Future of Embryology by Attuluri Vamsi Kumar

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1 Lecture by Attuluri Vamsi Kumar
Lecture on Future of Embryology: New Guidelines by ICMR
Overview
on
“Future of Embryology: New Guidelines by ICMR”
Attuluri Vamsi Kumar
Assistant Professor
Department of Medical Lab Technology
Chandigarh University
(23-12-2023)
Lecture by Attuluri Vamsi Kumar
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Lecture on Future of Embryology: New Guidelines by ICMR
Guest Lecture in the program: Five Days Faculty Development Program, Rayat Bahra University, Mohali

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Lecture on Future of Embryology: New Guidelines by ICMR 2
Contents
1. Introduction
2. Evolution of Embryology
3. ICMR’s role in embryology
4. New ICMR Guidelines – Overview
5. Deep Dive into Key guidelines
6. Technological Advances in Embryology
7. Ethical Considerations
8. Case Studies/Examples
1. Application of New Guidelines
9. Future of Embryology
10. Conclusion
11. Q&A Session

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Introduction

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Embryologists
Geneticists
OB/GYN
Reproductive
Endocrinologists
Biomedical
Researchers
Stem Cell
Researchers

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Parameter/Profession
Work with Genetic Material ✔ ✔ ✔
Involved in Human Reproduction ✔ ✔ ✔
Integral to Reproductive Medicine ✔ ✔
Conduct Medical Research ✔ ✔ ✔ ✔
Focus on Early Human
Development
✔
Manage Health During Pregnancy ✔
Treat Hormonal Disorders ✔
Work in Various Medical Fields ✔
Therapeutic Use of Cells ✔
Embryologists Geneticists OB/GYN
Reproductive
Endocrinologists
Biomedical
Researchers
Stem Cell
Researchers
Comparison between Embryologists and Related Medical Professions

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Pregnancy Stages and the Role of Embryologists
Stages of Pregnancy
First Trimester
(0-12 Weeks)
Second Trimester
(13-26 Weeks)
Third Trimester
(27-40 Weeks)
Involvement of Embryologists
Fertilization ✔
Primary role in fertilization,
especially in ART like IVF.
Embryo Development ✔
Key involvement in monitoring and
supporting early embryonic
development.
Fetal Development ✔ ✔ ✔
Limited to early fetal
development; main focus is on the
first few weeks.
Preparation for Birth ✔
No direct involvement, as this is
beyond the embryonic stage.

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Definition: Embryology
• Definition: Embryology is the branch of biology
that studies the development of gametes (sex
cells), fertilization, and development of embryos
and fetuses. Additionally, it encompasses the
study of congenital disorders that occur before
birth.
• Key Processes: Includes gametogenesis
(formation of gametes), fertilization, zygote
formation, embryonic development, and fetal
development.
• Significance: Understanding embryological
development is crucial for insights into human
development, genetic disorders, and potential
treatments.

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Importance of Embryology in Medicine
1.Foundation in Reproductive Health: Embryology is pivotal in fertility
treatments and understanding reproductive health, significantly aiding in
assisted reproductive technologies like IVF.
2.Insights into Developmental Disorders: It plays a key role in
diagnosing and understanding congenital anomalies, enhancing early
intervention strategies.
3.Advancements in Genetics: Embryology contributes to genetic
research, enabling breakthroughs in gene therapy and understanding of
hereditary conditions.
4.Stem Cell Research: It informs stem cell research and regenerative
medicine, aiding in developments in tissue engineering and cell
regeneration.
5.Ethical Guidance: Embryology guides ethical practices in sensitive
areas like genetic editing and stem cell use, shaping responsible
medical protocols.

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Lecture on Future of Embryology: New Guidelines by ICMR10
Evolution of Embryology: A Brief History
1.Ancient Observations: The earliest recorded studies of embryology
are found in ancient civilizations like Greece and India, where
philosophers like Aristotle made observations on chicken eggs and
animal gestation.
2.Renaissance Advances: During the Renaissance, scientific interest
in embryology grew. Anatomists like Leonardo da Vinci and Andreas
Vesalius made detailed anatomical drawings, enhancing the
understanding of human and animal development.
3.Microscopy Era: The invention of the microscope in the 17th century
revolutionized embryology. Scientists could now observe the previously
unseen early stages of embryonic development.
4.19th Century: The 19th century saw significant strides in
embryological understanding. The cell theory by Schleiden and
Schwann and the work of von Baer on embryonic development were
pivotal.
5.20th Century to Present: The discovery of DNA and advancements
in molecular biology in the 20th century opened new horizons in
embryology. Today, embryology is integral to reproductive medicine,
genetics, and developmental biology, with breakthroughs in IVF, stem
cell research, and genetic engineering.

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The Birth of first IVF Baby
In Vitro Fertilization
(1978): The birth of Louise
Brown, the first baby
conceived via IVF, marked
a ground breaking
moment, bringing new
hope to couples struggling
with infertility.

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The era of CRISPER

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The era of CRISPER

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The era of CRISPER
The raise of Designer
Babies!

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The unthinkable happened!

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The unthinkable happened!

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The summary of He Jiankui Case
1. Event: In November 2018, Chinese scientist He Jiankui claimed to have created
the first genetically edited babies, Lulu and Nana, using CRISPR-Cas9 to make
them HIV resistant.
2. Global Reaction:
1. Widespread condemnation from the scientific community and regulatory
authorities.
2. Ethical concerns: Lack of transparency, peer review, potential risks.
3. Legal and Ethical Fallout:
1. Chinese government halted He's research and conducted an investigation.
2. December 2019: He Jiankui sentenced to three years in prison for illegal
medical practices.
4. Broader Impact:
1. Sparked global debate on ethics and regulation of human gene editing.
2. Calls for international standards and oversight in gene editing research.
5. Current Status:
1. He Jiankui completed his sentence; current activities unknown.
2. Ongoing global discussions on ethical guidelines for human gene editing.
• Conclusion: The He Jiankui case highlights the critical need for ethical guidelines
and regulatory oversight in human gene editing.

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Overview of ICMR (Indian Council of Medical Research) and its role in
setting guidelines
The Indian Council of Medical Research (ICMR) is India's
leading body for biomedical research, functioning under
the Ministry of Health and Family Welfare.
Key Roles of ICMR:
1.Research Promotion: Facilitates and funds medical
research across various health domains.
2.Guideline Development: Establishes ethical and
scientific guidelines for medical practices and research.
3.Policy Influence: Influences health policy formulation
by integrating research findings.
4.Capacity Building: Enhances research capabilities
through training and establishing centers of excellence.
5.Public Health Initiatives: Addresses major health
challenges with proactive interventions.
ICMR's role is pivotal in guiding medical research and
practice in India, ensuring scientific rigor and ethical
standards.
ICMR is instrumental in shaping the
direction of medical research in India, setting
guidelines that ensure ethical and effective
medical practices and research, and
translating research findings into policy and
practice.

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Historical role in embryology guidelines by
ICMR
1.1980s-1990s: Foundational Guidelines
1. Initial focus on basic ethical considerations in embryology and reproductive technologies.
2. Establishment of guidelines for the safe and ethical use of ART (Assisted Reproductive Technologies).
2.Early 2000s: Comprehensive Frameworks
1. Introduction of comprehensive guidelines to regulate and standardize embryology practices.
2. Focus on ethical concerns, patient consent, and safety in IVF and other ART procedures.
3.Mid-2000s: Ethical Expansion
1. Expansion of guidelines to address the ethical complexities of embryology, particularly in IVF, genetic testing,
and embryo handling.
2. Implementation of stricter norms for patient information and consent.
4.Late 2000s - Early 2010s: Inclusion of Technological Advances
1. Incorporation of new findings and technologies like stem cell research and preimplantation genetic diagnosis
(PGD).
2. Guidelines updated to reflect these advancements and their ethical implications.
5.Mid-2010s Onwards: Alignment with Global Standards
1. Further updates to align with international best practices and advancements in embryology.
2. Emphasis on global collaboration and adapting international guidelines to the Indian context.
6.Recent Years: Continuous Updates
1. Ongoing updates to guidelines to incorporate the latest research findings, ethical debates, and technological
advancements in the field of embryology.

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ICMR Proactive Role in ART Bill
• Background:
• The Government had been working on the bill
to regulate the ART industry since 2008 when it
was first drafted by the Indian Council of Medical
Research (ICMR).
• The bill was first introduced in Lok Sabha in
2020 but the House had referred it to a standing
committee.

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About the ART Bill

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The ART Act has been Passed!

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About the Surrogacy (ART) Act, 2021
• Regulate ART Services:
• It seeks to regulate and supervise Assisted
Reproductive Technology (ART) clinics
and ART banks, prevent misuse, adopt safe
and ethical practice and so on.
• National Board:
• The bill proposes the constitution of a
national board.
• The board will set minimum standards of
physical infrastructure, laboratory, diagnostic
equipment and expert manpower to be employed
by clinics and banks.

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• Stringent Punishment:
• It further seeks stringent punishment for
those practicing sex selection, sale of human
embryos or gametes, or found running agencies,
rackets and organisations for such practices in
violation of the law.
• For First-Time Offenders:
• It may attract a penalty between Rs. 5 lakhs and Rs. 10
lakhs.
• For Subsequent Contraventions:
• Punishable with imprisonment for a term between eight and
12 years, and a fine between Rs. 10 and Rs. 20 lakh.
• Any Clinic or Bank Advertising or Offering Sex-
Selective ART:
• Punishable with imprisonment between five and ten years,
or fine between Rs. 10 lakh and Rs. 25 lakh, or both.

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• Need:
• To Standardise Protocols:
• There are so many such ART clinics that have
been running without regulation and there
are implications on the health of those who
undertake the procedure.
• If there is no regulation, the unethical practices
will increase.
• To Protect Women and Children:
• The oocyte (a cell in an ovary) donor needs to be
supported by an insurance cover. Multiple embryo
implantation needs to be regulated and children
born through ART need to be protected.

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• Concerns:
Discrimination in Accessibility:
• The Bill allows for a married heterosexual
couple and a woman above the age of
marriage to use ARTs and excludes single
men, cohabiting heterosexual couples and
LGBTQ+ individuals and couples from
accessing ARTs.
• Duplicacy:
• Both Surrogacy and ART Bills will set up
multiple bodies for registration which will
result in duplication or worse, lack of regulation.
• For example, a surrogacy clinic is not required to report
surrogacy to the National Registry.
Cohabitation is an arrangement where people who are not
married, usually couples, live together. They are often
involved in a romantic or sexually intimate relationship on
a long-term or permanent basis. Wikipedia

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• Violates Article 14:
• The bill violates Article 14 of India's
constitution and is also silent on the rights
of children.
• According to Article 14, equality before law and
equal protection of law to any person within India
cannot be denied.
• Cost of the Services:
• The cost of the procedure should be
effectively monitored so that even the poor
can avail of its services.
Potential Violation of Article 14:
1.Selective Access: If the bill creates scenarios where
only certain sections of society can access ART due to
economic, marital status, or other discriminatory reasons,
it may be seen as violating the principle of equality.
2.Children's Rights: If the bill does not adequately
address the rights of children born through ART, there
could be a perception of inequality, especially if these
children are treated differently under the law compared to
those conceived naturally.

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Way Forward
1. Clinics must have ethics committees and mandated
counselling services should be independent of them.
2. Prior versions of the Bill regulated research using
embryos, which must be brought back and definitions of
commissioning “couple”, “infertility”, “ART clinics” and
“banks” need to be synchronised between the Bill and
the Surrogacy (Regulation) Bill.
3. All ART bodies should be bound by the directions of
central and state governments in the national interest,
friendly relations with foreign states, public order,
decency and morality.
4. All the constitutional, medico-legal, ethical and
regulatory concerns raised by the Bill must be
thoroughly reviewed before affecting millions.

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Comparison of Old & New ICMR Guidelines on
ART
1.Incomplete Coverage: They may not have addressed
all ART aspects, leaving gaps in procedures and
stakeholder inclusion.
2.Regulatory Gaps: There was potentially weak
enforcement and monitoring of the guidelines.
3.Ethical Concerns: Ethical safeguards regarding the
rights of donors, surrogates, and children might have
been insufficient.
4.Vagueness: Ambiguities in the guidelines could lead to
inconsistent application.
5.Exclusivity Issues: Marginalized groups might not
have been adequately considered.
6.Technological Lag: The guidelines could quickly
become outdated as ART technology advanced.
7.Global Standards Misalignment: There might have
been a lack of adherence to international ART practices.
8.Data Protection: Previous guidelines may have
lacked robust data privacy measures.
9.Commercial Exploitation: There was potentially
inadequate regulation of the ART market and costs.
10.Research Support: Limited emphasis on research
and development in ART might have been present.
Old ICMR Guidelines -
Overview: 1.Ethical Practices: The latest guidelines likely emphasize
enhanced ethical standards for ART, including informed
consent, confidentiality, and non-exploitation of donors and
surrogates.
2.Quality Control: There may be updated protocols for
quality assurance in ART clinics, ensuring high standards of
laboratory and clinical practice.
3.Technological Integration: New guidelines may
incorporate recent technological advancements, such as
next-generation sequencing (NGS) for preimplantation
genetic testing.
4.Expanded Scope of Practices: The inclusion of newer
ART procedures and treatments, reflecting the broadening
scope of reproductive technologies.
5.Regulatory Compliance: Stricter regulations for the
accreditation, supervision, and functioning of ART clinics may
be part of the new guidelines.
6.Surrogacy Regulations: Given the ethical and legal
complexities of surrogacy, the latest guidelines might include
more stringent rules for surrogate selection, compensation,
and rights.
7.Data Management: Enhanced requirements for record-
keeping and reporting of ART outcomes to ensure
New ICMR Guidelines -
Overview:

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Future of Embryology
Predictions and Trends:
•Technological Innovations: The
integration of AI and machine learning for
embryo selection in IVF could improve
success rates.
•Gene Editing: Advancements in CRISPR
technology may allow for more precise
genetic interventions, potentially preventing
hereditary diseases.
•Stem Cell Breakthroughs: Progress in
stem cell research might offer new
treatments for infertility and congenital
conditions.

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Future of Embryology
Potential Amendments in Guidelines:
•Ethical Regulations: As genetic editing
advances, guidelines will likely be amended to
address ethical concerns surrounding designer
babies and eugenics.
•Data Security: With increased digitization, stricter
data protection laws will be essential for
safeguarding patient genetic information.
•Global Harmonization: Efforts may be made to
standardize ART and embryology practices
internationally, facilitating global cooperation and
research.
•Inclusivity: Future guidelines will probably
expand to be more inclusive of diverse family
structures and individuals, reflecting societal
changes.

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Future of Embryology: An artificial
Woumb
Source:
https://www.youtube.com/watc
h?v=dt7twXzNEsQ

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Embryologists can make Avatar a reality!

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A quick Summary
The Assisted Reproductive Technology (Regulation) Act, 2021: A Step in the
Right Direction
Vishan Dev Singh Jamwal and Arun Kumar Yadav1

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Summary of Surrogacy (ART) Act, 2021

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Conclusion
• The future of embryology holds exciting potential for medical
science, yet it also calls for careful consideration of ethical
implications and proactive guideline updates to navigate the
challenges ahead.

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Reference
• https://www.drishtiias.com/daily-news-analysis/assisted-
reproductive-technology-regulation-bill-2021
• Jamwal VDS, Yadav AK. The Assisted Reproductive Technology (Regulation)
Act, 2021: A Step in the Right Direction. Indian J Community Med. 2023 Jan-
Feb;48(1):4-6. doi: 10.4103/ijcm.ijcm_169_22. Epub 2022 Dec 8. PMID:
37082392; PMCID: PMC10112746.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10112746/

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Any Questions?

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Future of Embryology by Attuluri Vamsi Kumar

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