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Can You Design Your Own Baby In India?

By: Koupal Jain & Ankit Saurashtriya 

Students, VI SEMESTER, B.A.LL.B (Hons.), Department of Law, Prestige Institute of Management and Research, Indore (M.P.)

A baby whose genetic makeup has been selected in order to eradicate a particular defect or ensure that particular gene is present is a designer baby. Designer babies are created either through embryo selection by pre-implantation Genetic Diagnosis (PGD) or genetically modified (Gene editing). Gene editing is a type of genetic engineering in which some methods are used to alter an organism’s DNA. There is the addition, removal, or alteration of genetic material in the genome. It involves changing genes in eggs, sperm, or very early embryos. The prominent approach used for this purpose is CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats). CRISPR-Cas9 is a scissors-like chemical tool that has the capability to precisely cut and customize stretches of genetic material, such as DNA. It can remove or add certain types of genes from a DNA molecule. It is done in order to replace a variant of a gene that has one kind of effect with another known variant that has a different effect. For this purpose, the embryo is created through in vitro fertilization (IVF) technology. After modification, the embryo with selected traits is implanted into the womb.

Why is there a need for this technology?

The initial objective behind embryo selection was to prevent inheriting genetic defects by selecting disease-free embryos. This could prevent inheritable diseases like Albinism, Cystic fibrosis, Thalassemia, etc. When every embryo carries the disease gene, gene modification is necessary, and gene editing tools can do this to produce a designer baby. The purpose of this technology is to avoid heritable diseases by causing mutations in DNA. The methods and procedures used for this purpose are Mitochondria DNA transfer and Precise Genome Editing tools. The child born will not carry the mutation, nor will any grandchild.

Incidents of Gene Editing

It was reported in 2018 that a scientist in China, He Jiankui, has already altered the germ line of live fetuses to make them HIV-free by genetic design. One couple in the trial gave birth to twin girls whose genes were modified, and scientists claim they are alive. But it is not clear what else this alteration has done to the children. This move was widely criticized all over the world. It sparked outrage and became controversial too. Some people saw it as an achievement to eliminate genetic disease, while others saw it as an opportunity to not just use it for disease prevention but also to choose specific aesthetic and personality traits in embryos to enhance the babies. It can influence, add to, or implant some specific traits in the resulting embryo. There is a huge difference between engineering a designer baby with desirable characteristics and fixing a genetic flaw, which is a warning of a slippery slope. The Chinese government said that the experiment broke the country’s law and that the scientists involved were suspended. In India, there is no germ line gene editing reported to date.

The concern is largely ethical

There is an ethical debate about whether it is okay to edit a baby’s genetic trait. It is an ethical concern whether to apply this technology to creating babies or not. Babies are created through genetic intervention against the order of nature. The objection against the use of this technology is due to the unawareness of the safety of the embryo. Any harm to the embryo during the procedure could be greater than the previous disease, and the defect caused by this harm will pass onto future generations. The high possibility of misusing this technology for the enhancement of traits and not just for the treatment of genetic disease is a matter of concern.

There are also other concerns about the hidden risks. Serious side effects may occur when essential genes are ripped, cut, or cleaved. A mistake in cleaving the gene other than the targeted one may happen, resulting in serious consequences that are even more unpredictable for the future generation. In any case, if the efficiency is low, the disease may still remain. Also, PGD screening is incapable of detecting successful or off-target mutations in edited embryos. It would also be difficult, expensive, and uncertain. It is also believed that edited embryos could become more vulnerable to other infections.

Ethical and social issues act as major hindrances as compared to the legal framework. There is anxiety about the misuse of technology to design offspring with some particular selected traits. This will result in genetically designed babies being superior in society to non-genetically designed babies. The health gap between rich and poor will widen within society and among nations. It will relatively worsen the health status of the world’s poor. Also, knowledge about the risks of these editing tools is insufficient, especially when modifications are heritable. The discriminatory selection of a particular embryo due to the presence or absence of a particular gene is regarded as highly unethical. In a society like India where prenatal sex determination is banned because of a strong cultural preference for male children, the era of designer babies could lead to further deterioration of the sex ratio.

Present Scenario

There is an international moratorium on the genetic editing of human embryos for reproductive purposes. Most countries do not have any legislation regarding genetic modification, but those that do have prohibited it. In many countries, these procedures are still prohibited by law. At present, it is formally prohibited in more than 40 countries, including Australia, Canada, Germany, and Switzerland. Still, the legality varies due to the differences in social, cultural, and religious norms followed in various countries. If it ever gets permitted, all the countries are going to face tough choices about how to regulate this industry.

Currently, PGD is allowed in India only for the screening of genetic disorders and not for selecting a gender. This is regulated by Section 25 of the Assisted Reproductive Technology (Regulation) Act, 2021. India does not have any laws that prohibit genetic editing. However, the Indian Council of Medical Research (ICMR) has issued the National Ethical Guidelines for Biomedical and Health Research on Human Participants, whose clause 10.14.8 states, “Eugenic genetic engineering for changing, selecting, or altering genetic characteristics and creating so-called designer babies is prohibited. It would be unethical to use genetic engineering for the improvement of intelligence, memory, the formation of body organs, fertility, physical, mental, and emotional characteristics, etc., even if the genes are identified in the future.” However, the 2017 National Guidelines for Stem Cell Research issued by the ICMR gave imperative directions for cellular research, including gene editing, but such editing can only be done through in vitro studies, i.e., outside the human body. All clinical trials involving genetic engineering products come under the Drugs and Cosmetics Act, 1940. However, editing the genome of an adult human cell is permissible since the technique is patient-specific and won’t affect future generations, for example, sickle cell anaemia and haemophilia. Still, it is subject to approval by an ethics committee. This experiment needs to be thoroughly reviewed by the established authorities. Some scientists are doing basic research on CRISPR, while others are doing it on plants and animals. To date, no such case or experiment of gene editing embryos has been reported in India.

In Roche Products India Pvt Ltd v. Drug Controller General of India, the Delhi High Court observed that it is a well-settled principle of law that guidelines have the nature of directions issued by the government. Till now, these guidelines are not in contravention of any law but merely an addition to already existing rules and regulations. Thus, it cannot be said that these guidelines don’t have legal validity, so there is no need to follow them because they are non-binding in nature. Administrative orders, directions, or guidelines do not create any justiciable right; this is a rule, but in cases where the guidelines are created to fill gaps in the legal framework or regulatory measures or are supplemental rules, then the court can proceed to enforce them like a legally justiciable right in such a scenario. Thus, any exploration that may lead to the creation of designer babies is not permitted by the non-mandatory guidelines in India.

Conclusion

Using genetic data to predict what kind of person an embryo would become is far more complicated than hypothesizing. The existing form of CRISPR may introduce new errors in the genome, resulting in unknown health risks. A gene linked to height might affect the mechanisms of other cells. Who knows, editing genes would affect not only height but what else? Rampant use may cause more gene-based diseases like cancer and birth abnormalities. There are many genetic diseases that could show up through specific gene mutations, which can’t be predicted with certainty as they also depend on environmental factors like diet. e.g., diabetes, heart disease, certain types of cancer, etc. The risks of gene editing are still being studied. More work needs to be done to understand the risks of the technology. As we learn more about genetics, a more clear mechanism will emerge.

Tinkering with genetic material is a sensitive issue because it impinges on one’s identity. What if, when the technology comes and the parents resort to embryonic selection to guarantee the child is of a particular sex, color, height, traits, characteristics, etc.? All clinical uses of this technology should be restricted by strict law until its safety is established by adequate scientific research. The common public should be made aware of the risks and possible legal issues arising from them.