The Assisted Reproductive Technology (Regulation) Bill, 2020 |The LexSphere Library

SECTION Section 1

Untitled Section

•25

•Bill No. 97 of 2020

•THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION)

•BILL, 2020

•——————

•ARRANGEMENT OF CLAUSES

•——————

SECTION Section 10

Untitled Section

6.State Board.

SECTION Section 100

Untitled Section

39.(1) The State Government may, from time to time issue to the State Board and to

•the Registration Authority with respect to the State Government such directions as it may

•think necessary in the interest of the sovereignty and integrity of India, security of the

•State, friendly relation with foreign States, public order, decency or morality.

(2)Without prejudice to the foregoing provisions of this Act, the State Board and the

•Registration Authority shall, in exercise of its powers or the performance of its functions

•under this Act, be bound by such directions on questions of policy as the State Government

•may give in writing to it from time to time:

•Provided that the State Board and the Registration Authority shall, as far as practicable,

•be given an opportunity to express its views before any direction is given under

•sub-section ( 1).

(3)If any dispute arises between the State Government and the State Board as to

•whether a question is or is not a question of policy, the decision of the State Government

•shall be final.

SECTION Section 101

Untitled Section

40.(1) If the National Board, the National Registry or the State Board has reason to

•believe that an offence under this Act has been or is being committed at any facility using

•assisted reproductive technology, such Board or any officer authorised in this behalf may,

•subject to such rules as may be prescribed, enter and search at all reasonable times with

•such assistance, if any, as such Board or officer considers necessary, such facility using

•assisted reproductive technology and examine any record, register, document, book,

•pamphlet, advertisement or any other material object found therein and seize the same, if the

•said Board has reason to believe that it may furnish evidence of the commission of an

•offence punishable under this Act.

(2)The provisions of the Code of Criminal Procedure, 1973, relating to searches and

•seizures shall, so far as may be, apply to every search or seizure made under this Act.

SECTION Section 102

Untitled Section

41.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 Registration Authority or any other officer authorised by the Central

•Power of

•Central

•Government

•to issue

•directions to

•National

•Board and

•National

Registry.

•Power of State

•Government

•to issue

•directions to

•State Board,

etc.

•Power to

•search and

•seize records,

etc.

•Protection of

•action taken

•in good faith.

•2 of 1974.

•5

•10

•15

•20

•25

•30

•35

•40

•45

•50

•14

•Government or the State Government or the National Board or the National Registry or the

•State Board or the Registration 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 Section 103

Untitled Section

42.(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 Section 104

Untitled Section

•section 5;

(b)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 Registration Authority under clause (h) of section 13;

(f)the other powers to be exercised by the Registration Authority under

SECTION Section 105

Untitled Section

•clause (d) of sub-section (1) of section 14;

(g)the format for granting of licences to the clinic or bank by the Registration

•Authority under sub-section ( 2) of section 14;

(h)the manner and the form 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 period, the form and 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 compliant 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 sub-clause (iii) of clause (j) of section 21;

•(

•p) the amount and the period of insurance coverage for oocyte donor under

SECTION Section 106

Untitled Section

•clause (b) of sub-section (1) of section 22;

(q)the manner of maintaining the records by the clinics and banks under

SECTION Section 107

Untitled Section

•clause (a) of section 23;

(r)the other duties of clinics under clause (h) of section 24;

(s)the other purposes for using of the Pre-implantation Genetic testing under

•sub-section (1) of section 25;

(t)examination of the donors by the assisted reproductive technology banks

•for diseases under clause ( c) of sub-section ( 2) of section 27;

•Power to

•make rules.

•5

•10

•15

•20

•30

•35

•25

•40

•45

•15

(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 Section 108

Untitled Section

•section 28;

(w)the manner of obtaining the consent of the commissioning couple or

•individual for perishing of the gametes of a donor or embryo under sub-section (2) of

SECTION Section 109

Untitled Section

•section 28;

(x)research on human embryo under sub-section ( 2) of section 30; and

(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.

SECTION Section 11

Untitled Section

7.Application of provisions of Surrogacy Act with respect to State Board.

SECTION Section 110

Untitled Section

43.(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 harvesting the oocytes under clause ( a) of section 24;

(b)the number of oocytes or embryos 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 Section 111

Untitled Section

44.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 Section 112

Untitled Section

45.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 and the Clinical Establishment (Registration and Regulation) Act, 2010

•or of any other law for the time being in force.

SECTION Section 113

Untitled Section

46.(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.

•Laying of

•rules,

•regulations and

notifications.

•Power to

•make

regulations.

•Application of

•other laws not

barred.

•Power to

•remove

difficulties.

•57 of 1994.

•23 of 2010.

•5

•10

•15

•20

•25

•30

•35

•40

•STA TEMENT OF OBJECTS AND REASONS

•Assisted reproductive technology (ART) has grown by leaps and bounds in the last

•few years. India has highest growths in the ART centres and the number of ART cycles

•performed every year. Assisted Reproductive Technology including in-vitro-fertilisation,

•has given hope to a multitude of persons suffering from infertility, but it has also introduced

•a plethora of legal, ethical and social issues.

SECTION Section 114

Untitled Section

2.India has over the years become one of the major centres of this global fertility

•industry, with reproductive medical tourism becoming a significant activity. Clinics in India

•offer nearly all the ART services—gamete donation, intrauterine insemination, in-vitro-

•fertilisation, intra cytoplasmic sperm injection, pre-implantation genetic diagonistic and

•gestational surrogacy. However, in spite of so much activity in India, there is yet no

•standardisation of protocols and reporting is still very inadequate. Furthermore, there is no

•law to regulate ART and it is regulated through guidelines.

SECTION Section 115

Untitled Section

3.The need to regulate the Assisted Reproductive Technology Services is mainly to

•protect the affected women and children from exploitation. The oocyte donor needs to be

•supported by an insurance cover. Multiple embryo implantation needs to be regulated and

•children born through ART need to be protected. The cryopreservation of sperm, oocytes

•and embryo by the ART Banks need to be regulated and the proposed legislation intends to

•make Pre Genetic Implantation Testing mandatory for the benefit of the child born through

•assisted reproductive technology.

SECTION Section 116

Untitled Section

4.There is a need to regulate ART clinics and banks by establishing the National

•Board, the State Boards, the National Registry and the State Registration Authorities for the

•regulation and supervision of assisted reproductive technology clinics and the assisted

•reproductive technology banks, for prevention of misuse and for safe and ethical practice of

•assisted reproductive technology services.

SECTION Section 117

Untitled Section

5.The proposed legislation, namely, the Assisted Reproductive Technology

•(Regulation) Bill, 2020 proposes to regulate the Assisted Reproductive Technology services

•in the country. The salient features of the Bill are as follows:—

(a)to define certain terms like "assisted reproductive technology", "assisted

•reproductive technology clinic", "commissioning couple", "Woman", etc.;

(b)to provide that the National Board and the State Board shall be the same

•Board as proposed in the Surrogacy Bill;

(c)to provide that the existing assisted reproductive technology clinics and the

•assisted reproductive technology banks, as on the date of the enactment of the

•proposed legislation, conducting assisted reproductive technology procedures partly

•or exclusively shall make an application to the Registration Authority within a period

•of sixty days from the date of establishment of the National Registry;

(d)to provide that the assisted reproductive technology services shall be

•available to a woman above the legal age of marriage and below the age of fifty years

•and a man above the legal age of marriage and below the age of fifty-five years;

(e)to provide that an oocyte donor shall be an ever married woman having at

•least one live child of her own with a minimum age of three years and to donate oocytes

•only once in her life and not more than seven oocyte shall be retrieved from the oocyte

•donor;

(f)to provide that the assisted reproductive technology clinics shall provide

•professional counselling to commissioning couple and woman about all the implications

•16

•17

•and chances of success of assisted reproductive technology procedures in the clinic;

•and they shall also inform the advantages, disadvantages and cost of the procedures,

•their medical side effects, risks including the risk of multiple pregnancy and any such

•other matter as may help the commissioning couple to arrive at an informed decision

•that would most likely be the best for the commissioning couple and woman;

(g)to provide that the assisted reproductive technology clinics and assisted

•reproductive technology banks shall ensure that commissioning couple, woman and

•donors of gametes are eligible to avail of assisted reproductive technology procedures;

(h)to provide for offences and penalties for the contravention of its provisions.

SECTION Section 118

Untitled Section

6.The Notes on clauses explain in detail the various provisions contained in the Bill.

SECTION Section 119

Untitled Section

7.The Bill seeks to achieve the above objectives.

•N

•EW DELHI; DR. HARSH VARDHAN.

•The 12th March, 2020.

•Notes on clauses

SECTION Section 12

Untitled Section

8.Powers and functions of State Board.

C.THE NATIONAL REGISTRY AND REGISTRATION AUTHORITY

SECTION Section 120

Untitled Section

•Clause 1.—This clause relates to short title and commencement of the proposed

legislation.

SECTION Section 121

Untitled Section

•Clause 2.—This clause contains the definitions of various expressions used in the

•proposed legislation.

SECTION Section 122

Untitled Section

•Clause 3.—This clause seeks to provide that the National Board to be constituted

•under sub-section (1) of section 15 of the Surrogacy Act shall be the National Board for the

•purposes of the proposed legislation.

SECTION Section 123

Untitled Section

•Clause 4.—This clause seeks to provide that subject to the provisions of the proposed

•legislation and the rules made thereunder, the provisions of the Surrogacy Act relating to—

(i)constitution of the National 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 the proposed legislation.

SECTION Section 124

Untitled Section

•Clause 5.—This clause relates to powers and functions of the National Board and

•seeks to provide that 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 proposed legislation, 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, 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 the proposed

•legislation 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 the proposed legislation; and

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

SECTION Section 125

Untitled Section

•Clause 6.—This clause seeks to provide that the State Board to be constituted under

•sub-section (1) of section 24 of the Surrogacy Act shall be the State Board for the purposes

•of the proposed legislation.

•18

•19

SECTION Section 126

Untitled Section

•Clause 7.—This clause seeks to provide that subject to the provisions of the pro-

•posed legislation and the rules made thereunder, the provisions of the Surrogacy Act relat-

•ing to—

(i)constitution of the State 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 pur-

•poses;

•(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 the proposed legislation.

SECTION Section 127

Untitled Section

•Clause 8.—This clause seeks to provide the powers and functions of the State Board,

•inter alia,—

(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 by rules.

•Sub-clause (3) of this clause seeks to provide that, in exercise of its functions under

•the proposed legislation, the State Board shall give such directions or pass such orders as

•directed by the National Board.

SECTION Section 128

Untitled Section

•Clause 9.— This clause seeks to provide for the establishment of the National Registry

•of Clinics and Banks.

SECTION Section 129

Untitled Section

•Clause 10.—This clause seeks to lay down the composition of the National Registry.

SECTION Section 13

Untitled Section

9.Establishment of National Registry of Clinics and Banks.

SECTION Section 130

Untitled Section

•Clause 11.—This clause seeks to lay down the functions of the National Registry.

SECTION Section 131

Untitled Section

•Clause 12.—This clause seeks to provide for the appointment of the Registration

Authority.

SECTION Section 132

Untitled Section

•Clause 13.—This clause seeks to provide for the functions of the Registration Authority.

SECTION Section 133

Untitled Section

•Clause 14.—This clause seeks to lay down the powers of the Registration Authority.

SECTION Section 134

Untitled Section

•Clause 15.—This clause seeks to provide for the registration of the assisted

•reproductive technology clinic or assisted reproductive technology bank.

SECTION Section 135

Untitled Section

•Clause 16.—This clause seeks to provide for the registration of the assisted

•reproductive clinic or bank.

SECTION Section 136

Untitled Section

•Clause 17.—This clause seeks to provide for the renewal of the registration granted

•under clause 16.

SECTION Section 137

Untitled Section

•Clause 18.—This clause seeks to provide for the suspension or cancellation of the

•registration granted to clinics and banks.

SECTION Section 138

Untitled Section

•Clause 19.—This clause seeks to provide for appeal by the clinic or bank or the

•commissioning couple or the woman.

SECTION Section 139

Untitled Section

•Clause 20.—This clause lays down the power of the National Board, the National

•Registry, the State Board and the Registration Authority.

•20

SECTION Section 14

Untitled Section

10.Composition of National Registry.

SECTION Section 140

Untitled Section

•Clause 21.—This clause lays down the general duties of the assisted reproductive

•technology clinics and banks.

SECTION Section 141

Untitled Section

•Clause 22.—This clause seeks, inter alia, to provide for the written consent of all the

•parties seeking assisted reproductive technology.

SECTION Section 142

Untitled Section

•Clause 23.—This clause seeks to lay down the duties of the assisted reproductive

•technology clinics and banks to keep accurate records.

SECTION Section 143

Untitled Section

•Clause 24.—This clause seeks to lay down the duties of the assisted reproductive

•technology clinics using human gametes and embryos.

SECTION Section 144

Untitled Section

•Clause 25.—This clause relates to Pre-implantation Genetic Diagnosis.

•Sub-clause (1) of this clause seeks to provide that the Pre-implantation Genetic testing

•shall be used to screen the human embryo for known, pre-existing, heritable or genetic

•diseases or for such other purposes as may be prescribed by rules.

•Sub-clause (2) of this clause seeks to provide that 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; and (b) when the

•embryo suffers from pre-existing, heritable, life-threatening or genetic diseases.

•Sub-clause (3) of this clause seeks to provide that the National Board may lay down

•such other conditions as it deems fit in the interests of the Pre-implantation Genetic testing.

SECTION Section 145

Untitled Section

•Clause 26.—This clause seeks to prohibit sex selection.

SECTION Section 146

Untitled Section

•Clause 27.—This clause seeks to provide for the sourcing of gametes by assisted

•reproductive technology banks.

SECTION Section 147

Untitled Section

•Clause 28.—This clause seeks to provide for the storage and handling of human

•gametes and embryos.

SECTION Section 148

Untitled Section

•Clause 29.—This clause seeks to provide that the sale, transfer or use of gamets,

•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

•gamets and embryos for personal use with the permission of the National Board.

SECTION Section 149

Untitled Section

•Clause 30.—This clause seeks to provide for the research on human embryo and

gametes.

SECTION Section 15

Untitled Section

11.Functions of National Registry.

SECTION Section 150

Untitled Section

•Clause 31.—This clause seeks to provide for the rights of child born through assisted

•reproductive technology.

SECTION Section 151

Untitled Section

•Clause 32.—This clause seeks, inter alia, to prohibit the sex selective assisted

•reproductive technology.

SECTION Section 152

Untitled Section

•Clause 33.—This clause seeks to provide for the offences and penalties.

SECTION Section 153

Untitled Section

•Clause 34.—This clause seeks to provide for the punishment for contravention of the

•provisions of the proposed legislation or rules for which no specific punishment is provided.

SECTION Section 154

Untitled Section

•Clause 35.—This clause provides for cognizance of offences.

SECTION Section 155

Untitled Section

•Clause 36.—This clause seeks to provide that all the offences under the proposed

•legislation shall be cognizable and bailable.

SECTION Section 156

Untitled Section

•Clause 37.—This clause seeks to provide for the offences by clinics or banks.

SECTION Section 157

Untitled Section

•Clause 38.—This clause seeks to lay down the power of the Central Government to

•issue directions, inter alia, to the National Board.

SECTION Section 158

Untitled Section

•Clause 39.—This clause seeks to lay down the power of the State Government to issue

•directions, inter alia, to the State Board.

•21

SECTION Section 159

Untitled Section

•Clause 40.—This clause seeks to provide for the power to search and seize records,

etc.

SECTION Section 16

Untitled Section

12.Appointment of Registration Authority.

SECTION Section 160

Untitled Section

•Clause 41.—This clause seeks to provide for the protection of action taken in good

faith.

SECTION Section 161

Untitled Section

•Clause 42.—This clause seeks to empower the Central Government to make rules for

•carrying out the provisions of the proposed legislation.

SECTION Section 162

Untitled Section

•Clause 43.—This clause empowers the National Board to make regulations consistant

•with the proposed legislation and the rules made thereunder.

SECTION Section 163

Untitled Section

•Clause 44.—This clause seeks to require that the rules, regulations and notifications

•made or issued under the proposed legislation shall be laid before Parliament.

SECTION Section 164

Untitled Section

•Clause 45.—This clause seeks to provide that the application of the other laws shall

•not be barred.

SECTION Section 165

Untitled Section

•Clause 46.—This clause seeks to provide for the power of the Central Government to

•remove difficulties.

•FINANCIAL MEMORANDUM

•The Assisted Reproductive Technology (Regulation) Bill, 2020 has been proposed 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. The proposed legislation, is framed in such a

•manner that it ensures effective regulation with the creation of the National Board, National

•Registry, State Boards and Registration Authorities at the Centre and State / Union-territory

level.

SECTION Section 166

Untitled Section

2.Clause 3 of the Bill provides that the National Board to be constituted under

•sub-section ( 1) of section 15 of the Surrogacy Act shall be the National Board for the

•purposes of the proposed legislation.

SECTION Section 167

Untitled Section

3.Clause 6 of the Bill provides that the State Board to be constituted under

•sub-section (1) of section 24 of the Surrogacy Act shall be the State Board for the purposes

•of the proposed legislation.

SECTION Section 168

Untitled Section

4.Clause 9 of the Bill provides that the Central Government may, by notification,

•establish for the purposes of the proposed legislation, a Registry to be called the National

•Registry of Clinics and Banks in India.

SECTION Section 169

Untitled Section

5.Sub-clause ( 1) of clause 12 of the Bill provides that the Central Government shall,

•within a period of ninety days from the date of commencement of the proposed legislation,

•by notification, appoint one or more Registration Authorities for each of the Union territories

•for the purposes of the proposed legislation.

SECTION Section 17

Untitled Section

13.Functions of Registration Authority.

SECTION Section 170

Untitled Section

6.Sub-clause ( iii) of clause 4, sub-clause ( iv) of clause 7 and sub-clause ( 4) of

SECTION Section 171

Untitled Section

•clause 12 of the Bill respectively provides that the members of the National Board, State

•Board and Registration Authority, other than ex officio members shall receive only

•compensatory travelling expenses for attending the meetings.

SECTION Section 172

Untitled Section

7.Clause 10 of the Bill provides that the National Registry referred to in section 9 shall

•consist of scientific, technical, administrative and supportive staff.

SECTION Section 173

Untitled Section

8.There will not be any financial implications except for the meetings of the National

•Board, the State Board, the Registration Authority and the aforesaid staff of the National

•Registry which will be met out of the regular budget of the Central Government and the State

Governments.

SECTION Section 174

Untitled Section

9.The Bill does not involve any other expenditure of recurring or non-recurring nature

•from the Consolidated Fund of India.

•22

•MEMORANDUM REGARDING DELEGATED LEGISLATION

SECTION Section 175

Untitled Section

•Clause 42 of the Bill seeks to empower the Central Government to make rules for

•carrying out the provisions of the proposed legislation in respect of matters, which shall,

•inter alia, include—(a) the other powers and functions of the National Board under clause (g)

•of section 5; (b) 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 Registration Authority under clause (h) of section 13; (f) the other powers to be exercised

•by the Registration Authority under clause (d) of sub-section (1) of section 14; (g) the format

•for granting of licenses to the clinic or bank by the Registration Authority under

•sub-section (2) of section 14; (h) the manner and the form 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 period, the form and manner in which

•an appeal may be preferred to the State Government or the Central Government under

SECTION Section 176

Untitled Section

•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

•compliant before a grievance cell and the mechanism adopted by the clinic under clause (f) of

SECTION Section 177

Untitled Section

•section 21; (o) the manner of providing information by the clinics and banks to the National

•Registry under sub-clause (iii) of clause (j) of section 21; (p) the amount and the period 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 Section 178

Untitled Section

•section 23; (r) the other duties of clinics under clause (h) of section 24; (s) the other purposes

•for using of the Pre-implantation Genetic testing under sub-section (1) of section 25;

(t)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 of the gametes

•of a donor or embryo under sub-section (2) of section 28; (x) research on human embryo

•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.

SECTION Section 179

Untitled Section

2.Clause 43 of the Bill seeks to empower the National Board, with the prior approval

•of the Central Government, by notification, to make regulations consistent with the proposed

•legislation and the rules made thereunder to provide for-- (a) the manner of harvesting the

•oocytes under clause (a) of section 24; (b) the number of oocytes or embryos under

SECTION Section 18

Untitled Section

14.Powers of Registration Authority.

SECTION Section 180

Untitled Section

•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 Section 181

Untitled Section

3.The matters in respect of which the aforementioned rules and regulations may be

•made are matters of procedure and administrative detail, and as such, it is not practicable to

•provide for them in the proposed Bill itself. The delegation of legislative power is, therefore,

•of a normal character.

•23

•LOK SABHA

•————

•A

•BILL

•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 and for matters

•connected therewith or incidental thereto.

•————

•(Dr. Harsh Vardhan, Minister of Health and Family Welfare)

•MGIPMRND—6169LS(S3)—19-03-2020.

•LOK SABHA

•------

•CORRIGENDA

•to

•THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) BILL, 2020

•[To be/As introduced in Lok Sabha]

SECTION Section 182

Untitled Section

1.Page (ii), in the Arrangement of Clauses, in clause 39,-

•for "State Board."

•read "State Board, etc."

SECTION Section 183

Untitled Section

2.Page 9, in line 46,-

•for “ regulations;"

•read “the regulations;"

•NEW DELHI;

•September 9, 2020

•Bhadrapada 18, 1942 (Saka)

SECTION Section 19

Untitled Section

•CHAPTER III

•P

•ROCEDURES FOR REGISTRATION

SECTION Section 2

Untitled Section

•CHAPTER I

•PRELIMINARY

SECTION Section 20

Untitled Section

15.Registration of assisted reproductive technology clinic or assisted reproductive

•technology bank.

SECTION Section 21

Untitled Section

16.Grant of registration.

SECTION Section 22

Untitled Section

17.Renewal of registration.

SECTION Section 23

Untitled Section

18.Suspension or cancellation of registration.

•AS INTRODUCED IN LOK SABHA

•26

SECTION Section 24

Untitled Section

19.Appeal.

SECTION Section 25

Untitled Section

20.Power to inspect premises, etc.

SECTION Section 26

Untitled Section

•CHAPTER IV

•DUTIES OF ASSISTED REPRODUCTIVE TECHNOLOGY CLINIC AND ASSISTED REPRODUCTIVE

•TECHNOLOGY BANK

SECTION Section 27

Untitled Section

21.General duties of assisted reproductive technology clinics and banks.

SECTION Section 28

Untitled Section

22.Written informed consent.

SECTION Section 29

Untitled Section

23.Duties of assisted reproductive technology clinics and banks to keep accurate

records.

SECTION Section 30

Untitled Section

24.Duties of assisted reproductive technology clinics using human gametes and

embryos.

SECTION Section 31

Untitled Section

25.Pre-implantation Genetic Diagnosis.

SECTION Section 32

Untitled Section

26.Sex selection.

SECTION Section 33

Untitled Section

27.Sourcing of gametes by assisted reproductive technology banks.

SECTION Section 34

Untitled Section

28.Storage and handling of human gametes and embryos.

SECTION Section 35

Untitled Section

29.Restriction on sale, etc., of human gametes, zygotes, and embryos.

SECTION Section 36

Untitled Section

30.Research on human embryo and gametes.

SECTION Section 37

Untitled Section

31.Rights of child born through assisted reproductive technology.

SECTION Section 38

Untitled Section

•CHAPTER V

•O

•FFENCES AND PENALTIES

SECTION Section 39

Untitled Section

32.Sex selective assisted reproductive technology.

SECTION Section 4

Untitled Section

1.Short title and commencement.

SECTION Section 40

Untitled Section

33.Offences and penalties.

SECTION Section 41

Untitled Section

34.Punishment for contravention of provisions of Act or rules for which no specific

•punishment is provided.

SECTION Section 42

Untitled Section

35.Cognizance of offences.

SECTION Section 43

Untitled Section

36.Offences to be cognizable and bailable.

SECTION Section 44

Untitled Section

37.Offences by clinics or banks.

SECTION Section 45

Untitled Section

•CHAPTER VI

•M

•ISCELLANEOUS

SECTION Section 46

Untitled Section

38.Power of Central Government to issue directions to National Board and National

Registry.

SECTION Section 47

Untitled Section

39.Power of State Government to issue directions to State Board.

SECTION Section 48

Untitled Section

40.Power to search and seize records, etc.

SECTION Section 49

Untitled Section

41.Protection of action taken in good faith.

SECTION Section 5

Untitled Section

2.Definitions.

SECTION Section 50

Untitled Section

42.Power to make rules.

SECTION Section 51

Untitled Section

43.Power to make regulations.

SECTION Section 52

Untitled Section

44.Laying of rules, regulations and notifications.

SECTION Section 53

Untitled Section

45.Application of other laws not barred.

SECTION Section 54

Untitled Section

46.Power to remove difficulties.

•(ii)

SECTION Section 55

Untitled Section

•CLAUSES

•1

•THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION)

•BILL, 2020

•A

•BILL

•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 and for matters connected

•therewith or incidental thereto.

•B

•E it enacted by Parliament in the Seventy-first Year of the Republic of India as

•follows:—

SECTION Section 56

Untitled Section

•CHAPTER I

•PRELIMINARY

SECTION Section 57

Untitled Section

1.(1) This Act may be called the Assisted Reproductive Technology (Regulation)

•Act, 2020.

(2)It shall come into force on such date as the Central Government may, by notification

•in the Official Gazette, appoint.

•Short title and

commencement.

•AS INTRODUCED IN LOK SABHA

•Bill No. 97 of 2020

•5

•2

SECTION Section 58

Untitled Section

2.(1) In this Act, unless the context otherwise requires,—

(a)"appointed day" means the date on which the provisions of this Act shall

•come into force;

(b)"artificial insemination" means the procedure of artificially transferring semen

•into the reproductive system of a woman and includes insemination with the husband's

•semen or with the donor's semen;

(c)"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;

(d)"assisted reproductive technology bank" means an organisation that is set

•up to supply sperm or semen, oocytes or oocyte donors to the assisted reproductive

•technology clinics or their patients;

(e)"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;

(f)"child" means any individual born through the use of the assisted

•reproductive technology;

(g)"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;

(h)"egg" means the female gamete;

(i)"embryo" means a developing or developed organism after fertilisation till

•the end of fifty-six days from the day of fertilisation;

(j)"gamete" means sperm and oocyte;

(k)"gamete donor" means a person who provides sperm or oocyte with the

•objective of enabling an infertile couple or woman to have a child;

(l)"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;

(m)"infertility" means the inability to conceive after one year of unprotected

•coitus or other proven medical condition preventing a couple from conception;

(n)"National Board" means the National Board for Surrogacy to be constituted

•under sub-section (1) of section 15 of the Surrogacy Act;

(o)"National Registry" of Assisted Reproductive Technology Clinics and Banks

•in India, means a Registry established under section 9;

(p)"notification" means a notification published in the Official Gazette and the

•expression "notify" shall be construed accordingly;

(q)"patients" means an individual or couple who comes to any registered

•assisted reproductive technology clinic for management of infertility;

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

(s)"Registration Authority" means the Authority appointed under section 12;

(t)"regulations" means the regulations made by the National Board under this

•Act;

Definitions.

•57 of 1994.

•5

•10

•15

•20

•30

•35

•25

•40

•45

•3

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

(v)"State Board" means a State Board for Surrogacy to be constituted under

•sub-section (1) of section 24 of the Surrogacy Act;

(w)"Surrogacy Act" means the Surrogacy (Regulation) Act, 2020; and

(x)"woman" means any woman above the legal age of marriage 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.".

SECTION Section 59

Untitled Section

•CHAPTER II

•A

•UTHORITIES TO REGULATE ASSISTED REPRODUCTIVE TECHNOLOGY

A.THE NATIONAL BOARD

SECTION Section 6

Untitled Section

•CHAPTER II

•AUTHORITIES TO REGULATE ASSISTED REPRODUCTIVE TECHNOLOGY

A.THE NATIONAL BOARD

SECTION Section 60

Untitled Section

3.The National Board to be constituted under sub-section ( 1) of section 15 of the

•Surrogacy Act shall be the National Board for the purposes of this Act.

SECTION Section 61

Untitled Section

4.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 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 Section 62

Untitled Section

5.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,

•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.

•National

Board.

•Application of

•provisions of

•Surrogacy Act

•with respect

•to National

Board.

•Powers and

•functions of

•National

Board.

•5

•10

•15

•20

•25

•30

•35

•40

•4

B.STATE BOARD

SECTION Section 63

Untitled Section

6.The State Board to be constituted under sub-section ( 1) of section 24 of the

•Surrogacy Act shall be the State Board for the purposes of this Act.

SECTION Section 64

Untitled Section

7.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 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 Section 65

Untitled Section

8.( 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.

C.THE NATIONAL REGISTRY AND REGISTRATION AUTHORITY

SECTION Section 66

Untitled Section

9.The Central Government may, by notification, establish for the purposes of this

•Act, a Registry to be called the National Registry of Clinics and Banks in India with effect

•from such date as may be specified in that notification.

SECTION Section 67

Untitled Section

10.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 Section 68

Untitled Section

11.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;

•State Board.

•Application

•of provisions

•of Surrogacy

•Act with

•respect to

•State Board.

•Powers and

•functions of

•State Board.

•Establishment

•of National

•Registry of

•clinics and

banks.

•Functions of

•National

Registry.

•Composition

•of National

Registry.

•5

•10

•15

•20

•30

•35

•25

•40

•5

(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 Section 69

Untitled Section

12.(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 Registration Authorities

•for each of the Union territories for the purposes of this 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 Registration Authorities

•for the whole or any part of the State for the purposes of this Act.

(3)The Registration 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 Registration Authority, other than ex officio members, shall receive

•only compensatory travelling expenses for attending the meetings of such Authority.

SECTION Section 7

Untitled Section

3.National Board.

SECTION Section 70

Untitled Section

13.The Registration 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.

•Functions of

•Registration

Authority.

•Appointment

•of

•Registration

Authority.

•5

•10

•15

•20

•25

•30

•35

•40

•45

•6

SECTION Section 71

Untitled Section

14.(1) The Registration 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 Registration 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 Section 72

Untitled Section

•CHAPTER III

•P

•ROCEDURES FOR REGISTRATION

SECTION Section 73

Untitled Section

15.(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 State Board 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 Registration

•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 Section 74

Untitled Section

16.(1) On receipt of the application under sub-section (1) of section 15, the Registration

•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 Registration Authority fails to grant the registration or reject the application,

•as the case may be, as provided under sub-section ( 1), the assisted reproductive clinic or

•bank shall be deemed to have been registered, and the Registration 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 registration number to the applicant.

•Registration

•of assisted

•reproductive

•technology

•clinic or

•assisted

•reproductive

•technology

bank.

•Powers of

•Registration

Authority.

•Grant of

registration.

•5

•10

•15

•20

•30

•35

•25

•40

•45

•7

(3)The Registration 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 Registration Authority.

SECTION Section 75

Untitled Section

17.The registration granted under section 16, may be renewed for a further period of

•five years by the Registration 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 Section 76

Untitled Section

18.(1) The Registration 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

•Registration 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 Section 77

Untitled Section

19.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 Registration

•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

•Registration Authority of a State;

(b)the Central Government, where the appeal is against the order of the

•Registration Authority of a Union territory,

•in such manner as may be prescribed.

SECTION Section 78

Untitled Section

20.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.

SECTION Section 79

Untitled Section

•CHAPTER IV

•D

•UTIES OF ASSISTED REPRODUCTIVE TECHNOLOGY CLINIC AND ASSISTED REPRODUCTIVE

•TECHNOLOGY BANK

SECTION Section 8

Untitled Section

4.Application of provisions of Surrogacy Act with respect to National Board.

SECTION Section 80

Untitled Section

21.The clinics and banks shall perform the following duties, namely:—

(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;

•Renewal of

registration.

•Suspension or

•cancellation of

registration.

Appeal.

•Power to

•inspect

•premises, etc.

•General duties

•of assisted

•reproductive

•technology

•clinics and

banks.

•5

•10

•15

•20

•25

•35

•40

•45

•30

•8

(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;

(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;

(d)the clinics shall make commissioning couple or woman, aware of the rights

•of a child born through the use of assisted reproductive technology;

(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;

(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;

(g)the clinics shall apply the assisted reproductive technology services,—

(i)to a woman above the legal age of marriage and below the age of fifty

•years;

•(ii) to a man above the legal age of marriage and below the age of fifty-five

•years;

(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;

(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.

SECTION Section 81

Untitled Section

22.(1) The clinic shall not perform any treatment or procedure without—

(a)the written consent of all the parties seeking assisted reproductive

•technology;

(b)an insurance coverage of such amount and for such period as may be

•prescribed 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.

•Written

•informed

consent.

•41 of 1999.

•5

•10

•15

•20

•30

•35

•25

•40

•45

•9

(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 and

•embryos;

•(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.

SECTION Section 82

Untitled Section

23.The duties of clinics and banks while keeping the records relating to such clinics

•and banks are as under:—

(a)all clinics and banks shall maintain detailed records of all donor oocytes,

•sperm or embryos used or unused, the manner and technique of their use in such

•manner as may be prescribed;

(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;

(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;

(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 and bank shall immediately transfer

•the records to the central database of the National Registry; and

(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.

SECTION Section 83

Untitled Section

24.While using human gametes and embryos, the duties to be performed by the

•clinics and banks shall be as under:—

(a)the clinics shall harvest oocytes in such manner as may be specified by

•regulations;

(b)the number of oocytes or embryos that may be placed in the uterus of a

•woman during the treatment cycle shall be such as may be specified by the regulations;

•Duties of

•assisted

•reproductive

•technology

•clinics and

•banks to keep

•accurate

records.

•Duties of

•assisted

•reproductive

•technology

•clinics using

•human

•gametes and

embryos.

•5

•10

•15

•20

•25

•30

•35

•40

•45

•10

(c)a woman shall not be treated with gametes or embryos derived from more

•than one man or woman during any one treatment cycle;

(d)a clinic shall never mix semen from two individuals for the procedures specified

•under this Act;

(e)the embryos shall not be split and used for twinning to increase the number

•of available embryos;

(f)the collection of gametes posthumously shall be done only if prior consent

•of the commissioning couple is available;

(g)the clinic shall not use ovum that are derived from a foetus, in any process

•of in-vitro fertilisation; and

(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.

SECTION Section 84

Untitled Section

25.(1) The Pre-implantation Genetic testing shall be used to screen the human embryo

•for known, pre-existing, heritable or genetic diseases or for such other purposes as may be

prescribed.

(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)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.

SECTION Section 85

Untitled Section

26.(1) Subject to the provisions of the Pre-conception and Pre-natal Diagnostic

•Techniques (Prohibition of Sex Selection) Act, 1994, the clinic shall not offer to provide a

•couple or woman with a child of a pre-determined sex.

(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)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.

SECTION Section 86

Untitled Section

27.(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.

•Pre-

•implantation

•Genetic

Diagnosis.

•57 of 1994.

•Sex selection.

•Sourcing of

•gametes by

•assisted

•reproductive

•technology

banks.

•5

•10

•15

•20

•30

•35

•25

•40

•45

•11

(2)The banks shall obtain—

(a)semen from males between twenty-one years of age and fifty-five years of

•age, both inclusive;

(b)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)A bank shall not supply the sperm or oocyte of a single donor to more than one

•commissioning couple.

(4)An oocyte donor shall be an ever married woman having at least one live child of

•her own with a minimum age of three years and to donate oocytes only once in her life and

•not more than seven oocyte shall be retrieved from the oocyte donor.

(5)All unused oocytes shall be preserved by the banks for use on the same recipient,

•or given for research to an organisations registered under this Act after seeking written

•consent from the commissioning couple.

(6)A bank shall obtain all necessary information in respect of a sperm or oocyte

•donor, including the name, identity and address 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)"oocyte" means naturally ovulating oocyte in the female genetic tract.

•(ii) "retrieval" means a procedure of removing oocytes from the ovaries of a

•woman;

•(iii) "screening" means the genetic test performed on embryos produced

•through in-vitro fertilisation;

SECTION Section 87

Untitled Section

28.(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)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 embryo or gamete 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.

SECTION Section 88

Untitled Section

29.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.

SECTION Section 89

Untitled Section

30.(1) The use of any human gametes and embryos or their transfer to any country

•outside India for research shall be absolutely prohibited.

(2)The research on human embryos or gametes within India shall be performed in

•such manner as may be prescribed.

SECTION Section 9

Untitled Section

5.Powers and functions of National Board.

B.STATE BOARD

SECTION Section 90

Untitled Section

31.(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)A donor shall relinquish all parental rights over the child or children which may be

•born from his or her gamete.

•Storage and

•handling of

•human

•gametes and

embryos.

•Restriction on

•sale, etc., of

•human

•gametes,

•zygotes and

embryos.

•Research on

•human

•embryo and

gametes.

•Rights of child

•born through

•assisted

•reproductive

technology.

•5

•10

•15

•20

•25

•30

•35

•45

•40

•12

SECTION Section 91

Untitled Section

•CHAPTER V

•OFFENCES AND PENALTIES

SECTION Section 92

Untitled Section

32.( 1) The clinic, or bank or agent thereof, shall not issue, publish, distribute,

•communicate or cause to be issued, published, distributed or communicated any

•advertisement in any manner including internet, regarding facilities of sex selective assisted

•reproductive technology.

(2)Whoever contravenes the provisions of sub-section ( 1) shall be punishable with

•imprisonment for a term which shall not be less than five years but may extend to ten years

•or with fine which shall not be less than ten lakh rupees but may extend to twenty-five lakh

•rupees or with both.

SECTION Section 93

Untitled Section

33.(1) Any medical geneticist, gynaecologist, registered medical practitioner or any

•person shall not—

(a)abandon, disown or exploit or cause to be abandoned, disowned or exploited

•in any form the child or children born through assisted reproductive technology;

(b)sell human embryo or gametes, run an agency, a racket or an organisation for

•selling, purchasing or trading in human embryos or gametes;

(c)import or help in getting imported in whatsoever manner, the human embryos

•or human gametes;

(d)exploit the commissioning couple, woman or the gamete donor in any form;

(e)transfer human embryo into a male person or an animal;

(f)sell any human embryo or gamete for the purpose of research; or

(g)use any intermediates to obtain gamete donors or purchase gamete donors.

(2)Whoever contravenes the provisions of clauses (a) to (g) of sub-section (1), shall

•be punishable with a fine which shall not be less than five lakh rupees but may extend to ten

•lakh rupees for the first contravention and for subsequent contravention, shall be punishable

•with imprisonment for a term which shall not be less than eight years but may extend to

•twelve years and with fine which shall not be less than ten lakh rupees but may extend to

•twenty lakh rupees.

SECTION Section 94

Untitled Section

34.Whoever contravenes any of the provisions of this Act or any rules made

•thereunder, for which no penalty has been provided in this Act shall be punishable as per

•sub-section (2) of section 33.

SECTION Section 95

Untitled Section

35.(1) No court shall take cognizance of any offence punishable under this Act, save

•on a complaint made by the National Board or the State Board or by an officer authorised by

it.

(2)No court inferior to that of a Metropolitan Magistrate or a Judicial Magistrate of

•the first class shall try any offence punishable under this Act.

SECTION Section 96

Untitled Section

36.All the offences under this Act shall be cognizable and bailable.

SECTION Section 97

Untitled Section

37.(1) Where an offence under this Act has been committed by any clinic or bank, the

•executive head of such clinic or bank shall be deemed to be guilty of an offence and shall be

•liable to be proceeded against and punished accordingly unless he proves that the offence

•was committed without his knowledge or that he had exercised all due diligence to prevent

•the commission of such offence.

•Sex selective

•assisted

•reproductive

technology.

•Offences and

penalties.

•Punishment

•for

•contravention

•of provisions

•of Act or rules

•for which no

•specific

•punishment

•is provided.

•Cognizance of

offences.

•Offences to be

•cognizable and

bailable.

•Offences by

•clinics or

banks.

•5

•10

•15

•20

•30

•35

•25

•40

•13

(2)Notwithstanding anything contained in sub-section ( 1), where an offence under

•this Act has been committed by any clinic or bank and it is proved that the offence has been

•committed with the consent or connivance of, or is attributable to any neglect on the part of

•any officer, other than the executive head of the clinic or bank, such officer shall also be

•deemed to be guilty of that offence and shall be liable to be proceeded against and punished

accordingly.

SECTION Section 98

Untitled Section

•CHAPTER VI

•M

•ISCELLANEOUS

SECTION Section 99

Untitled Section

38.(1) The Central Government may, from time to time issue to the National Board, the

•National Registry and the Registration Authority with respect to the Union territory, such

•directions as it may think necessary in the interest of the sovereignty and integrity of India,

•security of the State, friendly relation with foreign States, public order, decency or morality.

(2)Without prejudice to the foregoing provisions of this Act, the National Board, the

•National Registry and the Registration Authority shall, in exercise of its powers or the

•performance of its functions under this Act, be bound by such directions on questions of

•policy as the Central Government or the State Government, as the case may be, may give in

•writing to it from time to time:

•Provided that the National Board shall, as far as practicable, be given an opportunity

•to express its views before any direction is given under sub-section ( 1).

(3)If any dispute arises between the Central Government and the National Board as

•to whether a question is or is not a question of policy, the decision of the Central Government

•shall be final.