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“BIOTECHNOLOGY REGULATORY AUTHORITY BILL 2013”

UNDER THE GUIDANCE OF

Ms. SUCHI SINGH

BY:
GAURAV KUMAR

B.SC.LL.B.(Hons.)

7th SEMESTER

CUSB1513115007

2015-2020

SCHOOL OF LAW AND GOVERNANCE

CENTRAL UNIVERSITY OF SOUTH BIHAR


GAYA-823001

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TABLE OF CONTENTS

S.NO. TOPICS PAGE. NO.

01. PREFACE 03

02. ACKNOWLEDGMENT 04

03. ABSTRACT AND INTRODUCTION 05-06

04. BRAI BILL, 2013: An Analysis: It’s Mandate and Characteristics 06-10

05. KEY ISSUES AND ANALYSIS 10-11

06. COMPOSITION OF THE APPELLATE TRIBUNAL AND BRAI 11-13

07. US IMPERIALISM AND THE BRAI BILL, 2013 13-14

08. DEMERITS OF THE BRAI BILL, 2013 14-15

10. CONCLUSION 16

11. BIBLIOGRAPHY 17

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PREFACE

It is a matter of great pleasure for me to present this project on a very useful part of Laws
relating to Environment that is the “Biotechnology Regulatory Authority Bill, 2013”. I
quite appreciate the overwhelming response of the teacher the effort to this project had
provided me an opportunity to revise the different provisions of the part and bring it to
up to date. This project had been continued with considering different recommendations
and proposals and case laws so far arose in the context.
This project outlines the different phases and traces the development which resulted in
the existence of the bill behind us.
Lastly, I appreciate the help and cooperation rendered by my teacher, Ms. Suchi Mam,
without which the project could not have been brought out in the present form.

My thanks are due to services which I got in identifying my project as for successful
completion.
Suggestions from the reader will be welcome and thankfully acknowledged.

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ACKNOWLEDGEMENT

I am eager to express my profound gratitude to my Respected teacher Ms. Suchi mam,


for his scholarly and insightful supervision, without which the fulfilment of this present
mini-research work would have been impossible. I would also like to thank my respected
teacher for his intuitive suggestions, and regular lectures.

It would be a gross-injustice if I fail to remember my friends support and the very


classmates who made me capable to initiate this project. They have always stood by my
side and helped me in many grounds as being my counterparts. So, I am equally thankful
to them.

Once again my deep thanks goes to teacher whose standing ovation lectures mean a lot to
me when it comes to attain some legal insights and think for the would-be legitimate-
course that would shape my life in near future.

Subsequently, I would also like to pay strong gratitude to all the concerned resources
which proved to be quite helpful in collecting and analysing the data. Without their help,
I would not be capable to draft this project.

Finally, I would like to remember my Parents and almighty without whose blessings
nothing would have been possible.

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ABSTRACT
India is one of the blistering blooming economy and market for the products of all known goods
within the globe. This Country along with other countries of the world have proved its steps in
regard to address the issues specifically related to the Health and food security. The answer to
all which lies in the Biotechnology. Since, the last two decades, biotechnology research has
succeeded to attain new-fangled horizons and hundreds of Genetically Modified creations
procuring their place in the international market. Finally, to have the streamlined development
and progress, India has come up with the BRAI concept, famously known as Biotechnology
Regulatory Authority of India. This has been recently tabled to the floor of Parliament in 2013,
monsoon session, and its pendency is still observable. The same had been a subject of
discussion for its progress and implications in future in between the peoples. This work while
giving overview of present bill has remarked upon its pros & cons along with the suggestions
that if incorporated could result into fruitful Act for the most prominent demand of the time.
INTRODUCTION
The term ‘Biotechnology’ is the manipulation of the genetic structure of organisms to alter
their characteristics and introduce specific traits. For instance, biotechnology has been used to
create synthetic human insulin to treat diabetes and Bt Cotton which produces an insecticide
that kills certain pests that eat it. Such products could include living modified organisms,
genetically modified organisms and genetically engineered organisms. Currently,
biotechnology is jointly regulated by the Ministry of Environment and Forests (MoEF) and the
Department of Biotechnology (DBT) under the Ministry of Science and Technology.
Biotechnology is governed by rules notified in 1989 under the Environment (Protection) Act,
19862 (1989 rules) and various guidelines issued by the DBT. A number of committees
including the Swaminathan Task Force and the Standing Committee on Agriculture have
reviewed the regulatory mechanism and made recommendations.1 Given the benefits and risks
associated with the use of this technology, these committees have recommended the
establishment of an “autonomous, statutory and professionally-led National Biotechnology
Regulatory Authority” (herein after NBRA) that would have “two separate wings”- ‘one
dealing with food and agricultural biotechnology’, ‘and the other with medical and
pharmaceutical biotechnology.’ It was further supported by the 2005 Report of the Task Force
on Recombinant Pharma chaired by Dr. R.A. Mashelkar (the Mashelkar Report) “providing a
professionally managed single window mechanism for giving various clearances including
biosafety issues.” In the same year DBT published a draft National Biotechnology
Development Strategy which elaborated a ten-year vision for the future of biotechnology in
India. Under the topic of regulatory mechanisms, the National Biotechnology Strategy
recommended “a competent single National Biotechnology Regulatory Authority be
established with separate divisions for agriculture products/transgenic crops,
pharmaceuticals/drugs and industrial products; and transgenic food/feed and transgenic
animal/aqua culture. The National Biotechnology Development Strategy was approved by the
Government of India in November, 2007 after a two-year consultation period with multiple
stakeholders including concerned ministries, universities, research institutes, private sector,

1
Report of the Task Force on Application of Agricultural Biotechnology (Chairperson: MS Swaminathan),
Ministry of Agriculture, May 2004, http://agricoop.nic.in/TaskForce/tf.htm; Cultivation of Genetically Modified
Food Crops –Prospects and Effects (Chairperson: Basudeb Acharia), Standing Committee on Agriculture, August
2012, http://164.100.47.134/lsscommittee/Agriculture/15_Agriculture_37.pdf.

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civil society, consumer groups, non-government and voluntary organizations and international
bodies. All these circumstances gave birth to the National Biotechnology Regulatory Bill,
2008. The DBT had held consultations on a draft Bill in 2008 and had circulated a draft
establishment plan for the proposed regulatory authority.2 After that the Bill was redrafted and
tabled in Parliament in 2011 in the winter session, but there could be no decision over the
matter The Supreme Court is also examining the efficacious and safe use of biotechnology. 3
Mr Jaipal Reddy, Minister of Science and Technology introduced the Biotechnology
Regulatory Authority of India Bill, 2013 in the Lok Sabha on April 23, 2013.4 The Bill sets up
a regulator which aims to promote the safe use of modern biotechnology by enhancing the
effectiveness and efficiency of regulatory procedures5 and if it will be passed the responsibility
will be taken over by the Environment Appraisal Panel, a sub-division of the BRAI.
The biggest issues which government is facing today is the origin of all this story, which is
backed by the agreement of Mahyco & Monsanto dated back in 2002, which has introduced
the Bt cotton in India & later approval from GEAC (Genetic Engineering Approval Committee)
in 2009 of the Bt-Brinjal in India. Not only in India, but from all over the world scientist were
disturbed to see that it was permitted in India with such an ease.

BRAI BILL, 2013: An Analysis: It’s Mandate and Characteristics

The Bill aims to promote the safe use of modern biotechnology by enhancing the effectiveness
and efficiency of regulatory procedures. Biotechnology Regulatory Authority: The Bill
establishes the Biotechnology Regulatory Authority of India (Authority). The Authority will
consist of a chairperson, two full time members, and two part time members. The bill is divided
into 88 sections & 14 Chapters. The bill vividly talks about the powers/functions/working of
the NBRA. There is establishment of the Appellate authority which will look into the appeal
provisions and there is coordination among different departments of the government. There are
independent wings of the NBRA which are regulatory divisions of the Authority. They have
been created for the implementation of safety assessment procedures and processes.

The divisions are:

(i) Agriculture, forest and fisheries,

(ii) Human health and veterinary products, and

(iii) Industrial and environmental applications.

There is another risk assessment unit established which will further assess the risk involved in
the projects/approval application. Risk Assessment Unit will appraise applications for
proposed research, transport or import of an organism or product, before final approval is
granted. The Product Rulings Committee will make recommendations to the Authority for the

2
Draft National Biotechnology Regulatory Bill, 2008,
dbtindia.nic.in/Draft%20NBR%20Act_%2028may2008.pdf.
3
Aruna Rodrigues vs.Union of India, (2012) 5 SCC 331.
4
Clause 2 of the Bill states it is expedient in public interest that the Union regulate organisms, products and
processes of the modern biotechnology industry. Hence, the legislative competence of the Parliament to enact this
law flows from the Union List Entry 52 of the Constitution, which states that Parliament can regulate industries
that it declares by law to be in public interest.
5
Preamble, Biotechnology Regulatory Authority of India Bill, 2013.

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manufacture or use of organisms or products. The Environmental Appraisal Panel will make
recommendations on environmental safety of organisms and products. An Inter-Ministerial
Governance Board has been established to promote inter-ministerial or departmental co-
operation for the effective discharge of the functions of the Authority. A Biotechnology
Advisory Council will render strategic advice to the Authority regarding developments in
modern biotechnology and their implications in India. Every care has been taken from the
drafters, that the bill could series the need of each & every concerned party. The bill has been
very systematic & has covered all the queries in regard to the subject. The power & functions
of the Biotechnology authority & tribunal are defined in elaborative way. The rejection &
acceptance of the proposal under the Act has also been explained in a logical way. Every effort
has been sorted to keep check on the biotechnological process. The appointment of the
committee as well as that of the members in BRAI has been kept very neutral based on the
qualification as per the Act. The only thing that can be apparently seen is the full-fledged
working of the BRAI, when it will be brought into effect.

 Superseding effect of the BRAI Act


Supreme Court of India has mentioned this in many judgments at many instances that the right
to information is the fundamental to the identity of a citizen in India, but the proposed Act is
having different attitude for the same. The Act (BRAI) tend to curtail this right of the citizens
of India, by giving a superseding effect above the RTI. The authority can even deny to give the
information whenever they feel so. Although there has been provision which says that the
authority if deem fit that it is expedient to do so in the larger interest of the public can even
disclose the information but that is very subjective & depend upon the discretion of the
authority.

 Selection of the members of the BRAI


The selection process for the members has been made in such a manner which will definitely
result in the influence of the corporate people over the public policy. Moreover, it has been
seen that the control of the BRAI from Ministry of Environment has been shifted to Department
of Science &Technology. Latter has already given permission to the Bt-Brinjal in country
which has clearly shown the influence of the corporate over its decisions. This could be further
dangerous when many Multi-National Companies are coming to India. Not only that there will
be issues in relation to the Bio-prospecting & bio-piracy too.

 Impact of the US- India Knowledge Initiative over the BRAI:


India has signed an agreement with US in 2005, which is “US-India Knowledge Initiative on
Agricultural Education, Teaching, Research, Services and Commercial linkages” or the KIA
agreement. As a result of this treaty, the control of the US based multi-nationals could be felt
on all areas of agriculture in India, from agricultural research to the marketing and retail sale
of agricultural products. As a part of this treaty, a board was established whose main objective
was to implement the different aims of the agreement, and it is also a hard fact that majority of
the members have their roots with the multinational giants in field of Biotechnology.

 Control of the BRAI over GEAC:


It can also be seen through this proposed bill that there will be whole control of the BRAI over
the committee which deals with the core aspects of the Biotechnology. Although there is no
harm as to it but, still the difference is that of only few persons taking over the work of the

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whole well-established team of the experts. Definitely this will result into the diminishing of
the impact of the GEAC, which could have been avoided. GEAC, is formed of the diversified
people from different & important field of the subject but limiting them to the work of few 5-
6 people would not yield the same desired results.

 Independent research & analysis of the proposed crops:


There has been a need & demand from all corners of the scientists & environmentalists that
India need an independent, erstwhile committee that can look into the projects that come for
the production of the Genetically modified crops or any other advancement in field of the
biotechnology. Unfortunately, nothing is done in the proposed bill in this regard. The
committee that is empowered for looking into this is comprised of only three members who are
not from the field of biotechnology per se; they are generalists who are from the department of
the health, medical or agricultural field. No doubt that it is very hazy to say or to suspect the
working of those specialists from their field (as the BRAI also give minimum qualification for
the members), but one thing is clear that they are not the specialist who would work
independently.

 Role of GEAC also delimited by the Act:


It is also apparent on the face of the Act that the BRAI want to make GEAC only a
recommendatory body & not the effective committee. As could be understood that the Act has
made the authority a superior body over the GEAC, which would result into the channelling of
the work and no one except the authority can regulate the work. As a result the very effective
& efficient committee which comprises of the persons with the expertise will be discouraged
to an extent that it will only remain as the recommendatory body. And this is also true with all
the recommendatory bodies in India that they remain so only through their life.

 Absolute authority to the BRAI over and above the usual law regulating bodies:
It can be easily seen that the authority formed under the bill has been given prominence over
the rest of the regulating bodies of the land. As there is formation of the tribunal too which is
not having any member from the judiciary! No matter that the present set up gives idea for the
specialist determining the issues of the cases but yet no one can underestimate the importance
of judicial member deciding the matters in relation to matter concerned there to. No qualm to
say that this will undermine the importance of judiciary in this field. Also, it is pertinent to note
that the authority has been given absolute rights over the information sent to it. It seems that it
is necessary to do so for the betterment of the subject matter but then there will be clash of the
authority in this regard, which can be avoided. Also, the clinical trials are not kept within the
ambit of the authority, which will create problem in this matter. The clinical trials, Drugs &
Cosmetic Act should also be a part of this Act, so that some concrete decision could have been
taken.

 Penalties under the Bill


The Bill provides imprisonment of up to three months and a fine of up to rupees five lakh for
providing false information, conducting unapproved field trials and obstructing an officer of
BRAI. Contravention of other provisions would be punishable with imprisonment of up to two
years and a fine of up to rupees 10 lakh.

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Biotechnology Regulatory Authority and its functions:
• BRAI will consist of a chairperson, two full time members, and two part time members for a
three-year term. They will have specified scientific qualifications and will be selected by a
committee composed of the Cabinet Secretary, secretaries of relevant ministries such as
agriculture and biotechnology and two eminent biotechnologists. • The functions of BRAI shall
include authorising and regulating the research, transport, import, containment, environmental
release, manufacture and use of organisms and products of modern biotechnology. • Field trials
require permission from BRAI, which will also prescribe safeguards to be followed. • For a
drug or vaccine with elements of biotechnology, the Central Drugs Standard Control
Organisation (CDSCO) will forward the application to BRAI to assess whether it is safe to
proceed with a clinical trial. Clinical trials will continue to be regulated by the CDSCO under
the Drugs and Cosmetics Act, 1940. • The Bill amends the Food Safety and Standards Act,
2006, which regulates the manufacture, import, sale and distribution of food items. The
amendment mandates that food items with elements of biotechnology have to be approved by
BRAI as safe for human consumption. • BRAI will have the power to call for information,
conduct an inquiry and issue directions for the safety of products or processes of modern
biotechnology. BRAI shall communicate its decisions on applications for authorisation to the
public and obtain objections or suggestions. • BRAI will not disclose confidential commercial
information made available to it in an application for authorisation. This is regardless of
anything contained in the Right to Information Act, 2005. However, BRAI may disclose the
information in public interest or if this disclosure will not harm any person.
Process For Approval of Applications :-
• BRAI will comprise of three units: Risk Assessment Unit (RAU), Product Rulings Committee
(PRC) and Environmental Appraisal Panel (EAP). BRAI will forward all applications seeking
authorisation for research, transport, import, manufacture or use of products and organisms of
biotechnology to the RAU. RAU will be composed of scientific officers possessing
qualifications as specified in regulations. The RAU will undertake science - based safety
assessments of the applications. For research, transport and import, BRAI will take a The
Biotechnology Regulatory Authority of India Bill, 2013 PRS Legislative Research November
27, 2013 - 3 - decision based on the RAU’s assessment. In the case of manufacture or use, the
report of the RAU will be forwarded to the PRC. The PRC is composed of members of BRAI
and its regulatory divisions, a representative from the CDSCO and between three to five
scientific experts. Based on this report, the PRC will make recommendations regarding the
safety of the product or organism. Further, BRAI may refer an application to the EAP, in case
of products or organisms having an environmental impact.
• BRAI will constitute an Enforcement Unit consisting of monitoring officers for enforcing its
decisions. A Scientific Advisory Panel will be created to provide scientific advice and technical
support to BRAI.
• Safety assessment procedures for products will be implemented by the three regulatory
divisions of BRAI. The divisions pertain to the following areas: (i) agriculture, forest and
fisheries, (ii) human health and veterinary products, and (iii) industrial and environmental
applications. Each of these will be headed by a Chief Regulatory Officer (CRO) with specified
scientific qualifications. The CROs will be a part of the PRC.

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Other bodies being established:-
• The Biotechnology Regulatory Appellate Tribunal will: (a) have jurisdiction over civil cases
where a substantial question relating to modern biotechnology is involved and arises from the
safety and use of organisms, products and processes specified in the Bill; and (b) hear appeals
from the decisions and orders of BRAI. It will consist of a full-time chairperson, who has been
a judge of the Supreme Court or a Chief Justice of a High Court, and five part time expert
members. Decisions of the Tribunal can be appealed to the Supreme Court. • An Inter-
Ministerial Governance Board has been established to promote inter-ministerial co-operation
for the effective discharge of BRAI’s functions. A Biotechnology Advisory Council will offer
advice to BRAI on developments in modern biotechnology and their implications. State
Biotechnology Regulatory Advisory Committees will co-ordinate between the state
government and BRAI and identify state-specific needs.
Legislative Impact:-
Amendments will be required to following Acts
 Drugs and Cosmetics Rules (8th Amendment), 1988
 The Food Safety and Standards Act, 2006.
The sections related to GMOs will be repealed in the “Rules for the Manufacture, Use, Import,
Export and Storage of Hazardous Micro-organisms/ Genetically Engineered Organisms or
Cells, 1989 issued under EPA”.
An overview: Supreme Court of India:-
The Supreme Court of India, for the first time, on September 22, 2006, issued an interim verdict
banning all field trials of genetically modified (GM) crops in the country and slammed its
regulatory mechanism. Supreme court constituted committee of five experts in Interim report
recommended ban on field trials, heard and stayed for detailed report with induction of one
more experts.
KEY ISSUES AND ANALYSIS
Regulation of Biotechnology
it is not assessed adequately for safety. Benefits of this technology include the introduction of
characteristics such as drought resistance, pest resistance, or high iron content in a plant. Risks
include adverse impact on the health of organisms that consume these products, and the
environment and biodiversity. Any regulatory structure for the sector will need to balance the
benefits with the risks and ensure the safe use of biotechnology. Several committees have said
that the current assessment system in India is not independent and lacks scientific rigour in its
assessment.6 The Bill envisages an independent scientific risk assessment to be undertaken by
experts in the field of biotechnology. BRAI’s role is restricted to certify that the product or
organism developed is safe for its intended use. All other laws applicable to the product will
continue to apply. For example, use of items such as drugs and seeds would be regulated by

6
Report of the Task Force on Application of Agricultural Biotechnology (Chairperson: MS Swaminathan),
Ministry of Agriculture, May 2004, http://agricoop.nic.in/TaskForce/tf.htm; Cultivation of Genetically Modified
Food Crops –Prospects and Effects (Chairperson: Basudeb Acharia), Standing Committee on Agriculture,
August 2012, http://164.100.47.134/lsscommittee/Agriculture/15_Agriculture_37.pdf.

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the Drugs and Cosmetics Act, 1940 and Seeds Act, 1966 respectively and any applicable state
laws. Table 1 compares differences between the current regulatory approval system under the
1989 rules with the regulatory approval system proposed under the Bill.
International Regulation:
The Convention on Biological Diversity and the Cartagena Protocol on Biosafety mandate
rigorous scientific regulation to ensure safe use of biotechnology. Countries around the world
have various mechanisms for regulating biotechnology. In USA and Canada, the government
departments of agriculture, health, environment and food regulate biotechnology. 7 Both
countries use existing laws and agencies rather than creating a specialised regulatory
mechanism. On the other hand, Australia has set up an independent regulator that conducts risk
assessment and authorises activities such as research and transport of products of
biotechnology.8 Countries have also adopted varying standards for assessing risk. USA and
Canada assess the safety of a biotechnology product by applying the principle of establishing
substantial equivalence (scientifically establishing that the biotechnology product is the same
as the conventional product in terms of its composition and nutritional value).9 Norway, on the
other hand, requires that the product should not lead to any risk of adverse impact on health
and the environment.10
Jurisdiction of the Appellate Tribunal :
The Tribunal will have jurisdiction over all civil cases where a ‘substantial question relating to
modern biotechnology’ is involved and these questions arise from the safety and use of
organisms, products and processes specified in the Bill. However, the Bill does not define
‘substantial question relating to modern biotechnology’. This may lead to uncertainty with
regard to the extent of jurisdiction of the Tribunal on matters of modern biotechnology and its
consequences. There can be two views on whether ‘a substantial question relating to…’ can
and ought to be defined. On the one hand, defining the term could reduce ambiguity. For
example, the NGT has jurisdiction over all civil cases where a ‘substantial question relating to
environment’ is involved. This term is defined within the relevant Act.11 On the other hand,
given the evolving nature of modern biotechnology and its consequences, leaving the term
undefined may allow for flexibility. For instance, the term ‘substantial question relating to law’
has not been defined in any statute and has been developed by the courts over time.
COMPOSITION OF THE APPELLATE TRIBUNAL AND BRAI
Inadequate judicial representation on the Appellate Tribunal
In the National Company Law Tribunal judgment of 2010, the Supreme Court laid down that
the number of technical members on a bench of a Tribunal cannot exceed the number of judicial

7
US Foods and Drugs Administration,
http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/default.htm; Health Canada, http://www.hc-
sc.gc.ca/sr-sr/biotech/about-apropos/index-eng.php.
8
Gene Technology Act, 2000, http://www.comlaw.gov.au/Details/C2011C00539.
9
US Foods and Drugs Administration,
http://www.fda.gov/food/foodscienceresearch/biotechnology/ucm346030.htm.
10
Gene Technology Act, 1993, http://www.regjeringen.no/en/doc/Laws/Acts/Gene-Technology-
Act.html?id=173031.
11
Section 2(m), National Green Tribunal Act, 2010.

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members.12 The Bill is not in conformity with this principle laid down by the Court. The Bill
provides that the Tribunal will consist of a fulltime chairperson, who has been a judge of the
Supreme Court or a Chief Justice of a High Court, and five part time expert members. Thus,
the number of technical members exceeds that of judicial members. In addition, in case the
post of the chairperson is vacant, an expert member of the Tribunal shall discharge the functions
of this post. This implies that cases before the Tribunal could be heard without a judicial
member.
Equivalence of expertise of various technical members
The Bill lays down the qualifications for expert members of the Tribunal and equates (a) an
eminent scientist in the field of biotechnology with at least 20 years experience, with (b) a Joint
Secretary in the central or state government who has held a post dealing with biotechnology
for at least three years and possesses special knowledge in the field. It is unclear whether 20
years of technical expertise of an eminent scientist can be equated with the three years of
administrative experience of a government official in the field of biotechnology.
Areas of expertise of technical members
The Bill requires that the experience of technical members in biological science or
biotechnology be related to any of the following fields: (i) healthcare, or (ii) agriculture, or (iii)
environmental, or (iv) industrial activities and processes. This implies that a Tribunal could be
constituted without representation from each field. Absence of a member from a specified field
could impede the Tribunal’s ability to examine a technical question related to it.
Qualification of chairperson and members of BRAI
The chairperson and members of BRAI and Chief Regulatory Officers of the three divisions of
BRAI are required to either have a doctorate degree in biological sciences or a postgraduate
degree in medical sciences from a university recognised by the University Grants Commission
or a university or institute established by law. It is unclear whether candidates who may have
obtained similar degrees from reputed universities outside India would qualify to be selected
as members of BRAI.
Determination of liability
The primary function of liability regimes is to provide compensation to affected parties and
incentivise the industry to minimise the risks of adverse impact. There are different types of
liability regimes. In some cases, liability is specified in a law (statutory liability). In other cases,
courts decide that the polluter should compensate: (i) regardless of any fault (no fault liability
such as strict liability and absolute liability), or (ii) based on proof of fault (fault liability). The
Bill does not specify any liability regime. Therefore, it will remain open to the courts to
determine the general civil liability arising out of any adverse impact of modern biotechnology.
The Nagoya Supplementary Protocol has stated that countries should have a liability regime
for living modified organisms either based on general rules and procedures on civil liability or

12
Union of India vs. R. Gandhi, Madras Bar Association, Civil Appeal No. 3067 of 2004, Supreme Court
Judgment on May 11, 2010.

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specific rules of liability developed for biotechnology.13 USA and Canada have not specified
any liability in the relevant Acts.14 Australia, in its statute regulating biotechnology, has
specified strict liability for offences such as dealing with a genetically modified organism
without a licence and for breaching conditions of a licence. In addition, causing significant
damage to health or safety of people or to the environment is an aggravated offence.15 The
Norwegian statute imposes strict liability for causing damage, nuisance or loss through the
deliberate or unintended release of genetically modified organisms into the environment.16
US IMPERIALISM AND THE BRAI BILL, 2013

Just as the greatest support for BRAI comes from corporations and a section technocrats and
agricultural scientists, US imperialism also has a direct role in the matter. One of the major
goals of US imperialistic interests is to fundamentally change the nature of Indian agriculture,
and make it subservient to the interests of multinational corporations, especially US
multinational corporations. The inception of this process was on the 18th of July 2005, when
the Ex- Prime Minister Dr. Manmohan Singh and the then US president George Bush signed
the “US-India Knowledge Initiative on Agricultural Education, Teaching, Research, Services
and Commercial linkages” or the KIA agreement. As a result of this treaty, the control of the
US based multi-nationals was consolidated on all areas of agriculture in India, from agricultural
research to the marketing and retail sale of agricultural products. As a part of this treaty, a board
was established whose main objective was to implement the different aims of the agreement,
and thereby usher in the “second green revolution”. The greatest emphasis in KIA was laid
upon the massive application of biotechnology in Indian agriculture. Under the KIA, one of the
approaches that these multi-nationals would be taking to establish their hold over Indian
agriculture is to take control of the huge agricultural research system in India and use it for
research and commercialization of biotechnology products. Their main target is the huge
research infrastructure of the Indian Council for Agricultural Research (ICAR) consisting of
59 institutes, 17 national labs and 78 research projects spread all over the country. Besides this,
there are also grants for several hundred research projects in the 50 agricultural universities
across India. In all, a huge infrastructure to be potentially used for agri-biotechnology. The
KIA effectively ensures the control of the US based multi-nationals over this infrastructure.

13
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on
Biosafety, United Nations, adopted October 15, 2010, https://bch.cbd.int/protocol/NKL_text.shtml. India is a
signatory to the Protocol; it is yet to come into force.
14
US: Federal Food Drug & Cosmetic Act, 1983; Federal Insecticide, Fungicide and Rodenticide Act, 1947;
Plant Protection Act, 2000. Canada: Food and Drugs Act, 1985; Feeds Act, 1985; Health of Animals Act, 1990;
Seeds Act, 1985; Plant Protection Act, 1990.
15
Gene Technology Act, 2000, http://www.comlaw.gov.au/Details/C2011C00539.
16
Gene Technology Act, 1993, http://www.regjeringen.no/en/doc/Laws/Acts/Gene-Technology-
Act.html?id=173031.

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But even then, the issue of government regulations on the commercialization and marketing of
GM-crops remained. And because of this, in order to fully implement the Indo-US agricultural
knowledge treaty, it became necessary to establish the BRAI, which will make the
commercialization process of GM crops simple and amenable to the interests of multinational
corporations.

It is worth noting that at the time when the new BRAI draft act was published in 2009, unknown
to the Parliament, an US-India memorandum-of-understanding (MOU) related to “cooperation
in agriculture and food security” was signed during the visit of the US foreign secretary Hillary
Clinton to India. The objective of the MOU was to increase US investment in the Indian food
and agriculture sector. Under the guise of “cooperation in agriculture”, this MOU opened the
door for privatization of the agricultural research system and flooding the Indian food market
with GM food crops under “food security”. It is easily understandable that the passing of the
BRAI bill is intimately linked with the interests of US imperialism in India and with the
interests of the multinational corporations, whose interests are served by US imperialism.

DEMERITS OF THE BRAI BILL, 2013

Ministry of Science & Technology promoting modern technology seeks to house the regulatory
authority in this Bill – promoters cannot be regulators since there is an inherent conflict of
interest.17 The BRAI Bill has been proposed by the DBT, under the Ministry of Science and
Technology which has a mandate to promote biotechnology in the country. In this situation the
promoter of biotechnology will play a major role in constituting the sector regulator and also
in assisting its functioning. With the promotion and regulation of GM crops under the same
ministry, there is huge conflict of interest.18 This regulatory Bill has as its objective, ‘promoting
the safe use’ of the technology. For promoting a technology, a legislation is not needed. The
need for regulation comes for only one reason: to protect our health and environment and
people’s livelihoods from the risks of modern biotechnology. The Bill does not have this as an
express mandate.

17
Bill Summary, The Biotechnology Regulatory Authority of India Bill, 2013, available at www.prsindia.org
(accessed on 18.08.2014).
18
Section 7(1) of the bill provides the member of the Selection Committee for the Chairperson and the Members
of the BRAI and includes the secretary-in-charge of the DBT and according to Section 7(2) a scientist from the
same department is required to convene the meetings of the selection committee. So, the BRAI would often have
to consider applications with which the Ministry of Science and Technology and the DBT is either directly or
indirectly associated with. Therefore, the decision making of BRAI, irrespective of whether there has been any
actual instance of bias, would be viewed with the apprehension of bias.

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The Bill has its implications on and impinges19 upon matters that are monitored by other
independent laws, such as Environment Protection Act, 1986, Biological Diversity Act, 2002,
Forest Rights Act, 2006, Forest Conservation Act, 1980, Food Safety and Standards Act, 2006,
Drugs and Cosmetics Act, 1940, Panchayat Raj Act, 1993, Nagarpalika Act, 1992, Right to
Information Act, 2005,20 to name but a few and keeps the powers of overriding effect on other
laws with it. Such an overarching Bill needs greater debates which have not happened so far.

The BRAI Bill is against the federal polity enshrined in the Constitution of India and the powers
vested in the Panchayat Raj Institutions. It denies these institutions their authority over
Agriculture, Health and natural resources and centralises decision-making in a narrow,
technical body.

The Tribunal has jurisdiction over a ‘substantial question relating to modern biotechnology’.
However, the Bill does not define this term. Leaving a term undefined could allow for
flexibility but could also increase ambiguity.

The Tribunal will consist of one judicial member and five technical members. This is not in
conformity with a Supreme Court decision21 that the number of technical members on a bench
of a Tribunal cannot exceed the number of judicial members.

The Tribunal’s technical members shall be eminent scientists or government officials with
experience in the field. It is unclear whether the technical expertise of the latter can be equated
with the former.

The Bill does not specify any liability for damage caused by a product of biotechnology.
Therefore, it will remain open to the courts to determine liability arising out of any adverse
impact of modern biotechnology.

19
Have an effect, especially a negative one, available at www.oxfordictionaries.com (accessed on 19.09.2014).
20
Section 28 of the BRAI Bill, 2013.
21
Union of India vs. R. Gandhi, Madras Bar Association, (2010) 6 SCR 857.

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CONCLUSION

The BRAI bill would do no good if it comes into force in its present structure. If it is passed by
the government as it is, then Bt Brinjal, Bt Rice and some 40-odd food crops would be at risk.
The bill attacks the very constitutional rights of the citizens, including their right to
information, their right to choose, even their right to seek redressal under court. The bill
envisages a limited role for the state government. The choice of safe food along with the right
to ask for it would be crushed underneath the multinational giants, who would then take over
the agricultural sector of this country. The farmers would be left at their mercy and very soon
out country would witness another advent of mass suicides by farmers if this bill comes into
force. The legislation should be made to enhance biosafety and ensure democracy in the
country and not otherwise.

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BIBLIOGRAPHY

1. https://www.lawctopus.com/academike/biotechnology-regulatory-authority-bill-
2013/.
2. http://www.prsindia.org/billtrack/the-biotechnology-regulatory-authority-of-india-
bill-2013-2709/.
3. https://www.worldwidejournals.com/global-journal-for-research-analysis-
GJRA/recent_issues_pdf/2014/September/September_2014_1411110035__82.pdf.
4. http://www.indiaenvironmentportal.org.in/files/file/BRAI-Monsanto-briefing.pdf.

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