The Need of Law Reforms for GMOs in India

Authored By: MARIA PIRES

PARUL INSTITUTE OF LAW, PARUL UNIVERSITY, VADODARA

Abstract

India has been grappling with the burden of feeding its multitude of 195 million population. Though Agriculture in India contributes to 17 to 18% of the country’s GDP, playing a vital role in national income, crops infestation can lead to crops losses threatening food security. A Messiah in the form of GMOs (Genetically modified Organisms ), a marvel of Biotechnology could offer a solution. However, the outright production of GM crops in India was constrained by widespread scepticism. Any innovation is always under the lens and it is right to do so. The need to legalise Genetically Modified Organisms (GMOs) arose from a combination of scientific advancements, environmental protection, food security concerns, agricultural autonomy, economic pressures, international trade obligations and regulatory necessity. The Environment (Protection) Act, 1986 and the 1989 GMO Rules have been the law governing GMOs in India, but India lacks a comprehensive biotechnology statute. This article critically examines the need of law reforms for GMOs in India which is need of the hour.

Introduction

Genetically modified organisms (GMOs) can be defined as organisms (and micro-organisms) in which the genetic material DNA has been altered in a way that does not occur naturally by mating or natural recombination. This technology is also known as genetic engineering, genetic manipulation or recombinant DNA technology. It allows selected individual genes to be transferred from one organism into another, also between non-related species by means other than crossing. The genetically modified (GM) plants have new properties such as tolerance to herbicides, protection from insect attack, improved nutritional value, agronomic characteristics etc. Since Genetically modified organisms (GMOs) seemingly are a solution to the hungry millions of India , it is of utmost importance to boost its production which is possible when law reforms align with scientific advancements , health and environment safeguards, farmer’s rights and democratic governance. Judicial interventions, including recent Supreme Court directives calling for a comprehensive national policy on GM crops, underscore the urgent need for legislative reforms. An analytical approach has been attempted in this article.

Regulatory bodies governing GMOs

The term “biotechnology was coined by a Hungarian agricultural engineer named Karoly Ereky, early in the 20 the century. He included within its meaning ‘all such works by which products are produced from raw materials with the aid of living organisms ’. With the rapid advances in molecular biology particularly the recombinant DNA (rDNA) technology which is now giving scientists a remarkable understanding and control over biological processes. By using these technique, it is possible to directly manipulate the heritable genetic material between different types of organisms, creating different combination of characters and functions not previously achievable by various traditional methods like breeding and mutations. The rDNA technology or the genetic engineering has not only given boost to biotechnology but has also made it a ‘dual use technology’.Therefore, it is appropriate to use the rDNA technology and develop the genetically modified organisms (GMOs) in a precautionary and judicious manner.

GMOs have been developed and applied successfully since early 1970s under contained conditions and since mid 1980s for commercial applications in the field and open environment .Various applications of GMOs have been growing at a rapid rate. However, it is widely recognized that use of GMOs should be subject to adequate safety measures because of apprehensions about their potential risk to human health and environment. Such measures should collectively ensure bio safety. Consultations on safety in use of GMOs have resulted in a number of national and international recommendations, guidelines and legislation.

India has a well-defined regulatory mechanism for development and evaluation of GMOs and the products thereof. The Department of Biotechnology (DBT) and the Ministry of Environment and Forests (MoEF) are the two apex regulatory bodies. Rules have been notified by MoEF in 1989 under environmental protection at 1986 (EPA ), as the production and preservation of the environment is vested upon the government. These rules cover procedures for the manufacture, import, use, research and release of GMOs as well as products made by the use of such organisms. The objective of the rule is to ensure that the use of such products or life forms is safe to the environmental and beneficial to the human beings. The competent authorities and their composition for dealing with all aspects of GMOs and products thereof has also been defined.

Guidelines for safety have been issued by the department of biotechnology ( DBT) in 1990 covering research in biotechnology, field trials and commercial applications . DBT had also brought out separate guidelines for research in transgenic plants in 1998 and for clinical products in 1999. Activities involving GMOs are also covered under other policies such as the Drugs and Cosmetic act 8th Amendment 1988, the Drug Policy 2002 and the National Seed Policy, 2002.

Presently, there are six component authorities for implementation of regulations and guidelines in the country :

Recombinant DNA Advisory Committee (RDAC)
Review committee on genetic manipulation (RCGM)
Genetic engineering approval Committee (GEAC), (apex bodies)
Institutional bio safety Committee (IBSC) attached to every organization engaged in rDNA research
State bio safety Coordination Committees (SBCC) and
District level Committees (DLC)

Judicial Interpretations

The landmark case on GMOs in India is the Aruna Rodrigues & Ors ( Petitioners ) versus Union of India & Ors (Respondents ). The Petitioners filed a writ petition (Civil) No. 260 of 2005 inter alia under Article 32 of the Constitution of India before the Supreme Court of India . The Petitioners contented that: Genetically Modified Organisms (GMOs) were being released into the Indian environment without adequate scientific bio safety examination, Such releases threatened environmental integrity, biodiversity, human health and long-term ecological stability, A comprehensive bio safety protocol and rules were necessary before any release, and The Court should prohibit any release /import/manufacture/use of GMOs until scientific safeguards were formally instituted.

Judicial Progress: Interim Orders & Directions

Between 2006 and 2012, the Supreme Court issued a series of interim orders as part of the proceedings:

Field Trials Regulation ( May1, 2006)

The court directed that field trials of GMOs could be conducted only with the approval of GEAC.

Withholding further approvals ( Sept 22, 2006)

GEAC was instructed to withhold further approvals for new GMO trials until further orders of the court with limited exceptions.

Conditional field trials ( May8, 2007)

The Court lifted the earlier moratorium on trials but imposed stringent conditions, e.g.:

A 200 metre isolation distance between GMO and non –GMO plots, and Requirements on containment and monitoring.

This order underscored the precautionary approach to bio safety in GM releases.

Detection protocol (April 8, 2008)

The court added a 0.01% level –of- detection protocol, tightening monitoring for cross-contamination risks.

Expert Appointment & Bt – brinjal

In later phases of the litigation, the Court appointed independent experts such as Dr.P.M. Bhagarva to examine safety issues; the Government subsequently voluntarily imposed a ban on Bt Brinjal commercialization.

Final Orders on Record (2012)

The Supreme Court, through its 10May 2012 order,reiterated the need for strict bio safety protocols and highlighted the continuing bio safety concerns raised in the petition.

While the writ petition itself was ultimately dismissed, the Court’s orders cumulatively:

Made a moratorium on unregulated GMO release enforceable, Framed Court- mandated conditions and protocols for field trials, and emphasized the necessity for scientific bio safety assessment and regulatory action before any broad environment release of GMOs.

Critical Analysis of the existing Legal Framework

The existing Legal Framework governing Genetically Modified Organisms (GMOs) is fragmented and Executive-Driven

The Environment (Protection) Act , 1986

This Act was not designed specifically for biotechnology regulation. It is a broad environmental statute. GMO governance under it remains rule-based and executive-controlled, not statute-specific. Thus it creates :

Lack of Parliamentary debate

Weak democratic legitimacy

Excessive executive discretion

Limited accountability mechanisms

A technology with irreversible ecological implications arguably requires a dedicated legislative framework rather than subordinate rules.

Food Safety and Standards Act, 2006 (FSSA)

However, for years specific enforceable regulations were either absent or insufficiently implemented creating a regulatory vacuum. There are not yet Standards laid down by the Food Safety and Standards Act,2006 , hence genetically engineered or modified food as defined in section 22(2) of the Food Safety and Standards At, 2006 “ means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology” cannot be released for human consumption as it will violate Article 21 ( Right to life and Personal liberty) of the Constitution of India. There exists dual control between GEAC (Environmental release) and FSSAI (Food Safety) . This overlap creates:

Institutional fragmentation

Delayed approvals

Regulatory confusion

Weak post-market surveillance

Seed Act and seed Policy

India lacks a fully harmonised bio-tech specific seed regime. The Seeds Bill has not adequately integrated biotechnology liability, farmer’s rights, and bio safety compensation mechanisms.

Recent Developments in GMOs scenario in India

Shift from Traditional GMOs to Genome – Edited Crops

India has approved its first genome-edited rice varieties developed with CRISPR-Cas9 that are free of foreign DNA, aimed at higher yields and stress tolerance- a significant scientific and regulatory milestone.

Recent approvals also include two GE rice types( Samba Mahsuri and MTU-1010 and a gene- edited mustard is in advanced trial stages.

Regulatory authorities have treated gene-edited (GE) plants more leniently than traditional GMOs, exempting them from the strictest bio safety rules because they don’t contain foreign DNA – only requiring Institutional Bio safety Committee approval.

Government funding for Genetic Engineering research

The Government of India provides robust support for genetic engineering research through a multi-pronged approach involving funding , policy, and infrastructure development.

Status of Traditional GM crop Commercialization

Limited Approved GM Crops

Bt- cotton remains the only GM crop commercially grown in India since 2002. Other genetic modification projects (e.g GM mustard DMH-11) have faced regulatory and legal hurdles.

Bt- brinjal, approved by the Genetic Engineering Appraisal Committee (GEAC) in 2009, has been stalled by ongoing moratoriums and debates.

Regulatory Review and Transparency

The government has moved to tighten transparent and conflict- of- interest disclosures in the GEAC( the main body responsible for GMO approvals ) to address public concerns .

The Supreme Court of India has asked the government to form a comprehensive, farmer-centric national policy on GM crops to balance science and public interest.

Controversies, Criticisms & Public Debate

Controversies

Civil society groups have challenged performance claims for some GMO trials, alleging underperformance and mishandling of scientific evidence.

National disclosure includes strong views on food sovereignty, environmental risk, and corporate influence – typical of GMO debates worldwide.

Illegal Gm material in Food

A study detected illegal Gm maize in food products in India , highlighting regulatory monitoring challenges and potential bio safety gaps.

India’s Food Safety and Standards Authority of India updated its scientific panel on GMOs and foods to bolster expertise in safety evaluation.

My Take

It would be worthwhile and it is a high time too to take GMOs seriously. Too much of mudslinging has been done by some environmentalists and anti- GMOs protestors to nip GMOs – a marvellous flower of genetic engineering in the bud cause of clouds of doubts , unknown fears and traditionalism.

India has to wake up from its deep slumber and tighten its belt of legal reforms, wash its face of all the controversies and debates, dress up with new garments of innovation and new legal reforms wear sandals of urgency and rush to welcome the new morn of genetic engineering (GMOs) revolution, jump and hold tight the reins of the horse of large scale production of GM food crops and ride high on dizzy heights of success in par with countries like USA and Canada.

Conclusion

India’s current GMO regulatory framework is outdated and fails to match and keep pace with complexities and opportunities of current science and societal needs. With ongoing debates around new gene technologies, judicial interventions, and emerging policy drafts , the moment of for legal reforms has arrived.

REFERENCES/ BIBLIOGRAPHY

Legislation

The Prevention of Food Adulteration Act, 1954.

The Seeds Act, 1966.

The Environment (Protection)Act, 1986.
Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms/Genetically Engineered Organisms or Cells1989 (India).
The Food Safety and Standards Act, 2006.
Biotechnology Regulatory Authority of India Bill 2008 (lapsed).
Draft Food Safety and Standards (Genetically Modified Foods) Regulations 2022.
Draft Seeds Bill (2025).

Cases

Murad Ali Khan versus State of Uttar Pradesh (1988 ) 4 SCC 655.
Aruna Rodrigues & Ors versus Union of India & Ors (2012) 7 SCC 1.
Gene Campaign & Anr versus Union of India ( 2024).

Journal Articles

Ahuja V, ‘Regulation of Emerging Gene Technologies in India (2018) 12 BMC Proceedings.
Choudhary B and others, ‘Regulatory Options for Genetically modified Crops in India (2014) 12 Plant Biotechnology Journal 135.
Shukla P and others, ’Status of Research Regulations and Challenges for Genetically Modified Crops in India ‘(2018) 9 Frontiers in Plant Science.
International Journal on Consumer Law and Practice.
Journal of Food Science and Technology.

Governmental & Institutional Handbook