IVF and Assisted Reproductive Technology (Regulation) Act, 2021

GS Paper III

News Excerpt:

The Ministry of Health and Family Welfare has requested a report from the Government of Punjab concerning the IVF treatment undergone by the mother of the late Punjabi singer Sidhu Moosewala.

More about the news:

  • Moose Wala’s mother had undergone IVF treatment at the age of 58 and was successful in conceiving a baby, the father of the baby is also over 60.
  • Under Section 21(g) of the Assisted Reproductive Technology (Regulation) Act, 2021, the age limit prescribed for a woman going under ART services is between 21-50 years.

In-vitro fertilisation (IVF)

  • IVF is a reproductive technology that is used to help individuals and couples conceive a child when natural conception is not possible or successful.
  • The process involves:
    • Retrieving mature eggs from the woman’s ovaries.
    • Fertilising the eggs with sperm in a laboratory.
    • Transferring the fertilized embryos (eggs) into the woman’s womb to grow into a baby.
  • IVF helps couples with blocked fallopian tubes, low sperm count and other fertility issues and  can be used for both male and female infertility.

Assisted Reproductive Technology (Regulation) Act, 2021

  • ART (Regulation) Act aims to regulate and supervise assisted reproductive technology clinics and banks, and prevention of misuse, safe and ethical practice of services.
  • The Act also covers the important aspect of research in assisted reproduction and provides guidelines for the use of human gametes, embryos, and gonadal tissues for research.
  • Provision of ART services
    • The Act defines ART to include all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte (immature egg cell) outside the human body and transferring the gamete or the embryo into the reproductive system of a woman.  
    • These include gamete donation (of sperm or egg), in vitro fertilization, and gestational surrogacy.  
    • ART services will be provided through: 
      • ART clinics, which offer ART related treatments and procedures.
      •  ART banks, which collect, screen and store gametes.   
  • Registration of ART clinics and banks
    • Every ART clinic and bank must be registered under the National Assisted Reproductive Technology and Surrogacy Registry.  
    • A National Registry will be established under the Act, which will act as a central database with details of all ART clinics and banks in the country. 
    • The registration will be valid for five years and may be renewed.  
  • Boards: 
    • The Act provides that the National and State Boards constituted under the Surrogacy (Regulation) Act, 2021 will also act as the National and State Boards for the regulation of ART services.  
    • Key functions of the National Board include:
      • Advising the central government on ART-related policy matters
      • Reviewing and monitoring the implementation of the Act
      • Formulating a code of conduct and standards for ART clinics and banks
      • Overseeing bodies constituted under the Act. 
    • Minister of Health and Family Welfare is the exofficio Chairperson of the National Board.
  • Eligibility criteria for commissioning parties:  
    • ART services may be commissioned by married couples or women where:
    • The woman is between 21 and 50 years of age.
    • The man is between 21 and 55 years old.  
    • Married couples must also be infertile or suffer from any other proven medical condition which prevents conception.  
  • Eligibility criteria for donors: 
    • A bank may obtain semen from males between 21 and 55 years of age, and eggs from females between 23 and 35 years of age.  
    • The woman may donate eggs only once in her life and not more than seven eggs may be retrieved from her. 
    • A bank must not supply gametes of a single donor to more than one commissioning party (i.e. couples or single women seeking services).
  • Rights of a child born through ART:  
    • A child born through ART will be deemed to be a biological child of the commissioning couple and will be entitled to the rights and privileges available to a natural child of the commissioning couple.  
    • A donor will not have any parental rights over the child.
  • Offences and penalties: 
    • Offences under the Act include: 
      • Abandoning, or exploiting children born through ART.
      • Selling, purchasing, trading, or importing human embryos or gametes.
      • Exploiting the commissioning couple, woman, or the gamete donor in any form.  
    • These offences will be punishable with a fine between five and ten lakh rupees for the first contravention.
    • Subsequent contraventions can attract imprisonment between three to eight years and a fine of Rs 10 to 20 lakh.
    • A court will take cognisance of an offence only on a complaint by the National or State Board. 

What is the legal status of IVF in India? 

  • Under the ART (Regulation) Act, 2021, the age restriction is based on several crucial health factors concerning the mother. 
    • As women age, the quality of their eggs diminishes, impacting the success rates of IVF. 
    • According to the experts, the risk of miscarriage rises in older people which can lead to complications.
    • Additionally, older women face an increased likelihood of chromosomal abnormalities in embryos, raising concerns for both mother and child. Lastly, the body’s response to fertility drugs may be less effective as women age, further complicating the IVF process.

What are the exceptions under law to allow woman over 50 to opt for IVF in India?

  • As several research indicate increased incidences of health-related issues including gestational diabetes, pre-eclampsia, and multiple births, amongst other risks, which surge with advancing maternal age, the age restriction has been put in place to lower these risk factors.
    • However, the law also includes a clause for exceptions. A woman surpassing the age ceiling of 50 years can still opt for ART services, including IVF after a thorough medical and mental health evaluation which will certify if she is suitable and fit for the procedures.
  • So, women above 50 years of age may opt for IVF in India if they fulfil the stipulated medical and mental health criteria.
    • Under normal circumstances, the Act clearly restricts services to persons aged between 23 and 50 years for women and from 26 to 55 years for men. 
    • However, an essential caveat is section 21(g)(i) which paves the way for exceptions, thereby expanding access to ART services, specifically, IVF.
  • Women above the age of 50 years who want to opt for IVF need to undergo a comprehensive health check-up encompassing physical, cardiovascular and gynaecological health is mandatory. 
    • Any underlying health conditions or potential risk factors have to be thoroughly evaluated and deemed manageable by a registered medical practitioner, the law states.
  • Additionally, the woman must provide insurance cover for the unborn child. Moreover, a clear plan regarding the guardianship of the child in case of any unfortunate eventuality is required.

Conclusion:

Hence, While the Assisted Reproductive Technology (Regulation) Act, 2021 imposes age-specific restrictions on the availing of ART services, it also incorporates exceptions under section 21(g)(i).

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