Latested Amended PC PNDTByDR R N GOELGynecologist & SonologistVice President-Indian Fed. of Ultrasound in med. & BiologyVice President – U P Nursing Home AssociationSecretary - Agra N H AssociationSecretary – IMS Agra ChapterExecutive Member - ISPATFOGSI - DOSST - Agra Obs Gyn SocietySecretary Agra Obs / gyn Society 2009 & 2010
THE PRE-NATAL DIAGNOSTICTECHNIQUES (REGULATION ANDPREVENTION OF MISUSE) RULES,was formed in 1994
In 1996, It was called asTHE PRE-CONCEPTION & PRE-NATAL DIAGNOSTIC TECHNIQUES(PROHIBITION OF SEX SELECTION)RULES, 1996
Registration of Centre started fromOctober 2001After order of Supreme Court in theWRIT PETITION [CIVIL] NO. 301 OF 2000Centre for Enquiry into Health And Allied themes[CHEHAT] & Ors ……….PetitionersVERSUSUnion of India & Ors. ………….Respondentsorder on May 4, 2001 & September 19, 2001
On 14thFebruary 2003THE PRE-CONCEPTION & PRENATALDIAGNOSTIC TECHNIQUES(PROHIBITION OF SEX SELECTION)RULES, 1996&Amendment Rules, 2003.
WHY this Act"An Act to provide for the prohibition of sexselection, before or after conception,andfor regulation of pre-natal diagnostic techniques for thepurposes of detecting genetic abnormalities or metabolicdisorders or chromosomal abnormalities or certaincongenital malformations or sex-linked disordersandfor the prevention of their misuse for sexdetermination leading to female feticide.
(A) Pre-natal diagnostic procedures(A) Pre-natal diagnostic procedures meansAll gynecological or obstetrical or medicalprocedures such as:* Ultrasonography* Foetoscopy* Taking or removing samples of-amniotic fluid, -chorionic villi-blood, -any tissue, -fluidof a man or a woman before or after conception
(B) Pre-natal diagnostic tests(B) Pre-natal diagnostic tests means* Ultrasonography* Foetoscopy* Test or analysis of-amniotic fluid, -chorionic villi -blood,-any tissue, -fluid of any pregnant woman orconceptus conduced to detect:-genetic disorder, -metabolic disorder,-chromosomal abnormalities, -congenital anomalies,-haemoglobinopathies, - sex- linked diseases
( C) Sex selection( C) Sex selection includes:* Technique* Procedure* Test* Administration* Prescription* Provisionof anything for the purpose of ensuring orincreasing the probability that an embryo will beof a perticular sex.
Under this Act there is provision ofRegistration in 3 category only1. Genetic Counselling Centre GCC2. Genetic Laboratory GL3. Genetic Clinic / UltrasoundClinic / Imaging Centre
Genetic Counselling Centremeans• An institute• Hospital• Nursing home• Any placeby whatever name called which providesgenetic counseling to patients.
The qualifications for a Genetic Counseling Centre shall beas under rule 3 (1):Any person being or employing(i) a gynaecologist or a paediatrician havingsix months experienceorfour weeks training in genetic counselingor(ii) a medical geneticists,may set up a genetic counselling center and get itregistered as a genetic counselling center.
Genetic Laboratorymeans• a laboratory; and• includes a placewhere facilities are provided for conductinganalysis or tests of samples received fromGenetic Clinic for pre-natal diagnostic test.
The qualifications for a Genetic Laboratory shall beas under rule 3 (2):a) Any person having adequate space and being or employing(i) a Medical Geneticist and(ii) a laboratory technician, having a B.Sc. degree inBiological Sciences or a degree or diploma in medicallaboratory course with at least one year experience inconducting appropriate prenatal diagnostictechniques, tests or proceduresmay set up a genetic laboratory.
for a Genetic Laboratory contd…(b) Such laboratory should have or acquiresuch of the following equipments as may benecessary for carrying outi) chromosomal studies,ii) bio-chemical studies andiii) molecular studies:-
(iii) 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 0.1 milligram.(13) Double distillation apparatus (glass).(14) P.C.R. machine.(15) Refrigerated centrifuge.(16) U.V. Illuminator with photographic attachment or other documentation system.(17) Precision micropipettes.(18) Such other equipments as may be necessary.
(ii) Biochemical studies:(requirements according to tests to be carried out)(1) Laminar flow hood with ultraviolet and fluorescent light or other suitable culture hood.(2) Inverted microscope.(3) Incubator and oven.(4) Carbon dioxide incubator or closed system with 5% CO2 atmosphere.(5) Autoclave.(6) Refrigerator.(7) Water bath.(8) Centrifuge.(9) Electrophoresis apparatus and power supply.(10) Chromatography chamber.(11) Spectro-photometer and Elisa reader or Radio-immunoassay system (with gamma beta-counter) or fluorometer for Various biochemical tests.(12) Vortex mixer.(13) Magnetic stirrer.(14) 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.
Chromosomal studies:(1) Laminar flow hood with ultraviolet and fluorescent light or other suitableculture 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% CO2 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 apparatus (glass).(15) Such other equipments as may be necessary
Genetic Clinicmeans• A clinic• Institute• Hospital• Nursing home• Any placeby whatever name called which is used forconducting pre-natal diagnostic procedures.
GENETIC CLINICPNDT Act 1996-----Schedule IIIAmendment 2003BOG Meeting on 26-12-2011CSB Meeting on 14-1-2012
Before Amendment 2003As per PC PNDT 1996 schedual IIIREQUIREMENTS FOR REGISTRATION OF A GENETIC CLINICC.EMPLOYEES(1) A gynaecologist with adequate experience in pre-natal diagnosticprocedures (should have performed at least 20 procedures under supervision of agynaecologist experienced in the procedure which is going to be carried out, forexample chorionic villi biopsy, amniocentesis, cordocentesis and others indicatedat B above).(2) A Radiologist or Registered Medical Practitioner for carrying outultrasonography. The required experience shall be 100cases under supervision of a similarly qualified personexperienced in these techniques.
Amendment 2003 as under rule 3 (3):(1) A. Any person having adequate space andB. being or employing(a) Gynaecologist having experience of performing atleast 20 procedures in chorionic villi aspirations pervagina or per abdomen, chorionic villi biopsy,amniocentesis, cordocentesis foetoscopy, foetal skin ororgan biopsy or foetal blood sampling etc. undersupervision of an experienced gynaecologist in thesefields,or
Amendment 2003 as under rule 3 (3)(b) aSonologist, Imaging SpecialistRadiologistorRegistered Medical Practitioner havingPost Graduate degree or diplomaor six months trainingor one year experience in sonographyor image scanning,or(c) A medical geneticist
Rule 3 (3) -2 The Genetic Clinic/ultrasound clinic/imaging centre should haveor acquire such of the following equipments, as may be necessary forcarrying out the tests or procedures -(a) Equipment and accessories necessary for carrying outclinical examination by an obstetrician orgynaecologist.(b) An ultra-sonography machine including mobileultrasound machine, imaging machine or any otherequipment capable of conducting foetal ultrasonography.(c) Appropriate catheters and equipment for carrying outchorionic villi aspirations per vagina or per abdomen.(d) Appropriate sterile needles for amniocentesis orcordocentesis.(e) A suitable foetoscope with appropriate accessories forfoetoscopy, foetal skin or organ biopsy or foetal blood samplingshall be optional.(f) Equipment for dry and wet sterilization.(g) Equipment for carrying out emergency procedures such asevacuation of uterus or resuscitation in case of need.(h) Genetic Works Station.".
A) The following qualified persons may be considered eligibleto perform USG for purposes and indications given under theprovisions of the PCPNDT Act/ Rules.I. Radiologist having Post Graduate Qualification inRadiology/ Imaging Sciences, as specified in the scheduleI/II/III of the IMC Act of 1956. (Modified because of differentPG degrees and their nomenclature in different states.)II. Ob/ Gyn. having Post Graduate Qualification in Ob./ Gyn.,as specified in the schedule I/II/III of the IMC Act of 1956.III. DNB qualification in Radiology /Obs/Gyn, as equated andas per provisions of the Medical Council of India forequivalence.IV. MBBS graduate from recognized University in India or anyother foreign medical graduate qualification recognized bythe Medical Council of India with Six (6) months of Obs/Gynultrasound training at any Govt. recognized teaching institute
On 7thFebruary 2012 GSR 80(E)Amendment 2012(g) “Mobile Medical Unit” means a mobile vehicle whichprovides specialized facilities for the patients, requiringbasic specialist services and provides improved access tohealthcare facilities and equitable distribution of healthservices at the doorsteps, across the country, especially inthe underserved areas.(h) “Mobile Genetic clinic” means a mobile medical unitwhere ultrasound machine or imaging machine or scanneror other equipment capable of determining set of thefoetus or a portable equipment which has the potential fordetection of sex during pregnancy or selection of sexbefore conception is used.
IVF Clinic OR IVF Centre gives1. Genetic Counselling2. Doing Prenatal Diagnostic Testing – LAB3. & Doing Prenatal Diagnostic Proceduremeanig Genetic clinicALL THREEThey should be registered in all threeCategory
Central Supervisory Board.-*the Minister in charge MOH&FW ……..………………...........Chairman, ex officio;*the Secretary to the GOI Dept. of FW-................................Vice Chairman, ex-officio;*(two members to be appointed by the Central Government to represent theMinistries of Central Government in charge of Woman and Child Development and ofLaw and Justice, …………………………………………………………….ex-officio;*the DGHS of the Central Government, ……...................................................ex officio;*ten members to be appointed by the Central Government,……………….two each from amongsteminent medical geneticists;eminent gynaecologists and obstetricians;eminent paediatricians;eminent social scientists; andrepresentatives of women welfare organisations;*three women M P, of whom two from House of the People and one by the Council ofStates;*(four members to be appointed by the Central Government by rotation to representthe States and the Union territories, two in the alphabetical order and two in thereverse alphabetical order: Provided that no appointment under this clause shall bemade except on the recommendation of the State Government or, as the case may be,the Union territory;*an officer, not below the rank of a Jt Sec. or equivalent of the Central Government, incharge of Family Welfare, who shall be the Member-Secretary, ………..ex officio.
State Advisory Board.-1.the Minister in charge MOH&FW ……..………………...........Chairman, ex officio;2.the Secretary to the GOI Dept. of FW-..............................Vice Chairman, ex-officio;3.Secretaries or Commissioners in charge of Departments of Women and ChildDevelopment, Social Welfare, Law and Indian System of Medicines and Homoeopathy,………………………………………………………………………………..….ex-officio;4.the DGHS of the Central Government, ……..................................................ex officio;5.Three women members of Legislative Assembly or Legislative Council;6.ten members to be appointed by the State Government,……………….two each from amongsti)eminent social scientists and legal experts;ii)eminent women activists from non-governmental organizations orotherwise;iii)eminent gynaecologists and obstetricians or experts of stri-roga or prasutitantra;iv)eminent paediatricians or medical geneticists;v)eminent radiologists or sonologists;7.an officer not below the rank of Joint Director in charge of Family Welfare, who shall bethe Member Secretary, .................................................................................... ex officio;
APPROPRIATE AUTHORITY AND ADVISORYCOMMITTEE17. Appropriate Authority and Advisory Committee.-(3) The officers appointed as AppropriateAuthorities under sub-section (1) or subsection (2)shall be,--(b) when appointed for any part of the State orthe Union territory,District Advisory Committee.-
Appropriate AuthorityThe Appropriate Authority shall have the followingfunctions, namely:--a) to grant, suspend or cancel registration of a GeneticCounselling Centre, Genetic Laboratory or Genetic Clinic;b) to enforce standards prescribed for the GeneticCounselling Centre, Genetic Laboratory and Genetic Clinic;c) to investigate complaints of breach of the provisions of thisAct or the rules made there under and take immediate action;andd) to seek and consider the advice of the Advisory Committee,constituted under sub-section (5), on application forregistration and on complaints for suspension or cancellationof registration
District Advisory Committee.-1. three medical experts from amongstgynaecologists, obstericians, paediatricians andmedical geneticists;2. one legal expert;3. one officer to represent the departmentdealing with information and publicity of theState Government or the Union territory, as thecase may be;4. three eminent social workers of whom not lessthan one shall be from amongst representativesof womens organisations.
Application Fee -• (1) Every application for registration under Rule 4 shall beaccompanied by an application fee of :-(a) Rs.25,000.00 for Genetic CounsellingCentre, Genetic Laboratory, Genetic Clinic,Ultrasound Clinic or Imaging Centre.Amendment 2012 by Gazette on 4.6.2012(b) Rs.35,000.00 for an institute, hospital,nursing home, or any place providing jointly theservice of a Genetic Counselling Centre, GeneticLaboratory and Genetic Clinic, Ultrasound Clinic orImaging Centre or any combination thereof.Amendment 2012 by Gazette on 4.6.2012
Application Fee -(2) The application fee shall be paid by ademand draft drawn in favour of theAppropriate Authority, on any scheduled bankpayable at the headquarters of theAppropriate Authority concerned.
Renewal FeeRenewal fee is half of the Application Feepayable after five years.Amendment 2012 by Gazette on 4.6.2012Rs. 12,500/ for Registration for onecategoryRs. 17,500/ for Registration for multiplecategory
Registration of Genetic Counselling Centre,Genetic Laboratory, Ultrasound clinic andGenetic Clinic.-(1) An application forregistration shall be made tothe Appropriate Authority i.eDM, in duplicate, in Form A.
Registration of Genetic Counselling Centre, GeneticLaboratory, Ultrasound clinic and Genetic Clinic.-Continue……..(2) The Appropriate Authority, or any personin his office authorized in this behalf, shallacknowledge receipt of the application forregistration, in the acknowledgementslip provided at the bottom of Form A,immediately if delivered at the office of theAppropriate Authority, or not later than thenext working day if received by post.
REGISTRATION OR REJECTIONGrant of certificate of registrationor rejection of application forregistration shall be communicated tothe applicant as specified in Form B orForm C, as the case may be, within aperiod of ninety days from the dateof receipt of application for registration.
INDICATION for obstetric ultrasound(i) Ultrasound is notindicated/advised/performed to determine thesex of foetus except for diagnosis of sex-linkeddiseases such as Duchenne Muscular Dystrophy,Haemophilia A & B etc.(ii) During pregnancy Ultrasonography shouldonly be performed when indicated. The followingis the representative list of indications forultrasound during pregnancy.
INDICATION for obstetric ultrasoundcontinue…….(1) To diagnose intra-uterine and/or ectopic pregnancy and confirmviability.(2) Estimation of gestational age (dating).(3) Detection of number of foetuses and their chorionicity.(4) Suspected pregnancy with IUCD in-situ or suspected pregnancyfollowing contraceptive failure/MTP failure.(5) Vaginal bleeding / leaking.(6) Follow-up of cases of abortion.(7) Assessment of cervical canal and diameter of internal os.(8) Discrepancy between uterine size and period of amenorrhoea.(9) Any suspected adenexal or uterine pathology / abnormality.(10) Detection of chromosomal abnormalities, foetal structural defectsand other abnormalities and their follow-up.(11) To evaluate foetal presentation and position.(12) Assessment of liquor amnii.
INDICATION for obstetric ultrasoundcontinue…….(13) Preterm labour / preterm premature rupture of membranes.(14) Evaluation of placental position, thickness, grading andabnormalities (placenta praevia, retroplacental haemorrhage,abnormal adherence etc.).(15) Evaluation of umbilical cord - presentation, insertion, nuchalencirclement, number of vessels and presence of true knot.(16) Evaluation of previous Caesarean Section scars.(17) Evaluation of foetal growth parameters, foetal weight andfoetal well being.(18) Colour flow mapping and duplex Doppler studies.(19) Ultrasound guided procedures such as medical termination ofpregnancy, external cephalic version etc. and their follow-up.(20) Adjunct to diagnostic and therapeutic invasive interventionssuch as chorionic villus sampling (CVS), amniocenteses, foetal bloodsampling, foetal skin biopsy, amnio-infusion, intrauterine infusion,placement of shunts etc.(21) Observation of intra-partum events.(22) Medical/surgical conditions complicating pregnancy.(23) Research/scientific studies in recognised institutions.
DUTIES OF REGISTERED CENTREPerson conducting ultrasonography on apregnant women shall keep complete recordthereof in the clinic/centre in Form - F and anydeficiency or inaccuracy found therein shallamount to contravention of provisions ofsection 5 or section 6 of the Act, unlesscontrary is proved by the person conductingsuch ultrasonography.
DUTIES OF REGISTERED CENTRE• GCC should fill Form D• Genetic Lab should fill Form E• Genetic Clinic / Ultrasound Clinic / ImagingCentre should fill Form FKEEP RECORDS FOR 2 YEAR
On 31stMay 2011 by GSR 426(E)Amendment 2011IN rule no. 11(2)These machines of the organizations may be released if suchorganization pays penalty equal to five times of theregistration fee to the Appropriate Authority concerned andgives an undertaking that it shall not undertake detection ofsex of foetus or selection of sex before or after conceptionSubstituted byThese machines of the organizations shall be confiscated andfurther action shall be taken asper the provision of the section 23 of the act.
IN rule no. 11(2)These machines of the organizations may bereleased if such organization pays penalty equalto five times of the registration fee to theAppropriate Authority concerned and gives anundertaking that it shall not undertake detectionof sex of foetus or selection of sex before orafter conceptionSubstituted byThese machines of the organizations shall beconfiscated and further action shall be taken asper the provision of the section 23 of the act.
DUTIES OF REGISTERED CENTRE1 Should not involve in fetal sex detection2. Should keep copy of Bare act of PC-PNDT3. Should display Board in local language also4. Copy of Form D/E/F / Summary of these Formsmust be submitted by 5thof every month in theoffice of appropriate authority.
13 Intimation of changes in employees,place or equipmentEvery Genetic Clinic shall intimate every change(Addition/Removal) of employee, place,address and equipment installed, to theAppropriate Authority within a period of Sevendays of such change. As per Delhi HC order in4009/2012 on 27.7.2012 in Amendment 2012by Gazette on 4.6.2012New Registration not required (Rule 13)
17.Public Information.-(1 ) Every Genetic Counselling Centre,Genetic Laboratory and Genetic Clinic shallprominently display on its premises a notice inEnglish and in the local language or languagesfor the information of the public, to effectthat disclosure of the sex of the foetus isprohibited under law.
17.Public Information.-(2) At least one copy each of the bare Act andthese rules shall be available on the premisesof every Genetic Counselling Centre, GeneticLaboratory and Genetic Clinic, and shall bemade available to the clientele on demand forperusal.
17.Public Information.-• (3) The Appropriate Authority, the CentralGovernment, the State Government, and theGovernment/Administration of the UnionTerritory may publish periodically lists ofregistered Genetic Counselling Centres, GeneticLaboratories and Genetic Clinics and findingsfrom the reports and other information in theirpossession, for the information of the publicand for use by the experts in the field.
18 Code of Conduct*Wear NAME TAG yourself and every employeeworking at the US Clinic. Write full name anddesignation under signatures.(Rule18-viii & ix)*Should not indulge in SEX DETERMINATION &FEMALE FETICIDE and do not commit any otheract of professional misconduct.(Rule18-x & xi
19 AppealAppeal against charge sheet can be filed toDAC / SAC within 30 days and decision hasto be taken within 90 days(Rule19-1-3).