Biotechnology Regulatory Bill,2013: A Boon or A Bane?

Status as on- 20/06/2023

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, 2013

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 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. 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 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.

Disclaimer: The above article is based on the personal interpretation of the related orders and laws. The readers are expected to take expert opinions before relying upon the article. For more information, please contact us at rera@centrik.in & ibc@centrik.in