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, Dhule.

scorn She faces society'sborn Even before she is

They don't see the rose only the thorn If she dies, none there will be to mourn

Because we think she has no worth She fights death even before birth

Sexratio
Thenumbervariessignificantlyaroundtheworld. Europe-105womenper100men. Thisgenderbiasbeginsbeforebirthand impactsthelengthofwomen'slives.

Censusreportsof1991and2001 Sexratiohasworsenedinmost partsofIndia. -FarworseinrespectofGirlchild populationintheagegroupof0-6, particularlyintheaffluentareasof Punjab(793girlsto1000boys), Haryana(820),Chandigarh(845), HimachalPradesh(897)andDelhi (865). G.H.Dhule-JantoDec07
Del- 6664 854 ) M-3594 F-3070 ( 1000 -

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

Sex Ratio India & Maharashtra, 1991-2011

Sr.No. Area Population Sex Ratio 1991 1India 927 933 2001 940 922 925 2011 946 Child Sex Ratio 1991 927 946 2001 914 913 883 2011

2 Maharashtra 934

Sr. No. Ratio -6 year

District 1991

Overall Sex Ratio Female/1000 2001 2011 879 857 1010 975 880 955 961 963 954 947 977 925 2011 952 961 952 944 920 907 961 880

Child Sex 0

1991 2001 1 Thane 2 Raigad 1205 1137 940 945 975 940

931 939 940 910 882 876 932 829

918

924

3 Ratnagiri 4Sindhudurg 5 Nashik 6 Dhule 7 Nandurbar 8 Jalgaon

1135 1077 924 945 975 932

1123 1037 931 941 972 922

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.

Female infanticide still prevails despite the fact that the gentle touch of a daughter and her voice hassoothingeffectonthe parents.

The traditional system of killing thegirlchild after her birth has now given way to the more modern techniques of sex selection andfemalefoeticide.

Markedspreadoffemalefoeticideisdueto: Biasaboutsmallfamilynorm. Easyaccesstomedicalfacilities. Abilitytopaythedoctorandabortionistforthetestand abortion. Agoodnetworkofroadstocutdownthecostandtimeof travel. Easily available technological advances for sexdeterminationinutero.
Unholyallianceoftraditionalthoughtsasreflectedintheson complex.

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.

Inordertocheckfemalefoeticide,thePrenatalDiagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 wasenacted. Becameoperationalfrom1stJanuary1996. TheActhasbeenamended,witheffectfromFebruary2003- Due to certain inadequacies, practicaldifficultiesinitsimplementation alsoduetoscientificadvancestoselectsexofa childbeforeconception Themainpurpose-toregulateandbantheuse/advertisementof sexselectiontechniquesandmisuseofpre-natal diagnostictechniquesforSSA. TheconvictionofSatyamDiagnosticCentersownerwasthefirst everconvictionunderthePNDTActinthecountry.

Definition AnActtoprovidefortheprohibitionofsexselection,before orafterconception,andforregulationofprenataldiagnostic techniques for the purposes of detecting genetic abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sexlinked disorders and for the prevention of their misuse for sexdeterminationleadingtofemalefoeticide;andformany mattersconnectedtherewithorincidentalthereto.

ProvisionsProhibition 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.

RegulationofGeneticCounselingCenters,Genetic Laboratories andGeneticClinics

OnandfromthecommencementofthisAct: 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. 1. 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. 1. 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. 1. 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,

Pre-natal diagnostic proceduresGynecological 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.

Pre-natal diagnostic testUltrasonographyoranytestoranalysisofamnioticfluid, chorionicvilli,bloodoranytissueorfluidofa pregnantwomanorconceptusconductedtodetect geneticormetabolicdisordersor chromosomal abnormalitiesorcongenitalanomaliesor Haemoglobinopathiesorsex-linkeddiseases.

Aspertheprovisionoftheact,followingcentersneedregistration (PC-PNDTCenters) a.GeneticCounselingCenter b.GeneticClinic c.GeneticLaboratory d.UltrasoundClinic e.ImagingCenter f.InVitroFertilization(IVF)Center g.Anyothercenterwhichiscapableofdetectingsexofthe foetus.

RegulationofPrenatalDiagnosticTechniques
Noprenataldiagnostictechniquesshallbeconductedexcept forthepurposesofdetectionofanyofthefollowing abnormalities,namely: Chromosomalabnormalities Geneticmetabolicdiseases Haemoglobinopathies Sex-linkedgeneticdiseases Congenitalanomalies Anyotherabnormalitiesordiseasesasmaybespecified bytheCentralSupervisoryBoard

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.

IndicationsofUSGduringpregnancy
Todiagnoseintra-uterineand/orectopicpregnancyand confirmviability. Estimationofgestationalage(dating). Detectionofnumberoffoetusesandtheirchorionicity. SuspectedpregnancywithIUCDin-situorsuspected pregnancyfollowingcontraceptivefailure/MTPfailure. Vaginalbleeding/leaking. Follow-upofcasesofabortion. Assessmentofcervicalcanalanddiameterofinternalos. Discrepancybetweenuterinesizeandperiodofamenorrhoea. Anysuspectedadenexaloruterinepathology/abnormality.

IndicationsofUSGduringpregnancy(Cont)
Detectionofchromosomalabnormalities,foetalstructuraldefectsand otherabnormalitiesandtheirfollow-up. Toevaluatefoetalpresentationandposition. Assessmentofliquoramnii. Pretermlabour/pretermprematureruptureofmembranes. Evaluationofplacentalposition,thickness,gradingandabnormalities (placentaprevia,retroplacentalhemorrhage,abnormal adherenceetc.). Evaluationofumbilicalcordpresentation,insertion,nuchal encirclement,numberofvesselsandpresenceoftrueknot. EvaluationofpreviousCaesareanSectionscars. Evaluationoffoetalgrowthparameters,foetalweightandfoetalwell being. ColorflowmappingandduplexDopplerstudies.

IndicationsofUSGduringpregnancy(Cont)
Ultrasoundguidedproceduressuchasmedicalterminationof pregnancy,externalcephalicversionetc.andtheirfollow-up. Adjuncttodiagnosticandtherapeuticinvasiveinterventionssuchas chorionicvillussampling(CVS),amniocenteses,foetalblood sampling, foetalskinbiopsy,amnio-infusion,intrauterine infusion,placementof shuntsetc. Observationofintra-partumevents. Medical/surgicalconditionscomplicatingpregnancy. Research/scientificstudiesinrecognisedinstitutions.

Preserve the referral slip.

Nopersonincludingarelativeorhusbandofthe pregnantwomanshallseekorencouragethe conductofanyprenataldiagnostictestonherexcept forthepurposementionedintheindications.

Nopersonincludingarelativeorhusbandofthe pregnantwomanshallseekorencouragethe conductofanysex-selectiontechniqueonherorhim orboth.

Writtenconsentofpregnantwomanandprohibitionof communicatingthesexofthefoetusNo 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.

Determinationofsexprohibited-

1. PrenataldiagnostictechniquesincludingUSGshould notbeperformedforsexdetermination.

2. Nopersonshall,bywhatevermeans,causeorallow tobecausedselectionofsexbeforeorafterconception.

Registration of centers-Prescribedform-AppropriateAuthority -FeesforregistrationisRs.3000/-& forrenewalofregistrationRs.1500/-Affidavit&undertaking -Certificateofreg-induplicate nontransferable validfor5yrs. renewal30daysbeforedateofexpiry. 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.

TechnicalQualificationsforsettingupPC-PNDTCenter:
For Genetic Counseling Center : a.Gynecologistorpediatricianhavingsixmonthsexperienceor fourweekstrainingingeneticcounseling. b.MedicalGeneticist For Genetic Laboratory : a.MedicalGeneticist b.LaboratoryTechnician(B.ScwithDMLT)withatleast oneyearexperience.

ForGeneticClinic/UltrasoundClinic/ImagingCenter:
a.Gynecologisthavingexperienceofperformingatleast20 proceduresinchorionicvilliaspirationspervaginaorper abdomen,ororganbiopsyorfoetalbloodsamplingetc. undersupervisionofexperiencedgynecologistinthese fieldsor b.Asonologist.ImagingSpecialist.RadiologistorRegistered MedicalpractitionerhavingPostGraduateDegreeor Diplomaorsixmonthstrainingoroneyearexperiencein Sonographyorimagescanning.or c.MedicalGeneticist.

PunishmentsaspertheAct(ForDoctors)Forfirstoffence-
1.Imprisonmentfor3yearsandfineuptoRs.10000/2.SuspensionofRegistrationofaDoctortillthecase isdisposedofffromthecourt. 3.Ifconvicted-cancellationofRegistrationofaDoctor forfiveyears.

ForSubsequentoffence1.Imprisonmentfor5yearsandfineuptoRs.50000/2.PermanentcancellationofRegistrationofaDoctor.

Otheroffences3months&/orRs.1000
Subsequent-Rs.5000/day.

OtherPersons: For1stoffence Imprisonmentfor3yearsandfineuptoRs.50000/For2ndoffence Imprisonmentfor5yearsandfineuptoRs.100000/-

Alloffencesunderthisactarecognizable,nonbailableand noncompoundable.

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,

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.

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

 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

Maintenance/preservation of Record

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)

 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

Intimation to Appropriate Authority

Code of Conduct
Display board. Availability of copy of the actwaiting area/ sonography room. Display original certificatewaiting area/ sonography room. Use of authorized machine. Filling F form completely & signature of concerned sonologist. Authorized person performing sonography.

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

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.

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.

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

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.

TheActprovidesforcertainrestrictiononthePC-PNDT centersThe 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.

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.

Regulatory & Supervisory authorities-

ForeffectiveimplementationoftheAct CentralSupervisoryBoard Chairman -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.

Mainfunctionsoftheboardareasfollows:
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 to female foeticide. To lay down code of conduct to be observed by persons working at genetic counseling center, genetic sex of the foetus leading

 State supervisory board Chairman-healthminister assistedbyofficials&Nonofficials. Functions-publicawareness,reviewofactivitiesofAA, tomonitorimplementation,tosend consolidatedreporttocentralgovt. Appropriate Authority- State-3members-ADHS,lawofficer, womanactivist Dist/Corporation Taluka/Sub-distAA Functions-

The functions and powers of the A.A.a. Grant,suspend/cancelreg.ofPCPNDTCenters. b. Inspection of centers-toenforcestandardsprescribed&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.

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.

TheMTPAct1972andPNDTAct1994arecloselylinked.
A law passed to curb illegal abortion,has ended up being misusedanddoingexactlytheopposite. Indias second trimester abortion rate is increasing and is highest intheworld. Illegalandunsafeabortionsaccountfor6.7millionabortionsperyear performedbyuntrainedpersonsinunhygienicconditions. The Indian Medical Association estimated that about five million female foetusesareabortedeachyearpurelyonthe groundsthat thechildrenbornwouldbeofthewrongsex. Punjabkillsalmost1lakhgirlsbeforetheyareborn.

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.

Solution
Empowerwomenandeducatethem. CreateawarenessandsensitizationamongsttheMPs,MLAs,Govt. Servants,andtoinvolvetheminthecampaignagainstsex selection. Interactionwithreligiousleadersinpreventingsex-selection. ASystemofawardsasencouragementtothegovt.servantsaswell asthepublicmaybeinstituted. "ValueGirlChild"Campaign-mayinclude DocumentationandResearch, Consultationswithallstakeholders, Sessionsin medicalcolleges,Shortfilmsonthe issue, Campaignincolleges andschools, Mediacampaigns. Specificcommitmentshouldbethereatthepolicylevelbythe CentralGovernmenttoreachequalsexratioatbirthby2010.

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

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 AIMNO DETERMINATION OF SEX AT ANY COST & AT ANY LEVEL.

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