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This article is written by Shivani Nair, from Manipal University, Jaipur. This is an exhaustive article which deals with the topic of Genetic Technologies and Laws Behind them.

Introduction

The subject ‘Biology’, all over the world tries to develop new and groundbreaking technologies. The attempt of human beings to mimic, manipulate, and map the genes of the animals and opening up new domains is what has always been a part of this field of science. The recent breakthrough provides that the field of biotechnology has emerged mighteous and has also provided for the societal changes in our world. Biotechnology offers for potential advances in the field of healthcare and technology.

What are Genetic Technologies?

Genetic technology has been emerging in the form of genetic testing. This means that there are tests that identify the variant of a gene one has inherited. They have a variety of uses which include diagnosis of rare diseases and services that are commercial that would provide the medical history and human history of the families. But the rapidly developing field is the analysis of the DNA (Deoxyribose Nucleic Acid) which is being conducted on a   large number of people to improve their lifespan. 

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Categories of Genetic Technologies

Three main categories have been recognized regarding the concern of the application of genetic technology. These are:

  • Human Cloning

Human cloning refers to the formation or the creation of the human embryos or genetically modified human children who are identical to their living and dead parents. There have been even more categories of human cloning technologies. These are:

  1. Research cloning- It means that the embryos of humans are used for the purpose of experiments. The clonal human embryo shall be used for this purpose. This form of cloning is also known as Somatic Cell Nuclear Transfer (SCNT). In the case of SCNT a nucleus, which is in the form of a Somatic cell (which could be a muscle cell or a skin cell), gets transferred to a female egg from which the genetic cloning material was removed. Towards the end of the process, the clonal embryo gets produced.
  2. Reproductive cloning- It means that a clonal embryo is created, but it is not used for experimental purposes. The clonal embryo obtained in this case will be used for implantation into a woman’s womb and brought to the terms as a human child. Embryonic stem cell cloning research, involves research cloning. Thus, it must be considered since it does not involve any sort of modification or trait selection of genes. 
  • Gene Trait Selection 

This form of trait selection refers to the selection of the eggs, sperm, or embryos that contain the genes that have been associated with certain traits. In the said process, the desired sperm, eggs, or even embryos that carry the interest are used to create the child of the humans. However, in the current process, the genetic selection may be used for non-medical related or medical-related purposes. For example: In the case where medically-related genetic selection takes place, also known as Preimplantation Genetic Diagnosis (PGD) and a single set of zygotes which were created through in-vitro fertilization are tested for the genes which cause cystic fibrosis or any other disease and only those zygotes which are free from those diseases or cysts are allowed to initiate a pregnancy. 

  • Human Genetic Modification 

The genetic modification of human beings can take place potentially at the therapeutic level or even at enhancement levels. At the therapeutic level, it can be seen that the illness or the deficiency in a person gets cured. At the level of enhancement, the condition of the health of a person is known to get better than the average person. The genetic modification can either be done at somatic or germline levels. The modifications made at the germline level can be passed on to all the succeeding generations. Therefore, in the area of human genetic modifications, there are four possibilities that tend to exist namely, the somatic therapy, the somatic enhancement, the germline therapy, and the germline enhancement. 

  • Somatic Therapy- It is a way by which the good genes of a person are transferred to the cells of the body to improve the rate of recovery if a person is said to suffer from diseases such as immunodeficiency or any cysts that have been formed inside his body. It is considered to be ethical and acceptable and has been used to treat patients with leukaemia. 
  • Somatic Enhancement- It is a way by which a new gene is inserted into the muscle of the person or the person’s lung tissues. The person is generally an athlete who is indulged in various sports activities to increase their respiratory capacity. Although these kinds of enhancement have not been carried out in humans to date. This has been considered as unethical as it could render changes into the human body and produce new forms of inequality. 
  • Germline Therapy- In this kind of therapy, it is practically possible to insert the healthy genes into the embryo that has the genes which contain the diseases such as cystic fibrosis. But, these techniques are still being developed and have not been tried on human beings as of yet. This therapy has been widely appreciated as it helps people recover from diseases without altering their functions. 
  • Germline Enhancement- In this kind of process, genetic modification, like the somatic enhancement is attempted in the muscle cell or the cells of the lungs at an early stage when the embryo has just been developing. This improves the respiratory functions of the body in the child that results from the mutated embryo. The process would be similar to that of the somatic enhancement. However, it has been suggested that the children born out of this might have extra cognitive behavioural traits that would make them distinct from the regular human species causing them to have emerged as a new-subspecies of homo sapiens that cannot breed with the general human beings. Thus, this treatment is generally viewed as a very dangerous form of treatment as it would result in the mutation and alteration of human beings, though making them potentially stronger, but also a civil threat. Changing the nature and form of human beings may have such consequences that can not be predicted at this stage. 

Legal Aspect

India did have a systematic and structured regulation regarding the framework of the genetic technology for the biosafety of the individuals and the researchers and still has an ongoing approach for it. There is also a structured framework for the biosafety of genetically modified organisms (also known as GMO) who are not human beings. India was one of the first few countries to introduce development in the field of biosafety regulatory systems for genetically modified individuals back in 1989. The main rules for all the activities related to the biosafety of the GMOs are mentioned in the Environment (Protection) Act, 1986. There have also been other rules and regulations that have been applicable to such genetically mutated organisms. 

Rules of Genetic Technology, 1989

In India, the Ministry of Environment, Forest and Climate Change had introduced the Environment Protection Act in 1986 as a legislation that provides a holistic framework to all the laws regarding the environment. After that, a series of rules were made to address the issue related to genetic technology. 

They introduced the rules for the manufacture, import, export, use, and storage of hazardous microorganisms, organisms or cells that have been genetically engineered. The power has been given by Regulation of Genome Engineering Technologies in India. They apply to any product, foodstuffs, substances, etc of which the cells, organisms, or the tissues hereof form the part. The new gene technologies apart from genetic engineering have also been included. There have been six competent authorities that have been notified under these Rules to look into the matters related to gene technology. These are:

  1. Recombinant DNA Advisory Committee (RDAC)- This committee takes note of the developments in the field of biotechnology at the national and international levels. The RDAC is an advisory committee that has been instituted to give recommendations from time to time on safety regulations and had prepared guidelines for the biosafety of the GMOs. 
  2. Institutional Biosafety Committee (IBSC)- It has been mandated that each of the institutions that intend to carry out research-related activities that involve mutation or manipulation of any living organism be it the plants, animals, or human beings and even the microorganisms. They should constitute the ISBC. 
  3. Review Committee on Genetic Manipulation (RCGM)- It functions as a body that monitors the safety-related aspect of the research that includes the on-going research on projects that are hazardous microorganisms. RCGM has also been mandated to bring out the specific procedure for the regulatory process with respect to the activities that take place. The RCGM includes representatives from all the departments of all the scientific institutions in the country. 
  4. Genetic Engineering Appraisal Committee (GEAC)- It is an Apex committee that functions and has its representatives from the concerned agencies and experts. It is responsible for the acceptance and approval of the activities that involve large scale use of hazardous organisms and the products that are recombinant in the research field and the industrial production from the angle of the environment. 
  5. State Biotechnology Coordination Committee (SBCC)- This committee has been constituted in all the States where there is research and the applications of the GMOs are underway. SBCC has been headed by the Chief Secretary of the State and has the responsibility of monitoring the research.
  6. District Level Committee (DMC)- This committee is held at the district level, as the name suggests. DLCs have been constituted in those districts where the research projects take place. It takes place wherever it is required to monitor the regulations related to safety and installation that have been engaged in the use of the GMOs or the hazardous microorganisms. Every DLC is headed by a District Collector along with the officers who are concerned with the public health, environment, pollution control, etc.m at the district level. 

The mechanism to interact between two committees have also been provided under the Rules of 1989. All the IBSCs have been required to review each application and then submit their reports to the RCGM. Post that, the RCGM will review the application and state its recommendations for the large-scale events, activities, the field trials, and the release of the environment to the GEAC. The DLCs are also required to submit their reports to the SBCC or the GEAC.

In addition to that, various committees, as well as the sub-committees, and also expert committees have been formed by the RCGM and the GEAC on the basis of the cases they administer and each case is a part of a different sub-committee or even an expert committee. Such committees constitute experts from various disciplines who are a part of the public sector institutions to prepare and even review the guidelines and the biosafety data. Committees such as the Central Compliance Committees have also been set up for the monitoring of the confined field trials on the basis of each case. 

The GEAC supervises the implementation of the terms and conditions which have been laid down in the connection with the approvals accorded by it. It may carry out these supervisions with the help of SBCC, DLC, or even any other person who has been authorized by law. The SBCC/DLC may take suitable measures against the person who fails to comply with the rules and regulations and can also incur the expenses from the person responsible. 

Conclusion

The article states that many countries have disproved the cloning and mutation aspect of genetic technology. However, the opinion shall remain divided over the research cloning. There has also been a concern regarding the somatic enhancement and genetic enhancement. Perhaps it is only a good thing that this has yet to be tried in human beings as one can never be sure of the results which may cause damage to the human body due to the genetic mutation in the future. As India is a signatory to the Cartagena Protocol, on Biosafety, a Bill was introduced for setting up the Biotechnology Regulatory Authority of India in 2013. However, the Bill had lapsed and further actions are awaited. But, presently we can ascertain that the cases will be taken up one at a time and shall be dealt with according to the Rules made in 1989. 

References


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