The Assisted Reproductive Technology (Regulation) Act, 2021

Administered Ministry: Ministry of Health and Family Welfare / Department of Health Research

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Section
Section 1 Short title, extent and commencement. 2 docs
(1) This Act may be called the Assisted Reproductive Technology (Regulation) Act, 2021.

(2) It shall come into force on such date1 as the Central Government may, by notification in the Official Gazette, appoint.

1. 25th January, 2022, vide notification No. S.O. 291(E), dated 20th January, 2022, see Gazette of India, Extraordinary, Part II, sec. 3(ii).

Section 2 Definitions.
(1) In this Act, unless the context otherwise requires, ---

(a) "assisted reproductive technology" with its grammatical variations and cognate expressions, means all techniques that attempt to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive system of a woman;

(b) "assisted reproductive technology bank" means an organisation which shall be responsible for collection of gametes, storage of gametes and embryos and supply of gametes to the assisted reproductive technology clinics or their patients;

(c) "assisted reproductive technology clinic" means any premises equipped with requisite facilities and medical practitioners registered with the National Medical Commission for carrying out the procedures related to the assisted reproductive technology;

(d) "child" means any individual born through the use of the assisted reproductive technology;

(e) "commissioning couple" means an infertile married couple who approach an assisted reproductive technology clinic or assisted reproductive technology bank for obtaining the services authorised of the said clinic or bank;

(f) "embryo" means a developing or developed organism after fertilisation till the end of fifty-six days from the day of fertilisation;

(g) "gamete" means sperm and oocyte;

(h) "gamete donor" means a person who provides sperm or oocyte with the objective of enabling an infertile couple or woman to have a child;

(i) "gynaecologist" shall have the same meaning as assigned to it in the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994);

(j) "infertility" means the inability to conceive after one year of unprotected coitus or other proven medical condition preventing a couple from conception;

(k) "National Board" means the National Assisted Reproductive Technology and Surrogacy Board to be constituted under sub-section (1) of section 17 of the Surrogacy Act;

(l) "National Registry" means the National Assisted Reproductive Technology and Surrogacy Registry established under section 9;

(m) "notification" means a notification published in the Official Gazette;

(n) "patients" means an individual or couple who comes to any registered assisted reproductive technology clinic for management of infertility;

(o) "prescribed" means prescribed by rules made under this Act;

(p) "appropriate authority" means the authority appointed under section 12;

(q) "regulations" means the regulations made by the National Board under this Act;

(r) "sperm" means the mature male gamete;

(s) "State Board" means a State Assisted Reproductive Technology and Surrogacy Board to be constituted under section 26 of the Surrogacy Act;

(t) "Surrogacy Act" means the Surrogacy (Regulation) Act, 2021; and

(u) "woman" means any woman above the age of twenty-one years who approaches an assisted reproductive technology clinic or assisted reproductive technology bank for obtaining the authorised services of the clinic or bank.

(2) The expressions "clinics" and "banks" occurring in this Act shall be construed as "assisted reproductive technology clinics" and "assisted reproductive technology banks".

(3) Words and expressions used herein and not defined in this Act but defined in the Surrogacy (Regulation) Act shall have the meanings respectively assigned to them in that Act.



Section 3 National Assisted Reproductive Technology and Surrogacy Board.
The National Assisted Reproductive Technology and Surrogacy Board to be constituted under sub-section (1) of section 17 of the Surrogacy Act shall be the National Board for the purposes of this Act.

Section 4 Application of provisions of Surrogacy Act with respect to National Board.
Subject to the provisions of this Act and the rules made thereunder, the provisions of the Surrogacy Act relating to---

(i) constitution of the National Assisted Reproductive Technology and Surrogacy Board;

(ii) term of office of Members of the National Board;

(iii) meetings of the National Board;

(iv) vacancies, etc., not to invalidate proceedings of the National Board;

(v) disqualifications for appointment as Member of the National Board;

(vi) temporary association of persons with the National Board for particular purposes;

(vii) authentication of orders and other instruments of the National Board; and

(viii) eligibility of Members of the National Board for re-appointment,

shall, mutatis mutandis, apply, so far as may be, in relation to assisted reproductive technology as they apply in relation to surrogacy, as if they are enacted under this Act.

Section 5 Powers and functions of National Board.
The National Board shall exercise and discharge the following powers and functions, namely:—

(a) to advise the Central Government on policy matters relating to the assisted reproductive technology;

(b) to review and monitor the implementation of the Act, rules and regulations made thereunder and recommend to the Central Government, any suitable changes therein;

(c) to lay down code of conduct to be observed by persons working at clinics and banks, to set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks;

(d) to oversee the performance of various bodies constituted under this Act and take appropriate steps to ensure their effective performance;

(e) to supervise the functioning of the National Registry and liaison with the State Boards;

(f) to pass orders as per the provisions made under this Act; and

(g) such other powers and functions as may be prescribed.

Section 6 State Assisted Reproductive Technology and Surrogacy Board.
The State Assisted Reproductive Technology and Surrogacy Board to be constituted under section 26 of the Surrogacy Act shall be the State Board for the purposes of this Act.

Section 7 Application of provisions of Surrogacy Act with respect to State Board.
Subject to the provisions of this Act and the rules made thereunder, the provisions of the Surrogacy Act relating to---

(i) constitution of the State Assisted Reproductive Technology and Surrogacy Board;

(ii) composition of the State Board;

(iii) term of office of members of the State Board;

(iv) meetings of the State Board;

(v) vacancies, etc., not to invalidate proceedings of the State Board;

(vi) disqualifications for appointment as member of the State Board;

(vii) temporary association of persons with the State Board for particular purposes;

(viii) authentication of orders and other instruments of the State Board; and

(ix) eligibility of member of the State Board for re-appointment,

shall, mutatis mutandis, apply, so far as may be, in relation to assisted reproductive technology as they apply in relation to surrogacy, as if they are enacted under this Act.

Section 8 Powers and functions of State Board.
(1) Subject to the provisions of this Act and the rules and regulations made thereunder, the State Board shall have the responsibility to follow the policies and plans laid by the National Board for clinics and banks in the State.

(2) Without prejudice to the generality of the provisions contained in sub-section (1), the State Board, taking into account the recommendations, policies and regulations of the National Board, shall—

(a) co-ordinate the enforcement and implementation of the policies and guidelines for assisted reproduction; and

(b) such other powers and functions as may be prescribed.

(3) In the exercise of its functions under this Act, the State Board shall give such directions or pass such orders as directed by the National Board.

Section 9 Establishment of National Registry of clinics and banks.
The Central Government may, within a period of ninety days from the date of commencement of this Act, by notification, establish for the purposes of this Act and Surrogacy Act, a Registry to be called the National Assisted Reproductive Technology and Surrogacy Registry

Section 10 Composition of National Registry.
The National Registry referred to in section 9 shall consist of such scientific, technical, administrative and supportive staff and the terms and conditions of their service shall be such as may be prescribed.

Section 11 Functions of National Registry.
The National Registry shall discharge the following functions, namely:—

(a) it shall act as a central database in the country through which the details of all the clinics and banks of the country including nature and types of services provided by them, outcome of the services and other relevant information shall be obtained on regular basis;

(b) it shall assist the National Board in its functioning by providing the data generated from the central database of the Registry;

(c) the data generated from the National Registry shall be utilised by the National Board for making policies, guidelines and shall help in identifying new research areas and conducting research in the area of assisted reproduction and other related fields in the country; and

(d) such other functions as may be prescribed.

Section 12 Appointment of appropriate authority.
(1) The Central Government shall, within a period of ninety days from the date of commencement of this Act, by notification, appoint one or more appropriate assisted reproductive technology and surrogacy authorities for each of the Union territories for the purposes of this Act and the Surrogacy Act.

(2) The State Government shall, within a period of ninety days from the date of commencement of this Act, by notification, appoint one or more appropriate assisted reproductive technology and surrogacy authorities for the whole or any part of the State for the purposes of this Act and the Surrogacy Act.

(3) The appropriate authority, under sub-section (1) or sub-section (2), shall, ---

(a) when appointed for the whole of the State or the Union territory, consist of---

(i) an officer of or above the rank of the Joint Secretary of the Health and Family Welfare Department--- Chairperson, ex officio;

(ii) an officer of or above the rank of the Joint Director of the Health and Family Welfare Department --- Vice Chairperson, ex officio;

(iii) an eminent woman representing women's organisation---member;

(iv) an officer of Law Department of the State or the Union territory concerned not below the rank of a Deputy Secretary---member, ex officio; and

(v) an eminent registered medical practitioner---member:

Provided that any vacancy occurring therein shall be filled within one month of the occurrence of such vacancy;

(b) when appointed for any part of the State or the Union territory, the officers of such other rank as the State Government or the Central Government, as the case may be, may deem fit.

(4) The members of appropriate authority, other than ex officio members, shall receive only compensatory travelling expenses for attending the meetings of such Authority.

Section 13 Functions of appropriate authority.
The appropriate authority shall discharge the following functions, namely: —

(a) to grant, suspend or cancel registration of a clinic or bank;

(b) to enforce the standards to be fulfilled by the clinic or bank;

(c) to investigate complaints of breach of the provisions of this Act, rules and regulations made thereunder and take legal action as per provisions of this Act;

(d) to take appropriate legal action against the misuse of assisted reproductive technology by any person and also to initiate independent investigations in such matter;

(e) to supervise the implementation of the provisions of this Act and the rules and regulations made thereunder;

(f) to recommend to the National Board and State Boards about the modifications required in the rules and regulations in accordance with changes in technology or social conditions;

(g) to take action after investigation of complaints received by it against the assisted reproductive technology clinics or banks; and

(h) such other functions as may be prescribed.

Section 14 Powers of appropriate authority.
(1) The appropriate authority shall exercise the powers in respect of the following matters, namely:—

(a) summoning of any person who is in possession of any information relating to violation of the provisions of this Act and the rules and regulations made thereunder;

(b) production of any document or material object relating to clause (a);

(c) searching of any place suspected to be violating the provisions of this Act and the rules and regulations made thereunder; and

(d) such other powers as may be prescribed.

(2) The appropriate authority shall maintain the details of registration of assisted reproductive technology clinics and banks, cancellation of registration, renewal of registration, grant of certificates to the commissioning couple and woman or any other matter pertaining to grant of licence and the like of the clinic or bank in such format as may be prescribed and submit the same to the National Board.

Section 15 Registration of assisted reproductive technology clinic or assisted reproductive technology bank.
(1) No person shall establish any clinic or bank for undertaking assisted reproductive technology or to render assisted reproductive technology procedures in any form unless such clinic or bank is duly registered under this Act.

(2) Every application for registration under sub-section (1) shall be made to the National Registry through the appropriate assisted reproductive technology and surrogacy authority in such form, manner and shall be accompanied by such fees as may be prescribed.

(3) Every clinic or bank which is conducting assisted reproductive technology, partly or exclusively shall, within a period of sixty days from the date of establishment of the National Registry, apply for registration:

Provided that such clinics and banks shall cease to conduct any such counselling or procedures on the expiry of six months from the date of commencement of this Act, unless such clinics and banks have applied for registration and is so registered separately or till such application is disposed of, whichever is earlier.

(4) No clinics or banks shall be registered under this Act, unless the appropriate authority is satisfied that such clinics and banks are in a position to provide such facilities and maintain such equipment and standards including specialised manpower, physical infrastructure and diagnostic facilities as may be prescribed.

Section 16 Grant of registration.
(1) On receipt of the application under sub-section (1) of section 15, the appropriate authority shall within a period of thirty days—

(i) grant registration subject to the provisions of this Act and the rules and regulations made thereunder, and provide a registration number to the applicant; or

(ii) reject the application for reasons to be recorded in writing, if such application does not conform to the provisions of this Act or the rules or regulations made thereunder:

Provided that no application shall be rejected unless the applicant has been given an opportunity of being heard in the matter.

(2) If the appropriate authority fails to grant the registration or reject the application, as the case may be, as provided under sub-section (1), the appropriate authority shall, within a period of seven days from the expiry of the said period of thirty days specified under sub-section (1), provide a reason for the failure to process the application.

(3) The appropriate authority shall, within a period of one month of registration being granted under this section, intimate such registration to the State Board.

(4) The State Board shall maintain a record of all registrations applied for and granted under this section.

(5) No registration shall be granted unless the State Board has inspected the premises of the applicant.

(6) The registration granted under this section shall be valid for a period of five years from the date of registration granted by the appropriate authority.

(7) The certificate of registration shall be displayed by the clinic or bank at a conspicuous place and such certificate shall contain the duration of validity of such registration.

Section 17 Renewal of registration.
The registration granted under section 16, may be renewed for a further period of five years by the appropriate authority, on an application made by the applicant, under such conditions, in such form and on payment of such fee as may be prescribed:

Provided that no application for renewal of registration shall be rejected without giving an opportunity of being heard to the applicant.

Section 18 Suspension or cancellation of registration.
(1) The appropriate authority may on receipt of a complaint, issue a notice to the clinic or bank to show cause as to why its registration should not be suspended or cancelled for the reasons mentioned in the notice.

(2) If after giving a reasonable opportunity of being heard to the clinic or bank, the appropriate authority is satisfied that there has been a breach of the provision of this Act or the rules or regulations made thereunder or if the data obtained from them periodically do not satisfy the provisions of this Act, the rules and regulations made thereunder, it may, without prejudice to any criminal action, suspend its registration for such period as it may deem fit or cancel its registration.

(3) On cancellation of registration, a copy of the cancellation letter shall be sent to the respective State Board and accordingly the State Board shall cancel the registration of such clinics and banks.

Section 19 Appeal.
The clinic or bank or the commissioning couple or the woman may, within a period of thirty days from the date of receipt of the communication relating to order of rejection of application, suspension or cancellation of registration passed by the appropriate authority under section 16 or section 18, prefer an appeal against such order to--

(a) the State Government, where the appeal is against the order of the appropriate authority of a State;

(b) the Central Government, where the appeal is against the order of the appropriated authority of a Union territory,

in such manner as may be prescribed.

Section 20 Power to inspect premises, etc.
The National Board, the National Registry and the State Board shall have the power to, --

(i) inspect, any premises relating to assisted reproductive technology; or

(ii) call for any document or material,

in exercise of their powers and discharge of their functions.