Академический Документы
Профессиональный Документы
Культура Документы
Topic:
“Biotechnological advancement and Biosafety Laws in India”
1
CONTENT
2
ACKNOWLEDGEMENT
3
INTRODUCTION
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.
Healthcare:
1
Pressinformationbureau-New Delhi
4
Dengue Vaccine
Bioenergy:
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.
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.
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.
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
5
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 biodiversity2.
2
Available on dbtindia.nic.in, last accessed on 15.10.2019.
6
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.
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
7
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.
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’.3
3
Outcome Document – Open Working Group on SDGs on URL
http://sustainabledevelopment.un.org/focussdgs.html.
8
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).
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.)4.
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 20055.
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.
4
Consumer Dispute No. 03/2004, Available on www.lawctopus.com.
5
On 10 May, 2012, Available on http://ddsindia.com/www/PDF/PIL.
9
BIOSAFETY LAW IN-THE-MAKING OF INDIA
6
Available on https://www.lawctopus.com/academike/biotechnology-regulatory-authority-bill-2013/.
7
No. 34 OF 2006.
10
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 foreigners8.
8
Available on dbtindia.ac.in.
11
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.
12
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.
13
BIBLIOGRAPHY
14
15.) Justice Dr. P.Jyothimani, “National Green Tribunal of India – A Historical
Perspective”, National Green Tribunal International Journal on Environment, Vol.1
2014.
16.) K.I. Vibhute, “Environment, Development and the Law: Indian perspective”,
The Indian Journal of Environmental Law, (1995).
17.) Madhushree Mazumdar, “Environmental Impact Assessment in India”, 3(1)
Journal of Social and Economic Development, 95 (2000).
Reports
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.
6. Economic and Political Weekly (1994)
7. Business Times, February 2010 WRM's bulletin No 116, March 2007.
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.
15