In the present day, biotechnology is defined as "the application of science and technology to living organisms, as well as parts, products, and models thereof, to alter living or non-living materials for the production of knowledge, goods, and services." Biological elements like enzymes, genetic circuits, and cells are the focus of the field of study known as synthetic biology. Complementary discoveries in physics, chemistry, and the computational and material sciences have widened the scope of such study alongside breakthroughs in biotechnology.

1. Biotechnology Regulatory Bill,2013: A Boon or A
Bane?
Introduction
In the present day, biotechnology is defined as "the application of science and
technology to living organisms, as well as parts, products, and models thereof,
to alter living or non-living materials for the production of knowledge, goods,
and services." Biological elements like enzymes, genetic circuits, and cells are
the focus of the field of study known as synthetic biology. Complementary
discoveries in physics, chemistry, and the computational and material sciences
have widened the scope of such study alongside breakthroughs in
biotechnology.
Biotechnology Regulatory Authority of India
According to the provisions of the Bill submitted to Parliament in 2013, the
Biotechnology Regulatory Authority of India (BRAI) is a planned regulatory
agency to control the use of GMOs. Due to India's signature on the Cartagena
Protocol, which requires the establishment of a Regulatory Body, BRAI became
necessary.
Highlights of The BRAI Bill, 2023
The Biotechnology Regulatory Authority of India is established by the Bill as
an autonomous body to oversee the control of biotech organisms and goods.
Research, shipment, import, containment, environmental release, production,
and consumption of biotechnology goods will all be subject to oversight under
BRAI. Expert scientists will evaluate your application at multiple stages before
BRAI gives its stamp of approval. The created product will be deemed safe for
its intended usage by BRAI. All other applicable laws regarding the goods shall
remain in effect. Appeals from BRAI's rulings and orders will be heard by the
Biotechnology Regulatory Appellate Tribunal, which will also consider civil
cases involving significant questions related to modern biotechnology. False

2. information provided to BRAI, unapproved field trials, obstruction of or
impersonation of a BRAI official, and violation of any other provisions of the
Bill all carries specific penalties.
Criticism Of the BRAI Bill, 2013
• This Bill proposes to place regulatory authority in the Ministry of
Science & Technology, which promotes modern biotechnology.
Promoters cannot regulate because of a conflict of interest. The DBT
under the Ministry of Science and Technology, which promotes
biotechnology, proposed the BRAI Bill. The biotechnology promoter will
help form and run the sector regulator in this case. The same ministry
promotes and regulates GM crops. This regulation Bill promotes
technology safety. Technology promotion does not require law.
Regulating biotechnology protects our health, environment, and
livelihoods. Not in the Bill.
• The Bill affects matters 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, and
others. An overall Bill requires more deliberations that have occurred so
far.
• BRAI Bill undermines the federal polity established by the Indian
Constitution and the authority of the Panchayat Raj Institutions. It
removes the power of these organizations and concentrates it in a small,
technical group, which then makes decisions about Agriculture, Health,
and natural resources.
• A "substantial question relating to contemporary biotechnology" falls
under the Tribunal's purview. But this phrase is not defined in the Bill.

3. The benefits of flexibility and the risks of ambiguity both increase when
a phrase is left ambiguous. There will be one judge and five experts on
the Tribunal's side. A Supreme Court ruling states that a Tribunal's
bench cannot include more technical members than judicial members,
hence this practice is illegal.
What Is the Actual Need?
A Biosafety Protection Law is necessary in India. Transgenic technology is
actively rejected by citizens and governments all over the world and is not a
fait accompli; therefore, the primary mandate of any regulatory regime
surrounding GMOs should be to protect the health of people and the
environment from the risks of modern biotechnology. It should necessarily
have the following components as cornerstones of the legislation:
• Precautionary Principle.
• Sequentially separating contained research and deliberate release and
their regulatory procedures.
• Regulation and decision-making must be conflict-free.
• Transparency and public/independent inspection.
• Participatory democracy.
• Risk assessment—(a) prescribing rigorous, scientific protocols and asking the crop
developer to conduct studies and then do an independent analysis of the dossier
supplied by the crop developer and evaluate it; (b) conducting independent testing with
all facilities and institutional structures in place and evaluating the results. Risk
management—monitoring, reviewing, and canceling approvals. Liability—including

4. penal clauses, redress, and remediation—covers crop developers and regulators.
Labeling for informed decisions, including import traceability.
• Without a time, limit, there should be oversight and appeals systems that
are easy to understand, cheap, and available to those who are affected.
Protection of the constitutional jurisdiction of Gramme Sabhas over their
natural resources; given India's federal structure, which recognizes
Agriculture as a topic for individual states.
Conclusion-
The parliament knew that if the bill passed into law in its current form, the
BRAI measure would be useless and hence, the bill has lapsed. The bill violates
the fundamental rights of the people, such as the right to know, the right to
make decisions, and the right to seek judicial recourse. The state government
is envisioned to play a minor role in the measure. If this bill becomes law,
farmers will be left defenseless, and our country would likely see another wave
of farmer suicides.