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LEGAL DEVELOPMENTS | July 16, 2025

“Framework for regulating genetically modified organisms (GMOs) in India.”

Introduction

 

Our mother nature has provided us with a variety of organisms in abundance which tend to reproduce and grow naturally as an offspring like humans, plants, animals etc. But humans tend to do experiments and research with their curious celestial brains and with such a curiosity they made genetic engineering techniques which helped in developing the genetically modified organisms.

So, what basically does genetically modified organisms mean?

Genetically Modified Organisms (GMOs) are living organisms such as plants, animals, or microorganisms whose genetic material has been altered in such a way that does not occur naturally through mating or natural recombination. This process involves modifying DNA, often by transferring specific DNA sequences from one organism to another to introduce desired traits. This is usually done using genetic engineering techniques, where specific genes from one organism or synthetic genes are inserted into another to give it new traits.

It is generally done to improve the quality or the nutritious value of that organism which would have not been possible with the natural mating or reproduction. This concept is generally used in agricultural sector, medical purposes and research work for example, GMO soyabean oil can be used instead of other trans-fat oils, Cows that have been genetically modified to produce milk with specific proteins, like human lysozyme, or with reduced levels of lactose.

 

Legal Framework

A strong legal framework for GMOs is important to ensure the safe, responsible, and ethical use of biotechnology in India. It provides a structured mechanism to analyze the risks and benefits of genetically modified organisms through scientific evaluation, thereby protecting human health, biodiversity, and the environment. Legal guidelines help prevent unregulated use, unauthorized field trials, and potential biohazards, while also promoting accountability among researchers, developers, and corporations.

The concept of Genetically modified organisms has been principally governed by the Environment (Protection) Act, 1986, whose objective is to protect and improve the environment, and to regulate environmental hazards from GMOs. It provides with the rules and regulations for the Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989 (commonly known as the 1989 Rules).

?Key Regulatory Bodies and acts for GMOs and their functions include the following:

• GEAC (Genetic Engineering Appraisal Committee) – It approves and monitors the commercial release of GMOs.
• RCGM (Review Committee on Genetic Manipulation) – It oversees research and trials relating to the GM foods.
• IBSC (Institutional Biosafety Committee) – It monitors and supervises the lab-level research.
• FSSAI (Food Safety and Standard Authority of India) – It regulates GM food safety (no GM food approved for sale as of now).
• Food Safety and Standards Act, 2006 – It regulated the standards of GM foods.
• Seeds Act, 1966 – It regulates the seed quality of GM foods.
• PPV&FR Act, 2001 – It protects the rights of the plant breeders and farmers.

 

Analysis

Just like a coin has 2 sides, every concept has both positive and negative aspects. The concept of Genetically Modified Organisms (GMOs) can be analyzed by going through both of its positive and negative aspects.

The legal framework for GMOs in India presents a mix of strengths and weaknesses, reflecting both the country’s cautious approach to biotechnology and the challenges of regulating a complex and evolving sector.

On the positive side, India’s legal structure is relatively comprehensive and precautionary. The framework mainly governed by the Environment (Protection) Act, 1986 and the 1989 Rules establishes a multi-tiered regulatory system involving bodies such as the GEAC, RCGM, and IBSCs. This allows for a step-by-step review of GMOs, from laboratory research to field trials and commercial release. The presence of environmental safeguards and mandatory approval system at each stage ensures that GMOs undergo thorough risk assessment. Moreover, the legal framework incorporates international biosafety norms (like the Cartagena Protocol), which ensures India’s commitment to global standards. This cautious, layered process helps minimize potential environmental and health risks associated with genetic modification.

However, the framework also has significant shortcomings. The regulatory system is fragmented, with overlapping roles across different ministries and committees, leading to delays and inefficiency. The absence of a single, independent biotechnology regulator creates confusion and slows down decision-making process, especially for commercial release and GM food regulation. Public participation and transparency are limited, and the lack of a clear labelling policy for GM foods undermines consumer rights. Moreover, the enforcement of field trial regulations is inconsistent at the state and district levels, leading to concerns about biosafety breaches. Furthermore, the legal framework is often influenced by political and public pressure rather than purely scientific evidence, which can further influence the innovation and investment in biotechnology research.

Conclusion

By concluding the analysis on both the positive and negative aspects of GMOs, it is clear that the legal framework for GMOs in India plays a vital role in regulating the development, testing, and use of genetically modified technologies in a safe and controlled manner. It ensures that scientific innovation aligns with environmental protection, public health, and socio-economic interests. While the current framework anchored in the Environment (Protection) Act, 1986 and supported by various regulatory bodies provides a foundational structure, there is a need for continuous improvement to address emerging challenges and public concerns. Strengthening coordination among regulatory authorities, enhancing transparency, and updating policies in line with scientific advancements are crucial steps forward. A clear, efficient, and inclusive legal system will be key to responsibly harnessing the benefits of GMOs for India’s agricultural and food security future.

Genetically Modified Organisms (GMOs) represent a powerful scientific advancement to combat the problems in the nation like food insecurity, crop losses, and nutritional deficiencies. While India has made cautious progress, notably with cotton and recent developments like GM mustard, maize etc. but it still lacks widespread acceptance and use remain limited due to regulatory uncertainty, public opposition, and ethical concerns.

The way ahead for GMOs in India lies in strengthening the regulatory framework to ensure timely approvals based on scientific evaluation while maintaining biosafety and environmental safeguards. Public awareness campaigns must be prioritized to address misconceptions and build trust among consumers and farmers. Encouraging scientific research and innovation in GM technology can reduce dependence on multinational corporations and ensure that biotech solutions are being focused mainly to Indian agricultural needs. At the same time, ethical considerations such as farmers' rights, seed sovereignty, and biodiversity conservation must be integrated into policy decisions. With coordinated efforts from the government, scientific community, farmers, and civil society, India can responsibly harness the potential of GMOs to enhance food security, boost farm productivity, and meet the challenges of climate change.

 

References / Bibliography

1. Legal framework for GMOs crops inindia
2. Environmental challenges for GMOs
3. Public acceptance worldwide of GM crops