FAQ’s regarding PCPNDT

Dr. (Prof.) Mahesh Baldwa,

M.D,D.C.H, FIAP

MBA, LL.B,LL.M , Ph. D(law)

SENIOR PEDIATRICIAN & MEDICOLEGAL ADVISOR

Formerly Assistant Professor of Pediatrics at T.N. Medical College and Nair Hospital, Mumbai-400008

Ex. Asst. Professor JJ Hosp, Grant medical college

Professor, paper setter & examiner of law to postgraduate students of University Department of Law, University of Mumbai

Baldwa Hospital, Sumer Nagar,S.V. Road,

Borivali (West)Mumbai 400 092

drbaldwa@yahoo.com

drbaldwa@gmail.com

m_baldwa@rediffmail.com

Cell 09322990138

RESPONSIBILITY OF THE MEDICAL PROFESSIONALS WITH RESPECT TO PCPNDT

To say “No” to requests for sex detection and gender-specific MTPS
discourage colleagues from doing so
To register Centres
To counsel to dissuade sex determination
To enlighten society about erring doctors who conduct sex detection and female-specific MTPs.
To regularly have stock-taking on the prevalence of sex determination by IMA & publish articles and statements on the subject to give prominent focus to the issue.
To himself/herself sincerely abide by the Act and its spirit.
To blow the whistle on those in the fraternity who are conducting these tests and practices. They should immediately be reported to the concerned AA.

Warnings for filling of form F

Do not start USG without filling form F
Each and every column and details be filled in meticulously
No space be left blank
Overwriting should not be done
Signature should bear the full name of doctor
Declaration of pregnant women is essential with her signature and address
Do not keep excess unfilled form F
Do not fill two forms for one lady
Do not make changes, alteration

General FAQ’s with respect to PCPNDT

What is the procedure for registering centre

The owner has to apply to the AA (the Chief Medical Officer at the district where the unit is situated or the officer appointed in the sub-district) , must be done before commencing business of USG. Rule 4(1)

Form A filling

All applications are to be made in duplicate in Form A( available in PCPNDT rules) and must be accompanied by enclosures containing

details of equipment available, the make and model of each equipment and the names,
qualifications,
registration number
Experience of medical professionals in USG.
The other documents which need to be submitted be listed
What is the registration fee and if there is more than one USG machine how much is the fee?
The registration fee of a Genetic Clinic is Rs. 3,000 or more as per current requirement. However, if the centre is providing more than one service as a Centre, then the registration fee is Rs. 4,000 or more as per current requirement.
This fee is non-refundable
It is irrespective of the number of USG machines in the centre. But the owner has to inform the AA about the exact number of sonography machines in details which are in the centre existing Provisio to Rule 5 (1).
if they are replaced or new machine is added and start work only after getting fresh new approval, and changes in registration form B are mandatory before using it.
Form B of registration of the Unit as a, whole including the place, equipment / machine and doctor using the machine, has to be registered with the AA. One copy of the certificate of registration should be prominently displayed by the unit in a conspicuous place at its place of business. Under Sec 19(4)
What if the application for registration is rejected? When can one reapply?

If the application is rejected in form C, the owner of the Genetic Centre can reapply within 90 days of the rejection and need not pay the fee again. But if it is rejected again, then the applicant has to pay the fee on any 3^rd and subsequent application. Rule 6 (5) and Rule 5(1)

If a GCC, GL or GC or medical professional has any grievance against any AA where should he/she lodge the complaint?
If the complainant is not satisfied with the decision of the AA at sub-district level she/he may appeal to the AA at district level; if she/he is not satisfied with AA at the district level, she/he may appeal to State AA/Union Territory
within 30 days of receiving the order.
The Appellate authorityas per Under Sec 21 to be read with Rule19 must give its decision within 60 days.26 The appeal must be made to the Central Government if the order is passed by the Central AA Under Sec 21 (i). Similarly theappeal shall be made to the State Government if the order is passed by the StateAA Under Sec 21 (ii).If the appeal is not made within the time prescribed, the AA may condone the delay if he/she is satisfied that the appellant was prevented with reason from making such appeal. Rule 19(4)
If a unit adds a new machine, is it to be registered again for Rs. 3,000 or as required by AA?

No, noadditional registration fee is to be given to AA, but the owner should inform the AA within 30 days of getting the machine and the relevant changes should be made in the Certificate of Registration.

Can portable ultrasound machines be carried in vehicles in emergencies?
For emergencies the vehicle is the unit and the machine is to be used in the vehicle.
Vehicles can be registered as Genetic Clinics, at the AA of the area where the owner resides. Hence portable ultrasound machines can be used in case of any emergency.
The vehicle need not be an ambulance or a van.
Such vehicles are obliged to maintain records for any ultrasound carried out on the portable machines.
It is important to note that the vehicle has to be registered as a unit, so in case of any breakdown of the vehicle or any other reason for not using the vehicle as a Genetic Clinic the AA has to be informed within 30 days. Explanation to Under Sec 2 ( d) (e) and only after getting approval in writing from AA.
If the owner of a GC has a portable machine in addition to stationary machines, what is the registration process?
The owner has to get a registration for the clinic and a separate registration for the vehicle.
The registration certificate of the GC will mention both the portable and stationary machines, while the vehicular registration will only mention the portable machine. For example, if a maternity clinic is using all its seven vehicles for carrying an Ultrasound machine cannot be used in a vehicle not registered as a vehicle under the Act. portable ultrasound machines, it has to obtain a joint registration for the maternity clinic and seven separate registrations for each of the vehicles, or designate one vehicle registered for carrying portable ultrasound machines.( Clarification given to Government of Punjab by Ministry of Health and Family Welfare, Government of India)
Can non-allopathic medical professionals perform USG?

Besides training/experience, the basic requirement is that the person should be a registered medical practitioner, i.e. the person’s name must have been entered in the State medical register and she/he must possess a recognized medical qualification as per the rules of the Medical Council of India. Since only allopathic medical professionals can register with MCI, a person with non –allopathic qualifications cannot perform the sonography.( 32 Under Sec 2 and (Prakash Motiram Khobragade v State of Maharashtra , A.I.R 2000 Bom.137 at p.138. In this case the Apex Court held that persons who are otherwise not qualified for registration under the Medical Practitioners Act, under the Indian Medical Council Act and the State Acts are not entitled to claim any right to practice medicine)

If a USG machine is in a Genetic Centre but is packed and not in use does it require registration?
Yes. The need for registration of the place arises by the very possession of the USG machine. Even if a USG machine is lying packed or is not being used, the registration of the centre where it is located/stored is mandatory and such a machine must be reported to the AA.
If a USG machine is used by IVF centre, surgeon ,cardiologist, ophthalmologist, pediatrician or any other non gynec obstetric practice and in use does it require registration?

Yes. The need for registration of the place arises by the very possession of the USG machine. the registration of the centre where it is located/stored is mandatory and such a machine must be reported to the AA.

If a registered clinic is handed over to another person, does the registration continue?
No. The registration is non-transferable. In the event of any change in the ownership or change in the management of the Genetic Centre, the original certificate of registration stands null and void. The new owner and the manager have to apply afresh on form A with the required fees to the AA for getting the registration certificate. Rule 6(6) and 6(7)
What is the validity of the registration certificate?
Five years, provided there is no violation under the Act. Rule 7
How does an owner renew the registration?
An application for renewal should be made in duplicate through Form A to the AA 30 days before the expiry date of the registration. The registration would be renewed after conducting an enquiry and with suggestions from the Advisory Committee. The renewal fee is half of the original fee. Rule 8(1) and Rule 8(4) read with Under Sec 18 & 19
What if there is no communication from the AA regarding renewal?
If the AA does not respond within 90 days, then it will be presumed that renewal has been granted. Rule 8(6)
How many types of records are to be maintained?
A register showing in serial order
Names and addresses of men or women seeking USG
Name of husband/wife or father
Date on which they first reported for such counselling, procedure or test. Rule 9(1)
Record under Form D. Rule 9( 2)
Record under Form F. Rule 9(4)
Sonographic plates or slides
Recommendations or letters Rule 9 (6) & 9 (7)
For how long do the records have to be maintained?

All records should be maintained for at least two years Under Sec 29(1) (as per Form D) after any prenatal diagnostic technique has been performed on a pregnant woman. However, if there is any legal proceeding pending in the court of law, then these records should not be destroyed till the proceedings have been disposed off. Provisio to Under Sec 29 (1) to be read with Rule 9 (6)

In case the records are maintained on a computer or any other electronic equipment, a printed copy of the record is to be taken and preserved after

authentication by the person responsible for such a record. Rule 9(7) Records at all reasonable times are to be made available for inspection to the AA or a person authorized by the AA. Section 29 (2)

What should the Scan Centers do under the Act?
Display

Registration certificate, PNDT board & pamphlets;

Records

Mandatory records

Register showing in serial order
Name & Addresses of men or women given genetic counselling and /or subjected to prenatal diagnostic procedure or test.
Names of their spouses or fathers;
Date on which they first reported for such counselling
FORM D/E/F under the Rules.
The scan centre shall send consolidated report on Form F statutorily by 5th for the previous month to the AA or any officer so authorized
Other kinds of records include :
Case Records
Forms of consent
Laboratory results
Microscopic pictures
Sonographic plates or slides
Recommendations & letters.
The referrals of the doctor recommending scan and a declaration from the pregnant mother regarding her non interest in knowing the sex of the foetus is a must for every case.
The medical practitioner is responsible for taking informed consent (form G) from the pregnant women in case invasive techniques are used.
What are the offences under the Act?
Persons Conducting or associating or helping in conducting USG in an unregistered unit
Taking the services of an unqualified person, whether on an honorary basis or on payment, Under Sec 4 (1)
Sale, distribution, supply, renting, allowance or authorization of use of any ultrasound machine to non-registered units Under Sec 3 (b) to be read with Rule 3 (a)
Unit owner / any organization including Commercial organization/ Company, Manufacturer, Importer, Dealer, Supplier Under Sec 2 (o) & 3(A)
Advertisement or communication in any form in print, by electronic media or internet saying services, medicines, or any kind of techniques, methods, ayurvedic medicines. Under Sec 22 then Distributors, Printers, Publishers, Website host, Website developer, Anyone connected with issuance of any such communication or advertisement shall be responsible
What are the punishments under the Act?
Breach of any provision of the Act by Medical professionals – 3 years imprisonment and/or fine of Rs. 10,000 and 5 years imprisonment Under Sec 23 (1) and/or fine of Rs.50,000
The AA will inform the State Medical Council and recommend suspension of the offender’s registration, Removal of name from register for 5 years on first conviction and permanently in cases of subsequent breaches Under Sec 23 (2)
Persons referring -Imprisonment extending up to 3 years and/or fine of Rs 50,000 Imprisonment up to 3 years and/or a fine of Rs. 10,000 with additional fine of continuing contravention at the rate of Rs. 500 per day Under Sec 22 (3)
Contravention of provisions of the Act or rules for which no specific punishment is provided with Act/Rule Imprisonment up to 5 years and/ or fine of Rs. 1,00,000 Under Section 23 (4)
Imprisonment up to 3 months and /or fine of Rs. 1,000 with additional fine of continuing contravention at the rate of Rs. 500 per day Under Sec 25
If the owner is convicted under the Act and undergoes punishment, what is the status of the registration of his unit?

In such a case, when charges are framed against him, the registration of his unit is suspended or cancelled, prohibiting use of USG. An owner, who is convicted or undergoes punishment, will have to apply afresh in form A after the expiry of the term of punishment. In such an event, the AA can grant or refuse to grant the registration, depending on whether the unit meets the requirements laid down in the Act and the Rules.

Who can be punished under the Act?
Person who performs the test
Every person in charge / Owner of Centre
Mediator who is responsible for directing the pregnant woman to such a unit
Husband/family of the pregnant woman
All other relatives of the pregnant woman who are responsible for forcing
The pregnant woman herself is considered innocent under the Act
The Offences under the Act shall be tried only in the court of the Metropolitan Magistrate or a Judicial Magistrate of First Class – Under Sec 28 (2)
What is the Code of Conduct ( Rule 18 )
not conduct or associate with, or help in sex determination
not employ unqualified
conduct USG for the purposes specified in sub-section (2) of section 4 of the Act
not conduct USG at unregistered place
ensure that no provision of the Act and these Rules are violated in any manner
help the law enforcing agencies in bring to book the violators of the provisions of the Act and these Rules;
display his/her name and designation prominently on the dress worn by him/her
write his/her name and designation in full under his/her signature;
on no account conduct or allow/cause to be conducted female foeticide;
not commit any other act of professional misconduct.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

VIOLATIONS	SECTION/RULE OF THE PNDT ACT	PENALTIES
Minor Offences Non-availability of copy of the PNDT Act in the registered centreNon- Display of registration certificate in the centre.Non-Display of Board in the premises in English and Local Language that ‘Disclosure of the sex of the foetus is prohibited under law’.	Rule No. 17(2) Rule No. 6(2) Rule No. 17(1)	For Minor Offences: Case may be launched in the court of JMIC u/s 25 of the Act. Punishment may extend to 3 months or with fine, which may extend to Rs. 1,000/-for first offence. Additional fine up to Rs. 500/- per day for the period of contravention for subsequent offence. Or Show cause notice u/s 20(1),(2) for temporary suspension of registration. Or Under Section 20(3)
2. Advertisement relating to pre-conception and pre-natal determination of sex.	Section 22(1), (2).	U/s 22(3) of the PNDT Amendment Act, imprisonment which may extend to 3 years and with fine which may extend to Rs. 10,000/-. Case is to be launched in the court u/s 28 of the Act
3.a Unregistered centres. b. It includes all such centres where any portable equipment capable of detecting sex c. even though owner of such equipment may be having a registered facility somewhere else.	Section 3	Any such equipment has to be sealed and seized by the Appropriate Authority concerned. He/She may Launch the case in the court u/s 28 of the Act. Register such centre after receiving 5 times the registration fee as penalty and after taking a undertaking as per the PNDT Rules-Rule 11(2). He
4. Irregularities in registered centre Owner/employee conducting the ultrasonography not qualified. More ultra sound Machines /equipments where as less number register. Minor deficiency in record Keeping.	Section 3(2) and Rule 3(b). Under Rule 4.6 and as per Form ‘A’. Sr. No. 8 Under rule 9.	The Appropriate Authority or person authorized thereupon may: Issue show cause notice u/s 20(1)(2) of the Act and with the endorsement of the Advisory Committee, may suspend (for a reasonable period) or cancel the registration, as per the magnitude of the violation. May take Suo Moto action u/s 20(3) and suspend the registration without issuing show cause notice. *Note:* 1.During the period of suspension of registration, the equipment needs to be sealed and signed and kept with the owner. 2. After cancellation of the registration, the equipment has to be sealed and seized. 3. Anybody aggrieved by the above decision may appeal to the higher-level Appropriate Authority within 30 days of the action. The appeal shall be disposed of by the higher authority within 60 days of its receipt.
Record Keeping Irregularities in record keeping as per revised form ‘F’ are a major offence.	Section 4, 29 and Rule-9.	Contravention (a major offence) of provision of section 5 and 6 of the Act and punishable U/s 23(1) of the PNDT Act.
6. Sex Selection	Section 3A. 4(5). 6 read with section 2(0)	Violation of section 5 and 6 of the Act and punishable u/s 23 of the Act.

All offences under the Act are cognizable, non-bailable and non-compoundable (Section 27).

Cognizable means A police officer may arrest the offender without warrant, Non-bailable means – Getting bail is not the right of the accused. The courts have discretion to grant bail

Non-compoundable means – Parties to the case cannot settle the case out of court and decide not to prosecute.( Sec 27 )