Central Ideas

• The Health Ministry of India introduced the Assisted Reproductive Technology Regulations (ART), 2023 earlier this year, aiming to improve medical care and security for donors and patients.
• However, industry insiders report that the new provisions have led to increased medical costs and pose challenges for doctors and couples seeking ART due to limited availability of donors.

Assisted Reproductive Technology (ART) in India

• ART refers to a range of techniques used to achieve pregnancy by handling sperm or egg cells outside the human body and transferring embryos into the woman’s reproductive tract.
• It is regulated by Assisted Reproductive Technology (Regulation) Act 2021 in India.
• ART in India is regulated by the Indian Council of Medical Research (ICMR).
• National Guidelines for Accreditation, Supervision, and Regulation of ART Clinics were established in 2005.

Definition and Techniques of ART

• ART encompasses various procedures, including sperm donation, in-vitro fertilization (IVF), and gestational surrogacy.
• It involves handling sperm and egg cells in a laboratory setting to facilitate fertilization and embryo development.

Types of ART Procedures permitted:

1. In Vitro Fertilization (IVF): Eggs and sperm are fertilized in a laboratory dish, and resulting embryos are transferred to the uterus.
2. Intracytoplasmic Sperm Injection (ICSI): A single sperm is directly injected into an egg.
3. Intrauterine Insemination (IUI): Sperm is placed directly into the uterus during ovulation.
4. Surrogacy: A surrogate mother carries and delivers a baby for another individual or couple.

Salient Provisions of the ART (Regulation) Act 2021:

[A] Regulation of ART Clinics and Banks:

• Registration Requirement: ART clinics and banks must be registered under the National Registry of Banks and Clinics of India, maintaining a central database of these institutions.
• Validity and Renewal: Registration is valid for five years and can be renewed for an additional five years.
• Compliance and Penalties: Violation of the Act’s provisions may result in cancellation or suspension of the institution’s registration.

[B] Conditions for Sperm Donation and ART Services:

• Eligibility Criteria: Registered ART banks can screen, collect, and store semen from men aged between 21 and 55 years, as well as store eggs from women aged between 23 and 35 years.
• Female Donor Requirements: Female donors must be married with at least one child of their own, aged at least three years.
• Parental Rights: A child born through ART procedures is legally considered the couple’s biological child, and the donor does not retain any parental rights over the child.

[C] Consent and Insurance Coverage:

• Informed Consent: ART procedures require written informed consent from both the couple seeking the procedure and the donor.
• Insurance Coverage: The couple must provide insurance coverage for the female donor, protecting against loss, damage, or death.

[D] Regulation of ART Processes:

• National and State Boards: The Surrogacy Act 2021 establishes National and State Boards responsible for regulating ART services.
• Advisory Role: These boards advise the government on policy matters, review and monitor law implementation, and formulate a code of conduct for ART clinics and banks.

[E] Offences and Penalties:

• Offences defined: Child abandonment or exploitation, sale or trade of embryos, exploitation of couples or donors, and transfer of embryos into males or animals.
• Penalties: Offenders may face imprisonment ranging from 8 to 12 years and fines up to Rs 10 to 20 lakhs.
• Sex-Selective ART Prohibition: Clinics and banks are prohibited from advertising or offering sex-selective ART, with penalties of imprisonment ranging from 5 to 10 years and fines up to Rs 10 to 25 lakhs.

New Provisions of the ART Regulations, 2023

• Donation Frequency Restrictions: The regulations limit the number of times a donor (male or female) can donate sperm or oocytes in their lifetime.
• Age Limits for Donors: The provisions specify age criteria for oocyte donors, requiring prior marriage and having at least one living child of their own.
• Limitations on Gamete Distribution: ART banks are prohibited from supplying reproductive cells from a single donor to more than one commissioning couple.
• Insurance Coverage Requirement: Parties seeking ART services must provide insurance coverage for oocyte donors against any loss, damage, or death.
• Prohibition on Pre-Determined Sex Selection: Clinics are prohibited from offering to provide a child of pre-determined sex.
• Genetic Disease Screening: Checking for genetic diseases before embryo implantation is mandated.

Issues with these regulations

[A] Impact on Availability of Suitable Donors

• Restricted Opportunities: The new provisions significantly limit the opportunities for ART couples to find suitable donors, affecting their chances of successful treatment.
• Increased Costs: The restrictions on donation attempts have the potential to increase costs for couples relying on assisted reproductive techniques.
• Challenges for Couples: The limitations pose challenges for couples in need of ART services, as finding compatible donors becomes more difficult.

[B] Implications for Fertility Rates:

• Declining Fertility Rates: Like other parts of the world, India is experiencing a decline in fertility rates.
• Increased Challenges: Further limiting the pool of available donors through the new regulations is likely to exacerbate the challenges faced by couples seeking ART.

Conclusion

• While the new ART regulations in India aim to enhance safety measures and transparency, they have inadvertently led to challenges in the availability of suitable donors.
• With declining fertility rates, the restrictions imposed by the regulations pose additional difficulties.
• Balancing the need for regulation and patient access to effective ART treatments will be crucial to ensure the well-being of couples and the continued progress of assisted reproductive technology in India.

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