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Assisted Reproductive Technology Regulations 2023


The Ministry of Health and Family Welfare (MoHFW) notified the Assiste  Reproductive Technology (Regulations) Amendment Rules 2023 (under the ART Act 2021) to provide donors and patients with better medical care and security.


GS II: Polity and Governance

Dimensions of the Article:

  1. What is Assisted Reproductive Technology (ART)?
  2. Salient Provisions of the Assisted Reproductive Technology (Regulation) Act 2021
  3. Significance of the Law on ART
  4. Concerns Regarding the above Provisions

What is Assisted Reproductive Technology (ART)?

Assisted Reproductive Technology (ART) refers to a range of techniques used to achieve pregnancy by manipulating sperm or egg cells outside the human body and transferring the resulting embryo into a woman’s reproductive tract. It includes procedures like sperm donation, in-vitro fertilization (IVF), and gestational surrogacy.

Salient Provisions of the Assisted Reproductive Technology (Regulation) Act 2021:

Registration and Database:

  • All ART clinics and banks are required to be registered under the National Registry of Banks and Clinics of India, which maintains a central database containing details of these institutions.
  • The registration is valid for five years and can be renewed for another five years. It can be cancelled or suspended if the institution violates the provisions of the Act.

Screening and Storage:

  • Registered ART banks can screen, collect, and store semen from men aged between 21 and 55 years. They can also store eggs from women aged between 23 and 35 years.

Donor Criteria:

  • Female donors must be married and have at least one child of their own, who is at least three years old.

Parental Rights:

  • A child born through an ART procedure is legally considered the biological child of the couple undergoing the procedure and is entitled to all the rights associated with that status.
  • The donor does not retain any parental rights over the child.

Informed Consent and Insurance:

  • Both the couple and the donor must provide written informed consent for the ART procedure.
  • The couple seeking an ART procedure is required to provide insurance coverage for the female donor in the event of loss, damage, or death of the donor.
Regulation of ART processes:
  • The Surrogacy Act 2021 establishes National and State Boards that are responsible for regulating ART services in addition to surrogacy.
  • These boards have various functions, including advising the government on policy matters, monitoring the implementation of the law, and formulating a code of conduct for ART clinics and banks.
  • The Act identifies several offences related to ART procedures.
  • These include abandoning or exploiting children born through ART, sale, purchase, or trade of embryos, exploitation of couples or donors, and transferring an embryo into a male or an animal.
  • Committing such offences can result in imprisonment ranging from 8 to 12 years and a fine ranging from Rs 10 to 20 lakhs.
Restrictions and Prohibitions:
  • ART clinics and banks are prohibited from advertising or offering sex-selective ART procedures.
  • Engaging in such activities is punishable by imprisonment ranging from 5 to 10 years and/or a fine of Rs 10 to 25 lakhs.

Significance of the Law on ART:

  • The implementation of this law is significant as it helps prevent congenital abnormalities and addresses the exploitation of donors.
  • By regulating the sector, the law aims to ensure the safety and well-being of individuals involved in ART procedures. It also aims to eliminate the presence of unregulated practices and untrained individuals in the field of ART.
  • Overall, the law is a step towards protecting the interests of individuals seeking ART services and promoting ethical practices in the field.

Concerns Regarding the above Provisions:

While the regulations aim to ensure the safety and ethical practices in ART procedures, there are concerns regarding the potential impact on accessibility and cost. Some of the concerns include:

  • Limited availability of donors: The restrictions on age and eligibility criteria for donors may limit the pool of available donors. This can create challenges as the demand for donor eggs and sperm may exceed the supply, leading to longer waiting times and reduced options for couples seeking ART services.
  • Increased costs: With a limited pool of donors, the cost of ART cycles may increase. Couples may face higher expenses for procedures such as egg or sperm donation, as additional investments such as insurance coverage for donors may be required. The increased costs can pose financial challenges for couples relying on ARTs, especially considering that multiple cycles are often needed for a higher chance of success.
  • Extended treatment duration: The requirement for multiple cycles is common in ART procedures, as individuals may require more than one attempt to achieve a successful pregnancy. By restricting the number of donation attempts or imposing stringent regulations, the treatment duration may be prolonged, leading to additional costs and emotional stress for couples.
  • Impact on fertility rates: Fertility rates in India and globally are declining. The limitations on available donors may further exacerbate this issue, as access to donor eggs or sperm plays a crucial role in assisting individuals or couples with fertility challenges. It may result in a decrease in the success rates of ART procedures and limit the options available to individuals seeking alternative paths to parenthood.

-Source: The Hindu

December 2023