A Critical Analysis of The Biotechnology

Regulatory Authority of India Bill, 2013

November 13, 2015 by kanchi Leave a Comment

By Kiruthika D, The Tamil Nadu Dr. Ambedkar Law University, Chennai

Editor’s Note: On 23 January 2003, India ratified the Cartagena Protocol which
protects biodiversity from potential risks of genetically modified organisms. Currently,
the Genetic Engineering Approvals Committee, a body under the Ministry of
Environment and Forests is responsible for approval of genetically engineered products
in India. However, a bill has been proposed for the regulation of modern biotechnology
in the country. It is the Biotechnology Regulatory Authority of India Bill (BRAI Bill) 2013
which has been tabled in Lok Sabha by the Minister for Science and Technology, Mr
Jaipal Reddy. If the bill is passed, the responsibility will be taken over by the
Environment Appraisal Panel, a sub-division of the BRAI. In this paper the author has
presented the various aspects and effects of the proposed bill.

INTRODUCTION
The controversy around genetically modified organisms (GMOs) in our food and farming
rages on with claims and counterclaims emerging constantly. India is a party to the
Convention on Biological Diversity, 1992 and ratified the Cartagena Protocol on Bio
safety which protects biodiversity from potential risks of GMOs, the products of modern
biotechnology on 23 January 2003[i]. The protocol requires setting up of a regulatory
body. India does not have an express statute unlike many other countries, to regulate
transgenics in our food and farming. It uses the 1989 Rules of the Environment
Protection Act (1986). Currently, the Genetic Engineering Approvals Committee, a body
under the Ministry of Environment and Forests is responsible for approval of genetically
engineered products in India. The regulatory regime created using these rules has
proven itself to be unscientific, biased, opaque, undemocratic and incapable in a variety
of ways time and time again. Conflicting interests prevail where GM crop developers are
an integral part of decision-making. Violations of the Rules, guidelines, orders and
norms are violated regularly without any liability fixed so far. The Bt brinjal moratorium
decision[ii] is a classic illustration of what is wrong with the current regulatory regime. A
statute is being proposed to be enacted for regulation of modern biotechnology in the
country and a Bill to this effect, called the Biotechnology Regulatory Authority of India
Bill (BRAI Bill) 2013 has been tabled in Lok Sabha by the Minister for Science and
Technology, Mr Jaipal Reddy, on April 22nd 2013. If the bill is passed, the responsibility
will be taken over by the Environment Appraisal Panel, a sub-division of the BRAI.

BACKGROUND OF THE BRAI BILL

 The first time talk of passing such an act came up in 2005 when the time came
for the renewal of the 2002 contract with Monsanto’s Indian subisidiary Maharashtra
Hybrid Seeds Company (MahyCo) for the distribution of genetically modified Bt-cotton
seeds. By that time, the negative effects of Bt-Cotton had become evident to many
farmers and environmental activists, and many had raised their voices against it. Some
effects of the protests were also evident on the Genetic Engineering Approval
Committee (GEAC), the highest body under the ministry of environment and forests
empowered to provide statutory clearances to all research and commercialization of
GMOs. Even the task force on agri-biotechnology formed in 2004, headed by the well-
known agricultural scientist M.S. Swaminathan, expressed their anxiety about the
regulatory mechanism of GMOs in India. In order to stifle these protests, and to keep
the door open for introduction of GM crops in the future, a governmental agency which
would be immune to such protests from farmers and activists was conceptualized.
Following up on that, the UPA government published a draft of a National Biotechnology
Regulatory Authority Act in 2008. In this draft, it was first proposed that the ultimate
authority of approving the introduction of biotechnology and GM crops should be
transferred from the GEAC under the Environment and Forests Ministry (MOEF) and
vested in a special committee under the Department of Science and Technology
(DST)[iii].

The public discussion regarding the bill that ensued was completely one-sided,
as it was done by an organization called the Biotechnology Consortium of India, which
had been created explicitly for the popularization of biotechnology in India. As a result,
the views of different peoples’ organizations, scientists, farmers or consumers were not
considered. Since then, Monsanto has made great progress in the marketing of Bt-
Brinjal, which would be their first GM food crop, and the second GM crop, in India. The
initial applied research was carried out in the Tamil Nadu Agricultural University,
Coimbatore, with funding from Monsanto/Mahyco. While this was going on, on 8th
February 2009, eighteen reputed scientists from all around the world wrote an open
letter to the Prime Minister Dr. Manmohan Singh stating reasons why GM crops and
food should not be introduced in India. Many agronomists, environmentalists, scientists
from various fields, farmer’s bodies and even some state governments also voiced their
opposition to the introduction of Bt-brinjal. But even on the face of this opposition, the
GEAC approved the commercialization of Bt-Brinjal on 14th October 2009. This
approval was based on the report of an expert committee established by the GEAC. As
soon as the committee was established, it was noticed that of its 16 members, at least
five were directly linked to Monsanto or were conducting research based on grants from
Monsanto/Mahyco. At that time, many organizations voiced their protests about this
composition of the Expert Committee (EC). But these protests were ignored, and EC
recommended the clearance to Bt-brinjal disregarding the absence of clear data about
tests done on it and on its potential effect on human and animal health. The storm of
protest that rose around the country as a result of this blatant act forced union
environment and forests minister Jairam Ramesh to hold public hearings in eleven cities
across the country. Pressured by the opinions expressed in these meetings, and
outside, by environmentalists, scientists, farmers and agricultural scientists and a large
cross-section of the public, Jairam Ramesh introduced a two-year moratorium on the
commercialization of Bt Brinjal. Soon after that, sections of the central government
bureacracy, various chambers of commerce and industry, a section of scientists and the
corporate media became vocal against this moratorium. These very same influential
groups started to create pressure on the central government to promulgate a law so that
the control over commercialization of biotechnology products would be transferred from
the MOEF to the DST. The influence of the corporate and technocratic bodies over the
DST has always been great and the latter has supported the commercialization of GM
food crops from the very beginning. The dream legislation of these corporations is the
Biotechnology Regulatory Authority of India (BRAI) Act, which is the new avatar of the
original act proposed in 2008[iv].

In 2011, when the Jan Lokpal movement led by Anna Hazare rocked
Parliament, the Prime Minister’s Office again tried unsuccessfully to push the BRAI bill
in a bid to replace the GEAC, the 31-member apex regulatory body with representation
from several ministries, with a three-member regulator offering all GM products single-
window clearance The next jolt was the August 2012 report of the Parliamentary
Standing Committee on Agriculture that consulted all stakeholders and examined the
BRAI Bill against the standard regulatory frameworks elsewhere in the world. It
observed that “regulating biotechnology is too small a focus in the vast canvas of
biodiversity, environment, human and livestock health, etc and a multitude of other such
related issues”. The panel recommended “setting up of an all-encompassing Bio-safety
Authority through an Act of Parliament, which is extensively discussed and debated
amongst all stakeholders, before acquiring shape of the law”, adding that “unless and
until such an authority is in place, any further movement in regard to transgenics in
agriculture crops will obviously be fraught with unknown consequences”[v]. Again on
April 22nd 2013, the BRAI Bill was introduced in Lok Sabha by the Minister for Science
& Technology, Government of India.

THE CURRENT BRAI BILL, 2013

The Biotechnology Regulatory Authority of India (BRAI) Bill-2013, was
introduced in the Lok Sabha on 22nd April 2013. The proposed Biotechnology
Regulatory Authority will have just a handful of technocrats[vi] taking all the decisions,
whereas the current apex regulator, GEAC, is a multi-ministerial body representing
various interests. Moreover, the objective of the Bill is to “promote” the safe use of
modern biotechnology[vii]. According to the bill, BRAI will have a Chairperson, two full-
time members and two part-time members; all will be required to have expertise in life
sciences and biotechnology in agriculture, health care, environment and general
biology. The BRAI Bill, 2013, provides for the setting up of an inter-ministerial governing
board to oversee the performance of the proposed BRAI. It will also provide for setting
up the Biotech Advisory Council to render strategic advice to the authority on matters
relating to developments in modern biotechnology and their implications in India. The
regulatory body will be an autonomous and statutory agency to regulate the research,
transport, import, and manufacture biotechnology products and organisms. The
proposed BRAI would be the nodal agency of the Government to ensure
comprehensive safety assessment of organisms and biotech products. It would
regulate the trials preceding the clinical trials in the health sector and the present
mechanism for regulating clinical trials would continue. It will also help India keep pace
in regulatory measures with the rapid technology advancement in biotechnology and at
the same time ensure safety to human and animal health and environment[viii].

The biotechnology bill was introduced in Parliament in April and was

subsequently referred to a Standing Committee on Science and Technology, which has
called for opinions and suggestions within 30 days, starting from June 10th 2013[ix].
Union Minister for Science and Technology Jaipal Reddy has asked the Speaker to
constitute a joint parliamentary committee of both Houses to discuss the bill.“The bill
was tabled even though the Parliament Standing Committee on Agriculture had
recommended that India does not need such a bill and instead required a bio-safety
protection authority. In the meantime there has been vociferous[x] opposition to the Bill
from all quarters including many MPs cutting across party lines. The bill has faced
opposition from farmer groups and anti-GMO activists[xi].

HIGHLIGHTS OF THE BRAI BILL,

2013[xii]
 The Bill sets up an independent authority, the Biotechnology Regulatory Authority
of India, to regulate organisms and products of modern biotechnology.

 BRAI will regulate the research, transport, import, containment, environmental

release, manufacture, and use of biotechnology products.

 Regulatory approval by BRAI will be granted through a multi-level process of

assessment undertaken by scientific experts.

 BRAI will certify that the product developed is safe for its intended use. All other
laws governing the product will continue to apply.

 A Biotechnology Regulatory Appellate Tribunal will hear civil cases that involve a
substantial question relating to modern biotechnology and hear appeals on the
decisions and orders of BRAI.

 Penalties are specified for providing false information to BRAI, conducting

unapproved field trials, obstructing or impersonating an officer of BRAI and for
contravening any other provisions of the Bill.

DEMERITS OF THE BRAI BILL, 2013

  A Ministry promoting modern biotechnology (Ministry of Science & Technology)
seeks to house the regulatory authority in this Bill – promoters cannot be
regulators since there is an inherent conflict of interest[xiii]. 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[xiv]. 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.
 The Bill has its implications on and impinges[xv] 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[xvi], 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 decision[xvii] 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.

US IMPERIALISM AND THE BRAI BILL

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. 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[xviii].

WHAT DOES INDIA NEED INSTEAD?

India needs a Biosafety Protection Legislation. Any regulatory regime around GMOs
should have the primary mandate of protecting health of people and the environment
from the risks of modern biotechnology and should also realize that transgenic
technology is being actively rejected by citizens and governments all over the world and
is not a fait accompli. It should necessarily have the following components as
cornerstones of the legislation[xix]:
  Precautionary Principle as the central guiding principle
 Going in for GM option only in case other alternatives are missing and only if
proven safe, including in the long-term
 Separating out very clearly the phases of contained research and deliberate
release and distinct regulatory mechanisms for both, in a sequential fashion
 No conflict of interest to be allowed anywhere in the regulation and decision-
making
 Transparent functioning: information disclosure and public/independent scrutiny
 Democratic functioning including public participation.
 Risk assessment – (a) prescribing rigorous, scientific protocols and asking the
crop developer to take up studies and then do independent analysis of the
dossier supplied by the crop developer and evaluate of the same; (b) to also take
up independent testing by having all facilities and institutional structures in place
for the same and evaluating the results
 Risk management – including monitoring, reviewing, revoking of approvals
 Liability – including penal clauses, redressal and remediation; Liability Regime to
cover both crop developers and regulators
 Labeling regime for informed choices covering traceability requirements,
including for imports
 Oversight and appellate mechanisms that are simple, affordable and accessible
by affected parties and ones who can approach in public interest, without time
limit set
 Given India’s federal structure with Agriculture as a state subject, special clauses
to allow state governments to form their own regulatory systems and
mechanisms; similarly, protection of the constitutional authority of Gram Sabhas
over their natural resources

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.

Edited by Kanchi Kaushik

[i] Biotechnology Regulatory Authority of India, available at en.wikipedia.org (accessed

on 18.08.2014).
[ii] On February 9, 2010, the then Minister of Environment and Forests, Government of
India, Jairam Ramesh, imposed an indefinite stoppage on the commercial release of Bt-
Brinjal in India.

[iii] Leo Saldhana and Bhargavi Rao, Environment Support Group, “Creating An
Undemocratic And Unaccountable Biotechnology Regulator”, November 2011,
Website: www.esgindia.org (accessed on 22.08.2014).

[iv] Partho Sarathi Ray, Biotechnology Regulatory Authority of India Act: The New
Weapon of the Second Green Revolution January 16, 2012, available at sanhati.com
(accessed on 18.08.2014).

[v] Vishwanath Kulkarni, Bill on independent regulator for biotech sector introduced in
Lok Sabha, published on April 22, 2013, available at www.thehindubusinessline.com
(accessed on 18.08.2014).

[vi]A technical expert, especially one in a managerial or administrative position,

available at www.dictionary.reference.com (accessed on 19.09.2014)

[vii] Refer to the Objective of the BRAI Bill, 2013.

[viii] Supra note 4.

[ix] Biotechnology Regulatory Authority of India Bill, 2013 (BRAI): “Wrong Bill by the
wrong people, for the wrong reasons” – a critique by the Coalition for a GM-Free India,
available at indiagminfo.org (accessed on 22.08.2014).

[x] Expressing feelings or opinions in a very loud or forceful way, available at

www.dictionary.reference.com (accessed on 19.09.2014).

[xi] Amitmitra, Scrap biotech regulatory bill, says farmers’ body, published on June 17,
2013, available at www.thehindubusinessline.com (accessed on 18.08.2014).

[xii] Bill Summary, The Biotechnology Regulatory Authority of India Bill, 2013, available
at www.prsindia.org (accessed on 18.08.2014).

[xiii] Supra note 5.

[xiv] 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.
[xv] Have an effect, especially a negative one, available at www.oxfordictionaries.com
(accessed on 19.09.2014).

[xvi] Section 28 of the BRAI Bill, 2013.

[xvii] Union of India vs. R. Gandhi, Madras Bar Association, (2010) 6 SCR 857.

[xviii] Supra note 3

[xix] ‘A Comment on the: Biotechnology Regulatory Authority of India (BRAI) bill,

available at www.cipra.in, (accessed on 22.08.2014).