The Assisted Reproductive Technology (Regulation) Act, 2021
Administered Ministry: Ministry of Health and Family Welfare / Department of Health Research
Section
Section 41 Protection of action taken in good faith.
No suit, prosecution or other legal proceeding shall lie against the Central Government or the State Government or the National Board or the National Registry or the State Board or the appropriate authority or any other officer authorised by the Central Government or the State Government or the National Board or the National Registry or the State Board or the appropriate authority for anything which is done in good faith or intended to be done in pursuance of the provisions of this Act or the rules or regulations made thereunder.
Section 42 Power to make rules.
(1) The Central Government may by notification make rules for carrying out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for--
(a) the other powers and functions of the National Board under clause (g) of section 5;
(b) the other powers and functions of the State Board under clause (b) of sub-section (2) of section 8;
(c) the terms of office and other conditions of service of scientific, technical and other employees of the National Registry under section 10;
(d) the other functions of the National Registry under clause (d) of section 11;
(e) the other functions of the appropriate authority under clause (h) of section 13;
(f) the other powers to be exercised by the appropriate authority under clause (d) of sub-section (1) of section 14;
(g) the format for granting of licences to the clinic or bank by the appropriate authority under sub-section (2) of section 14;
(h) the form and manner in which an application shall be made for registration and fee payable thereof under sub-section (2) of section 15;
(i) the facilities and equipments to be provided and maintained by the clinics and banks under sub-section (4) of section 15;
(j) the conditions, form and fee for application of renewal of the registration of clinic or bank under section 17;
(k) the manner in which an appeal may be preferred to the State Government or the Central Government under section 19;
(l) the criteria for availing the assisted reproductive technology procedures under clause (a) of section 21;
(m) the medical examination of the diseases with respect to which the donor shall be tested under clause (b) of section 21;
(n) the manner of making a complaint before a grievance cell and the mechanism adopted by the clinic under clause (f) of section 21;
(o) the manner of providing information by the clinics and banks to the National Registry under clause (j) of section 21;
(p) the amount of insurance coverage for oocyte donor under clause (b) of sub-section (1) of section 22;
(q) the manner of maintaining the records by the clinics and banks under clause (a) of section 23;
(r) the manner of collection of gametes posthumously under clause (f) of section 24;
(s) the other duties of clinics under clause (h) of section 24;
(t) the examination of the donors by the assisted reproductive technology banks for diseases under clause (c) of sub-section (2) of section 27;
(u) the manner of obtaining information in respect of a sperm or oocyte donor by a bank under sub-section (6) of section 27;
(v) the standards for the storage and handling of gametes, human embryos in respect of their security, recording and identification under sub-section (1) of section 28;
(w) the manner of obtaining the consent of the commissioning couple or individual for perishing or donating the gametes of a donor or embryo under sub-section (2) of section 28;
(x) the manner of performing research on human gametes or embryo within India under sub-section (2) of section 30;
(y) the manner of entry and search by the National Board, the National Registry or the State Board or any officer authorised by it under sub-section (1) of section 40;.
(z) any other matter which is to be, or may be prescribed, or in respect of which provision is to be made by rules.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for--
(a) the other powers and functions of the National Board under clause (g) of section 5;
(b) the other powers and functions of the State Board under clause (b) of sub-section (2) of section 8;
(c) the terms of office and other conditions of service of scientific, technical and other employees of the National Registry under section 10;
(d) the other functions of the National Registry under clause (d) of section 11;
(e) the other functions of the appropriate authority under clause (h) of section 13;
(f) the other powers to be exercised by the appropriate authority under clause (d) of sub-section (1) of section 14;
(g) the format for granting of licences to the clinic or bank by the appropriate authority under sub-section (2) of section 14;
(h) the form and manner in which an application shall be made for registration and fee payable thereof under sub-section (2) of section 15;
(i) the facilities and equipments to be provided and maintained by the clinics and banks under sub-section (4) of section 15;
(j) the conditions, form and fee for application of renewal of the registration of clinic or bank under section 17;
(k) the manner in which an appeal may be preferred to the State Government or the Central Government under section 19;
(l) the criteria for availing the assisted reproductive technology procedures under clause (a) of section 21;
(m) the medical examination of the diseases with respect to which the donor shall be tested under clause (b) of section 21;
(n) the manner of making a complaint before a grievance cell and the mechanism adopted by the clinic under clause (f) of section 21;
(o) the manner of providing information by the clinics and banks to the National Registry under clause (j) of section 21;
(p) the amount of insurance coverage for oocyte donor under clause (b) of sub-section (1) of section 22;
(q) the manner of maintaining the records by the clinics and banks under clause (a) of section 23;
(r) the manner of collection of gametes posthumously under clause (f) of section 24;
(s) the other duties of clinics under clause (h) of section 24;
(t) the examination of the donors by the assisted reproductive technology banks for diseases under clause (c) of sub-section (2) of section 27;
(u) the manner of obtaining information in respect of a sperm or oocyte donor by a bank under sub-section (6) of section 27;
(v) the standards for the storage and handling of gametes, human embryos in respect of their security, recording and identification under sub-section (1) of section 28;
(w) the manner of obtaining the consent of the commissioning couple or individual for perishing or donating the gametes of a donor or embryo under sub-section (2) of section 28;
(x) the manner of performing research on human gametes or embryo within India under sub-section (2) of section 30;
(y) the manner of entry and search by the National Board, the National Registry or the State Board or any officer authorised by it under sub-section (1) of section 40;.
(z) any other matter which is to be, or may be prescribed, or in respect of which provision is to be made by rules.
Section 43 Power to make regulations.
(1) The National Board may, with the prior approval of the Central Government, by notification make regulations consistent with this Act and the rules made thereunder to carry out the provisions of the Act;
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may provide for--
(a) the manner of retrieving the oocytes under clause (a) of section 24;
(b) the manner of placing the oocytes or embryos in the uterus of a woman under clause (b) of section 24; and
(c) any other matter which is required to be, specified by regulations or in respect of which provision is to be made by regulations.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may provide for--
(a) the manner of retrieving the oocytes under clause (a) of section 24;
(b) the manner of placing the oocytes or embryos in the uterus of a woman under clause (b) of section 24; and
(c) any other matter which is required to be, specified by regulations or in respect of which provision is to be made by regulations.
Section 44 Laying of rules, regulations and notifications.
Every rule or regulation made and notification issued under this Act shall be laid, as soon as may be after it is made or issued, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rules or regulations or notifications, as the case may be or both Houses agree that the rules or regulations or notifications, as the case may be, should not be made or issued, such rules or regulations or notifications, as the case may be, shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule or regulation or notification, as the case may be.
Section 45 Application of other laws not barred.
The provisions of this Act shall be in addition to, and not in derogation of, the provisions of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994) and the Clinical Establishment (Registration and Regulation) Act, 2010 (23 of 2010) or of any other law for the time being in force.
Section 46 Power to remove difficulties.
(1) If any difficulty arises in giving effect to the provisions of this Act, the Central Government may, by order published in the Official Gazette, make such provisions not inconsistent with the provisions of this Act as may appear to it to be necessary or expedient for removing the difficulty:
Provided that no such order shall be made after the expiry of a period of three years from the date of commencement of this Act.
(2) Every order made under this section shall, as soon as may be made, be laid before each House of Parliament.
Provided that no such order shall be made after the expiry of a period of three years from the date of commencement of this Act.
(2) Every order made under this section shall, as soon as may be made, be laid before each House of Parliament.