Act Number: 42

Act Name: The Assisted Reproductive Technology (Regulation) Act, 2021

Year: 2021

Enactment Date: 2021-12-18

Long Title: An Act for the regulation and supervision of the assisted reproductive technology clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services for addressing the issues of reproductive health where assisted reproductive technlogy is required for becoming a parent or for freezing gametes, embryos, embryonic tissues for further use due to infertility, disease or social or medical concerns and for regulation and supervision of research and development and for matters connected therewith or incidental thereto.

Ministry: Ministry of Health and Family Welfare

Department: Department of Health Research

Section 22: Written informed consent.
    (1) The clinic shall not perform any treatment or procedure without--
        (a) the written informed consent of all the parties seeking assisted reproductive technology;
        (b) an insurance coverage of such amount as may be prescribed for a period of twelve months in favour of the oocyte donor by the commissioning couple or woman from an insurance company or an agent recognised by the Insurance Regulatory and Development Authority established under the provisions of the Insurance Regulatory and Development Authority Act, 1999 (41 of 1999).
    (2) The clinics and banks shall not cryo-preserve any human embryos or gamete, without specific instructions and consent in writing from all the parties seeking assisted reproductive technology, in case of death or incapacity of any of the parties.
    (3) The clinic shall not use any human reproductive material, except in accordance with the provisions of this Act to create a human embryo or use an in-vitro human embryo for any purpose without the specific consent in writing of all the concerned persons to whom the assisted reproductive technology relates.
    (4) Any of the commissioning couple may withdraw his or her consent under sub-section (1), any time before the human embryos or the gametes are transferred to the concerned woman's uterus.
    Explanation. --For the purposes of this section, the expressions--
        (i) "cryo-preserve" means the freezing and storing of gametes, zygotes, embryos, ovarian and testicular tissues;
        (ii)"insurance" means an arrangement by which a company, individual or commissioning couple undertake to provide a guarantee of compensation for specified loss, damage, complication or death of oocyte donor during the process of oocyte retrieval; and
        (iii) "parties" includes the commissioning couple or woman and the donor.
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