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National biosafety system for regulating agricultural biotechnology in India

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DOI: 10.1504/IJBT.2016.077941

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Int. J. Biotechnology, Vol. 14, No. 2, 2016 151

National biosafety system for regulating agricultural

biotechnology in India

Sheetal Menon* and Shishir Kumar Jha

Shailesh J. Mehta School of Management,
Indian Institute of Technology Bombay, India
Email: sheetal.menon@iitb.ac.in
Email: skjha@iitb.ac.in
*Corresponding author

Abstract: Agricultural biotechnology has the potential to improve crop

productivity, increase farm incomes, and alleviate food security concerns in
India. Adoption of such technologies has resulted in the need for establishing
biosafety regulatory systems to reduce and eliminate potential risks arising
from agribiotechnology on plant, animal and human life, environment and
biodiversity. As a Party to the Convention on Biological Diversity and
Cartagena Protocol, India has taken the role of strengthening her biosafety
system very seriously. In this paper, we have undertaken a comparative study
of the existing national biosafety framework (NBF) in place in India, with the
UNEP-GEF Framework implemented across 126 countries. On comparison
with the UNEP-GEF Framework, the Indian experience has been admirable,
but not without its own challenges. The purpose of this exercise is to identify
challenges within the system, in an endeavour to transform the Indian biosafety
regulatory system into a predictable, transparent and sustainable system.

Keywords: national biosafety system; agricultural biotechnology; Convention

on Biological Diversity; Cartagena Protocol; national biosafety framework;
UNEP-GEF Framework; Biotechnology Regulatory Authority of India;
Biosafety Clearing House; Ministry of Environment and Forests; MoEF;
Department of Biotechnology; genetically modified organisms; living modified
organisms; Bt cotton; India.

Reference to this paper should be made as follows: Menon, S. and Jha, S.K.
(2016) ‘National biosafety system for regulating agricultural biotechnology in
India’, Int. J. Biotechnology, Vol. 14, No. 2, pp.151–169.

Biographical notes: Sheetal Menon is a Doctoral candidate under the MHRD

IPR Chair Fellowship at the Shailesh J. Mehta School of Management, IIT
Bombay, specialising in the area of intellectual property and innovation
management.

Shishir Kumar Jha is an Associate Professor at the Shailesh J. Mehta School of

Management, IIT Bombay, specialising in the area of knowledge economy and
international business.

Copyright © 2016 Inderscience Enterprises Ltd.

152 S. Menon and S.K. Jha

1 Introduction

Agricultural biotechnology has the potential to improve agricultural crop productivity,

increase adaptation to climate change stresses, and alleviate food security concerns.
However, the impact of adoption and deployment of such new technologies has brought
criticality to the issue of biosafety – a concept that has gained significance and
contentiousness owing to the information asymmetry surrounding this field. Products of
agribiotechnology, especially living modified organisms (LMOs) or genetically modified
organisms (GMOs) remain a major source of concern with regard to conservation and
sustainable use of biodiversity, as well as to human health (Craig et al., 2012). Thus,
evolved the need for establishing biosafety regulatory systems in order to have processes
in place to reduce and eliminate potential risks resulting from biotechnology and its
products on plant, animal, or human health, genetic resources, or the environment
(Ministry of Environment, Forest and Climate Change, n.d.a).
Inherently, products of agribiotechnology are global in nature, involving
transboundary movement of GMOs/LMOs for research and development, or for trade
purposes. Hence, it does not suffice for only individual countries to enact national-level
biosafety systems; regulations at international level are also necessary to ensure
cooperation in achieving safe use of the technology and its products.
In order to meet challenges offered by rapidly evolving technologies such as
agribiotechnology, biosafety systems must be continually reformed. This study is a
comparative account of the existing national biosafety framework (NBF) in place in India
with the UNEP-GEF Framework which has been implemented in over 126 countries.
Through this exercise, we intend to identify challenges within the system, in an
endeavour to transform the Indian biosafety regulatory system into a predictable,
transparent, and sustainable framework.

2 International initiatives for biosafety development and implementation

There are multiple international agreements influencing regulation of GM and non-GM

plant and plant products for issues pertaining to plant health or trade across nations – the
Agreement on the Applications of Sanitary and Phytosanitary Measures (SPS),
Agreement on Technical Barriers to Trade (TBT), Agreement on Trade Related Aspects
of Intellectual Property Rights (TRIPS), and the International Treaty on Plant Genetic
Resources for Food and Agriculture (McLean et al., 2012). However, we find the
Convention on Biological Diversity (CBD), and its supplementary environmental treaty,
the Cartagena Protocol on Biosafety (CPB) most relevant to our study.
The objectives of the CBD are centred on conservation and sustainable use of
biodiversity, as well as fair and equitable system of benefit-sharing arising from
utilisation of plant genetic resources (PGRs). However, it was acknowledged that
application of modern biotechnology could also contribute toward achieving objectives of
the CBD, if developed and deployed with adequate safety measures in place for the
environment and human health. The CPB was a result of this acknowledgement, where
 National biosafety system for regulating agricultural biotechnology in India 153

contracting parties agreed upon the need to develop appropriate procedures to address
safe transfer, handling and use of GMOs/LMOs resulting from biotechnology, that may
have adverse effect on the conservation and sustainable use of biological diversity
(Ministry of Environment, Forest and Climate Change, n.d.a). The Protocol exclusively
deals with products of modern biotechnology, and the subsequent issue of biosafety
regulation for said products (McLean et al., 2012). The CPB came into force on
September 11, 2003, and has since been ratified by over 168 parties (as of September
2014). As a Contracting Party to the CBD, India ratified the Protocol on January 23, 2003
(BCH, 2014).
The Global Environment Facility (GEF)1, a pivotal institution entrusted to become the
financial mechanism for the UN CBD, endorsed and approved an array of biosafety
capacity building projects. The United Nations Environment Programme2 (UNEP), an
Implementing Agency of the GEF along with the World Bank and the United Nations
Development Programme (UNDP), played a critical role in supporting countries to
develop and execute GEF projects. For the purposes of this discussion, among the global
projects endorsed by GEF, the UNEP-GEF Project on Development of NBFs and the
UNEP-GEF Project for Building Capacity for Effective Participation in the Biosafety
Clearing House (BCH) of the Cartagena Protocol, are of much significance to this study
(McLean et al., 2012; GEF, 2013).
The GEF, through its biosafety capacity building projects, provided assistance to
12 countries in developing their NBFs in order to meet their obligations as Parties to the
CPB (refer Table 1). These countries included: India and Colombia (their projects were
implemented by the World Bank), Malaysia and Mexico (projects implemented by
UNDP), Bulgaria, Cameroon, China, Cuba, Kenya, Namibia, Poland, and Uganda
(projects implemented by UNEP). Out of these, six countries that include China,
Colombia, India, Kenya, Mexico and Uganda, already developed their biosafety
regulatory framework prior to the Cartagena Protocol. The projects offered the following
support to participating nations in the process of developing their NBFs (McLean et al.,
2012):

a drafting regulations, guidelines, and reviewing NBFs prior to implementation

b operational regulatory and administrative systems in order to handle applications

related to biosafety

c decision-making mechanisms to handle applications for releases and transboundary

movements of GMOs/LMOs

d technical guidelines for risk assessment, risk management, monitoring and

enforcement

e enhancing public awareness, education and participation for strengthening

information systems on GMOs/LMOs

f setting up databases for the purpose of BCH.

 154

GEF capacity building funded projects Table 1

Region/country GEF eligible CPB parties Pilot project NBF-dev NBF-imp-demo NBF-imp BCH-I BCH-II Regional projects
(1) (2) (3) (4) (5) (6) (7)
China * * * *
Colombia * * * LAM-PubAw;
LAM-Compl
India * * * * *
Kenya * * * *
Mexico * * * LAM-Compl
S. Menon and S.K. Jha

Uganda * * * *
Malaysia * * * *
Bulgaria * * * *
Cameroon * * * *
Cuba * * * * * *
Namibia * * * * *
Poland * * *
Projects funded by GEF for implementing NBFs

Notes: *Indicates participation in GEF-funded projects.

The exact names of the GEF funded projects are as follows:
(1) Pilot Biosafety Enabling Activity (Pilot project, 1998–2000)
(2) Development of National Biosafety Frameworks (NBF-Dev, 2001–2007)
(3) Support to the Implementation of the National Biosafety Frameworks (NBF-Imp-Demo, 2002–2006)
(4) Support to the Implementation of the National Biosafety Frameworks (NBF-Imp, 2002–ongoing)
(5) Building capacity for effective participation in the Biosafety Clearing House (BCH) (BCH-I, 2004–2008)
(6) UNEP-GEF Project for Continued Enhancement of Building Capacity for Effective Participation in the BCH (BCH-II, 2010–2012)
(7) Regional projects:
• West African Regional Biosafety Program (Imp-WAfr, 2007–2012)
• Latin-America: Communication and Public Awareness Capacity-Building for Compliance with the Cartagena Protocol on Biosafety
(LAM-PubAw, 2008–2011)
• Latin America: multi-country capacity-building for compliance with the Cartagena Protocol on Biosafety (LAM-Compl, 2008–2011).
Source: BCH (2012a)
 National biosafety system for regulating agricultural biotechnology in India 155

It can be observed from Table 1 that India (under the Ministry of Environment and
Forests – MoEF) successfully implemented the NBF and completed Phase-I Capacity
Building Project on Biosafety through the assistance of GEF-World Bank by June 2007.
The MoEF also initiated Phase-II Capacity Building Project on Biosafety through
UNEP-GEF assistance (BCH, 2012b).

3 Framework for establishing national biosafety regulatory system

The UNEP-GEF Global Project on Development of NBFs was designed to assist

countries in biosafety capacity building in order to comply with the Cartagena Protocol.
The Project was implemented in June 2001 under the UNEP-GEF. By 2005, over 126
countries decided to strengthen their biosafety capacity under the UNEP-GEF Project,
while 40 countries completed the draft versions of their respective NBFs. This project
was intended for capacity building operational at the individual, institutional and
systemic levels (UNEP, 2012).
A NBF is a combination of policy, legal, administrative and technical instruments
developed to ensure adequate level of protection in the safe transfer, handling and use of
modern biotechnology and their products thereof. The following section discusses key
characteristics of the UNEP-GEF Framework, incorporated by several nations in the
process of establishing their own versions of a biosafety regulatory system (Karihaloo
et al., 2006; UNEP-GEF, 2003), which includes:
a a national biosafety policy, which may be a standalone policy on biosafety, or a
part of the policies on biotechnology, agriculture, food production, food safety,
biosecurity and quarantine, biodiversity conservation, environmental protection,
science and technology, or sustainable development
b a regulatory regime, comprising legislations, laws, acts, regulations, or guidelines.
The regulatory component must include the following elements:
1 general provisions (objectives of the biosafety system, scope, definition of
terms, institutional arrangements, and general obligations)
2 operational provisions (contained use, experimental environmental release,
commercialisation, import, export, transit, decision-making procedures,
mechanisms for public participation)
3 miscellaneous provisions (public participation, monitoring enforcement,
offences and penalties, confidentiality, liabilities and redress, labeling and
traceability)
c an administrative system, responsible for receiving and handling requests for permits
(import, export, domestic use, intentional introduction into the environment, field
trials, contained use and transit), risk assessment, meeting obligations under the BCH
d Mechanisms for public awareness, education and participation, that takes
care of public access to information on GMOs/LMOs, public involvement in the
decision-making process for GMOs/LMOs, awareness, education, and access to the
BCH
156 S. Menon and S.K. Jha

e follow-up systems, which monitor environmental effects on human, animal, plant life
or health, enforcement to ensure compliance, offences and penalties.
The UNEP-GEF Framework (refer Figure 1) further elaborates on the key aspects that a
regulatory regime must fulfil (UNEP, 2012):
a clarity: Biosafety regimes must be clear and unambiguous in setting objectives,
definitions, as well as scope of the framework to ensure correct interpretation
b transparency: Any biosafety regime must be transparent in the provisions for
applying for permits and procedures, time limits for tasks, information accessible to
the public, and protection of confidential information
c consistency: Regimes must be consistent internally with the legal provisions of the
nation, as well as international agreements to which the country is a party
d workable
e enforceable: In the process of ensuring compliance of the biosafety regime with the
many national and international agreements (to which one is a party), often results in
a complex and over-ambitious regulatory framework that may be difficult to
implement, and may require a reality check prior to finalisation
f adaptability: For rapidly evolving technologies such as agribiotechnology, the
biosafety regime must be flexible to accommodate and incorporate any necessary
modifications, which requires an efficient mechanism for review and rapid
implementation.

Figure 1 Key aspects of a biosafety regulatory system (modelled on the UNEP-GEF Framework)

As a part of this study, our objective is to compare the existing biosafety regulatory
system in India with the framework endorsed by the UNEP-GEF project, in order to
comply with the Cartagena Protocol. It is imperative that NBFs must strive to achieve a
balance between agricultural productivity, competitiveness, environmental, and human
health concerns, while adhering to science-based principles to evaluate risks and benefits
(UNEP-GEF, 2003). A comparative account of our existing biosafety regulatory system
with the UNEP framework can offer scope for improvement in our system.
 National biosafety system for regulating agricultural biotechnology in India 157

The UNEP-GEF designed a list of ‘key-questions’ that dealt with five different but
interlinked entry points for assessing the progress of the biosafety capacity building
projects in individual countries. These questions enabled UNEP to draw lessons from the
experiences of individual countries in their capacity building process. In a similar
fashion, by inviting such fundamental questions within the Indian context, we can raise
issues concerning ownership, development context, time horizon, stakeholders, and tools
used in developing our biosafety framework. These questions are tabulated as follows:
Table 2 UNEP-GEF key questions

Key question Purpose of the question

(1) Who drives and owns This question brings out an important factor of ‘ownership’ in
the capacity building capacity building initiatives to achieve success of the project.
process at the Ownership essentially means ‘country-driveness’ – indicating
country-level? that more a project is owned and driven from within the country
indicates greater commitment on its part towards the project.
(2) What is the context in This question attempts to address the process of aligning
which the capacity national biosafety goals with the country’s national
building project has to development plans, science and technology policies,
operate? biodiversity strategies as well as trade policies.
(3) What are the The process of setting time horizon depends on which stage of
considerations in terms the biosafety capacity building process is the nation at present:
of timing and time a NBF development stage
horizon for capacity
building? b NBF implementation stage.
Due considerations must be given to the different starting point
for each country, national level awareness of biosafety, priority
allocated to biosafety, basic level of capacity, time for
reviewing and revising existing NBFs.
(4) Who is involved in the This question addresses an important element of ‘stakeholder
capacity building participation’ in NBF -who to involve, how to involve,
project and in which effectiveness of their participation, and when are they involved
ways? in the capacity building process.
(5) How to build capacity This question raises the issue of availability of technical
using global, regional capability or human resource within the country, or
and national-level collaborating with other nations in the process of learning from
tools? their experience.
Source: UNEP (2012)

4 Existing biosafety regulatory system in India

Origin of the biosafety regime in India dates back to 1982, when the National
Biotechnology Board was constituted to issue biotechnology safety guidelines to
undertake research in laboratory and contained use settings. By 1986, the National
Biotechnology Board was promoted to form the Department of Biotechnology (DBT)
under the Ministry of Science and Technology (MST). During the early years of its
functioning, DBT was responsible for monitoring global trends in biotechnology,
developing safety guidelines, and promoting large-scale use of biotechnologies relevant
within the country. Realising the significance of biosafety in assessing risks associated
158 S. Menon and S.K. Jha

with biotechnology, and its impact on biodiversity, environment and human and animal
health, the responsibility of environment protection and biodiversity conservation was
assigned to the MoEF. In order to avoid any conflict of interest with the DBT, the
mandate for research, product development and commercial release involving hazardous
substances3 (which included GMOs/LMOs), as well as their transboundary movement
was allocated to MoEF (Choudhary et al., 2014).

Figure 2 (a) Regulatory coordination among the competent authorities (b) Regulatory
coordination at the ministerial level (see online version for colours)

(a)

(b)

At present, the responsibility of regulatory oversight is primarily shared between two

apex bodies under Government of India – DBT (under MST), and MoEF. Under the
Environmental Protection Act of 1986, India already had in place a biosafety regulatory
framework in the form of the Rules for manufacture, use, import, export and storage of
 National biosafety system for regulating agricultural biotechnology in India 159

hazardous microorganisms/genetically engineered organisms or cells, 1989 (henceforth

referred to as Rules 1989), jointly implemented by MoEFs (as the lead ministry) and
DBT (under MST). These rules not only regulate research, development and large-scale
commercialisation of GM crops but also post-approval monitoring of violation and non-
compliance to biosafety guidelines. Rules 1989 assigned biosafety, risk assessment and
risk management related aspects of GM crops to DBT due to their subject matter
experience and expertise. In fact, DBT was made an integral part of EPA Rules 1989,
allowing both ministries – MoEF and DBT (under MST) to partake in the process
of regulation, risk-benefit analysis, as well as safeguard from consequences
of environmental release of GMOs/LMOs (Choudhary et al., 2014; Ministry of
Environment, Forest and Climate Change, n.d.b).
Rules 1989 has defined five competent authorities under the biosafety regulatory
framework [refer Figure (2a]), which include the Institutional Biosafety Committees
(IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering
Appraisal (formerly Approval) Committee (GEAC), State Biotechnology Coordination
Committee (SBCC) and District Level Committee (DLC), each responsible for handling
various aspects of the biosafety system (Ministry of Environment, Forest and Climate
Change, 2013). Aside from the regulatory coordination existing among the above
mentioned competent authorities, the Indian biosafety system also exhibits
inter-ministerial coordination. The regulatory system includes the ministries of
Agriculture and Health, in addition to the core ministries of Environment and Science and
Technology [refer Figure 2(b)]. There is a three-tier system of approval for GMOs/LMOs
as well as their products under Rules 1989. The initial assessment of the applications
begins at the institutional level itself by the IBSCs, where the proposals are evaluated and
recommended to the RCGM. After in-depth evaluation of the forwarded proposals, the
RCGM sends it recommendations to the GEAC. However, the responsibility of
post-monitoring and field trials of GM crops is assigned to respective state governments
(Choudhary et al., 2014).
The IBSCs are setup at every organisation in India involved in recombinant DNA
(rDNA) activities. Presently, there are approximately 500 IBSCs in place in India, each
reporting to the RCGM, with the primary responsibility of ensuring compliance at
institutional level, and acting as the nodal point for interaction with other regulatory
committees. The RCGM is setup by DBT under MST, with the responsibility of
reviewing all research and controlled field experiments and preparation of guidelines or
manuals. Members of RCGM include experts from multiple disciplines as well as
nominees from leading scientific agencies such as Council of Scientific and Industrial
Research (CSIR), Indian Council of Agricultural Research (ICAR), Indian Council of
Medical Research (ICMR), and Drug Controller General of India (DCGI), etc. The
GEAC, which operates under the MoEF is the apex committee for permit and
authorisation of the use of GMOs/LMOs and their products for large scale field trials and
commerical applications. Members of GEAC include nominees from concerned
ministries and agencies such as Ministry of Agriculture, Ministry of Health, Ministry of
Commerce and Industry, Ministry of External Affairs, Department of Atomic Energy,
etc. (Karihaloo and Kumar, 2009; Damodaran, 2005; Ahuja, 2014; Ministry of
Environment, Forest and Climate Change, n.d.d) Although central in its role for efficient
functioning of the biosafety regulatory framework in India, the GEAC had not been
functional since March 2013 with a backlog of 70 applications pending since 2011 to
160 S. Menon and S.K. Jha

2012, 60 of which have been cleared so far (The Hindu, 2014). The SBCC is setup as a
nodal agency in every state, with the responsibility of inspecting, investigating, and
monitoring activities involving GMOs/LMOs, assess safety procedures and on-site
control measures in the event of release of these products, as well as take punitive action
in case of violations.4 The SBCC also coordinates activities related to GMOs/LMOs in
the state with the central ministries. These committees have been active in some states
where there are substantial GMO-related activities underway. The DLC is setup in each
district with powers to inspect, investigate and report to the SBCC or the GEAC
regarding compliance (or lack of) with regard to rDNA guidelines or violation under the
EPA, 1986. DLC is the nodal agency at the district level to assess damage (if any) in the
event of release of GMOs, as well as take on-site control measures (Karihaloo and
Kumar, 2009; Damodaran, 2005; Ahuja, 2014; MoEF).

5 Comparison of Indian experience with UNEP-GEF framework

The previous section dealt with an overview of the existing biosafety regulatory system
in India. In this section, we attempt to map the extent of compliance of the Indian
biosafety system with the requirements of the CBD, the CPB, as well as the UNEP-GEF
Framework.
As a Contracting Party to the CBD as well as the Protocol, India agreed to implement
systems in place to address safe transfer, handling and use of products resulting from
agribiotechnology that may have adverse effect on conservation and sustainable use of
biological diversity. In order to facilitate its implementation, the Protocol requires that
Parties establish BCH for nations to avail provisions (Ministry of Environment, Forest
and Climate Change, 2015; BCH, 2015) including:
a access to relevant biosafety-related information to assist governments to make
informed decisions regarding importation or release of GMOs/LMOs
b facilitate sharing of information and experiences handling these products
c facilitate scientific and technical cooperation between parties and stakeholders
d access to relevant national laws and regulations governing biotechnology related
activities, or decisions made by nations especially with regard to transboundary
movements.
In accordance with this requirement, with support from GEF-World Bank Capacity
Building project, India established its BCH in 2006, under the MoEF. Members are also
required to designate competent national authorities to administer functions mandated by
the Cartagena Protocol, authorised to act on its behalf with respect to those functions. In
India, the MoEF is the designated competent national authority (MoEF, 2014). Toward
fulfilling our obligations under the Protocol, India submitted the Interim National Report
in 2005, First National Report in 2007, and the Second National Report in 20115, for
reporting on the implementation of the Protocol. The MoEF successfully implemented
NBFs as well as completed Phase-I Capacity Building Project on Biosafety through the
GEF-World Bank assistance in June 2007 (BCH, 2012b). The MoEF also initiated Phase-
II Capacity Building Project on Biosafety through UNEP-GEF assistance (Refer Table 1).
 National biosafety system for regulating agricultural biotechnology in India 161

In Section 3 of this paper, we briefly discussed the framework for biosafety

regulatory system under UNEP-GEF. In this section, we intend to raise the five key-
questions (enlisted below) in order to identify the successes, challenges as well as
shortcomings within the Indian biosafety framework (UNEP, 2012).
Question 1 Ownership: Who drives and owns capacity building process at the country-
level?
Question 2 Development Context: What is the development context in which capacity
building has to operate?
Question 3 Timing: What are the considerations in setting the time horizon for building
capacity?
Question 4 Stakeholders: Who is involved in capacity building project and in what
ways?
Question 5 Tools: How to build capacity using global, regional and national-level
tools?
Question 1 essentially measures the extent of ‘country-driveness’ as a contributory factor
for completing of biosafety capacity building projects. Based on UNEP-GEF learnings
from the experiences of other nations, it has been observed that more a project is owned
and driven by a country, greater the commitment toward the project. A good example of
this case is India, which already had in place a functional NBF, Competent National
Authority as well as a National Focal Point, existence of specific legal and policy
instruments in place – national biosafety laws and regulations as well as biosafety
guidelines for safe handling of GMOs/LMOs, procedures in place for risk assessment,
submission of Reports on Implementation of the Protocol (Interim, First and Second), and
a BCH. It is evident from the initiatives taken by the concerned authorities that India is
driven toward establishing a comprehensive biosafety regulatory system, in order to
accrue benefits arising from agribiotechnology while minimising the risks to environment
and human health (BCH, 2012b).
In a way, Question 2 assesses how individual nations have aligned biosafety capacity
building goals with the nation’s sustainable developmental priorities, science and
technology policies, biodiversity strategies and biosecurity. Regulation of
agribiotechnology in India intersects the mandates and interests of multiple ministries
including Ministry of Agriculture, MST, MoEF, as well as Ministry of Health and Family
Welfare (refer Figure 2b). Capacity building projects are designed to ensure meaningful
inter-ministerial coordination, with clear delineation of roles and responsibilities between
competent authorities (McLean et al., 2012). India has in place a comprehensive
biosafety regulatory framework for ensuring safety while dealing with transboundary
movements of GMOs/LMOs. This was achieved by the inclusion of relevant guidelines
and regulations (from across several ministries) for the manufacture, use, export, import
and storage of GMOs/LMOs. In addition to the EPA (1986) and Rules (1989), additional
legislations include – Protection of Plant Varieties and Farmers Rights Act (2001),
Biological Diversity Act (2002), Plant Quarantine Order – Regulation of Imports into
India (2003), Biological Diversity Act (2004), Food Safety and Standards Act (2006),
DGFT (Directorate General Foreign Trade) Notification on Inclusion of GM Policy in the
Foreign Trade Policy (2006–2009), National Green Tribunal Act (2010), Recombinant
162 S. Menon and S.K. Jha

DNA Safety Guidelines (1990), Revised guidelines for research in transgenic plants
(1998), guidelines for generating preclinical and clinical data for rDNA vaccines,
diagnostics, and other biological (1999), Guidelines for conduct of confined field trials of
regulated GE Plants (2008), and Guidelines and Protocols for the safety assessment of
foods derived from GE Plants (2008) (BCH, 2012b).
Question 3 deals with the issue of setting timelines to achieve targets set for biosafety
capacity building and implementation. Most capacity building projects under UNEP were
granted 18-month duration to achieve targets. However, due consideration must be given
to factors such as starting level of capacity building in the country, availability of funding
for such activities, administrative procedures, awareness and priority allocated to
biosafety, among many other country-specific challenges to achieving biosafety
implementation and development within a given time-horizon. As previously mentioned,
with support from GEF, India already established a functional biosafety regulatory
system, successfully implemented the NBF and completed Phase-I Capacity Building
Project, with Phase-II Project under progress. However, there were certain difficulties in
accessing GEF funds attributed to operational reasons, extensive documentation
requirements and review processes, causing inadvertent delays in adhering to timelines.
By the time funds were made available, changes in national-level policies further affected
and delayed project implementation schedules and outcomes (BCH, 2012b).
In response to Question 4, stakeholder participation is an important element in the
process of developing regulatory framework. Composition of the stakeholder
participation reflects country’s needs and priorities. In India, the process of preparation
and validation of national reports (interim, first and second) invited participation from
various stakeholders including ministries and departments including Department of
Agriculture and Cooperation, Department of Agricultural Research and Education,
Customs departments, National Biodiversity Authority, National Bureau of Plant Genetic
Resources, as well as enforcement agencies, academic institutions involved in
biotechnology research, industry associations, civil societies, farmers associations, and
NGOs. In short, the stakeholder participation in India has been broader and inclusive,
resulting in designing a comprehensive NBF (BCH, 2012b).
Question 5 brings out the core of any capacity building project – the availability of
technical or absorptive capacity within a country, a dearth of which can result in
countries seeking assistance from regional or international human resources. In an
endeavour to learn from other nations, share experiences on implementation of national
biosafety regulations, risk assessment and management procedures, experts from India
participated in workshops organised by Government of Vietnam, Thailand, Sri Lanka,
Bhutan, Malaysia, as well as hosted conferences and preparatory meetings for the
information exchange on capacity building initiatives. India per se does not lack in
technical and legal expertise in the matters of biosafety development and implementation.
The involvement of diverse expertise part of committees like GEAC, RCGM, IBSC,
SBCC, or DLC are indicative of the absorptive capacity of India. However, since India is
not a Party to importation of GMOs/LMOs for the purpose of food, feed or processing,
her experience in handling such material beyond research and contained use is limited.6
The transgenic events listed in Table 3 have been approved for contained environmental
release in India. Nonetheless, efforts are underway to strengthen our capability for
activities beyond contained use (BCH, 2012b).

GMOs/LMOs
MON-ØØ531-6 – Bollgard™
cotton
MON-15985-7 – Bollgard II™
cotton
Insect resistant cotton
GTL-GFM311-6 – Cotton
modified for insect resistance
Insect resistant cotton (MLS 9124)
Source: Biosafety Clearing House National Mode (n.d.)
Date of decision Features
26/03/2002 Resistance to antibiotics – Kanamycin,
Streptomycin resistance to diseases and pests –
Insects – Lepidoptera (butterflies and moths)
22/05/2006 Resistance to antibiotics – Kanamycin,
Streptomycin resistance to diseases and pests –
Insects – Lepidoptera (butterflies and moths)
Selectable marker genes and reporter genes
04/04/2006 Resistance to antibiotics – Kanamycin resistance to
diseases and pests – Insects – Lepidoptera
(butterflies and moths)
04/04/2006 Resistance to antibiotics – Kanamycin resistance
to diseases and pests – Insects – Lepidoptera
(butterflies and moths) – Cotton bollworm
(Helicoverpa spp.) selectable marker genes and
reporter genes
13/05/2009 Resistance to antibiotics – Kanamycin resistance to
diseases and pests – Insects – Lepidoptera
(butterflies and moths) – armyworm (Spodoptera
frugiperda)
Table 3
Risk assessment
Approval for environmental release of three Bt
cotton hybrids containing Cry 1Ac gene (MON531
event) developed by Maharashtra HybridSeeds
Company (MAHYCO)
Approval for environmental release of Bt cotton
hybrids (Bollgard II) containing stacked
genescry1Ac and cry2Ab2 genes (MON 15985)
developed by M/s Maharashtra Hybrid Seeds
Company Limited (MAHYCO).
Approval for environmental release of four
ransgenic Bt hybrid cotton containing Cry 1Acgene
(Event-1) developed by JK Agri Genetics Ltd.
Approval for environmental release of three
transgenic Bt cotton hybrids containing GFM
Cry 1A gene developed by Global Transgenes
(Nath Group Company)
Approval for environmental release of two Bt
cotton hybrids expressing synthetic cry 1C gene
(event MLS 9124) for central and south zones
developed by M/s Metahelix Life Sciences Pvt.
List of GMOs/LMOs approved for environmental release in India
Ltd., Bangalore
National biosafety system for regulating agricultural biotechnology in India 163
164 S. Menon and S.K. Jha

Section 5 dealt with the Indian experience in the process of establishing her biosafety
regulatory system. Based on these findings, we understand that the Indian experience
although admirable, but not without its own challenges. Currently, under funding from
GEF-World Bank, India is in Phase-II of Building Capacity for Effective Participation in
the BCH. As a part of this project, India is carrying out a capacity-building needs
assessment that includes – support for building institutional capacity, human resource
development and training, risk assessment, risk management as well as other scientific
and technical expertise, public awareness, participation and education in biosafety,
scientific, technical and institutional collaboration at subregional, regional and
international levels, technology transfer, identification of GMOs/LMOs as well as their
detection, socio-economic considerations of implementing biosafety regulatory system,
handling of confidential information, measures to address unintentional or illegal
transboundary movements of GMOs/LMOs, scientific biosafety research related to
handling of such products, and potential risks to human health (BCH, 2012b).

6 Recent trends in biosafety regulation in India

Despite the existence of a formal regulatory system in place, biosafety has been a bone of
contention for years. In India, the United Progressive Alliance (UPA) government (which
remained in power till mid 2014) imposed a ten-year moratorium on the
commercialisation and release of Bt Brinjal. This decision was further supported by a
report released in 2012 based on the findings of a six-member Technical Expert
Committee (TEC) appointed by the Supreme Court of India as well as the Parliamentary
Standing Committee, both of which recommended a moratorium on any further field tests
for GM crops unless shortcomings in the regulatory process were remedied. Since then,
the GEAC was in a state of functional uncertainty for over a year, with over 60 pending
cases of field trials. However, toward the early part of 2014, when the GEAC was
reconvened to clear proposals to conduct GM trials, the UPA government seemed to have
relaxed its stance. With support from the then Prime Minister and Union Agriculture
Minister, the Environment Minister gave formal approval to field trials (since the 2010
and 2012 moratorium), virtually reversing the decision of his predecessors. Nonetheless,
the decision was attached with a disclaimer stating that organisations receiving heads-up
from GEAC would have to approach respective state governments to avail an NOC
(no-objection certificate) prior to beginning trials, since agriculture was a state subject
(Livemint, 2014).
While UPA paved the way in approving field testing of new crops and traits, the new
government – the National Democratic Alliance (NDA) which came into power in
mid-2014, was also of the view that research in GM and confined field trials for
generating biosafety data with all due precautions, should be allowed to continue in
national interest. The NDA government approved recommendations of GEAC for field
trials for 12 GM crops (including rice, wheat, maize, potato, sorghum, brinjal, sugarcane,
chickpea, groundnut, mustard, cotton, and castor) that have awaited entry into the Indian
market for years. However, this decision was overturned within a matter of weeks, when
the MoEF decided to keep on hold field trials of these crops, after alleged pressure from
certain political organisations within the country (Livemint Op-Ed, 2014).
The Gujarat State Government has so far permitted field trials only for cotton, while
refusing permission as far as food crops are concerned. They have argued that
 National biosafety system for regulating agricultural biotechnology in India 165

consumption of GM food crops can pose risk to the health of people, in addition to the
environment. Recently, Maharashtra State Government has given an NOC for field trials
of five GM crops – Brinjal, maize, rice, chickpea and cotton. Based on the results of the
field trials, the central government will make a decision on whether to introduce these
GM crops into market. Following suit of its neighbour, the Karnataka State Government
will also allow confined field trials of GM crops. While Andhra Pradesh, Gujarat, Punjab,
Haryana, Maharashtra and Karnataka (still in process) are allowing confined field trials,
states like Kerala, Tamil Nadu, Madhya Pradesh, Chattisgarh, Bihar, West Bengal and
Rajasthan have not yet given their consent. Differences in consent across state
governments also reflect uncertainty and non-uniformity in terms of acceptance of the
technology. These events indicate that mere existence of a biosafety framework
does not necessarily culminate into streamlined approval and commercialisation of
agribiotechnology (DNA, 2015).
With the intention of setting up a statutory ‘science-based regulatory mechanism’,
Government of India proposed the Biotechnology Regulatory Authority of India (BRAI)
as the nodal agency for serving this purpose. The BRAI Bill was introduced in the
Parliament on April 22, 2013, under the MST, with the purpose of setting up an
independent authority to regulate products of modern biotechnology. Their
responsibilities would include regulating research, transport, import, containment,
environmental release, manufacture and use of modern biotechnology and products
thereof. Under the current system, the MoEF through Rules 1989 (under EPA 1986),
primarily regulates the manufacture, use, import, export, and storage of hazardous
organisms (which include GMOs/LMOs). Under the Rules, GEAC is responsible for
large-scale production, environmental applications and use. In addition, the DBT and
MST issue Guidelines on rDNA safety concerns. Under the DBT, the RCGM deals with
research and field trials under controlled conditions. However, implementation of the Bill
would bring about the following changes (refer Table 4) – BRAI would be the nodal
agency dealing with matters related to biosafety, the GEAC and RCGM would become
non-functional, a 17-member Inter-Ministerial Governing Board (IMGB) would be setup
to promote cooperation and coordination between different ministries, departments,
directorates, councils and authorities, set-up of a 15-member Biotechnology Advisory
Council (BAC) to give strategic advice to the BRAI, and a Biotechnology Regulatory
Appellate Tribunal to hear civil cases involving substantial questions relating to
biotechnology and its products. The BRAI will comprise three units – Risk Assessment
Unit (RAU), Product Rulings Committee (PRC) and Environmental Appraisal Panel
(EAP). For research, transport and import of GMOs/LMOs, the BRAI will refer to the
RAU, in case of manufacture or use, the PRC will make recommendations regarding
safety of the product and for environmental impact of any product, BRAI would refer to
the EAP. However, there have been concerns among certain group of stakeholders that
the BRAI Bill would shift the balance of power for biosafety-related matters from MoEF
to the MST. According to the Bill, environmental safety matters would be referred to the
EAP that would be setup by the BRAI in consultation with MoEF. Although it is
mandatory for the BRAI to obtain the opinion of the EAP, but it is not bound abide by it
(PRS Legislative Research, 2013). The following table provides a snapshot of the
differences between the existing regulatory system and under BRAI Bill (if and when
implemented).
166 S. Menon and S.K. Jha

Table 4 Biosafety regulatory system in India: comparison of current vs. BRAI Bill Regime

Current Regulatory System under Regulatory System under BRAI

Rules 1989 Bill 2013
Authority MoEF & DBT under MST give Independent Statutory body will
approvals give approvals
Regulated Activities Manufacture, use, sale, import, Research, transport, import,
export and storage of manufacture and use of
GMOs/LMOs GMOs/LMOs
Approval Agencies Final approval by GEAC, Single regulator comprising RAU,
technical review by RCGM PRC and EAP
Assessment of GEAC approves proposals for EAP shall make
Environmental release of products into the recommendations on safety of
Impact environment products for environmental
release
Representation Ministry officials, representatives Personnel with scientific expertise
from scientific and technical in the area of biotechnology
bodies
Judiciary Body Authority to be notified by MoEF, Appeals to be heard by
National Green Tribunal (NGT) Biotechnology Regulatory
has jurisdiction in some cases Appellate Tribunal
Source: PRS Legislative Research (2013)
At present, the Biotechnology Regulatory Authority of India Bill is pending approval in
the Parliament since 2013. It has been learnt from experience that most regulatory bodies
often end up as mere licensing agencies, at the disposal of political ambitions. Under
present circumstances, irrespective of the implementation of BRAI or the continued
existence of the current biosafety regulatory framework, success can only be achieved if
decision-making is scientific, efficient and independent of political influence.

7 Conclusions

Agricultural biotechnology has the potential to improve crop productivity, increase farm
incomes, and alleviate food security concerns in India. Adoption of such technologies has
resulted in the need for establishing biosafety regulatory systems in place in order to
reduce and eliminate potential risks arising from the technology and its products on plant,
animal and human life and health, environment and biodiversity. In this study, we
highlighted the functioning of the regulatory framework in India, along with recent
events with regard to biosafety events. However, the most essential aspect of the study
was the comparative account of the existing NBF in place in India with the UNEP-GEF
framework (implemented in over 126 countries). On comparison with the UNEP-GEF
Framework, the Indian experience of establishing her biosafety regulatory process
although admirable, but not without its own challenges. Through this exercise, we
intended to identify challenges within the system, in an endeavour to transform the Indian
biosafety regulatory system into a predictable, transparent and sustainable framework.
 National biosafety system for regulating agricultural biotechnology in India 167

Acknowledgements

This work was supported by funding from the IPR Chair Project at IIT Bombay, under
the Ministry of Human Resource Development (MHRD), Government of India.

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Notes
1 The GEF is an independently operating financial organisation, in partnership with
international institutions, civil society organisations (CSOs) and private sector, to provide
funding to support activities related to biodiversity, climate change, international waters, land
degradation, chemicals and waste in the context of development projects and programmes.
The UNDP, the United Nations Environment Program, and the World Bank were the three
initial partners implementing GEF projects. However, after 1994 Rio Summit, GEF was
restructured and moved out of the World Bank to become a permanent, separate institution
(with World Bank serving only as a Trustee of the GEF Trust Fund). GEF serves as a financial
mechanism for the following conventions –CBD, United Nations Framework Convention on
Climate Change (UNFCC), Stockholm Convention on Persistent Organic Pollutants (POPs),
UN Convention to Combat Desertification (UNCCD), and Minamata Convention on Mercury,
in addition to providing support to several projects targeted at improving global environment
(GEF, 2013).
2 UNEP is the only implementing agency of GEF whose core business is the environment
(UNEP, 2003).
 National biosafety system for regulating agricultural biotechnology in India 169

3 The Environment Protection Act (1986) does not separately describe GMOs in the law per se,
instead it is included under the legislative provisions to regulate environmental pollution
caused by ‘hazardous substances’ – any substance/preparation by virtue of its chemical or
physiochemical properties or handling is liable to cause harm to human beings other than
plants, animals, microorganism, or environment.
4 In case of violations, SBCC can take action through the State Pollution Control Board or the
Directorate of Health.
5 The deadline for submitting the Third National Report is 1st November 2015 (BCH, 2012b).
6 Currently, technical clearance for import of transgenic plant material is issued by the RCGM,
and import permit for research purposes is issued by the National Bureau of Plant Genetic
Resources (NBPGR).

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