NATIONAL LAW INSTITUTE UNIVERSITY

BHOPAL

BIOTECHNOLOGICAL ADVANCEMENT
AND
BIOSAFETY LAWS
XII TRIMESTER
SESSION 2019-2020

Submitted to: Submitted by:

Dr. Rajiv Khare Vipul Dohle
2016BALLB110
1
 ACKNOWLEDGMENT
An enterprise of such a magnitude as this research on the topic “Biotechnological
advancement and Biosafety laws in India” could only fructify in such a short span of
time due to the coalescing of able guidance and support of many learned and able
persons, whose efforts and cooperation, I as the researcher, with a sense of gratitude,
being duty bound too, acknowledge in no particular order. My deepest gratitude and
thanks to the Hon’ble Prof. Dr Ajay Kumar Barnwal, Assistant Professor, Central
University of South Bihar, an eminent professor and scholar gave enough time and space
for free exchange of ideas and, opinions greatly benefiting me in augmentation and
critiquing of many of the opinions which find their place in this work.
Despite the busy schedule and onerous academic responsibilities, she gave me ample time
whenever he was approached for his invaluable guidance. I am highly indebted to the
library staff to help me find the relevant books and journals, and other officials and office
staffs, who have also extended their help whenever needed. I would like to extend my
sincere thanks to all of my friends for their review and honest remarks. Last, but not the
least my eternal gratitude is due, to my loving Parents whose constant unflinching
support, blessings and encouragement both, temporal and emotional support, to meet any
challenge with confidence including, of this purposive academic exercise.

Vipul Dohle
2016BALLB110

2
TITLE OF THE PROJECT:
Biotechnological Advancement And Biosafety Laws

STATEMENT OF PROBLEM:
One of the major challenges in the process of regulation is to establish and maintain an
appropriate balance between potential benefits of the technology and environmental and
health risks posed by it.

OBJECTIVE OF STUDY:
 To understand the need to protect human and animal health and environment from the
possible adverse effects of the products of modern biotechnology and the Biosafety laws in
India.

HYPOTHESIS:
There is a new law—the Biotechnology Authority of India (BRAI)—under consideration of
the Central government.

RESEARCH QUESTIONS:
1. What is Biosafety?
2. What are LMO’s?
3. Why there is a need of Biosafety of the Environment?
4. What policy is undertaken in India to ensure biosafety?

RESEARCH METHODOLOGY:
In accordance with the objectives of the present study, doctrinal research design has been
adopted. The doctrinal design has been used to study the Biosafety Laws. Doctrinal Research
is a research, as we all know, based on the principles or the propositions made earlier. It is
more based on the sources like books of the library, and through resources collected through
access to various websites. For the purpose of the Research Project, the Researcher has
collected relevant materials from books on Environmental Law and Biosafety Laws, and also
from various websites. The Research has been done primarily with the help of case laws and
leading judgements of various courts as well as legislative provisions. Various articles from
the internet sources have also been referred.

3
 TABLE OF AUTHORITIES

I. CASES

 Nalla Yadagiri v. Monsanto India Ltd.)1.

 Aruna Rodrigues & Others v. Union of India & Others, Special Leave Petition (Civil)
No. 260 of 20052.

II. TREATIES AND CONVENTIONS

 Convention on Biological Diversity

 The Cartagena Protocol on Biosafety

III. STATUTES
1. Environment (protection) act 1986 and rules 1989
2. Food safety and standards act, 20063:
3. Biological diversity act 2002
4. BRAI Bill, 2013

IV. ARTICLES

 Biosafety Policy and Implications in India By Sachin Chaturvedi

 Regulation of emerging gene technologies in India by Vibha Ahuja
 India and the international biosafety law: a critical legal appraisal of the
Biotechnology Regulatory Authority of India Bill, 2013
Authors: S.R. Subramanian; A. Saravanan; S.R. Sethu Narayanan

1
Consumer Dispute No. 03/2004, Available on www.lawctopus.com.
2
On 10 May, 2012, Available on http://ddsindia.com/www/PDF/PIL.
3
No. 34 OF 2006.

4
 CONTENTS

INTRODUCTION.....................................................................................................................4

Major initiatives and achievements of the Department of Biotechnology (DBT) during

2017:.......................................................................................................................................4

Healthcare:.............................................................................................................................5

Bioenergy:..............................................................................................................................5

Environment and Sanitation:..................................................................................................5

Biosafety:...............................................................................................................................6

What are LMOs?................................................................................................................6

Biosafety for the environment:..................................................................................................7

Environmental Law Principles:..............................................................................................8

Cases:.......................................................................................................................................10

BIOSAFETY LAW IN-THE-MAKING OF INDIA...............................................................11

FOOD SAFETY AND STANDARDS ACT, 2006:............................................................11

HIGHLIGHTS OF THE BRAI BILL, 2013:.......................................................................13

CONCLUSION........................................................................................................................14

BIBLIOGRAPHY....................................................................................................................15

5
 INTRODUCTION

The Department of Biotechnology (hereinafter DBT) is a department, under

the Ministry of Science and Technology responsible for administrating development and
commercialisation in the field of modern biology and biotechnology in India. It was set
up in 1986. The Mission and Vision of the Department is “Attaining new heights in
biotechnology research, shaping biotechnology into a premier precision tool of the
future for creation of wealth and ensuring social justice-specially for the poor.”
Through several research and development projects, demonstrations, grants and creation
of infrastructural facilities a clear visible impact of this field has been seen. The
department has made significant achievements in the growth and application of
biotechnology in the broad areas of agriculture, health care, animal sciences,
environment, and industry. The proven technologies at the laboratory level have been
scaled up and demonstrated in field.

Major initiatives and achievements of the Department of Biotechnology

(DBT) during 20174:

For the Department of Biotechnology, the year 2017 has been marked by path breaking
research and cutting-edge technology in myriad of areas. The key areas span across
healthcare, agriculture, food and nutrition, bio energy, and environment, which have reached
people translating into benefits for them. The Department has also scored high in supporting
innovations, start-ups and entrepreneurs, and in collaborating to pool international expertise
to escalate science excellence. At the same time, it has worked relentlessly to nurture human
resource excellence in biotechnology in several ways.

4
Pressinformationbureau-New Delhi

6
A summary of the achievements in across different areas are presented below:

Healthcare:

National Bio Pharma Mission Launched.

India is now a leader in vaccine manufacture & development with several advancements.
Dengue Vaccine

Bioenergy:

 India’s first biomass to ethanol plant & its commercialization.

 Biomass to Ethanol plant at Kashipur being inaugurated.

The Institute of Chemical Technology (ICT), Mumbai, has developed India’s first home
grown technology to convert biomass to ethanol with speed and efficiency. The
technology, which converts agricultural waste into ethyl alcohol, or bio-ethanol, is
superior to other prevalent technologies as the rate of conversion is four times faster than
those available in the international market. While the time taken to convert biomass to bio
fuel is about 4 to 7 days with prevalent technologies, the one developed by the team at
DBT-ICT does the same in about 18-20 hours, and produces about 300 litres of ethanol
per ton of biomass. The produce can be blended with petrol to be used in vehicles as fuel.
The country’s first second-generation (2G) Ethanol plant was inaugurated by the Union
Minister for Science and Technology and Earth Sciences, Dr. Harsh Vardhan, at Kashipur
in Uttarakhand.

Environment and Sanitation:

 Green remediation technology for waste water

The green remediation technology and the cleaned-up waste water. DBT is participating
in the Swachh Bharat Abhiyan through a range of initiatives including bioremediation of
filthy water.

7
  Waste treatment technologies galore
With the support of BIRAC, a technology for removing organic waste from
municipal waste water at 95% efficiency has been developed. The technology,
called anaerobic membrane bioreactor An MBR (2000L), is a product of a
company called Thermax.
 Conversion of waste to green chemicals

An economical, end-to-end process to convert waste to chemicals via biogas has been
developed with the help of engineered strains. Lactate dehydrogenase genes from
different hosts have been expressed and tested in methanotrophs. Recombinant strains
show higher levels of lactic acid compared to wild strains.

BIOSAFETY:

Paragraph 3(i) of the Cartagena Protocol on Biosafety:- The term biosafety is sometimes
used interchangeably with ‘biosecurity’, but the latter has now acquired a specific
meaning with respect to the efforts to prevent the transmission of infectious pests and
diseases.
Biosafety is to be practiced both inside the laboratory where life forms are being altered
and tested, and outside in the open environment where they may be released. Biosafety
can be with reference to various sectors like pharmaceuticals, nutrition and industrial
applications. In this unit, because the context is environmental law, the focus will be on
the importance of biosafety laws in agriculture and biodiversity 5.

What are LMOs?

The subject matter of biosafety laws are living modified organisms (LMOs). These
organisms are quite literally constructed in a laboratory. They are organisms that would
not normally be found in nature, but are made from the rearrangement of the organism’s
own genes (sysgenics) or by the introduction of gene(s) foreign to its original genetic
structure (transgenics). In other words, LMOs are living forms that nature has not made,
but have been made by human intervention in naturally-existing life forms.
As per international law, an LMO is ‘any living organism that possesses a novel
combination of genetic material obtained through the use of modern biotechnology’
5
Available on dbtindia.nic.in, last accessed on 15.10.2019.

8
(Article 3, Cartagena Protocol on Biosafety). The words popularly used to describe such
altered life forms are either genetically modified (GM) or genetically engineered (GE).

BIOSAFETY FOR THE ENVIRONMENT:

For the purposes of biosafety, there is need for not only well-drafted legal texts but also
supportive administrative and other measures. These include having the necessary
technical infrastructure, scientific expertise and the institutional capacities, as well as
public awareness on how to handle the possible risks to environment.
Biosafety could become a serious concern when LMOs are released in the open
environment. The smallest part of living matter – a gene, by itself may not be potentially
hazardous. But when that gene is isolated and subsequently inserted in another living
form, which does not normally possess it, the genetic structure of that living organism is
fundamentally altered. It can make the LMO/GMO interact in unpredictable ways with
the natural world around it. This introduces the element of uncertainty. The law then has
to factor in the element of risk to the environment. For that very reason the law has to
provide for both risk assessment and risk management.
There is no agreement worldwide on the degree of risk from LMOs. Nonetheless, what
makes biosafety a risk-prone endeavour in itself is that LMOs do not follow the laws of
the land; they follow the laws of nature. Lawmakers might make the best laws and
scientists may make unique LMOs, but no one has the power to control every interaction
that happens in the natural environment amongst its different components. There are no
means to recall a LMO that has been unleashed into the open environment. Though the
core focus of biosafety laws has to be both prevention of contamination and the
protection of both human and ecological health, yet there are inherent limits to laws on
biosafety.

9
Environmental Law Principles:

There are two well-established principles in environmental jurisprudence, namely:

1.) The precautionary principle:- Principle 15 of the Rio Declaration on Environment and
Development, 1992 makes it clear that in order to protect the environment; the
precautionary approach shall be widely applied by States according to their capabilities.
Where there are threats of serious or irreversible damage, lack of full scientific certainty
shall not be used as a reason for postponing cost-effective measures to prevent
environmental degradation.

The principle really asks for one to tread with caution when the risks from a technology
are not fully known. This is with an end to protect the environment. When applied to
biosafety, it implies that given the lack of scientific consensus on the safety of LMOs,
there is no reason to relax the preventive actions or precautionary measures. The
biosafety regime can be made less stringent only once there is adequate proof that
LMOs/GM products are safe; but one cannot be any less cautious while awaiting
scientific proof. Until then the onus is on the user/promoter of LMOs to handle the
technology with care and show that they are safe. The standard of care to be taken is to be
prescribed by the biosafety law.

2.) The ‘polluter pays’ principle:- Principle 16 of the Rio Declaration lays down another
idea central to environmental laws: National authorities should endeavour to promote the
internalisation of environmental costs and the use of economic instruments, taking into
account the approach that the polluter should, in principle, bear the cost of pollution, with
due regard to the public interest and without distorting international trade and investment.
Requiring the polluter to pay has both ethical and other more practical considerations. At
an ethical level, it is about insistence on taking responsibility for the harm caused to
human or ecological health from the use of potentially hazardous products. It is normative
in terms of suggesting ‘what ought to be’; in doing so it prescribes the morally correct
behaviour that is to be enforced by law.

10
3.) Sustainable development: There is a third overarching principle for future actions that
is now further developing, i.e. sustainable development. In 1987, the World Commission
on Environment and Development had in its report ‘Our Common Future’ posited the
idea of ‘sustainable development’ as ‘(d)development that meets the needs of the present
without compromising the ability of future generations to meet their own needs’. Post
Rio+20 United Nations Conference on Sustainable Development, there is an ongoing
international process to draft Sustainable development goals (SDGs). The proposed Goal
15 among other things, aims ‘to take urgent and significant action to reduce degradation
of natural habitat, (and) halt the loss of biodiversity’. 6

While the capacity of LMOs to contribute to sustainable development is still

questionable, the role of biosafety laws that embody the above principles cannot be
undermined.

4.) Cartagena Protocol on Biosafety (CPB):-

The CPB is a daughter treaty of the CBD. This international protocol2 – a kind of sub-
treaty, in its 40 articles elaborates the international regime on biosafety. It is based on the
idea that a country cannot regulate LMOs unless it is aware of them being transported
into its area.
Negotiations for this Protocol began under the CBD in 1994 and it took nearly a decade
for the text to enter into force. This was due to the opposing viewpoints on the issue of
safety of LMOs. Today there are 168 countries that are members of this Protocol. They
meet every two years alongside the meetings of the CBD, through a process called the
Meeting of Parties (MOP).

6
Outcome Document – Open Working Group on SDGs on URL
http://sustainabledevelopment.un.org/focussdgs.html.

11
 CASES:

Environmental law is not only enacted through legislative processes or made by rules and
regulations notified by executive bodies. The judiciary through its various decisions also
develops the body of law in this area. Across the globe, various aspects of biosafety have
also come before regular courts, quasi-judicial bodies and other forum, such as consumer
disputes redressal commissions (see, for example Nalla Yadagiri v. Monsanto India
Ltd.)7.

Over the years, NGOs and ordinary citizens have filed cases in public interest for a proper
biosafety system to be set up in the country. The one currently ongoing in the highest
court of the land – the Supreme Court of India - is Aruna Rodrigues & Others v. Union
of India & Others, Special Leave Petition (Civil) No. 260 of 2005 8.
In this case, the petitioners approached the Court to ask for necessary directions so that
biosafety regulation is undertaken by independent scientific agencies. Till such a system
is put in place, the petitioners are seeking that the Court not allow any release of GMOs
into the environment by way of import, manufacture, use or any other manner.

7
Consumer Dispute No. 03/2004, Available on www.lawctopus.com.
8
On 10 May, 2012, Available on http://ddsindia.com/www/PDF/PIL.

12
 BIOSAFETY LAW IN-THE-MAKING OF INDIA

Under Biosafety Research programme main emphasis is given to facilitate the

implementation of biosafety procedures, rules and guidelines under Environment
(Protection) Act 1986 and Rules 1989 to ensure safety from the use of Genetically
Modified Organisms (GMOs) and products thereof in research and application to the
users as well as to the environment. A three tier mechanism comprising Institutional
Biosafety Committees (IBSC) at the Institute/ company; the Review Committee on
Genetic Manipulation (RCGM) in the Department of Biotechnology; and the Genetic
Engineering Approval Committee (GEAC) in the Ministry of Environment & Forests
(MoE and MoF) for granting approval for research and development activities on
recombinant DNA products, environmental release of genetically engineered (GE)crops
and monitoring and evaluation of research activities involving recombinant DNA
technology has been established. Applications in pharma/ agriculture sectors for import/
export/ transfer / exchange of GE materials including GE seeds, conduct of pre-clinical
toxicity studies, evaluation of pre-clinical study reports and recommendations to DCGI
for appropriate phase of clinical trials of new drug(s) or similar biologics, confined field
trials on GE crops etc., were examined by the RCGM and appropriate decisions were
taken. RCGM has taken several policy decisions on biosafety research on agricultural/
bio-pharmaceuticals / industrial products9.

FOOD SAFETY AND STANDARDS ACT, 200610:

An Act to consolidate the laws relating to food and to establish the Food Safety and
Standards Authority of India for laying down science based standards for articles of food
and to regulate their manufacture, storage, distribution, sale and import, to ensure
availability of safe and wholesome food for human consumption.
India does not have a full-fledged legislation on biosafety though the matter has come up
in different contexts in the Union Parliament, for example, through the questions raised in

9
Available on https://www.lawctopus.com/academike/biotechnology-regulatory-authority-bill-2013/.
10
No. 34 OF 2006.

13
the Houses of Parliament, as well as through multi-party Parliamentary Standing
Committees addressing the issue.
India enacted Biological Diversity Act in 2002 for giving effect to the provisions of the
CBD. Objective of this act is to regulate the access to genetic resources and protection of
biodiversity. This act provides for establishment of statutory bodies such as National
Biodiversity Authority, State Biodiversity Boards, National and State Biodiversity Funds,
Biodiversity Management Committee etc.
National Biodiversity Authority, National Biodiversity Office has been established in
Chennai as per provisions of the BDA-2002.

Structure of NBA:-

One chairman, Seven Ex-officio members and five non-official members; all to be
appointed by central government. Chairman appointed by Central Government.
Chairman appointed by Central Government. He / she shall be an eminent person having
adequate knowledge and experience in the conservation and sustainable use of biological
diversity and in matters relating to equitable sharing of benefits. The chairman can be
removed by the Central government.
Seven Ex-officio members are from the following fields: Agricultural Research and
Education; Biotechnology; Ocean Development; Agriculture and Cooperation; Indian
Systems of Medicine and Homoeopathy; Science and Technology; Scientific and
Industrial Research; Five non-official members will also be appoint. These will be
persons with good domain knowledge in biodiversity.
Powers and Functions of NBA:-
All foreign nationals require approval from NBA for obtaining Biological Resources from
India.
All Indian individuals/entities are required to seek NBA approval before transferring
knowledge / research and material to foreigners11.

11
Available on dbtindia.ac.in.

14
 HIGHLIGHTS OF THE BRAI BILL, 2013:
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.

In May 2003, the Union Ministry of Agriculture set up a Task Force, chaired by the
agricultural scientist Dr. M.S. Swaminathan, to formulate a policy on the application of
genetic engineering in agriculture. The Task Force recommended that a national law be
legislated and an independent biotechnology regulatory authority, which would oversee
biosafety concerns, be established. The Government of the day moved to revamp the
biosafety regime of the country through first drafting a National Biotechnology
Development Strategy, 2007. This was followed by the Union Ministry of Science and
Technology, through the DBT, drafting a new biosafety law: National Biotechnology
Regulatory Authority Bill, 2008.
There were serious concerns about the independence of the proposed Authority, with the
draft law emanating from the very governmental agency whose function is to promote
biotechnology. In the light of strong public opposition, a revised version of the proposed
law followed. This Bill, namely the Biotechnology Regulatory Authority of India (BRAI)
Bill, 2012, is still in draft form. It assigns the same definition to environment as in the
Environment (Protection) Act, 1986.

15
 CONCLUSION

Biosafety is concerned with the safety of human and ecological health when products
developed by modern biotechnology are used, either in laboratory conditions or in the
open environment. LMOs are living modified organisms, which are not normally found in
nature, but are constructed in laboratory conditions. Biosafety relies heavily on the use of
law. But it also requires technological infrastructure to be able to test for the presence of
genetic material. The international law on biosafety has developed under the Convention
on Biological Diversity. There are two specific Protocols on the issue. There are
environmental law principles that form the basis of biosafety legislation. The law on
biosafety in India is still developing. The country’s biosafety Rules of 1989 are poised for
change. The biosafety agencies set up thereunder might be replaced with a full-fledged
law establishing a biotechnology regulatory authority. There are several other laws, apart
from core biosafety laws, which also have a bearing on the issue of biosafety.

16
 BIBLIOGRAPHY

Books & Article

1.) Amod S, Tilak,, “Environmental Law” (New Delhi: Snow White Publications, 2009).
2.) Buck J,Susan , Understanding Environmental Administration and Law, 3rd edn,
(Washington, Island Press, 2006).
3.) Geetanjoy, Sahu, Environmental Jurisprudence and the Supreme Court: Litigation,
Interpretation, Implementation, (New Delhi: Orient Blackswan, 2014).

News
1. Financial Express, 2 June 2007.
2. Economic and Political Weekly, XXXII, July 1997
3. The observer of Business and Politics, April 2000.
4. Frontline 20, no. 20 (September 23-October 10, 2003).
5. CEERA Newsletter, National Law School of India University, Bangalore, India.
February, 2003.

Internet:
1.) www.mondaq.com/india/x/26049/Healthcare/Biotechnology+Laws+in+India

2.) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069684/

3.)
epgp.inflibnet.ac.in/epgpdata/uploads/.../law/06...law/...biosafety/.../7611_et_08_et.pd...

4.) https://www.lawctopus.com/academike/biotechnology-regulatory-authority-bill-2013/

6.) www.dbtindia.nic.in/.../Regulations-Guidelines-for-Reocminant-DNA-Research-and-
B...

7.) https://www.omicsonline.org/.../biosafety-issues-of-genetically-modified-organisms-2.

17