Close to the International Women’s Day, I started writing this blog on the enigma that is India’s PCPNDT act. Established as a supposedly powerful tool to curb female foeticide in the country, it has developed into one of the major medico-legal issues facing Indian radiologists who have to face miles of red tape for regular ultrasound practice. It has been cited as the most common cause of stress among Indian radiologists.^[1]However this blog is not about discussing the shortcomings of the PCPNDT act, which are explored in detail on other blogs and forums.

This blog is meant as an introduction to PCPNDT for radiology residents, to make them well versed in the practical points of the act. The points mentioned here can also be used by residents for writing long or short answer questions, as also for answering various common viva questions. The radiology resident upon completion of his/her course is expected to be well versed in the basics of the PCPNDT act, understand its importance and follow it in order to practice radiology in a medico-legally apt manner.

The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition Of Sex Selection) Act should ideally be read in its entirety by every radiology resident and practising radiologist. It is possible to stay up to date regarding the various amendments in the act via IRIA bulletins.^[2]

I. Need for the PCPNDT act

India has an abysmal sex ratio due to female feticide. A few decades back, amniocentesis was the technique misused for female feticide. After ultrasound has become widely available across the country, it soon earned this dubious distinction. To counter female feticide, the Indian parliament enacted the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act on 20 September 1994 : the PNDT act. It came into effect from 1996.

However as per the 2001 census the sex ratio was still declining. It was realized that pre-conceptional selection of the sex of the fetus was also possible due to techniques such as in vitro fertilization. Hence an amended act was passed, known as the The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition Of Sex Selection) Act, which came into effect from 14 February 2003. Despite the act however the child sex ratio has continued to decline, from 927 in 2001 to 919 in 2011.^[3] Clearly, the PCPNDT Act is not having the effect it was supposed to!

II. Definitions under PCPNDT

1. Pre-natal diagnostic procedure: Include-

USG

Fetoscopy

Amniocentesis

Chorionic villous sampling

Blood tests

2. Conceptus – any product of conception from fertilization till birth including extra-embryonic membranes and embryo as well as fetus

3. Embryo – till the end of 8^th week (56 days) after fertilization

4. Fetus – from 57^th day after fertilization till birth

5. Places-

a. Genetic counselling centre – Any hospital / institute / place which provides genetic counselling to patients

b. Genetic clinic –Any hospital / institute / place for conducting prenatal diagnostic procedures

c. Genetic laboratory –Any hospital / institute / place for conducting analysis or tests of samples

As per amendment made in 2003, Ultrasound comes under genetic clinic.

The first line of form F states: “Name and address of Genetic Clinic / Ultrasound Clinic / Imaging Centre”.

III. Qualified persons under PCPNDT

1. Gynaecologist – can do counselling, USG and prenatal procedures
2. Medical Geneticist– only counselling
3. Paediatrician – only counselling
4. Registered Medical Practitioner – should have 6 months training in USG
5. Laboratory technician – only laboratory work
6. Radiologist – can do USG and prenatal procedures
7. Sonologist – Any person who possesses an MBBS degree and post-graduate qualification in either Radiology (MD / DNB / DMRD / DMRE) or in USG – 6 months

 IV. Government institutions for implementing the PCPNDT act

A. Policy making: The Central Supervisory Board and the State Supervisory Board

B. Policy implementing: The Appropriate Authority and the Advisory committee

a. Central Supervisory Board-

1. Head of Ministry of Department of Family Welfare is the Chairman
2. Board has to meet every 6 months
3. Advises government on policy making
4. Monitors implementation of PCPNDT
5. Creates awareness among public

b. State Supervisory Board-

1. Creates awareness in public
2. Monitors Appropriate Authorities
3. Sends regular report to Central Supervisory Board

c. Appropriate Authority-

1. Appointed at state, district and sub-district levels
2. At district and sub-district level – Chief Medical Officer or Civil Surgeon
3. Can grant, suspend or cancel registration
4. Conducts regular inspection of all USG centers registered once every 90 days
5. Investigates complaints under PCPNDT act
6. Takes the complaints to court
7. Can issue search warrant of any imaging centre suspected of performing sex selection

d. Advisory Committee-

1. Advises Appropriate Authority
2. Meets every 60 days
3. Appropriate Authority has to attend the meetings

V. Forms under PCPNDT

• Form A – Registration of imaging centre or renewal of registration
• Form B – Certificate of registration (to be displayed at the clinic)
• Form C – Rejection of registration of imaging centre
• Form D – Form for maintenance of records by genetic counselling centre
• Form E – Form for maintenance of records by genetic laboratory
• Form F – Form for maintenance of records by genetic clinic / imaging centre
• Form G – Consent form for prenatal invasive diagnostic techniques
• Form H – Form for permanent maintenance of application for grant / rejection of registration

VI. Registration

• Is mandatory for government as well as private institutions/centers
• The place where USG is done is registered
• Application to be made 3 months in advance
• Application made to-
  • Chief Medical Officer of district OR
  • Any other medical officer constituted as Appropriate Authority (AA) of the subdistrict
• Application made in duplicate in Form A
• Affidavit to be attached stating sex selection will not be done, and that notice regarding same will be put up in centre
• Application fee-^[2]
  • Rs 3000 – Imaging Centre / USG clinic / Genetic counselling centre / Genetic laboratory
  • Rs 4000 – Joint services of Imaging Centre / USG + Genetic counselling centre / Genetic laboratory

VII. Renewal of registration

• Registration is valid for 5 years
• 1 month before expiry – application for renewal should be sent
• If not sent – centre will be unregistered with penalty of Rs. 15,000

VIII. PCPNDT act provisions

• Prohibits sex selection before or after conception and misuse of pre-natal diagnostic techniques for determination of the sex of the foetus, leading to female foeticide
• Prohibits advertisements in relation to such techniques for detection or determination of sex.
• Specifies the punishment for violation of its provisions.
• No disclosure of sex of conceptus to be made either to patient, relative or referring physician
• Not to be disclosed orally, in writing, by gesture, sign or any manner whatsoever

IX. Guidelines for sonologists / imaging centers (some of these may vary from state to state; so do check with the local appropriate authority)

• Only registered doctors can perform USG
• Place is registered and number of machines within centre to be specified at time of application with their model numbers
• If new machine is bought – notification to be given 1 month in advance
• No limit on number of USG machines in 1 centre
• USG machine cannot be transferred from one centre to another
• Record of all PCPNDT related USGs and procedures is to be sent to Appropriate Authority till 5^th of every month
• CT and MRI machines have to be registered under PCPNDT also
• All PCPNDT related documents and images to be preserved for 2 years
• Written consent is required for invasive procedures like amniocentesis, chorionic villous sampling and is provided in Form G

X. To be displayed in USG room / clinic

1. Certificate of registration of the place
2. Copy of PCPNDT act
3. Names of doctors registered with qualification
4. Notice displaying ‘conduct of sex determination / disclosure of sex is prohibited by law and not done at this centre’ in English as well as local languages

XI. Filling Form F

• Two copies of Form F to be filled-
  • 1 given to Appropriate Authority
  • 1 kept at USG clinic for 2 years
• If online Form F submission done-
  • Printout of online form to be kept at USG clinic with patient’s signature
  • OR another Form F is to be preserved at the clinic
• Form F should be signed by doctor doing the USG and not owner of centre
• Three signatures of doctor are required on Form F and two signatures of patient

XII. Medical termination of pregnancy

• Can be done upto 12 weeks
• From 12 to 20 weeks – can be done with opinion of two registered medical practitioners (since sex of fetus can be determined after 12^th week – opinion of 2 doctors is required)
• Reasons for termination of pregnancy-
  • Congenital anomalies
  • Immediate risk to life of the pregnant woman if pregnancy is continued
  • Pregnancy due to rape
  • Failure of methods of family planning

XIII. Offenses under PCPNDT act are cognizable, non-bailable and non-compoundable-

1. Cognizable: Police officer may arrest without warrant.
2. Non-bailable: Police cannot grant bail.
3. Non-compoundable: Parties to the case cannot settle the case and decide not to prosecute.

XIV. Who can make a complaint under PCPNDT?

1. Appropriate Authority
2. A person who has given notice of 15 days to Appropriate Authority and if AA has not taken action, then that person can directly approach court

The offense can be tried only in court of Metropolitan Magistrate or Judicial Magistrate of First Class

XV. Punishments under PCPNDT

The maximum cases filed against doctors under PCPNDT act have been against non-radiologists (MBBS doctors / technicians / even quacks) doing ultrasound.

a. Major offenses

Major offenses	Punishment
Sex selection, determination and communication	First there is temporary suspension of registration number by the MCI from the time of framing the case up to its disposal. If found guilty: 1.For first offence: jail up to 3 years + fine up to Rs. 10,000 and removal of name from MCI register for 5 years 2.For second offence onwards: jail up to 5 years + fine up to Rs. 50,000 and permanent removal of name from MCI register
Gross deficiency or inaccuracy in record keeping as per revised form F	Same punishment as above
Advertisement regarding sex selection	Jail up to 3 years + fine up to Rs. 10,000

b. Minor offenses

Minor offenses	Punishment
Non-display of- –     PCPNDT registration –     PCPNDT act –     Notice saying sex selection is not performed	3 months jail + Rs. 1000 fine. Rs. 500 per day for every additional day of non-compliance
Non-registration of centre	Seizure and sealing of USG machines. Have to pay fine of 5 times the registration fees to get centre registered
Irregularities in registered centre- –     Non-qualified person performing USG –     More USG machines at centre than are registered –     Minor deficiency in record keeping	Suspension of registration of centre may be done without show cause notice. During this period machine to be sealed.

For a case registered under PCPNDT, appeal can be made within 30 days to a higher level Appropriate Authority. The case has to be solved by the higher authority within 60 days of receipt.

XVI. Cancellation of imaging centre registration

• Can be done if a breach of provisions of PCPNDT act is found
• Appeal can be made to a higher authority within 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.
  • State government if the order is passed by the State Appropriate Authority.
  • Central Government if the order is passed by the Central Appropriate Authority.
• Each appeal has to be disposed of within 60 days of receipt.

 XVII. Burden of proof under PCPNDT

• Burden of proof is with the accused doctor.
• Doctor has to prove innocence and is considered guilty until proven innocent.
• This is opposite to many sections of IPC where a person is considered innocent until proven guilty.

A useful resource for further PCPNDT related reading is the PCPNDT special issue of Indian Journal of Radiology.^[4]

 –  Ameya Kawthalkar, MD, DNB, FRCR

Assistant Professor, Sir JJ hospital and Grant Medical college, Mumbai

References

1. Kawthalkar AS, Sequeira RA, Arya S, Baheti AD.Non-radiation occupational hazards and health issues faced by radiologists – Across‑sectional study of Indian radiologists. Indian J Radiol Imaging. 2019 (in press).
2. IRIA website – https://www.iria.in/pndt.php
3. Census of India 2001 and 2011. Press Information Bureau, Ministry of Health and Family Welfare, Government of India,.
4. Indian Journal of Radiology. April-June 2012. http://www.ijri.org/showbackIssue.asp?issn=0971-3026;year=2012;volume=22;issue=2