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PC-PNDT Latest Law Book

This document outlines Indian laws related to pre-conception and pre-natal diagnostic techniques. It discusses the Pre-Conception and Pre-Natal Diagnostic Techniques Act of 1994 and subsequent amendments. The document defines key terms, establishes regulatory bodies, and prohibits sex-selective abortions. Violations of the act carry criminal penalties.

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Arun Kumar
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0% found this document useful (0 votes)
195 views84 pages

PC-PNDT Latest Law Book

This document outlines Indian laws related to pre-conception and pre-natal diagnostic techniques. It discusses the Pre-Conception and Pre-Natal Diagnostic Techniques Act of 1994 and subsequent amendments. The document defines key terms, establishes regulatory bodies, and prohibits sex-selective abortions. Violations of the act carry criminal penalties.

Uploaded by

Arun Kumar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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lF:ie-l

Yhe
Fre-conception and Pre-natal
Diagnostic Techniques
{Prohibition of Sex Sel-ection)
Act, 1994
$r of 19e4)
rhe jammu an d {{!"Ysunis ation Act, 20te
"::#:i
(34 ot 2019) (w.e.f. Bt -10-2019,

* The pre-conc "orrlli#{ure-natal Diagnostic


Techniques (Prohibilion of Sex Selection) n?t"r, fggO

rhepre-conception;i;Tr-:;{rl'rr^*o"ricrechniques
(Prohibition bf sex selection) AmenEment Rules, zo)r
(G.S.R. 345(E), dated gt-B-Z}Zt)
* The Pre-Natal
lrfgpostic Techniques (Regulation
and Prevention of Misuse) (Adviroiy Comrilittees)
* the pre-conc"rffl":"f i:"-rrtat Diasrostic
Techniques (Plohibition of Sex Selecti"on)
(Six Montirs Training) Rul es, 2014

2023
#*Tf#],* Price<l2ooo
CONTENTS
THE PRE.CONCEPTION AND PRE-NATAL
DIAGNOSTIC TECHNTQUES (PROHIBITION
OF SEX SELECTIOM ACT, 1gg4
Sectiou
Page
CT{AI'TER I
PRELIMINARY
1. Short title, extent and commencement
2
2. Definitions
2
CHAPTERII
RECULATION OF GENETIC COLINSELLING CENTITES,
GENETIC LABORATORIES AND GENETTC CLINI'S-
3. Regulation of Genetjc Counselling Cenhes, Genetic
Laborahories and Genetic Clinics "
3-A. Prohibition of sex selection 4
3-8. Prohibition on sale of ultrasound machine, etc., to persons. 5
laboratories, clinics, etc., not registeredr',ria;;tG,{ii*""' 5
CHAPTERIII
REGULATION OF PRE-NATAL DIAGNOSTIC TECHNIQUES
4. Regulation of pre.natal diagnostic techniques
5. Written consent of pregnant wonran and prohibition of 5
communicating thc sex of foetus
5. Detcrmination-of sex prohibited 6
7
CHAPTERIV
CENTRAL SUPERVISORY BOARD
7. Constitution of Central Supervisory Board
8. Term of office of members' 7
9. Meetings of the Board 8
.l 8
0. Vacancies, etc., no t to invalidate proceedings of
tl-re Board 9
1 1. Temporary associa tion of person's
witli ihe Boarcl for
parttcutar purposes
Appoin hnbrr t bf officers ancl othcr employees of the Board 9
] l. 9
I 3. Au then tication of orders and other
insiruinents of the Board 9
14. Disqualification for appoin tment as *"-t".
15. Ellgibility of member'fbr the re_appoi^d;;r 9
16. Frrnctions of thc, Board 10
16-4. Co.stihrtion of sta.te supervisory Board and union 10
territory
Supcrvisory Board
11
CHAPTERV
APPROPRIATE AUTHORITY AND ADVISORY COMMITTEE
17. Appropriate Atrthority and Advisory Cornmittee
._ t2
r/-4. I,owers ol AppropriateAutlroritjes -
11
CHAPTERVI
REGISTRATION OF GENETIC COUNSELI-ING C E NTRES,
NETI C LA BORA TORI ES A N D G E NEiIC-Ci'INTb^S"*
G E

18. I{egistration of Genetic Counselling Centres,


Genetic
Laboratories or Genetic Clinics
19. Certjficate of registration 14
20. Cancellation or suspension of registration 15
21. Appeal 15
15
(iv) CONTENTS

Section Page
CHAPTERVII

a.,u.,l::t")'t::f,[.'" ]::]::r
22. p rorr ibitio., o r u ti on a nd
pre-natal determination of sex and punishment for contravention t6
23. Offences and penalties 16
24. Presumptionin thecase of conduct of pre-natal
diagnostic techniques 17
25, Penalty for contravention of the provisions of the Act or rules
for which nospecific punishment is provided 18
26. Offences by compahies 18
27. Offence to be cognizable, non-bailable and non-compour-rdabie 18
28. Cognizance of offences 18
CHAPTER VIII
MISCELLANEOUS
29, Maintenanceof records t9
30. Power to search and seize records, etc. 1.9
31. Protection of action taken in good faith 1,9
31-A. Removal of difficulties 20
32, Powertomakerules 2d
33.-Power to make regulations 21
34.-Rules and regulations to be laid before Parliament 21

THE PRE-CONCEPTION AND PRE.NATAL


DIAGNOSTIC TECHNIQUES (PROHIBITION
oF sEX SELECTION) RULET 1996
Rule
1. Short title and commencement 22
2. Definitions 22
3. Minimum requirements 22
3-A. Sale of ultrasound machines/imaging machines 25.
3-8. Regulation of portble mqchinee 26
4. Registration of Genetic Counselling Centre, Genetic Laboratory,
Genetic Clinic, Ultrasound Clinic and Imaging Centres 27
5. Applicationfee 28
6. Certiflcate of registration 28
7. Validity of registration 30
8. Renewal of registration 30
9. Maintenance and preservation of records 30
10. Conditions for conducting pre-natal diagnostic procedures 30'
11. Faciiities for inspection 5Z
1 2, Procedure for search and seizure 32
13 . Intimation of changes in employees, place or equipment JJ
14. Conditions for analysis or test and pre-natal diagnostic procedures JJ
15. Meetings of the advisory Committees 34
16. Aliowances to members of the Central Strpervisory Board 34
17. Public Information 34
18. 34
18-A. Code of Conduct to be observed by Appropriite .luthorities 35
CONTENTS (")
Rule Page
19. Appeals 38
19-A. The manner for filing and disposal of the appeal under
clause (l) and (ir) of section 21 of the Act 38
SCHEDULE l-lOmitted) 38
SCHEDULE ll-fOmittedl 38
SCHEDULE III - lOmittedl 38
FORMS 39

THE PRE-NATAI DIAGNOSTIC TECHNIQUES


(REGULAIION AND PREVENTION OF MISUSE)
(ADVISORY COMMITTEES) RULES, 1996
1. Short title and commencement 44-1
2. Definitions 44-l
3. Terms and conditions of appointment as a member of an
Advisory Committee 44-l
4. Meetings of the Advisory Committees 44-l
5. Notice of meetings 44-I
6. Business ordinarily to be transacted at meetings 4-K
7. Quorum 4J.-K
8. Chairman of the meeting 4+K
9. Assistance to be rendered by the Appropriate Authority to
the Advisory Committee 4-K
10. Decisions on questions before the Advisory Committee M-K
1.1. Vacancies, etc., not to invalidate proceedings of the
Advisory Committees 4+K
12. Record of proceedings of the Advisory Committee 44-L

THE PRE.CONCEPTION AND PRE-NATAI DIAGNOSTIC


TECHNTQUES (pROHrBrTrON OF SEX SELECTTON)
(SIX MONTHS TRAINING) RULES, 201.4
1. Short title and commencement 45
2. Definitions ... 45
3. Nomenclature of the Six months training in ultrasonography 45
4. Period of the trainin9 45
5. Components of the six months training curriculum 45
6. Eligibility for training 46
7. Accreditation of institutions for six months training and its
recognition 46
8. Selection of students 45
9. Changed criteria to be made prospective 46
10. Fee strucftrre for the training 46
11. Staff-Faculty 46
12. Monitoring requirements 47
13. Competenry based evaluation 47
14. Validity of the training certificate 47
SCHEDULEI 47
SCHEDULEII 59
List of Amending Acts
1. Pre-natal Diagnostic Tedrniques (Regulation and Prevention of Misuse)
Amendment Act, 2001 (32 of 2001)
2. Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse)
Arnendment Act, 2002 (l 4 of 2003)
3. )ammu and Kashmir Reorganisation Act, 2019 (34ot2019)

(ai)
THE PRE.CONCEPTION AND PRE-NAIAL
DIAGNOSTIC TECHNIQUES (PROHIBITION
OF SEX SELECTION ACT,1994
(s7 0F 19941
[20th Septunber,l994l
llAn Act to proaide the prohibition of sex selection, before or after conceptiort, arfi
for
for regulation of pre-natal diagnostic teclttiques for tlrc purplses of detecting genetic
abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital
mnlfurmations or sex-linked disorders and for the preoention of their misuse for sex
determination leading to female foeticide and for matters connected therezuith or incidental
thereto.l
Br it enacted by Parliament in the Forty-fifth Year of Republic of India as
follows;-
Statement of Objects and Reasons.-It is proposed to prohibit pre-natal diagnostic
techniques for determination of sex of the foefus leading to female foeticide. Such abuse of
tectmiques is discriminatory against the female sex and affects the dignity and status of
women. A legislation is required to regulate the use of such techniques and to provide
deterrent punishment to stop such inhuman act.
(2) The Blll, inter alia, provides for:-
(l) prohibition of the misuse of pre-natal diagnostic techniques for determination
of sex of foerus, leading to female foeticide;
(li) prohibition of advertisement of pre-natal diagnostic techniques for detection
or determination of sex;
(iii) permission and regulation of the use of pre-natal diagnostic techniques for the
purpose of detection of specific genetic abnormalities or disordersi
(icr) permitting the use of such techniques only under certain conditions by the
registered institutions; and
(o) punishment for violation of the provisions of the proposed legislation.
Amendment Act 32 of 2l07-Statement of Objects and Reasons.-The Pre-natal
Diagnostic Techniques (Regulation and Prevention of Misuse) Act, L994 arrd the Rules
framed thereunder came into force with effect from 1.st January, 1996. The Act provides for
regulation of the use of pre-natal diagnostic techrniques for detecting genetic or metabolic
disorders, chromosomal abnormalities, certain congenital malformations of sex linked
disorders and for the prevention of the misuse of such techniques for the purpose of pre-
natal sex determination leading to female foeticide, and for matters connected therewith or
incidental thereto.
2. A Central Supervisory Board has been constituted under section 7 of the Act which
includes three women Members of Parliament. At present, there is no provision in the Act
for deemed termination of membership of a Member of Parliament on her subsequent
appointment as a Minister or Minister of State or Deputy Minister or the Speaker or Deputy
Speaker, Lok Sabha or Deputy Chairman, Rajya Sabha. It is proposed to provide that
consequent upon a Member of Parliarrnent becoming a Minister cr Minister of State or.

l.Substituted by Act 14 of 2003,5.2, for long title (w.e.f. 1,4-2-2003). Prior to its
substitution, long title read as wder:-"An Act to prouide for the regulatiot't of tlu use of pre-
natal diagnostic techniques for the purpose of detecting genetic or nutabolic disorders or
chromosomal abnormalities or certnin congenital mal-formations or sex linkcd disortlers nnd for tlrc
p.reaention of tlrc mixrse of such techniques for tlrc purpose of pre-natal sex determination lending to
femalefoeticide; and,for matters connected therewith or incidental thereto."
2 PRE-CONCEPTIONANDPRE.NATALDIAGNOSTICTECHNIQUES [S.1
(PROHTBITTON OF SEX SELECTTON) ACT,1994

Deputy Minister or the Speaker or Deputy Speaker of the House of the Peoplg or the
Deputy Chairman of the Council of States, her membership of that body shall stand
terminated.
3. The Bill seeks to adrieve the above object by ammding the relevant of the Act.
Amendment Act 74 of 2003-Statement of Objects and Reasons.-The Pre-natal
Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 seeks to prohibit
pre-natal diagnostic techniques for determination of sex of tlre foefus leading to female
foeticide. During recent years, certain inadequacies and practical difficulties in the
administration of the said Act have come to the notice of the Government, which has
necessitated amendments in the said Act.
2. The pre-natal diagnostic techniques like amniocentesis and sonography are useful
for the detection of genetic or chromosomal disorders or congenital malformations or
sex linked disorders, etc. Howevet the amniocentesis and sonography are being used
on a large scale to detect the sex of the foetus and to terminate the pregnanry of the
unbom child if found to be female. Techniques are also being developed to select the sex
of ddld before conception. These practices and techniques are considered
discriminatory to the female sex and not conducive to the dignity of the women.
3. The proliferation of the technologies mentioned above may, in future, precipitate a
catastrophe, in the form of severe imbalance in male-female ratio. The State is also duty
bound to intervene in sudr matters to uphold the welfare of the society, especially of the
women and ddldren. It is, therefore/ necessary to enact and implement in letter and spirit
a legislation to ban the pre-conception sex selection teclrniques and the misuse of pre-
natal diagnostic techniques for sex-selective abortions and to provide for the regulation of
such abortions. Sudr a law is also needed to uphold medical ethics and initiate the process
of regulation of medical technology in the larger interests of the society.
4. Accordingly, it is proposed to amend the aloresaid Act with a view to banning the
use of both sex selection tedmiques prior to conception as well as the misuse of pre-
natal diag-nostic teduriques for sex selective abortions and to regulate such techniques
with a view to ensuring their scientific use for whieJr they are intended.
5. The Bill seeks to achieve the aforesaid objects.
CFIAPTERI
PRELIMINARY
1. Short tifle, extent and commencement. 2[Tru Pnr-
- (1) This Act may be called
coNcEprroNANDPns-NarerDrAcNosrrcTECHNreuES (PRoHlnmoN oF SExSELECTIoN)] Acr,
1994.
(2) It shall extend to the whole of India h[* * *].
(3) It shall come into force on such date3 as the Central Government may, by
notification in the OfficialGazette, appoint.
Definitions. - Lr this Act, unless the context otherwise requires, -
2.
(a) "Appropriate Authorit5r" means the Appropriate Authority appointed
under section 17;
(b) "Board" means the Central Supervisory Board constituted under section Z
af(bn)"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;

2. Substituted by Act 1,4 2003, S.3, for "Tsr Pnr-Nerar DncNosuc TrcryteuBs
of
(Rrcur-a,uou auo Pruvmruou or Mnusr)" (w.e.f. 14-2-2003).
2a. The words "except the State of |ammu and Kashmir" omitted by Act 34 of 2019,
Ss.95,96 and Sch. V (w.e.f.31-10-2019).
3. Brought into force on 1st January, 1996.
4. Irrserted by Act 14 of 2003, S. 4 (w.e.f. 1,4-2-2003).
S.2] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 3
(PROHTBTTTON OF SEX SELECTION) ACT,t994

(bb) "embryo" means a developing human organism after fertilisation till the
end of eightweeks (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;]
(c) "Genetic Counselling Centre" means an institute, hospital, nursing home
or any place, by whatever name called, which provides for genetic counselling to
patients;
(d) "Genetic Clinic" means a clinic, institute, hospital, nursing horne or any
place, by whatever name called, which is used for conducting pre-natal diagnostic
procedures.
sfExplanation the purposes of this clause, "Genetic Clinic" includes a
vehicle, where -For
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;] i
"Genetic Laboratory" means a laboratory, and includes a place where
(e)
facilities are provided for conducting analysis or iests of samples received from
Genetic Clinic for pre-natal diagnostic test.
6fExplanation the purposes of this clause, "Genetic Laboratory" includes a
-For
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 selectionbf sex before
conceptiory is used;]

_ (fl "Gynaecologist" means a person who possesses a post-graduate


qualification in gynaecology and obstetrics;
_ - '[k) "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, 1.956 (102 of 7956); or
(ii) a post-graduate degree in biological sciences;]

- (h) "paediatrician" means a person who possesses a post-graduate


qualification in paediatrics;
5. AddedbyActl4of 2003,5. 4 (w.e.f. 14-2-2003).
5. Inserted by Act 14 of 2003, S. 4 (w.e.f. 14-2-2003).
7. Substituted by Act 14 of 2003, S. 4, for Cl. Q) (w.e.f. L4-2-2003). Prior to its substitution,
Cl. (g) read as under:-"(g) "Medical geneticist" mearls a person who possesses a degree or
diploma or certificate in medical genetics in the field of pre-natal diagnostic techniques or
has experience of not less than two years in such field aftei obtaining--
(l) any one of the medical qualifications recognised under the Indian Medical
Council Act, 1.956 (102 of 1956); or
(ll) a post-graduate decree in biological sciences;"
4 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S. 3
(PROHIBTTION OF SEX SELECTION) ACT,1994
8[(l) "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 orTluid of a mary or of a woman before or after conceptiory 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;]
ff) "pre-natal diagnostic techniques" includes all pre-natal diagnostic
procedures and pre-natal diagnostic tests;
e[(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 metaboiic disorders or
chromosomal abnoimalities or congenital anomalies or haemoglobinopathies or
sex-linked diseases;l
(l) "prescribed" means prescribed by mles made under this AcU
(rn) "registered medical practitioner" means a medical practitioner who
possesses any recogni'sed medical qualification as defined in clause (/r) of section 2
of the Indian Medical Council Act, 1956 (102 of 1956), and whose name has been
entered in a State Medical Register;
(n) "regulations" means regulations framedby the Board under this Act.
r0[(o) "sex selection" includes any procedure, technique, test or
administration or prescription or provision of anything for ttre 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,
19ffi (102 of 1956) or who possesses a post-graduate qualification in
ultrasonography or imaging techniques or radiology;
(4) "State Board" means a State Supervisory Board or a Union territory
Supervisory Board constituted under section 16-4;
(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.l.
CHAPTERII
REGULATION OF GENETIC COUNSELLING CENTRES, GENETIC
LABORATORIES AND GENETIC CLINICS
3. Regulation of Genetic Counselling Centres, Genetic Laboratories and
Genetic Clinics.-On and from the commencement of this Act,-
8. Substituted by Act 14 of 2003, S. 4, for Cl. (l) (w.e.f. 14-2-2003). Prior to its substirution,
Cl. (l) read as under:-"(l) "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, blood or any tissue of a pregnant woman for being
sent to a Genetic Laboratory or Genetic Clinic for conducting pre-natal diagnostic test;"
9. Substituted by Act 14 of 2003, S. 4, for Cl. (k) (w.e.f. 14-2-2003). Prior to its substitution,
Cl. (k) read as under:-"(k) "pre-natal diagnostic test" means ultrasonography or any test or
analysisof amniotic fluid, chorionic villi, blood or any tissue of a pregnant woman
conducted to detect genetic or metabolic disorders or chromosomal abnormalities or
congenital anomalies or haemoglobinopathies or sex-linked diseases;"
10. Inserted by Act 14 of 2003, S. 4 (w.e.f .14-2-2003).
S.4] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 5
(PROHIBITTON OF SEX SELECTTON) ACT,7994

(1) no Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic


unless registered under this Act, shall conduct or associafe with, or help in,
conducting activities relating to pre-natal diagnostic techniques;
11[(2) no Genetic
Counselling Centre 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 quilifications as may be
prescribed;]
(3) no medical geneticist, gynaecologist, paediatrician, registered medical
practitioner or any other person shall conduct or cause to be conducted or aid in
conducting by li*t"U or through any other person, any pre-natal diagnostic
techniques at a place other than a place registered under thii Act.
"[3-A. Prohibition of sex selection.-No person, including a specialist or a
team of specialists in the filed of infertility, shall conduct or cauie to'be conducted
or aid in conducting by himself orby 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.
3-B. Prohibition on sale of ultrasound machine, etc., to persons, laboratories,
clinicq etc., not registered under the Act.-No person shall sell any ultrasotrnd
Tl.hilu or imaging machine or scanner or any other equipment capable of
detecting-sex of foetus to any Genetic Counselling Centre,'Genetic Latioratory,
Genetic Clinic or any other person not registered under the Act.]
CHAPTERIII
REGUI-ATiON OF PRE.NATAL DIAGNOSTIC TECHNIQUES
4. Regulation or pre-natal diagnostic techniques.-on and from the
commencement of this Act
-
no plTe induding a registered Genetic Counselling Centre or Genetic
(1)
Laboratory or Genetic Clinic shall be used or caused to be use? by any person for
conducting pre-natal diagnostic teihniques except for the p.r.p5ses'siecified in
clause (2) and after satisfying any of the ionditions'specified ir cfause (3)j
(2) no- pre-natal diagnosti-c techniques shall be conducted except for the
purposes of detection of any of the following abnormalities, namel y:-
(l) chromosomal abnormalities;
(li) genetic metabolic diseases;
(iil) heamoglobinopathies;
(io) sex{inked genetic diseases;
(z) congenital anomalies;
(tti) alY other abnormalities or diseases as may be specified by the Central
Supervisory Board;

substitution, Cl. (2) read asunder:-"(2) no Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic shall employ or cause to be employed any perion *ho does not possess thL
prescribed qualifications;"
12. Insertedby Act1.4of 2003, S, 6 (w.e.f.14-?-2003).
6 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S.5
(PROHIBTTION OF SEX SELECTION) ACT,1994
t3[(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 wriling that
any of the following conditions are fulfilled, namely:-
(i) age of the pregnant woman is above thirty-five years;
(if) the pregnant woman has undergone two or more spontaneous
abortions or foetal loss;
(ili) the pregnant woman had been exposed to potentially teratogenic
agents such as, drugs, radiation, infection or chemicalsi
(lzi) tl-re pregnant woman or her spouse has a family history of mental
retardation or physical deformities such as, spasticity or any other genetic disease;
(o) 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 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.]
5. Written consent of pregnant woman and prohibition of communicating the
sex of foetus.-(1) No person referred to in clause (2) of section 3 shall conduct the
pre-natal diagnostic procedures unless-
(a) he has explained all known side and after effects of such procedures to
the pregnant woman concerned;
(D) he has obtained in the prescribed form her written consent to undergo
suchprocedures in the language whichshe understands; and
(c) a copy of her written consent obtained under clause (b) is given to the
pregnantwoman.
13. Substituted by Act 14 of 2003, S. 7, for Cls. (3) and (4) (w.e.f. 1,4-2-2003). Prior to their
substitution, Cls. (3) and (4) read as under:-"(3) no pre-natal diagnostic techniques shall be
used or conducted unless the person qualified to do so is satisfied that any of the following
condi tions are fulfilled, namely:-
(i) age of the pregnant woman is above thirty-five years;
(li) the pregnant woman has undergone two or more spontaneous abortions.or
foetal loss;
(ili) the pregnant woman had been exposed to potentially teratogenic agents such
as drugs, radiation, infection or chemicals;
(io) the pregnant woman has a family history of mental retardation or physical
deformities such as spasticity or any other genefic disease;
(a) any other condition as may be specified by the Central Supervisory Board;
(4) no person, being a relative or the husband of the pregnant woman shall seek or
encourage the conduct of any pre-natal diagnostic techniques on her except for the purpose
specified in clause (2);"
5.71 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 7
(pRoHrBrTION OF SEX SELECTTON\ ACT,L994
1a[(2) No person including the person conducting pre-natal diagnostic
procedures shall communicate to the pregnant woman concemed or her relatives
or any other person the sex of the foetus by words, signs, or in any other manner.]
6. Deterrrination of sex prohibited.-4n and from the commencement of this
Act,-
(a) no Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic
shall conduct or cause to be conducted in its Centre, Laboratory or Clinic, pre-natal
diagnostic techniques including ultrasonography, for the purpose of determining
the sex of a foetus;
(b) no person shall conduct or cause to be conducted any pre-natal diagnostic
techniques including ultrasonography for the purpose of determining the sex of a
foetusi
15[(c) no person shall, by whatever means, cause or allow to be caused
selection of sex before or after conception.]
CHAPTERTV
CENTRAL SUPERVISORY BOARD
7. Constitution of Central Supervisory Board.-(1.) The Central Government
shall constitute a Board to be known as the Central Supervisory Board to exercise
the powers and perform the functions conferred on the Board under this Act.
(2) The Board shall consist of-
(a) the Minister in charge of the Ministry or Department of Family
Welfare, who shall be the Chairman, ex officio;
(b) the Secretary to the Govemment of India in charge of the Department
of Family Welfare, who shall be the Vice{hairman, ex officio;
16[(c)
three members to be appointed by the Central Government to
represent the Ministries of Central Government in charge of Woman and Child
Development, Departurent of Legal Affairs or Legislative Deparhnent in the
Ministry of Law and fustice, and Indian System of Medicine and Homoeopathy, ex
officiq7
(d) the Director General of Health Services of the Central Government, ex
ofrcio,
(e) ten members to be appointed by the Central Govemment, two each
from amongst-
(l) eminent medical geneticists;
1'[(i) eminent gynaecologist and obstetrician or expert af stri-roga or
prasuti-tanta;l;
14. Substituted by Act '1.4 of 2003, S.8, for sub-S. (2) (w.e.f. lk2-2003). Prior to its
substitution, sub-S. (2) read as under:-"(2) No person conducting pre-natal diagnostic
procedures shall communicate to the pregnant woman concemed or her relatives the sex of
the foefusbywords, signs or in anyother manner."
15. lnserted by Act 1,4 of 2003, S. 9 (w.e.f . 1.4-2-2003).
16. Substituted by Act 14 ol (c) (w.e.f . 1+2-2003). Prior to its
2003, S. 10, for Cl.
substitution, Cl. (c) read 3s sndsl;-'l(c) two members to be appointed by the Central
Government to represent the Ministries of Central Govemment in charge of Woman and
Child Development and of Law and ]ustice, ex officiof'
17. Substituted by Act L4 of 2003, S. 10, for sub-Cl. (l) (w.e.f. 1,4-2-2003). Prior to its
substitution, sub-Cl. (u) read as un der:-" (ii) eminent glmaecologists and obstetricians;"
8 PRE.CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S. 8
(pRoHIBmON OF SEX SELECTTON) ACT, 1994

(20 eminent paediatricians;


(iv) eminent social scientists; and
(v) representatives of women welfare organisations;
(/) three women Members of Parliament, of whom two shall be elected by
the House of the People and one by the Council of States;
(g) four members to be appointed by the Central Government by rotation
to represent the States and the Union territories, two in the alphabetical order and
two in the reverse alphabetical order:
Provided that no appointment under this clause shall be made except on the
recommendation of the State Govemment or, as the case may be, the Union
territory;
(ft) an officer, not below the rank of a ]oint Secretary or equivalent of the
Central Govemment, in charge of Family Welfare, who shall be the Member-
Secretary, exofficio.
8. Term of office of members.-(1) The term of office of a member, other than
an ex officiomembet shall be,-
(a) in case of appointment under clause (e) or clause (1) of sub-section (2) of
section Z three years 18[*]:
1e[Provided that the term of office of a member elected under clause (4 of sub-
section (2) of section 7 shall come to an end as soon as the member becomes a
Minister of Minister of State or Deputy Minister, or the Speaker or the Deputy
Speaker of the House of the People, or the Deputy Chairman of the Council of
States or ceases to be a member of the House from which she was elected: and]
(b) in case of appointment under clause (g) of the said sub-section, one
year.
(2)lf a casual vacancy occurs in the office of any other members, whether by
reason of his deattu resignation or inability to discharge his functions owing to
illness or other incapacity, such vacancy shall be filled by the Central Government
by making a fresh appointment and the member so appointed shall hold office for
the remainder of the term of office of the person in whose place he is so appointed.
(3) The Vice-Chairman shall perform such functions as may be assigned to
himby the Chairman from time to time.
(a) The procedure to be followed by the members in the discharge of their
functions shall be such as may be prescribed.
COMMENTS
Female Foeticide-Comments on.-It should be clearly spelt out that female foeticide is
the worst type of dehumanisation of the human race: Voluntary Health Association oI
Punjabv. Unionof IndiaA.I.R.2013 S.C.7571,: (2013) 4 S.C.C. 1.
9. Meetings of the Board.--(L) The Board shall meet at such time and place, and
shall observe such rules of procedure in regard to the transaction of business at its
meetings (including the quorum at such meetings) as may be provided by
regulations:
Provided that the Board shall meet at least once in six months.
18. The word "and" omitted by Act 32 of 2001,,5.2 (w.e.f .3-9-2001).
1.9. Inserted by Act 32 of 2001, 5. 2 (w.e.f . 3-9-2001 ).
S. 14] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 9
(PROHIBITION OF SEX SELECTION) ACT, t994
(2) The Chairman and in his absence the Vice-Chairman shall preside at the
meetings of the Board.
(3) If for any reason the Chairman or the Vice-Chairman is unable to attend
any meeting of the Board, any other member chosen by the members present at the
meeting shall preside at the meeting.
(4) An questions which come up before any meeting of the Board shall be
decided by a majority of the votes of the members present and voting, and in the
event of an equality of votes, the Chairman, or in his absence, the person presiding,
shall have and exercise a second or casting vote.
(5) Members other than er officio members shall receive such allowances, if
any, from the Board as maybeprescribed,
10. Vacancies, etc., not to invalidate proceedings of the Board.-No act or
proceeding of the Board shall be invalid merely by reason of-
(a) any vacancy in, or any defect in the constitution of, the Board; or
(b) any defect in the appointment of a person acting as a member of the
Board; or
(c) any irregularity in the procedure of the Board not affecting the merits of
the case.
11. Temporary association of persons with the Board for particular
purposes,-(1) The Board may associate with itself, in such manner and for such
purposes as may be determined by regulations, any person whose assistance or
advice it may desire in carrying out any of the provisions of this Act.
(2) A person associated with it by the Board under sub-section (1) for any
purpose shall have a right to take part in the discussions relevant to that purpose,
but shall not have a right to vote at a meeting of the Board and shall not be a
member for any other purpose.
12. Appointment of officers and other employees of the Board.-(1) For the
purpose of enabling it efficiently to discharge its functions under this Act, the
Board may, subject to such regulations as may be rnade in this behalf, appoint
(whether on deputation or otherwise) such number of officers and other
employees as it may consider necessary:
Provided that the appointment of such category of officers, as may be specified
in such regulations, shall be subject to the approval of the Central Government.
(2) Every officer or other employee appointed by the Board shall be subject to
such conditions of service and shall be entitled to such remuneration as may be
specified in the regulations.
13. Authentication of orders and other instruments of the Board.-All orders
and decisions of the Board shall be authenticated by the signature of the Chairman
or any other member authorised by the Board in this behalf, ancl all other
instruments, issued by the Board shall be authenticated by the signature of the
Member-Secretary or any other officer of the Board authorised in like rnanner in
this behalf.
14. Disqualification for appointment as member.-A person shall be.
disqualified for being appointed as a member if, he-
(a) has been convicted and sentenced to imprisonment for an offence which,
in the opinion of the Central Goverhment, involves moral turpitude; or
(b) is an undischarged insolvent; or
10 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S. 15
(PROHIBITION OF SEX SELECTION) ACT,1994
(c) is of unsound mincl and stands so declared by a competent Court; or
(d) has been removed or dismissed from the service of the Government or a
Corporation owned or controlled by the Governmen! or
(e) has, in the opinion of the Central Government, such financial or other
interest in the Board is is likely to affect prejudicially the discharge by him of his
functions as a member; or
,o[(fl has, in the opinion of the Central Government, been associated with the
Lrse or promotion of pre-natal diagnostic technique for determination of sex or
with any sex selection technique.]
1.5. Eligibility of member for the re-appointment.-Subject to the other terms
and conditions of service as may be prescribed, any Person ceasing to be a member
shall be eligible for re-appointment as such member:
2l[Provided that no member other than an ex
fficia member shall be appointed
for more than two consecutive terms.]
22[16. Functions of the Board.-The Board shall have the following functions,
namely:-
(i) to advise the Central Government on policy matters relating to use of ore-
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 Govemment changes in the said Act
and rules;
(ili) to create public awareness against the practice of pre-conception sex
selection and pre-natai determination of sex of foetus leading to female foeticide;
(la) to lay down code of conduct to be observed by Persons working at
Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics;
(a) to oversee the performance of various bodies constituted under the Act
and take appropriate steps to ensure its proper and effective implementation;
(ai) any other functions as may be prescribed under the Act.]
20. Substituted by Act 14 of 2003, S. 11, for Cl. (r) (w.e.f. L4'2-2003). Prior to its
substitution, Cl. (fl read as under:-"(fl has, in the opinion of the Cenhal Government, been
associated with the use or promotion of pre-natal diagnostic technique for determination of
sex.'1
21. Inserted by Act 14 of 2003, s. 1 2 (w.e. f . 14-2-2003).
22. Substituted by Act 14 of 2003, S. 13, for S. 16 (w.e.f. 14-2-2003). Prior to its
substitution, S. 15 read as under:-"16. Furtctions of the Board.-The Board shall have the
foliowing functions, namely:-
(l) to advise the Government on policy matters relating to use of pre-natal diagnostic
techniques;
(ii) to review implementation of the Act and the rules made thereunder and
recommend changes in the said Act and rules of the Central Governmen!
(ill) to create public awareness against the practice of pre-natal determination of sex
and female foeticide;
(izr) to lay down code of conduct to be observed by persons working at Genetic
Counselling Centres, Genetic Laboratories and Genetic Clinics;
(zr) any other flrnctions as may be specified under the Act."
S, 16-4'] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 11
(pRoHrBrTroN oF sEX SELECTTON) ACT,1.994

'?3[16-A. Constitution of State Supervisory Board and Union territory Supervisory


Board.-(1) Each State and Union territory hAving Legislature shall constitute a
Board to be known as the state Supervisory Board or the uniorl territory
Supervisory Board, as the case maybe, *hich shill have the following functions:-1
(i) to create public awareness against the practice of pre-conception sex
selection and pre-natal determination of sex of foetus leading to female fo'eticide in
the State;
(ll) to review the activities of the Appropriate Authorities functioning in
the State and recommend appropriate actionagainst them;
(iii) to monitor the implementation of provisions of the Act and the rules
and make suitable recommendationsrelating thereto, to the Board;
(lu) to send such consolidated reports as may be prescribed in respect of
the various activities undertaken in the State under ihe Act to the Board ind the
CentralGovernmenf and
(a) 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) secre_tary rl charge of the D-epartment of Health and Family werfare
who shall be the Vice-Chairperson,exofficio;
(c) secretaries or Commissioners in charge of Departments of women and
Child Development, social welfare, Law and Indian system of Medicines and
Homoeopathy, ex officio, or their representatives;
(d) Director of Health and Family Welfare or Indian Svstem of Medicines
and Homoeopathy of the State Governm6nt, ex officio;
(e) three women members of Legislative Assembly or Legislative Council;

-(fl ten members to be appointed by the state Government out of which


two each shall be from the foltowing categoiies,-
(i) eminent social scientists and legal experts;
(ii) eminent women activists from non-governmental organisations or
otherwise;
(lil) eminent gynaecologists and obstetricians or experts of striroga or
prasuti-tantra;
(la) eminent paediatricians or medical geneticrsts;
(a) eminent radiologists or sonologists;
(g).an officer not below the rank of ]oint Director in charge of Family
Welfare, who shall be the Member Secretary , ex officio.
(3) The State Board shall meet at least once in four months.
(a) The term of office of a member, other than an ex member, shali be
fficio
three years.

,(5)
if a.vacancy-occllrs in the office of any member other than an ex
fficio
member, it shall be filled by making fresh appoiritment.
72 PRE-CONCEPTTON AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S. 17
(PROHIBITION OF SEX SELECTION) ACT,1994
(5) If a member of the Legislative Assembly or member of the Legislative
Council who is a member of the State Board, becornes Mirdster-sr Speaker or
Depuly 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 do-es 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 sechion, the State Board shall
follow procedures and conditions as are applicable to the Board.l
CHAPTERV
APPROPRIATE AUTHORITY AND ADVISORY COMMITTEE
17. Appropriate Authority and Advisory Committee.-(1) The Central
Government shall appoint by notification in the Official Gazette, one or more
Appropriate Authorities for each of the Union territories for the purposes of this
Act.
(2) The State Government shall appoint, by notification in the Official
Gazette, one or more Appropriate Authorities for the whole or part of the State for
the purposes of this Act having regard to the intensity of the problem of pre-natal
sex determination leading to female foeticide.
(3) The officers appointed as Appropriate Authorities under sub-section (1)
or sub-section (2) shall be,-
2a[(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-{hairperson;
(li) 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 shail be filled within three
months of the occurrence,]
(b) when appointed for any part of the State or the Union territory, of such
other rank as the State Government or the Central Govemment, as the case may be,
may deem fit.
24. Substituted by Act t4 oI 2003, S. 15, for Cl. (a) (w.e.f . 14-2-2003). Prior to its
substitution, Cl. (a) read as under:-"(a) when appointed for the whole of the State or the
Union territory, of or above the rank of the Joint Director of Health and Family Welfare;
and".
5.17] PRE-CONCEPTTON AND PRE-NATAL DIAGNOSTIC TECHNIQUES 13
(PROHIBITION OF SEX SELECTION) ACT,7994

(a) The Appropriate Authority shall have the following functions, namely:-
(a) to grant, strspend or cancel registration of a Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic;
(b) to enforce standards prescribed for the Genetic Counselling Centre,
Genetic Laboratory and Genetic Clinic;
(c) to investigate complaints of breach of the provisions of this Act or the
rules made thereunder ar-rd take immediate actioni and
(d) to seek and consider the advice of the Advisory Committee, constituted
under sub-section (5), on application for registration and on complaints for
suspension or cancellation of regislration;
5[(e) to take appropriate legal action against tht- us€ of any sex selection
technique by any persbir af any place, suo motu or brought to its notice and also to
initiate independent investigations in such matter;
(fl to create ptrblic awareness against the practice of sex selection or Pre-
natal determination of sex;
Q.) to supervise the implementation of the provisions of the
Act and rttlc's;
(ft) 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.]
(5) The Central Government or the State Government, as the case may be,
shall constitute an Advisory Committee for each Appropriate Authority to aid and
advise the Appropriate Authority in the discharge of its functions, and shall
appoint one of the members of the Advisory Committee to be its Chairman.
(5) The Advisory Committee shall consist of-
(n) three medical experts from amongst gynaecologists, obstetricians,
paediatricians and medical geneticists;
(b) one legal expert;
(c) one officer to represent the department dealing with information and
publicity of the State Government or the Union territory, as the case may be;
(d) three eminent social workers of whom not less than one shall be fron'r
amongst representatives of women's organisations.
'?6[(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 rnember of the Advisory Committee.l
25. Inserted b y Act 4 of 2003, S. 15 (w .e.f . 1 4-2-2003).
1,

26. Snbstituted by Act 14 of 2003, S. 15, for sub-S. (7) (w.e.f . 14-2-2003). Prior to its
substitutiorr, sub-S. (7) read as under:-"(7) No person who, ilr the opinion of the Central
Government or the State Government, as the case may be, has been associated with the use
or promotion of pre-natal diagnostic technique for determination of sex shall be appointc'd
as a member of the Advisory Committee."
14 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S. 17-A
(PROHTBITION OF SEX SELECTION) ACT,1994

(8)The Advisory Committee may meet as and when it thinks fit or on the
request of the Appropriate Authority for consideration of any application Jor
registration or any complaint for suspension or cancellation of registration and to
give advice thereon:
Provided that tl're period intervening between any two meetings shali not
exceed the prescribed period.
(9) The terms and conditions subject to which a person may be appointed to
the Advisory Committee and the procedure to be followed- by- such Comrnittee in
the discharge of its functions shall be such as may be prescribed.
27[L7-A. Powers of Appropriate Authorities'-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 the indulging in sex
selection tecluriques or pre-natal sex determination; and
(d) any other matter which may be prescribed.]
CHAPTERVI
REGISTRATION OF GENENC COLTNSELLING CENTRES, GENETIC
LABORATORIES AND GENETIC CLINICS
18. Registration of Genetic Counselling Centres, Genetic Laboratories or
Genetic Clinics.-8[(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 strch centre,
laboratory or clinic is duly registered under the Act.l
(2) Every application for registration under sub-section (1), shall be made to
the Appropriate Authority in such form and in such maruler and shall be
accompanied by such fees as may be prescribed.
(3) Every Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic
engaged, either partly or exclusively, in counselling or conducting pre-natal
diagnostic techniques for any of the purposes mentioned in section 4 immediately
before the commencement of this Act, shall apply for registration witl'rin sixty d.ays
from the date of such commencement.
(4) Subject to the provisions of seclion 6 every Genetic Cotrnselling Centre,
Genetic Laboratory or Genetic Clinic engaged in counselling or conducting
pre-natal diagnostic techniques shall cease to conduct any such counselling or
technique on the expiry of six months from the date of commencement of this Act
27. lrrsertecl by Act 14 ol 2003,5. 1 6 (w "e. f . 74-2-2003\.
28.Substituted by Act 71 of 2003,5.77, for sub-S. (1) (w.e.f. 14-2-2003). Prior to its
substihrtion, sub-S. (1) read as rlnder:-"(1) No person shall open any Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic after the commencernent of this Act r.urless
such Centre, Laboratory or Clinic is duly registered separately or jointly under this Act."
s. 211 PRE-CONCEPTION AND PRE-NATAL DTAGNOSTIC TECHNTQUES 15
(PROHTBTTTON OF SEX SELECTTON) ACT, 1994

unless such Centre, Laboratory or Clinic has applied for registration and is so
registered separately or jointly or till sr.rch application is disposecl of, whichevel is
earlier.
(5) No Genetic Cotrnselling Centre, Genetic Laboratory or Genetic Clinic
shall be registered under this Act unless the Appropriate Authority is satisfied that
such Centre, Laboratory or Clinic is in a position to provide such facilities,
maintain such equipment and standards as may be prescribed.
19.Certificate of -registration.-(1)The Appropriate Authority shall, after
holding an inquiry ui-rd lfte. satisfying itself that the applicant has iomplied with
all the requirements of this Act and the rules made thereunder and having regard
to the advice of the Advisory Committee in this behalf, grant a certificate of
registration in the prescribed form jointly or separately to the Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic, as the case maybe.
(2) If , after the inquiry and after giving an opportunity of being heard to the
applicant and having regard to the advice of the Advisory Committee, the
Appropriate Authority is satisfied that the applicant has not complied with the
requirements of this Act or the rules, it shall, for reasons to be recorded in writing,
reject the application for registration.
(3) Every certificate of registration shall be renewed in such manner and after
such period and on payment of such fees as may be prescribed.
(a) The certificate of registration shall be displayed by the registered Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic iir a conspicuous place at
its place of business.
20. Cancellation or suspension of registration.-(1) The Appropriate
Authority may suo motu, or on complaint, issue a notice to the Genetic Cbirnselling
Centre, Genetic Laboratory or Genetic Clinic to show cause why its registratioir
should notbe suspended or cancelled for the reasons mentioned in the notice.

- (2) If, after


Counselling
giving a reasonable opportunity of being heard to the Genetic
Cenke, Genetic Laboratory or Genetic Clinic and having regard to the
advice of the Advisory Committee, the Appropriate Authority is satisfied that
there has been a breachof the provisions of irus act or the rules, it may, without
qlejudice to any criminal action that it may take against such Centre, Laboratory or
Clinic, suspend- its registration for such period as it may think fit or cancei its
registration, as the case maybe.
(3) Notwithstanding anything contalned in sub-sections (1) and (2), if the
{Ppropriate Authority is of the opinion that it is necessary or expedient so to do in
the public interest, it may, for reasons to be recorded-in writing, suspend the
re-gistration of any Genetic Counselling Centre, Genetic Laboratory oi Genetic
Clinic without issuing any such notice referred to in sub-section (1).
Appeal,-jhg cenetic Counselling Centre, Genetic Laboratory or Genetic
^..21.
Clinic-may, within thirty days from the date of receipt of the order of suspension or
cancellation of registration passed by the Appropriate Authority under iection 20,
prefer an appeal against such order to-
_ (l) the Central Government, where the appeal is against the order of the
Central Appropriate Authority; and
(il) the state Government, where the appeal is against the order of the state
Appropriate Authority,
in the prescribed manner.
16 PRE-CONCEPTTON AND PI{E-NATAL DIAGNOSTIC TECHNIQUES [5.22
(PROHIBITTON OF SEX SEI ECTION) 4CT,1994

CHAPTERVII
OFFENCESAND PENALTIES
2'q[22. Prohibition of advertisement relating to pre-conception and pre-natal

determination of sex and punishment for contravention.-(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
9f sex of foetus or sex selection shall issue, publish, distribute, cotnmttnicate or
carrse to be issued, published, distributed or communicated any advertisement, in
any form, includinf 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 includir-rg Genetic Counselling Ceutre, Genetic
Laboratory or GeneLic Clinic shall issue, publish, distribute, communicate or caLrse
to be issued, published, distributed or communicated any advertisement in any
maruter 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 sttb-
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.
Explanntion.-For the purposes of this section, "advertisement" includes any
notice, circular, label, wrapper or other document including advertisement
through internet or any other media in electronic or print form and also incltrdes
any visible representation made by means of any hoarding, wall-painting, signal,
light, sound, smoke or gas.]
23.Offences and penalties.-(1)Any medical geneticist, gynaecologist,
registered medical praclitioner or any person who owns a Genetic Counselling
Centre, a Genetic Laboratory or a Cenetic Clinic or is employed in such a Centre,
Laboratory or Clinic and renders his professional or technical services to or at such
a Centre, Laboratory or Clinic, whether on an honorary basis or otherwise, and
who contravenes any of the provisions of this Act or rules made thereunder shall
be punishable with imprisonment for a. term which may extend to three years and
with fine which may extend to ten fhousand rupees and on any subsequent
29.Substituted by Act 14 of 2003, S.18, for 5.22 (w.e.f. 14-2-2003). Prior to its
srrbstitution, 5.22 read as under'-/22. Prohibitiort of ndzrertisenrcrrt relnting to pre-nntal
determinatiott of sex and purislunent for contrauertio,l.-(1) No person, organisation, Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic shall issue or cause to be issued
any advertisement in any mamer regarding facilities of the pre-natal determination of sex
available at such Centre, Laboratory, Clinic or any other place.
(2) No person or organisation shall publish or distribute or cause to be pr.rblished or
distributed any advertisement in any manner regarding facilities of pre-natal determination
of sex available at'any Genetic Counseliing Centre, Genetic Laboratory or Genetic Clinic or
any other place.
(3) Any person who contrarvenes the 1'rrovisions of sub-section (L) or sub-section (2)
shall be punishable with imprisonment for a terrn which may extend to three years and with
fine ra,hich may extend to ten thousand rupees.
Explnnntiotr.-For the pLlrposes of this section, "advertisement" includes any notice,
circular, label wrapper or other document and also includes any visible representation
made by means of any light, sound, smoke or gas."
5.241 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 17
(PROHIBITION OF SEX SELECTION) ACT,'1994

conviction, with imprisonment which may extend to five years and with fine
which may extend to fifty thousand rupees.
s[(2) The name of the registered medical practitioner shall be reported by the
Appropriate Authority to ihe State Medical Council concernecl for -taking
r,""Lsi.y action including suspension of the regishation if the charges are framed
by the Cburt and till the iase is disposed of and on conviction for removal of his
nime from the register of the Couniil 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, Ge'netic
Laboratory,-Genetic Clinic or ultrasound clinic or imaging clinic or of a medical
geneticist, gynaecologist, sonologist or imaging specialist or registered medical
practitionei or any other person for sex selection or for conduc-ting-pre-r'ratal
diagnostic techniques on any pregnant women for the PlrPoses other than those
speiified in sub-settion (2) o'f section 4, he shall, be punishable with irnprisonment
for a term which may extend to three years and with fine which may extend to fifty
thousand rupees f6r 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 mpees.
(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.l
3r[24. Presumption in the case of conduct of pre-natal diagnostic
techniques.-Notwithstanding anything contained in the Indian Evidence Act,
1872 (1, of 1872), the Court shall presume unless the contrary is proved that the
pregnant woman was compelled by her husband or any other relafive, 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 thatsection.l
30. Substituted by Act of 2003, S. 19, for sub-Ss. (2) and (3) (w.e.f. 14-2-2003). Prior tc
1,4
their substitution, sub-Ss. (2) and (3) read as under:-"(2) The name of the registered
medical practitioner who has been convicted by the Court under sub-section (1), shall be
reported by the Appropriate Authority to the respective State Medical Council for taking
necessary action including tl're removal of his name from the register of the Council for a
period of lwo years for the first offence and permanently for the subsequent offence.
(3) Any person who seeks the aid of a Genetic Counselling Centre, Genetic Labora tory
or Genetic Clinic or of a medical geneticist, gynaecologist or registered medical practitioner
for conducting pre-natal diagnostic techniques on any pregnant woman (including such
woman r.rnless she was compelled to undergo such diagnostic techniques) for purposes
other than those specified in clause (2) of section 4, shall be punishable with irnprisonment
for a term which may extend to three years and with fine which may extend to ten thotrsand
rupees and on any snbsequent conviction with imprisonment which rnay extend to five
years and with fine which may extend to fifty thousand rupees."
3l.Substituted by Act t4 of 2003, S.20, for 5.24 (w.e.f. 1.4-2-2003). Prior to its
substitution, S . 24 reid as under:-"2 4. Prexnnption in tlrc case of conduct of pre-natal diagnostig
'teclmiques.-Notwithstanding anything in the Indian Evidence Act, 1872 (1 of 1872), the
Court shall presume unless the contrary is proved that the pregnant womall has been
compelled by her husband or the relative to undergo pre-natal diagnostic technique and
sucli person shall be liable for abetment of offence under snb-section (3) of section 23 and
shall be punishable for the offence specified under that section."
18 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S. 25
(PROHIBITION OF SEX SELECTION) ACT,1994

25. Penalty for contravention of the provisions of the Act or rules for which no
specific punishment is provided.-Whoever contravenes any of the provisions of
this Act br any rules made thereunder, for which no penalty has been elsewhere
provided in this Act, shall be punishable with imprisonment for a term which may
extend to three months or with fine, which may extend to one thousand ruPees or
with both and in the case of continuing contravention with an additional fine
which may extend to five hundred ruPees for every day during which such
contraveniion continues after conviction for the first such contravention.
25. Offences by companies.-(1) \A/here any offence, punishable under this Act
has been commitfed by a company/ every Person who, at the time the offence was
committed was in chaige of, ind was responsible to, the company fol the conduct
of the business of the iompany, as well as the comPany, shall be deemed to be
guilty of the offence and dhali be liable to be proc6ed6d against and punished
accordingly:
Provided that nothing contained in this sub-section shall render any such
person liable to any punishment, if 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.
(2) Notwithstanding anything contained in sub-section (1), where any
offence punishable under this Act has been committed by a company and it is
proved fhat the offence has been committed with the consent or corurivance of, or
is attributable to any neglect on the part of, any director/ manager, secretary or
other officer of the tompany, such director/ manager, secretary or other officer
shall also be deemed to be guilty of that offence and shall be liable to be proceeded
against and punished accordingly.
Explanation.-For the purposes of this section,-
(a) "company" means any body corporate and includes a firm or other
assqcilrtion of individuals, and
(b) "director," in relation to a firm means a parbrer in the firm.
27, Offence to be cogni zable, non-bailable and non-compoundable.-Every
offence under this Act shallbe cognizable, non-bailable and non-comPoundable.
28. Cognizance of offences.-(1) No Court shall take cognizance of an offence
under this Actexcepton a complaint madeby-
(a) the Appropriate Authority concemed, or any officer authorised in this
behalf by the Central Government or State Government, as the case may be, or the
Appropriate Authority; or
(b) a person who has given notice of not less than s2[fifteen days] in the
manner prescribed, to the Appropriate Authority, oI the alleged offence and of his
intention to make a complaint to the Court.
Explanation.-For the purpose of this clause, "person" includes a social
organisation
(2) No Court other than that of a Metropolitan Magistrate or a judicial
Magistrate of the first class shall try any offence punishable under this Act.
32, Substituted by Act 1.4 of 2003, S. 27, for "ttirty days" (w.e.f. 14-2-2003).
S.31] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 1'9
(PROHIBITION OF SEX SELECTION) fuCT,7994
(3) Where a complaint has been made under clause (D) of sub-section (1), the
Court may, on dernand by such person, direct the Appropriate Authority to make
available iopies of the relevant records in its possession to such person.
CHAPTERVIiI
MISCELLANEOUS
29. Maintenance of records.-(1) All records, charts, forms, reports, consent
letters and all other documents required to be maintained under this Act and the
rules shall be preserved for a period of two years or for such period as may be
prescribed:
Provided that, if any criminal or other proceedings are instituted against any
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, the records and
all other documents of such Centre, Laboratory or Clinic shall be preserved till the
final disposal of such proceedings.
(2) An such records shall, at all reasonable times, be made available for
inspection to the Appropriate Authority or to any other person authorised by the
Appropriate Authority in this behalf.
30. Power to search and seize records, etc.-33[(1) If the Appropriate Authority
has reason to believe that an offence under this Act has been or is being cornmitted
at any Genetic Counselling Centre, Genetic Laboratory, GeneticClinic 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 und'er this Act.]
(2) The provisions of the Code of Criminal Procedure, \973 (2 of 7974)
relating to searches and seizures shall, so far as may be, apply to Bvery search or
seizure made under this Act.
31. Protection of action taken in good faith.-No suit, prosecution or other
legal proceeding shall lie against the Central or the State Government or the
Appropriate Auihority or any officer authorised by the Central or State
Government, or by the Authority for anything which is in good faith done or
intended to be done in pursuance of the provisioris of this Act.
33.Substituted by Act 14 of 2003,5.22, for sub-S.(1) (w.e.l. 14-2-2003). Prior to its
substitution, sub-S. (1) read as under:-"(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 or Genetic Clinic, such Arlthority or any officer
authorised thereof in this behalf rnay, subject to such rules as may be prescribed, enter and
search at all reasona.ble times with such assistance, if any, as such authority or officer
considers necessary, such Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic
and examine any record, regibter, docnment, book, pamphlet, advertisen'rent or any other
rnaterial object found therein and seize 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 "
20 PRE.CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [S. 3t-r
(PROHIBITION OF SEX SELECTION) ACT,1994
34[31-,{. Removal of difficulties.-(1) If any difficulty arises in giving effect r.
the provisions of the Pre-natal Diagnostic Techniques (Regulation and Preventio:
of Mistrse) Amendment Act,2002, the Cenhal Govemmentmay, by order publishec
in the Official Cazette, make such provisions not inconsistent with the provisioru
of the said Act as appear to it tobe necessary orexpedientfor removing the difficulty:
Provided that no order shall be made under this section after the expiry of r
period of three years from the date of commencement of the Pre-natal Diaghostic
Techniques (Regulation and Prevention of Misuse) Amendment Act,2002.
(2) Every order made under this section shall be laid, as soon as may be afte
it is made, before each House of Parliament.]
32. Power to make rules.-(l) The Central Government may make rules fs
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-
3s[(i)
the minimum qualifications for persons employed at a registered
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic under clause (2)
of section3;
(la) 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;l
(ll) the form in which consent of a pregnant woman has to be obtained
under section 5i
(lil) the procedure to be followed by the members of the Central
Supervisory Board in the discharge of their functions under sub-section (4) of
section 8;
(io) allowances for members other than ex officio members admissible
under sub-section (5) of section 9;
361(iua) code of conduct to be observed by
persons working at Genetic
Counselling Cenkes, Genetic Laboratories and Genetic Clinics to be laid down by
the Cenhal Sgpervisory Board under clause (iu) of section 16;
(lub) the manner in which reports shall be furnished by the State and
Union territory Supervisory Boards to the Board and the Central Covernment in
respect of various activities undertaken in the State under the Act under clause (ia)
of sub-section (1) of section 16-4;
(ioc) empowering the Appropriate Authority in any other matter under
clause (d) of section 17-A;1
(o) the period intervening between any two meetings of the Advisory
Committee under the proviso to sub-section (B) of section 17;
34. Inserted by Act 14 of 2003, S. 23 (w.e.f .14-2-2003).
35.Substituted by Act 14 of 2003, 5.24, for Cl. (l) (w.e.f, 14-2-2003). Prior to its
substihrtion, Cl. (l) read as under:-"(i) the minimum qualifications for persons employed
at a registered Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic under
clause (1) of section 3;".
36. Inserted by Act1,4 of 2003,5.24 (w.e.f .14-2-2003).
s. 341 I'RE-CONCEPTTON'AND PRE-NATAL DTAGNOSTTC TECHNIQUES 27
(PROHIBTTION OF SEX SELECTTON) ACT,1.994

(al) the terms and conditions subject to which a person may be appointecl
to the Advisory Committee and the procedrrre to be followed by such Committee
under sub-section (9) of section 17;
(aii) the form and manner in which an application shall be made for
registration and the fee payable thereof under sub-section (2) of section 18;
(aiii) the facilities to be provided, equipment and other standards to be
maintained by the Genetic Counselling Centre, Genetic Laboratory'or Genetic
Clinic under sub-section (5) of section 18;
(lr) the form in whicll a certificate of registration shall be issued under
sub-section (1) of section 19;
(r) the manner in which and the period after which a certificate of
registration shall be renewed and the fee payable for such renewal under sub-
section (3) of section 19;
(ri) the manner in which an appeal may be preferred under section 21;
(xli)_the period up-to which records, charts, etc., shall be preserved under
.
sub-section (1) of section 29;
(xiii) tr'rc manner in which the seizure of documents, records, objects, etc.,
shall be made and the manner in which seizure list shall be prepared and clelivered
to the person from whose custody such documents, recordi oiobjects were seized
under sub-section (1) of section 30;
(rio) any other matter that is required to be, or may be, prescribed.
33. Power to make regulations.-The Board may, with the previous sanction of
the Central Government, by notificatign in the Official Gazett'e, make regulabions
not inconsistent with the provisions of this Act and the rules made there"under to
provide for-
(a) the time and place of the meerings of the Board and the procedure to be
followed for the traniaction of businesiat such meefings and^the number of
members which shall form the quorum under sub-section (1") of section 9;
(b) the manner in which a person may be temporarily associated with the
Board under sub-section (1) of section 11;
(c) the method of appointment,_the conditions of service and the scales of
pay
and allowances of the officer and other employees of the Board appointed
section 1 2; ""i&
(d) generally for the efficient conduct of ihe affairs of the Board.
34. Rules and regulations to be laid before Parliament.-Every rule and everv
regulation made under this Act siull be laid as soon as may be'after it is madJ,
before each House of Parliament, while it is in session, for altotal period rf inirti
days which may be comprised in one session or in two or more successive session"i,
and if, before the expiry of.lh9 session imrnediately foilowing the session or the
successive sessions aforesaid, both Houses agree in making iny modification in
the rule or_regulation or both Houses agree tliat the rule or ?egiation shouid not
be made, the rule or regulation shall tGreafter have effect or,iv ir, such modified
form or be of no effect as the case may be; so, however, that any'such modification
or arurulment shall be withou.t prejudice to rhe validity of ahything p."rio,.rsly
done under that rule or regulatioir. '
THE PRE.CONCEPTION AND PRE.NATAL
DIAGNOSTIC TECHNIQUES (PROHIBITION
OF SEX SELECTION) RULES, 1996
In exercise of the powers conferred by section 32 of the Pre-natal Diagnostic
Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994)2, the
Central Government hereby makes the following rules, namely:-
1. Short title and comtnencement.-(1) These rules may be called 3[Tue Pne-
coNcEprroN axo PRs-r{eral Dracuosrrc TrcsNreum (PnoHmtrroN oF Sox Sei,ecitorv)]
Rui-es, 1996.
(2) They shall come into force on the datea of their publication in the
Official Gazette.
2. Definitions.-In these rules, unless the context otherwise requires:-
(a) " Act" means The Pre-natal Diagnostic Techniques (Regulation and
Prevention of Misuse) Act,1994 (57 of 1994)2;
(D) "employee" means a person working in or employed by a Genetic
Counselling Centre, a Genetic Laboratory or a Genetic Clinic or an Ultra Sound
Clinic or Imaging Centre, and includes those working on part-time,
contractual, consultancy, honorary or on any other basis;
(c) "Form" means a Form appended to these rules;
u[* * *]

(e) "section" means a section of the AcU


(r) words and expressions used herein and not defined in these rules but
defined in the Act, shall have the meanings, respectively, assigned to them in
the AcU
6[(9) "Mobile Medical Unit" means a mobile vehicle which provides
specialised facilities for the patients, requiring basic specialist services and
provides improved access to healthcare facilities and equitable distribution of
health services at the doorsteps, across the country, especially in the
underserved areas,'
(.&) "Mobile Genetic Clinic" means a mobile medical unit where
ultrasound machine or imaging machine or scanner or other equipment
capable of deiermining 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.]
3. Minimum requirements.-3[The qualifications of the employees, the
requirement of equipment etc., for a Genetic Counselling Centre, Genetic
1. Published in the Gazette of India, Ext., Pt. II, S. 3(.r), dated 7-l-1996.
2. Now see the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex
Selection) Ac|1994.
3. Subsrituted by G.S.R. 109(E), dated 74-2-2003(w.e.f .14-2-2003).
4.1-1-1996
5. Cl. (d) omitteC by G.S.R. 109(E), dated1,4-2-?fr03 (w.e.f. L4-2-2OB). Prior to its omission
Cl. (a) read as under:-"(a) "Schedule" means a schedule appended to these rules;"
6. Lrserted by.G.S.R. 80(E), dated 7 -2-201,2 (w.e.f . 9 2.-2012).
R.3] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 23
(pRoHIBrTrON OF SEX SELECTTON) RULES, 1996
Laboratory, cenetic Clinic, Ultrasound Clinic and Imaging Centre shall be as
under:-
(1) Any person being or employing
(z) a gynaecologist or a paediatrician having six months experience or
four weeks training in genetic counselling, or
(il a medical geneticists,
having adequate space and educational charts/models/equipments for
carrying out genetic counselling may set up a genetic counsellinf center and
get it registered as a genetic counselling center.
(2)(a) Any person having adequate space and being or employing
(r) a Medical Geneticist and
(rz) a -laboratory techniciary having a B.Sc. degree in Biological
Sciences or a degree or diploma in medical laboratory course with at leasione
year experience in conducting appropriate pre-natal diagnostic techniques,
tests or procedures,
may set up a genetic laboratory.
(6) Such laboratory should have or acquire such of the following
equipments as may be necessary for carrying out chromosomal studies, bio--
chemical studies and molecular studies:-
(z) Chromosomal studies:
(1) Laminar flow hood with ultraviolet and fluorescent light or
-
other suitable culture hood.
(2) Photo-microscope with fluorescent source of light.
(3)Inverted microscope.
(4) Incubator and oven.
(5) Carbon dioxide incubator or closed system with 5% CO,
atmosphere.
(6) Autoclave.
(7) Refrigerator.
(8) Water bath.
(9) Centrifuge.
(10) Vortex mixer.
(11) Magnetic stirrer.
(12) pH Meter.
(13) A sensitive balance (preferably electronic) with sensitivity of
0.1 milligram.
(14) Double distillation app_aratus (glass).
(15) Such other equipments as may be necessary.
(rr) Biochemical studies:
(requirements according to tests to be carried out)
24 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES lR.3
(PROHIBIflON OF SEX SELECTION) RULES, 1996
(1) Laminar flow hood with ultraviolet and fluorescent light
other suitable culture hood.
(2)Inverted microscope.
(3) Incubator and oven.
(4) Carbon dioxide incubator or closed system with 5% CQ
atrnosphere.
(5) Autoclave.
(6) Refrigerator.
(7) Water bath.
(8) Centrifuge.
(9) Electrophoresis apparatus and power supply.
ChromatograPhY chamber.
('10)

fttr)€pectro,photometer and Elisa reader or Radio--immunoassay


system (with'gamma betaiounter) or fluorometer for various biochemical tests.
(12) Vortex mixer.
(13) Magnetic stirrer.
(1a) pH meter.
(15) A sensitive balance (preferably electronic) with sensitivity of
0.1 milligram.
(16) Double distillation aPParatus (glass).
(17) Liquid nitrogen tank.
(18) Such other equipments as may be necessary.
(ir.r) Molecular studies:
(1) Inverted microscoPe
(2) Incubator.
(3) Oven.
(4) Autoclave.
(5) Refrigerators (4 degree and minus 20 degree Centigrade).
(6) Water bath.
(7) Microcentrifuge.
(8) Electrophoresis apparatus and power supply.
(9) Vertex mixer.
(10) Magnetic stirrer.
(11) pH. meter.
(12) A sensitive balance (preferably electronic) with sensitivity of

(13) Double distillation apparitus (glass).


(14) P.C.R. machine.
(15) Refrigerated centrifuge.
R.3-AI PRE-CONCEPTTON AND PRE-NATAL DTAGNOSTTC TECHNTQUES 2s
(PROHIBITION OF SEX SELECTION) RULES, 1996
(16) U.V. Illuminator with photographic attachment or other
documentation system
(17) Precision micropipettes.
(18) Such other equipments as may be necessary. -
(3)(1) Any person having adequate space and being or employing
(a)_Gynaecologist having experience of performing at leaqt 20
procedures in chorionic villi aspirations per vagina or per abdorien, chorionic
villi biopsy. amniocentesis, cordocentesis foetoscopy, foetal skin or organ
biopsy or foetal blood sarnpling, etc., under supeivision of an experienied

u'Ub) a sonologist or imTging specialist or registered


medical
practitioner having Post Graduate degiee or diploma or six months training
duly im-pTted in the manner pres(iibed in the "the pre-conception and
Pre-natal Diagnostic Techniques (Prohibition of sex selection) (six Months
Training) Rules, 2074; or)
(c) A medical geneticist
may set up a genetic clinic/ultrasound clinic/imaging centre.
(2) The Genetic Clinic/ultrasound clinic/imaging centre should have or
acquire such of the following equipments, as may be necessary for carrying out
the tests or procedures-
(a) Equipment and accessories necessary for carrying out clinical
examination by an obstetrician or gynaecologist.
(b) An ultra-sonography machine including mobile ultrasound
mach.ine, imaging machine or any other equipment capable of conducting
foetal ultrasonography
(c) Appropriate catheters and equipment for carrying out chorionic
villi aspirations per vagina or per abdomen.
(a) Appropriate sterile needles for amniocentesis or cordocentesis.
(e) A suitable foetoscope with appropriate accessories for foetoscopy,
foetal skin or org?n biopsy or foetal blood iampling shall be optional
(/) Equipment for dry and wet sterilization.
(g') Equipment for carrying out emergency procedures such as
evacuation of uterus or resuscitation in case of need.
(1r) Genetic Works Station.l
?[(3) Each medical practitioner
qualified under the Act to conduct
ultrasonography in a genetic clinic/ultrasound clinic/imaging centre shall be
permitted to be registered with a maximum of two such clinici/centres within a
district. The Consulting hours for such medical practitioner, shall be clearly
specified by each clinic/centre.l
7'[3-A. Sale of ultrasound machines/imaging
machines.-(1) No
organization including a commercial ,organization or a person, including:
6a. Substituted by G.S.R. 13(E), dated 9-L-2074 (w.e.f. 10-1-2014).
7. Inserted by G.S.R. 41 8 (E), dated 4-5201.2 (w .e.f . 5 -G2012).
7a. Inserted by G. S. R. 109(E), dated I 4-2-2003 (w .e.f . 1 4l2-2Cf,r3).
26 PRE-CONCEPTION AND PRE.NATAL DIAGNOSTIC TECHNIQUES [R.3.t
(PROHIBmON OF SEX SELECTION) RULES, 1996
manufacturer, importer, dealer or supplier of ultrasound machines/ima_ging
machines or any 6ther equipment, capable of detecting sex of foetus, shall sel
distribute, supply, rent, allow or authorize the use of any such machine or
equipment in iny manner, whether on Payment or o-therwisg, to any- G91etk
C6unselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic
imaging Centre or any other body or person unless such Centre, Laboraton
Clinic, body or person is registered under the Act.
(2) The provider of such machine/equipment to aly_ person/body
registered under the Act shall send to the concerned State/UT {PPropriac
Arlthority and to the Central Govemmen! once in three months a list of thost
to whom the machine/equipment has been provided'
(3) Any organization or Person, including manufacturer, importer,_dealer
or supplier'of ultrasound machines/imaging machines or any.other equipmert
capabli: of detecting sex of foetus selling, distributing, supplying (r
authorizing, in any manner, the use of any such machine or equipment to any
Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound
Clinic, Imaging Centre or any other body or Person registered under the Act
-
shall thke an affidavit from the Genetic Counselling Centre, Geneti
Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre or any othe
body or person purchasing or getting authorization for using,such machi
equipment that the machine/equipment shall not be used for detection of
of foetus or selection of sex before or after conception.]
s[3-B. Regulation of portable machines.-(1) The rlse of portable ultrasou
maihine orlny other portable machine or device which has the potential.
selection of sei before ionception or detection of sex during pregnancy shall
permitted only in the following conditions, namely:-
(a) the portable machine being used, within the premises it
registered, for providing services to the indoor patientsi
(b) as part of a mobile medical unit, offering a bouquet of other
and medical services.
Explanation -For the purpose of this sub-rule, the expression "other
and hedical services" means the host of services provided by the mobi
medical unit which may include the following, namely:-
(r) Curative
(a) Referral of complicated cases;
(b) Early detection of TB, Malaria, Leprosy, Kala-Azar and other loc
endemic communicable diseases and non-communicable diseases such
hypertension diabetes, cataract cases, etc.;
(c) Minor surgical procedures and suturing;
(dl specialist services such as o and G specialist, Paediatrician
Physician.
(z) Reproductive and Child Health Services
(a) Ante natal check up and related services;
(D) Referral or complicated pregnancies;
8. Inserted by G. S.R. 80 (E), d ate d 7 -2-2012 (w'e. f . 9 -2-2072).
R.4] PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES 27
(PROHTBTTTON OF SEX SELECTTON) RULES,19e6

(c) Proinotibn of institutional deliveries;


(d) Post-natal check up;
(e) Immunization clinics;
(fl Treatment of common childhood illness;
(g) Treatment of reproductive tract infection or sexually transmitted
lnfectionsi
(h) Adolescents care such as lifestyle educatiory counselling, treatment of
minor ailments.
(lii) Family planning services
(a) Counselling for spacing and permanentmethod;
(b) Distribution of contraceptives.
(io) Diagnostic
(a) Lrvestigation facilities like haemoglobin, urine examination;
(b) Clinical detection of leprosy tuberculosis or endemic diseases;
(c) Screning of cancer, etc.
(a) Specialised facilities and services
(a)X-ray;
(b)ECG;
(c) Llltrasound test.
(ar) Emergency services and care in times of disaster or epidemic or public
health emergency or accidents, etc.
(2) Regulation of seraices to be offered by Mobile Genetic Clinic.-(a) A Mobile
Genetic Clinic shall operate and offer pre-natal diagnostic techniques, only as
part of a Mobile Medical Unit offering a bouquet of other health and medical
services, in urban slums or rural or remote or hilly or hard to reach areas for
improved access to health care services by underserved populations.
(b) The machine under no circumstances shall be used for sex
determination of the foetus.
(c) The stand alone mobile ultrasound clinic offering only pre-natal
diagnostic facilities are prohibited.
(d) The mobile medical unit offering diagnostic services shall have
adequate space for providing the facilities to patients.l
4. Registration of e[Genetic Counselling Centre, Genetic Laboratory, Genetic
Clinic, Ultrasound Clinic and Imaging Centresl.-'[(1) An application for
registration shall be made to the Appropriate Authority, in duplicate, in Form A,
duly accompanied by an Affidavit containing-
(l) an undertaking to the effect that the Genetic Centre/Laboratory/Clinic/
lJltrasound Clinic/Imaging Centre/Combination thereof, as the case may be, shall
not conduct any test or procedure, by whatever name called, for selection of sex
before or after conception or for detection of sex of foetus except for diseases
specified in section 4(2) nor shall the sex of foetus be disclosed to any body; and
(ll) an undertaking to the effect that the Genetic Centre/Laborctoryl
Clinic/Combination thereof, as the case may be, shall display prominently a
9. Substituted by G.S.R. 109(E), dated14-2-2003 (w.e.f. 14-2-2003).
28 PRE-CONCEPTIONANDPRE.NATALDIAGNOSTICTECHNIQUES [R. 5
(PROHTBTTTON OF SEX SELECTTON) RLILES, 1996

notice that they do not conduct any technique, test or procedure, etc., bv
whatever name called, for detection of sex of foetus or for selection of sex before or
after conception;]
10[(lii) the registrdtion of a genetic clinic shall also include the registration
of each and every mobile genetic clinic offering pre-natal diagnostic facilities as
part of a medical mobile unit and such a vehicle has to be registered as a mobile
genefic unit.l
(2) The Appropriate Authority, or any person in his office authorised in this
behali shall acknowledge receipt of the application for registration, in the
acknowledgement slip providelt, at the bottom of Form A, immediately if
delivered at the office of the Appropriate Authority, or not later than the next
working day if received by post.
10"[5. Application fee.-(1) Every application for registration under rule 4 shall
be accompanied by an application fee of:
-
(a) lob[Rupees twenty five thousand] for Genetic Counselling Centre,
Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre.
(b) 1ob[Rupees thirty five thousand] for an institute, hospital, nursing
home, or any place providing jointly the service of a Genetic Counselling Centre,
Genetic Laboratory and Genetic Clinic, Ultrasound Clinic or Imaging Centre or
any combination thereof:
Provided that if an application for registration of any Genetic Clinic/
Laboratory/Centre, etc., has rejected by the Appropriate Authority, no fee shall
be required to be paid on re-submission of the application by the applicant for the
same body within 90 days of rejection. Provided further that any subsequent
application shall be accompanied with the prescribed fee. Application fee once
paid will notbe refunded:
lo'[Provided further that no govemment institution which provides health
and medical services shall be required to pay fee for registration and renewal of
registration.l
(2) The application fee shall be paid by a demand draft drawn in favour of
the Appropriate Authority, on any scheduled bank payable at the headquarters
of the Appropriate Authority concerned 10d[or by electronic mode]. The fees
collected by the Appropriate Authorities for registration of Genetic Counselling
Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging
Centre or any other body or person under sub-rule (1), shall be deposited by the
Appropriate Authority concerned in a bank account opened in the name of the
official designation of the Appropriate Authority concemed and shall be utilized
by the Appropriate Authority in connection with the activities connected with
implementation of the provisions of the Act and these rules.]
6. Certificate of registration.-(1) The Appropriate Authority shall, after
making such enquiry and after satisfying itself that the applicant has complied
with all the requirements, place the application before the Advisory Comrnittee
for its advice.
10. Inserted by G.S.R. 80(E), dated 7-2-201.2 (w.e.f.7-2-2012).
10a. Substituted by G.S.R. 109(E), dated1.4-2-2003 (w.e.f. 14-2-2003).
10b. Substituted by G.S.R. 418(E), dated 4-6-20'1.2 (w.e.f .5-6-20t2).
10c. Inserted by G.S.R. 599(E), dated.19-6-2017 (w.e.f .1,9-6-2017).
L0d. Irrserted by G.S.R. 345(E), dated 31-3-2021, (w.e.t.25-5-2021).
R.6] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 29
(PROHTBTTTON OF SEX SELECTTON) RULES, 1996

(2) Flaving regard to the advice of the Advisory Committee the


Appropriate Authority shall grant a certificate of registration, in dupiicate, in
Form B to the applicant. One copy of the certificate of registration shall be
displayed by the registered Genetic Counselling Centre, Genetic Laboratory or
Genetic Clinic, Ultra Sound Clinic or Imaging Centre at a conspicuous place at
its place of business:
Provided that the Appropriate Authority may grant a certificAte of
registration to a Cenetic Laboratory or a Genetic Clinic to conduct one or more
specified pre-natal diagnostic tests or procedures, depending on the
availability of place, equipment and qualified employees, and standards
maintained by such laboratory or clinic.
11[(2-A)(a) One copy of the certificate of registration shall:be displayed
bv
the registered mobile medical unit inside the vehicle at a conspicuous place.
(b) The certificate of registration for such unit, shall clearly specify the
following:-
(r) the area of its operatiory which shall not exceed the district wherein
it is registered;
(it the number of portable machines installed and being used in the
vehicle;
(lrz) the make and model number of the portable machine;
registration number of the vehicle;
(rrz) the
full address of the service provider for the mobile medical unit.
( rr)

(2-B) The portable equipment used for conducting. pre-natal diagnostic


test shall be an integral part of the mobile medical unit and such equipment
shall not be used outside such unit under any circumstances.,
(2-C) In case of a brehkdown of the vehicle or for any other reason due to
whigh the registered unit cannot be used as a Genetic Clinig the Appropriate
Authority has to be informed within a period of seven days.l
(3) It after enquiry and after giving an opportunity of being heard to the
applicant and having regard to the advice of the Advisory Committee, the
Appropriate Authority is satisfied that the applicant has not complied with the
requirements of the Act and these rules, it shall, for the reasons to be recorded
in writing, reject the application for registration and communic4te such
rejection to the applicant as specified in Form C.
(4) An enquiry under sub-rule (1), including inspection at the premises of
the Genetic Counselling Centre, Geneijc Laboratory or Genetic Clinic, Ultra
sound Clinic or Imaging Centre shall, be carried out only after due notice is
given to the applicant by the Appropriate Authority.
(5) Grant of certificate of registration or rejection of application for
registration shall be communicated to the applicant as specified in Form B or
F.;rm C, as the case may be, rvithin a period of ninety days from the date of
receipt of application for registration.
(6) The certificate of registrJtion shall be non-transferable. In the event of
change of ownership or change of management or on ceasing to function as a
f i. fr,t
JO PRE-CONCEPTION AND PRE-NATr'.L DIAGNOSTIC TECHNIQUES [R.7
(PROHIBITION OF SEX SELECTION) RULES,.1996

Cerretic Counselling Centre, Genetic Laboratory or Genetic Clinic, Ultra


Sound Clinic or Imaging Centre both copies of the certificate of registration
shall be surrendered to the Appropriate Authority.
(7) In the event of change of ownership or change of management of the
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, Ultra
Sound Clinic or Imaging Centre the new owner or manager of such Centre,
,l.aboratory or Clinic shall apply afresh for grant of certificate of registration.
7. Validity of registration.-Every certificate of registration shall be valid for
a period of five years from the date of its issue.
8. Renewal of registration.-(1) An application for renewal of certificate of
registration shall be rhade in duplicate in Form A, to the Appropriate Authority
thirty days before the date of expiry of the certificatg of registration.
Acknowledgement of receipt of such application shall be issued by the
Appropriate Authority in the manner specified in sub-rule (2) of rule 4.
(2) The Appropriate Authority shall, after holding an enquiry and after
satisfying itself that the applicant has complied with all the requirements of
the Act and these rules and having regard to the advice of the advisory
Committee in this behall renew the certificate of registration, as specified in
Form B, for a further period of five years from the date of expiry of the
certificate of registration earlier granted.
' (5) tf, after enquiry and after giving an opportunity of being heard to the
applicant and having regard to the advice of the Advisory Committee, the
Appropriate Authority is satisfied that the applicant has not complied -with the
requirements of the Act and these rules, it shall, for reasons to be recorded in
writing, reject the application for renewal of certificate of registration and
communicate such rejection to the applicant as specified in Form C.
(4) The fees payable for renewal of certificate registraticn shall be one half
of the fees provided in sub-rule (1) of rule 5. \
(5) On receipt of the renewed certifica-te of registration in duplicate or on
receipt of communication or rejection of application for renewal, both copies
of the earlier certificate or registration shall be surrendered immediately to the
Appropriate Authority by the Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic, Ultra Sound Clinic or Imaging Centre.
(6) In the event of failure of the Appropiiate Authority to renew the
certificate of registration or to communicate rejection of application for
renewal of registration within a period of ninety days from the date of receipt
of application for renewal of registration, the certificate of registration shall be
aeem-ed to have been renewed.-
9" Maintenance and preservation of records. -r2[(1 ) Every Genetic
Counselling Centre, Ger-retic Laboratory, r3[Gendtic Clinic including a Mobile
C,enetic Clinic], Ultrasound Clinic and In-raging Centres shall rnaintain a rcgister
:;howing, in serial order, the names and addresses of the men or womc'n given
g;e.rretic counselling, subjected to pre-natal dipgnostic p-rocedures or pre-natal
diaSnostic tests, tire names of their spouse or fathg{ and the date on which they
first reported for such counselling, procedure or test. r

12: Substituted by G.S.R. 109(E), dated 14-2-2003 (w.e.f. 14'2r-2003).


13. Substif.rted by G.S.R. 80(E), dated 7-2-2012(w.e.t.7-2-2012).
R 101 PRE-CONCEPTTON AND PRE-NATAL DTAqNOSTTC TECHNTQUES 31
(PROHIBITION OF SEX SELECTTON) RULES, 1e96

(2) The record to be maintained by every Genetic Counselling Centre, in


respect of each woman counselled shall be as specified in Form D.
13'[(3)
The record to be maintained by every Genetic Laboratory, in
respect of
e,ach man or woman subjected to any pre-natal diagnostic
procedure/techniqueltest, shall be as specified in Form E.l-
1a[Genetic Clinie
""[(4) The record to be maintained by every including a
Mobile Genetic clinic], in respect of each man or woman subjected to any p"re-
natal diagnostic procedure/techniqueltest, shall be as specifieil in Form F.l '
(5) The Appropriate Authority shall maintain a permanent record of
-
applica_tio_ns for grant or renewal of certificate of registiation as specified in
Form H. Letters of intimation of every change of employee, place, address and
equipment installeC shall also be preserved a permanent records.
(6) All case-related records, forms of , consent, laboratory results,
microscopic pictures, sonographic plates or slides, recommendaiions and
letters shall be preserved by the Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic, Ultra Sound Clinic or Imaging Centre for a period
of two years from the date of completion of counselling, pre-natal diagnostic
procedure orpre-natal diagnostic test, as the case may 6e.-In the event-of any
legal proceedings,- the records shall be preserved till the final disposal of legal
proceedings, or till the expiry of the said period of two years, whichever is ht6r.
(7) ln case the Genetic Counselling Centre or Genetic Laboratory of
Genetic Clinic, Ultra sound Clinic or Imaging Centre maintains recordi on
co_mputer or other electronic equipment a printed copy of the record shall be
taken .and preserved after authentication by a person responsible for such
record"
Every Genetic Counselling Centre, Genetic Laboratory, Genetic
^. 'tt-(Q
Clinic, ultrasound Clinic and Imaging Centres shall send a complet-e report in
respect o.f all pre-conception or pregnancy related procedufes/techniques/
-
tests conducted by them in respect of each month by 5th day of the following
month to the concerned Appropriate Authority.l
10. Conditions for conducting pre-natal diagnostic procedures.-
'3'1111 Before conducting preimplantation genetic diagiosis, or any pre-natal
diagnostic technique/test/procedure such as amniocentesis, choiionic villi
biopsy, foetoscopy, foetal skin or organ biopsy or cordocentesis, a written
consent, as specified in Form G, in a language the person undergoing such
procedure understands, shall be obtained from her/him.]
't[(1-A) Any person conducting uitrasonography/image scanning on a
pregnant woman shall give a declaration on each report on ultrasonography/
image scanning that he/she has neither detected nor disclosed the sex of foetus
of the pregnant woman to any body. The pregnant woman shall before
undergoing ultrasonography/image scanning declare that she does not want to
know the sex of her foetus.l
13a. Substituted by G.S.R. 109(E), dated 14-2-2003 (w.e.f .1+2-2003).
14. Substituted by G.S.R.80(E), dated 7-2-2012(w.e.f .7-2-2012).
15. Inserted by G.S.R. 109(E). dated 14-2-2003 (w.e.f. 142-2003).
32 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [R. rr
(I'ROHIBITION OF SEX SELECTION) RULES, 1996

(2) All the State Governments and Union territories may issue translation
of Form G in languages used in the State or Union territory and where no
official translation in a language understood by the pregnant woman is
available, the Genetic Clinic may translate Form G into a language she
understands.
i6[11. Facilities for inspection.-(1) Every Genetic Counselling Centre,
Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre,
nursing home, hospital, institute or any other place where any of the machines
or equipments capable of performing any procedure, technique or test capable
of pre-natal determination of sex or selection of sex before or after conception
is used, shall afford all reasonable facilities for inspection of the placg
equipment and records to the Appropriate Authority or to any other person
authorised by the Appropriate Authority in this behalf for registration of such
institutions, by whatever name called, under the Act, or for detection of misuse
of such facilities or advertisement therefor or for selection of sex before or after
conception or for detection /disclosure of sex of foetus or for detection of cases
of violation of the provisions of the Act in any other manner.
1?[(2) The Appropriate Authority or the officer authorised by it may seal
and seize any ultrasound machine, scanner or any other equipment, capable of
detecting sex of foetus, used by any organisation, if the organisation has not got
itself registered under the Act. These machines of such organisations shall be
confiscated and further action shall be taken as per the provisions of section
23 of the Act.ll
12. Procedure for search and seizure.-'u[(1) The Appropriate Authority or
any officer authorised in this behalf may enter and search at all reasonable times
any Ger-retic Counselling Centre, Genetic Laboratory, Genetic Clinic, Imaging
Centre or Ultrasound Clinic in the presence of two or more independent
witnesses for the pamphlet, advertisement, or any other material object found
therein and seal and seize the same if there is reason to believe that it may
furnish evidence of commission of an offence punishable under the Act.
Explanation -In these rules-
(1)"Genetic Laboratory/Genetic Clinic/Genetic Counselling Centre"
would include an ultrasound centre/imaging centre/nursing home/hospital/
institute or any other place, by whatever name called, where any of the
machines or equipments capable of selection of sex before or after conception
or perforining any procedure technique or test for pre-natal detection of sex of
foetus, is used;
(2) "material'object" would include records, machines and equipments; and
(3) "seizd' and "seizure" would include "seal" and "sealing" respectively.]
(2) A list of any document, record, register, book, pamphlet,
advertisement or any other material object found in the Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic and seized shall be prepared in
duplicate at the place of effecting the seizure. Both copies of such list shall be
16. Substituted by G.S.R. 109(E), dated 14-2-2003 (w.e.f .142-2W3).
17^ Substituted by G.S.R. 426(E), dated3l-5-201i (w.e.f.31-5-2011).
R. 14] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES 33
(PROHTBTTTON OF SEX SELECTTON) RULES, 1e96

signed on every page by the appropriate authority or the officer authorised in


this behalf and by the witnesses to the seizure:
Provided that the list may be prepared, in the presence of the-witnesses, at a
place other than the place of seizure if, for reasons to be recorded in writing, it
is not practicable to make the list at the place of effecting the seizure.
(3) One copy of the list referred to in sub-rule (2) shall be handed over, under
acknowledgement to the person from whose custody the document, record, regrster;
book pamphlet advertisement or any other material object have been seized:
Provided that a copy of the list of such document, record, register, book,
pamphlet, advertisment or other material object seized may be delivered
under acknowledgement, or sent by registered post to the owner or manager of
the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, if no
person acknowledging- custody of the documeni record, register, book,
pamphlet, advertisement or other material object seized is available at the
place of effecting the seizure.
(4) If any material object seized is perishable in nature, the Appropriate
Authority, or the officer authorised in this behalf shall make arrangements
promptly for sealing, identification and preservation of the material object and
also convey it to a facility for analysis or test if analysis or test be required:
Provided that the refrigerator or other equipment used by the Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic for preserving'such
perishable material object may be sealed until such time as arrangenients can
be made for safe removal of such perishable material object and in such
eventuality, mention of keeping the material object seized, on the premises of
the Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall
be made in the list df seizure.
(5) In ihe case of non-completion of search and seizure operatibn, the
Appropriate Authority or the officer authorized in this behalf may make
arrangements, by way of mounting a guard or sealing of the premises of the
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, for safe
keeping, listing and removal of documents, records, book or any other material
object to be seized, and to prevent any tempering with such documeilts,
records, books or any other material object.
l3.Intimation of changes in employees, place or equipment.-Every
Cenetic Counselling Centre, Genetic Laboratory or Genetic Clinic shall
intimate every change of employee, place, address and equipment installed, to
the Appropriate Authority l7u[atleast thirty days in advance of the expected
date of such change, and seek re-issuance of certificate of registration from the
Appropriate Authority, with the changes duly incorporated.l
14. Conditions for analysis or test and pre-natal diagnostic procedures.-
(1) No Genetic Laboratory shall accept for analysis or test any sample, unless
referred to it by a Genetic Clinic.
(2) Every pre-natal diagnostic procedure shall invariably be immediately
preceded by locating the foetus and placenta through ultrasonography,
and the pre-natal diagnostic proeedure shall. be done under direit
1 7a. Substituted by G.S. R. 418 (E), dated 4 6-2012 (w .e.f . 5-G2012).
3{ PRE-CONCEP'TIONANDPRE-NA'I'ALDIAGNOSI'ICTECIINIQUES [R.15
(PROTIIBTTION OF SEX SELEC'rrON) nUr-ES, 1996

ultrasonographic monitoring so as to prevent any darnage to the foetus and


placenta.
15. Meetings of the advisory Committees.-'the intervening period
between any two meetings of Advisory Committees constituted under sub-
section (5) of section 17 to advise the Appropriate Authority shall not exceed
sixty days.
l6.Allowances to members of the Central Supervisory Bomd.-(1)The
ex officio members, and other Central and State Government officers
appointed to the Board will be entitled to Travelling allowance and Daily
Allowance for attending the meetings of the Board as per the Travelling
Allowances rules applicable to them.
(2) The non-official members appointed to, and Members of Parliament
elected to, the Board will be entitled to Travelling Allowance and Daily
Allowance for attending the meetings of the Board as admissible to non-
officials and Members of Parliament as the case may be, under the Travelling
Allowances rules of the Central Government.
17. Public Information.-(1) Every l8[Genetic Counselling Centre, Genetic
Laboratory, Genetic Clinic, Ultrasound Clinic and Inlaging Centresl shall
prominently display on its premises a notice in English and in the local
language or languages for the information of the public, to the effect that
disclosure of the sex of the foetus is prohibited under law.
(2) At least one copy each of the Act and these rules shall be available on
the prerhises of every 18[Genetic Counselling, Centre, Genetic Laboratory,
Genetic Clinic, Ultrasound Clinic and Imaging Centres], and shall be made
available to the clientele on demand for perusal.
(3) The Appropriate Authority, the Central Government, the State
Government, and the Government/Administration of the Union Territory may
publish periodically lists of registered l8[Genetic Counselling Centres, Genetic
Laboratories, Genetic Clinics, Ultrapound Clinic and Imaging Centresl and
findings from the reports and other information in their possession, for the
information of the public and for use by the experts in the field.
1e[18. Code of Conduct to be observed by persons working at Genetic
Counselling Centres, Genetic Laboratories, Cenetic CIinics, Ultrasound
Clinics, Imaging Centres, etc.
All pbrsons including the owner, employee or any other persons associated
with Genetic Counselling Centres, Genetic Laboratories, Genetic Clinics,
Ultrasound Clinics, Imaging Centres registered under the Act/these Rules
shall -
(r) not conduct or asSociate with, or help in carrying out detection or
disclosure of sex of foetus in any manner;
(z) not ernploy or cause to be employed any person not possessing
qualifications necessary for carrying out pre-natal diagnostic techniques/
procedures, techniques and tests including ultrasonography;
(lz) not conduct or cause to be conducted or aid in conducting by
himself or through any other pcrson any techniques or procedure for selection
18. Substituted by G.S.R. 109(E), dated t4-2-2003 (w e.f. 14-2-2003).
19. Inserted by G.S.R. 109(E), dated 14-2-2003 (r.r,.e .f .14-2-2003).
R.18-A] PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHMQUES 35
(PROHIBITION OF SEX SELECTION) RULES, 199 6

of sex before or after conception or for detection of sex of foetus except for the
purposes specified in sub-section (2) of section 4 of the AcU
(ia) not conduct or cause to be conducted or aid in conducting by himself
or through any other person any techniques or test or procedure under the Act at
a place other than a place registered under the Act/these Rules;
(a) ensure that no provision of the Act and these Rules are violated in any
manner;
(al) ensure that the person, conducting any techniques, test or procedure
leading to detection of sex of foetus of purposes not covered under section 4(2) of
the Act or selection of sex before or after conceptiory is informed that such
procedures lead to violation of the Act and these Rules which are punishable
offences;
(uil) help the law enforcing agencies in bring to book ihe violators of the
provisions of the Act and these Rules;
(oiii) display his/her name and designation prominently on the dress
worn by him/her;
(lr) write his/her name and designation in full under his/her signature;
(r) on no account conduct or allow /cause to be conducted female
foeticide;
(ri) not commit any other act of professional misconduct.
'z0[18-A. Code of Conduct to be observed by Appropriate
Authorities.-(1) All the Appropriate Authorities including the Statg District
and Sub-district notified under the Act, inter alia, shall observe the following
general Code of Conducf namely;
-
(i) maintain dignity, and integrity at all times;
(ll) observe and implement the provisions of the Act and Rules in a
balanced and standardised manner in the course of their work;
(lll) conduct their work in a just manner without any bias or a perceived
presumption of guilt;
(lo) refrain from making any comments which demean individuals on the
basis of gender, race, religion;
(a) delegate his or her powers by administrative order to any authorised
officer in his or her absence and preserve the order of authorisation as
documentary proof for further action.
(2) Ali the Appropriate Authorities including the State, District and
Sub-district notified under the Act inter alia, shall observe the following
Conduct for Advisory Committees, namely:-
(i) ensure that the re-constitutiory functions and other relevant matters.
related to advisory committee shall be in accordance with the provisions of the
Advisory Committee Ruleq 1996;
20. Inserted by G.S.R. 1 19(E), dated 24-2-201,4 (w .e.f . 26-2-201,4).
36 PRE.CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES [R.l&A
(PROHIBITION OF SEX SELECTION) RULES, 1996
(d ensure that a person who is the part of investigating machinery in
cases under the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition
of Sex Selection) Act, 1994 (57 of.7994), shall not be nominated or appointed as a
member of the Advisory Committee;
(zr) enbure that the process of filling up of vacancies in Advisory
Committee shall start at least ninety days before the probable date of the
occurrence of vacancy;
(rv) ensure that no person shall participate as a member or a legal expert
of the Advisory Committee if he or she has conflict of interest;
" (d conduct frequent meetings of the Advisory Commiitee to expedite the
decisions regarding renewal, cancellation and suspension of registration.
(3) All the Appropriate Authorities including the State, District and
Sub-district notified uhder the Act, inter alia, shall observe the following conduct
for processing of complaint and investigatiory namely:-
(r) maintain appropriate diaries in support of registration of each of the
complaint or case under the Ac!
(z) attend to all complaints and maintain transparency in the follow-up
action of the complaints;
(zr) investigate all the complaints within twenty four hours of receipt of
the corirplaint and complete the investigation within forty-eight hours of receipt
of such complian[
(l'r,) as far as possible, not involve police for investigating cases under the
Act as the cases uncler the Act are tried as complaint cases under the Code of
Crimjnal Procedure, 1973 (2 of 7974).
(4) All the Appropriate Authorities including the State, District and
Sub-district notified uhder the Act, inter alia, shall observe the following conduct
for registration and renewal of applications under the Act, namely:-
(, dispose of the application for renewal and new registration within a
period of seventy days from the date of receipt of application;
20"[(z) ensure that no application for fresh registration or renewal of
registration is accepted if any case is pending in any Court against the- applicant
foi violation of anyprovision of the Act and the rules made thereunder.]
(5) All the Appropriate Authorities including the State, District and
Sub-district notified unaer the Act, inter alia, shall observe the following conduct
for Legal Actiory namely:-
(r) ensure that protection and expenses of witness shall be met from the
registration amount coilected;
(r.r) ensure that all the notifications of the Government be produced in
original inthe Court and a copy of the same be preserved i
(nz) ersure that while fiting the cases, all the pdperg records. statemenb, evidencg-
pandurama and other material objects attadred to the casefile shall be in origina!
(.irz) suspend the certificate of registration in the course of taking legal
action of seizure and sealing of the facility;
R.18-Al PRE-CONCEPTIONANDPRE-NATALDIAGNOSTTCTECHNIQUES 37
(PROHTBITION OF SEX SELECTION\ RULES, 1,996
(a) ensure that there shall be no violation of the provisions of the Medical
Termination Pregnancy Act, 7971. (34 of 7977) and the Rules made thereunder
while implementing the provisions of the Pre-conception and Pre-natal
Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996;
(ai) take immediate action for filing appeal, revision or other proceeding
in higher Courts in case of order of acquittd wiihin a period of thirty days but no-t
later than fifteen days of receipt of the order of acquitthl.
(6) All the Appropriate Authorities including the State, District and
Sub-district notified- under the Act, inter alia, shall Submit quarterly prosress
report to the Government of India through State Government ahd maiirtdin Form
HTor keeping the information of all the rEgistrations made readily available.
(7) All the Appropriate Authorities including the State, District and
Sub-district notified under the Act, inter alia, sha-lI observe the following
regulation of ultrasound equipments, namely:
-
. . (r) molitor the sales -and import of ultrasound machines including
portable or buyback, assembled, gift, scfap or demo;
(li) ensue regular quarterly reports from ultrasound manufacturers,
dealers, wholesalers and retailers hnd any person dealing with the sales of
ultrasound machines at the State level;
(ili) conduct periodical survey and audit of all the ultrasound machines
sold and operating inthe State or distiict to identify the unregistered machines;
(iu) file complaint against any owrrer of the unregistered ultrasound
machine and against the selleiof the uriregistered ultrasound"machine.
(8) All the Appropriate Authorities including the State, District and
Sub-district notified uhdei the Act, inter alia, shall obs6rve the following conduct
for inspection and monitoring, namely:-
(l) conduct regular inspection of all the registered facilities once in every
ninety days and shalf preserv-e the inspection reiort as documentarv evidenc"e
and 5 cofy of the sam^e be handed overto the ornrner of facility insfected and
obtain ackirowledgement in respect of the inspection;
(li) place all the inspection reports once in three months hefore the
Advisory Committee for follow up actioir;
(iii) maintain bimonthly progress report containing number of cases filed
and persons convicted, registration made-, suspended -or cancelled, medical
Iicenses cancelled, suspeniled, inspections con?ucted, Advisory Committee
meetings held at the distiict level and quarterly progress report at the State level;
(ia) (a) procure the copy of the charges framed within seven days and in
the case of doctors, the detaifs-of the charg"es f,'amed shall be submittdd within
seven days of the receipt of copy of charges f,ramed to the State Medical Council;
(b) procure the certified cop1l vr the order of conviction as soon as
possible and iri the case of conviction of the doctors, the certified copy of the order
bf conviction shall be submitted within seven days of the receiptUf copy of the
order of conviction.
(9) All the Appropriate Authorities including the State, District and
Sub-district notifiedunrlir the Act, inter alia, shall obs-erve the following conduct
for accountability, namely: -
(l) obtain prior sanction or approval of the Government of India for any
resolution conceniing the implementition of the provisions of the Act;
(ii) take actiory if any, required under the Act and immediately on receipt
-sub-dection
of notice under clause (b) of (1) of section 28 of the Act andif he or sfie
fails to do so, shall not be entitled for the protection under section 31 of the said
Act and defend the case in his or her own capacity and at his or her own cost.
(10) All the Appropriate Authorities iniluding the State, District and
Sub-district notified undei the Act, inter alia, shall follSw the following financial
guidance, namely:-
38 PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES [R.19
(PROHIBITION OF SEX SELECTTON) RULES, 1996
(i) maintain a separate and independent bank account operated by two
officers jbintly, at all levels;
(ii) ensure transparency and adherence to standard Government
financial norms for disbursement of money.]
L9. Appeals.-(l) Anybody aggrieved by the decision of the Appropriate
Authority at sub-diStrici level malappeal tothe Appropriate Authority at district
level within 30 days of the order of the sub-district level Appropriate Authority,
(2) Anybody aggrieved by the decision of the Appropriate Authority at
district level mav anpeal to the Aoorooriate Authoritv at State/UT level within
30 days of the orderbt tne District t^eiret Appropriate Arithority.
(3) Each appeal shall be disposed of by the District Appropriate Authority
or by the StateAJnion Territory Appropriate Authority, as the case may be,
within 50 days of its receipt.
(4) If an appeal is not made within the time as prescribed under sub-rule (1),
(2) or (3), the Ap-propriate Authority under that su6-rule may condone the delay
in case he/she is sati-sfied that appellant was prevented for sufficient cause from
making such appeal.l
zou119-A. The rnanner for filing and disposal of the appeal under clause (i) and
(ii) of section 21 of the Act. (1)(a) The Central Government may, by notification
in the Official Gazette, appoiht- a Central Appellate Authority foi each of the
Union territories, for the furpose of hearin'g-appeal against'the order of the,
Central Appropriate Authority or the Union terrilory Appropriate Authority.
(b) The Central Appellate Authority shall consist of an officer not below
the rank'o'f the Union territbry AppropriatdAuthority.
(2)(a) The State Government may, by notification in the Official Gazette,
appoint a State Appellate Authority for the whole State, for the purpose of appeal
against the order of State Appropriate Authority.
(b) The State Appellate Authority shall consist of the Principal Secretary,
Health irid Family Welfare or an officer not below the rank^of the Stale
Appropriate Authcirity as notified by the State Government.
(3)(a) An appeal against the order of suspension or cancellation of
registration passed bv the Central Appropriate Authority or the Union territory
Aflpropriate'Authorifu shall lie with'tfre Central Appe[a(e Authority.
(b) An appeal aeainst the order of suspension or cancellation of
registratidn puss6d by th"e State Appropriate Authbrif shall lie with the State
Appellate Authority appointed by the State Government.
(4) An appeal to the Central Appellate Authority or the State Appellate
Authority sha-l[-
(a) be made in the form of a memorandum of appeal specified in Form I;
(b) be accompanied by an Affidavit explaining the facts of the case,
specified in Form I; and
(c) contain an index, synopsis and list of documents as specified in
AppendixA.
(5) Everv apoeal before the Central Appellate AuthoriW or the State
eppeitite eutfroiiiy shall be supported by the following documeri.ts, namely:-
(a) self-certified copies of orders or documents against which appeal is
being preterred;
(b) copies of documents relied upon by the appellanf
(c) index to the appeal; and
(d) synopsis containing particulars of events and list of documents.
(5) Every appeal shall be filed within a period of thirty days of the date of
receipt bf tf,e irrde? against which the appeal is'preferred: "
20b. Inserted by G.S.R. 492 (E), dated 22-5-2017 (w.e.f . 23-5-201n.
FORMS] PRE.CONCEPTIONANDPRE.NATALDIAGNOSTICTECHNIQUES 39
(PROHIBITION OF SEX SELECTION) RULES, 1996
Provided that the Central Appellate Authority or the State Appellate
Authoritv
rthority mav appeal ilter
may allow the aoneal period df
hlter the oeriod tnirty days, if there is a
cif thirtu
sufficien[ caus-e
sufficienl filingihe
causir for not filing tfie appeal u,ithi
u,ithii-r the said perio&.
(7) The Central Appellate Authority or the State Appellate Authority shall
issue notice to the respondent, which shall be served iri any y of the following
modes, namely:-
(u) servipe by the appellant; or
(b) byhand delivery (dasti); dr
(c) by registered post with acknowledgement due; or
(d) by electronic mail or fax.
(8)(a) The Central or the State AppellateAuthority shall hear the parties on
receipt of the appeal and shall intimale the date of hearine which shall be seven
days'before thd &ate of hearing, by email or courier at the%ddress mentioned in
thd appeal.
(b) The appellalt may present in person or tirrc ugh his duly authorised
legal representative, at the time of hearing of the appeal.
(c) If the appellant fails to appear before the Central Appellate Authority
or the State Appellale Authority on ihe specific date, the appealmay be dismisseil
tor default.
(d) The Central Appellate Authority or the State Appellate Authority
may, if sufficient cause is s'hown, at any stag"e of appeal, granf time to the partie"s
or tb any of them and may from time to time"adjourn the fiearing of the apfeal for
reasons to be recordecl rn wrrtrng:
Provided that more than three adjournments shall not be given to the
appellant.
.(g) Thg Appeal shall be disposed of within a period of sixty days from the
-appeal.
rf filingof
date of filing of thehppeal.
the
(9) The Central Appellate Authoritv
Authority or the State Appellate Authoritv
Authority shall
,s-e oI
dispose
cusPose of tlp appeal
9f me
the appgal by
Dy passmg
passing a spealsng order tn
speaking orcter writiirg and lssue
wriiihg
in wrrtlng under the
issue undler
seal ot
of the Central Appellate Authorr$z or
Aooellate Authorrtv Anoellate fitr_thority
o1 the State Apr:ellate
Appellulg Authoritv dulv
duly
authenticated bv the o?ficer
officer authorised bv
6v the Central A66eUate Authori#or
Appellate Authoritv or the
thl:
State Appellate'Authority for this purpo6e within a peribh of sixty days fiom the
reteipt of the apptial.l
date of ieiceipt
SCHEDULEI
21[+ + *]

SCHEDULEII
21[r * *J

SCHEDULE III
21[+ + *]
,r[FORMA
[See rules a(1) and 8(1)]
(To be submitted in Duplicate u,ith supporting documents as enclosures)
FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION
OF A GENETIC COUNSELLING CENTRE/GENETIC LABORATORY/
GENETIC CLINICruLTRASOUND CLINICfl MAGING CENTRE
1. Name of the applicant
(Indicate name of the organisation sought to be registered)
2. Address of the applicant
3. Type of facility to be registered
21. Omitted by G.S.R. 109(E), dated 14-2-2003(w.e.1.14-2-2003).
22. Substituted by GS.R. 109(E), dated L42-2003 (w.e.f.1+2-2003).
40 PRE-CONCEbTIONANDPRE-NATALDIAGNOSTICTECHMQUES [FORMS
(PROHIBITION OF SEX SELECTION) RULES, 1996
(Please specify whether the application is-for registJulgl.ol a Genetic Counselling
E""tt"lCt""ti'. Laboratory/Geiri,tic ClinicAlltrasound ClinicAmaging Centre or any
combination of these)
4. Full name and address/addresses d( Genetic Counselling Centre/Genetic
LaUoratory/Genetic Clinic/Ultrasound Clinicflmaging Centre with Telephone/Fax
number(si Telegraphicffelex/E-mail address(s)'
5. Type of'owr,"ohip of Organisation-(individual ownership/partnershipTcompanyJco-
operative/any other to bJ specifiedi. In case type _of organization is other
than
iia-r*a"i*,i"^"irnip, rr*i"t copy of articlei'of association and names and
uaJ..*"" of other plrsons .esponsifile for managemen! as enclosure.
(Govt. HojpitalMgucln3!. HospitavPublic Hospital/Private
-' Type of Instirution
5.
Nuisin!- Ho*"/Ph,rute Clini;/Private
-Laboratorylarry
other to be
rio'rpituffrivate
stated.)
7. Specific pre-natal diagnostic procedures/tests for
which approval is sought
(a) Invasive (i) amniocentesis/chorionic villi
aipiration/chtomosomal/biochemical/molecular
studies
(b) Non-Invasive Ultrasonography
Leave blank if registration is sought for Genetic
Counselling Centre onlY.
8. Equipment available with the make and model of
eaifi-equipment (List to be attadred on a separate
sheet).
9. (a) Facitities available in the Counselling Centre'
(b) Whether facilities are or would be available in
the Laboratory/Clinic for the following tests:
(l) Ultrasound
(ii) Amniocentesis
(iii) Chorionic villi asPiration
(io) FoetoscoPY
(o) Foetal bioPsY
(ul) Cordocentesis
Whether facilities are available in the
Laboratory/Clinic for the following:
(l) Chromosomal studies
(ir) Biochemical studies
(iil) Molecular studies
(io) Preimplantation gehetic diagnosis
10.Names, qualifications, experience and registration
number of employees (may be fumished as an
enclosure).
11. State whether the Genetic Counselling Centre/
Genetic Laboratory/Genetic ClinicMtrasound
Clinicflmaging Cenire* qualifies for registration
in terms oflequirements laid down in rule 3']
12. For renewal aPPlications onlY:
(a) Registration No.
(b) Date of issue and date of expiry of existing
certificate of registration.
*Strike out whichever is not applicable or not necessary. All enclosures are to be
authenticatedby signature of the applicant.
FORMS] PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQLIES 41
(pRoHrBrTroN oF sEx SELECTION) RULES, 1.996

13. List of Enclosures:


(Please attach a list of enclosures/supporting documents attached to this
application.)
Date:

Place
Name, designation and signature of the person authorized to
sign on behalf of the organisation to be registered.
DECLARATION
I, Sh./Smt./Kum./Dr.......... ........ son/daughter/wife of......................... aged
;;;;;;;;il;;;;i
working as (indicate designation)
:::
in (indicate name of
the organisation to be registered) ........ hereby declare that I
have read and understood the Pre-natal Diagnostic Techniques (Regulation and
Prevention of Misuse) Act, L994 (57 of 1994) and the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Rules, 1996.
I also undertake to explain the said Act and Rules to all employees of the Genetic
Counselling Centre/Genetic Laboratory/Genetic Clinic/tJltrasbuird Clinicflmaging
Centre in respect of which registration is sought and to ensure that Act and Rules are
tullycomplied with.
Date:
( . . . . . . . ... . . . . . . . .. . . . . . . .)
. .

Place
Name, designation and signature of the person authorized to
sign on behalf of the organisation to be registered
[SEAL OF THE ORGANISATION SOUGHT TO BE REGISTERED]
ACKNOWLEDGEMENT
[See rules a(2) and 8(1)]
The application in Form A in duplicate for grant*/renewal* of registration of Genetic
Counselling Centre*/Genetic Laboratory*/Genetic ClinicrflJltrasound Clinic*[maging
lentre* by ................. (Name and address of applicant) has been recefued
by the Appropriate Authority.......................... On (date).
+The list
of enclosures attached to the application in Form A has been verified with the
enclosures submitted and found to be correct.
OR
*On verification it is found that the following documents mentioned in the list of
I enclosures are not actually enclosed.
This acknowledgement does not confer any rights on the applicant for grant or
I renewal of registration.
(. . ............... ....................)
Sigtrature and Designation of Appropriate
Authority, or authorised person in the
Office of the Appropriate Authority.
Date:
Place:
SEAL
ORIGINAL/DUPLICATE FOR DISPLAY*
tStrike out whichever is not applicable or not necessary.
DISPLAY ONE COPY OF THIS CERTIFICATE AT A CONSPICUOUS PLACE AT THE
PLACEOFBUSINESS.
A PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQI:}I{ [FORMS
(PROHIBTTION OF SEX SELECTTON) RULES, 7996
FORMB
[Seerules 6(2), 6(5) and 8(2)]
CERTIFICATE OF REGISTRATION
(To be issued in duplicate)
1. Ln exercise of the powers conferred under section 19(1) of the Pre-natal Diagnostic
Techniques (Regulation-and Prevention of Misuse) Act, 1994 (57 of. 1994) the Appropriate
Authoritv...................:........ hereby grants registration to the Genetic CounsellinE CentreY
Genetic Laboratory*/Genetic Clinic*AJltrasbund Clinic*Amaging Centre* namld below
for purposes of iarrying out Genetic Counselling/Pre-nathl Diagnostic Procedures*/
Pre-natal Diagnostic Test6/ultrasonography under the aforesaid Acf for a period of i:..'e
years ending on.........................
2. This resistration is eranted subiect to the aforesaid Act and Rules ther< rnde: a,rd
anv contraveldon thereo? shall resuli in suspension or cancellation of this Certificate of
Relistration before the expiry of the said perlod of five years apart from prosecution.
A. Name and address of the Genetic Counselling
Centre*/Genetic Laborator5f/Genetic CliniC/
Lllhasound Clinidfimaging Centne*.
B. Pre-natal diagnostic procedures* approved for
(Genetic Clinic).
Non-Invasive
(l) Ultrasound
Invasive
(li) Amniocentesis
(iii) Chorionic villi biopsy
(iu) Foetoscopy
(o) Foetal skin or organ biopsy
(oi) Cordocentesis
(ztifl Any other (specify)
C. Pre-natal diagnostic testd approved (for
Genetic Laboratory)
(l) Chromosomal studies
(li) Biochemical studies
(ili) Molecular studies
D.A.y other purpose (please specify)
3. Model and make of equipments being used (any
change is to be intimated to the Appropriate
Authority under rule 13).
4. Regiolration No. allotted
5. I'eriod of validity ol earlier Certificate of
Registration.
(For renewed Certificate of Registration only) From......,...............To........
Signature, name apd designation
the Appropriate Authori
Date: SEAL

FORMC
[See rules 6(3),6(5) and 8(3)]
FORM FOi REJECTION OF APPLICATION FOR GRANT/RENEWAL
OF REGISTRATION
In exercise of the powers conferred under section 19(2) of the Pre-natal
Technigues (Regulatibn and, Prevention of . Misuse) Act, 1994 the-,A
Authority............-.................... hereby rejects the application for grant*/renew
Legistratio_n of the underme4tione-d Genetic Counselling -
Centre*/Genetic Labor,
Ge-neticClinic*AlltrasoundClinic*[magingCentre*.
(1) Name and address of the Genetic Counselling Centre+/Genetic
Genetic Clinic*Mtrasound Clinic*fimaging Centre*
(2) Reasons for rejection of application for grant/renewal of registration:
*Strike out whichever is not applicable or not necessary.
FORMS] PRE{OI\CEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES 43
(PROHIBruON OFSEX SELECTiON) RULES, 1996
Signature, name and designation of
the Appropriate Authority with
Seal of office
Date:
Place:
FORIVID
tSee rule9(2)l
FORM FOR MAINTENANCE OF RECORDS BY THE GENETIC
COIINSELLINGCENTRE
1. Name and address of Genetic Counselling
centre.
, Registration No.
3. Patient's name
4. Age
5. Husband's/Father's name
6. Full address with Tel. No., if any
7. Referred by Full name and address of Doctor(s)
with registration No.(s) (Referral note to be
preserved carefully with case papers)
8. Last menstrual period/weeks of pregnanry
9. History of genetic/medical disease in the family
(specify)
Basis of diagnosis:
(a) Clinical
(b) Bio-chemical
(c) Cytogenetic
(d) Other (e.9. radiological, ultrasonography)
10. l:rdication for pre-natal diagnosis
A. Previous child/children with:
(l)Chromosomal disorders
(ll) Metabolic disorders
(lli) Congenital anomaly
(la) Mental retardation
(o) Haemoglobinopathy
(zi) Sex linked disorders
(oil) Single gene disorder
(oiii) Any other (specify)
B. Advanced matemal age (35 years or above)
C.Mother#ather/sibling having genetic disease
(specify)
1a\ D. Others (specify)
11. Procedure advised*
(l) Ultrasound
(ll) Amniocentesis
(lii) Chorionic villi biopsy
(la) Foetoscopy
(o) Foetal skin or organ biopsy
(ol) Cordocentesis
(t:ii) Any other (specify)
12. Laboratory tests to be carried out
(l) Chromosomal studies
(il) Biochemical studies
*Strike out whichever is not applicable or not necessary.
4 PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES [FOR}C
(PRoHTBITION OF SEX SELECTION) RULES, 1996
(iii) Molecular studies
(rz) Preimplantation genetic diagnosis
13. Result of diagnosis
If abnormal give details. Normal/Abnormal
14. Was MTP advised?
1.5. Name and address of Genetic Clinic*
to which patient is referred.
16. Dates of commencement and completion of genetic
counselling.
Name, Signature and Registration No. of tL
Medical Geneticist/GynaecologistlPaediatricir
administering Genetic Counse\
Place:
Date:

FORME
. tSee rule 9(3)l
FORM FOR MAINTENANCE OF RECORDS BY GENETIC LABORATORY

1. Name and address of Genetic Laboratory


2. Registration No.
3. Patient's name
4. Age
5. Husband's/Father's name
6. Full address with Tel. No., if any
7. Referred bylsample sent by (full name and
address of Genetic Clinic) (Referral note to be
preserved carefully with case papers)
8, Type of sample: Matemal blood/Chorionic
villus sample/amniotic fluid/Foetal blood or
other foetal tissue (specify)
9. Specify indication for pre-natal diagnosis
A. Previous child/children with
(i)Chromosomal disorders
(li) Metabolic disorders
(iil) Malformation(s)
(io) Mental retardation
(o) Hereditary haemolytic anaemia
(ol) Sex linked disorder
(air) Single gene disorder
(oiii) Any other (speciff)
B. Advanced matemal age (35 years or above)
C. Motherfather/sibling having genetic
disease (specify)
D. Other (specify)
FORMS] PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHMQUES &A
(PROHIBITTON OF SEX SELECTTON) RLTLES, 1996
10. Laboratory tests carried out (give details)
(i)Chromosomal studies
(li) Biochemical studies
(iil) Molecular studies
(lu) preimplantation genetic diagnosis
L1. Result of diagnosis
If abnormal give details. Normal/Abnormal
12. Date(s) on which tests carried out.
The results of the Pre-natal diagnostic tests were conveyed to....................
on.....................
Nu*e Signature and Registration No. of the
Medical Geneticist/Director of the Institute
Place:
Date:
,3[FORM F

[See proviso to section 4(3), rule 9(4) and rule 10(1-,4,)]


FORM FOR MAINTENANCE OF RECORD IN CASE OF PRENATAL
DIAGNOSTIC TEST IPROCEDL]RE BY GENETIC CLINICruLTRASOUND
CLINICIIv{AGING CENTRE
Section A: To be filled in for all Diagrrostic Procedures/Tests
1.. Name and complete address of Genetic ClinicMtrasound Clinicfimaging centre.........

2. Registration No. (Under PC & PNDT Act, 1.994).....


3. Patientls name............ .....................Age..............
4. Total Number of living children........
(a) Number of living Sons with age of each living son (in years or months):

(b) Number of living Daughters with age of each living daughter (in years or months):

). 5. Husband's lWite'sl Father's / Mother's Name.............

6.Fu11postaladdressofthepatientwithContactNumber,ifany........'.'..

(Referral slips to be preseroed carefully with Form F)

23. Substituted by G.S.R. 77(E), datedSl-1-2014 (w.e.f .31-L-2014).


M-B PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES ["d
(PROHTBTTTON OF SEX SELECTTON) RULES,[9e6
(&) Self-Referral by Gynaecologist/Radiologist/Registered Medical Practr:::'.
conducting the diagnostic procedures

(Referral note with indications and case papers of the patient to be presented with Form F)

(Self-referral does not mean a client coming to a clinic and requesting for the tr*
the relative/s requesting for the test of a pregnant woman)
8. Last menstrual period or weeks of pregnanry
section B: ro o" ttrl:f".lt"*:, ,Tl"rfing :ron-invasive diagnostic

9. Name of the doctor performing the procedure/s..................


L0. Indication/s for diagnosis procedure....................
(specify with reference to the request made in the referral slip or in a self-reis
note)
(Ultrasonography prenatal diagnosis during pregnancy should only be perfora
when indicated. The following is the representative list of indications for ultrascr
during pregnancy. (Put a "Tick" against the appropriate indicationls for'ultrasouni
(i) To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.
(ii) Estimation of gestational age (dating).
(iil) Detection of number of fetuses and their chorionicity.
(ro) Suspected prcgnancy with IUCD in situ or suspected pregnancy follcwing contracefl
failureMTP failure.
(z) bleeding/leaking.
Vaginal 1

i
(oi) Follow-up of cases of ahortion. I

os.
(zri) Assesslnent of cervical canal and diameter of intemal I
I
(oili) Discrepancy between uterine size and period ofamenorrhea. I

(rx) Any suspected adenexal or uterine pathology/abnormality.


I
(x) Detectio,. of cluomosomal abnormalities, fetal strucfural defects and other abnorma{
and i-ireirfollow-up.
I
(rl) To evaluate fetal presentation and position. I
(xil) Assessment of Iiquor amnii.
I
(xlll) Pre-term labor / pre-term premature rupture of membranes.
I
(xia) Evaluation of placental position, thickness, grading and abnormalities (pla{
praevia, retro placental hemorrhage, abnormal adherence etc.).
I
(xu) Evaluation of umbilical cord - presentation, insertion, nuchal encirclement, nuul
of vessels and presence of true knot.
I
(xol) Evaluation of previous Caesarean Section scars. I
(xaii) Evaluation of fetal growth parameters, fetal weight and fetal well being.
I
(xaiii) Color flow mapping and duplex Doppler studies. I
(xlr) lJltrasound guided procedures such as medical termination of pr"g.,uory,
cephalic version etc. and their follow-up. "r{

I
FORMS] PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQL]ES 44-C
(PROHIBTTION OF SEX SELECTION) RULES, 1996
(xr) Adfunct to diagnostic and therapeutic invasive interventions such as chorionic villus
sampling (CVS), amniocentesei, fetal blood sampling, fetal skin biopsy, amnio-
infusioru intrauterine infusion, placement of shunls, etc.
(xrl) Observation of intra-partum events.
(rxii) Medical/surgical conditions complicating pregnancy.
(xriii) Research/scientific studies in recognized institutions.
11. Procedures carried out (Non-Invasive) (Put a "Tick" on the appropriate procedure)
(l) Ultrasound
(Important Nofe.-Ultrasound is not indicated/advised/performed to determine the
sex of fetus except for diagnosis of sex-linked diseases such as Duchene Muscular
Dystrophy, Hemophilia A & B etc.)
(r0 Any other (specify)................................
12. Date on which declaration of pregnant woman/ person was obtained
1.3. Date on which procedures carried ou1.................
14. Result of the non-invasive procedure carried out (report in brief of the test including
ultrasound carried out)...............
15. The result ofpre-natal diagnostic procedures was conveyed 1o..................on.....................
16. Any indication for MTP as per the abnormality detected in the diagnostic procedures/
tests..,...........
Date:
Place:

Name, Signature and Registration Number


with Seal of the Gynaecologist/Radiologist/
Registered Medical Practitioner performing
Diagnostic Procedure/s

section C: To be filled for perfonning invasive procedures/ Tests only


17. Name of the doctor/s performing the procedure/s.................
I 18. History of genetic/medical disease in the family (specifu).................
I Basis of diagnosis ("Tick" on appropriate basis of iiagirosis):
(a) Clinical (b) Bio-chemical
(c) Cytogenetic (d) other (e.g., radiologicaf ultrasonography etc.-
specify)
l.9. Irrdication/s for the diagnosis procedure ("Tick, on appropriate indication/s):
A. Previous child/children with:
(i) Chromosomal disorders (ii) Metabolic disorders
(ili) Congenital anomaly (lo) Mental Disability
(a) Haemoglobinopathy (ol) Sex linked disorders
(ail) Single gene disorder (oiii) Any other (specif)
B. Advanced maternal age (35 years)
C. Motherffather/sibling has genetic disease (specify)
&D PRE.CONCEPTIONANDPRE-NATALDIAGNOSTICTECHMQUES tF[
(PROHTBTTTON OF SEX SELECTTON) RULES, 1996

D. Other (specify)........
20. Date on which consent of pregnant woman / person was obtained in Form G prescd
in PC&PNDT Act, 1994.......
21. Invasive procedures carried out ("Tick" on appropriate indication/s)
(r) Amniocentesis (ft) Chorionic Villi aspiration
(ili) Fetal biopsy (io) Cordocentesis
(u) Any other (specify)
22. Any complication/s of invasive procedure (specify).......

23. Additional tests recommended (Please mention if applicable)


(l) Chromosomal studies (il) Bio&emical studies
(iif) Molecirlar studies (ia) Pre-implantation gender diagnosis
(z) Any other (specify)
24. Result of the Procedures/Tests carried out (report in brief of the invasive h
procedures carried out)................
25. Date on which procedures carried out.................
25. The result of pre-natal diagnostic procedures was convq
to.....,.......,...on.........,,...........
27. Any indication for MTP as per the abnormality detected in the diagnostic procedu
tests.....,........

Date:

Place:

Name, Signafure and


with Seal of the Place Gyni
Registered

Section D: Declaration
DECLARATION OF THE PERSON UNDERGOING
PRENATAL DIAGNOSTIC TEST/ PROCEDURE
L Mrs.Mr..... .............dec1are
by undergoin9..................... ..Prenatal Diagnostic Test/ Procedure. I
want to know the sex of my foetus.

Date:

Place:

Signatureflhump impression of the person under


the Prenatal Diagnostic Test/ Proo
FORMS] PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES M-E
(pRoHrBrTION OF SEX SELECTION) RULES, t996
In Case of thumb Impression:
Identified by (Name).......... ...........Age..................Sex............
Relation(ifany)..........''.....'...Address&ContactNo...'.....'........
Signature of a person attesting thumb impression.... .........Da1e......

DECLARATION OF DOCTOR/?ERSON CONDUCTING


PRE NATAL DIAGNOSTIC PROCEDURETIEST
I,..................... ..................(name of the person conducting
ultrasonography/image scanning) declare that while conduiting ultrasonographyT
image scanning on Ms.At4r ...(name of the pregnant woman
or the person undergoing pre natal diagnostic procedure/ test), I have neither
detected nor disclosed the sex of her fetus to anybody in any manner.

Signature
Date:
Place:

*,ilHit?r'3*"ts:;,:f.*#il&:l
lRegistered Medical Practitioner Conducting
Diagnostic procedure]

FORMG
[See rule 10]
FORMOFCONSENT
(For invasive techniques)
I, .................. wife/daughter of ............ ........Agu
.j..jj....:... years residing at ............... . hereby state that I have been explained
fully the probable side effects and after effects of the pre-natal diagnostic procedures.
I wish to undergo the preimplantation/pre-natal diagnostic technique/test/
procedures in my own interest to find out the possibility of any abnormality (i.e., diseasel
deformity/disorder) in the child I am carrying.
I undertake not to terminate the pregnancy if the pre-natal procedure/technique/test
conducted show the absence of disease/deformity/disorder. ,

I understand that the sex of the foetus will not be disclosed to me.
I understand that breach of this undertaking will make me liable to penalty as prescribed
in the Pre-natal Diagnostic Tedrniques (Regulation and Prevention of Msuse)-Act, 1994
(57 ot199$ and rules framed thereunder.

Date:
Place:

Signature of the pregnant wom€u:r.


44-F PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHMQUES [FORMS
(PROHIBITION OF SEX SELECTION) RULES, 1996
I have explained the contents of the above to the patient and her companion (Name
...... Address Relationship ........) in a
language she/they understand.

Name, Signafure and/Registration number


of Gynaecologist/Ivledical Geneticist/Radiologist
/Paediatrician/Director of the Clinic/Centre/
Laboratory
Date:
Name, Address and Registration number
of Genefic Clinicflnstitute
SEAL
FORMH
[See rule 9(5)]
FORM FOR MAINTENANCE OF PERMANENT RECORD OF APPLICATIONS FOR
GRAI\ryREIECTION OF REGISTRATION UNDER THE PRE-NATAL DIAGNOSTIC
TECHNIQUES (REGULATION AND PREVENTION OF MISUSE ACT, 1994
1. Sl.No.
2. File number of Appropriate Authority.
3. Date of receipt of application for grant of registration.
4. Name, Address, Phone/Far etc., of Applicant:
5. Name and address(es) of Genetic Counselling -Centre*/Genetic Laboratory*/Genetic
Clinic*/ lJltrasound Clinic*flmaging Centre*.
6. Date of consideration by Advisory Committee and recommendation of Advisory
Committee, in summary.
7. Outcome of application (state granted/rejected and state of issue of orders-record
date of issue of order in Form B or Form C).
8. Registration number allotted and date of expiry of registration.
9. Renewals (date of renewal and renewed upto).
10. File number in which renewals dealt.
11. Additional inlormatiory i{ any.

Name, Designation and Signature of


Appropriate Authority
Guidance for Appropriate Authority
(a) Form H is a permanent record to be maintained as a register, in the custody of the
Appropriate Authority.
(b) *Means strike out whichever is not applicable.
(c) On renewaf the Registration irlumber of the Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic/Ultrasound Clinic/Imaging Centre will not change. A fresh
registration Number will be allotted in the event of change of ownership or
management.
(d) Registration number shall not be allotted twice.
(e) Each Genetic Counselling Centre/Genetic Laboratory/Genetic ClinicAJltrasound
Clinic/Imaging Centre may be a-llotted a folio consisting of fwo pages of the Register for
recording Form H.
(fl The space provided for "additional information" may be used for recording
suspension, cancellations, rejection of application for renewal, change of ownership/
management, outcome of any legal proceedings, etc.
(g) Every folio (i.e. 2 pages) of the Register shall be authenticated by signature of the
Apf"iopriaie Authority wilth date, and Every subsequent entry shall'alsd be similarly
authenticated.l
FORMS] PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQUES *G
(PROHIBMON OF SEX SELECTION) RULES, L996
zlFoRM I
[See rule 19-A($(a))
BEFORE TFIE CENTRAL APPELLATE AUTHORITY OR TFIE STATE APPELLATE
AUTHORITY APPEAL NO,.....,,..,........1 20
INTHEMATTEROF:
NAME AND ADDRESS OF APPELLANT
yERSUS
NAME AND ADDRESS OF THE AUTHORITY
WHOSE ORDER IS CHALLENGED REST'ONDENT
Most respectfully showeth:
The above mentioned appellant appeals against the order passed by the..............,.......,
concerned Appropriate Authority a1.....................(Name of place and address) against the
appellant in (details of the case if any) dated........................and sets forth the following
grounds of objection of the order appealed:-
1. Particulars of the order including number of order,
if any, against which the appeal is preferred
2. Bnef. facts of the case
3. Findings of the Appropriate Authority challenged
4. Grounds of appeal
5. Copy of the order mclosed along with all the documents relied upon by the Appellant
6. A.y other information/docummts in support of appeal
7. Pnyer
That the appellant, therefore prays for the reasons stated above and as may be
argued at the time of hearing, the records and proceedings be called for, this appeal be
allowed, the order.under the appeal be set aside and quashed, and order deemed just
and proper may kindly be passed in favour of the appellant.

Signature of the Appellant


Place
Date
Veification
I ,...................................do hereby verify that the contents of para.............to...............are
true and correct to the best of my knowledge and belief and no part is false and nothing
material has been concealed therein.

Signature of the Appellant.


FORMJ
lSee rule 19-A(4)(&)I
PROFORMA AFFIDAVIT
BEFORE THE CENTRAL APPELLATE AUTHORITY OR THE STATE APPELLATE
AUTHORITY
INTHEMATTEROF:
NAMEOFTHEAPPELLANT APPELLANT
vERSUS
CONCERNED APPROPRIATE AUTHORITY RESPONDENT
AFFIDAVIT

24. Inserted by G.S.R. 492(E), dated22-5-2077 (w.e.t.23-5-20L7).


4-H PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHMQUES [ruR\G
(PROHTBTTTON OF SEX SELECTTON) RULES, 7996

1. That I am the Appellant in the captioned matter filed before the AppelLc
Authority and aware of all the facts and circumstances of the case, lrerrr
competent to swear this affidavit.
2. That the accompanying Memo of Appeal has been drafted by my counsel unJa
my instruction and the same has been understood by me, the same may be rer-'
as the part and parcel of this affidavit, and the same has not been repeated trc-
for the sake of brevity.
Deponet
Verification
Verified on this duy..........................of...............(month and year) that the contents of th.
appeal are true and correct on the basis of my knowledge/records/documentsflegr
advice received from the counsel and nothing material has been concealed therefrom.
Deponen:
APPENDXA
[See rule 19-A(a)(c)]
BEFORE THE CENTRAL APPELLATE AUTHORITY oT THE STATE APPELLATE
AUTHORITY
INTHEMATTEROF:
NAMEOFTHEAPPELLANT APPELLANT
yERSUS
CONCERNEDAPPROPRIATEAUTHORITY RESPONDENT
Index
S. No. Particulars Page No.

Signature of the Appellant


Synopsis
Date Particulars of events

Signature of the Appellant


LISTOFDOCUMENTS
S.NO PARTICULARS

Signature of the Appellantl


THE PRE-NATAL DIAGNOSTIC TECHNIQUES
(REGULATION AND PREVENTION OF MISUSE)
(ADVISORY COMMITTEES) RULES, 1996',
ln exercise of the pourers conferred by section 32 of the Pre-natal Diagnostic
Techniques (Regulation tndPreaention of Mixtse) Act,1994 (57 of L994f , the Central
Gaoerrunent hereby makes the following rules, namely:
-
, 1.Short title and commencement.-(1) These rules may be called rse
-Pnr-NATAL DncNosrc
TecuNreuss (RacuraroN eNp PnrvsuroN oF Mrsusr)
"($.ovrsonv Couun'rsEs) Ruus, 1996.
(2) They shall come into force on the date of their publication in the
Official Gazette"
2. Definitions.-In these rules, unless the context otherwise requires:-
Act" means the Pre-natal Diagnostic Techniques (Regulation and
(a) "
Prevention of Misuse) Act, L994 (57 of 7994)2;
(&) "Advisory Committee" means an Advisory Committee constifuted
under sub-section (5) of sectionlT of. the AcU
(c) "Chairman" means the Chairman of the Advisory Committee
appointed under sub-section (5) of section L7;
(d) "Principle rules" means the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Rules, 1996;
(e) "section" means a section of the AcU
(fl "words and expressions" used herein and not defined in these rules
but defined in the Act or in the principal rules, as the case may be, ihall have
the'meanings, respectively, assigned to them in the Act or in the principle
rules.
3. Terms and conditions of appointment as a member of an Advisory
Committee.-(1)No person shall be appointed as a member of an Advisory
Committee if he-
(a) has been convicted and sentenced to imprisonment for an offence
which, in the opinion of the Central Government or the State Government,
as the case may be, involves moral turpifude; or
(b)is an undischarged insolvent; or
(c) is of unsound mind and stands so declared by a competent Courf
or
(d) has been removed or dismissed from the service of the
Government or a Corporation owned or controlled by the Government; or
1. trdeG.S.R.540(E),dated26-11-l.996,publishedintheGazetteofIndia,Ext.,Pt"[,S.3(4,
dated26-7'.1-7996.
2. Now sce the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex
Selection) Act,1994.
44.J PRE-NATALDIAGNOSTICTECHNIQUES(REGULATIONAND [R.4
PREVENTION OF MISUSE) (ADVISORY COMMITIEES) RULES, 1996

(e) has, in the opinion of the Central Government or the State


Government, as the case may be, such financial or other interest as is likely
to affect prejudicially the discharge by him of his functions as a member of
the Advisory Committee; or
(flhas, in the opinion of the Central Government or the State I

Government, as the case may be, been associated with the sue or promotion
of pre-natal diagnostic techniques for determination of sex.
(2) Every member of an Advisory Committee shall be a resident of the
State or Union Territory, for which the Advisory Committee to which he is
appointed as a member, has been constituted.
(3) A member of an Advisory Committee shall hold office during the
pleasure of the Central Government or the State Government, as the case
maybe.
(a) Subject to the provisions of sub-rule (3), every such member shall
hold office for a period not exceeding three years:
Provided that any person holding office as a member of an Advisory
Committee immediaie[y before the c6mmencement of these rules shall holi
such office only for the term of three years from the date of his appointment.
(5) A retiring member or a member whose term of office has expired
efflux of time shall be eligible for re-appointment.
(6) A casual vacancy in an Advisory Committee caused by
resignatiory death, transfer or removal of any me.mber or otherwise shall
filled by fresh appointment and the person so appointed shall hold office
a period not exceeding--the term of office of the member in whose place he
afpointed. \..
(7) The Central Government or the State Government as the case
be, may remove from office any member of an Advisory Committee before
expiration of his term of office.
(8) Every member of an Advisory Committee shall be entitled to drr
traveling and daily allowances for journeys performed by him for attendi
the meetings (including a meeting adjourned for want of quorum), of I
Advisory Committee or ror
Aovlsory Lommr[ee for me
the purpose of olscnargln8
PurPose or discharging any orner
other oudut
prescribed under the Act, or under the Principle rules or under these ru
on the scale admissible to First Grade Officers of the Government of the S
or of the Union Territory, as the case may be.
4. Meetings of the Advisory Committees.-The intervening peri
between any two meetings of an Advisory Committee shall not exceed si>
days.
5. Notice of meetings.-(1) At least seven clear days' notice of all meeti
of the Advisory Committee shall be, given to each member, but an u
meeting may be called by the Chairman at three clear days notice:
Provided that if the Chairman is not available, and a meeting is requi
to be held within the time limit prescribed in rule 4, the Approp
4+L PRE-NATALDIAGNOSTICTECHNIQUES(REGULATIONAND IRE
PREVENTION OF MISUSE) (ADVISORY COMMITTEES) RULES, 1996

(b) any defect in the appointment of a person to be a member of th


Advisory Committee; or I
(c) any irregularity in the procedure adopted by the Ad
Committee not affecting the merits of the case.
12. Record of proceedings of the Advisory Committee.-One set of
agenda, notes on agenda,- supporting documents and minutes of et
nieeting of the AdviJory Committee shall be authenticated by-the si
pr
ehairman or in his absence by the signature of the member p
of the ehair*an
and preserved by the Appropriate Authority as permanent records.
THE PRE-CONCEPTION AND PRE.NATAL DIAGNOSTIC
TECHNTQUES (PROHTBTTION OF SEX SELECTTON) (SrX
MONTHS TRAINING) RULES, 2014,
ln exercise of the powers conferred by clause (i) of sub-section (2) of section 32 of the
Pre-conception and Pre-natal Diagnostic Techniques @rohibition of Sex Selection) Act, 1994
(57 of 1994), the Central Goaunmenthereby makes thefollowingrules, namely:-
1. Short title and commencement.-(1) These rules may be called rnu
PRn-coNcsprrou euo PRr-NRrar DncNosrrc TrcsNrgues (PnormruoN oF Srx SurecrroN)
(Sx Momrs Tnar.mvc) Rur.ts, 2014.
(2) They shall come into force on the date of their publication in the Official
Gazette.
2. Definitions. -In these rules, unless the context otherwise requires, -
(a) " Act"
means the Pre-conception and Pre-natal Diagnostic Techniques
(Prohibition of Sex Selection) Act,1994 (57 of 1994);
(b) "principle rules" means the Pre-conception and Pre-natal Diagnostic
Techniques (Prohibition of Sex Selection) Rules,L996;
(c) "Six months training" means the training imparted under these rules.
(d) "syllabus" means the syllabus given in Schedule I;
(e) "Log book and assessment" means the Log book and assessment as
specified in Schedule II;
(fl words and expressions used herein and not defined in these rules but
defined in the Act or in the principal rules, as the case may be, shall have the
meanings, respectively, assigned to them in the Act or in the principle rules.
3. Nomenclature of the six months training in ulhasonography.-The six
months training imparted under these rules shall be known as "the Fundamentals
in Abdomino-pelvii tltra sonography: Level one for M.B.B.S. Doctors".
4. Period of the training.-The period of training for obtaining a certificate of
training shall be 300 clock hours.
5. Components of the six months training curriculum.-(1) The major
components of the training curriculum shallbe-
(a) theory based knowledge to equip registered medical practitioners
with the knowledge, professional skills, attitudes and clinical competencies;
(b) skill based knowledge;
(c) log book and Assessment.
(2) The comprehensive syllabus for the said six months training is as
specified in Schedule I.
(3) The details related to log book and assessment are as specified in
Sdreduletr.
6. Eligibility for training.-(1) Any registered medical practitioner shall be
eligible for undertaking the said six months training.
1[(2) The existing registered medical practitioners, who are conducting
ultrasound procedures in a Genetic Clinic or Ultrasound Clinic or Imaging Centre
on the basis of one year experience or six months training are exempted from
*Vide G.S.R. 14(E), dated 9-1-201,4, published in the Gazette of India Ext., Pt. I| S. 3(0,
dated 10-1-2014.
1.. Substituted by G.S.R. 419(E), dated26-6-2020 (w.e.f. 29-G2020).
(4s)
46 PRE-CONCEPTIONANDPRE-NATALDIAGNOSTICTECHNIQLIES
" (PROHtsmON OF SEX SELECION) (SD( MONTHS TRAINIIIG) RULES, 201{

undertaking the said training provided they are able to qualify the com
based assessment as specified in Schedule II.
(3) If
a medical practitioner fails to clear the said competency
examination after three attempts, he shall undertake the complete six
training, as provided under these rules, for the purpose of renewal of registr
7. Accreditation of institutions for six months training and its
(1) The following teaching institutions would be accredited as training
impart the six months training, namely:-
(a) Centres of Excellence established under the Acts of Parliament;
1[(b) Medical Council of India recognised institutions offering
Graduate programmes in Obstetrics and Gynaecology or Radiology;l
1[(c) Institutions offering full time residenry DNB prograrnme
Obstetrics and Gynaecology or Radiology.l
(2) The names of the institutions recognised for this purpose shall be
State wise by the State Health Medical Education Department:
Provided that the training institutes recognised for imparting the six m
training shall maintain the standards of infrastructure, equipment
manpower including the faculty as per apex regulatory bodies like the
Council of India or the National Board of Examination.
8. Selection of students.-(1) The selection and intake of registered
practitioners for admission to such trainings shall be on the basis of the
criteria:
1[(a) Intake for admission to such trainings shall be up to 1:4 tea
students ratio.
(b) Selection shall be as per the merit list of the State Post Gr
Entrance Exam or any other appropriate merit recognised by the (
Government/State Govemments.
(c) Preference upto 50 percent of the seats shall be given to
Govemment in service candidates.
(d) Seats as mutually decided by the StatesAJnion Territories shall
provided to the candidates from other States or Union Territories where there
no accredited institutes for imparting Six Months Training in ultrasonograp\
9. Changed criteria to be made prospective. -These rules shall come into
with immediate effect in case of new registrations. However, all regis
medical practitioners employed in a Genetic Clinic or Ultrasound Clinic
Imaging Centre on the basis of one year experience or six months training
failed to qualify the competency based exam as specified in Schedule II shall l
to apply and clear six months training'[* * *].
3[(1) The StatesAJnion Territories shall complete the Competenry
assessment for already registered medical practitioners within two years of
notification.l
10. Fee structure for the training.-(1) The training fee for conducting the
months training shall not exceed Rs. 20,000.
(2) For registered medical practitioners who are already registered
conducting ultra sonography in a Genetic Clinic or Ultrasound Clinic or Imal
Centre and require to clear a competency based evaluation, the fee shall
exceed Rs. 10,000.

1. Substituted by G.S.R. 419(E), dated26-6-2020 (w.e.f. 29-6-2020),


2. Omitted by G.S.R.419(E), dated 26-6-2020 (w.e.1.29-6-2020).
3. Inserted by G.S.R. 419(E), dated26-6-2020 (w.e.f. 29-6-2020).
SCH. I] PRE-CONCEPTIONANDPRE-NATALDIAGNOSIICTECHMQUES 47
(PROHTBruON OF SEX SELECflON) (SD( MONTr-rS TRATND{G) RLTLES, 2014

(3) Fee structure or waiver thereof for in seroice registered medical


practitioners shall be decided by the respective State Governments.
L1. Staff-Faculty.-(1) The institute conducting the said six months training
for registered medical practitioners shall appoint the Post graduate teachers in
Radiology or Obstetrics or Gynaecology recognised by the respective regulatory
bodies as full time faculty for the said training programme.
(2) The Deans or Head of the respective teaching institutions shall be
responsible for monitoring the training programme in entirety.
12.Monitoring requirements.-Monitoring of the training institutions
imparting the six months training shall be as per the existing norms laid down by
the respective apex regulatory bodies.
13. Competency based evaluation.
-The final competency based evaluation at
the end of the six months training shall be held as per the mechanism specified in
ScheduleII.
14. Validity of the training certificate.
- Certification of training obtained from
any State shall be applicable for the purposes of registration under Act in all
States.
1[(a) Certificate for qualifying Six Months Training in Ultrasonography and
Competency based assessment shall be issued by Director Medical Education and
countersigned by the concemed State Appropriate Authority.l
SCHEDULEI
FUNDAMENTALS IN ABDOMINO PELVTC ULTRASONOGRAPHY: Level one 5
Months Course for M.B.B.S. Doctors
Ultrasonogr aphy Syllabus
This training will equip individuals with the knowledge, professional skills, attitudes
competencies to use ultrasound imaging in an appropriate and safe
ilfl;H",
Training will have broadly two components:
1. Knowledge Based.-The theoretical course will cover lectures on Physics of
ultrasound, ultrasound machines & probes, How to use ultrasound Pre-natal
Diagnostic Techniques Act, laws of ultrasound, Medicolegal aspects, Methodology,
patient preparations, Complete Obstetric LJltrasound uses including use in first,
second & third trimesters, Diagnosis of threatened abortion, ectopic pregnancy,
biometery, anomaly scanning, Intra-uterine Growth Retardation (IUGR), Placental
evaluatiory Amniotic fluid evaluatiorL color doppler uses and 3D & 4D ultrasound.
Complete Gynecological uses in evaluating female pelvis and evaluating infertility.
2- Skill Based.-(L) Ability to visualise in two dimensional image and a three
dimensional structure,
(2) Hand-Eye co-ordination.
(3) Supervision is essential.
Summary Listing
I. KNOWLEDGE BASED: THEORY COURSE
The contents of the theoretical course should include at least the following, in
addition to covering the subjects outlined in the syllabus above:
(A) Principles of Ultrasound Examination
(i) Physics, instrumentation and safety
(ii) Ultrasound systems and probes
(ili) Instrumentation and control panel
1. Inserted by G.S.R. 419(E), dated26-6-2020 (w.e.f. 29-6-2020).
48 PRII-CONCEI/flONANDPRE-NATALDIAGNOSTICTECI-INTQULS .\'
(pRor{lBrTtoN ori sEX sEr.EClloN) (Sx MoNn]S'IRAININC) tt[J].].,S, 2(tl i
(R) Concluct of ultras<tund scanning
(,,) Consent
(z) Chaperonc
(zr) Confidentiality
(rz) Infection control
(r) Examination technique: probe movements and image orientation
(Q Normal pel vic anatomy
(r) The Ultrasor"rnd Scan appearances of the norm'al uterus, ovary, endomt't: ;-
and pelvis
(ri) Endometrial and ovarian changes during menstrttal cycles
(rr) How to take measttrements of dimensions of peh,it structLrres
(-rrz) Measurement of endometrial thickness l

(Q Earlypregnancy
(r) The Ultrasound Scan appearances in eariy pregnancy - Embryo, Placc:l
Cestational Age, Twin pregnancy
(r) Recognition and diagnosis of complications of early pregnancy including-
( a) extra-uterine pregnancy
miscarriage
(D)
(c) retained products of conception
( Q Id en ti fi ca ti o n or R ecogn i ti on of pe I vi c pa th o I ogy

(4 Use of Ultrasound Scan in managing menorrhagia, iniermenstrual bleedi:{,


postmenopausal bleeding
(z) Ultrasound Scan appearances in polyrystic ovaries, uterine
adenomyosis and endometrial polyps
(i.rr) Ultrasound Scan appearances of ovarian rysts . corplrs iutcum, .simple ,

complex cysts and masses


(rrz) Complex ovarian masses oi ovariatr screening -
(a) Endometrial pathology in postmenopausal women
(b) Gesta tional trophoblastic neoplasia
(c) Chronic pelvic pain
(d) The assessment of tubal patency in infertility and follicular tracking,
assisted conception
(e) The assessment of prolapse, incontirrence, and anal sphincter damage
(fl Reprod u cti ve med icine'
(r) Effect of contraceptive hormones and menopause on ihe endometrir.rm
(14 Use of Ultrasound Scan in identification of Intra-uterine Device or Intr
uterine System and Implanon position
Nole.-Attendance at a theoretical colrrse is mandatory. The theoretical course need
include any hands-on component.
II. SKILLS BASED
(A) Basic Imaging Skills
(r) Machine set-up
(l) Counselling for scan
(ll) Decide transabdominalvs.transvaginal route
SCH: I] PRE{ONCEPIION AND PRE-NATAI- DIAGNOSTIC TECI-{MQLIES 49
(PROHTBruON OF SEX SELECnON) (Six MONII{S TRATNTNG) nUI,}]S, 20.1 4

(irz) Choiceof probe


- (r) Patient positioning
( rzr) Orientation
( rlr) Identify normal endometrium
( rzllr) Identify normal myometrium
(rx) Identify normal ovaries
(x) Measurc cervical length
(xr) Recorcling images
(xz) Note keeping and documentation
(B) Early Pregnancy
(r) Confirmviability
(z) Date pregnancy
(zr) Diagnose corpus luteum cyst
(rr) Diagnose multiple pregnpnry
( r) Determine chorionicity lzygosity
( rz) Identifi retroplTcental haematoma
( rzz) Diagnose anembryonic pregnanry
( rzzr) Diagnose missed miscarriage
(rx) Diagnose retained products of conception
(x) Courselling for failed pregnancy
(xr) Diagnose ectopic pregnancy
(Q Menorchagia
(r) Identify submucous fibroid
(.'r) Identify intramural fibroid
(ir) Identify subserous and pedunculated fibroid
( i rz) Identifya denomyosis
(D) Pos tm en opa u sa I a n d i n term enstru a I b leed ing
(r) Measr.rre endometrial thickness
(r) Identify atrophic endometrium
( zr) Identify hyperplastic endometrium

(rr,) Identify endometrial polyps


( r) Identify functional ovarian tumours
(E) Pelvic Mass
(r) Identify mass as uterine
(lr) Identify unilocular ovarian mass
(zr) Identify compiex ovarian mass
(rrz) Identify ascites
(fl Reprod u cti ve Med i ci n e
(r) Identify cyclical changes in endometrium
(rz) Identify ryclical changes in ovary
(ar) Identify polyrystic ovary
(rrz) Locatelntra-uterine Device or Intra-uterine system position in uterus
50PRE-CoNCEPTIoNaNornr-NRTaLDIAGNOSTICTECHMQUES...ITH
(PROHEITIoNorsrxsplrcnoN(SxMoNI}ISTRAINING)RtII,rjS,2014
(Q Extra-PelvicScans
(r) Identify normal placement of Implanon
(.lr) Locate non-palpable Implanon
(It) Contents - Section One
(l) Instrumentations and basics
(z) Physics for practical applications
(ll) Examination techniques
(ir,) Trans-abdominaland Trans-vaginal Scan
. (1') Principles of ultrasound examination:
1 The knowledge base' -
(r) PhYsics
(.rr) SafetY

(rr) Machine set-up and operation


(rrz) Patient care
( rz) PrinciPles of rePort writing
(rz) Consent
absorption' rreflection, sPeed I
(2) The relevant principles of acoustics' attenttatiory
sound.
(3) The effect on tissues of pulsed,h1d continuous
wavi: ultrasound beams:biologicl
effects, thermal and non-thermal; safety,
(4) Basic operating principles of medital instruments
(5) TyPes of transducers:
2. Skill sets.-(1) Use of ultradound controls :

(l) Signal processing-gray scale-time gain compensation' acoustic


relationship;
(rl)Artefacts,interpretationandavoidance_reverberation_sidelobes
fects-registration shadowing enhanceme'nt;
ef -
(ll) Measuring systems-linear' circumference' area and volLlme-
ultrasounf;
ff;t", recording, storage and analysis;
(rz)Interpretationofacousticoutputinformationanditsclinicalrelevance;
( rz) Patient information and preparation
reporting'
(l) Contettts - Sectiott Two
fetus;
(r) Ultrasound anatomy of the abdomen' pelvis and
in short as applied to abd-pelvis'
(l) Embryology or pathophysiology
1.Tl-teknowleclgebase._(i)KnowledgeofnormalultrasoundapPearanceso
a menstrual cycle'
endometrium, myometrium ani ovaries thioughout
(tl) Undersianding of techniques to measure the uterus'
endometrium' t
ovaries and adnexa'
(zl) Knowledgu of ,to'*ul t'tltrasound appearances of the
( a) Gynaecologi cal a bnormali ties
: u terine
appearances of fibroids and adenomyosis
1lj rnowledge of the ultrasound
(zr) Knowledge of endometrial pathology
(zr) Intra-uterine Contraceptive Device localisation
SCH. I] PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECI'INIQUES 51
(PROHIBITTON OF SEX SELECTION) (SD( MONlrrS TRAINTNG) RULES,2014

b) Gyna eco logica I abnorma li ties: ova rian lesions


(

(r) Knowledge of the differential diagnosis of ovarian and para-ovarian lesions.


(z) Knowledge of typical ultrasound findings of common ovarian appearances
such as polyrystic ovaries.
(ll) Knowledge of ultrasound features of ovarian cancer and the features of
advanced disease.
(Q Extraovarian lesions
(r) Knowledge of the principles of condurcting ultrasound examination in
chronic pelvic pain.
(.u) Knowledge of typical morphological features of endometriosis, and pelvic
adhesions.
(d) ultrasonography Anatomy of Abdomen
(r) Knowledge Base - Normal appearance
(r) Abnormalities commonly found
(zr) Reporting of Mass lesions
(,rd Measurements - specific locations & Proper Techniques
2. Skill sets.-(i) Ability to consisten{ly identify and examine the uterus, ovaries,
adnexa and pouch ofDouglas.
(r, Ability to assess ryclical endometrial changes and endometrial responses to the
combined pill and other hormonal preparations.
(rlr) Ability to assess the uterine size and to accurately lneasure endomctrial
thickness.
(1r) Ability to assess ovarian volume and functional changes in the ovaries and
adnexa during menstrual rycle: follicular appearances, variation in the morphology of
corpora lutea, functional rysts, fluid in pouch of Douglas.
( tz) Ability to diagnose uterine fibroids, measure their size and assess their relation to
the endometrial cavity. Correlate ultrasound findings to clinical symptoms.
( zr) Ability to assess fibroids and adenomyosis and differentiate where possible.

(vii) Ability to interpret the measurement of endometrial thickness in tlre clinical


context,
( r.ilz) Ability to differentiate between focal and global endometrial thickness.
(zx) To be able to identify Intra-uterine Contraceptive Device and its location within
I
I
the uterus.
' (x) Ability to perform ultrasound examination combined with palpation in order tr>
accurately identify the origin of pelvic lesion and interpret this in the clinical conte.xt.
(xr) Ability to assess the size of adnexal lesions including mean diameter and
volume.
(xn) Ability to approach the assessment of adnexal lesions in a systematic way,
Familiarity with standardised terms and definitions to describe sonographic features of
adnexal lesions.
(xlr) Ability to diagnose simple fun*ional and haemorrhagic cysts, polycystic
ovaries, dermoids and endometriomas based on subjective assessment alone.
(xrrz) Ability to recognise abnormal pelvic fluid/ascites.
(xr,) Ability to take a good clinical history in order to facilitate differential diagnosis of
pelvic pain.
52 PRE-CONCEPflONANDPRE-IIATAI-DIAGNOSI"ICTECI-INIQUES iS* . I
(PROHIBITION OF SEXSELECTION) (SrX MONTI]STI{ATNING) ITUL]]' 2O1I

(xvflBe able to assess tenderness and mobility of pelvic organs including tl.rc r ,-,:r
of Douglas on transvaginal ultrasound scan.
(xvit) Ability to recognise ovarian endometriomas, hydrosalpinges, 't
consequences of pelvic adhesions and peritoneal pseudocysts on ultrasound scan.
(a) (l) Gynaealogical ultrasound
(r) Accurate measurement of the
(lr) endometrium in the accepted sagittal plane
(rz) Assessment of the adnexal regions: accllrate identification o[ the no:-r
ovaries, normal fallopian tube, normal pelvic fluid
(rz) Accurate measurement of normal and abnormal adnexal strLlctLrrcs: rr.rr
diameter and volume
( rz) Recognise and evaluate common endometrial and myometrial abnormaliti..
( rz) Recognise and evaluate common ovarian abnormalities
(rll) Recognise and evaluate complex ovarian masses and refer on appropriateir
( rzzr) Communicating normal results to patients
(rx) Communicating appropriate abnormal results to patients
(x) Producing written summary and interpretation of results
(xr) Issue structured written report
(xlr) Arranging appropriate follow up or intervention
(2) Skilt Set
(, Ability to consistently identify and examine Abdomrnal structlrres
(d Identify Normal ]

(zr) Identify Common Pathological Lesions


opinion
1

(iv) How and Wl'ren to seek further


(b) LIVER AND SPLEEN OR BILIARY SYSTEM OR GALL BLADDEI{ q I

PANCREAS I
Patientpreparartionand ScaningTechniques I

-Sonographic Anatomy I
(4 LIVER-Diffuse liver disease, Fatty Liver, Grades. Acute hepatitis, cirrlrosis an{
portal hypertensiory Focal-Mass-lesions-Cystic Lesions or Solid Lesions
I
(14 SPLEEN-Splenomegalyor Focal splenic mass-Solid mass, cysts, subphrcr{
uott"Trr,
GALL BLADDER-Cholelithiasis or GB filled with calculi or Atypi.ut .ut.utu.l
ott'u"ir,r,
PANCREAS-lnflammatory Acute pancreatitis (pancreatic und
manifestation "",rrprn.r"uol
I
(a) Pseudocystor Chronic Pancreatitis or Neopiasms (solid and cystic kroking) I
(c)PRosrArE I
(l) Sonographic anatomy (prostate, seminal vesicles) I
(d Technique (transabdominal approach) I
(iit)Toidentify central zone & peripheral zone or Measurement of prostate vohrmc I
(rrz) Pathology I
(a) Benign hypertrophy Prostatitis I
(b) ProstaticabscessCancerofprostate

I
SCH. I] PRE{ONCEPTION AND PRE.NATAL DI,AGNOSTIC TECHNIQUES 53
(PROHTBruON OF SEX SELECTTON) (SD( MONTFIS TRAINING) IIULES, 2014

(d) URINARY SYSTEM


Kidneys & ureters-scanning technique
(e) KIDNEYS
(l) Sonographic anatomy
(z) Echogenicity, corticomedullary demarcation, renal sinus, Hypertrophied
(zr) Coltrmnof Bertin
(irz) URETERS Congenital anamolies (agenesis, ectopia, duplex collecting system &
uretrocele )
( rz) Hydronephrosisor Renal calculus or Infection or Tumours or Mimics of calculus
(r.l)Nephrocalcinosis or Pyelonephrotis, pyonephrosis, renal and pelinephric
abscess, chr. Pyelonephritis or Tuberculosis or Renal cell carcinoma, spectrum'.of
sonographic appearance orAngiolipoma
( rzz) Benign Cystic lesions (simplecorical cyst, complex cortical cyst, parapelvic cyst )
( vi i i) P oly cy stic kidney disease
(4 BLADDER
(r) Bladder calculus, bladder volume measurement.
(ir) Bladder wall (techniryre of thickness measurement)
(ar) Bladder mass, cystitis
(, CON]'ENTS_SECTION THREE: BASICS OF OBSTETRIC SCANNING AND
INTERPRETATION IN ALL TRIMESTERS_3 MODULES
L Module 1 Early pregnancy: trans-abdominal ultrasound examination of early
Pre8nancy
THE AIMS OF THE MODULE:
(r) For trainees to become familiar with ideal machine set tt1'r and r.rse of the
transabdominal probe (including probe orientation).
(lr) To gain competence in undertaking a basic "dating scan" using transabdominal
scanning between 8-12 weeks gestation.
(iii)To encourage an acute awareness of what can and cannotbe seen using the
transabdominal route in early pregnancy.
(a) LEARNING OUTCOMES
To be able to carry out appropriate:
(r) ultrasound identification of an intrauterine pregnanry
( d ultrasound identification of cardiac activity

(zl) basic first trimester biometry


(/rz) referral as required
(b) Tr{E KNOWLEDGE BASE
(r) Understand morphological features of normal early pregnanry
(l) Understand physiology of cardiac activity in first trimester
(rz) Understand principles of gestational sac diameter and crown-rump length
measurements
( rzr) Understand the principles of differences between normal intrauterine
gestation sac and a pseudosac
(rz) Understand diagnostic problems.which may occur e.E. empty bladder,
obese women and those with large uterine fibroids
( rzr) Know when to refer for a Trans-vaginal scan
54 PRE.CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES [SC::. I
(PROLtrBTTION OF SEX SELECTION) (SX MONTI-{S TRAINING) RULES, 201{

@ UNDERSTAND THE DIAGNOSIS OF MULTIPLE


(r) pregnancy, chorionicity and amnionicity.
(z) Understand criteria to diagnose miscarriage.
(lr) Understand the principles of ultrasound diagnosis of ectopic pregnan!-.
(rrz) Understand the management of women rvith Pregnanry of Unknown Ltx-l-.r.r
( rr) Knowledge of clinical and tiltrasound findings suspicious of molar

@) sKrLL SETS
(r) Ability to identify the features of a normal
(z) gestational sac and confirm its intrauterine location
(rd Ability to measLtre gestational sac size and crown-rump length
(irz) Ability to identify early cardiac activity using B-mode
( r) Identify fetal number

( rzr) Ultrasound diagnosis of early embryonic demise


(rzz) Ultrasound assessment of a woman with susPected ectopic pregnarrcl'
(rzzr) Ability to estatlish the diagnosis of multiple Pregnancy with confide
and to assess chorio4icity and amnionicity
(rx) Ability to diagnose early embryonic demise based on assessmcnt
gestational sac size and/or crown-rumP length. Identify, assess and measure retai
products of conception in women with incomplete miscarriages
(x) Ability to correlate clinical, morphological and biochemical findings
(xr) Ability to evaluate adnexa in a systematic and effective way and
interpret the findings in a clinical context. Idenlify the site and the number of corporalu
(xz) Identify tubal and non-tubal ectopic pregnanry and examine for the
of a yolk sac or an embryo. Assess the amount and qualiry of fluid in the pouch of Douglas
. (xiit) Seek help with confirmation of diagnosis and further management
(xirz) Recognise limits of comPetency
(xrz) Know limits of own ability and when to refer for further opinion Accur
documentation of measurements
(xrur) Producing written summary and interpretation of results
(xrzlr) Communicating normal results to Parents
(xrzzr) Communicating abnormal results to parents
(xlx) Arranging appropriate referral, follow up or intervention
IL Module 2- Basic: Ultrasound assessment of telal size,liquor and the placenta
(a)THE AIMS OF THE MODULE:
To gain basic competences that are potentially useful in day-to-day obstetric pr
including lie, presentatiory placental site and liquor assessment. Basic biometry techr
will be taught but competence to the level of "independent practice" is not required.
(b) THE KNOWLEDGE BASE
1.. Biometry
(r) Awareness of the various lies and presentations
(d Fetal growth or PhysiologY
(zr) Pathology
(,4) Maternal
(^B) Placental
(O Fetal
SCH. I] PRX{ONCEPTIONAND PRE-NATAL DTAGNOSfiC TECHMQUES 55
(PROHIBITION OF SEX SELECNON (SE( MONTHS TRAINING) RULE9
2014
(ir) Fetal biometry or Anatomical landmarks or Reference charts or
Interpretation (including variability)
( rz) Calculation and value of:
(,4) Ratios
(8) Estimated fetal weight
2. Amnioticfluid
(;) Amniotic fluid volume or physiology or Change with gdstation
or
Pathology
. (it) Ultrasound measurernent
(lr) Subjective vs objective
(rr) Max vertical pocket or Amniotic Fluid Index
( ru) Reference charts
( rur) Interpretation (including variability)
(rz) Oligohydramnios
( rzr) Definition and associations
(rx) Polyhydramnios
(x) Definition and associations
3. Placenta
(r) Ultrasound assessmentof site
(r) Indication for Transabdominal and transvaginar ultrasound
(lr) Placenta praevia
(1.) Clas.sification
(r) Management
(c) SKILL SETS
(r) Accurate measurement of Bi-parietal Diameter, Head Circumference,
Abdominal Circumference Femure Length
(ri) Accurate documentation of measurements and observations, including.chart
plotting
.

(r.u) Assessment of liquor volume


(rr)Be able to-perform and interpret assessment of Amniotic Fluid Volume,
maximum vertical pool depth and Amniotic Fluid Index using ultrasound
( rz) Measurement of Amniotic Fluid Index
( zr) Assessment of Iiquor volume
( zd Measurement of Maximal Vertical pool Depth :

( rzrd Assessment of placental position using the trans-abdominal route


(rx) Arranging appropriate follow up or referral
(x) Producing-written summary and interpretation of results
(xr) Communicating normal results to parents
(xz) Maintains awareness of limitations of own competence
IIL Module 3-Intermediate: Ultrasound of normal fetal anatomy r

(a)THE AIMS OF THE MODULE:


The overall aim of this module is to ensure that the trainee understands
the indications
for a fetal anatomy scary is able to perform the scan safely and competently
and to report
the findings of the scan.
I

i
56 PRE{ONCEI'IION AND PRE.NATAL DIAGNOSTIC TECFIMQUES 13(
(I'ROHIBruONOFSEXSELECTION)(SIXMONTHSTRAINING)RLIT-LS,2014
I
(,)LEARNING OUTCOMES I

The trainee should be able to: ]


I
proper clinical history
(r) take a |

(il carry out ultrasound examination in the appropriate environment with re^urti
to the patients privacy, culturai and religious needs
(rz) understand the normal morphological ultrasound appearances of the 'C
and its environment
(rr.) diagnose normal fetal anatomy
i

(rz) be aware of the normal anatomical variants


(r,r) understand the limits of their competence and the need to seek advice rr r(
appropriate
( rrr,r) Commtrnicate the results to the parents
(uiii) wrire a structured report
(rx) learn when to refer patients where appropriate.
(c)THE KNOWLEDGE BASE
(l) Know, anatomical landmarks for performing standard fetal measurems
Bi-parietal Diameter, Head Circumference, Abdominal Circumference, Femure Lengtl:
. (il Recognise normal appearance of fetal structures ard appreciate diffe.r
appearance at dif ferent gestations
(r.rl) Know the detection rates of common anomalies
(rrz) Provide parents with necessary information in a form they understand
( rz) Communicate sian findings and information given to p61sn1s to other heal
professionals
(r1) SKILL SETS -
-'.
(r) Identify fetal position within uterus
(it) Be able to move probe with-purpose to identify
(rz) fetal structures
(rrz) Be able to consistently and systematically identify the features describec
an "optimal" anomaly scan
Be able to perform standard fetal measurements Bi-parietal Diameter, lis
Circnmference, Abdominal Circttmference,Femure Lengthincluding ancl lt
transcerebellar diameter, ventricular atrial diameter and Antero-posterior diameter of i
renal pelvis
(ru) Identify placental site
( rzr) Recognise limits of competency
( rzl) Recall patients appropriately for further scans if structures not seen ciearlr'
(rziz) Accurate measurements of Bi-parietal Diameter, Head Cir-cumferent
Abdominal Circumference, Femure Length, Transverse Cerebral Diameter and latt'r
atrial diameter of the cerebral ventricies
(rx) Confirm normal anatomy of head and face
(x) Confirm normal anatomy of spine
(xr) Confirm normal anatomy of heart anC chest
(xz) Confirm normal anatorny of abdomen
(xzr) Confirm normal anatomy of limbs
(xlrz) Perform ftrll anontaly scan
scH. rl PRE-coNCEpnoN AND PRE-NATAL DLAGNOSTTC TECHMQLTES s7
(PROHTBruON OF SEX SELECTTON) (SIx MONTHS TRATNTNC) RULES, 2014

(xrz) Recognise common structural anomalies


(xrzr) Locate and assess placenta
(xrzrr) Assess liqugr volume
(xviii) Provide parents with information about
(xrx) Ngrmal scan findings
(xx) Abilities and limitations of ultrasound
(xxr) To be aware of the limitations of this technique and know when to refer
(xxii)"1'o be able to discuss with parents the possibility of an abnormality and the
need for a further opinion
(& CoNTENTS-SECTTON FOUR
1. Introduction to the problem of dedining child sex ratio and provisions of tl-re Pre-
conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act.
Continuous decline in child sex ratio since 1961 Census is a matter of concern for thc'
country, Beginning from976 in 1951 Census, it declined to927 in 2001. As per Census
2011 the Child Sex Ratio (0-5 years) has dipped further to 919 against 927 gir[s per
thousand boys recorded in 2001 Census. Child sex ratio has declined in 18 States and 3 UTs
and except for the States of Himachal Pradesh (909), Punjab (846), Chandigarh (8{i0),
Haryirna (834), Mizoram (970), Tamil Nadu (943), Karnataka (948), Delhi (871), Coa (942),
Kerala (964), Gujarat (890), Arunachal Pradesh (972), and Andaman & Nicobar Islands
(968) showing marginal improvement, rest of the 21 States/ UTs have shown decline:
"The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection)
Acl."
"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 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 lead ing
to female foeticide and for matters connected therewith or incidental thereto."
2. Implementation of the Pre-conception and Pre-natal Diagnostic Techniqtres
(Prohibition of Sex Selection) Act 1994:
The Pre-natal Diagnostic'I'echniques (Regulation and Prevention of Misuse) Act was
enacted on September 20, "1994 and the Act was further amended in 2003. 'l'he Act
provides for the prohibition of sex selection, before or after conceptiory and for regulation
of pre-natal diagnostic techniques for the purposes of detecting genetic abnormaiities or
metabolic disorders or chromosomal abnormalities or certain congenital malformations t'rr
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.
Tl-re Act is implemented through the following implementing bodies:
(r) Central Supervisory Board
(d State Supervisory Boards and Union Territory Supervisory Boards
(zr) Appropriate Authority for the whole or a part of the State or Union Territory
(1tz) State Advisory Committee and Union Territory Advisory Committee

(rz) Advisory Committees for designated areas (part of the, State) attacl,ed tcr each
Appropriate Authority
( rzr) Appropriate Authorities at the District and Sub-f)istrict levels

3. Registration:
Appropriate Authority of the district is iesponsible for re6;istration of ultrasouncl
diagnostic facilities.
58 PRE{ONCEPTIONAND PRE-NATAL DIAGNOSTIC TECHNIQUES IT
(PROHIBmON OF SEX SELECTTON) (SD( MONTHS TRATNTNG) RULES, 2014

4. Application fee:
(1) Rs, 25,00b.00 for Genetic Counselling centre, Genetic laboratory, Genetic C.:
Ultrasound Clinic or Imaging Cenhe.
' (2) Rs.35,000.00 for an institfite, hospitai, nursing home, or any place provrc
jointly the service of Genetic Counselling Centre, Genetic laboratory, Genetic Ci:
Uhrasound Clinic or Imaging Centre or any combination thereof.
5. Mdndatory Displays at ultrasound center:
(1) Pre-conception ind Pre-natal Diagnostie Techniques (PC and PNDT),Certihc
It is mandatory for eyery clinic or facility or hospital, etc., registered under the !
conception and Pre-natal Diagnostic Techniques Act to display the certificatt
registration at a conspicuous place at such Centre, Laboratory or Qlinic.
(2) Signage, board or banner in English & local language indicating that foetal sc
not disclosed at the concerned facility.
(3) Copy of the Pre-conception and Pre-natal Diagnostic Techniqtles Act mus
available in every ultrasound center.
6. Renewal of registration:
(1) Every certificate ofregistration is valid for a period of5 years.
(2) Renewal of registratiirn to be done 30 days before the date of expiry of
certif icate of registration.
7. Mandatory maintenance of records Register showing in serial order:
(1) Names and addresses of men or women subjected to pre-natal diagno
procedure or test.
(2) Names of their spouses or fathers.
(3) Date onwhich they first reported for such counsetling, procedure or test.
A monthly report should be submitted to the Appropriate Authority regule
(4)
before the Sth of every month. A copy of same monthly reports with the signature of I
Appropriate Authority acknowledging receipt must be preserved.
8. Preservationof the following duly completed forms:
(r) Form F
(l) Referral Slips of Doctors
(zr) Forms of consent l

. (iv)Sonographicplatesorslides l

9. Recordstorage:
All above records should be preserved for 2 years.
1 0. Powers of Appropriate Authority

(1) Appropriate Authority can enter freely into any clinic or facility for search
seizure.
(2) Examine and inspect of registers, records including consent forms, referral
Forms, sonographic plates or slides and equipment like ultrasonography machines.
(3) To ensure presence of at least two independent witnesses of,the same local
different locality duringtl're search.
1.1.. For further Do's and Don'ts abotrt following the Pre-conception and pre-
Diagnostic Techniques (Prohibition of Sex Selection) Act and rules a l{and
Pre-conception and Pre-natal Diagnostic Techniques Act and rules
Amendments published by Ministry of Health, Government of India has made ava
online on www.pndt.nic.in
/
SCH. II] PRE-CONCEPTION AND PRE-NATAL DI,AGNOsTIC TECHMQUES 59
eRoHrBrrroN oF sEx sELECnorg (sx MoNTHS TRATNINC) RULES, 2014

SCHEDULE II
LOGBOOK AND ASSESSMENT
1. The Logbook.-
The Logbook records the traiiin_g activity, tutorials and self-directed learning
undertaken and competencies achieved. Maintenance and regular review of the logbooks
during interim assessments will allow the Principal Trainer and Trainee to monitor
progress and identify deficiencies over the course of training. The Trainer will sign the
appropriate sections of the Logbook documents with regard to attendance, skill and
competence. It is imperative that all participants appreciate that the Trainee's progress has
to meet standards that satisfy the Trainers. At the end of the training programmc, the
Principal Trainer has to certify that the competencies and skills attained by the Trainr'e are
to his/her satisfaction.
(1) TRAINING PLAN LEVEL 1 EXERCISE TO BE PERFORMED UNDEIT
DIRECT SUPERVISION:
At this initial assessment, a training plan should be agreed between the Principal
Trainer and the Trainee, using the competency, skills and attitudes libts to set the learning
objectives. (This shoutd include, identifying a theory course to be attended within 6
months of induction assessment, if not aiready undertaken.) The initial le4rning oblectives
and the activity plan to meet these should be tailored to the individual learnirrg needs of the
Trainee. Subsequent learning objectives should be set at interim assessments until thc
Trainee has attained all the competencies, skills and attitudes on the lists.
It is the Trainee's responsibility to undertake this planned learning. The Principal
Trainer should guide thig but need notundertake all training themselves.
In addition to the recording of competence, the logbook also contains sections for the
recording of ultrasound images and basic clinical details of clients seen by the trainee. The
ultrasound images should be of high quality and demonstrate aspects of the ultrasound
scan which are pertinent to the clinical case and should have been obtained by the trainee.
The trainee should review suitable images with the Trainer, prior to attaching them to the
logbook.
This logbook is intended to record experience of ultrasound imaging in clinics where
clients are referred for ultrasound imaging as part of the management of their abdomino-
pelvic and gynecological conditions (early pregnanry clinics, pre-abortion assessment
clinics, etc) either in hospital or community setting.
It also:
(a) Provides a summary of the syllabus in the form of a list of necessary
competencies.
(b) Records the outcomes of the learning objectives agreed between you and yotrr
Trainers.
(c) Provides a record of your achievements as you attain competence in the reqtrired
areas.
(d) Records the certified assessment of your competence when applying for the
Certificate.
(e) Provide a permanent record of interesting cases to act as a reference for futr.rre
practice.
60 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHMQTIES [SCt-.
(pRoHrBmoN oF sEX SELECTION (SD( MONTHSTRAININC) RLILES,2014
(2) N,IINIMUM NUMBER OF SCANS FOR LEVEL-I TRAINING (TOTAL :
CASES)
ObstetricScans
Viable Pregnancies 10
Non Viable Pregnancies 10
Normal Biometry 10
Growth Restrictions 10
Abnormal Pregnancy 10 (ectopic or
multiple etc.)
Gynaec 10
IUCD's 05
Fibroids 10
Ovarian Cysts 10
Gynaec Disorders 10
Non-Obstetric Scans
Normal abdominal Scan 20
Gall Stone Disease 10
Extra hepatic Biliary Channel 05
Hepatic Solid Masses 05
Hepatic Cystic Lesions 05
Pancreas 05
Urinary 25
Normal Scan 10
Cystic lesions of Kidney including Hydronephrosis 05
Solid lesions of Kidneys 05
Ureteric and Bladder Stones 05
Prostate 05
Observations
Transvaginal Scan 10
Color Doppler Studies Obstetric 10
2. Assessmenf,-As well as the initial assessment, the Principal Tralner must pcrfc
at least one interim assessment to check the Trainee's progress and the summative (fin
assessment of competence. The Principal Trainer has to certify that the competencics q
skills attained by the Trainee are to his/her satisfaction.
It is the responsibility of the independent examiner to be nominated by Direcf
Medical Education Department of the concerned State to certify final competence, in or{
to exit the training programme. I

(1) GUIDELINES FOR ASSESSORS


(a) Assessors may be Ultrasonographers, Obstreticians or Gynaecologists {
doctorsexperienced intrltrasonography. I

(b) Assessor should explain to the person being assessed, that the purpose of {
exercise is to assess technical competence. I
(c) The trainee should perform the procedure based on his/her usr"ral practice. !
trainee and trainer should fill in the forms separately and use them to irrform discuss{
I

I
SCH. II] PRE{ONCEPTION AND PRE-NATAL DTAGNOSTIC TECHMQUES 61
(I,RoFrlBrrroN oF sEX SELECTION) (SX MONIIS TRATNTNG) r{ULES, 2014
following observation of the trainee.'I'he assessment is designed to assess technical skills.
It enables disctrssion on techniqne and will allow discussion on why the trainee actcd as
she/he dic'l.
(ri) It is planned that each trainee should be assessed by Objective Stluctured
Assessment of 'fechnical Skills at least twice in a training programmc; by diffcrent
assessors, one of whom should be the Independent Examiner, as part of tlre surrrmative
assessment.
(e) Trainees must already have achieved competence (direct supervision), in tl.re
procedure being evaluated.
For each procedure, the following rnust be completed:
(a) Itemised Cirecklist Score
(b) Objective Stru ctured Assessment of Technical Skills assessment sheet.
It is not necessary to obtain written co.rseilt from patients, but it would be prtrdcnt to
say that the Trainee is partaking in an assessment with full supervision. Patients may
choose not to be part of the assessment process.
3 copies of tlre forms should be kept;
(a) One for the trainee's portfolio
(b) One for the Principal Trainer
(c) One to go back to the Factrlty with ail forms when the certificate is applied for.
(2) OB]ECTIVE STRUCTURED ASSESSMENT OF TECHNICAL SKILLS (OSA]'S)
(A). BASIC SKILI-S Level 1 Level 2 Trainer to sign and
Skill date when competence
achieved
Strpervised lndependent
Machine set-up
Counselling for scan
Decide transabdominal
Transvaginal route
Choice of probe
, Patient positioning
Orientation
-ldentify normal

endometrium
Identify normal
Myometrium
Identify normal ovaries
Measure cervical length
Recbrding images
Notekeeping
SPECIAL REMARKS
62 PRE-CONCEPTION AND PRE-NATAL DIACNOSNC TECHNTQiTES ISC'
GROT.TIBmON OF SEX SELECTTON) (SIX MONrtrS',rl<AlNtNG) R[rr.L]S, 2014

(B). EARLY PRECNANCY Level 1 Lr.vel 2 Trainer to sign arrt.i


skill date when compctcrl.
achievc.d
Supervised Independent
Confirm viability
Date pregnancy

Diagnose corpLls luteum cyst


Diagnose multiple pregnancy
Identify retroplacental haema toma
Diagnose anembryonic pregnanry
Diagnose missed miscarriage
Diagnose retained products
of conception
Counselling for failed pregrlancy
Diagnose ectopic pregnancy
SPECIAL REMABKS

(c). MENORRHAGTA Level 1 Level 2 Trainer to sign and


skill date when competenct'
achieved
Supervised Independent
Identify submrlcous fibroi d
Identify intramural f ibroid
Identify subseroLrs and pendunculated fibroid
Identify adenomyosis
SPECIAL REMARKS

(D). POSTMENOPSA Level 1 Level 2 Trainer to si6;n and


AND date when compctence
INTERMENSTRUAL achieved
BLEEDING
skill
Supervised

Measure endometrial
thickness
Identify atrophic
endometrium
SCH. II] PRE{ONCEPTION AND PIiE-NATAL DIAGNOSNC
TECIilIIQI.'ES
(PROI{iBMON OF SEX SELECIION) (SD( 'Ur- 63
MONTFIS rNA_rr.ilr-I' hS,2O14
Identify l-ryperplastic
endometrium
Iclentify endometrial
polyps
Identify ftrnctional
ovarian tllmoLtrs
SPECIAL REMARKS

(E). PELVIC MASS L"""l t


date when competence
achievcd
Supervised Independent
Identify mass as
uterine
Identify unilocular
ovarian mass
Identify complex
ovarian.rnass
Ideniify ascites
SPECIAL REMARKS

oTt3?j:,T'u Leve
'o' MEDICINE . datc. when competencc
skill
achieved
Supervised Independent
Identify ryclical changes
in endometrium
Identify cycl ical cha nges
ln ovary
Identify polyrystic ovary
Locate Intra-uterine
Device or Intra-uterine
System position in utenrs

EXTRA PELVIC SCANS


Identify normai placement
, of Implanon
Locate non-palpable
Implanon
SPECIAL REMARKS
64 PRE-CONCEI'rON AND PRE-NATAL DIAGNOSTIC TECHNIQUES [SC.
(pRoHIBmON OF SEX SELECnOI{) (SX MONII{S TRATNTNG) RULES, 2014

(G). GENERAL Level 1 Level 2 Trainer to sign anc


ABDOMEN date when competer:.
skill achieved
Supervised Independent
LIVER AND SPLEEN
OT BILIARY SYSTEM
Patient preparartion and
Scaning Techniqnes-
Sonographic Anatomy
Diffuse liver disease
Fatty Liver, Grades.
Acute hepatitis, cirrhosis
anu portal hypertension
Focal Mass lesions
-Cystic
Lesions or Solid Lesions
Spleen- Splenomegaly or
Focal splenic mass -Solid
mass, cysts, subphrenic
abscess
SPECIAL REMARKS

(H). GENERAL I-evel1 Level 2 Trainer to sign and


ABDOMEN date when com
skill ac,!rieved
Strpervised Independent
URINARY SYSTEM
Kidneys & ureters. ..
scanning techniqr-re
Sonographic anatomy
Echogenicity,
corticomedullary
demarcation, renal sinus,
Hypertrophied
Column of Bertin
URETERS Congenital
anamolies (agenesis,
ectopia, duplex collecting
system & uretrocele)
SCH
%.,i,HfiH.3H3i,ffi.ix#ffi l,:llsyojr.rEcrilrQuEs 55
Uyaron"ph.oriro. ttilui o,n
calculus or Infection
or
I umoursor Mimics
of
calculus
Nuph.o"rl.inii[.,"-
Pyelonephrotis,
pyorrephrosis, renal
&
perrnephric abscess,
chr.
l?elonephritis or
Tuberculosis or
Renal
celI carcinoma,
spectrum
or sonographic
appearance
orAngiolipoma
Benign Cyrtl. luIo,.,!
(simple corical
cyst,
complex corticaicvst.
parapelvic cyst
)
pory.yrti.
tiai! a i.I.il -_
SPECTALTREM,AiE

(r) GENERAL
Level
ABDOMEN 1
Level 2
Trainer to rig"-_lnJ-
skilt ,
Oate l^rhen cornpc,l(ln
cL,

Supervised achieved
BLADDER Independent

Bladder Alilrq
blrdd;
votume measurement.
Bladder *utt
of th ickness *
flu.hiloin-
"urrr"a"-n r;
Bluddu. *aGEJitE
SPECIAL REMMG

0). GENERAL
ABDOMEN Level 1
Level 2
Traint,r t" Sln un.f_---
skilI .
da te when criilpc.tcrr
cc,
Supervised achieved
GALL BLADDER; Independent
PANCREAS
cutt atuaae. IEt oteiitililil
GB filled *itf,-*f..,fil.---
Atypical calculus
or pitfalls
66 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHMQUES [SCI]
(PROHTBmON OF SEX SELECTION) (SD( MONTI{S TRAININTq RULES, 2014

Pancreas -Inflammatory
Acute pancreatitis
pancreatic and extra
pancreatic manifestation
Pseudorystor Chronic
Pancreatitis or Neoplasms
(solid and cystic looking )
SPECIAL REMARKS

(K). GENERAL Level 1 Level 2 Preceptor to sigrl and


ABDOMEN datewhen competeno
skill achieved
Supervised Independent
PROSTATE
Sonographic anatomy
(prostate, seminal vesicles)
Technique
(transabdominal
approach)
To jdentify central zone
and peripheral zone
or Measurement of
prostate volurire
Pathology-Benign
hypertrophy
Prostatitis
Prostatic abscess-
Canier of prostate
SPECIAL REMARKS

GUIDELINES FOR ASSESSMENT FOR FINAL EXAMINATION


Minimum pass marks-For practicals 60 and Theory 50
I. THEORY ASSESMENT
(a) 100 marks-two hours
(D) 50 multiple choice questions of one mark each= 50 marks
(c) L0 short answers with five marks each = 50 marks
(d) Short Question will have a defined space for the candidate to fii answer
II. PRACTICAL ASSESMENT
(a) 20 marks for log book
(D) 50 marks for demonstrations
(c) 30 marks viva
1

each.
Nofe.-The examiner can chose any FIVE of these TEN for demo and allot 10
4
scH. rrl pRE{oNCEpTIoNANDpRE-NATALDrAGNosrICrecrilvrouEs ei
(PROHIBruONOF SEXSELECIION) (SXMONTHSTRAIN TG) RULES, 2014
1[II. (a) PRACTICAL ASSESMENT FINAL EXAMINATION

(a) 20 marks for log book


(b) 50 marks for dernonstrations
(c) 30 marks viva
II. (b) PRACTICAL ASSESMENT COMPETENCY BASED ASSESSMENT
(a) 60 marks for demonstrations
(b) 40 marks viva
Nofe.-The examiner can choose any FIVE for Final Examination and SIX for
Competency Based Assessment of these TEN for demo and allot 10 marks each.
III. VIVA-30 marks on three case sifuations for Final Examination and 40 marks on
four case situations for Competency Based Assessment.]
Step 1: Preparation
1.1 Equipment preparation
1.2 Patient preparation
1.3 Operator preparation
L.4 Expose the lower abdomen and apply the gel
. l.5Selectthetransducer
Step 2: Commence the growth and high-risk pregnancy scanning protocol
2.1 Patientposition
2.2 Scan plane
2.2 Transabdominal scan plane Endovaginal scan plane
2.3 Standard second and third trimester protocol image requirements
1. Fetal lie, life, number, presentation, and sifus
2. Maternaluterus and adnexae
3. Amniotic fluid and placental location
4. Fetal biometry
5. Fetal anatomy
Step 3: Ovewiew of second and third trimester routine ultrasound examination
Step :Performtargeted scan relevant to clinical condition of fetus and/or mother
4.L Scan for multiple pregnancy
Step 5: Scan for intrauterine growth restriction
5.L Fetal growt[ and weight
biometry,
Step 6: Scarfor amniotic fluid and membranes
6.1 Calculate the amniotic fluid volume
Step 7: Scanfor placenta and umbilical cord abnormalities
7.1 Placenta
Umbilical cord
7.2
Step 8: Scan for fetal biophysical profile
Step 9: Scan for fetal complications of matemal disease
9.1 Fetal hydrops
9.2 Matemal diabetes

1. Inserted by G.S.R. 419(E) dated26-6-2020 (w.e.f. 29-6-2020).


68 PRE{ONCEPTIONANDPRE'NATALDIAGI{OflICTECI{NIQUES
GRoHtsmoNti;ffi;ffit""*'}{sxMoNnFlsrRAINhlqRtrLES'
and pre-eclampsia
9.3 Maternal hypertension
9.4 Other matemal diseases scan-matemal
asses general abdominal
Step 1A: Demonstrate-to
bladder/kidneYs
situations
m. VIVA-30 marks on three
caQe

ClinicosonograPhic co-relation
video cliP and case studies
Iv. CASESTUDY Date:
Case Number:
Preliminary data
lJltrasonograPhY Findings
Impressions
Key Leamings

I
I
I

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