2. PCPNDT ACT
Moderator: Dr. C N PRADEEP KUMAR
ASSOCIATE PROFESSOR
DEPARTMENT OF RADIO-DIAGNOSIS.
MMCRI, MYSORE
Presenter: Dr. ANVITH M
POST-GRADUATE,
DEPARTMENT OF RADIO-DIAGNOSIS.
MMCRI, MYSORE
3. • Q. Preconception and Prenatal Diagnostic Techniques (PC-PNDT).
• Q. Briefly describe recent amendments of PC-PNDT,2012.
• Q. Legal responsibilities and duties of radiologist in clinical practice.
• Q. Preconception and Prenatal Diagnostic Techniques{Regulation and
Prevention of Misuse} Act, 1994.[PC-PNDT Act|.
5. Introduction
• The pre-natal diagnostic techniques (regulation
and prevention of misuse) act, was formed in
1994.
• Came into effect on 1st January 1996.
• AN "ACT" IS A WRITTEN ORDINANCE OF
PARLIAMENT
• NATIONAL SEX RATIO – 940/1000 (2011 CENSUS)
924/1000 (2020 STATS)
• Credit for this act goes to
Centre for the Enquiry of Health and Allied Themes
(CEHAT)
The Mahira Sarvangeen Utkarsh Mandal (MASUM)
6. • In 1996, it was called as the pre-conception & pre-natal diagnostic techniques
(prohibition of sex selection) act,1996.
• Registration of Centre started from October 2001.
• Certain amendments have also been brought about in the Rules of 1996, to
ensure effective implementation of the Act . The amended Rules have come
into effect from 14th Feb.2003.
7. Definition
1. An act to provide for the prohibition of sex selection, before or after
conception.
2. Regulation of pre-natal diagnostic techniques for detecting
genetic abnormalities
metabolic disorders
chromosomal abnormalities
congenital malformations
sex-linked disorders
3. Prevention of female feticide due to misuse of sex selection.
8. The act governs Three ‘p’
• PROCEDURES (TECHNIQUES)
• PLACES
• PERSONS
10. (A) Pre-natal diagnostic procedures
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.
11. (B) Pre-natal diagnostic tests
* Ultrasonography
* Test or analysis of
- amniotic fluid, - chorionic villi, - blood,
- any tissue, - fluid
Of any pregnant woman or conceptus conduced to detect:
- Genetic disorder,
- Metabolic disorder,
- Chromosomal abnormalities,
- Congenital anomalies,
- Haemoglobinopathies,
- Sex linked diseases.
12. (C) Sex selection includes:
* Technique
* Procedure
* Test
* Administration
* Prescription
* Provision
Of anything for the purpose of ensuring or increasing the probability that
an embryo will be of a particular sex.
14. Genetic Counselling Centre
means
• An institute
• Hospital
• Nursing home
• Any place
by whatever name called which provides genetic counselling to
patients.
15. Genetic Clinic
means
• A clinic
• Institute
• Hospital
• Nursing home
• Any place
by whatever name called which is used for conducting pre-
natal diagnostic procedures.
16. 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.
17. QUALIFIED PERSONS
• Gynaecologist
• Medical Geneticist
• Paediatrician
• Registered Medical Practitioner
• laboratory technician
• Radiologist
• Sonologist or Imaging Specialist
18. Gynaecologist
• For a genetic counseling center, the gynaecologist must have
- 6 months experience in genetic counseling; or
- 4 weeks training in genetic counseling.
• For a genetic clinic
Should have performed at least 20 procedures in
Chorionic villi aspirations per vagina or per abdomen,
chorionic villi biopsy, Amniocentesis, cordocentesis ,foetoscopy, foetal skin
or organ biopsy or foetal blood sampling etc. Under supervision of an experienced
gynaecologist in these fields.
19. (B) 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.
(C) Paediatrician
For a genetic counseling center, the paediatrician must have
- 6 months experience in genetic counseling; or
- 4 weeks training in genetic counseling
20. (d) For a genetic laboratory, 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.
21. (e) 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
22. REGISTRATION
• What is to be registered?
• Centre/USG machine/ Sonologist/Place etc.?
• The answer is that it is the place (clinic or centre or nursing home or mobile van
where U/S is performed).
• No separate registration for number of machines in the same clinic/centre.
23. Under this Act there is provision of
Registration in 3 categories only
1. Genetic Counselling Centre (GCC)
2. Genetic Laboratory (GL)
3. Genetic Clinic / Ultrasound Clinic / Imaging
Centre
24. Procedure of registration
• Application to the Chief Medical Officer of the district or any other medical officer
constituted as appropriate authority, owner needs to register at least 3 months In
advance
• Submission of Form “ A” in duplicate
• Affidavit: an undertaking that the clinic/Center shall not conduct any test or procedure
for sex determination.
• Another affidavit undertaking that the center/clinic prominently display a signage
board of no sex determination
Application fee in the form of a DD(free for govt institutions)
• 25,000 since 2012 FOR GCC/GC/GL & ULTRASOUND CLINIC
• 35,000 since 2012 FOR ANY PLACE PROVIDING A COMBINATION OF THE ABOVE
25. REGISTRATION CERTIFICATE
• Certificate of registration shall be given in duplicate and in the form as
prescribed in FORM B.
• The grant of certificate of registration shall be communicated < 90 days from
the date of receipt of application for registration.
• Doctors using USG machines need to have their names entered in the PC-PNDT
certificate.
• It is mandatory for everybody registered under this act to display certificate of
registration
• Valid for a period of five years since its issuance.
• Non-transferable
26. • Change of ownership – old certificate is surrendered
• new owner- apply for fresh application.
• One center can have multiple USG machines, but the manufacturer’s name and
the makes and models of the machines should be noted in the PC-PNDT
registration certificate (all ultrasound machines available at that center including
port. u/s should be registered on the certificate or on a separate attached
sheet).
• No doctor other than the one registered in that particular center may use the
machine installed there.
• Any changes in the center (e.g, Change in machine or place of use) should be
intimated to the AA 30 days in advance.
• Any change of the doctor operating the machine should be intimated to the AA
within 30 days.
27. REJECTION OF APPLICATION FOR
REGISTRATION
• If applicant has not complied with the requirements of the act then the said
application will be rejected.
• The reasons for the rejection shall be given in writing and as specified in form c
• The rejection of registration shall be communicated to the applicant within 90
days from the date of the receipt of the registration
28. CANCELLATION OR SUSPENSION OF
REGISTRATION
• Show cause notice
• Appeal: < 30 days.
• The appeal may be made to:
- The appropriate authority at the district level if the order is passed by the
appropriate authority at sub-district level.
-The appropriate authority at the state/UT level if the order is passed by the
appropriate authority at district level.
• Each appeal shall be disposed of within 60 days of its receipt
29. RENEWAL OF REGISTRATION
• Application form A in duplicate to appropriate authority (AA) 30 days
before the expiry of reg. Certificate.
• Registration fees of half of what was initially(free for govt institutions)
12500 FOR GCC/GC/GL & ULTRASOUND CLINIC
17500 FOR ANY PLACE PROVIDING A COMBINATION
• Authority will renew the certificate of registration in the prescribed Form
B for a further period of 5 years starting from the date of expiry of the old
certificate.
• Two copies of earlier certificates to be surrendered.
• If AA fails to renew the certificate within 90 days , it will amount to
automatic renewal or deemed renewal.
30. Prohibitions
Every genetic counselling centre or genetic
clinic or genetic laboratory is required to
DISPLAY prominently a notice in ENGLISH and
in the LOCAL LANGUAGE or languages that
“conduct of sex-determination
tests/disclosure of sex of the foetus is
prohibited”.
31. PRESCRIPTIONS AND REGULATIONS
• The act prohibits the conduct of pre-natal diagnostic techniques for
determination of the sex of the foetus but allows the conduct of pre-natal
diagnostic techniques for detection of:
CHROMOSOMAL ABNORMALITIES
CONGENITAL ANOMALIES
GENETIC METABOLIC DISEASES
HAEMOGLOBINOPATHIES
SEX-LINKED GENETIC DISEASES
• Written consent
• Give a declaration on each report on ultrasonography/image scanning that
he/she has neither detected nor disclosed the sex of foetus.
32. FURTHER PERMISSIBLE [“4 A’s”]–
• AGE OF THE PREGNANT WOMAN IS ABOVE 35YEARS
• ABORTIONs - PREGNANT WOMAN HAS UNDERGONE 2 OR MORE
SPONTANEOUS ABORTIONS OR FOETAL LOSS
• AGENTS - PREGNANT WOMAN HAS BEEN EXPOSED TO POTENTIALLY
TERATOGENIC AGENTS SUCH AS DRUGS, RADIATION, INFECTION OR CHEMICALS
• AMENTIA -THE PREGNANT WOMAN OR HER SPOUSE HAS A FAMILY HISTORY OF
MENTAL RETARDATION OR PHYSICAL DEFORMITIES SUCH AS, SPASTICITY OR
ANY OTHER GENETIC DISEASE
33. INDICATIONS FOR OBSTETRIC ULTRASOUND
• Ultrasound is not indicated/advised/performed to determine the sex of
fetus except for diagnosis of sex-linked diseases such as Duchenne
Muscular Dystrophy, Hemophilia A & B etc.
• During pregnancy ultrasonography should only be performed when
indicated. The following is the representative list of indications for
ultrasound during pregnancy.
34. 1. To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.
2. Estimation of gestational age (dating).
3. Detection of number of foetuses and their chorionicity.
4. Suspected pregnancy with iucd in-situ or suspected pregnancy following
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 defects and
other abnormalities and their follow-up.
35. 11. To evaluate foetal presentation and position.
12. Assessment of liquor amnii.
13. Preterm labour / preterm premature rupture of membranes.
14. Evaluation of placental position, thickness, grading and abnormalities
(placenta praevia, retroplacental haemorrhage, abnormal adherence etc.).
15. Evaluation of umbilical cord – presentation, insertion, nuchal encirclement,
number of vessels and presence of true knot.
16. Evaluation of previous caesarean section scars.
17. Evaluation of foetal growth parameters, foetal weight and foetal well being.
36. 18. Colour flow mapping and duplex doppler studies.
19. Ultrasound guided procedures such as medical termination of pregnancy,
external cephalic version etc. And their follow-up.
20. 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.
37. MANDATORY PREREQUISITES FOR A U/S
CLINIC
• Signage Board in English and in the local language must be displayed prominently,
indicating the fetal sex is not disclosed in the clinic
• A copy of Registration Certificate Shall be displayed in the U/S Room
• A copy of PC-PNDT ACT Book shall be available in the U/S Department.
• Form ‘F’ shall be filled before every OBS examination and for any invasive procedure
Form ‘G ‘ shall be filled and to be signed by the Patient and the Doctor.
• A Register containing the name of the patient and spouse, address, ref. Doctor name and
date of the scanning etc. to be maintained.
• Form ‘F ‘and Ref. Doctor Requisition to be preserved.
38. • Case Records and U/S Report to be preserved.
• Sonographic plates/Films/slides to be preserved.
• A complete statement of report of all the OBS scans/procedures to be sent by 5th
day of following month to AA.
• Intimation about every change of employee, place, address and equipment
installed shall be sent to the appropriate authority within a period of 30 days.
• Preservation of Records: 2 Yrs.
• In case of legal disputes: till the final disposal of legal proceedings.
• In the event portable ultrasound machines are taken to
health camps prior permission of the aa under whose
jurisdiction camp is conducted should be obtained
39. Can one arrange for a locum sonologist when
one is on leave or vacation
• One month notice has to be given to local AA with copies of certificates of that
doctor.
• A recent gazette notification has stated that application for locum to adding a
doctors name for registration certificate has to be done 30 days in advance.
• This gazette has been challenged by IRIA in Delhi high court in July 2012 and an
interim relief of 7 days has been given
40. Is there a restriction on number of places a
sonologist can visit?
• As per the recent gazette dated 5 June 2012, a sonologist can visit only 2 places
in one district.
• This has been challenged in delhi high court by IRIA and ad-interim has been
obtained.
• In the next hearing the appropriate authority informed the court that they were
unconditionally withdrawing the restriction on number of places visited by
radiologist.
41. CODE OF CONDUCT
• Wear NAME TAG yourself and every employee working at the US
Clinic. Write full name and designation under signatures.
(Rule18 - viii & ix)
• Should not indulge in SEX DETERMINATION & FEMALE FETICIDE
and do not commit any other act of professional misconduct.
(Rule18 - x & xi)
42. OFFENCES AND PENALTIES
• A.A. Can inspect any time and can seize the machine and records in case of any omission
of rules.
• Offences by service provider:
• First offence - 3 yrs imprisonment and fine Rs.10000/-.
• Subsequent offences - 5 yrs imprisonment & fine up to 50,000/-.
• Offences by medical professionals:
• Suspension by State Medical Council and removal of name from the register of MCI – 5
yrs for first offence & permanently for subsequent offence.
43. • Persons seeking to know the sex of the foetus:
• First offence: Imprisonment extending upto 3 years and/or fine of Rs.
50,000/-.
• Subsequent offence: Imprisonment upto 5 years and/ or fine of Rs.
1,00,000/-.
• Offences by company:
• Director/Manager/Secretary/officer.
• Arrest without warrant and Non bailable warrant(NBW).
• Non – compoundable.
45. Functions of the Board
• ADVISE the central government on policy matters relating to use of pre-natal
diagnostic techniques, sex selection techniques and against their misuse
• to review and monitor implementation of the ACT and the rules made
thereunder and to recommend to the central government changes in both.
• To create public awareness against the practice of preconception sex selection
and pre-natal determination of sex of foetus leading to female foeticide
• To lay down code of conduct to be observed by persons working at gcc, gl &
genetic clinics.
• Oversee the performance of various bodies (appropriate authority) constituted
under the act & take appropriate steps to ensure its proper and effective
implementation
46. Appropriate authority:
District level, the CHIEF MEDICAL OFFICERS or THE CIVIL SURGEONS
Functions:
▪ To grant, suspend or cancel the registration
▪ To enforce the standards for genetic counselling Centre, genetic clinic and
genetic laboratory.
▪ To investigate complaints of breach of provisions of the act and the rules
▪ to take the complaints to the court.
47. ▪ To take appropriate legal action & also to initiate independent investigations in
such matter
▪ To create public awareness against the practice of sex selection or pre-natal
determination of sex.
▪ To supervise the implementation of the provisions of the act and rules
▪ To recommend to the CSB and state boards modifications.
▪ To take action on the recommendations of the advisory committee made after
investigation.
48. MAINTENANCE AND PRESERVATION OF
RECORDS
Genetic counselling center, genetic clinic or genetic laboratory, ultrasound clinic
and imaging center is required to maintain certain records
Register showing in serial order:
• Names and addresses of men or women given genetic counselling and/or
subjected to pre-natal diagnostic procedure or test
• Names of their spouses or fathers
• Date on which they first reported for such counselling, procedure or test.
In case records are maintained in computer or any other electronic equipment, a
printed copy has to be preserved.
Records at all reasonable times made available for inspection.
49. • Record by every
Genetic Counselling Centre FORM D
Genetic Laboratory FORM E
Genetic Clinic FORM F
• Other records
Case records
Forms of consent
Laboratory results
Microscopic pictures
Sonographic plates or slides
Recommendations and letters
50. The appropriate authority is to maintain a permanent record of
• Applications for grant of certificate of registration
• Applications for renewal of registration as specified in form H under the rules.
• Letters of intimation of every change in employee, place, address and equipment
installed
51. SEARCH AND SEIZURE
• Enter freely into the place of search.
• Examine and inspect all documents.
• Search at all reasonable times.
• Seize and seal any document, record,
material object or equipment .
• Amendment 2011 in rule no. 11(2)
These machines of the organizations may be released if such organization pays
penalty equal to five times of the registration fee to the Appropriate Authority
concerned and gives an undertaking that it shall not undertake detection of sex of
foetus or selection of sex before or after conception
Substituted by These machines of the organizations shall be confiscated and
further action shall be taken as per the provision of the section 23 of the act.
53. THE PRE-NATAL DIAGNOSTIC TECHNIQUES
(REGULATION AND PREVENTION OF MISUSE) ACT, 1994 AND THE PRE-NATAL
DIAGNOSTIC TECHNIQUES (ACT NO. 57 OF 1994)
(REGULATION AND PREVENTION OF MISUSE) AMENDMENT ACT, 2002
Added definitions & rules of Registration of Genetic Counselling Centres,
Genetic Laboratories or Genetic Clinics
54. PORTABLE USG MACHINES
amendment rules,2012
Its use is permitted with certain conditions:
• Has to be used within the premises its registered.
• The machine under no circumstances used for sex determination.
• The stand alone mobile ultrasound clinic offering only prenatal diagnostic tests is
prohibited.
• In case of breakdown the AA has to be informed within 7 days.
• One copy of certificate of registration shall be displayed which should specify
-area of operation, -no. of portable machines installed,
-make and model no., -registration no of the vehicle, full address of service provider.
55. • Doctors conducting USG examination will have to restrict themselves
to 2 ultrasound centres.
• Hike of registration fee from 3000 to 25,000.
• Registration application should be filled and filed a month prior.
• Purchase of a USG machine and change of radiologists at scan centre
to be notified in advance to the authority.
56. Amendment rules, 2014 ( concerned with Form F substitution)
• All column mentioned in “F” form should be filled up, no column should be
added/ deleted.
• Previous obst. History of patients with number of children with sex of each child
should be mentioned in “F” form.
• ‘F” form to be filled up in duplicate and copy to be given to appropriate
authority i.E., (M.O.H {Medical Officer Of Health} Of the wards.)
• Name of referral doctor, indication, results of USG must be mentioned
whichever column is not required must be filled up as not applicable.
• “F” form should be signed by doctor conducting sonography & not by the owner
of the centre.
• Declaration of the patient and doctor should be signed before doing the
sonography and after explaining the patient in her own language as per the act.
57. Registration of CT/MRI/B-SCAN(2015),
echocardiography(2016)
• Centre registered – if new– submit details of the new equipment to the
appropriate authority – no need to apply for fresh registration/fees.
• Exclusively CT /MRI/echocardiography – not registered – need to apply for fresh
registration.
• Require to fill form f – when investigation is done on pregnant woman – for
abdomen scan only
58. • Amendment rules 2015, rule 18(A) subrule (4) in clause (ii) has been substituted
to ensure that no fresh application or renewal of registration is accepted if any
case in any court is pending against the applicant for violation of the act.
• Section 22 of the PCPNDT act prohibits any advertisement in any form,
including internet relating to preconception and prenatal determination of sex
or sex selection.
Hon’ble supreme court order dated 16/11/2016 directed union of India to
constitute a Nodal agency for monitoring E-advertisements related to the act.
Nodal agency has been constituted accordingly on 17/1/2017.
59. • Amendment dated 19th June 2017 exempts govt institutions which provides
health and medical services not to pay fee for registration and renewal of
registration.
• Amendment 23 may,2017 appointment of state appellate authority.
60. Covid 19 updates
4 April 2020
No changes in the PCPNDT act however there is relief in
• Rule8, renewals will be considered till lockdown
• Rule 9(8), monthly report can be submitted till 30 June 2020
• rule18A(6), for AA for submission of form H
Filling form F, signing, maintenance of records and all other rules of the act must
be followed strictly
61. PCPNDT FORMS
• Form A Form of application of registration or renewal of registration
• Form B Certificate of registration
• Form C Form of rejection of application for grant /renewal of registration
• Form D Form of maintenance of records by genetic counselling centre
• Form E Form of maintenance of records by genetic laboratory
• Form F Form of maintenance of records in case of pregnant woman by
genetic clinic/ultrasound clinic/imaging centre
• Form G Form of consent for invasive techniques
• Form H Form for maintenance of permanent record of applications for
grant/rejection of registration
62. Summary
1. Register all the places wherever USG machine/any imaging machine like color
doppler/2D/3D/4D machine is used, including medical/ surgical nursing
home/ICCU wherever USG machine is used.
2. The machine should not be shifted from one center to other center. The
company name & make of machine should be noted in PCPNDT registration
certificate.
3. All radiologist /sonologist / doctors using machines, their names to be entered
in the pcpndt certificate or on the separate sheet to be displayed along with
pcpndt registration certificate
4. No doctor other than registered in that particular centre should use that
machine. Other qualified doctor may use that machine after notifying to
appropriate authority.
63. 5. Display registration certificate in original in waiting area and USG room
6. Display on notice board the message in english and local language that "sex
selection and detection is not done in this centre" and is punishable under the
act. This should be displayed in waiting area and USG room
7 PCPNDT act book copy both in English and local language should be maintained
in the centre
8 F" form to be maintained by USG centre / genetic clinic as per PCPNDT act book
for pregnant patients only.
9. Monthly report should be sent in time by 1st of month by all PNDT registered
centres to appropriate authority / by 3rd of month by A.A. To special officer, F.W.
& M.C.H./M.I.S.
64. 10. All records of all the patients to be maintained for minimum 2 years or if any
legal case against the centre is pending then records to be maintained till the
same case is disposed off.
11. Any changes in centre - like machine / doctor should be intimated to A. A.
Within 30 days. Accordingly he/she should do changes in registration certificate
immediately and inform special officer, F.W. & M.C.H. In writing and also does the
changes in "H" register.
12. For renewal of registration, apply one month in advance to A.A. Otherwise
centre will be considered as un-registered. Penalty of rs.15,000/- will be charged
13. Advertisement of any sort is banned even on internet, or coding form -
punishable under the act - rs.1 lac fine with 5 years imprisonment
65. REFERENCES
• Handbook on PCPNDT Act.
http://qi.nhsrcindia.org/sites/default/files/Handbook%20on%20PC%26P
NDT%20Act%20%26%20Rules%20with%20Amendments.pdf
• SPECIALITY BOARD REVIEW, ESSENTIALS OF RADIOLOGY 1ST EDITION 2021 BY DR RAJESH
RAMAN, DR H N PRADEEP
