Delhi High Court Judgement clarifies who can do an ultrasound
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With a recent landmark judgement dated 17/02/2016, Delhi High Court seems to have put to rest a number of contentions arising out the the PC-PNDT act. With the judgement, the Delhi High Court disposed of 3 different writ petitions filed by IRIA, IMA as well as Sonology Society of India respectively and clarified a number of questions related to the PC-PNDT Act, finally declaring Rule 3(3)(1)(b) of the PNDT Rules (as it stands after the amendment with effect from 9th January, 2014) as ultra vires to the extent it requires a person desirous of setting up a Genetic Clinic / Ultrasound Clinic / Imaging Centre to undergo six months training imparted in the manner prescribed in the Six Months Training Rules.
The major takeaways from the judgement are as follows:-
The major contention of the parties pertained to explanation of Section 2(p) of the Act that mainly deals with who is authorised to operate and use a ultrasound machine as well as Rule 3(3)(1)(b) which prescribes the qualifications for setting up of or for employment in a genetic clinic /ultrasound clinic/imaging centre. After the amendment of 2014, the rule required a person possessing one of the medical qualifications recognised by MCI Act to undergo six months training as prescribed in the Six Months Training Rules or if having experience of one year in ultrasonography, to take the competency test, for operating and using a ultrasound machine.
Speaking on the issue of qualifications required to operate a machine under the PC-PNDT act, the honourable court made the following observations:-
For meeting the said objective/purpose ( of the PC-PNDT Act), we fail to understand what difference it makes, whether the sonologist or imaging specialist i.e. a person who can use and operate an ultrasound machine, is a mere MBBS or has a Post Graduate qualification in medicine or has experience of one year or has undergone six months training.....
......In our opinion, to understand the said aspects, the one year experience or passing the competency test or undergoing the six months training or acquiring the post-graduate qualification, add no further to the person....
......that the aim and objective of the PNDT Act was not to prescribe the qualification of persons eligible / qualified to do medical diagnosis with the aid of ultrasound machine but to only prevent misuse thereof for sex determination resulting in female foeticide.
TO this effect, Justice Endlaw has passed the following directions:-
The Court while understanding the contention of the petitioners that ultrasound machines have other important uses apart from sex-determination, could not undermine the possibility that a machine, for whatever purpose installed, if could be used for the purpose of sex determination needs to fall under the ambit of the act. Hence, as said in the judgement, all such places where machine capable of sex determination would require registration under the act.
However, the court also observed that if a person registering the machine provides an declaration stating that the said machine would not be used for prenatal diagnostics and places some sort of "silent observer" on the machine, would be exempt from the compliance under the act, as present for genetic clinics etc.
The relevant judgement (Portion) read as follows:-
With this judgement, hopefully the modality of ultrasound and the said machines would be able to realise their full potential as a first hand diagnostic tool in majority medical cases, rather than being limited to just being a " potential tool for sex determination."
You can read a copy of the judgement by clicking on the following link
Delhi high court judgement_2016_PCPNDT
The major takeaways from the judgement are as follows:-
QUALIFICATION TO PERFORM AN ULTRASOUND UNDER THE ACT
The major contention of the parties pertained to explanation of Section 2(p) of the Act that mainly deals with who is authorised to operate and use a ultrasound machine as well as Rule 3(3)(1)(b) which prescribes the qualifications for setting up of or for employment in a genetic clinic /ultrasound clinic/imaging centre. After the amendment of 2014, the rule required a person possessing one of the medical qualifications recognised by MCI Act to undergo six months training as prescribed in the Six Months Training Rules or if having experience of one year in ultrasonography, to take the competency test, for operating and using a ultrasound machine.
Speaking on the issue of qualifications required to operate a machine under the PC-PNDT act, the honourable court made the following observations:-
For meeting the said objective/purpose ( of the PC-PNDT Act), we fail to understand what difference it makes, whether the sonologist or imaging specialist i.e. a person who can use and operate an ultrasound machine, is a mere MBBS or has a Post Graduate qualification in medicine or has experience of one year or has undergone six months training.....
......In our opinion, to understand the said aspects, the one year experience or passing the competency test or undergoing the six months training or acquiring the post-graduate qualification, add no further to the person....
......that the aim and objective of the PNDT Act was not to prescribe the qualification of persons eligible / qualified to do medical diagnosis with the aid of ultrasound machine but to only prevent misuse thereof for sex determination resulting in female foeticide.
TO this effect, Justice Endlaw has passed the following directions:-
- that Section 2(p) of the PNDT Act defining a Sonologist or Imaging Specialist, is bad to the extent it includes persons possessing a postgraduate qualification in ultrasonography or imaging techniques – because there is no such qualification recognised by MCI and the PNDT Act does not empower the statutory bodies constituted thereunder or the Central Government to devise and coin new qualification;
Rule 3(3)(1)(b) of the PNDT Rules (as it stands after the amendment with effect from 9th January, 2014) is ultra vires the PNDT Act to the extent it requires a person desirous of setting up a Genetic Clinic / Ultrasound Clinic / Imaging Centre to undergo six months training imparted in the manner prescribed in the Six Months Training Rules.
WHO NEEDS TO REGISTER UNDER ACT? WHO IS FREE FROM COMPLIANCE UNDER THE ACT?
The Court while understanding the contention of the petitioners that ultrasound machines have other important uses apart from sex-determination, could not undermine the possibility that a machine, for whatever purpose installed, if could be used for the purpose of sex determination needs to fall under the ambit of the act. Hence, as said in the judgement, all such places where machine capable of sex determination would require registration under the act.
However, the court also observed that if a person registering the machine provides an declaration stating that the said machine would not be used for prenatal diagnostics and places some sort of "silent observer" on the machine, would be exempt from the compliance under the act, as present for genetic clinics etc.
The relevant judgement (Portion) read as follows:-
- We hold that all places including vehicles where ultrasound machine or imaging machine or scanner or other equipment capable of determining sex of the foetus or has the potential of detection of sex during pregnancy or selection of sex before conception, require registration under the Act;
- However, if the person seeking registration (a) makes a declaration in the form to be prescribed by the Central Supervisory Board to the effect that the said machine or equipment is not intended for conducting pre-natal diagnostic procedures; (b) gives an undertaking to not use or allow the use of the same for pre-natal diagnostic procedures; and, (c) has a “silent observer” or any other equipment installed on the ultrasound machines, as may be prescribed by the Central Supervisory Board, capable of storing images of each sonography tests done therewith, such person would be exempt from complying with the provisions of the Act and the Rules with respect to Genetic Clinics, Genetic Laboratory or Genetic Counselling Centre;
- If however for any technical reasons, the Central Supervisory Board is of the view that such “silent observer” cannot be installed or would not serve the purpose, then the Central Supervisory Board would prescribe other conditions which such registrant would require to fulfil, to remain exempt as aforesaid;
- However such registrants would otherwise remain bound by the prohibitory and penal provisions of the Act and would further remain liable to give inspection of the “silent observer” or other such equipment and their places, from the time to time and in such manner as may be prescribed by the Central Supervisory Board;
With this judgement, hopefully the modality of ultrasound and the said machines would be able to realise their full potential as a first hand diagnostic tool in majority medical cases, rather than being limited to just being a " potential tool for sex determination."
You can read a copy of the judgement by clicking on the following link
Delhi high court judgement_2016_PCPNDT
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