fund will earmark 1% of the annual plan allocation of the departments benefiting by
biotechnology. Another avenue is to seek grants from international agencies and involve private
and public enterprises. The Kerala Biotechnology Commission will be responsible for the
implementation of the biotechnology policy and related guidelines laid down by the Kerala
Biotechnology Board.
4.14 Madhya Pradesh:
The major objectives of the ‘Biotechnology Policy’ of the Madhya Pradesh state government are
drafted as follows:
 Conservation of the state’s biodiversity and the sustainable use of its bioresources,
 Production of high-yielding, draught and pest-resistant seeds for agriculture and
horticulture crops suited to different agro-climatic zones,
 Improvement of the quality of livestock and poultry, especially the breeds indigenous to
the state,
 Enhancement of the productive potential of the aquatic ecosystem,
 Promotion and cultivation of medicinal and aromatic plants, and the processing and value
addition of their products,
 Production of cost-effective drugs that help counter diseases common in the tropical and
sub-tropical regions of the country,
 Promote environmentally safe technologies for pollution abatement, especially treatment
of urban waste and industrial effluents,
 Afforestation, especially in the quick revival of species which have shown a tendency to
decline,
 Generation and use of different types of bio-energy.
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The thrust areas which are going to see viable opportunities in the State are agriculture, animal
husbandry & fisheries; forests; medicinal & aromatic plants; health and Medical Biotechnology;
environment protection and Bio-energy; traditional knowledge and wisdom & awareness
generation; community biotechnology applications; education & training; Research and
Development; and promotion of biotechnology industry.
4.15 Maharashtra:
The State has an excellent intellectual infrastructure. Through nearly 1000 institutions, it
produces around 1,63,000 trained technical personnel each year. The State has already set up
specialized parks for different sections including biotechnology. Major Indian companies such as
Wockhardt, Cipla, Lupin, Nicholas Piramal, etc, do not only have their presence in Maharashtra,
but they are also marching forward in the most challenging and frontline areas of biotechnology.
Maharashtra has the strength to make it the most preferred destination for the pharmaceutical
industry, and to attract and accelerate investment in Drugs and Pharmaceuticals. Maharashtra
already contributes ~40% of the total turnover. It has 4,100 registered pharmaceutical
manufacturers out of the total 20,053 in India. The ‘Maharashtra Biotechnology Policy’ relies on
‘bio-future’ and the State wants to be a leading participant in building this bio-future. The State
has already taken strategic initiatives in the following sectors:
1. Institutional Mechanisms: By creation of the Maharashtra Biotechnology Board and the
Maharashtra Biotechnology Commission,
2. State as an Enabler and a Facilitator for land acquire,
3. Financial Incentives,
4. Special Incentives for Promoting Biotechnology Parks,
5. Infrastructure Development including creation of the Biotechnology Resource Centre.
4.16 Manipur, Meghalaya, Mizoram, Nagaland, Sikkim, and Tripura:
As per mandate 10% of DBT’s annual budget is earmarked for promoting development in the
north-eastern region comprising eight states viz. Arunachal Pradesh, Assam, Manipur,
Meghalaya, Mizoram, Nagaland, Sikkim and Tripura. The ‘Industrial and Investment Policy’
(2011) declared by the Manipur state government has a special emphasis on developing
biotechnology based industries in the State. Many of these states although do not have a defined
policy on biotechnology till date. The government of Nagaland has set up a Biotechnology Hub
with the support of DBT, in the year 2011. Tripura Biotechnology Council is an autonomous
organization, formed under the aegis of Department of Science, Technology & Environment,
Government of Tripura with a mandate to popularize biotechnological implication in the society
for sustainable economic growth.
4.17 Odisha:
The Odisha government has declared that the present ‘Biotechnology Policy’ (2005) is going to
be updated very soon. The state government has identified biotechnology as a priority area for
long. The State is advantageously positioned to harness biotechnology applications owing to its
rich mineral and bioresources. Agriculture biotechnology, medical biotechnology, industrial
biotechnology, animal biotechnology, aquaculture and marine biotechnology, environmental
biotechnology, and alternative sources of energy are the priority areas selected for development.
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Grants for setting up or upgrading R&D facilities in universities in the area of biotechnology,
infrastructure for the industry, incentives for the biotech-based industries, single window project
clearance, and human resource development program are the initiatives already taken up by the
state government for social, especially rural development.
4.18 Punjab:
The Punjab State Council for Science and Technology has been making consistent efforts for
development of world-class infrastructure in Punjab in the area of biotechnology. The National
Agri-Food Biotechnology Institute coordinated by the Council has already been made operational
by the DBT in a transit campus set up at Mohali. The Punjab Biotechnology Incubator, a spin-off
of the Council is also operative in Mohali and is providing facilities for quality testing &
certification of agri-produce/products. The Council is now facilitating Mohali Biotechnology
Park Project on behalf of the State government. The Park would provide facilities to industry for
R&D, processing and other operations in various application areas of biotechnology including
agriculture, food, pharmaceutical, energy, etc.
4.19 Rajasthan:
The State has a dedicated ‘Biotechnology Policy’ (2015) aimed at very specific Rajasthan-
oriented development initiatives through biotechnology. The Rajasthan Biotechnology Council
and the Rajasthan State Biotechnology Mission have been set up for smooth governance and as
regulatory organizations. Along with them web-based regulation, Bio e-commerce agency and
Bioinformatics institutes are proposed to be created in the State.
4.20 Tamil Nadu:
According to the ‘Biotechnology Policy’ (2014) the Tamil Nadu state government has chosen the
following thrust areas which have tremendous opportunities in the State: Vaccines and
recombinant therapeutics, bioactive therapeutic proteins, stem cell research, cell engineering, cell
based therapeutics, clinical trial & outsourcing, bioinformatics, agricultural biotechnology,
animal biotechnology, etc. The State government will support creation of Biotechnology Centre
of Excellence, Bio-IT Parks, Medical Biotechnology Industrial clusters, Biotechnology Research
Fund, and other Biotech research Institutions.
4.21 Telangana:
The ‘Life Sciences Policy’ for the State of Telangana (2015−2020) has categorized forthcoming
opportunities for the State is in the increased focus of pharmaceutical companies in
biotechnology. The government wishes to promote this sector through a comprehensive policy
covering the entire range of life sciences including biotechnology, pharmaceutical, nutraceuticals
and medical devices. The chosen thrust areas are biologics & bio-similars, vaccines, medical
biotechnology, agricultural biotechnology, industrial biotechnology, marine biotechnology,
nanotechnology, regenerative medicine and clinical research. Telangana is known as the seed
capital of India and it continues to be in the top position due to location advantage and
environment conducive for both breeding as well as seed production and storage. The State also
has a number of research institutions and seed companies with focus on GM Crops.
Establishment of Genome Valley, the first and the largest organized cluster in the country for
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biotechnology, was a landmark and successful initiative of the government to create purpose-built
infrastructure for this sector. The other initiatives and programs include Biotechnology Research
Assistance Scheme, Small Business Innovation Research Initiative, Biotechnology Industry
Partnership Program, Biotechnology Ignition Grant, Biotech Park Phase I−IV,
Biotechnology/Pharma special economic zones, etc.
4.22 Uttar Pradesh:
Uttar Pradesh in its ‘Biotechnology Policy’ wishes to become a more prosperous state through
utilizing modern tools of biotechnology by bringing prosperity to farmers, generating
employment in rural areas, food for all, good health and clean environment. The Policy aims to
develop knowledge based economy, assure benefit of biotechnology to all section of the State and
to promote entrepreneurship in biotechnology based industries. Single Window Facility,
constitution of Biotechnology Development Board, relaxation of taxes on biotechnology based
products, relaxation on land for establishment of biotechnological units, constitution of
Biotechnology Development Cell, establishment of Biotech Parks, etc, have been proposed.
4.23 Uttarakhand:
Uttarakhand is emerging as a potent Biotech Hub with basic strengths and the reasons for this
area being imminently suitable for bio-industrial investment. Towards accomplishing the overall
gains through biotechnology, the State is proposed to urgently establish a Biotechnology Park and
a state-of-the-art R&D institute at Halide, Pantnagar. The research institute would have cross
sectoral & multi-disciplinary facilities including units on genomics and proteomics, advanced
microscopy, bioinformatics, r-DNA technology, analysis and bio-separation, plant tissue culture,
cell and molecular biology, nanotechnology, DNA fingerprinting, industrial microbiology, food
processing & product diversification, hybrid seed production and an IPR cell. It may be
mentioned that the ‘Five Year Plan Document’ of Uttarakhand places considerable importance on
the growth of biotechnology sector in the State. To undertake this ambitious project and to put
this vision on a practical platform it is proposed to establish the Uttarakhand Biotechnology
Board, an autonomous body to steer the State Biotechnology Programe, and to put in place the
Biotechnology Policy of the State.
4.24 West Bengal:
The government of West Bengal through its ‘Biotechnology Policy’ (2013) intends to promote the
creation of Biotechnology Parks within the State with following aims.
i. Biotechnology Park will act as an instrument to develop Biotech industries for
socioeconomic development of the State.
ii. This will be a combined venture of industries, academia and government with clearly
specified responsibilities of each. It will be a self-sustaining setup for business startup
support, business attraction and technology support in areas of biotechnology.
iii. The strategy of creating such Biotech Park is to make up a common ground for the
development of prospective technologies and the commercialization of ventures with
minimum gestation time.
iv. In accordance with the strength of the state of West Bengal the major thrust in such Biotech
parks will be given towards Agri-Biotechnology and Biopharmaceuticals. The Park will act
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as an incubator and will lead to the development of Biotech industries, improvement in
quality of life, environmental, employment generation and finally sustainable development
in rural sectors.
v. The Parks will contain industrial, commercial and R&D infrastructure, developed plots of
land, power, water and telecom facilities for users. The Parks will act as the technology
providers to the small scale Biotech industries which will be housed within these Parks.
These will lend R&D support to the prospective entrepreneurs. It will provide training to
the farmers in order to enable them to adopt the new technological activities. The Parks will
further provide marketing support to the users.
vi. In order that the Parks appear attractive to the Biotech industries, the government of West
Bengal will evolve and set up effective administrative mechanisms so that quick approvals
under various statutes are duly facilitated.
Further, to cope with the rapid advancement in the field of biotechnology the State will create a
Centre of Excellence in Biotechnology which will have the state-of-the-art infrastructure for
R&D activities by skilled professionals. The government of West Bengal will promote creation of
facilities for the identification of the genetic defects in the human body in order to rectify them by
gene therapy. The government will assist in getting the genetic profile of the people in Indian
Subcontinent, especially in West Bengal so as to help the upcoming research companies in
evaluating the appropriate gene therapy models.
4.25 Chandigarh:
The Chandigarh administration has declared the following action plans in its ‘Biotechnology
Policy’: Creation of Biotechnology Incubator Facility, provision of state-of-the-art research
facilities, establishment of Bioinformatics facilities, Consultancy Services Cell, Identification of
business potential, plant breeding, cloning, and creation of Biotechnology Facilitation Committee.
4.26 Puducherry:
Immense growth potential of the biotechnology sector in Puducherry has been emphasized in
drafted ‘Industrial Policy’ (2016) by the Puducherry administration. State-of-the-art infrastructure
is proposed to be created to attract industries and R&D institutions in the areas of biotechnology,
nanotechnology, pharmaceuticals, bio-medicine and life sciences. There are plans for establishing
a Biotechnology Park. With strong educational base of the region, especially in the sciences,
medicine and engineering, strong potential exists for promoting biotechnology.
5. PRIORITY AREAS OF BIOTECHNOLOGY POLICY IN INDIA
5.1 Agricultural Biotechnology:
For about 10,000 years, farmers have been improving wild plants and animals through the
selection and breeding of desirable characteristics. This breeding has resulted in the domesticated
plants and animals that are commonly used in crop and livestock agriculture. In the 20th century,
breeding became more sophisticated, as the traits that breeders select for include increased yield,
disease and pest resistance, drought resistance and enhanced flavor. Traits are passed from one
generation to the next through genes, which are made of DNA. All living things—including the
fruits, vegetables and meat that we eat—contain genes that tell cells how to function. Recently,
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scientists have learned enough to begin to identify and work with the genes (DNA) that are
responsible for traits. Agricultural biotechnology is a collection of scientific techniques used to
improve plants, animals and microorganisms. Based on an understanding of DNA, scientists have
developed solutions to increase agricultural productivity. Starting from the ability to identify
genes that may confer advantages on certain crops, and the ability to work with such
characteristics very precisely, biotechnology enhances breeders’ ability to make improvements in
crops and livestock. Biotechnology enables improvements that are not possible with traditional
crossing of related species alone. The thrust areas of agri-biotechnology include:
 Conservation, characterization and utilization of genetic biodiversity;
 Identification of the problems and exploration of unique capabilities of biotechnology for
their remediation to ensure food-security and food products of high nutritional value;
 Introduction of genetically engineered plants/crops after clearance by relevant national
institutions/authorities
 Micro propagation of horticultural and ornamental crops for mass multiplication;
 Replacement of chemical fertilizers, weed-killers and pesticides by eco-friendly
substances and development of integrated nutrient management for various crops to
minimize cost of fertilizers;
 Lowering the costs of agricultural inputs;
 Genetic improvement of medicinal aromatic and timber yielding species;
 Increased productivity of animals through embryo transfer technology, genetic
improvement, vaccines and disease diagnostics;
 Exploration of unique capabilities of biotechnology and their utilization in aquaculture.
 Biotic and abiotic stresses
 Crop and animal stock improvement
 Gene discovery and designer plants
 Value addition by post-harvest technology and processing
Agricultural Biotechnology includes development of transgenic cereal crops like rice, chickpea,
potato, tomato, other vegetables, large scale seed production, and development of hybrid seeds of
nutritionally enhanced vegetables (more protein content, higher lysine content) with higher
yields. Development of edible vaccines in plants & fruits such as banana; improving jute and tea
cultivation; planting trees of economic importance which will grow easily but which may not be
growing on a mass scale at present due to lack of technology or incentives; development of Agro-
forestry plantation (bamboo, teak, eucalyptus, pine, etc) to replace denuded forests and to
increase economic value by inter cropping; development of horticulture plants according to
economic importance through cloning propagation; enhancement of floriculture using tissue
culture, micro-propagation and macro-propagation; extension of regional hardening facilities to
the benefit of tissue culture plants raised at the grass roots level; cultivation of medicinal and
aromatic plants in high altitudes and plains; establishment of gene banks, germplasm for
maintenance and propagation of superior quality crops and plants of special value, etc, are some
of the priority areas chosen for development in India.
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5.1.1 Concerns Regarding Uses of Genetically Modified Organisms (GMOs):
A growing body of research suggests that GMOs may be doing more harm than good when it
comes to human health and the health of the environment. GMOs are organisms that have been
created through the application of transgenic, gene-splicing techniques that are part of
biotechnology. These methods for moving genes are also referred to as genetic engineering (GE).
This relatively new science allows DNA from one species to be transferred into another species,
creating transgenic organisms with combinations of genes from plants, animals, bacteria, and
even viral gene pools. Mixing genes from different species that have never shared genes in the
past makes GMOs and GE crops unique. It is impossible to create such organisms through
traditional crossbreeding methods. Because of this uniqueness, there are many unknowns about
GE crops and GMOs. Today, 94% of the soybeans and 72% of the corn grown in the US are
genetically engineered to be “Roundup Ready”, or able to withstand Monsanto’s Roundup
herbicide or its generic form, glyphosate. While Monsanto initially marketed Roundup as being
“safer than table salt,” several studies have pointed to health risks. A 2008 study in Sweden
linked Roundup exposure to non-Hodgkin’s lymphoma. A 2007 study in Ecuador found a higher
degree of DNA damage in a population that had been aerially sprayed. DNA damage can
ultimately lead to cancer or birth defects. A 2003 study of tadpoles exposed to Roundup in
Argentina found a higher incidence of skull, eye, and tail abnormalities. Corresponding to that
study, a 2009 study in Paraguay found that women exposed to Roundup during pregnancy were
more likely to give birth to babies with skull and brain abnormalities.
Seventy-two percent of US GMO crops are engineered to tolerate a certain type of herbicide. But
the weeds that these herbicides used to kill are coming back bigger and stronger, creating
herbicide-resistant “superweeds” that require greater quantities of more toxic pesticides to
eradicate. Every three minutes, a farmer commits suicide in India due to meet rising debts, a
phenomenon that has been steadily rising since the 1970s. While the causes behind the farmers’
crushing debt and resultant suicides are complex—ranging from unfair government floor prices
for cotton to international trade agreements skewed in favor of other countries—GM seeds do
appear to play a role. In 2002, Bt cotton seeds arrived, and though they promised higher yields
and higher earnings, the suicide rate has kept going up. These seeds are injected with the Bt soil
bacterium so they “naturally” produce an insecticide to fight off the bollworm, a primary pest.
But to produce the higher yields as promised, Bt cotton needs more water and fertilizer than
cotton from heirloom or hybrid seeds, to be also applied according to precise timetables. But 90%
of farmers in Kopulwar’s region have no irrigation and are rain-dependent. They have no money
for extra fertilizer. And so, as the rains fail to come, their cotton plants start to wither. In addition,
new pests like mealy bugs have started destroying cotton crops in India, because genetic
engineering “weakens the plants”, says scientist and international activist Dr. Vandana Shiva. As
farmers across India continue to pay Monsanto a royalty to plant Bt cotton—often the only kind
of seeds available at local markets—the farmer suicide rate continues to climb. Even when a
farmer is not growing GM crops, contamination can easily occur—through seed mixing or pollen
drift from neighboring GM fields. While this contamination is troubling for those who wish to
avoid GMOs, it can be an economic disaster for organic and family farmers.

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5.2 Healthcare Biotechnology:
Biotechnology has contributed to the discovery and manufacturing of traditional small molecule
pharmaceutical drugs as well as drugs that are the product of biotechnology. This is sometimes
called ‘biopharmaceutics’. Modern biotechnology can be used to manufacture existing medicines
relatively easily and cheaply. The first genetically engineered products were medicines designed
to treat human diseases. To cite one example, in 1978 Genentech developed synthetic humanized
insulin by joining its gene with a plasmid vector inserted into the bacterium Escherichia coli.
Insulin, widely used for the treatment of diabetes, was previously extracted from the pancreas of
abattoir animals (cattle and/or pigs). The resulting genetically engineered bacterium enabled the
production of vast quantities of synthetic human insulin at relatively low cost. Biotechnology has
also enabled emerging therapeutics like gene therapy. The application of biotechnology to basic
science (for example through the Human Genome Project) has also dramatically improved our
understanding of biology and as our scientific knowledge of normal and disease biology has
increased, our ability to develop new medicines to treat previously untreatable diseases has
increased as well. The thrust areas of healthcare biotechnology include:
 Development of diagnostic kits for major infectious and tropical diseases
 Development of diagnostic kits for genetically inherited disorders
 Up scaling and commercialization of already developed and available ELISA and PCR
based diagnostics
 Up scaling and commercialization of genomics based technologies like microarray, chips
and drug development
 Characterization of antimicrobial and antiviral agents from natural products
 Microbial production of recombinant therapeutic agents at low cost
 Methods to develop and use stem cell lines for research and tissue regeneration for
medical use
 Undertaking reproductive health and contraceptive research
 Developing strategies for prevention and cure of diseases induced by faulty diet and
lifestyle like diabetes, heart disease and obesity
 Development of ayurveda and traditional medicines
 Discovering new medicines from nature
Medical biotechnology would be maximally utilized to develop affordable tools for prevention,
detection and treatment of such diseases, particularly those which affect women, children and the
poor. Newer vaccines, especially for malaria, tuberculosis, cholera, HIV, rabies, snakebites and
Japanese Encephalitis among other diseases are given utmost priority. Development of strategies
for prevention and cure of diseases induced by malnutrition, faulty diet and lifestyles as well as
epidemiological studies covering research on air borne microbes (Bio-allergens) through various
media like air, water and food are also given stress.
5.2.1 Concerns regarding Biosafety Issue:
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology
and human health. These prevention mechanisms include conduction of regular reviews of the
biosafety in laboratory, as well as strict guidelines to follow. Biosafety is used to protect from

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harmful incidents. Many laboratories handling biohazards employ an ongoing risk management
assessment and enforcement process for biosafety. Failures to follow such protocols can lead to
increased risk of exposure to biohazards or pathogens. Human error and poor technique
contribute to unnecessary exposure and comprise the best safeguards set into place for protection.
The primary goals of biosafety are as follows:
 To determine in advance when hazards to human health and natural systems will result if
any particular GMO is released into the environment
 To anticipate when a GMO or any of its products will be harmful if consumed in food
 To discern whether a GMO actually will yield the Goals of Biosafety
 To discern whether a GMO actually will yield the benefits it was designed to provide
 To make as certain as possible that hazards will not occur when GMOs are transported
intentionally or internationally, among different ecosystems and nations
The different arenas for concern regarding biosafety issue are:
i. Risks for animal and human health: toxicity & food/feed quality/safety; allergies;
pathogen drug resistance
ii. Risks for the environment: gene flow; invasiveness of GMOs might become
predominant; susceptibility of non-target organisms, changes to biodiversity
iii. Horizontal gene transfer: genetic pollution through pollen or seed dispersal & transfer of
foreign gene to microorganisms (DNA uptake) or generation of new live viruses by
recombination (transcapsidation, complementation, etc)
iv. Risks for agriculture: resistance/tolerance of target organisms; superweeds; alteration of
nutritional value (attractiveness of the organism to pests), loss of familiarity/changes in
agricultural practice
v. General concerns: ethical issues (e.g. labeling); risk assessment/risk management; general
biosafety; public attitudes, perception; legislation, monitoring; socioeconomics (eg.
situation of poor farmers in developing countries); Intellectual Property Rights; GM
traceability/commodity segregation
The international efforts on biosafety lie in heightened global environmental awareness and
concern over accelerating ecological degradation during the latter quarter of the 20th century
resulted in a desire by the international community to push the protection of the environment
higher up the political agenda. These efforts came to fruition in 1992 when the ‘Convention on
Biological Diversity’ (CBD) came into force. Its objectives include “the conservation of
biological diversity, the sustainable use of its components and the fair and equitable sharing of
the benefits arising out of the utilization of genetic resources”. During the elaboration of the
Convention, negotiators recognized that biotechnology could contribute to achieving these
objectives, if developed and used with adequate safety measures for both the environment and
human health. Accordingly, procedures were developed to address the safe transfer, handling and
use of any living modified organism resulting from biotechnology that may have an adverse
effect on the conservation and sustainable use of biological diversity (Article 19.3, CBD). These
procedures formed the ‘Cartagena Protocol on Biosafety’ (CPB), which came into force on 2003
and has 170 signatory countries to date (2017). Parties lacking a cohesive biosafety policy
undertook, or are currently undertaking, a number of initiatives to put a national framework in
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place in order to comply with the CPB. This has resulted in a great demand for biosafety-related
information, training programs, and capacity-building projects.
5.3 Environmental Biotechnology:
Environmental biotechnology is the application of biotechnology to study the natural
environment. Environmental biotechnology tries to harness biological process for commercial
uses and exploitation. The ‘International Society for Environmental Biotechnology’ defines
environmental biotechnology as “the development, use and regulation of biological systems for
remediation of contaminated environments (land, air, water), and for environment-friendly
processes (green manufacturing technologies and sustainable development”. According to the
‘Agenda 21’ the aim of environmental biotechnology is to prevent, arrest and reverse
environmental degradation through the appropriate use of biotechnology in combination with
other technologies, while supporting safety procedures as a primary component of the program.
Environmental biotechnology policy of different state governments attempts to create a
biotechnology enterprise equipped with viable green and clean technologies. The critical areas of
environmental biotechnology include eco-restoration, conservation of biodiversity, generation of
indigenous eco-friendly technologies, training & research, updating environmental regulation,
etc. India is a signatory member of the ‘Kyoto Protocol’ and the ‘Paris Agreement’, and thus the
biotechnology policy will encourage industries to take up the ‘Clean Development Mechanism’
(CDM) to place the industries in green category. Such industries will then be able to gain
‘Certified Emission Reduction’ (CER) credit points, which can be utilized in ‘Carbon Trading’ in
international market. Such industries will also be able to attract international collaboration, which
will boost the economy of the country.
An important sector of environmental biotechnology is the ‘Waste to Wealth’ techniques. Waste
is often defined as the unwanted things and has no economic value. Applying different
technology the waste can be used as a resource with certain economic values for another user.
Today, the quantity and diversity of wastes generated by different industries and municipalities
pose serious risks to both human health and the environment. The situation is alarming in
developing countries such as India, mainly due to their inefficient technologies, ineffectual
policies and insensitivity on the part of the industrial sector. Chemical waste streams often
contain either precious or toxic metals. These streams regularly require treatment to become more
environmentally acceptable, but treatment may also be due to the need to recover valuable
resources. The recovery and recycling of platinum group metals from catalytic, plating and
mining streams are an increasingly essential process. With good reason, strict regulation limits
the quantities of numerous toxic and heavy metals that may be released into the environment,
notably Cd, Cr, Pb and Hg. The removal of such contaminants may greatly reduce waste
processing costs. Considerable revenue can be generated from waste through:
a. Recycling of useful materials from municipal solid waste
b. Generation of energy from municipal or agricultural wastes (such as palm oil empty fruit
bunches and animal waste)
c. Production of composts or fertilizer from organic municipal and agricultural waste, or
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d. Other specific technologies to convert wastes to useful materials (such as converting rice
husk to charcoal, sludge to bricks, extraction of oil from used plastics, conversion of used
tires to carbon black and rubber granulates etc.)
Other than the common biogas plants energy can also be generated through biomass hydrolyzing
enzymes from the aquatic weed. Water hyacinth (Eicchornia crassipes), one of the most
productive aquatic plants is also an aquatic pest and a menace creating navigational problems and
pollution in water bodies. The use of the renewable plant biomass for the production of cleaner
and cheaper fuels has rejuvenated the interest in developing cheaper technologies for large scale
production biomass saccharifying enzymes. Municipal solid waste (MSW) is one of three major
waste-to-energy technologies (the others are anaerobic digestion and biomass). MSW can be
directly combusted in waste-to-energy facilities as a fuel with minimal processing, known as
mass burn; it can undergo moderate to extensive processing before being directly combusted as
refuse derived fuel; or it can be gasified using pyrolysis or thermal gasification techniques.
‘Vermi-composting’ is very successful at community level but it is yet to develop at commercial
scale. Manual composting is carried out in smaller urban centers. Although mechanical
composting plants were set up in cities but presently, only few plants out of them continue to be
in operation. Another process involves the conversion of assorted polymers into petroleum by a
much less precise thermal depolymerization process. Such a process would be able to accept
almost any polymer or mix of polymers, including thermoset materials such as vulcanized rubber
tires and the biopolymers in feathers and other agricultural waste. Like natural petroleum, the
chemicals produced can be made into fuels as well as polymers.
Environmental biotechnology also has a huge potential in metal extraction from electronic waste
(‘E-waste’). Large volumes of electronic goods, such as computers, mobile phones, music
players, televisions and cameras, are being disposed every day. These devices contain various
metals such as Pb, Cu, Au, Al, Ag, Pd and ferrous metals, which are often disposed as E-waste.
These metals are usually extracted by manually sorting and grinding the materials and then
separating the metals in smelters. The facilities used for this process are often unsafe, exposing
the workers and the environment to toxic gases and metals. Current technologies for metal
recovery from E-Wastes can be broadly categorized as thermal processing, bioleaching and
hydrometallurgical processing. There are both regulatory and economic drivers behind the use of
these technologies. Developed countries, such as those in the European Union, have passed laws
and regulations mandating original equipment manufacturers to collect E-waste from private
users and dispose of it in an eco-friendly manner. Developing countries are also started in taking
action in this regard. Hence, India has to develop its potential in this segment utilizing aid from
environmental biotechnology.
The major benefits of environmental biotechnology are it helps to keep our environment safe and
clean for the use of the future generations. ‘Biomarker’ is another application of environmental
biotechnology which gives response to a chemical that helps to measure the level of damage
caused or the exposure of the toxic or the pollution effect caused. In other word, biomarker can
also be called as the biological markers which help to relate the connection between the oils and
its sources. ‘Bioremediation’ is the process of cleaning up the hazardous substances into non-
toxic compounds. This process is majorly used for any kind of technology clean up that uses the
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natural microorganisms. ‘Biotreatment’, ‘bioreclamation’ and ‘biorestoration’ are the other
terminologies used for bioremediation. The different types of bioremediation are
mycoremediation (use of fungal mycelia in bioremediation), phytoremediation (use of the green
plants and their microorganisms to balance or decrease the contamination of soil, sludge,
sediment, surface water or groundwater), and microbial remediation (use of microorganisms to
degrade organic contaminants or to reduce bioavailability of metals). A ‘biosensor’ is an
analytical device that converts a biological response into a physical, chemical or electrical signal.
The development of biosensors involves integration of a specific and sensitive biologically
derived sensing element (immobilized cells, enzymes or antibodies). These are then integrated
with physicochemical transducers (either electrochemical or optical). When immobilized on a
substrate, their properties change in response to some environmental effect in a way that is
electronically or optically detectable.
5.4 Patent Policy, Bioresources and Intellectual Property Right (IPR):
The amendment of the Patents Act (1970) of India in 2002 included biochemical,
biotechnological and microbiological processes within the definition of potentially patentable
process. Competition and commerce are the two key essence of today’s world. A significant
benchmark of both of these two is intellectual property which today has become a crucial driver
of economic growth. The value of intellectual property rights depends on the cost incurred in
creating intellectual property assets and the magnitude of knowledge & information generated
and disseminated for commercial activities. India enjoys a large asset of R&D personnel and
infrastructure facilities. To bridge the gap between the research outcome and its use for the
benefit of the stakeholders, scientists and policymakers need information and facilities for
protecting their research. As a step in this direction, DBT established a ‘Biotechnology Patent
Facilitation Cell (BPFC)’ in 1999. The cell provides a single window awareness-cum-facilitation
mechanism to create awareness and understanding about IPRs among the scientists and
researchers. The objectives of BPFC are:
 Creating awareness as well as understanding among the biologists and biotechnologists
relating to patents and the challenges and opportunities in this area; arranging workshops,
seminars, conferences, etc, at all levels
 Introducing patent information as a vital input in the process of promotion of R&D
programs in biotechnology and biology
 Providing patenting facilities to the biologists and biotechnologists in the country for
filing Indian and foreign patent applications on a sustained basis
 Keeping a watch on developments in the area of IPRs and bring important issues to the
attention of policy makers, scientists, biotech industries, etc.
The combined annual global market for the products derived from bioresources is roughly
between US$ 500 billion and US$ 800 billion. India is one of the 12 global mega biodiversity
centers harboring approximately 8% of the global biodiversity existing in only 2.4% of the land
area. The country is also home to 2 of the world’s 25 hotspots. The varied cultural diversity
across the country as well as a very ancient traditional knowledge system associated with the
biodiversity represents added assets. Thus, if the goal of converting our bioresources animal,
plant, and microbial into commercially useful products, it is to be realized that we need to not
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only conserve the biodiversity but, also to utilize it in a sustainable manner. In this context,
absence of a good quantitative information network on bioresources combining remote sensing
data and ground surveys is a major constraint. The situation is even worse for microorganisms.

Animal resources of India are an estimated 86,874 species accounting for 7.25% of global animal
diversity. Several species, their products and the services rendered by them are crucial to India’s
economic wellbeing: pollination services by insects (e.g. honey bees, bumble bees, moths,
butterflies, beetles, flies, etc), agricultural and forestry crops, honey, silk, musk, skins are just a
few examples. Other species (e.g. mollusks, frogs, toads, spiders, termites, and snakes) represent
potential reservoirs of useful products such as toxins, venoms, enzymes, therapeutic molecules
and other bioactive substances. Prospecting for these and other products should be a priority.
Biotechnology should be effectively employed for molecular characterization along with
bioscreens in search of useful products. Utilization of selected species as bioreactors for
production of complex proteins is another important opportunity.

India has a huge treasure of plant resources with over 45,000 known species representing 11% of
earth’s flora. In terms of flowering plant diversity alone, India ranks 10th in the world. About 33%
of flowering plants and 29% of total plants are endemic in India. Biotechnology can contribute
substantially in providing cost-effective therapeutically active biomolecules through
target/mechanism based screens, biotransformation, metabolic engineering and transgenic
approaches. Biotechnology should also be utilized to add value to our traditional knowledge
especially Ayurveda, Sidha and Unani systems as well as tribal and folk medicine. Medicinal
plants are also the prime targets of bioprospecting. Besides, the tools of biotechnology can be
used for conservation and characterization of plants. India imports nearly 70% of its annual crude
petroleum requirement which generate huge import bill for the country. Thus, development of
biofuel sector utilizing biotechnology has a huge potential. Two major biofuels for the transport
sector, bioethanol and biodiesel, are fast becoming popular in many countries around the world.
While bioethanol is produced from raw materials such as molasses, beet, sugarcane juice, grains,
tubers, etc, biodiesel is produced from oil (derived from oil-bearing seeds such as Jatropha
curcas, Pongamia pinnata).

Currently only 5% of microbial resources are culturable but there are others of considerable
potential value that need to be characterized by new and novel techniques. The 5% culturable
microbes have been detected to be a source of valuable products. The priority areas include
preparation of inventories based on primary and secondary data; exploration of microflora in the
north-eastern regions of the country, and extreme habitats (hydrothermal vents, deep sea
sediments, highly acidic, alkaline and anaerobic regions, degraded ecosystems, etc) for discovery
of novel bioactive molecules; and study, characterization and screening of uncultivable microbes
through appropriate biotechnological approaches.

5.5 Industrial Biotechnology:

Industrial biotechnology is a set of practices that use living cells (such as bacteria, yeast, algae) or
component of cells like enzymes, to generate industrial products and processes. Industrial
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biotechnology thus uses biological systems for the production of useful chemical entities. In
Europe it is known as the ‘White Biotechnology’. This section of biotechnology is mainly based
on biocatalysis and fermentation technology in combination with recent breakthroughs in the
forefront of molecular genetics and metabolic engineering. This new technology has developed
into a main contributor to the so called ‘green chemistry’, in which renewable resources such as
sugars or vegetable oils are converted into a wide variety of chemical substances such as fine and
bulk chemicals, pharmaceuticals, biocolorants, solvents, bioplastics, vitamins, food additives,
biopesticides and biofuels such as bioethanol and biodiesel. The application of industrial
biotechnology offers significant ecological advantages. Agricultural crops are used as raw
materials, instead of fossil resources such as crude oil and gas. This technology consequently has
beneficial effects on greenhouse gas emissions and at the same time supports the agricultural
sector producing these raw materials. Industrial biotechnology frequently shows significant
performance benefits as compared to conventional chemical technology processes. The strategic
action plan of biotechnology policy will focus on reducing chemical and toxic load in effluents,
developing non-fossil fuels that are eco-friendly and developing green technologies in industrial
processing.

Industrial biotechnology aims to reduce the environmental impact of manufacturing; for example
by treating industrial wastewater onsite using biological mediums such as microbes. Technology
can be used to modify and develop new industrial processes, such as by using enzymes to reduce
the amount of harsh chemicals used in the textile or pulp & paper industries. It can replace
petroleum-based feedstock by processing biomass in biorefineries to produce electricity, transport
fuels or chemicals. It also has potential to create new products, such as plant-based biodegradable
plastics. The other applications of industrial biotechnology include metabolite production
(microorganisms are used to produce a number of metabolites during their growth using cheap
substrates), anaerobic digestion (for methane production), waste treatment (both municipal and
industrial), production of biocontrol agents (biopesticides, bioherbicides, etc), fermentation of
food products, generation of biota-based fuel & energy, recovery of metals (microbes can be
employed to recover valuable metals from low grade ores and also from dilute solutions for
which the conventional metallurgical processes are uneconomical and, generally, rather
polluting), etc. The successful recovery of metals includes leaching of copper as Cu2SO4 from
ores, desulphurization of coal by Thiobacillus sp., etc.

Sustainable biotechnology solutions when applied in the industrial sector, it can provide a vital
contribution in the transition from current, unsustainable, economic practices to more sustainable
economic systems that can meet human needs without destroying the natural ecosystems that
support life on our planet. To achieve such a transition several critical changes are required, both
in mindset and practice. If the existing biotechnology solutions were used throughout the food
industry today they would save between 114 and 166 million tones GHG emissions every year. If
existing biotechnology solutions were used extensively in other traditional industries, such as
detergent, textile, and pulp & paper manufacturing, another 52 million tonnes of GHG emissions
reductions would be achieved annually.

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 Biotechnology Policy in India
6. PROPOSED BIOTECHNOLOGY REGULATORY AUTHORITY OF INDIA (BRAI)
A complex system comprising of different ministries of the central government regulates the
present biotechnology regime in India. The present system does not have a strong supportive
legal backup mechanism other than the Rules for the Manufacture, Use, Import, Export and
Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989. In this
scenario establishment of the BRAI is proposed for promoting safe usage of the modern
biotechnology and also to increase the affectivity and efficiency of biotechnological regulation on
research, transport, import, manufacture, and use of organisms and products of biotechnology.
The draft BRAI bill was published in 2008, and then on its necessities and functions were under
continuous debate. Some have labeled the BRAI as unconstitutional as it would intervene on the
agricultural sector including GM crops, which is under a state government’s authority. Another
opposition to the BRAI is that it lacks in people participation as it would not involve any
representative from civil society while most of the proposed officials are bureaucrats.

The proposed BRAI is aimed to redefine the governance system of the Indian biotechnology
sector. A three-tier governance system is proposed to be headed by a top governance body
comprising of one chairperson, two full-time members, two part-time members, and two advisory
bodies. The other two levels would be the inter-ministerial Governing Board of ~10 delegates and
the Biotechnology Advisory Council of ≤15 members. One product ruling committee, risk
assessment and enforcement units, and 3 divisions covering agriculture, forestry, and fisheries;
human health and veterinary; and industrial and environmental application would be operational
to regulate the biotechnology sector (Figure 2).

Figure 2: Proposed Biotechnology Regulatory Authority of India (BRAI)

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 Progress of Biotechnology in India
The BRAI is proposed to be established as an independent, autonomous, statutory agency to
safeguard the health and safety of the people of India and also to protect the environment by
identifying risks posed by, or as a result of modern biotechnology, and to manage those risks
through regulating the safe development and deployment of biotechnological products and
processes. The GM foods are regulated by the Food Safety and Standards Authority (FSSA)
under the Food Safety and Standards Act, 2006. Product safety, efficacy, clinical trials, and
market authorization of recombinant drugs are regulated by the Drug Controller General of India
(DCGI) under the authority of the Drugs and Cosmetics Rules, 1945. The BRAI would study all
these regulations to unify them into a single authorized body for efficient and rapid enforcement.
The GM food safety assessment and regulation on GMOs (for applications in human and
veterinary health and derived products) would also come under the BRAI’s responsibilities. This
would thus include the regulation of recombinant biologics such as the DNA vaccines,
recombinant gene therapy products and recombinant- and transgenic-plasma-derived products
like clotting factors and veterinary biologics.

7. CONCLUSIONS
Prominent standard of living with high quality of life of people of a country is the ultimate
resultant of technological innovations. It offers significant opportunities for both the
industrialized as well as developing/under developing countries to address social and economic
problems like poverty alleviation, job creation, food security, etc. With contrast to some other
countries India is carrying out a so called ‘democratic’ approach for its biotechnology
management. The Indian biotechnology policy and the DBT (regulatory agency) are proclaiming
the BRAI legislation to establish and empower the biotechnology regulatory incentives through
the BRAI. Different components of the biotechnology regulation currently cover multiple acts
and agencies, many of which will need to be amended in order to establish and operate the BRAI.
The new legislation would have provision for the improvement of the biotechnology sector,
increasing collaboration with the state governments, and would certainly promote public
confidence in the regulatory system. This would ultimately facilitate international trade.
FURTHER READING
1. http://www.eolss.net/sample-chapters/c14/e1-36-13.pdf
2. https://www.bio.org/articles/2013-policy-principles-promote-biotechnology
3. https://www.apindustries.gov.in/APIndus/Data/Industry1/Andhra%20Pradesh%20Biotechnology%20P
olicy%202015-20.pdf
4. http://guwahatibiotechpark.com/userfiles/Draft%20Biotech%20policy.pdf
5. http://www.chips.gov.in/sites/default/files/BTPolicy.pdf
6. http://www.goaditc.gov.in/biotech.html
7. https://btm.gujarat.gov.in/images/Draft-Biotech-Policy-16.pdf
8. http://documents.gov.in/HR/15233.pdf
9. http://desthp.nic.in/pdf_docs/DraftBTPolicy2014_A1b.pdf
10. http://jksandtcouncil.nic.in/Biotech.pdf
11. https://www.nriforumkarnataka.org/policy/Bio%20Technology%20Policy.pdf
12. http://www.biotechcommission.kerala.gov.in/index.php?option=com_content&view=article&id=57&It
emid=63
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13. http://www.mpbdandbt.nic.in/bt%20policy%202-5-2003.pdf
14. http://www.midcindia.org/Lists/Policies%20Circulars%20and%20Notification/Attachments/2/BioTech
Policy.pdf
15. http://www.orissa.gov.in/biotechnology%20policy-2005-circulated%20copy.pdf
16. http://swcs.rajasthan.gov.in/Upload/bf209791-24f4-46eb-aee5-f8e6374089eebtpolicy2015.pdf
17. http://www.investingintamilnadu.com/tamilnadu/doc/policy/Tamil_Nadu_Biotechnology_Policy_2014
.pdf
18. http://www.cstup.gov.in/PDF/biotech-policy.pdf
19. http://deskuenvis.nic.in/pdf/Uttarakhand%20b%20t.pdf
20. http://www.indiaenvironmentportal.org.in/files/file/Biotechnology%20Policy%20-
%20west%20bengal.pdf
21. http://www.agbioforum.org/v18n1/v18n1a09-dang.htm
22. http://www.dbtindia.nic.in/
23. http://www.dst.gov.in/
24. http://envfor.nic.in/
25. http://agriculture.gov.in/
26. http://agricoop.nic.in/

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