- What are the provisions of PCPNDT Act?
The Act provides prohibition of sex selection before or after conception and regulations of PNDT for purpose of detecting genetic abnormalities or metabolic disorders or chromosomal abnormalities and it prevents their misuse for sex selection & leading to sex selection abortion.
- What is the procedure of Registration a Genetic clinic, Counseling center, a Laboratory or Ultra Sonography clinic ?
Application in form A to be submitted to Appropriate Authority. Submit details of person place and equipment. Pay fee Rs. 25000/- or 35000/- as applicable and submit the affidavit.
- Why this was brought into the force and what are the amendments of 2003 PCPNDT Act and does it cover?
Advanced medical technologies are misused to detect sex before or after conception. Act is for prohibition of sex selection, for regulation & Pre conception & Pre natal diagnostic Techniques & to prevent the misuse.
- What do you mean by Sex Selection?
It includes any procedure, techniques, test or administration or prescription or provision of anything for the purpose of ensuring or increasing the probability that embryo will be of particular sex.
- How does the PCPNDT Act relate to Gynecologist?
As per Act Gynecologist can use USG, after proper registration with Appropriate Authority. He/She has to follow all sections & rules of Act 1994 amendment 2003.
- Is the Act against technology?
No, Act is not against technology. But it prevents misuse, regulates purposes prohibits sex selection before or after disclosing sex of conceptions, embryo or fetus is illegal.
- What are the various types Pre – natal diagnostic techniques, tests and procedures?
As per section 2 (j) Pre – natal Diagnostic techniques includes all pre-natal diagnostic procedures & Post natal Diagnostic tests.
Sec2(K) says pre natal diagnostic test means USG ar any test or analysis of amniotic fluid, chrorimic villi, blood or any tissue or fluid of pregnant women or concept us conducted to detect genetic or metabolic disorders or chromosonel abnormilities or congenital abnormalities or hamoloinopaties, or sex linked diseases.
Sect2(i) Procedure means all gynecological or obstetrical or medical procedures such as USG feetoscopy taking or reaming samples of man or women before or after conception for being sent to GL,GC for conducting any type of analysis.
- How many types of Registration are done now?
- Genetic Counseling Center
- Genetic Center
- Genetic Laboratory
- Ultra Sonography Center
- All these centers can be registered singly or in combination of one or two or three or all, as the case may be.
Registration of all these type of centers / clinics/Laboratory/ counseling center is must.
- What are indications for doing pre-natal & Pre conceptive test in a patient?
- Chromosonal Abnormalities
- Genetic Metabolic diseases
- Sex linked genetic diseases.
- Congenital anamolies
- Any other diseases as specified CSB.
- What are the specific indications for doing ultra sonography? ( As per the PCPNDT Act)
As per Act, there is representatives list of 23 indications as follows:
- To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.
- Estimation of gestational age (dating).
- Detection of number of foetuses and their chorionicity.
- Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive fail- ure/MTP failure.
- Vaginal bleeding/leaking.
- Follow-up of cases of abortion.
- Assessment of cervical canal and diameter of internal os.
- Discrepancy between uterine size and period of amenorrhoea.
- Any suspected adenexal or uterine pathology/abnormality.
- Detection of chromosomal abnormalities, foetal structural defects and other abnormalities and their follow-up.
- To evaluate foetal presentation and position.
- Assessment of liquor amnii.
- Pre-term labour/pre-term premature rupture of membranes.
- Evaluation of placental position, thickness, grading and abnormalities (placenta praevia, retroplacental haemorrhage, abnormal adherence etc.).
- Evaluation of umbilical cord – presentation, insertion, nuchal encirclement, number of vessels and presence of true knot.
- Evaluation of previous Caesarean Section scars.
- Evaluation of foetal growth parameters, foetal weight and foetal well being.
- Colour flow mapping and duplex Doppler studies.
- Ultrasound guided procedures such as medical termination of pregnancy, external cephalic version etc. and their follow-up.
- 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.
- Observation of intra-partum events.
- Medical/surgical conditions complicating pregnancy.
- Research/scientific studies in recognized institutions.
- Can a medical professional perform pre-natal Diagnostic techniques on a pregnant woman without her consent?
No, her written consent must be obtained before any procedure or techniques.
- If there is more than one machine what is registration fees?
As per rule (5), Rs. 25000/- for GCC, GL,GL USG or imaging machine and Rs. 35000/- for an institute, hospital, nursing home or any place where jointly services of GCL, GL,Ge, USG or combination thereof.
- What if the application is rejected, when can one re-apply?
He can apply if reason for rejections noted by App. Authority in written are complied by applicant. Act is silent about the duration or interval of re- apply
- If the obGyn has to complain where should he/she approach and how?
As per rule 19(1) Gynecologist may appeal to District Appropriate Authority against the decision sub district level Appropriate Authority and as per 19(2) he/she may appeal to State Appropriate Authority against decision of District Appropriate Authority if one is not satisfied.
- If you buy machine it is to be registered again?
As per rule 13-change or new entry of machine is intimated to Appropriate Authority at least 30 days in advance of expected data of change and seek re-issuance of certificate of registration from the Appropriate Authority concern.
- Is the registration clinic is handed over to another person does the Registration continue?
No, Registration is non – transferable, but once registered, any change in person, place or equipment is to be intimated to Appropriate Authority al least 7 days before (Amendment & High Court Delhi Directives)
- What is validity of registration certificate and renewal procedure?
Validity is for 5 years Registration must be renewed after 5 yrs. Renewal application must be submitted at least 30 days before the expiry date.
- What are offences under the Act & Punishment under the Act?
Act 23(1) one who contravenes any of the provision of this Act or rules shall be punishable for a term of which may extend to three years imprisonment & with five which may extend Rs.10 thousand & for subsequent offence Rs. Fifty Thousand & imprisonment for five years. Act 23(2) If charges are framed suspension of medical council registration till case disposed of & an convictions for removal of name from register for 5 year and permanently for subsequent offences.
- Who can be punished under the Act?
- Medical Geneticist, Gynecologist, RMP, Sonologist or any person who owns the center if contravenes the Act.
- Person who renders his professional, technical services in the center as honorory basis or otherwise who contravenes the provision of Act & Rules.
- Relatives of pregnant woman, who compels her for sex determination.
- What is code of conduct to be maintained by employee of the clinic?
Sect-17 Board - Disclosure of sex of fetus is prohibited under Act. Copy of Act in English & local language. As per Rule 18
- What are the records to be kept by ultrasound centers/registered center? When are they supposed to be destroyed?
Sect (5) 1) Five Colum register 2) Form-D 3) Form-E 4) Form – F 5) Registration of center certificate form( B) 6) Case related records – consent forms, results copy, microscopic pictures ( if any) Sonography plates or slides, referral slips 7) Events if any of legal procedures and all records should be preserved for 2 yrs. Or till final disposable of legal procedure.
- Police can arrest doctor as section -27 offence is cognizable, non compoundable?
No unless case is lodged by Appropriate Authority and presented before duty magistrate.
- Police can arrest doctor as section -27 offence is cognizable, non compoundable?
No unless case is lodged by Appropriate Authority and presented before duty magistrate.
- NIMC under which section has power to perform their duty?
See PNDT Act chapter IV CSB 16 i,ii,v under Central Supervisory Board….Function of Board…. To review and monitor implementation of the Act.
- Non medical person can open sonography clinic or not?
Rule (3) Yes, He may if he/she is employing Gynecologist sinologist, Rediologist, Medical Genetist, having adequate space and USG machine registered with District Appropriate Authority.
- Can Appropriate Authority refuse NEW/RENEWAL registration certificate to GCC, GCL or CENTER? If yes or no please justify your answer?
Yes, Sec 19(2) If after enquiry and after given opportunity of being heard and having regard to advice of Adv. Committee, Appropriate Authority come to conclusion that applicant has not complied with requirement of Act.
- Can AA have power to seal premises?
- Under MTP Act one cannot disclose woman identity & her records what is in PCPNDT Act doctor can disclose her records or not? If yes why or not why?
PCPNDT records may be shared with District Appropriate Authority or person given authorization by District Appropriate Authority.
- Can Non medical person open sonogrphy clinic or not?
Non Medical person can be owner not operator.
- Under which circumstances sonography registration is surrendered?
When any of the requirements eg. Qualified operator, space, date of registration/renewal etc are deficient, it is better to inform the Appropriate Authority and request them to seal it or keep it with them temporarily till all requirement are fulfilled.
- What are the qualifications required for doing ultra Sonography/Registration of USG center?
As per sec(3)(b) a Sonologist, imaging specialist, Radiologist or Registered Medical prationer having post graduate degree or diploma or six months training or one year experience in sonography or image scanning or a medical geneticist.
- Can A. A. refuse renewal registration certificate to GCC or CENTER? If yes or no please justify your answer?
Yes, if deficient in qualification, place, machine etc.
- Can A.A. have power to seal premises?
Yes, if it is satisfied that premises which are being used for sonography say room etc. (Not whole building) are being misused for female foeticide. However AA should be able to justify its action in court- Supurtnama
- Can one do MTP of unmarried girl under MTP Act if yes or no justify your answer?
Yes, if she is a major/adult. Yes with consent of parents if she is minor, only if there is risk to mother/child & if she wishes.
- Once machine is sealed can SAA / DAA reseal the machine?
Act is silent but as per judgment of Justice Roshan Dalvi
- Can a person buy machine by submitting an affidavit and supply for Registration simultaneously. Registration at times takes too long?
Under Rule 3 (a), it is essential for the center to be registered prior to sale/ distribution/supply/rent – out / authorization of use of ultrasound / imaging machine.
- Are same Rules applicable for Govt. facilities also?
Act & Rules in totality are applicable for Government. facilities also
- Does the IVF/ART center require registration? Similarly, one may not be doing scans for pregnant women, then, what are PC & PNDT Act requirement?
Registration is mandatory under clause 2 (i),(j),(k) & section 18 of the Act. In case Genetic laboratory is functioning, record on form – E has to be maintained. In case the center does not entertain scan for pregnant women, it has to display prominently accordingly and many furnish undertaking to this effect to the AA . in case violation is detected, action under the Act will be taken.
- Is it necessary that the application for renewal of registration be made before the registration lapses? What is wrong with requesting renewal soon after the expiry?
Renewal of registration is granted under Rule no. 8 and application has to be made 30 days prior to expiry of registration. Once the date expires, the place automatically becomes unregistered and action can accordingly be taken.
- Can the center submit the monthly report in consolidated table instead of individual forms F?
- What are the provisions of PCPNDT Act?
No record keeping of USG has to be on F as per Rule no -9(4) & copies of individual form F have to be submitted to the AA every month.
- Are the Govt. US centers also to be checked thoroughly for record keeping etc?
Yes, law is same. People can ask this information under R.T.I
- If the ultra-Sonologist doesn’t sign form F on the day of scan & report itself & incomplete forms are detected & he/she pleads that he/she will signs it later on, is it offence?
Yes, complete record keeping including signatures of ultra-sonologist is mandatory as per Rule no. 9 (4).
- Can record-keeping to be treated as a minor offence as advocated by Ultra-Sonologist?
No, Under the Act and Rules, deficiency in record keeping is violation of section 4 (3)(V) provision section 29 & Rule no-9. No offence is considered a minor offence under the Act.
- Is it mandatory in the Act to maintain a patient’s register in addition to form F and other forms? There is no prescribed format for the register. Do the details in the in the register and the form have to tally?
Record on a register showing, serial no, names and addresses of men and women, names of spouse or father and date of procedure has to be kept under rul no-9(1) one can maintain these columns in an ordinary register. There is on requirement of maintaining a patient’s register for Non – PNDT cases. The details have to be tally in both.
- How should the AA scrutinize the forms F received from the centers every month?
- At random, check if all columns of the form are filled & duly signed by the patient & the Ultra – Sonologist especially check the forms of suspected centers. Suspected center may be IVF, USG + MTP, managed by non gynecologist & Non – Radiologist.
- At Random, gather Photostat copies of USG reports of some centers from Anti- natal clinics in Govt. Hospitals as well as Pvt. Nursing homes & check if corresponding form F are available or not.
- The experience and qualifications criteria for Ultra- Sonography are not clearly stated in the Act and Rules and there is confusion among AA does please clarify?
The matter is learnt to be under consideration of the MOHFW and MCI. Deliberations on this held during the recent CSB and proposed amendment in Rules will be shared by the Ministry shortly.
- How to deal with complaints of harassment made by the centers to SAA when some action has been contemplated by DAA against the center?
In case the DAA has taken action under section 20, ask the center to file an appeal under Rule no 19 to the SAA.
- At the time of inspection, can the AA seal the machine without a show cause notice? Shouldn’t one get a chance to explain?
Under section 20(3), the AA can take action in public interest by suspension of registration of the center and automatically once the registration is suspended, the machine will be sealed for the period of suspension.
- Can an AA Constitute teams for ultimate period for inspection of US centers?
No, only a person (Officer) Specially authorized for a specific day for a specific day & specific centers by the AA can inspect the centers.
- What does the Law say about use of decoy patients?
There is no direct reference to decoy operations in the PC-PNDT Act and Rules. Since the crime of SD and SS is conducted with mutual consent of family , the Ultra – sinologist, there is no complainant / evidence, therefore the Government or AA can take help of sting operations and decoy patients under section 17(4( (e).
- What action needs to be taken against Govt. run US centers which do not maintain proper record as per Act & Rules?
Action as per Act & Rules has to be taken.
- How to proceed when Violation of both MTP as well as PC & PNDT Act is detected at one center/place?
FIR has to be filed for violation of the MTP act & a Court case has to be filled for violation of the PC & PNDT Act separately.
- What is the responsibility of AAs in implementation of the Act & Rules?
The AA’s have to perform function ( Duties) under section 17(4) & are accountable for enforcement of the Act & Rules in the area of Jurisdiction.
- Can any action to be taken against AA, who doesn’t perform the assigned functions under the Act?
Yes, Government can initiate administrative action under section 17(4) of the Act.
- What should be done if an AA is pressurized by a leader / influential person / officer for shielding an US center found violating the Act/Rules?
The AA is accountable for implementing the Act & Rules. He/She is mandated to initiate due penal action under intimation to higher authorities.
- From whom should the AA seek legal opinion?
The AA can seek opinion from legal member of the Advisory Committee. The AA can also hire a private Lawyer for specific court cases, if required.
- In the absence of complainant, every US centre can be considered to be violating the Act & Rules. What is the remedy?
Very few Doctors (Ultra Sonologist) are indulging into SD but bring a bad name to the whole fraternity. Objectives of the PC & PNDT Act are to stop SD/ SS and aim is not to harass the medical community. Gather information of suspected centers from field and form health functionaries & keep a close watch specifically on the working of suspected centers.
- Is there any time frame for checking the US/Genetic centers?
No time frame is specified in the Act/Rules; however the AA needs to check every center at least once in each quarter & send the report to State HQ.
- Can an authorized person suspend or cancel the registration under section 20 of the Act?
No, only AA has the authority.
- If charges are framed by the Court, should the registration of the center be suspended?
Discuss the case in the meeting of the Advisory Committee & Consider suspension of the registration until the final decision on the case by the court.
- Can the AA increase / decrease the period of suspension of registration awarded under section 20(1) or 20(3) of the Act?
The AA cannot change the punishment on hos/her own. It can be considered by the Appellant Authority if an appeals has been filed by the erring center.
- Can the appellate Authority at District or State level keep the appeal pending beyond 60days of receipt?
No, as per Rule no. 19(3) each appeals has to be disposed of within 60 days of receipt.
- During inspection of the centers, under which clauses of the Act/Rules, the AA should proceed?
The AA or authorized person should usually proceed under Rule no.11 & Spot memo prepared at the time of inspection should clearly indicate inspection under Rule no .11 It is good practice to write deficiencies detected during inspection in the spot memo, which should be signed there & then by the AA/Authorized person & Ultra-Sonologist / owner of the center.
- If action against an earring center has been taken under section 20, can a court case also be launched or not?
Yes, court case can also be launched simultaneously along with suspension of registration under section 20(1) or 20(3)
- Can an ultra Sonologist conduct USG as a self referred case or a self referral?
The ultra-Sonologist can conduct self referral USG only if , the said Doctor is running an OPD & also examines pregnant women. He/She has to keep a Separate obstetrical chekup record of the pregnant women (PW) examined in his/her clinic. He/She cannot perform USG of PW on the request of patient or relative mentioning the case as self referral or referred by the patient herself.
- What could be some of the roles to be assigned to the State Nodal Officers?
- To help & assist the DAA’s in implementation of the Act & Rules.
- To assist the SAA in State level administration tasks related to Act implementation.
- Monthly review of performance of DAAs
- Keep a liaison with associated NGO’s
- Gather information of centers suspected of conducting SD/SS from various sources.
- Conduct surprise State led inspections along with DAAs
- Liaison with MOHFW
- What is minimum space for USG Room?
Minimum space for USG room is not specified in Act. But it should have sufficient space, to accommodate USG machine, its monitor & other attachment, examination table/cot for patient, Doctor’s chair and space for female attendant, without overcrowding.
- Map required not …should be building completion is must?
As per PCPNDT Act is concerned, it is not necessary but I Maharashtra Nursing home Act, plan & map of hospital with completion certificate from local body are essential, and to trace out exact location of the machine, AA should take map while registration.
- How many places one sinologist visit as on today?
On 4th June, 2012 The Central Govt. has inserted Rule 3 (3) as: “ Each medical practioner qualified under the Act to conduct ultrasonography in a genetic clinic/Ultrasound clinic/ imaging center shall be permitted to be registered with maximum of two such clinic /centers within a district. The consulting hours for such medical practionar shall be clearly specified by each clinic/center’.
This amendment has been challenged by Dr. Rajeev Zankar in writ petition no (L) 1829/2012 at Mumbai High Court pleased to grant ad-interim Relief for this ( Stay). Hence, there is no any restriction with reference to the said amendment as on today.
- Role of NGOs?
- According to S. (2) (e) (v) representative of women welfare organization are to be appointed by Central Govt. as member of CSB.
- According to Section. 16-A(2) (f) (ii) eminent women activists from NGO be appointed by State Govt. as a member of SSB.
- As per Section 17 (6)(d), social workers are members of advisory committee constituted at center, state & District level especially amongst representatives of women organization.
- Crucial role in performing sting operation.
- Crucial role in awareness campaign
- Crucial role in court cases as intervener, witness etc.
- Why non medical person given powers to check records?
According to section 17(2), State Government has power to notify AA for the whole or part of State for purpose of this Act having regard to the intensity of the problem of pre-natal Sex Determination leading to female feticide.
These officers are well versed with administrative and legal procedures and some officers are discharging quasi judicial powers.
They are vested with administrative power ( e.g, SDO, Tahasildar, etc)
- Who can seal machine? Who has power to re-open the seal?
AA are notified by State Government as per Section 17(2) have power to search & seize Record and seal sonography machine for violation of provision of PCPNDT Act and for non registered USG machine. He may delegate his power for this purpose also.
AA are sealing machine for breach of provision of PCPNDT Act having reason to belive that it may furnish evidence of commission of offence and according to Section 20(2) provision of Cr. P.c. 1973 are applicable for search, seizure, hence the only the court ( JMFC,H.C. etc) have power to de-seal machine.
As per judgment given machine sealed remain sealed till final trial is over
- Online F Form advantages and disadvantages?
- Easy Accesses to data
- Immediate report generation
- Latest undated information
- Standardization of reports
- Can be viewed at any place by concerned authority.
- Will help in keeping strict control on Sonography centers.
- Easy access would help keeping check on misuse.
- Information can be saved in small place & can be made available within a click of mouse.
- An information is filled on the spot there are no chances for tempering the data.
- Easy for State Appropriate Authority for monitoring sonography centers dorm a central place.
- What is the case that comes to State Nodal office?
Nodal officer is appointed to help the State Appropriate Authority in monitoring PCPNDT Act in Maharashtra and being part of the State Appropriate Authority and is assisting in appeals placed before State Appropriate Authority under Rule 19 (2)
- Appointment of new sinologist/locum/leave1month prior notice or intimation…can it be compromised in situation?
There is no such provision for compromising the issue in this regard.
- Can I practice as Non obstrict sinologist to get rid of PC-PNDT?
It is the choice of sinologist whether to option for non – obstetric or all sonography subject to registration of center under PCPNDT Act.