RISE IN INDIAN GENETIC TECHNOLOGY IN LIGHT OF COVID-19

INTRODUCTION

Back in 1989, India was one of the first countries to initiate advancement in the area of biosafety
regulatory systems for genetically modified individuals. Gene inventions provide a wide range of
applications, including the identification of rare disorders and commercial services to include the genetic
and human histories of families. Gene trait selections and human genetic modification allows eliminating
the disease-causing factor in the DNA. At present, India did have a formal policy about the framework of
genetic science for human and researcher biosafety. There is also a formal system in place for the
biosafety of GMOs that are not human.

INDIAN NEED FOR GENETIC TECH INTERFERENCE

India is a signatory to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, and
its domestic export management rules are entirely compliant with the Australia Group's guidance (AG).
The advancement of gene sequencing technology, as well as correlation and practical genetic
experiments, offered astounding evidence of disease pathology. This eventually opened the way for gene
therapy, through which scientists and physicians worldwide aspired to create new methods and therapies
to target faulty genes and restore normal functioning. Although medical trials come at an expense, the
area seems promising in light of the Covid 19 pandemic.

NATIONAL GUIDELINES FOR GENE THERAPY PRODUCT DEVELOPMENT AND CLINICAL

TRIALS, 2019

The draft further suggests establishing the Gene Therapy Advisory and Assessment Committee (GTAEC),
an autonomous panel of specialists in biological science and gene therapy that will oversee clinical and
ethical reviews of proposed therapies. 1For effective science and ethical assessment, the field of gene
therapy is concerned with special ethical, societal, and legal concerns for GTP use, which necessitates
additional supervision and expertise. For diseases like hemophilia, thalassemia, sickle-cell anemia,
lysosomal storage disorders, and cancer, disease-specific protocols can be established as part of normal
operating procedures.

REGULATORY FRAMEWORK UNDER THE DRAFT PROPOSED

All these universities and organizations involved in the establishment of GTPs must maintain an
Institutional Bio-safety Committee (IBSC), which must be established in accordance with the Regulations

1
https://www.nhp.gov.in/NHPfiles/guidelines_GTP.pdf
and Guidelines on Bio-safety of Recombinant DNA Research and Biocontainment 2017. All gene therapy
technologies must first be approved by the Review Committee on Genetic Manipulation. Prior to referral
to the Central Drugs Standard Control Organization, all clinical trial applications involving GTPs should
be reviewed and recommended by GTAEC (CDSCO). Before beginning the clinical trial, approval from
the EC of the participating sites/institutions is required. 2Further, the IBSC and Ethics Committee consent
is needed for research requiring the implementation of new GTPs.

OBLIGATIONS AND RESPONSIBILITY OVER GENE TECH PROGRAMS

The draft manuals and contractual terms must be well understood and familiarized by all investigators,
organizations, and sponsors who are performing or participating in research, production, or clinical trials.
The draft guidelines for institutional biosafety and clinical technological trials maintain the highest level
of research rigor and settlement of ethical questions by regular reviews of success in this area.

Several committees have been established to ensure scrutiny into proper conduct of such tech based
genetic programmes and research facilities. The Review Committee on Genetic Manipulation (RCGM) is a
body that oversees the safety related aspects of science, including ongoing research on projects involving
gene modifications. The RCGM has since been tasked with developing a clear framework for the
legislative process in relation to the operations that take place. Recombinant DNA Advisory Committee
(RDAC) monitors biotechnology advances at the national and international levels. The RDAC is an
advisory committee that was formed to provide advice on safety regulations on a regular basis

NEW GENETIC TECHNOLOGY APPLICATIONS & RISE OF PANDEMIC

In India, Scientists explore the boundaries of emerging technologies and create promising new solutions
through a time of familiarization and exploration. Owing to their novelty, these innovations often threaten
current ethical and regulatory standards at this stage of technical maturity. However, the pandemic
experience demonstrates that current national and international regulatory procedures are insufficient to
resolve the evolving biosafety and biosecurity threats faced by emerging technologies. Earlier in India,
National Guidelines for Stem Cell Research, 2017 was also issued by the Indian Council of Medical
Research (ICMR) and the Department of Biotechnology (DBT). 3 The guidelines limit stem cell, germ-line
stem cell, or gamete genome alteration, including gene editing by CRISPR-Cas9 technology, to in-vitro
studies only. At present, India Expands Its COVID-19 tests using CRISPR gene editing technology. This
is made possible by Tata Medical and Diagnostics, in partnership with Apollo hospitals in India. They

2
“New Drugs and Clinical Trials Rules, 2019,” Ministry of Health and Family Welfare,  Government of
India.
3
“National Guidelines for Stem Cell Research, 2017,” Indian Council of Medical Research, Government
of India.
created this fast, inexpensive, and effective diagnostic test that uses only throat swabs or lung fluids. This
test has been authorized by the Indian Council of Medical Research and the Drug Controller General of
India.

He Jiankui, a Chinese scientist, confirmed the birth of the world's first-ever CRISPR twins in 2018. He
used CRISPR technology to edit the genomes of human embryos to eliminate unwanted mutations in the
CCR5 gene, which leaves the cells vulnerable to the Human Immunodeficiency Virus (HIV). Although
successful, this scientific programmed reveals the flaws in oversight procedures, both at the global and
Chinese government levels, that enabled such a risky experiment to be carried out in the first place.
Physicians can engage in time-consuming, immoral, and highly condemning behavior as a result of a lack
of regulatory oversight.4

In light of the pandemic, regulatory control over genetic technology spectrum has brought rising concerns
in code of conduct, privacy and biosafety issues. The genotyping procedure calculates a patient's chance
of contracting serious disease from COVID-19 by combining their clinical profile with their genetic
material.5 Although technologically adept companies and funding governments have progressed the gene
technology paradigm, some instances of misconduct have ensured proper due diligence and care for
involvement of humans in such cases. In the united states of America, in 1999 the case of Jesse Gelsinger
shook the medical field for this person was the first to be officially declared as dying in a gene therapy
clinical trial.6The scientists participating in the trial violated those codes of ethics, according to the
(USFDA) investigation. The gene-therapy technique suffered a significant setback as a result of this.

VERSATILE INDIAN REGULATORY BODIES

The rapid speed of technical advancement guarantees the development of newer and improved
technology. Regulators also have to keep up with science and technical advancements. National Ethical
Guidelines for Biomedical and Health Research Including Human Participants, 2017 were also released
by the ICMR. These rules apply to all health-related biomedical, social, and behavioral science research
in India that involves human subjects, biological content, and data.

The National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) was established by the
Ministry of Health and Family Welfare in 2017 to oversee stem cell research in India. The committee
investigates stem cell research and therapy from a scientific, technical, ethical, legal, and social

4
David Cyranoski, “China set to introduce gene-editing regulation following CRISPR-baby
furore,” Nature, May 20, 2019.
5
https://www.bioworld.com/articles/504419-genetic-technologies-pairs-up-with-infinity-biologix-for-covid-19-risk-
test
6
Meir Rind, “The Death of Jesse Gelsinger, 20 Years Later,” Science History Institute, June 4, 2019.
standpoint. The Ministry of Environment, Forests, and Climate Change (MoEFCC), the Ministry of
Science and Technology (MoST), and the Ministry of Health and Family Welfare (MoHFW) in India are
in charge of controlling various aspects of biotechnology research and development.

During the early stages of the Covid-19 pandemic, governments all over the world boosted their spending
in healthcare, with the private sector following suit. This will undoubtedly boost Research &
Development, encourage creativity, and aid the evolution of existing technology.

REGULATORY CHALLENGES FOR GENETIC TECHNOLOGY

Previously, inventions with national security ramifications were subjected to regulation aimed at
restricting their spread and tracking their use. Ethical norms for research and development (R&D)
practices are generally implemented by national governments by regulations or recommendations. Many
developed countries currently lack the basic infrastructure for ethical study and health treatment, such as
academic ethics boards, governmental regulatory authorities, and independent bioethical research bodies.
Because of the transnational scope of biotechnology research, scientists and businesses are finding it
extremely difficult to comply with various regulatory standards in different countries. As a result, India
must rely on international processors and equipment to advance biotech applications, thus once again
making us dependent on the developed & economically stable nations. Subject to export norms, Tight
export control regulations will suppress research and development (R&D) operations, despite the fact that
these developments are quickly becoming the backbone of biomedical research in a variety of fields.

CONCLUSION

Further, developing countries like India see export control systems as a way of denying them access to
sophisticated technology, especially during unprecedented times like the pandemic and medical
emergencies. As a result, export restrictions are unlikely to become the basis for regulating newly
evolving biotechnology technologies. Given the complex, technological, and uncertain existence of
scientific experimentation, more effective regulatory mechanisms are needed to address current
challenges. At the same time, these interventions do not stifle scientific freedom or trigger undue concern
in the general public or policymakers.