This article has been written by Mrs. Swati Harshal Shirodkar pursuing a Startup Generalist & Virtual Assistant Training Program from Skill Arbitrage.

 This article has been edited and published by Shashwat Kaushik.

Introduction

Biotechnology is an interdisciplinary science that involves the use of principles and processes from the fields of biology, chemistry, genetics and related disciplines to manipulate living organisms for a desired outcome. Biotechnology basically engages in the strategic transfer of the desired gene from one organism to another. This facilitates the introduction of novel properties or characteristics into the recipient organism. The process of gene transfer is accomplished by the use of genetic engineering techniques, namely recombinant DNA technology (rDNA).

Biotechnology is emerging as a powerful tool in the field of agriculture, where it has given rise to genetically modified organisms (GMOs). GMOs are manipulated at the genetic level for their specific traits. The outcome of these manipulations can solve global problems of food security, crop diseases, environmental sustainability, etc. However, the introduction of GMOs into the environment involves complex legal issues that require careful consideration. This article explores the role of biotechnology law in governing the research, production and application of GMOs nationally and internationally. First, understand the advantages and disadvantages of GMOs.

Advantages of GMOs

Increased crop yield

The primary advantage of GMOs is their potential to increase crop yield significantly. GMOs are engineered to be resistant to pests, diseases and environmental changes in order to enhance productivity. GM plants are also enhanced with a better post harvest shelf life. This will prove to be a boon in the agriculture sector that can ensure sufficient food availability on a global scale.

Improved nutritional content

GMOs provide scope for altering the nutritional value of crops. This has been a boon to the parts of the world addressing malnutrition issues in their populations. The nutritional value of staple crops can be enhanced through genetic engineering, e.g., biofortified crops containing enhanced levels of important vitamins and minerals.

Reduced dependence on pesticides

Genetically modified plants are resistant to pests and diseases. This minimises the health risk farmers are exposed to while using pesticides and other chemicals. These GM plants are able to shield themselves from common plant diseases, which would otherwise lead to crop loss and economic loss for farmers.

Adaptation to climate change

GM plants are engineered to withstand extreme weather conditions and ensure a resilient food supply. Food tolerant crops are genetically modified to withstand waterlogging and, hence, prevent yield losses. Drought tolerant crops are a boon to regions prone to irregular rainfall. They can withstand water scarcity and maintain productivity in the region. Rising global temperatures have a dangerous effect on crop growth; heat resistant crops are promising solutions to this global issue.

Economic benefits for farmers

Crop loss due to pest attacks and diseases is minimised. Crop loss due to weather conditions is reduced. Decrease in the use of chemicals and pesticides. All these factors, together, result in high incomes and improved livelihoods for farmers. This, in turn, contributes to national economic growth.

Disadvantages of GMOs

Environmental concerns

Releasing genetically modified organisms into the environment raises concerns about potential ecological consequences. Cross-breeding with wild species can result in unintended effects on non-target organisms and disruption of ecosystems. These are the environmental risks associated with GMOs.

Unknown long term effects

The long-term effects of GMOs on human health and the environment remain uncertain. As these organisms are relatively new, there is a lack of extensive research on the potential consequences of their widespread use.

Biodiversity threats

The widespread adoption of genetically modified crops, especially those resistant to herbicides, may lead to monoculture and threaten biodiversity. This may, in turn, reduce crop diversity, making agricultural systems more susceptible to pests and diseases.

Corporate control and patents

The commercialization of GMOs often involves the patenting of genetic sequences, leading to concerns about corporate control over the global food supply. This raises ethical questions about access to genetic resources and the concentration of power in the hands of a few multinational corporations.

Ethical and social concerns

The genetic modification of organisms raises ethical questions about interfering with nature’s law and the potential consequences for future generations. Social acceptance of GMOs varies, and concerns about transparency, labelling, and consumer choice are significant issues.

Biotechnology law

Biotechnology law involves a legal framework, which makes it an important body to govern various aspects of the biotechnology sector. These include research and development, production, intellectual property rights, the development and use of genetically modified organisms (GMOs), environmental risk assessment, and consumer protection. The law ensures that all biotechnological practices comply with legal standards. Biotechnology law maintains a balance between promoting innovation in the field of biotechnology and safeguarding public health, environmental sustainability and ethical considerations. 

Regulatory framework

The inception of the Indian biotechnology industry can be traced back to the establishment of the Department of Biotechnology (DBT) under the Ministry of Science and Technology in 1986. As the world’s pioneer government department exclusively dedicated to the biotechnology sector in India, DBT holds a pivotal role. It oversees and regulates various aspects, including research and development, as well as the manufacturing and commercialization endeavours within the biotechnology sector in the country.

Another governing body for biotechnology in India is the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment, Forest and Climate Change (MoEF&CC). This committee is responsible for the assessment of proposals related to experimental field trials and the release of genetically engineered (GE) organisms and products into the environment.

Numerous committees have been established under the auspices of the relevant ministries to oversee and regulate activities related to the handling, production, storage, testing, and release of genetically modified materials in India. Endowed with statutory authority, these committees play a crucial role in ensuring compliance with established guidelines. Composed predominantly of scientific experts and personnel from the Department of Biotechnology (DBT) and the Ministry of Environment, Forest and Climate Change (MoEF), these committees contribute to a comprehensive and scientifically informed governance framework.

In India, biotechnology law is governed by a number of acts and policies depending upon its applicability in the sector. Some acts and policies are mentioned below:

1. The Patents Act, 1970: This Act governs the grant of patents for inventions in all fields of technology, including biotechnology. It provides for the protection of new and innovative inventions and sets out the criteria for obtaining a patent.
2. The Drugs and Cosmetics Act, 1940: This Act regulates the manufacture, sale, and distribution of drugs and cosmetics in India. It also includes provisions for the regulation of clinical trials of new drugs and vaccines.
3. The Environment Protection Act, 1986: This Act provides for the protection and improvement of the environment, and includes provisions for the regulation of biotechnology activities that may have an impact on the environment.
4. The Genetic Engineering Appraisal Committee (GEAC): This committee is responsible for the approval of genetically modified organisms (GMOs) in India. It reviews applications for the import, export, and use of GMOs and makes recommendations to the government on whether or not to approve them.
5. The National Biotechnology Development Strategy (NBDS): This strategy was launched by the government of India in 2007 and aims to promote the development of biotechnology in India. It includes a number of initiatives to support biotechnology research and development and to create a favourable environment for the biotechnology industry.
6. The Biotechnology Regulatory Authority of India (BRAI): This authority was established in 2013 and is responsible for the regulation of biotechnology in India. It has the power to issue regulations and guidelines and to enforce the provisions of the various biotechnology laws and policies.

These are just some of the key acts and policies that govern biotechnology law in India. The field is constantly evolving, and new laws and policies are being developed to address the challenges and opportunities presented by biotechnology. Some other laws are:

• The Plants, Fruits and Seeds [Regulation of Import in India] Order 1989 was issued under the Destructive Insects and Pests Act of 1914;
• The Guidelines for Generating Preclinical and Clinical Data for rDNA Therapeutics of 1999;
• The Drug Policy of 2002;
• The Biological Diversity Act of 2002
• The Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells of 1989, notified by the Ministry of Environment & Forests on December 5, 1989, under the Environment and Protection Act of 1986;
• The Regulations and Guidelines for Recombinant DNA Research and Biocontainment of 2017;
• The Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts of 1998;
• The National Seed Policy of 2002; and
• The Seeds Act of 1966. 

Intellectual property rights protection in biotechnology

Intellectual Property Rights (IPR) are an important aspect of biotechnology law, which imparts different forms of protection such as patents, trademarks, and trade secrets. The Indian system of IPR allows patent protection on the methodology of making the substance that will be used as medicine or a drug and the product as a whole. The Biotechnology Patent Facilitation Cell (BPFC) was established by the Department of Biotechnology (DBT) in July 1999 to help provide patenting facilities to biotechnologists and to create awareness and understanding among biotechnologists about the development of the IPR sector. The Council of Scientific and Industrial Research (CSIR) is another government body involved with IPR, with the slogan “Patent or Perish. India has signed the Trade Related Intellectual Property Rights [TRIPs] Agreement of the WTO.

Biosafety in biotechnology

Due to the threat associated with the release of GMOs into the environment, many countries have developed biosafety regulations to address the risks. The Convention on Biological Diversity (CBD) adopted the Cartagena Protocol on Biosafety on January 29, 2000. The Biosafety Protocol seeks to protect biological diversity from the potential risks posed by genetically modified organisms as a result of biotechnological advancements. India is a part of the CBD and a signatory to the Cartagena Protocol on Biosafety, January 2003.                                                         In India, the rDNA Safety Guidelines, 1990, revised in 1994, state that biosafety measures must be taken for contained research activities, large scale environmental release of genetically modified agricultural and pharmaceutical materials and also for screening transgenic plants and seeds for toxicity and allergenicity. The guidelines should be followed prior to the commercial release of genetically modified technologies or organisms.

Conclusion

Presently, biotechnology is playing a key role in a variety of sectors, namely, pharmaceuticals, biochemistry, bioremediation, immunology, genetics, molecular biology, stem cell research, embryology, cell biology, biodegradation and biosciences. Biotechnology has transformed the ability to use fundamental principles of life sciences to address global challenges and improve the quality of human life. Biotechnology Law is a regulatory body that safeguards and ensures that the benefits of GMOs are used responsibly and ethically.

References

• https://dbtindia.gov.in/about-us/introduction#
• http://www.geacindia.gov.in/about-geac-india.aspx 
• https://www.mondaq.com/india/patent/506468/protection-of-biotechnology-under-indian-laws 
• https://www.mondaq.com/india/healthcare/26049/biotechnology-laws-in-india