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DR. Ravindra Mohan
M.D.(Obs & Gynae)
Member Secretary , District Advisory
Committee , Saharsa ,Bihar
 Socially , culturally and religiously women
are given secondary status .
 In marriage too - women are given Sub
ordinate status
 Women are vulnerable to violence .
 Various methods were used to eliminate the
girl child after her birth like starving her,
crushing her under the bed or giving her
poison etc .
 Belief that - only the son can perform the
last rites, that lineage and inheritance runs
through the male line, sons will look after
parents in old age, men are the bread
winners etc .
 In some cases parents accept the daughter
if the first child but thereafter they want
only sons.
 The consequent elimination of the female
child has continued to increase rather than
decline with the spread of education.
.
 The sex of the foetus -done by methods like
amniocentesis, chorion villus biopsy and now
by the most popular technique-
ultrasonography.
 Varying between female infanticide and
female foeticide, for female foeticide the
assistance of a third party namely a medical
practitioner, is required to determine the sex
of the foetus .
 sex determination centres have mushroomed
in all parts of the country including small
districts and villages .
 In many cases, these centres are manned not
by qualified doctors but only by technicians.
 The increase in female foeticide has seen the
proportionate decrease in female sex ratio.
 If this decline is not checked the very
delicate equilibrium of nature can be
permanently destroyed.
 Female infanticide had been prohibited through
legislation in the pre-independence period..
 With the rise of pre-natal diagnostic techniques
especially amniocentesis, the government in
1978 banned the misuse of amniocentesis in
government hospitals/laboratories.
 The relentless efforts of activists, a law to
prevent sex determination tests was passed in
Maharashtra known as the Maharashtra
Regulation of Pre-natal Diagnostic Techniques
Act, 1988.
 The Parliament enacted the Pre-Natal Diagnostic
Techniques (Regulation and Prevention of Misuse)
Act on 20th September 1994 (hereinafter referred to
as the PNDT Act).
 After detailed deliberations, the PNDT Act
has been amended with the amended Act
having come into force with effect from
January 2003 .
PC -PNDT ACT .
An Act to provide for the prohibition of sex
selection, before or after conception,
All Gynecological or obstetrical or medical
procedures such as::-
 􀀀Ultrasonography;
 􀀀Foetoscopy;
 􀀀Taking or removing samples of:
 􀀀 Amniotic fluid
 􀀀 Chorionic villi
 􀀀 Blood
 􀀀 Any tissue
 􀀀 Fluid
of a man or a woman before or after conception -
for conducting any type of analysis/
diagnostic tests for selection of sex before or after
 Pre-natal diagnostic test means:
 􀀀Ultra sonography
 􀀀Test or analysis of:--
 􀀀 Amniotic fluid
 􀀀 Chorionic villi
 􀀀 Blood.
 􀀀 Any tissue
 􀀀 Fluid
of any pregnant woman or conceptus conducted to detect:
 􀀀 Genetic disorders
 􀀀 Metabolic disorders
 􀀀 Chromosomal abnormalities
 􀀀 Congenital anomalies
 􀀀 Haemo globinopathies
 􀀀 Sex-linked diseases.
 Genetic Laboratory means
 􀀀A laboratory; and
 􀀀Includes a place
 where facilities are provided for conducting
analysis or tests of samples received from
Genetic Clinic
 for pre-natal diagnostic test.
For a genetic clinic, the gynecologist should
have adequate experience in pre-natal
diagnostic procedures
 i.e. should have performed at least 20
procedures in chorionic villi aspirations per
vagina or per abdomen,
 under supervision of an experienced
gynecologist in these fields.
Medical Geneticist includes a person who
possesses:
 􀀀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 .
 Under the amended definition, possessing a
certificate does not make one a qualified
medical geneticist .
 For a genetic counseling centre, the
paediatrician must have
 􀀀6 months experience in genetic counselling;
or
 􀀀4 weeks training in genetic counselling.
 There should be a laboratory technician
 􀀀Having
 􀀀 B.Sc. degree in Biological Sciences; or
 􀀀 Degree or;
 􀀀 Diploma, in medical laboratory course; and
 􀀀At least one year’s experience in conducting
appropriate pre-natal diagnostic techniques,
tests or procedures.
 Genetic Counselling Centre:
 The requirements for a Genetic Counselling Centre
are enumerated in Rule 3(1) in the amended Rules.
 􀀀The centre should have adequate space.
 􀀀The centre should contain educational
charts/models/equipments for carrying out genetic
counselling .
 .
 􀀀The centre must have any one of the following
employees namely:
 􀀀A medical geneticist
 􀀀A gynaecologist; or
 􀀀A paediatrician
 Genetic Laboratory
 The laboratory should have adequate space for
conducting the tests.
 Equipments to conduct
 chromosomal studies, biochemical studies and
molecular studies.
 􀀀The laboratory must have both a medical
geneticist and a laboratory technician in its
employment
For Genetic Clinic
 The centre should have adequate space.
 The clinic/ultrasound clinic/imaging centre
should have or acquire – Equipments
 as may be necessary for carrying out the tests or
procedures:
 An obstetrician/gynaecologist
 An ultra-sonography machine including mobile
ultrasound machine, imaging machine or
 any other equipment capable of conducting
foetal ultrasonography.
 Appropriate catheters and equipment for
carrying out chorionic villi aspirations per
vagina or per abdomen.
 Appropriate sterile needles for amniocentesis
or cordocentesis.
 A suitable foetoscope with appropriate
accessories for foetoscopy, foetal skin or
organ biopsy or foetal blood sampling .
 4.6 lac girls are missing at birth every year
over the last five years between 2013-17.
Bihar :-
 53,283 missing / year over 12 years between
2001-12 .
 4.0% of all female births .
Total sex ratio of India – 943
Total child sex ratio of India – 919 (0- 6 yrs)
( More child at Birth )
Total sex ratio of Bihar –918
Total child sex ratio of Bihar – 935
Section / Rule Prohibitory provisions under the Act
Section 3A Prohibition of sex selection .
Section 3B Prohibition of sale of ultrasound machine to persons ,
laboratories , clinics ,etc not registered under the Act .
Section 5(2) Prohibition on communication of sex of foetus by words
, sign or in any other manner .
Section 6 Determination of sex prohibited .
Section 22 Prohibition of advertisement relating to Pre concption
and prenatal determination of sex .
Section/ Rule Regulatory prohibitions
Section 4 Regulation of pre natal diagnostics techniques .
Section 5(1) Written consent of women
Section 29 and
rule 9
Maintenance and preservations of records .
Section 18 and
rule 4
Registration of genetic counseling centers , genetic
laboratories and genetic clinics .
Section 19 / rule
6
Certificate or registration
Section 20 Cancellation or suspention of registration .
Rule 6 (6)
Rule 6 (7)
Certificate of registration shall not be transferable
.
Rule 3 Minimum requirement for conducting sonography
Rule 3 (B) Regulation of portable machine .
Rule 13 Intimation of changes in employees , place or
equipment .
Rule 3 (3) Qualified medical practitioners shall be permitted
to be registered with a maximum of two clinics
within a districts .
 Any radiologist or gynecologist with a post
graduate degree / diploma .
 Any RMP who has undergone a 300 hour
training titled Fundamentals in Abdomino-
Pelvic ultrasonography .
 RMPs already practicing need to qualify a
competency based assessment specified in
schedule 2 .
Section / Rule Penal Prohibitions
Section 22 (3) Penalty for advertising under the act .
Section 23 (1) Punishment for Medical practitioner contravening
any provision of the act or rules
Section 23 (2) Suspension of registration / removal of name from
register of Medical Practitioner by State Medical
Council .
Section 23 (3) Punishment for person seeking aid for pre
conception or pre natal diagnosis for the purpose
of sex selection .
Section 23 (4) Provisions of section 23 (3) does not apply to
Pregnant women .
Section / Rule Provisions
Section 27 Offences are cognizable , non-bailable and non
compoundable .
Section 28 (1) Court to take cognizance on a complaint made by
AA or a person who has given a notice of no less
than 15 days to AA of alleged offence .
Section 28 (2) Cases to be tried by court of Metropolitan Magistrate
or JMFC .
Section 24 Presumption that pregnant women was forced to
undergo pre natal tests .
Section 31 Protection of Action taken in good faith .
 What to be registered :-
 All genetic counseling centers .
 All genetic laboratories .
 All genetics clinics
 All centers where any imaging machine having
potential of determining the sex of fetus before
or after conception is being used.
 Registration is binding on all govt./semi
govt./private /company owned hospitals/clinics
and medical colleges- if providing above services
 Details of place – where center is to be established .
 Details of machine/probe (make, model, serial no. &
number of machine .
 Registration fee either Rs 25000 or Rs 35000
 No fees for public institutes .
 As per rule fees should be paid by DD drawn in favor
of Appropriate Authority .
 After receipt of application AA should make enquiry
for verification .
 After satisfaction , application should be placed to
Advisory Committee .
 As per rule 6(2) – having regards to the advice –
Registration Certificate to be issued in duplicate in
form B .
 Doctors Details :-
 1. Dr. Image
 2. Matric Certificate
 3. M.B.B.S. Certificate
 4.Degree/ Diploma ( Radio Diagnosis/ Obs &
Gynae )
 5. State Medical Council/ NMC Registration
 6. Consent Letter
 7. PAN Card
 8. Aadhar Card
 9. Affidavit By Judicial Magistrate
 Proprietor Details :-
 1. New Machine Quotation Paper / Old
Machine Paper
 2. Affidavit by Judicial Magistrate
 3. Aadhar Card
 4. PAN card
 5. Registered Place Map
 6. Contract of Proposed Place / Current
Holding Tax receipt of Place
 No qualified doctor
 Incomplete Form F
 No register maintained
 Registration expired
 Unregistered machine
 Book unavailable
 Board not displayed
 Unregistered place
 Non submission of monthly records
 Deficiency in recor keeping
 Late submission of reports
Non – availability of copy of the
PC-PNDT act in the registered
center
Cases may be launched in the
court of Judicial Magistrate 1st
Class u/s 25 of the act .
Show cause notice u/s 20(1) ,(2)
for temporary suspension of
registration .
Non – Display of Registration
Certificate in the center
- Above penalty -
Non – Display of board in the
premises in English and local
language
-Above penalty -
Advertisement relating to pre-
conception and pre-natal
determination of sex
u/s 22 (3) of the PC-PNDT
amendment act , case to be
launched in the court u/s 28 of the
act.
Unregistered centers / machine Equipment to be sealed & seized
by the Appropriate authority
concerned .
Launch the case in the court u/s
28 of the act .
Registration granted after penalty
& affidavit .
Record keeping irregularities
( revised Form F – major offence )
Punishable u/s 23(1) of the PC-
PNDT Act .
Sex Selection Violation of section 5 and 6 of the
act and punishable u/s 23 of the
act .
 Central Supervisory Board (section 7)
 State Supervisory Board ( section 16 A)
 State Appropriate Authority / State Advisory
Committee (section 17)
 District Appropriate Authority / District
Advisory Committee
 Minister of H &FW – Chairperson
 Secretary H & FW – Vice chairperson
 Senior Officer of H & FW – Member Secretary
 Representative of WCD , Law and Judiciary
 Ex – officio women members from NGOs
 Elected Representatives
 Specialists from legal and medical field
 Highest decision making and advisory body
 Reviews and monitors implementation of Act
in states .
 Creates awareness on the issue
 Can suggest amendments to Rules
 Meets once in six months
 Monitors implementation of Act in Districts
 Reviews activities of Appropriate Authority
 Creates Public awareness
 Sends consolidated reports to Central
Supervisory Board regarding activities
undertaken in the State
 Meets once in four months
 State Appropriate Authority – Three members
team ( Officer of rank of Joint Director or
above of Department of Health and Family
Welfare , Eminent women from NGO , Officer
of Law and Judiciary Department )
 District AA - Civil Surgeon / Chief Medical
Officer .
 Corporation AA – Medical Officers of Health
( some states e.g. Maharashtra )
 Medical Experts – Three
 Social Workers - Three ( one from women’s
representative )
 Legal Expert
 Officer of Information and Publicity
department .
 ( Eight members : under section 17 (5)
 Search , seize or seal equipment or clinic and
seize records at a genetic counseling centre ,
laboratory and clinic .
 Filling a complaint ( section 28 A )
 Cancellation or Suspension of Registration (
section20 )
 Report name of medical practitioner against
whom carge has been framed to State Medical
Council – ( section 23-2)
 To aid and advise the AA in discharge of function.
 They may be :-
 To grant , suspend and cancel registration .
 To enforce prescribed standard .
 To investigate complaints .
 To take appropriate legal action against person who
misuse technique of PC-PNDT .
 To create public awareness .
 To recommend modification in the act .
 To support AA in taking legal action for violation of
Act
 To help in supervising and implementing the
provisions of the act to AA .
 Adv. Committee shall meet as and when it
thinks fit .
 On the request of AA for consideration of any
application for registration or any complaint
for suspension or cancellation of registration
and to advice thereon .
 The period between two meetings shall not
exceed 60 days .
 1. Name, Address of Genetic
 Counselling Centre
 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 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 pregnancy
 9. History of genetic/medical disease in the family
 (specify)
 Basis of diagnosis:
 (a) Clinical
 (b) Bio-chemical
 (c) Cytogenetic
 (d) Other (e.g.radiological, ultrasonography)
 Indication for pre-natal diagnosis
 10.A. Previous child/children with:
 (i) Chromosomal disorders
 (ii) Metabolic disorders
 (iii) Congenital anomaly
 (iv) Mental retardation
 (v) Haemoglobinopathy
 (vi) Sex-linked disorders
 (vii) Single gene disorder
 (viii) Any other (specify)
 B. Advanced maternal age (35 years)
 C. Mother/father/sibling having genetic disease (specify)
 D. Others (specify)
 11. Procedure advised2
 (i) Ultrasound
 (ii) Amniocentesis
 (iii) Chorionic villi biopsy
 (iv) Foetoscopy
 (v) Foetal skin or organ biopsy
 (vi) Cordocentesis
 (vii) Any other (specify)
 12. Laboratory tests to be carried out
 (i) Chromosomal studies
 (ii)Biochemical studies
 (iii) Molecular studies
 (iv) Pre implantation gender diagnosis
 13. Result of pre-natal diagnosis
 If abnormal give details. Normal/Abnormal
 14. Was MTP advised?
 15. Name and address of Genetic Clinic* to which patient
is referred.
 16. Dates of commencement and completion of genetic
counselling .
 Place: Name, Signature and Registration No. of the
 Date: Medical Geneticist/Gynaecologist/Paediatrician
 administering Genetic Counselling.
 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 by/sample sent by
 8. Type of sample: Maternal 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
 (ii) Metabolic disorders
 (iii) Malformation(s)
 (iv) Mental retardation
 (v) Hereditary haemolytic anaemia
 (vi) Sex-linked disorder
 (vii) Single gene disorder
 (viii) Any other (specify)
 B. Advanced maternal age (35 years or above)
 C. Mother/father/sibling has genetic disease (specify)
 D. Other (specify)
 10. Laboratory tests carried out (give details)
 (i) Chromosomal studies
 (ii) Biochemical studies
 (iii) Molecular studies
 (iv) Pre implantation gender diagnosis
 11. Result of pre-natal 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 …………………….
 Name, Signature and Registration No. of the
 Medical Geneticist/Director of the Institute
 FORM I (under the MTP Regulations)
 (See Regulation 3)
 l…………………………………………………….
 (Name and qualification of the Registered Medical Practitioner in block letters)
 …………………………………………………….
 (Full address of the Registered Medical Practitioner)
 I,…………………………………………………
 (Name and qualification of the Registered Medical Practitioner in block letters)
 ……………………………………………………
 (Full address of the Registered Medical Practitioner) hereby certify that
*I/we/am/are of opinion, formed in good faith,
 that it is necessary to terminate the pregnancy of ………………………………….
 (Full name of pregnant woman in block letters)
 resident of……………………………………..
 (Full address of woman in block letters)
 for the reasons given below**,
 *I/We hereby give intimation that *I/we terminated the pregnancy of the woman
referred to above who bears the serial
 No. ……………….in the Admission Register of the Hospital/approved place.
 Signature of Registered Medical Practitioner
 i) In order to save the life of the pregnant woman.
 (ii) In order to prevent grave injury to the physical or mental
health of pregnant woman.
 (iii) In view of the substantial risk that if the child was born it
would suffer from such physical or mental abnormalities
 as to be seriously handicapped.
 (iv) As the pregnancy is alleged by pregnant woman to have been
caused by rape.
 (v) As the pregnancy has occurred as a result of failure of any
contraceptive device or method used by the married
 woman or her husband for the purpose of limiting the number of
children.
 Note- Account may be taken of the pregnant woman’s actual or
reasonably foreseeable environment in determining
 whether the continuance of a pregnancy would involve a grave
injury to her physical or mental health.
 Signature of Registered Medical Practitioner
 FORM C*
 (See rule 8)
 I,………………………………………………………daughter/wife
of………………………………………………………
 aged about ……… years of ……………. (here state the permanent
address) ……………………………
 …………………………………………………………………at present
residing at …………………………………………………
 ……………… …………………………………………………… do hereby
give my consent of the termination of my pregnancy
 at ……………………………………… (state the name of a place
where the pregnancy is to be terminated).
 Signature
 Place:
 Date:
 (To be filled in by guardian where the woman is lunatic or minor)
 I,………………………………………………………daughter/wife
of………………………………………………………
 aged about ……………..years of ……..…….. at present residing at
………………………………………………………………
 ………………………… (permanent address)
……………………………………………………….do hereby give my
consent to
 the termination of the pregnancy of my ward
…………………………………………………………………who is a
minor/
 lunatic at ……………………… (place of termination of pregnancy).
 Signature
 Place:
 Date:
 47
 FORM-II*
 [See Regulation 4 (5)]
 1. Name of the State.
 2. Name of Hospital/approved place.
 3. Duration of pregnancy (give total number only):
 (a) upto 12 weeks.
 (b) Between 12-20 weeks.
 4. Religion of woman:
 (a) Hindu
 (b) Muslim
 (c) Christian
 (d) Others
 (e) Total
 5. Termination with acceptance of contraception:
 (a) Sterilization
 (b) I.U.D.
 6. Reasons for termination: (give total number under each sub-head):
 (a) Danger to life of the pregnant woman.
 (b) Grave injury to the mental health of the pregnant woman.
 (c) Grave injury to the physical health of the pregnant woman.
 (d) Pregnancy caused by rape.
 (e) Substantial risk that if the child was born it would suffer from such physical or mental abnormalities as to be
 seriously handicapped.
 (f) Failure of any contraceptive device or method.
 Signature of the Officer
 In-charge with date.
 * Under the MTP Act
Implementation of pre conception and pre natal diagnostics By DR.R.Mohan
Implementation of pre conception and pre natal diagnostics By DR.R.Mohan

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Implementation of pre conception and pre natal diagnostics By DR.R.Mohan

  • 1. DR. Ravindra Mohan M.D.(Obs & Gynae) Member Secretary , District Advisory Committee , Saharsa ,Bihar
  • 2.  Socially , culturally and religiously women are given secondary status .  In marriage too - women are given Sub ordinate status  Women are vulnerable to violence .  Various methods were used to eliminate the girl child after her birth like starving her, crushing her under the bed or giving her poison etc .
  • 3.  Belief that - only the son can perform the last rites, that lineage and inheritance runs through the male line, sons will look after parents in old age, men are the bread winners etc .  In some cases parents accept the daughter if the first child but thereafter they want only sons.  The consequent elimination of the female child has continued to increase rather than decline with the spread of education.
  • 4. .  The sex of the foetus -done by methods like amniocentesis, chorion villus biopsy and now by the most popular technique- ultrasonography.  Varying between female infanticide and female foeticide, for female foeticide the assistance of a third party namely a medical practitioner, is required to determine the sex of the foetus .
  • 5.  sex determination centres have mushroomed in all parts of the country including small districts and villages .  In many cases, these centres are manned not by qualified doctors but only by technicians.  The increase in female foeticide has seen the proportionate decrease in female sex ratio.  If this decline is not checked the very delicate equilibrium of nature can be permanently destroyed.
  • 6.  Female infanticide had been prohibited through legislation in the pre-independence period..  With the rise of pre-natal diagnostic techniques especially amniocentesis, the government in 1978 banned the misuse of amniocentesis in government hospitals/laboratories.  The relentless efforts of activists, a law to prevent sex determination tests was passed in Maharashtra known as the Maharashtra Regulation of Pre-natal Diagnostic Techniques Act, 1988.
  • 7.  The Parliament enacted the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act on 20th September 1994 (hereinafter referred to as the PNDT Act).  After detailed deliberations, the PNDT Act has been amended with the amended Act having come into force with effect from January 2003 . PC -PNDT ACT . An Act to provide for the prohibition of sex selection, before or after conception,
  • 8. All Gynecological or obstetrical or medical procedures such as::-  􀀀Ultrasonography;  􀀀Foetoscopy;  􀀀Taking or removing samples of:  􀀀 Amniotic fluid  􀀀 Chorionic villi  􀀀 Blood  􀀀 Any tissue  􀀀 Fluid of a man or a woman before or after conception - for conducting any type of analysis/ diagnostic tests for selection of sex before or after
  • 9.  Pre-natal diagnostic test means:  􀀀Ultra sonography  􀀀Test or analysis of:--  􀀀 Amniotic fluid  􀀀 Chorionic villi  􀀀 Blood.  􀀀 Any tissue  􀀀 Fluid of any pregnant woman or conceptus conducted to detect:  􀀀 Genetic disorders  􀀀 Metabolic disorders  􀀀 Chromosomal abnormalities  􀀀 Congenital anomalies  􀀀 Haemo globinopathies  􀀀 Sex-linked diseases.
  • 10.  Genetic Laboratory means  􀀀A laboratory; and  􀀀Includes a place  where facilities are provided for conducting analysis or tests of samples received from Genetic Clinic  for pre-natal diagnostic test.
  • 11. For a genetic clinic, the gynecologist should have adequate experience in pre-natal diagnostic procedures  i.e. should have performed at least 20 procedures in chorionic villi aspirations per vagina or per abdomen,  under supervision of an experienced gynecologist in these fields.
  • 12. Medical Geneticist includes a person who possesses:  􀀀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 .  Under the amended definition, possessing a certificate does not make one a qualified medical geneticist .
  • 13.  For a genetic counseling centre, the paediatrician must have  􀀀6 months experience in genetic counselling; or  􀀀4 weeks training in genetic counselling.
  • 14.  There should be a laboratory technician  􀀀Having  􀀀 B.Sc. degree in Biological Sciences; or  􀀀 Degree or;  􀀀 Diploma, in medical laboratory course; and  􀀀At least one year’s experience in conducting appropriate pre-natal diagnostic techniques, tests or procedures.
  • 15.  Genetic Counselling Centre:  The requirements for a Genetic Counselling Centre are enumerated in Rule 3(1) in the amended Rules.  􀀀The centre should have adequate space.  􀀀The centre should contain educational charts/models/equipments for carrying out genetic counselling .  .  􀀀The centre must have any one of the following employees namely:  􀀀A medical geneticist  􀀀A gynaecologist; or  􀀀A paediatrician
  • 16.  Genetic Laboratory  The laboratory should have adequate space for conducting the tests.  Equipments to conduct  chromosomal studies, biochemical studies and molecular studies.  􀀀The laboratory must have both a medical geneticist and a laboratory technician in its employment
  • 17. For Genetic Clinic  The centre should have adequate space.  The clinic/ultrasound clinic/imaging centre should have or acquire – Equipments  as may be necessary for carrying out the tests or procedures:  An obstetrician/gynaecologist  An ultra-sonography machine including mobile ultrasound machine, imaging machine or  any other equipment capable of conducting foetal ultrasonography.
  • 18.  Appropriate catheters and equipment for carrying out chorionic villi aspirations per vagina or per abdomen.  Appropriate sterile needles for amniocentesis or cordocentesis.  A suitable foetoscope with appropriate accessories for foetoscopy, foetal skin or organ biopsy or foetal blood sampling .
  • 19.
  • 20.  4.6 lac girls are missing at birth every year over the last five years between 2013-17. Bihar :-  53,283 missing / year over 12 years between 2001-12 .  4.0% of all female births . Total sex ratio of India – 943 Total child sex ratio of India – 919 (0- 6 yrs) ( More child at Birth ) Total sex ratio of Bihar –918 Total child sex ratio of Bihar – 935
  • 21. Section / Rule Prohibitory provisions under the Act Section 3A Prohibition of sex selection . Section 3B Prohibition of sale of ultrasound machine to persons , laboratories , clinics ,etc not registered under the Act . Section 5(2) Prohibition on communication of sex of foetus by words , sign or in any other manner . Section 6 Determination of sex prohibited . Section 22 Prohibition of advertisement relating to Pre concption and prenatal determination of sex .
  • 22. Section/ Rule Regulatory prohibitions Section 4 Regulation of pre natal diagnostics techniques . Section 5(1) Written consent of women Section 29 and rule 9 Maintenance and preservations of records . Section 18 and rule 4 Registration of genetic counseling centers , genetic laboratories and genetic clinics . Section 19 / rule 6 Certificate or registration Section 20 Cancellation or suspention of registration .
  • 23. Rule 6 (6) Rule 6 (7) Certificate of registration shall not be transferable . Rule 3 Minimum requirement for conducting sonography Rule 3 (B) Regulation of portable machine . Rule 13 Intimation of changes in employees , place or equipment . Rule 3 (3) Qualified medical practitioners shall be permitted to be registered with a maximum of two clinics within a districts .
  • 24.  Any radiologist or gynecologist with a post graduate degree / diploma .  Any RMP who has undergone a 300 hour training titled Fundamentals in Abdomino- Pelvic ultrasonography .  RMPs already practicing need to qualify a competency based assessment specified in schedule 2 .
  • 25. Section / Rule Penal Prohibitions Section 22 (3) Penalty for advertising under the act . Section 23 (1) Punishment for Medical practitioner contravening any provision of the act or rules Section 23 (2) Suspension of registration / removal of name from register of Medical Practitioner by State Medical Council . Section 23 (3) Punishment for person seeking aid for pre conception or pre natal diagnosis for the purpose of sex selection . Section 23 (4) Provisions of section 23 (3) does not apply to Pregnant women .
  • 26. Section / Rule Provisions Section 27 Offences are cognizable , non-bailable and non compoundable . Section 28 (1) Court to take cognizance on a complaint made by AA or a person who has given a notice of no less than 15 days to AA of alleged offence . Section 28 (2) Cases to be tried by court of Metropolitan Magistrate or JMFC . Section 24 Presumption that pregnant women was forced to undergo pre natal tests . Section 31 Protection of Action taken in good faith .
  • 27.  What to be registered :-  All genetic counseling centers .  All genetic laboratories .  All genetics clinics  All centers where any imaging machine having potential of determining the sex of fetus before or after conception is being used.  Registration is binding on all govt./semi govt./private /company owned hospitals/clinics and medical colleges- if providing above services
  • 28.  Details of place – where center is to be established .  Details of machine/probe (make, model, serial no. & number of machine .  Registration fee either Rs 25000 or Rs 35000  No fees for public institutes .  As per rule fees should be paid by DD drawn in favor of Appropriate Authority .  After receipt of application AA should make enquiry for verification .  After satisfaction , application should be placed to Advisory Committee .  As per rule 6(2) – having regards to the advice – Registration Certificate to be issued in duplicate in form B .
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.  Doctors Details :-  1. Dr. Image  2. Matric Certificate  3. M.B.B.S. Certificate  4.Degree/ Diploma ( Radio Diagnosis/ Obs & Gynae )  5. State Medical Council/ NMC Registration  6. Consent Letter  7. PAN Card  8. Aadhar Card  9. Affidavit By Judicial Magistrate
  • 36.  Proprietor Details :-  1. New Machine Quotation Paper / Old Machine Paper  2. Affidavit by Judicial Magistrate  3. Aadhar Card  4. PAN card  5. Registered Place Map  6. Contract of Proposed Place / Current Holding Tax receipt of Place
  • 37.
  • 38.
  • 39.
  • 40.  No qualified doctor  Incomplete Form F  No register maintained  Registration expired  Unregistered machine  Book unavailable  Board not displayed  Unregistered place  Non submission of monthly records  Deficiency in recor keeping  Late submission of reports
  • 41. Non – availability of copy of the PC-PNDT act in the registered center Cases may be launched in the court of Judicial Magistrate 1st Class u/s 25 of the act . Show cause notice u/s 20(1) ,(2) for temporary suspension of registration . Non – Display of Registration Certificate in the center - Above penalty - Non – Display of board in the premises in English and local language -Above penalty - Advertisement relating to pre- conception and pre-natal determination of sex u/s 22 (3) of the PC-PNDT amendment act , case to be launched in the court u/s 28 of the act.
  • 42. Unregistered centers / machine Equipment to be sealed & seized by the Appropriate authority concerned . Launch the case in the court u/s 28 of the act . Registration granted after penalty & affidavit . Record keeping irregularities ( revised Form F – major offence ) Punishable u/s 23(1) of the PC- PNDT Act . Sex Selection Violation of section 5 and 6 of the act and punishable u/s 23 of the act .
  • 43.
  • 44.  Central Supervisory Board (section 7)  State Supervisory Board ( section 16 A)  State Appropriate Authority / State Advisory Committee (section 17)  District Appropriate Authority / District Advisory Committee
  • 45.  Minister of H &FW – Chairperson  Secretary H & FW – Vice chairperson  Senior Officer of H & FW – Member Secretary  Representative of WCD , Law and Judiciary  Ex – officio women members from NGOs  Elected Representatives  Specialists from legal and medical field
  • 46.  Highest decision making and advisory body  Reviews and monitors implementation of Act in states .  Creates awareness on the issue  Can suggest amendments to Rules  Meets once in six months
  • 47.  Monitors implementation of Act in Districts  Reviews activities of Appropriate Authority  Creates Public awareness  Sends consolidated reports to Central Supervisory Board regarding activities undertaken in the State  Meets once in four months
  • 48.  State Appropriate Authority – Three members team ( Officer of rank of Joint Director or above of Department of Health and Family Welfare , Eminent women from NGO , Officer of Law and Judiciary Department )  District AA - Civil Surgeon / Chief Medical Officer .  Corporation AA – Medical Officers of Health ( some states e.g. Maharashtra )
  • 49.  Medical Experts – Three  Social Workers - Three ( one from women’s representative )  Legal Expert  Officer of Information and Publicity department .  ( Eight members : under section 17 (5)
  • 50.  Search , seize or seal equipment or clinic and seize records at a genetic counseling centre , laboratory and clinic .  Filling a complaint ( section 28 A )  Cancellation or Suspension of Registration ( section20 )  Report name of medical practitioner against whom carge has been framed to State Medical Council – ( section 23-2)
  • 51.  To aid and advise the AA in discharge of function.  They may be :-  To grant , suspend and cancel registration .  To enforce prescribed standard .  To investigate complaints .  To take appropriate legal action against person who misuse technique of PC-PNDT .  To create public awareness .  To recommend modification in the act .  To support AA in taking legal action for violation of Act  To help in supervising and implementing the provisions of the act to AA .
  • 52.  Adv. Committee shall meet as and when it thinks fit .  On the request of AA for consideration of any application for registration or any complaint for suspension or cancellation of registration and to advice thereon .  The period between two meetings shall not exceed 60 days .
  • 53.
  • 54.
  • 55.
  • 56.
  • 57.
  • 58.
  • 59.
  • 60.
  • 61.
  • 62.
  • 63.
  • 64.
  • 65.
  • 66.
  • 67.
  • 68.
  • 69.
  • 70.
  • 71.
  • 72.
  • 73.
  • 74.
  • 75.
  • 76.  1. Name, Address of Genetic  Counselling Centre  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 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 pregnancy  9. History of genetic/medical disease in the family  (specify)  Basis of diagnosis:  (a) Clinical  (b) Bio-chemical  (c) Cytogenetic  (d) Other (e.g.radiological, ultrasonography)
  • 77.  Indication for pre-natal diagnosis  10.A. Previous child/children with:  (i) Chromosomal disorders  (ii) Metabolic disorders  (iii) Congenital anomaly  (iv) Mental retardation  (v) Haemoglobinopathy  (vi) Sex-linked disorders  (vii) Single gene disorder  (viii) Any other (specify)  B. Advanced maternal age (35 years)  C. Mother/father/sibling having genetic disease (specify)  D. Others (specify)  11. Procedure advised2  (i) Ultrasound  (ii) Amniocentesis  (iii) Chorionic villi biopsy  (iv) Foetoscopy  (v) Foetal skin or organ biopsy  (vi) Cordocentesis  (vii) Any other (specify)
  • 78.  12. Laboratory tests to be carried out  (i) Chromosomal studies  (ii)Biochemical studies  (iii) Molecular studies  (iv) Pre implantation gender diagnosis  13. Result of pre-natal diagnosis  If abnormal give details. Normal/Abnormal  14. Was MTP advised?  15. Name and address of Genetic Clinic* to which patient is referred.  16. Dates of commencement and completion of genetic counselling .  Place: Name, Signature and Registration No. of the  Date: Medical Geneticist/Gynaecologist/Paediatrician  administering Genetic Counselling.
  • 79.  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 by/sample sent by  8. Type of sample: Maternal 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  (ii) Metabolic disorders  (iii) Malformation(s)  (iv) Mental retardation  (v) Hereditary haemolytic anaemia  (vi) Sex-linked disorder  (vii) Single gene disorder  (viii) Any other (specify)  B. Advanced maternal age (35 years or above)  C. Mother/father/sibling has genetic disease (specify)  D. Other (specify)
  • 80.  10. Laboratory tests carried out (give details)  (i) Chromosomal studies  (ii) Biochemical studies  (iii) Molecular studies  (iv) Pre implantation gender diagnosis  11. Result of pre-natal 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 …………………….  Name, Signature and Registration No. of the  Medical Geneticist/Director of the Institute
  • 81.
  • 82.
  • 83.
  • 84.
  • 85.  FORM I (under the MTP Regulations)  (See Regulation 3)  l…………………………………………………….  (Name and qualification of the Registered Medical Practitioner in block letters)  …………………………………………………….  (Full address of the Registered Medical Practitioner)  I,…………………………………………………  (Name and qualification of the Registered Medical Practitioner in block letters)  ……………………………………………………  (Full address of the Registered Medical Practitioner) hereby certify that *I/we/am/are of opinion, formed in good faith,  that it is necessary to terminate the pregnancy of ………………………………….  (Full name of pregnant woman in block letters)  resident of……………………………………..  (Full address of woman in block letters)  for the reasons given below**,  *I/We hereby give intimation that *I/we terminated the pregnancy of the woman referred to above who bears the serial  No. ……………….in the Admission Register of the Hospital/approved place.  Signature of Registered Medical Practitioner
  • 86.  i) In order to save the life of the pregnant woman.  (ii) In order to prevent grave injury to the physical or mental health of pregnant woman.  (iii) In view of the substantial risk that if the child was born it would suffer from such physical or mental abnormalities  as to be seriously handicapped.  (iv) As the pregnancy is alleged by pregnant woman to have been caused by rape.  (v) As the pregnancy has occurred as a result of failure of any contraceptive device or method used by the married  woman or her husband for the purpose of limiting the number of children.  Note- Account may be taken of the pregnant woman’s actual or reasonably foreseeable environment in determining  whether the continuance of a pregnancy would involve a grave injury to her physical or mental health.  Signature of Registered Medical Practitioner
  • 87.  FORM C*  (See rule 8)  I,………………………………………………………daughter/wife of………………………………………………………  aged about ……… years of ……………. (here state the permanent address) ……………………………  …………………………………………………………………at present residing at …………………………………………………  ……………… …………………………………………………… do hereby give my consent of the termination of my pregnancy  at ……………………………………… (state the name of a place where the pregnancy is to be terminated).  Signature  Place:  Date:
  • 88.  (To be filled in by guardian where the woman is lunatic or minor)  I,………………………………………………………daughter/wife of………………………………………………………  aged about ……………..years of ……..…….. at present residing at ………………………………………………………………  ………………………… (permanent address) ……………………………………………………….do hereby give my consent to  the termination of the pregnancy of my ward …………………………………………………………………who is a minor/  lunatic at ……………………… (place of termination of pregnancy).  Signature  Place:  Date:
  • 89.  47  FORM-II*  [See Regulation 4 (5)]  1. Name of the State.  2. Name of Hospital/approved place.  3. Duration of pregnancy (give total number only):  (a) upto 12 weeks.  (b) Between 12-20 weeks.  4. Religion of woman:  (a) Hindu  (b) Muslim  (c) Christian  (d) Others  (e) Total  5. Termination with acceptance of contraception:  (a) Sterilization  (b) I.U.D.  6. Reasons for termination: (give total number under each sub-head):  (a) Danger to life of the pregnant woman.  (b) Grave injury to the mental health of the pregnant woman.  (c) Grave injury to the physical health of the pregnant woman.  (d) Pregnancy caused by rape.  (e) Substantial risk that if the child was born it would suffer from such physical or mental abnormalities as to be  seriously handicapped.  (f) Failure of any contraceptive device or method.  Signature of the Officer  In-charge with date.  * Under the MTP Act