Chapter IV DUTIES OF ASSISTED REPRODUCTIVE TECHNOLOGY CLINIC AND ASSISTED REPRODUCTIVE TECHNOLOGY BANK

The clinics and banks shall perform the following duties, namely:---

1. (a) the clinics and banks shall ensure that commissioning couple, woman and donors of gametes are eligible to avail the assisted reproductive technology procedures subject to such criteria as may be prescribed;
2. (b) the clinics shall obtain donor gametes from the banks and such banks shall ensure that the donor has been medically tested for such diseases as may be prescribed;
3. (c) the clinics shall---
   • (i) provide professional counselling to commissioning couple and woman about all the implications and chances of success of assisted reproductive technology procedures in the clinic;
   • (ii) inform the commissioning couple and woman of the advantages, disadvantages and cost of the procedures, their medical side effects, risks including the risk of multiple pregnancy; and
   • (iii) help the commissioning couple or woman to arrive at an informed decision on such matters that would most likely be the best for the commissioning couple;
4. (d) the clinics shall make commissioning couple or woman, aware of the rights of a child born through the use of assisted reproductive technology;
5. (e) the clinics and banks shall ensure that information about the commissioning couple, woman and donor shall be kept confidential and the information about treatment shall not be disclosed to anyone except to the database to be maintained by the National Registry, in a medical emergency at the request of the commissioning couple to whom the information relates, or by an order of a court of competent jurisdiction;
6. (f) every clinic and every bank shall maintain a grievance cell in respect of matters relating to such clinics and banks and the manner of making a compliant before such grievance cell shall be such as may be prescribed;
7. (g) the clinics shall apply the assisted reproductive technology services,---
   • (i) to a woman above the age of twenty-one years and below the age of fifty years;
   • (ii) to a man above the age of twenty-one years and below the age of fifty-five years;
8. (h) the clinics shall issue to the commissioning couple or woman a discharge certificate stating details of the assisted reproductive technology procedure performed on the commissioning couple or woman;
   • (i) all clinics and banks shall co-operate and make available their premises for physical inspection by the National Board, National Registry and State Boards;
9. (j) all clinics and banks shall provide all information related to---
   • (i) enrolment of the commissioning couple, woman and gamete donors;
   • (ii) the procedure being undertaken; and
   • (iii) outcome of the procedure, complications, if any, to the National Registry periodically, in such manner as may be prescribed.

1. (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. (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. (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. (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.

The duties of clinics and banks while keeping the records relating to such clinics and banks are as under:--

1. (a) all clinics and banks shall maintain detailed records of all donor’s oocytes, sperm or embryos used or unused, the manner and technique of their use in such manner as may be prescribed;
2. (b) all clinics and banks shall, as and when the National Registry is established, submit by online, --
   • (i) all information available with them in regard to progress of the commissioning couple or woman; and
   • (ii) information about number of donors (sperm and oocyte), screened, maintained and supplied and the like to the National Registry within a period of one month from the date of receipt of such information;
3. (c) the records maintained under clause (a) shall be maintained for at least a period of ten years, upon the expiry of which the clinic and bank shall transfer the records to a central database of the National Registry: Provided that if any criminal or other proceedings are instituted against any clinics or banks, the records and all other documents of such clinics and banks shall be preserved till the final disposal of such proceedings;
4. (d) in the event of the closure of any clinic or bank before the expiry of the period of ten years under clause (c), such clinic or bank shall immediately transfer the records to the central database of the National Registry; and
5. (e) all such records shall, at all reasonable times, be made available for inspection to the National Board or the National Registry or the State Board or to any other person authorised by the National Board in this behalf.

While using human gametes and embryos, the duties to be performed by the clinics and banks shall be as under:--

1. (a) the clinics shall retrieve oocytes in such manner as may be specified by regulations;
2. (b) not more than three oocytes or embryos may be placed in the uterus of a woman during the treatment cycle in such manner as may be specified by regulations;
3. (c) a woman shall not be treated with gametes or embryos derived from more than one man or woman during any one treatment cycle;
4. (d) a clinic shall never mix semen from two individuals for the procedures specified under this Act;
5. (e) the embryos shall not be split and used for twinning to increase the number of available embryos;
6. (f) the collection of gametes posthumously shall be done only if prior consent of the commissioning couple is available in such manner as may be prescribed;
7. (g) the clinic shall not use ovum that are derived from a foetus, in any process of in-vitro fertilisation; and
8. (h) such other duties as may be prescribed. Explanation.--For the purposes of this section, the expression--
   • (i) "fertilisation" means the penetration of the ovum by the spermatozoon and fusion of genetic materials resulting in the development of a zygote; and
   • (ii) "foetus" means a human organism during the period of its development beginning on the fifty-seventh day following fertilisation and ending at birth or abortion.

1. (1) The Pre-implantation Genetic testing shall be used to screen the human embryo for known, pre-existing, heritable or genetic diseases only.
2. (2) The donation of an embryo after Pre-implantation Genetic Diagnosis to an approved research laboratory for research purposes shall be done only--
   • (a) with the approval of the commissioning couple or woman; and
   • (b) when the embryo suffers from pre-existing, heritable, life-threatening or genetic diseases.
3. (3) The National Board may lay down such other conditions as it deems fit in the interests of the Pre-implantation Genetic testing. Explanation.--For the purposes of this section, the expression--
   • (i) "Pre-implantation Genetic Diagnosis" means the genetic diagnosis when one or both genetic parents has a known genetic abnormality and testing is performed on an embryo to determine if it also carries a genetic abnormality; and
   • (ii) "Pre-implantation Genetic testing" means a technique used to identify genetic defects in embryos created through in-vitro fertilisation before pregnancy.

1. (1) Subject to the provisions of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, (57 of 1994) the clinic shall not offer to provide a couple or woman with a child of a pre-determined sex.
2. (2) It is prohibited for anyone to do any act, at any stage, to determine the sex of the child to be born through the process of assisted reproductive technology to separate, or yield fractions enriched in sperm of X or Y variations.
3. (3) A person shall not knowingly provide, prescribe or administer anything that shall ensure or increase the probability that an embryo shall be of a particular sex, or that shall identify the sex of an in-vitro embryo, except to diagnose, prevent or treat a sex-linked disorder or disease.

1. (1) The screening of gamete donors, the collection, screening and storage of semen; and provision of oocyte donor, shall be done only by a bank registered as an independent entity under the provisions of this Act.
2. (2) The banks shall--
   • (a) obtain semen from males between twenty-one years of age and fifty-five years of age, both inclusive;
   • (b) obtain oocytes from females between twenty-three years of age and thirty-five years of age; and
   • (c) examine the donors for such diseases, as may be prescribed.
3. (3) A bank shall not supply the sperm or oocyte of a single donor to more than one commissioning couple.
4. (4) An oocyte donor shall donate oocytes only once in her life and not more than seven oocyte shall be retrieved from the oocyte donor.
5. (5) All unused oocytes shall be preserved by the banks for use on the same recipient, or given for research to an organisation registered under this Act after seeking written consent from the commissioning couple.
6. (6) A bank shall obtain all necessary information in respect of a sperm or oocyte donor, including the name, Aadhaar number as defined in clause (a) of section 2 of the Aadhaar (Targeted Delivery of Financial and other Subsidies, Benefits and Services) Act, 2016, address and any other details of such donor, in such manner as may be prescribed, and shall undertake in writing from such donor about the confidentiality of such information. Explanation. --For the purposes of this section, the expressions---
   • (i) "retrieval" means a procedure of removing oocytes from the ovaries of a woman;
   • (ii) "screening" means the genetic test performed on embryos produced through in-vitro fertilisation.

1. (1) The standards for the storage and handling of gametes, gonadal tissues and human embryos in respect of their security, recording and identification shall be such as may be prescribed.
2. (2) The gamete of a donor or embryo shall be stored for a period of not more than ten years and at the end of such period such gamete or embryo shall be allowed to perish or be donated to a research organisation registered under this Act for research purposes with the consent of the commissioning couple or individual, in such manner as may be prescribed.

The sale, transfer or use of gametes, zygotes and embryos, or any part thereof or information related thereto, directly or indirectly to any party within or outside India shall be prohibited except in the case of transfer of own gametes and embryos for personal use with the permission of the National Board. Explanation.--For the purposes of this section, the expression "zygote" means the fertilised oocyte prior to the first cell division.

1. (1) The use of any human gametes and embryos or their transfer to any country outside India for research shall be absolutely prohibited.
2. (2) The research on human gamete or embryo within India shall be performed in such manner as may be prescribed.

1. (1) The child born through assisted reproductive technology shall be deemed to be a biological child of the commissioning couple and the said child shall be entitled to all the rights and privileges available to a natural child only from the commissioning couple under any law for the time being in force.
2. (2) A donor shall relinquish all parental rights over the child or children which may be born from his or her gamete.