SEMESTER 1 (Academic Year 2022-2023)

LEGAL METHODS
Topic- “Regulations relating to Genetically Modified Crops in India ”

SUBMITTED TO:
Dr. Akshaya Desai
NMIMS Kirit P. Mehta School of Law

SUBMITTED BY:
Anchita Singhania
B.B.A LL.B(Hons.)
Div E, Roll No. 030
 Regulations relating to Genetically Modified Crops in India

Abstract
Genetically Modified foods containing desired novel traits have been incorporated into
agricultural foods and newer researches are underway. This paper explains the need for GM
foods in India and examines how it will help the country’s economic and social problems. The
aim of this paper is to analyse the pre-existing laws and regulations in place regarding GM
foods. The research methodology adopted by the author is secondary doctrinal research. The
paper will go on to explain the legal challenges forming barriers in the way of regulation of
GM crops. At the crux of these challenges, lies the Aruna Rodrigues v. Union of India case
whose arguments have been interpreted in a coherent manner. The author has opined
suggestions that will aid the government in tackling the aforementioned issues and if accepted,
will promote the cultivation of GM foods. The last chapter is formed by the conclusion of this
study that identifies the execution of laws to be the heart of the problem.

Keywords- Genetically Modified crops, regulations, GM foods, India

Introduction
India has primarily been an agricultural based economy for decades but the agricultural and
farming sector has not evolved efficiently with the advent of technology. Genetic Modification
(hereafter referred to as ‘GM’,) is a sub-field of biotechnology that is vital in enhancing the
features of biotic organisms. “GM is a technology that involves inserting DNA into the genome
of an organism.”1 To produce a GM crop, the edited genes are pasted into the new or
recombinant DNA which is grown into a tissue culture of the original plant and the seeds
produces thereafter will have the desired gene quality. In agriculture, this process is done to
alter and enhance the nutrients of a crop or to benefit the farmers and increase yield by making
it insect and pest resistant, drought tolerant, herbicide tolerant, etcetera.

In spite of the widespread farming-related activities pan India, its vast population and uneven
distribution of resources leads to socio-economic problems like malnutrition, starvation and

1
[Murali Krishna Chimata, Gyanesh Bharti], [Regulation of genome edited technologies in India], [28], [TR],
[175], [180-181], [(2019)]
overall poor food security. GM crops have the potential to be used as a technological welfare
tool to provide a futuristic solution to these issues.

Indian researchers and scientists in congruence with the legal system took the early advantage
to start evaluation of GM foods over 2 decades ago. However, several challenges including
government intervention and legal ramifications have severely impeded the development and
progress of transgenic foods.

Research Question
1. What are the laws and regulations regarding GMOs in India?
2. What are the legal challenges in approving newer varieties of GM crops?

Research Methodology
The paper has been authored via means of doctrinal research which has been carried out from
a legal perspective by analysing case judgements and existing statutory provisions relating to
the subject matter. Doctrinal research is surrounded on understanding what the law is and how
it has evolved pertaining to the research topic of GM crops in India. Also known as “black-
letter” methodology, the law in actions stands second to the theoretical provisions or letter of
law. The author has conducted a qualitative analysis to collate, arrange and describe these laws
and then provide observation-based remarks on the same. A thorough analysis of pre-existing
case judgements, government regulations, research article publications in both Scopus-indexed
and law journals has been performed by the author to gather information. Primary research lies
outside the purview of this research paper and the scope has been limited to secondary data
only.

Research Objective
This study aims at studying the regulations in place regarding genetically modified crops in
India. There are numerous executive bodies created by the government to monitor GM crops
and this paper will shed light on their jurisdictions and how the redundance of their overlapping
tasks has had detrimental affects on the GM industry. It will also highlight the acts that initially
incorporated genetically modified organisms, especially plants.

The research paper aims to further understand the legal challenges against GM food varieties.
A case study has been analysed to factor in the anti-GM food activists and to explain the
alternate perspective of this issue. The timeline for the evolution of regulations pertaining to
transgenic foods will be explained also. The author will provide inputs and commentary in the
form of suggestions after analysing the aforementioned research objectives of this study.

Regulations regarding Genetically Modified Crops in India

India is a signatory to the “Cartagena Protocol” which outlines the biosafety issues in relation
to genetically modified organisms. Under domestic regulations, India was one of the first
countries to incorporate GM related laws in its statutes. All products of genetically modified
organisms were regulated under the “Rules for the manufacture, use, import, export and storage
of hazardous microorganisms, genetically engineered organisms or cells, 1989”. These rules
were added and notified in the “Environment (Protection) Act, 1986”2. These guidelines are
executed by the “Ministry of Environment, Forest and Climate Change, Department of
Biotechnology and State Governments”. This implementation is being undertaken by six
different authorities formed by the government. These authorities include “The Recombinant
DNA Advisory Committee (RDAC), Institutional Biosafety Committee (IBSC), Review
Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee
(GEAC), State Biotechnology Coordination Committee (SBCC)and the District Level
Committee (DLC)”.

The jurisdiction of the competent decision-making bodies has not been clearly laid down by
the government. This ambiguity is a source of poor legal framework in contesting matters of
GM crop production.

Although these provisions were included in the year 1989, the first Gm regulated crop in India
was permitted in the year 2002. This regulation was passed because farmers were cultivating
illegally sourced GM seeds of Bt Cotton. This rampant usage of GM crop in the agricultural
community nudged the government to the realization that these biotechnologically enhanced
crops are indeed vital. This process of law making that stems from the need of a democracy’s
citizens is known as “Botton-up development of law”.

2
Environment (Protection) Act, 1986, Acts of Parliament, 1986 (India)
 Legal Challenges: Aruna Rodrigues and Others v. Union of India
In the year 2006, a public interest litigation plea was filed by Aruna Rodrigues3 in the Supreme
Court. The acceptance of this plea meant that all the six established bodies set up to deal with
GM crops related complaints and grievances had been disregarded and ignored. This writ
petitioned to introduce a blanket ban on all GM foods in India, including both, the ones which
are existing and regulated as well as those under research.

After multiple deliberations, in 2012 the Apex Court of the country set up another body to
research into these issues surrounding the GM crops debate. This new Technical Expert
Committee considered under its ambit the following issues raised by anti-GM crop activists in
the Aruna Rodrigues plea.

• Ethical Issues

There were socio-cultural points raised arguing that it is unethical to manipulate natural food
composition. Arguments also included that not every consumer will know which product is
genetically modified and which is ‘authentic’ or organic, and every person has a right to
information as to what is being consumed by them. If legalised, consumers would not have a
say in this.

• Health Concerns

Although several scientific studies have been conducted to know the health benefits after
enhancing nutrients via the process of gene engineering, there is next to no published data with
concrete evidence that proves the benefits of GM foods. On the flip side, probable medical
ramifications of consuming modified food is one of the major concerns that has not been
addressed by any of the competent bodies.

• Invasive Species

From a strictly scientific outlook, genetically modified crops if not grown by adhering to all
guidelines have the potential of evolving themselves into a threat to their ecosystem. This is
because the insect resistant gene or herbicide resistant gene has the capability to spread and
make the modified crop into an invasive species in a different crop field.

3
Aruna Rodrigues & Ors v. Union Of India & Ors, (2006), WP(C)No.260/2005
Post consideration of these issues and concerns raised, the Technical Expert Committee
imposed a 10-year moratorium on all kinds of field trial for newer varieties of GM food crops.

This decision was reversed before the completion of the time period for this stay order in 2021.
Food trials for 2 varieties of Bt Brinjal were permitted by the court again. The PIL filed by in
the case remains undecided by the Supreme Court till date.

Suggestions
There needs to be awareness amongst the citizens as to what genetic modification is. In the 10-
year moratorium when field trials were not permitted, the government should have conducted
detailed scientific studies and spread awareness among the consumers about GM foods. It is an
alien concept for majority of the population which leads to mass hysteria regarding cultural
and ethical ramifications. Along with this, there are also legitimate health concerns which need
to be addressed with supporting evidence.

As stated in the paper, there are several bodies set up to do the same task with overlapping
authorities. This leads to unclarity of jurisdiction thereby proving to be detrimental to the main
cause of resolving issues. The execution needs to be organised and clear guidelines regarding
distribution of subject-matter need to be laid down by the government.

When the concept of genetic modification was introduced initially, it was added to the 1986
Act. Since then, over 3 decades later, this branch of biotechnology has boomed and evolved
greatly. Keeping this a part of the “Environment (Protection) Act” along with hazardous
microorganisms creates a prejudice that genetically modified organisms are harmful to humans
and their environment. A separate act needs to be drafted pertaining only to genetic
modification with specific sections catering to field trials, varieties of crops, guidelines for safe
cultivation and sales rules to distinguish GM foods.

Conclusion
Transgenic crops provide a lot of advantages. Factors improving food and nutrition security
have been established with consideration of the contribution of gene modification. Many other
benefits, like as increased nutritional content, resistance to herbicides and viruses, and the
capacity to withstand a wide variety of abiotic stressors, can enhance food quality and thereby
provide farmers with a decent market. Arguments regarding whether GM crops are safe or not
are ceaseless owing to lack of research regarding the same. For genetically modified foods
GOI-funded institutions must adhere to the primary policies of the Indian government and
demonstrate to the government that they are committed to combating poverty and hunger. This
fair concern is raised since various members of India's Supreme Court of “Safety and
Guidelines for Research on Genetically Modified Crops and Suggestions” for the future of GM
crop research in India were put together. Despite the fact that India has minimal infrastructure
and tight guidelines for GM crop research and risk assessment, we cannot halt this exhibition
because of India's pressing need. Ideally, India should continue its work on genetically
modified crops and their deregulation, as well as the creation of essential infrastructure and the
development of severe biosafety and marketing norms. Despite the existence of authorities
such as GEAC and (GMO Research Information System for India), the Biosafety Clearing
House is performing its duty of analysing biosafety and how they govern GM crops, but there
is need to develop one as quickly as feasible. GMO crops must be controlled, regulated, and
authorised. Any transgenic event in the works must display their registration number and the
date they were registered with a website or online portal created to obtain licence to sell in any
jurisdiction.

In conclusion, after outlining the need for GM crops and the legal challenges existing despite
several competent authorities, it is clear that legislation is not the issue but the execution is.
Genetically modified foods will aid in boosting India’s agro-economy if the laws and
regulations are well-suited.
 Similarity Report ID: oid:9832:26643548

PAPER NAME

E030_AnchitaSinghania_LM.docx

WORD COUNT CHARACTER COUNT

1985 Words 10867 Characters

PAGE COUNT FILE SIZE

7 Pages 41.5KB

SUBMISSION DATE REPORT DATE

Nov 11, 2022 2:00 PM GMT+5:30 Nov 11, 2022 2:01 PM GMT+5:30

4% Overall Similarity
The combined total of all matches, including overlapping sources, for each database.
0% Internet database 2% Publications database
Crossref database Crossref Posted Content database
3% Submitted Works database

Excluded from Similarity Report

Quoted material Small Matches (Less then 8 words)

Summary
 SEMESTER 1 (Academic Year 2022-2023)

LEGAL METHODS
Topic- “Regulations relating to Genetically Modified Crops in India”

SUBMITTED TO:
Dr. Akshaya Desai
NMIMS Kirit P. Mehta School of Law

SUBMITTED BY:
Anchita Singhania
B.B.A LL.B(Hons.)
Div E, Roll No. 030
 Regulations relating to Genetically Modified Crops in India

Abstract
Genetically Modified foods containing desired novel traits have been incorporated into
agricultural foods and newer researches are undergo. This paper explains the need for GM
4
foods in India and examines how it will help the country’s economic and social problems. The
aim of this paper is to analyse the pre-existing laws and regulations in place regarding GM
foods. The research methodology adopted by the author is secondary doctrinal research. The
paper will go on to explain the legal challenges forming barriers in the way of regulation of
GM crops. At the crux of these challenges, lies the Aruna Rodrigues v. Union of India case
whose arguments have been interpreted in a coherent manner. The author has opined
suggestions that will aid the government in tackling the aforementioned issues and if accepted,
will promote the cultivation of GM foods. The last chapter is formed by the conclusion of this
study that identifies the execution of laws to be the heart of the problem.

Keywords- Genetically Modified crops, regulations, GM foods, India

Introduction
India has primarily been an agricultural based economy for decades but the agricultural and
6
farming sector has not evolved efficiently with the advent of technology. Genetic Modification
(hereafter referred to as ‘GM’,) is a sub-field of biotechnology that is vital in enhancing the
features of biotic organisms. “GM is a technology that involves inserting DNA into the genome
of an organism.”1 To produce a GM crop, the edited genes are pasted into the new or
recombinant DNA which is grown into a tissue culture of the original plant and the seeds
produces thereafter will have the desired gene quality. In agriculture, this process is done to
alter and enhance the nutrients of a crop or to benefit the farmers and increase yield by making
it insect and pest resistant, drought tolerant, herbicide tolerant, etcetera.

In spite of the widespread farming-related activities pan India, its vast population and uneven
distribution of resources leads to socio-economic problems like malnutrition, starvation and

1 2
[Murali Krishna Chimata, Gyanesh Bharti], [Regulation of genome edited technologies in India], [28], [TR],
[175], [180-181], [(2019)]
 5
overall poor food security. GM crops have the potential to be used as a technological welfare
tool to provide a futuristic solution to these issues.

Indian researchers and scientists in congruence with the legal system took the early advantage
to start evaluation of GM foods over 2 decades ago. However, several challenges including
government intervention and legal ramifications have severely impeded the development and
progress of transgenic foods.

Research Question
1. What are the laws and regulations regarding GMOs in India?
2. What are the legal challenges in approving newer varieties of GM crops?

Research Methodology
The paper has been authored via means of doctrinal research which has been carried out from
a legal perspective by analysing case judgements and existing statutory provisions relating to
the subject matter. Doctrinal research is surrounded on understanding what the law is and how
it has evolved pertaining to the research topic of GM crops in India. Also known as “black-
letter” methodology, the law in actions stands second to the theoretical provisions or letter of
law. The author has conducted a qualitative analysis to collate, arrange and describe these laws
and then provide observation-based remarks on the same. A thorough analysis of pre-existing
case judgements, government regulations, research article publications in both Scopus-indexed
and law journals has been performed by the author to gather information. Primary research lies
outside the purview of this research paper and the scope has been limited to secondary data
only.

Research Objective
This study aims at studying the regulations in place regarding genetically modified crops in
India. There are numerous executive bodies created by the government to monitor GM crops
and this paper will shed light on their jurisdictions and how the redundance of their overlapping
tasks has had detrimental affects on the GM industry. It will also highlight the acts that initially
incorporated genetically modified organisms, especially plants.

The research paper aims to further understand the legal challenges against GM food varieties.
A case study has been analysed to factor in the anti-GM food activists and to explain the
alternate perspective of this issue. The timeline for the evolution of regulations pertaining to
transgenic foods will be explained also. The author will provide inputs and commentary in the
form of suggestions after analysing the aforementioned research objectives of this study.

Regulations regarding Genetically Modified Crops in India

India is a signatory to the “Cartagena Protocol” which outlines the biosafety issues in relation
to genetically modified organisms. Under domestic regulations, India was one of the first
countries to incorporate GM related laws in its statutes. All products of genetically modified
organisms were regulated under the “Rules for the manufacture, use, import, export and storage
of hazardous microorganisms, genetically engineered organisms or cells, 1989”. These rules
were added and notified in the “Environment (Protection) Act, 1986”2. These guidelines are
executed by the “Ministry of Environment, Forest and Climate Change, Department of
Biotechnology and State Governments”. This implementation is being undertaken by six
different authorities formed by the government. These authorities include “The Recombinant
DNA Advisory Committee (RDAC), Institutional Biosafety Committee (IBSC), Review
Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee
(GEAC), State Biotechnology Coordination Committee (SBCC)and the District Level
Committee (DLC)”.

The jurisdiction of the competent decision-making bodies has not been clearly laid down by
the government. This ambiguity is a source of poor legal framework in contesting matters of
GM crop production.

Although these provisions were included in the year 1989, the first Gm regulated crop in India
was permitted in the year 2002. This regulation was passed because farmers were cultivating
illegally sourced GM seeds of Bt Cotton. This rampant usage of GM crop in the agricultural
community nudged the government to the realization that these biotechnologically enhanced
crops are indeed vital. This process of law making that stems from the need of a democracy’s
citizens is known as “Botton-up development of law”.

3
2
Environment (Protection) Act, 1986, Acts of Parliament, 1986 (India)
 Legal Challenges: Aruna Rodrigues and Others v. Union of India
In the year 2006, a public interest litigation plea was filed by Aruna Rodrigues3 in the Supreme
Court. The acceptance of this plea meant that all the six established bodies set up to deal with
GM crops related complaints and grievances had been disregarded and ignored. This writ
petitioned to introduce a blanket ban on all GM foods in India, including both, the ones which
are existing and regulated as well as those under research.

After multiple deliberations, in 2012 the Apex Court of the country set up another body to
research into these issues surrounding the GM crops debate. This new Technical Expert
Committee considered under its ambit the following issues raised by anti-GM crop activists in
the Aruna Rodrigues plea.

 Ethical Issues

There were socio-cultural points raised arguing that it is unethical to manipulate natural food
composition. Arguments also included that not every consumer will know which product is
genetically modified and which is ‘authentic’ or organic, and every person has a right to
information as to what is being consumed by them. If legalised, consumers would not have a
say in this.

 Health Concerns

Although several scientific studies have been conducted to know the health benefits after
enhancing nutrients via the process of gene engineering, there is next to no published data with
concrete evidence that proves the benefits of GM foods. On the flip side, probable medical
ramifications of consuming modified food is one of the major concerns that has not been
addressed by any of the competent bodies.

 Invasive Species

From a strictly scientific outlook, genetically modified crops if not grown by adhering to all
guidelines have the potential of evolving themselves into a threat to their ecosystem. This is
because the insect resistant gene or herbicide resistant gene has the capability to spread and
make the modified crop into an invasive species in a different crop field.

7
3
Aruna Rodrigues & Ors v. Union Of India & Ors, (2006), WP(C)No.260/2005
Post consideration of these issues and concerns raised, the Technical Expert Committee
imposed a 10-year moratorium on all kinds of field trial for newer varieties of GM food crops.

This decision was reversed before the completion of the time period for this stay order in 2021.
Food trials for 2 varieties of Bt Brinjal were permitted by the court again. The PIL filed by in
the case remains undecided by the Supreme Court till date.

Suggestions
There needs to be awareness amongst the citizens as to what genetic modification is. In the 10-
year moratorium when field trials were not permitted, the government should have conducted
detailed scientific studies and spread awareness among the consumers about GM foods. It is an
alien concept for majority of the population which leads to mass hysteria regarding cultural
and ethical ramifications. Along with this, there are also legitimate health concerns which need
to be addressed with supporting evidence.

As stated in the paper, there are several bodies set up to do the same task with overlapping
authorities. This leads to unclarity of jurisdiction thereby proving to be detrimental to the main
cause of resolving issues. The execution needs to be organised and clear guidelines regarding
distribution of subject-matter need to be laid down by the government.

When the concept of genetic modification was introduced initially, it was added to the 1986
Act. Since then, over 3 decades later, this branch of biotechnology has boomed and evolved
greatly. Keeping this a part of the “Environment (Protection) Act” along with hazardous
microorganisms creates a prejudice that genetically modified organisms are harmful to humans
and their environment. A separate act needs to be drafted pertaining only to genetic
modification with specific sections catering to field trials, varieties of crops, guidelines for safe
cultivation and sales rules to distinguish GM foods.

Conclusion
Transgenic crops provide a lot of advantages. Factors improving food and nutrition security
have been established with consideration of the contribution of gene modification. Many other
benefits, like as increased nutritional content, resistance to herbicides and viruses, and the
capacity to withstand a wide variety of abiotic stressors, can enhance food quality and thereby
provide farmers with a decent market. Arguments regarding whether GM crops are safe or not
are ceaseless owing to lack of research regarding the same. For genetically modified foods
GOI-funded institutions must adhere to the primary policies of the Indian government and
demonstrate to the government that they are committed to combating poverty and hunger. This
fair concern is raised since various members of India's Supreme Court of “Safety and
Guidelines for Research on Genetically Modified Crops and Suggestions” for the future of GM
1
crop research in India were put together. Despite the fact that India has minimal infrastructure
and tight guidelines for GM crop research and risk assessment, we cannot halt this exhibition
because of India's pressing need. Ideally, India should continue its work on genetically
modified crops and their deregulation, as well as the creation of essential infrastructure and the
development of severe biosafety and marketing norms. Despite the existence of authorities
such as GEAC and (GMO Research Information System for India), the Biosafety Clearing
House is performing its duty of analysing biosafety and how they govern GM crops, but there
is need to develop one as quickly as feasible. GMO crops must be controlled, regulated, and
authorised. Any transgenic event in the works must display their registration number and the
1
date they were registered with a website or online portal created to obtain licence to sell in any
jurisdiction.

In conclusion, after outlining the need for GM crops and the legal challenges existing despite
several competent authorities, it is clear that legislation is not the issue but the execution is.
Genetically modified foods will aid in boosting India’s agro-economy if the laws and
regulations are well-suited.
 Similarity Report ID: oid:9832:26643548

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