pndta technical aspects 2012

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THE PRECONCEPTION & PRENATAL DIAGNOSTIC TECHNIQUES (PROHIBITION OF SEX SELECTION) ACT 2003 Dr. Arun Moray M.D. Asso. Prof. & H.O.D. Dept. of OB-GYN S.B.H.Govt. Medical College

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Page 1: PNDTA Technical Aspects 2012

THE PRECONCEPTION &

PRENATAL DIAGNOSTIC

TECHNIQUES (PROHIBITION

OF SEX SELECTION) ACT 2003

Dr. Arun MorayM.D.Asso. Prof. & H.O.D.Dept. of OB-GYNS.B.H.Govt. Medical College, Dhule.

                                

Page 2: PNDTA Technical Aspects 2012

                                                                                                                         

                                                                                                                         

She faces society's scornEven before she is bornThey don't see the rose only the thornIf she dies, none there will be to mourn

Because we think she has no worthShe fights death even before birth

Page 3: PNDTA Technical Aspects 2012

Sex ratio•The number varies significantly around the world. •Europe- 105 women per 100 men. •This gender bias begins before birth and

impacts the length of women's lives.

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Census reports of 1991 and 2001 –Sex ratio has worsened in most parts of India.

-Far worse in respect of Girl child population in the age group of 0-6, particularly in the affluent areas of Punjab (793 girls to 1000 boys), Haryana (820), Chandigarh(845), Himachal Pradesh (897) and Delhi (865).

G.H.Dhule- Jan to Dec 07

Del- 6664 M-3594 F-3070 ( 1000 - 854 )

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Important Definitions

Population sex ratio Number of Females to 1000 males in general population India 940; Maharashtra 925 (Census 2011)

Child sex ratio Number of girls to 1000 boys in 0-6 age group India 914, Maharashtra 883 (Census 2011

Sex ratio at birth Number of girls to 1000 boys at birth India 904, Maharashtra 884 ( SRS 2006-08

Page 7: PNDTA Technical Aspects 2012

Sex Ratio India & Maharashtra, 1991-2011

Sr.No. Area Population Sex Ratio Child Sex Ratio

1991 2001 2011 1991 2001 2011

1India 927 933 940 946 927 914

2 Maharashtra 934 922 925 946 913 883

Page 8: PNDTA Technical Aspects 2012

Sr. No. District Overall Sex Ratio Child Sex Ratio Female/1000 0 -6 year 1991 2001 2011 1991 2001 2011

1 Thane 879 857 880 952 931 918 2 Raigad 1010 975 955 961 939 924 3 Ratnagiri 1205 1135 1123 961 952 940 4Sindhudurg 1137 1077 1037 963 944 910 5 Nashik 940 924 931 954 920 882 6 Dhule 945 945 941 947 907 876 7 Nandurbar 975 975 972 977 961 932 8 Jalgaon 940 932 922 925 880 829

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Scenario

•> 10mil female births in India may have been lost to abortion and sex selection in the past 20 years.

•Prenatal selection and selective abortion was causing the loss of 500,000 girls a year- Lancet.

•“Girl deficit" was more common among educated women but did not vary according to religion.

•If preceding child was a girl, the ratio of girls to boys in the next birth was 759 to 1,000.

•If two preceding children were girls, then the ratio for the third child born was just 719 girls to 1,000 boys.

•However, for a child following the birth of a male child, the gender ratio was roughly equal.

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Female infanticide still prevails despite the fact that the gentle touch of a daughter and her voice has soothing effect on the parents.

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The traditional system of killing the girl child after her birth has now given way to the more modern techniques of sex selection and female foeticide.

Page 20: PNDTA Technical Aspects 2012

Marked spread of female foeticide is due to:

•Bias about small family norm .

•Easy access to medical facilities .

•Ability to pay the doctor and abortionist for the test and abortion .

•A good network of roads to cut down the cost and time of travel .

•Easily available technological advances for sex-determination in utero .

•Unholy alliance of traditional thoughts as reflected in the ‘son complex’ .

Page 21: PNDTA Technical Aspects 2012

What was the need for such an Act?

The Supreme Court, taking a serious view of the onslaught of sex-selective discriminatory practices by the medical fraternity, and the connection it may have with the use of pre-natal sex determination, directed the Centre to implement the PC & PNDT Act in all its aspects. The order came following a public interest petition filed by the centre for the Enquiry of Health and Allied Themes (CEHAT), the Mahila Sarvangeen Utkarsh Mandal (MASUM) and Dr. Sabu George, who had done extensive research in this area.

Page 22: PNDTA Technical Aspects 2012

•In order to check female foeticide, the Prenatal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 was enacted.

•Became operational from 1st January 1996.

•The Act has been amended, with effect from February 2003- Due to certain inadequacies,practical difficulties in its implementation also due to scientific advances to select sex of a

child before conception

• The main purpose- to regulate and ban the use/advertisement of sex selection techniques and misuse of pre-natal

diagnostic techniques for SSA.

•The conviction of Satyam Diagnostic Center’s owner was the first ever conviction under the PNDT Act in the country.

Page 23: PNDTA Technical Aspects 2012

Definition

“An Act to provide for the prohibition of sex selection,

before or after conception, and for regulation of prenatal

diagnostic techniques for the purposes of detecting genetic

abnormalities or metabolic disorders or chromosomal

abnormalities or certain congenital malformations or sex-

linked disorders and for the prevention of their misuse for

sex determination leading to female foeticide; and for many

matters connected therewith or incidental thereto”.

Page 24: PNDTA Technical Aspects 2012

Provisions-

•Prohibition for determination of sex of fetus, leading to female feticide.

•Prohibits advt of PNDT techniques for detection of sex.

•Permits & regulates its use for detection of specific disorders at regd institutions only.

•Prohibits sale of USG & other machines.

•Punishment for violations of the provisions.

Page 25: PNDTA Technical Aspects 2012

Regulation of Genetic Counseling Centers, Genetic Laboratories and Genetic Clinics

On and from the commencement of this Act:

1. No genetic counseling center, genetic laboratory or genetic clinic unless registered under this Act shall conduct or associate with or help in conducting activities relating to prenatal diagnostic techniques.

2. No genetic counseling center, genetic laboratory or genetic clinic shall employ or cause to be employed any person who does not possess the prescribed qualification.

3. No medical geneticist, gynecologist, pediatrician or any other person shall conduct or aid in conducting by himself or through any other person, any prenatal diagnostic techniques at a place other than a place registered under the Act.

4. No person shall sell any ultrasound machine or imaging machine or scanner or any other equipment capable of detecting sex of the foetus to any genetic counseling center, genetic laboratory or genetic clinic or any other person not registered under the Act.

Page 26: PNDTA Technical Aspects 2012

Pre-natal diagnostic procedures-

Gynecological or obstetrical or medical procedures –

Ultrasonography,

Foetoscopy,

Amniocentesis,

Sampling of chorionic villi / embryo / blood or any other tissue or fluid of a man, or of a woman before or after conception, for being sent to a Genetic Laboratory or Genetic Clinic for conducting any type of analysis or pre-natal diagnostic tests for selection of sex before or after conception.

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Pre-natal diagnostic test-

Ultrasonography or any test or analysis of amniotic fluid,

chorionic villi, blood or any tissue or fluid of a

pregnant woman or conceptus conducted to

detect genetic or metabolic disorders or

chromosomal abnormalities or congenital

anomalies or Haemoglobinopathies or sex-

linked diseases.

Page 28: PNDTA Technical Aspects 2012

As per the provision of the act,following centers need registration (PC-PNDT Centers)

a. Genetic Counseling Center

b. Genetic Clinic

c. Genetic Laboratory

d. Ultrasound Clinic

e. Imaging Center

f. In Vitro Fertilization (IVF) Center

g. Any other center which is capable of detecting sex of the foetus.

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Regulation of Prenatal Diagnostic Techniques

No prenatal diagnostic techniques shall be conducted except for the purposes of detection of any of the following abnormalities, namely:

• Chromosomal abnormalities

• Genetic metabolic diseases

• Haemoglobinopathies

• Sex-linked genetic diseases

• Congenital anomalies

• Any other abnormalities or diseases as may be specified by the Central Supervisory Board

Page 30: PNDTA Technical Aspects 2012

No prenatal diagnostic technique shall be used or conducted unless the person qualified to do so is satisfied that any of the following conditions are fulfilled, namely:

• Age of the pregnant woman is above 35 years.

• The pregnant woman has undergone two or more spontaneous abortions or foetal losses.

• The pregnant woman has been exposed to potentially teratogenic agents such as drugs, radiation, infection or chemicals.

• The pregnant woman or her spouse has a family history of mental retardation or physical deformities such as spasticity or any other genetic disease.

• Any other condition as may be specified by the Central Supervisory Board.

Page 31: PNDTA Technical Aspects 2012

 Indications of USG during pregnancy  

• To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.

• Estimation of gestational age (dating).

• Detection of number of foetuses and their chorionicity.

• Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive failure/MTP failure.

• Vaginal bleeding / leaking.

• Follow-up of cases of abortion.

• Assessment of cervical canal and diameter of internal os.

• Discrepancy between uterine size and period of amenorrhoea.

• Any suspected adenexal or uterine pathology / abnormality.

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 Indications of USG during pregnancy (Cont…)• Detection of chromosomal abnormalities, foetal structural defects and

other abnormalities and their follow-up.

• To evaluate foetal presentation and position.

• Assessment of liquor amnii.

• Preterm labour / preterm premature rupture of membranes.

•  Evaluation of placental position, thickness, grading and abnormalities (placenta previa, retro placental hemorrhage, abnormal

adherence etc.).

• Evaluation of umbilical cord – presentation, insertion, nuchal encirclement, number of vessels and presence of true knot.

•  Evaluation of previous Caesarean Section scars.

•  Evaluation of foetal growth parameters, foetal weight and foetal well being.

•  Color flow mapping and duplex Doppler studies.

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• Ultrasound guided procedures such as medical termination of pregnancy, external cephalic version etc. and their follow-up.

• Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus sampling (CVS), amniocenteses, foetal blood sampling, foetal skin biopsy, amnio-infusion, intrauterine infusion, placement of shunts etc.

• Observation of intra-partum events.

• Medical/surgical conditions complicating pregnancy.

• Research/scientific studies in recognised institutions.

 Preserve the referral slip.

 Indications of USG during pregnancy (Cont…)

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No person including a relative or husband of the pregnant woman shall seek or encourage the conduct of any prenatal diagnostic test on her except for the purpose mentioned in the indications.

No person including a relative or husband of the pregnant woman shall seek or encourage the conduct of any sex-selection technique on her or him or both.

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Written consent of pregnant woman and prohibition of communicating the sex of the foetus-

No person shall conduct the prenatal diagnostic procedures unless-

• He has explained all known side and after effects of such procedure to the pregnant woman concerned.

• He has obtained in the prescribed form her written consent to undergo such procedure in the language, which she understands.

• A copy of her written consent obtained given back to the pregnant woman.

• No person conducting prenatal diagnostic procedure shall communicate to the pregnant woman concerned or her relative the sex of the foetus by words, signs or in any other manner.

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Determination of sex prohibited-

1. Prenatal diagnostic techniques including USG should

not be performed for sex determination.

2. No person shall, by whatever means, cause or allow

to be caused selection of sex before or after conception.

Page 37: PNDTA Technical Aspects 2012

Registration of centers--Prescribed form - Appropriate Authority

-Fees for registration is Rs. 3000/- &

for renewal of registration Rs. 1500/-

- Affidavit & undertaking

-Certificate of reg - in duplicate

non transferable

valid for 5 yrs.

renewal – 30 days before date of expiry.

•Grant of certificate of registration or rejection of application is done within 90 days from the date of receipt of application.

•In the event of change of ownership or change of management of the center a fresh application for registration certificate is mandatory.

Page 38: PNDTA Technical Aspects 2012

Technical Qualifications for setting up PC-PNDT Center :

For Genetic Counseling Center :

a.Gynecologist or pediatrician having six months experience or

four weeks training in genetic counseling.

b.Medical Geneticist

For Genetic Laboratory :

a.Medical Geneticist

b.Laboratory Technician (B.Sc with DMLT) with at least

one year experience.

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For Genetic Clinic/Ultrasound Clinic/Imaging Center :

a.Gynecologist having experience of performing at least 20

procedures in chorionic villi aspirations per vagina or per

abdomen,or organ biopsy or foetal blood sampling etc.

under supervision of experienced gynecologist in these

fields or

b.A sonologist. Imaging Specialist. Radiologist or Registered

Medical practitioner having Post Graduate Degree or

Diploma or six months training or one year experience in

Sonography or image scanning. or

c.Medical Geneticist.

Page 40: PNDTA Technical Aspects 2012

Punishments as per the Act (For Doctors)-

For first offence-

1.Imprisonment for 3 years and fine up to Rs. 10000/-

2.Suspension of Registration of a Doctor till the case is disposed off from the court.

3.If convicted- cancellation of Registration of a Doctor for five years.

For Subsequent offence-

1.Imprisonment for 5 years and fine up to Rs. 50000/-

2.Permanent cancellation of Registration of a Doctor.

Other offences – 3 months &/or Rs.1000

Subsequent- Rs.5000/day.

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Other Persons :

For 1st offence Imprisonment for 3 years and fine up to Rs. 50000/-

For 2nd offence

Imprisonment for 5 years and fine up to Rs. 100000/-

All offences under this act are cognizable, nonbailable and noncompoundable.

Page 42: PNDTA Technical Aspects 2012

Registration Of Centre• Application in form A (duplicate).• Authorized place.• Machine – Make/model/serial number.• Quotation/Proforma invoice for

sonography machine from authorized dealer/manufacturer.

• Person to be employed – MMC registration, experience/training certificate, willingness letter, affidavit.

Page 43: PNDTA Technical Aspects 2012

Cont….• Affidavit of applicant.• Acknowledgement of application

submission.• Receipt of Payment.• Approval/any other correspondence

for registration.• Registration certificate- Name of

employed persons/details of machines.

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Registration/ Renewal• Valid for 5 years• Non transferable• Fresh application- change in

place/Applicant • Application should be submitted 30

days before the expiry of the current registration.

• Surrender the previous certificate on receiving the renewal .

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Maintenance/preservation of Record

• All records to be preserved for two years. • In case of court matter record to be

preserved until the case is disposed off.• F form- completely filled, signed by

sonologists along with referral slip.• Registers to be maintained as applicable.• Hard copy to be preserved even if soft

copy maintained.• All documents submitted for registration.• Report- by 5th of subsequent month.• All the correspondence with AA.

Page 46: PNDTA Technical Aspects 2012

Various Forms in PNDT• Form A – Application for the

Registration.

• Form B – Certificate of Registration.

• From C – For Rejection of Application.

• Form D – Genetic Counselling Centre

• Form E – Genetic Laboratory

• Form F - Genetic clinic/ultrasound clinic/imaging centre

• Form G - Form of consent (For invasive

techniques)

• Form H - For permanent record by AA-

Page 47: PNDTA Technical Aspects 2012

Intimation to Appropriate Authority

• Change of place.( fresh application )• Change of applicant.( fresh

application)• Change of machine• Details of old machines• Change in employee• Portable machines- details of centre

visits, schedule• Intimation to use machine in a demo/

workshop/conference with place.

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Code of Conduct• Display board.• Availability of copy of the act- waiting area/

sonography room.• Display original certificate- waiting area/

sonography room.• Use of authorized machine.• Filling F form completely & signature of

concerned sonologist.• Authorized person performing sonography.• Submission of report in time.

Page 49: PNDTA Technical Aspects 2012

Observations• Unregistered centre carry out

technique/procedure.• Unauthorized person carry out

technique/ procedure.• F form not filled up completely.• F form signed by person other than the

one actually performing the technique/procedure.

• F form signed by owner instead of concerned person.

Page 50: PNDTA Technical Aspects 2012

Cont….

• Referral slips not kept along with the F form.

• F form signed in advance.• Use of different ink.• New machine- not intimated in time.• Details of old machines not

informed.• Portable machines- different

places/schedule not intimated.

Page 51: PNDTA Technical Aspects 2012

Cont….• Notice board not displayed.• Copy of the act not available.• Registration Certificate not

displayed.• Photocopy of certificates displayed at

unregistered place.• Monthly reports not submitted to AA• Unregistered nursing homes. (other

than maternity homes)

Page 52: PNDTA Technical Aspects 2012

Mis-concepts

• Hospitals other than Maternity Homes need not register.

• Authorized person can carry out procedure at any place.

• CT/ MRI/2D- Echo machines need not register.

• Residents can carry out procedure/technique.

• Intimation to AA means approved to proceed further

Page 53: PNDTA Technical Aspects 2012

Cont….

• Portable machine once registered can be used at any place

• Ignorance of act is an excuse for action

• Center registered under PNDT act means approved for Genetic clinic, Genetic counseling centre, Genetic lab.

Page 54: PNDTA Technical Aspects 2012
Page 55: PNDTA Technical Aspects 2012

The Act provides for certain restriction on the PC-PNDT centers-

The center has to -

a. Exhibit valid registration certificate at prominent place usually in the OPD room.

b. Appoint the Staff as per the qualifications mentioned in the Act.

c. Keep the equipments as per the list given in the Act.

d. Exhibit a board at prominent place mentioning that "Sex determination is not done in this center."

e. Keep booklet of Act readily available in OPD premises.

f. Inform the changes made in the equipments, Workers or the place within 30 days to the concerned Appropriate Authority.

g. Apply within 30 days for renewal of registration certificate.

h. Submit the report in prescribed format before 5th of every month to the concerned Appropriate Authority.

Page 56: PNDTA Technical Aspects 2012

Restrictions on doctors-

• Prohibition of sex selection.

• Determination of sex prohibited.

• Prohibition of communication of sex by words / signs / any manner.

• Written consent must in indicated cases.

• Maintenance of records- F form / consent / declaration of patient & doctor. Preserve for 2 yrs.

Page 57: PNDTA Technical Aspects 2012

Regulatory & Supervisory authorities-

For effective implementation of the Act

Central Supervisory BoardChairman -Minister in charge of the Family Welfare

Vice-Chairman- Secretary of Government of India for Family Welfare Two

Members - Law and Judiciary Department

Women and Child Department

Eminent medical geneticist

Gynaecologist

Paediatrician

Social scientist

Representatives of women welfare organization.

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Main functions of the board are as follows:

• To advise the Central Government on policy matters relating to use of prenatal

diagnostic techniques, sex-selection techniques and against their

misuse.

• To review implementation of the Act and the rules made there under and

recommend changes in the said Act and Rules to the Central Government

• To create public awareness against the practice of prenatal determination of

sex of the foetus leading to female foeticide.

• To lay down code of conduct to be observed by persons working at genetic

counseling center, genetic laboratory or genetic clinic.

Page 59: PNDTA Technical Aspects 2012

• State supervisory board

Chairman- health minister

assisted by officials & Non officials.

Functions- public awareness, review of activities of AA, to monitor implementation, to send consolidated report to central govt.

• Appropriate Authority- State-3 members- ADHS, law officer, woman activist

Dist / Corporation

Taluka / Sub-dist AA

Functions-

Page 60: PNDTA Technical Aspects 2012

The functions and powers of the A.A.-

a. Grant , suspend / cancel reg. of PC PNDT Centers.

b. Inspection of centers-to enforce standards prescribed & to

supervise.

c. Reports submission to State Appropriate Authorities.

d. To create Awareness.

e. To take action on the recommendations of State

Appropriate Authorities.

f. To take legal actions against those who violate the act.

g. To investigate the complaints.

Page 61: PNDTA Technical Aspects 2012

Powers to A.A.:

1. Seize the machine

2. Suspend or cancel registration

3. Summon any person

4. Issue search warrant for any place

5. File a complaint in Court directly.

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The MTP Act 1972 and PNDT Act 1994 are closely linked.

A law passed to curb illegal abortion,has ended up being

misused and doing exactly the opposite.

India’s second trimester abortion rate is increasing and is highest

in the world.

Illegal and unsafe abortions account for 6.7 million abortions per year

performed by untrained persons in unhygienic conditions.

The Indian Medical Association estimated that about five million

female foetuses are aborted each year purely on the grounds that

the children born would be of the wrong sex.

Punjab kills almost 1 lakh girls before they are born.

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Reality

Pre-natal scans to check for abnormalities are legal and it can be impossible to prove that a doctor has in fact used one to reveal a baby's sex.

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Solution

• Empower women and educate them .

• Create awareness and sensitization amongst the MPs,MLAs, Govt. Servants, and to involve them in the campaign against sex selection.

• Interaction with religious leaders in preventing sex-selection.

• A System of awards as encouragement to the govt. servants as well as the public may be instituted.

• "Value Girl Child" Campaign - may include Documentation and Research,

Consultations with all stakeholders, Sessions in medical colleges , Short films on the issue, Campaign in colleges and schools, Media campaigns.

• Specific commitment should be there at the policy level by the Central Government to reach equal sex ratio at birth by 2010.

Page 66: PNDTA Technical Aspects 2012
Page 67: PNDTA Technical Aspects 2012

Take Home Lesson• The Unit as a whole (Place, person &

machine) has to be registered.• Any change in a unit has to be

intimated.• Any procedure/technique/machine

capable of sex determination has to registered.

• Records of all related procedures must be maintained and preserved.

• Timely reporting • Observe code of conduct firmly.

Page 68: PNDTA Technical Aspects 2012

CONCLUSION-

• Serious social implications due to sex imbalance.

• Act is implemented by Health Department.

• Violations by doctor, patient or relatives are punishable.

• Ignorance about law is no excuse.

Ultimate AIM-Ultimate AIM-

NO DETERMINATION OF SEX AT ANY COST & AT ANY LEVEL.

Page 69: PNDTA Technical Aspects 2012

We are all God's children.  The entire creation and existence is created in the image of the almighty.   God does not have a favorite.  We are all created equal. 

Nanak