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THE
PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION
OF MISUSE) AMENDMENT ACT, 2002
No.
14 of 2003
[17th
January, 2003]
An Act further to amend the Pre-natal Diagnostic
Techniques (Regulation and Prevention of Misuse) Act, 1994.
BE it enacted by Parliament in the Fifty-third
year of the Republic of India as follows:-
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1.(1)
This Act may be called the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Amendment Act, 2002.
(2)
It shall come into force on such date as the Central Government
may, by notification in the Official Gazette, appoint.
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Short
title and commencement |
57
of 1994 |
2. In the Pre-natal Diagnostic Techniques (Regulation and Prevention
of Misuse) Act, 1994 (hereinafter referred to as the principal Act),
for the long title, the following long title shall be substituted,
namely:-
"An
Act to provide for the prohibition of sex selection, before or after
conception, and for regulation
of pre-natal diagnostic
techniques for the purposes of detecting genetic abnormalities or
metabolic disorders or chromosomal
abnormalities or
certain congenital malformations or sex-linked disorders and for
the prevention of their misuse for sex determination leading to
female foeticide and for matters connected therewith or incidental
thereto.”.
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Substitution
of long title. |
Amendment
of section 1. |
3.
In section 1 of the principal Act, in sub-section
(1), for the words and brackets “the Pre-natal
Diagnostic Techniques (Regulation and Prevention of Misuse)”,
the words and brackets “the Pre-conception and Pre-natal Diagnostic
Techniques (Prohibition of Sex Selection)” shall be substituted.
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Amendment
of section 2.
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4. In section 2 of the principal Act, -
(i)
after clause (b), the following clauses shall be inserted, namely:-
‘(ba)
“conceptus” means any product of conception at any stage
of development from fertilisation
until birth including extra embryonic membranes as well as the embryo
or foetus;
(bb)
“embryo” means a developing human organism after fertilisation
till the end of eight weeks (fifty-six days);
(bc)
“foetus” means a human organism during the period of
its development beginning on the fifty-seventh day following fertilisation
or creation (excluding any time in which its development has been
suspended) and ending at the birth;’;
(ii)
in clause(d), the following Explanation shall be added, namely:-
‘Explanation – For the purpose of this
clause, “Genetic Clinic” includes a vehicle, where ultrasound
machine or imaging machine or scanner or other equipment capable
of determining sex of the foetus or a portable equipment which has
the potential for detection of sex during pregnancy or selection
of sex before conception, is used;’;
(iii)
in clause (e), the following Explanation shall be added,
namely:-
‘Explanation:- For the purposes of this clause
“Genetic Laboratory” includes a place where ultrasound
machine or imaging machine or scanner or other equipment capable
of determining sex of the foetus or a portable equipment which has
the potential for detection of sex during pregnancy or selection
of sex before conception, is used;’;
(iv)
for clause(g), the following clause shall be substituted, namely:-
‘(g)
“medical geneticist” includes a person who possesses
a degree or diploma in genetic science in the fields of sex selection
and pre-natal diagnostic techniques or has experience of not less
than two years in any of these fields after obtaining –
(i)
any one of the medical qualifications recognised under the Indian
Medical Council Act, 1956; or
(ii)
a post-graduate degree in biological sciences;’;
(v)
for clause (i), the following clause shall be substituted,
namely:-
‘(i)
“pre-natal diagnostic procedures” means all gynaecological
or obstetrical or medical
procedures such as ultrasonography, foetoscopy, taking or removing
samples of amniotic fluid, chorionic villi, embryo, blood or any
other tissue or fluid of a man, or of a woman before or after conception,
for being sent to a Genetic Laboratory or Genetic Clinic for conducting
any type of analysis or pre-natal diagnostic tests for selection
of sex before or after conception;’;
(vi)
for clause (k), the following clause shall be substituted,
namely:-
‘(k)
“pre-natal diagnostic test” means ultrasonography or
any test or analysis of amniotic fluid, chorionic villi, blood or
any tissue or fluid of a pregnant woman or conceptus conducted to
detect genetic or metabolic disorders or chromosomal abnormalities
or congenital anomalies or haemoglobinopathies or sex-linked diseases;’;
(vii)
after clause (n), the following clauses shall be inserted, namely:-
‘(o)
“sex selection” includes any procedure, technique, test
or administration or prescription or provision of anything for the
purpose of ensuring or increasing the probability that an embryo
will be of a particular sex;
(p)
“sonologist or imaging specialist” means a person who
possesses any one of the medical qualifications recognised under
the Indian Medical Council Act, 1956 or who possesses a post-graduate
qualification in ultrasonography or imaging techniques or radiology
;
(q)
“State Board” means a State Supervisory Board
or a Union territory Supervisory Board constituted under section
16 A;
(r)
“State Government” in relation to Union territory
with Legislature means the Administrator of that Union territory
appointed by the President under article 239 of
the Constitution.’.
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102 of 1956
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5. In section 3 of the principal Act, for clause (2), the following
clause shall be substituted, namely: -
“(2)
no Genetic Counselling Center or Genetic Laboratory or Genetic
Clinic shall employ or cause to be employed or take services of
any person, whether on honorary basis or on payment who does not possess the qualifications as may be prescribed.”.
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Amendment
of section 3. |
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6. After section 3 of the principal
Act, the following sections shall be inserted, namely:-
“3A.
No person, including a specialist or a team of specialists in the
field of infertility, shall conduct or cause to be conducted or
aid in conducting by himself or by any other person, sex selection
on a woman or a man or on both or on any tissue, embryo, conceptus,
fluid or gametes derived from either or both of them.
3B.
No person shall sell any ultrasound machine or imaging machine
or scanner or any other equipment capable of detecting sex of foetus
to any Genetic Councelling Centre, Genetic Laboratory, Genetic Clinic
or any other person not registered under the Act.”.
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Insertion
of new sections 3A and 3B.
Prohibition
of sex-selection.
Prohibition
on sale of ultrasound
machine etc. to persons, laboratories,
clinics etc. not registered under the Act.
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7. In section 4 of the principal
Act, for clauses (3) and (4), the following clauses shall be substituted,
namely:-
“(3)
no pre-natal diagnostic techniques shall be used or conducted unless
the person qualified to do so is satisfied for reasons to be recorded
in writing that any of the following conditions are fulfilled namely:-
(
i) age of the pregnant
woman is above thirty-five
years,
(ii)
the pregnant woman has
undergone two or more spontaneous
abortions or
foetal loss;
(iii)
the pregnant woman had been exposed to potentially teratogenic agents
such as, drugs, radiation, infection or chemicals;
(iv)
the pregnant woman or her spouse
has a family history of mental retardation or physical deformities
such as, spasticity or any other genetic disease;
(v)
any other condition as may be specified by the Board:
Provided
that the person conducting ultrasonography on a pregnant woman shall
keep complete record thereof in the clinic in such manner, as may
be prescribed, and any deficiency or inaccuracy found therein shall
amount to contravention of the provisions of section 5 or section
6 unless contrary is proved by the person conducting such ultrasonography;
(4)
no person including a relative or husband of the pregnant woman
shall seek or encourage
the conduct of any pre-natal diagnostic techniques on her except
for the purposes specified in clause (2);
(5)
no person including a relative or husband of a woman shall seek
or encourage the conduct of any sex-selection technique on her or
him or both.”.
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Amendment
of section 4. |
Amendment
of section 5. |
8. In section 5 of the principal
Act, for sub-section (2), the following sub-section shall be substituted,
namely:-
“(2)
No person including the person conducting pre-natal diagnostic procedures
shall communicate to the pregnant woman concerned or her relatives
or any other person the sex of the foetus by words, signs, or in
any other manner.”.
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Amendment
of section 6.
Amendment
of Section 7
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9.
In section 6 of the principal Act, after clause (b), the following
clause shall be inserted, namely :-
“(c)
no person shall, by whatever means, cause or allow to be caused
selection of sex before or after conception”.
10.
In section 7 of the principal Act,-
(i)
in sub-section (2), for clause (c), the following clause
shall be substituted, namely:-
“(c)
three members to be appointed by the Central Government to represent
the Ministeries of Central Government in charge of Women and Child
Development, Department of Legal Affairs or Legislative Department
in the Ministry of Law, Justice, and Indian System of Medicine and
Homeopathy, ex officio;”;
(ii)
in clause (e), for sub-clause (ii), the following
sub-clause shall be substituted, namely:-
“(ii)
eminent gynaecologist and obstetrician or expert of stri-roga or
prasuti-tantra.”.
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Amendment
of section 14. |
11. In section 14 of the principal
Act, for clause (f), the following clause shall be substituted,
namely:-
“(f)
has, in the opinion of the Central Government, been associated with
the use or promotion of pre-natal diagnostic technique for determination
of sex or with any sex selection technique.”.
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Amendment of section 15. |
12. In section 15 of the principal
Act, the following proviso shall be inserted, namely: -
“Provided
that no member other than an ex-officio member shall be appointed
for more than two consecutive terms.”.
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Substitution of new section for
section 16.
Functions
of the Board. |
13. For section 16 of the principal
Act, the following section shall be substituted, namely:-
“16.
The Board shall have the following functions, namely:-
(i)
to advise the Central Government on policy matters relating to use
of pre-natal diagnostic techniques, sex selection techniques and
against their misuse;
(ii)
to review and monitor implementation of the Act and rules made thereunder
and recommend to the Central Government changes in the said Act
and rules.
(iii)
to create public awareness against the practice of pre-conception
sex selection and pre-natal determination of sex of foetus leading
to female foeticide;
(iv)
to lay down code of conduct to be observed by persons working at
Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics;
(v)
to oversee the performance of various bodies constituted under the
Act and take appropriate steps to ensure its proper and effective
implementation;
(vi)
any other functions as may be prescribed under the Act.”.
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14. After section 16 of the principal Act, the following section
shall be inserted, namely: -
“16A
(1) Each State and Union territory having Legislature shall
constitute a Board to be known as the State Supervisory Board or
the Union territory Supervisory Board, as the case may be, which
shall have the following functions: -
(i)
to create public awareness against the practice of pre-conception
sex selection and pre-natal determination of
sex of foetus leading to female foeticide in the State;
(ii)
to review the activities of the Appropriate Authorities
functioning in the State and recommend appropriate action against
them;
(iii)
to monitor the implementation of
provisions of the Act and the rules
and make suitable recommendations relating thereto, to the
Board;
(iv)
to send such consolidated reports as may be prescribed
in respect of the various activities undertaken in the State under
the Act to the Board and the Central Government; and
(v)
any other functions as may be prescribed under the Act.
(2)
The State Board shall consist of: -
(a)
the Minister in-charge of Health and Family Welfare in the
State, who shall be the Chairperson, ex officio;
(b)
Secretary in-charge of the Department of Health and Family
Welfare who shall be the Vice-Chairperson, ex officio;
(c)
Secretaries or Commissioners in charge of Departments of
Women and Child Development, Social Welfare, Law and Indian System
of Medicines and Homeopathy, ex officio, or their representatives;
(d)
Director of Health and Family Welfare or Indian System of
Medicines and Homeopathy of the State Government, ex officio;
(e)
three women members of Legislative Assembly or Legislative
Council;
(f)
ten members to be appointed by the State Government out of which two each shall be from the following categories:-
(i)
eminent social scientists and legal experts;
(ii)
eminent women activists from
non-governmental organizations or otherwise;
(iii)
eminent
gynaecologists and obstetricians or experts of stri roga or prasuti-tantra;
(iv)
eminent pediatricians or medical geneticists;
(v)
eminent radiologists or sonologists;
(g)
an officer not below the rank of Joint Director incharge of Family
Welfare, who shall be the Member Secretary, ex officio
(3)
The State Board shall meet at least once in four months.
(4)
The term of office of a member, other than an ex officio
member, shall be three years.
(5)
If a vacancy occurs in the office of any member other than
an ex officio member, it shall be filled by making fresh
appointment.
(6)
If a member of the Legislative Assembly or member of the Legislative
Council who is a member of the State Board, becomes Minister or
Speaker or Deputy Speaker of the Legislative Assembly or Chairperson
or Deputy Chairperson of the Legislative Council, she shall cease
to be a member of the State Board.
(7)
One-third of the total number of members of the State Board shall
constitute the quorum.
(8)
The State Board may co-opt a member as and when required, provided
that the number of co-opted members does not exceed one third of
the total strength of the State Board.
(9)
The co-opted members shall have the same powers and functions as
other members, except the right to vote and shall abide by the rules
and regulations.
(10)
In respect of matters not specified in this section, the State Board
shall follow procedures and conditions as are applicable to the
Board.”.
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Insertion of new section 16A.
Constitution of State Supervisory Board and Union
territory Supervisory Board.
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Amendment of section 17. |
15. In section 17 of the principal Act,-
(i)
in sub-section (3), for clause (a), the following
clause shall be substituted, namely:-
“(a)
when appointed for the whole of the State or the Union territory,
consisting of the following three members -
(i)
an officer of or above the rank of the Joint Director of
Health and Family Welfare - Chairperson;
(ii)
an eminent woman representing women’s
organisation; and
(iii)
an officer of Law Department of the State or the Union territory
concerned:
Provided
that it shall be the duty of the State or the Union territory concerned
to constitute multi-member State or Union territory level Appropriate
Authority within three months of the coming into force of the Pre-natal
Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment
Act, 2002:
Provided
further that any vacancy occurring therein shall be filled within
three months of the occurrence.”;
(ii)
in sub-section (4), after clause (d), the following
clauses shall be inserted, namely:-
“(e)
to take appropriate legal action against the use of any sex
selection technique by any person at any place, suo-motu or brought
to its notice and also to initiate independent investigations in
such matter;
(f)
to create public awareness against the practice
of sex selection or pre-natal determination of sex;
(g)
to supervise the implementation of the provisions of the Act
and rules;
(h)
to recommend to the Board and State Boards modifications required
in the rules in accordance with changes in technology or social
conditions;
(i)
to
take action on the recommendations
of the Advisory Committee made after investigation of complaint
for suspension or cancellation of registration.”;
(iii)
for sub-section (7), the following sub-section shall be substituted,
namely:-
“(7)
No person who has been associated with the use or promotion of pre-natal
diagnostic techniques for determination of sex or sex selection
shall be appointed as a member of the Advisory Committee.”.
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16. After section 17 of the principal
Act, the following section shall be inserted, namely :-
“17A.
The Appropriate Authority shall have 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 or the rules made thereunder;
(b)
production of any document or material object relating to clause
(a);
(c)
issuing search warrant for any place suspected to be indulging
in sex selection techniques or pre-natal sex determination; and
(d)
any other matter which may be prescribed.”.
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Insertion of new section 17A.
Powers
of Appropriate Authorities.
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17.
In section 18 of the principal Act, for sub-section (1),
the following sub-section shall be substituted, namely :-
“(1)
No person shall open any Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic, including clinic, laboratory or centre
having ultrasound or imaging machine or scanner or any other technology
capable of undertaking determination of sex of foetus and sex selection,
or render services to any of them, after the commencement of the
Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse)
Amendment Act, 2002 unless such centre, laboratory or clinic is
duly registered under the Act.”.
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Amendment
of section 18. |
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18. For section 22 of the principal
Act, the following section shall be substituted, namely:-
’22.
(1) No person, organisation, Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic, including clinic, laboratory
or centre having ultrasound machine or imaging machine or scanner
or any other technology capable of undertaking determination of
sex of the foetus or sex selection shall issue, publish, distribute,
communicate or cause to be issued, published, distributed or communicated
any advertisement, in any form, including internet, regarding facilities
of pre-natal determination of sex or sex selection before conception
available at such centre, laboratory, clinic or at any other place.
(2)
No person or organisation including Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic shall issue, publish, distribute,
communicate or cause to be issued, published, distributed or communicated
any advertisement in any manner regarding pre-natal determination
or pre-conception selection of sex by any means whatsoever, scientific
or otherwise.
(3)
Any person who contravenes the provisions of sub-section (1)
or sub-section (2) shall be punishable with imprisonment
for a term which may extend to three years and with fine which may
extend to ten thousand rupees.
Explanation.-
For the purposes of this section, ‘advertisement’ includes
any notice, circular, label, wrapper or any other document including
advertisement through internet or any other media in electronic
or print form and also includes any visible representation made
by means of any hoarding, wall-painting, signal, light, sound, smoke
or gas.”.
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Substitution
of new section for section 22.
Prohibition
of advertisement relating
to pre-conception
and pre-natal
determination of sex and
punishment for contravention. |
Amendment
of section 23. |
19. In section 23 of the principal
Act, for sub-sections (2) and (3), the following sub-sections
shall be substituted, namely:-
“(2)
The name of the registered medical practitioner shall be reported
by the Appropriate Authority to the State Medical Council concerned
for taking necessary action including suspension of the registration
if the charges are framed by the court and till the case is disposed
of and on conviction for removal of his name from the register of
the Council for a period of five years for the first offence and
permanently for the subsequent offence.
(3)
Any person who seeks the aid of any Genetic Counselling Centre,
Genetic Laboratory, Genetic Clinic or ultrasound clinic or imaging
clinic or of a medical geneticist, gynaecologist, sonologist or
imaging specialist or registered medical practitioner or any other
person for sex selection or for conducting pre-natal diagnostic
techniques on any pregnant women for the purposes other than those
specified in sub-section (2) of section 4, he shall, be punishable
with imprisonment for a term which may extend to three years and
with fine which may extend to fifty thousand rupees for the first
offence and for any subsequent offence with imprisonment which may
extend to five years and with fine which may extend to one lakh
rupees.
(4)
For the removal of doubts, it is hereby provided, that the provisions
of sub-section (3) shall not apply to the woman who was compelled
to undergo such diagnostic techniques or such selection.”.
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Presumption
in the case of conduct of pre-natal diagnostic techniques. |
20. For section 24 of the principal Act, the following section
shall be substituted, namely:-
“24
Notwithstanding anything contained in the Indian Evidence Act, 1872,
the court shall presume unless the contrary is proved that the pregnant
woman was compelled by her husband or any other relative, as the
case may be, to undergo pre-natal diagnostic technique for the purposes
other than those specified in sub-section (2) of section
4 and such person shall
be liable for abetment of offence under sub-section (3) of
section 23 and shall be punishable for the offence specified under
that section.”.
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Substitution
of new section for section 24. |
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21. In section 28 of the principal
Act, in sub-section (1), in clause (b), for the words
“thirty days”, the words “fifteen days”
shall be substituted. |
Amendment
of section 28. |
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22. In section 30 of the principal Act, for sub-section
(1), the following sub-section shall be substituted, namely:-
“(1)
If the Appropriate Authority has reason to believe that an offence
under this Act has been or is being committed at any Genetic Counselling
Centre, Genetic Laboratory, Genetic Clinic or any other place, such
Authority 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 Authority or officer
considers necessary, such Genetic Counselling Centre, Genetic Laboratory,
Genetic Clinic or any other place and examine any record, register,
document, book, pamphlet, advertisement or any other material object
found therein and seize and
seal the same if such Authority or officer has reason to believe
that it may furnish evidence of the commission of an offence punishable
under this Act.”. |
Amendment
of section 30.
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23. After section 31 of the principal Act, the following section
shall be inserted, namely:-
“31A.
(1) If any difficulty arises in giving effect to the
provisions of the Pre-natal Diagnostic Techniques (Regulation and
Prevention of Misuse ) Amendment Act, 2002,
the Central Government may, by order published in the Official
Gazette, make such provisions not inconsistent with the provisions
of the said Act as
appear to it to be necessary or expedient for removing the difficulty:
Provided
that no order shall be made under this section after the expiry
of a period of three years from the date of commencement of the
Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse)
Amendment Act, 2002.
(2)
Every order made under this section shall be laid, as soon as may
be after it is made, before each House of Parliament.”.
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Insertion
of new section
31 A.
Removal of difficulties. |
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24.
In section 32, in sub-section (2),-
(i)
for clause (i), the following clauses shall be substituted,
namely:-
“(i)
the minimum qualifications for persons employed at a registered
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic
under clause (2) of section 3;
(ia)
the manner in which the person conducting ultrasonography on a pregnant
woman shall keep record thereof in the Clinic under the proviso
to sub-section (3) of section 4;”;
(ii)
after clause (iv), the following clauses shall be inserted,
namely:-
“(iva) code of conduct to be observed by persons
working at Genetic Counselling Centres, Genetic Laboratories and
Genetic Clinics to be laid down by the Central Supervisory Board
under clause (iv) of section 16;
(ivb) the manner in which reports shall be furnished
by the State and Union territory Supervisory Boards to the Board
and the Central Government in respect of various activities undertaken
in the State under the Act under clause (iv) of sub-section
(1) of section 16A;
(ivc)
empowering the Appropriate Authority in any other matter under clause
(d) of section 17A;”.
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Amendment
of section 32. |
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