declarations / directions:
(i) 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;
(ii) 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;
(iii) 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;
(iv) 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;
(v) 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; and,
(vi) 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.
IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of decision: 17th February, 2016
W.P.(C) 6968/2011
INDIAN RADIOLOGICAL AND
IMAGING ASSOCIATION (IRIA) ..... Petitioner
Versus
UNION OF INDIA AND ANR ..... Respondents
CORAM:
HON'BLE THE CHIEF JUSTICE
HON'BLE MR. JUSTICE RAJIV SAHAI ENDLAW
Dated;FEBRUARY 17, 2016
1. The petitioner claims to be a Society registered under the Societies
Registration Act, 1860 established with the aim and objective inter alia to
promote the study and practice of radio-diagnosis, ultrasound, CT, MRI and
other imaging modalities and, having more than 8600 radiologists and
imaging experts having recognised post-graduate degrees in the field of
radio-diagnosis and imaging recognised by the Medical Council of India
(MCI) as its members. The petition is filed contending:
(i) that to overcome the growing problem of sex-selective
termination of pregnancy of female foetuses after determining sex of
the foetus by using pre-natal sex determination techniques, the Preconception
and Pre-natal Diagnostic Techniques (Prohibition of Sect
Selection) Act, 1994 (PNDT Act) was enacted with the objective of
prohibition of sex selection and for regulation of misuse of pre-natal
diagnostic techniques and the Pre-conception and Pre-natal
Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996
(PNDT Rules) framed thereunder for matters connected therewith;
(ii) that though the aim of the Act was to restrict the use of
ultrasound machine by allowing use thereof only by qualified
individuals, who could be monitored, the same has had the opposite
effect of enlarging the category of persons authorised to use and
operate ultrasound machines;
(iii) that the PNDT Act, owing to its lackadaisical and ineffective
implementation, has failed to serve the purpose and the child sex ratio
continues to fall;
(iv) that this lead to the filing of W.P.(C) No.301/2000 titled Centre
for Enquiry Into Health and Allied Themes (CEHAT) Vs.
Union of India in the Supreme Court of India and vide order
dated 4th May, 2001 wherein, directions were issued (i) to the
Central Government to create public awareness against the
practice of pre-natal determination of sex and female foeticide
through appropriate releases / programmes in the electronic
media; (ii) to implement with all vigour and zeal the PNDT Act
and PNDT Rules and to strictly adhere to the rule as to the
periodicity of meetings of the Advisory Committees constituted
under Section 17(5) of the PNDT Act; (iii) to the Central
Supervisory Board constituted under the Act to review and
monitor the implementation of the Act and to seek quarterly
returns from the States / Union Territories and to make
recommendations as may be required as per the exigencies of
the situation; and, (iv) to the Appropriate Authorities under the
Act to take prompt action with respect to violators of the Act;
(v) that the aforesaid directions of the Supreme Court also did not
serve the purpose, as was lamented by the Supreme Court in
the subsequent order dated 10th September, 2003 in the
aforesaid petition;
(vi) that the aforesaid resulted in amendment to the Act and the
Rules being mooted and certain amendments were carried out
to the Act with effect from 14th February, 2003;
(vii) that Section 2(p) of the amended PNDT Act defines a
“sonologist or imaging specialist” as:
(p) sonologist or imaging specialist” means a person
who possesses any one of the medical qualifications
recognised under the Indian Medical Council Act, 1956
(102 of 1956) or who possesses a post-graduate
qualification in ultrasonography or imaging techniques
or radiology.
but there is no post-graduate qualification, neither in the field of
ultrasonography nor in the field of imaging techniques which is
recognised by the respondent No.2 MCI;
(viii) that similarly the amended Rule 3(3)(1) of the PNDT Rules
entitles the following persons to set up a genetic clinic / ultrasound
clinic / imaging centre
3.3.(1) Any person having adequate space and being or
employing—
(a) Gynaecologist having experience of performing
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, or
(b) 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; or
(c) a medical geneticist,
may set up a genetic clinic/ultrasound
clinic/imaging centre.
but there is no qualification recognised by MCI in the field of
sonography or image scanning and the same enables registered
medical practitioners, who as per MCI are not qualified, to set up the
sonographic clinic or an imaging centre;
(ix) that representations to the aforesaid effect were made to the
Central Supervisory Board constituted under the Act which though
had been deliberating thereon, had failed to take any decision;
(x) that though the Rules aforesaid also speak of a six months
training in sonography or image scanning but no formal training
programme has been devised;
(xi) that the PNDT Act is not concerned with conferring or
recognising medical qualifications, the sole repository whereof is the
respondent No.2 MCI.
2. The petition seeks a declaration:
(a) that Section 2(p) of the PNDT Act to the extent it
recognises a person possessing a post-graduate
qualification in ultrasonography or imaging techniques
as bad inasmuch as there is no post-graduate
qualification in ultrasonography or imaging techniques
recognised by the MCI;
(b) that Rule 3(3)(1)(b) of the PNDT Rules to the extent it
permits sonologists, imaging specialists or registered
medical practitioner having six months training or one
year experience in sonography or image scanning to set
up ultrasound clinics or imaging centres, is
unconstitutional, as there is no qualification in
sonography and image scanning recognised under the
Indian Medical Council Act, 1956 (MCI Act).
We may notice that though averments in the petition are also
made with respect to the appointments under Section 17 of the Act of
District Magistrates / District Collectors as District Appropriate
Authorities and of the meetings of the Central Supervisory Board
constituted under the PNDT Act but at the time of hearing, no
arguments were addressed in that behalf and we as such do not deem
it appropriate to deal therewith.
3. The respondent No.1 Union of India (UOI) has filed a counter
affidavit to this petition pleading (a) that though PNDT Act is a central
legislation committed to providing a legal framework for intensifying efforts
to curb the practice of sex determination but the implementation of the Act
lies primarily with the States which are expected to enforce the said Act
through the statutory bodies in the States constituted under the Act; (b) that
the MCI Act recognises the medical qualification of Doctor of Medicine
M.D. (Radio Diagnosis) which is registered as M.D. (Radio Diagnosis) /
Diploma in Radio Diagnosis (DMRD); (c) imaging techniques and
ultrasonography is a critical part of the discipline of M.D. (Radiology) /
DMRD to equip a medical professional to practice, teach and do research in
the broad discipline of radiology including ultrasound; (d) that the MCI has
submitted guidelines enumerating the minimum criteria regarding
qualification, training, accreditation of training institutes, for determining
who should be recognised as qualified to undertake ultrasound test and have
valid registration under the PNDT Act; (e) that the Central Government is
in the process of finalizing the requirements in terms of qualifications and
training required to be registered as a sonologist and the same shall be
explicated as amendment to Rule 3(3)(1)(b) of the PNDT Rules; (f) that
the Central Supervisory Board had considered the representations and the
suggestions and had not considered any amendment to Section 2(p) of the
PNDT Act to be necessary and was of the opinion that the purpose could
well be achieved by amending Rule 3(3)(1)(b) of the Rules; and, (g) that
the Central Supervisory Board has decided that in view of shortage of
doctors with post-graduate qualification on the one hand and the growing
demand of ultrasound services on the other, amendment of Section 2(p) of
the PNDT Act is unnecessary and the purpose could be served by
amendment of Rule 3(3)(1)(b) by laying down the criteria with regard to
educational qualification for eligibility for training, length and content of
training, accreditation of training institutions as well as the experience.
4. The petitioner in its rejoinder has pleaded that though
ultrasonography is a part of the curriculum in MD in Radiology but is not a
separate discipline and is not so recognised by the MCI and Rule 3(3)(1)(b)
is therefore admittedly illegal, inasmuch as there is no recognised discipline
of medicine known as sonologist and there is no post-graduate qualification
in ultrasonography or imaging techniques recognized by the MCI. It is
further pleaded that the post-graduate training programme for MD in radio
diagnosis and DMRD is not a post-graduate qualification, either in the field
of ultrasonography or imaging techniques.
5. The respondent No.2 MCI failed to file any counter affidavit inspite
of opportunity.
6. The disposal of the petition was delayed for the reason of the counsel
for the Union of India (UOI) from time to time informing that a Transfer
Petition has been filed before the Supreme Court and notice thereof had
been issued. However, when inspite of waiting for sufficiently long time no
order for transfer was received and on the contention of the petitioner that
the matter before the Supreme Court was distinct, the hearing of the petition
was begun. W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 11 of 83
7. During the pendency of the petition, the PNDT Rules were amended
vide Notification dated 9th January, 2014.
W.P(C) No.2721/2014.
8. This petition is filed impugning the Notification dated 9th January,
2014 amending Rule 3(3)(1)(b) of the PNDT Rules as well as the amended
Rule. The amended Rule 3(3)(1)(b) is as under:-
3.3.(1) Any person having adequate space and
being or employing—
(a) .....
(b) a Sonologist, Imaging Specialist, Radiologist or
Registered Medical Practitioner having Post
Graduate degree or diploma or six months training
duly imparted in the manner prescribed in the “the
Pre-conception and Pre-natal Diagnostic
Techniques (Prohibition of Sex Selection) (Six
Months Training) Rules, 2014;
(c) ....
9. It is the contention of the petitioner
(a) that the aforesaid Rule is contrary to the PNDT Act as it
contains an additional requirement of a six months training to
be registered as a sonologist when the Act does not contain
such an additional requirement and enables an MBBS doctor to
be registered as a sonologist; the Rule is thus beyond the Act;W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 12 of 83
(b) that Rule 6 of the Pre-conception and Pre-natal Diagnostic
Techniques (Prohibition of Sex Selection) (Six Months
Training), Rules, 2014 (Six Months Training Rules) also
notified vide the same Notification dated 9th January, 2014 is as
under:-
6. Eligibility for training.-(1)Any registered medical
practitioner shall be eligible for undertaking the said
six months training.
(2) The existing registered medical practitioners, who
are conducting ultrasound procedures in a Genetic
Clinic or Ultrasound Clinic or Imaging Centre on the
basis of one year experience or six month training
are exempted from undertaking the said training
provided they are able to qualify the competency
based assessment specified in Schedule II and in case
of failure to clear the said competency based exam,
they shall be required to undertake the complete six
months training, as provided under these rules, for
the purpose of renewal of registrations.
It is argued that thus the said Rule not only prescribes six
months training to register as a sonologist but even requires
existing sonologist to qualify a competency based assessment
to renew the registration and consequently provides that if the
existing sonologist fails to clear the said assessment, he would
be required to undertake the complete six months training. It is
contended that the Rule is unreasonable and illogical – the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 13 of 83
curriculum for graduation of MBBS doctors includes specific
knowledge and skills in the field of radio-diagnosis and
imaging and the knowledge and skills set out in the Six Months
Rules is merely a repetition of the knowledge and skills set out
in the curriculum of MBBS doctors. It is argued that it is
unreasonable and illogical for an MBBS doctor to undergo
additional six months training under the Six Months Training
Rules for the same knowledge and skills that he has already
gained in his curriculum;
(c) that though as per PNDT Act, MBBS doctors are sonologist but
the Authorities under the said Act do not register the MBBS
doctors as sonologist compelling them to take additional six
months training or one year experience and which is not
required by the Act; and,
(d) that now-a-days ultrasound is not being treated as a specialty
but as a diagnostic tool like stethoscope and many institutions
are running courses for non-medical persons to do
echocardiography etc. W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 14 of 83
10. It is the stand of the respondent UOI in its counter affidavit
(i) That the impugned Notification dated 9th January, 2014 was
preceded by a consultative process pursuant to the judgment
dated 5th July, 2010 of a Single Judge of this Court in W.P.(C)
No.6654/2007 titled Dr. K.L. Sehgal Vs. Office of District
Appropriate Authority highlighting the need for prescribing
qualifications of a person seeking to run diagnostic clinics and
for prescribing the qualification, training and experience to be
recognised and registered as a sonologist.
(ii) That to the said consultative process MCI was also privy and
proposed a framework of minimum criteria regarding
qualification, training, accreditation of training institutions and
the contents of the training. The framework proposed by MCI
was re-evaluated by a broad based Core Committee and which
in turn appointed an Expert Committee. The recommendations
of the Expert Committee and the Core Committee were
considered by the Central Supervisor Board constituted under
the PNDT Act and only thereafter the amendment to Rule
3(3)(1)(b) and the Six Months Training Rules were notified.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 15 of 83
(iii) That neither Rule 3(3)(1)(b) as amended vide Notification
dated 9th January, 2014 nor the Six Months Training Rules
contravene any provision of the PNDT Act.
(iv) That the Secretary General of the petitioner is also a notified
member of the Central Supervisory Board but the petitioner has
not acted proactively in the matter.
(v) That the Six Months Training Rules would ensure better
quality among all member of profession by making the six
months training mandatory and uniform throughout the country
for the registered medical practitioners.
(vi) That registered medical practitioners possessing any of the
medical qualification as prescribed in Section 2(h) of the MCI
Act may set up a genetic clinic / ultrasound clinic / imaging
centre based on their MCI recognised qualification and
subsequent mandatory six months training in sonology as
prescribed in Six Months Training Rules.
(vii) That though Rule 3(3)(1)(b) supra prior to its amendment w.e.f.
9
th January, 2014 also mentioned six months training but did
not specify the nature and duration of six months training, W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 16 of 83
necessitating amendment thereof.
(viii) That the amendment aforesaid also became necessary in view
of the observations of this Court in K.L. Sehgal supra and has
been effected after a detailed consultative process.
(ix) That the amended Rule 3(3)(1)(b) is within the rule making
power of the Central Government under Section 32 of the
PNDT Act and the Notification dated 9th January,2014 was
duly laid on the Table of both the Houses of Parliament.
(x) Rule 6(2) of the Six Months Training Rules exempts those
registered medical practitioners from undertaking the six
months training who are having experience of one year or more
in ultrasonography and who had already undergone six months
training, provided they pass the prescribed competency based
assessment. To conduct such competence based test for
registered medical practitioners having one year experience or
six months training, the States have been given time till 1st
January, 2017, by which time the States are expected to
complete the assessment and fulfil the training requirements of
the registered medical practitioners.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 17 of 83
(xi) The Six Months Training Rules came into force w.e.f. 9th
January, 2014 in case of new registrations only; however
earlier registrants will have to either undergo training or if
claim exemption will have to qualify the competency based test
on or before 1st January, 2017. Liberty has thus been provided
for all registrants prior to 9th January, 2014 and the amended
Rule 3(3)(1)(b) and the Six Months Training Rules are thus not
illogical or arbitrary.
(xii) The knowledge and skill set out in the Six Months Training
Rules are not a repetition of the knowledge and skills set out in
the graduate medical curriculum for MBBS doctors. The
syllabus set out for the MBBS doctors is quite general in
nature, while the curriculum as prescribed in the Six Months
Training Rules is specific and known as “Fundamentals In
Abdomino Pelvic Ultrasonography: Level-one 6 Months
Course for MBBS doctors”. The radiology curriculum for
MBBS doctors is mostly theoretical, providing for only 30
hours of clinical posting in radiology. On the other hand the
curriculum prescribed in the Six Months Training Rules W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 18 of 83
contains theory as well as practical training of 300 hours
duration. Further, MBBS curriculum clubs the doctors in terms
of central development, only to devise appropriate diagnostic
procedures in specified circumstances but not proficient in
conducting such diagnostic procedures. On the contrary the
curriculum under the Six Months Training Rules enables the
registered medical practitioners to be proficient in conducting
the ultrasonography as a diagnostic tool.
(xiii) The training will equip the registered medical practitioners
professionally and would also sensitise them to the declining
trend of child sex ratio and their responsibility towards it as an
important stakeholder; and,
(xiv) Easy access to ultrasound diagnostic techniques since the early
1980s has contributed to the increased opportunity of sex
selection with increased incidences of female foeticide
resulting in the rapid decline in the child sex ratio.
W.P.(C) No.3184/2014.
11. This petition is filed by a society established with the aim and
objective to promote awareness in the field of diagnostic ultrasound and to W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 19 of 83
educate and spread awareness amongst general public against female
foeticide, and with medical professionals as its members.
12. The cause of action for the said petition is the Circular dated 27th
March, 2014 of the respondent No.2 Directorate of Family Welfare, Govt.
of NCT of Delhi (GNCTD) and on the basis whereof it is averred that
registration / renewal of registration is not being granted to several members
of the petitioner running ultrasound clinics.
13. It is the contention of the petitioner, (i) that though this court in K.L.
Sehgal supra clarified that as long as the person concerned possesses one of
the medical qualifications recognised under the MCI Act, he could be a
sonologist and that the word “or” between the words “...Indian Medical
Council Act, 1956 (102 of 1956)” and “who possess a post-graduate
qualification...” in Section 2(p) of the PNDT Act is not to be read as “and”,
the respondents are insisting upon persons holding medical qualification
recognised by the MCI also either underging a six months training or
passing a competency test; (ii) that Rule 3(3)(1)(b) as amended with effect
from 9th January, 2014 is contrary to Section 2(p) of the Act as interpreted
by this Court in K.L. Seghal supra; (iii) that various members of the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 20 of 83
petitioner society who are registered medical practitioners in terms of
Section 2(m) of the PNDT Act and are sonologist in terms of the definition
in Section 2(p) of the Act as interpreted by this Court in K.L. Sehgal, are
not being granted registration / renewal of registration of their ultrasound
clinics citing the amendments dated 9th January,2014 to the PNDT Rules
and the Circular dated 27th March, 2014 supra; (iv) that the amendment to
Rule 3(3)(1)(b) of the PNDT Rules is thus in violation of the judgment of
this Court in K.L. Sehgal supra; (v) that denial of registration / renewal of
registration under the PNDT Act to the medical practitioners who are
sonologist in terms of Section 2(p) of the Act is in restraint of their
fundamental right to carry on lawful trade; (vi) that the amendment of Rule
3(3)(1)(b) has retrospective application inasmuch as, even those MBBS
doctors who are sonologist in terms of Section 2(p) of the PNDT Act and
have been practising ultrasound since decades and have international
recognition in the field of ultrasound have to appear in competency test,
while all the post-graduates have been exempted, even though many of them
have no exposure to ultrasound at any stage; (vii) that the amended Rule
3(3)(1)(b) is discriminatory and violative of Article 14 of the Constitution of
India as all the post-graduates have been exempted from undertaking six W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 21 of 83
months training, even though many of the Post Graduate (PG) speciality
courses vis. physiology, microbiology, biochemistry, pathology etc. do not
have ultrasound training in the curriculum; (viii) that though in terms of the
amended Rule 3(3)(1)(b), all registered medical practitioners having PG
degrees / diplomas in any speciality can open and run ultrasound clinic and
get registered under the PNDT Act, but as per the Circular dated 27th March,
2014 only post-graduate degree / diploma holders in obstetrics, gynaecology
radiology will be entitled for registration under the PNDT Act; (ix) that
ultrasound is a modality like modern day stethoscope; (x) that no other
modality training like ECG, laparoscope etc. require PG Entrance Exam;
(xi) that in India the doctor-patient ratio is very poor; in many places
sonologist patient ratio is one for a population of five lakhs; (xii) that the
impugned notification will further lead to shortage of sonologist and which
will not be in the interest of the patients; and, (xiii) that in terms of the
judgment of this Court in K.L. Sehgal supra, the change would only be
prospective and not retrospective.
14. The petition (I) seeks a mandamus to the Union of India and
Directorate of Family Welfare of GNCTD to grant registration / renewal of
registration under the PNDT Act to those medical practitioners who come W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 22 of 83
under the realm of definition of sonologist in terms of Section 2(p) of the
PNDT Act; and, (II) seeks quashing of the amendment dated 9th January,
2014 to Rule 3(3)(1)(b) of the PNDT Rules and notifying the Six Months
Training Rules to the extent inconsistent with the definition of sonologist
under Section 2(p) of the PNDT Act.
15. UOI filed its counter affidavit dated 22nd September, 2014 to this
petition pleading (a) that the child sex ratio has been continuously declining
all over India including in the rural and far flung areas; the child sex ratio
presently is the lowest since independence; (b) that to overcome the malady
of termination of pregnancy after determining the sex of the foetus by using
pre-natal techniques, the PNDT Act and PNDT Rules were enacted; (c) that
though Rule 3(3)(1)(b) as it stood prior to its amendment with effect from
9
th January, 2014 mentioned six months training and one year experience
but the institutions / individuals from which /whom this experience /
training was to be obtained were not specified; (d) that this resulted in
numerous ultrasonographic centres flourishing across the country making
ultrasonography tests without standardised training / curriculum and
resulting in mushrooming ultrasonographic centres by ill-qualified/poorly
trained sonologist resulting in unethical practises throughout the country; W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 23 of 83
(e) observations to this effect were made by this Court in K.L. Sehgal; (f)
that in compliance with the observations in K.L. Sehgal, the PNDT Rules
were amended and the Six Months Training Rules notified with effect from
9
th January, 2014; (g) denying that there is any retrospectivity in the
amendment with effect from 9th January, 2014; (h) denying that there is any
discrimination in exempting the registered medical practitioners having
post-graduate degree / diploma in radiology / imaging or sonography from
the six months training; it is stated that all those having PG degree / diploma
in obstetrics, gynaecology are also exempted from the said training; (i) that
the amendments with effect from 9th January, 2014 apply only for new
registration; however old sonologist have been given time to pass the
competency test on or before 1st January, 2017.
16. The respondent No.2 Directorate of Family Welfare, GNCTD in its
counter affidavit has pleaded that by virtue of the amendment with effect
from 9th January, 2014, doctors possessing MBBS degree who were
practising as sonologist by claiming to have six months training or having
one year experience from any unregulated hospital / training institute /
individual doctor, would henceforth be required to satisfy the requirements
of Rules 6 & 7 of the Six Months Training Rules inter alia by undergoing a W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 24 of 83
prescribed 300 clock hours curriculum course to be spread over six months
to be conducted by identified accredited institutions recognised either by the
MCI or the National Board of Medical Speciality or centres of excellence
established by an Act passed by the Parliament; however those who are
qualified as PG in radiology and gynaecology/obstetrics will continue to be
eligible for registration as they are exempted from training.
CONTENTIONS.
17. The counsel for the petitioner in W.P.(C) No.6968/2011 argued (i)
that there is no post-graduate qualification in ultrasonography or imaging
techniques or radiology as mentioned in Section 2(p) of the Act; (ii) that
there is no qualification as a sonologist or imaging specialist as mentioned
in Rule 3(3)(1)(b); (iii) support in this regard was drawn from the reply
dated 1st June, 2011 of the MCI to a query under the Right to Information
Act, 2005, to the effect that MCI does not recognise certificate course issued
by the radiologist for ultrasonography training.
18. The senior counsel for the petitioner in W.P.(C) No.2721/2014
contended (i) that prior to coming into force of the PNDT Act, even a
person having a decree of MBBS, not necessarily of M.D. (Radiology)
could own and operate a ultrasound machine; (ii) that Section 2(p) of the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 25 of 83
Act also includes in the definition of sonologist or imaging specialist, every
such person who holds a medical qualification recognised by the MCI, again
recognising persons holding the MBBS qualification as sonologist and
imaging specialist; (iii) that there is no post-graduate qualification in
ultrasonography or in imaging techniques; (iv) that under Section 32 of the
Act the power of the Central Government to make Rules extends only to
make rules for minimum qualifications of persons employed at the
registered genetic counselling centre, genetic laboratory or genetic clinic
and not to make rules for persons employed at ultrasound clinics; (v) that
the technique of ultrasound is used for diagnostic purpose qua various
organs and not only for sex determination and thus all clinics using
ultrasound machines would not qualify as genetic clinics; (vi) instance is
given of specialist hospitals / clinics dealing with specific organs, say heart,
lung or liver and it was contended that they also use ultrasound machine but
can by no stretch of imagination be called a genetic clinic; (vii) that the
requirement, in Rule 3(3)(1)(b) as amended with effect from 9th January,
2014, of six months training can only be qua registered medical
practitioners as defined in Rule 2(ee) of the Drugs and Cosmetics Rules,
1945 and cannot possibly be qua those who qualify as sonologist within the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 26 of 83
meaning of Section 2(p) of the Act; (viii) alternatively, Rule 3(3)(1)(b) has
to be confined to the genetic clinics only and cannot be extended to
ultrasound clinics; all ultrasound clinics are not genetic clinics; those who
have been practising as a radiologist or have been using ultrasound for tens
of years cannot be asked to undergo six months training or take any test, as
the same cannot take the place of their experience of decades; (ix) that the
amendment of Rule 3(3)(1)(b) w.e.f. 9th January, 2014 takes away the one
year experience in sonography or image scanning as existed earlier and thus
Rule 6(2) of the Six Months Training Rules is bad; and, (x) that under Rule
8 there was/is a right of renewal of registration; the amendment w.e.f. 9th
January, 2014 takes away the said right; reliance is placed on G.P. Singh’s
Interpretation of Statues to urge that interpretation rendering certain
words otiose, cannot be adopted and on Dr. Indramani Pyarelal Gupta Vs.
W.R. Nathu AIR 1963 SC 274 laying down that the Central Government
as a delegate of the legislature, without being specifically empowered can
only make Rules having prospective operation and not with retrospective
effect. W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 27 of 83
19. At this stage, the counsel for the petitioner in W.P.(C) No.6968/2011
contended that PNDT Act was concerned with the misuse of the techniques
of ultrasound for sex determination but has ended up, permitting all MBBS
Doctors to conduct ultrasound. However on enquiry, whether prior thereto,
there was any bar on MBBS Doctors doing ultrasound or reporting on ultra
sound procedure, no reply was forthcoming.
20. The office bearer of the petitioner in W.P.(C) No.3184/2014 arguing
in person addressed the same arguments, as the senior counsel for the
petitioner in W.P.(C) No.2721/2014 and contended that all MBBS Doctors,
without any post-graduate qualification in radiology, are in any case entitled
to conduct ultrasound and if it were to be held that only those with postgraduate
qualification in radiology can conduct ultrasound, the same would
require frequent referrals to such specialist and increase in the cost of
treatment.
21. The senior counsel for the petitioner in W.P.(C) No.2721/2014
resuming his arguments contended that the provisions of six months training
for a person holding qualification recognised by the MCI is otiose. Reliance
in this regard was placed on Academy of Nutrition Improvement Vs. Union
of India (2011) 8 SCC 274. It was contended that the issue of misuse of W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 28 of 83
technology for sex determination is a moral one and has nothing to do with
training. It was further contended that since the Act is intended to prevent
sex determination, it cannot possibly apply to a Heart Institute. We were
informed that owing to the respondents interpreting the term genetic clinic
as meaning all places where ultrasound machines are kept, reputed and wellknow
medical professions also having an ultrasound machine or even a
portable equipment in their clinic though intended for use in their respective
specialisations but capable of determining sex are forced to get themselves
registered as a genetic clinic and to comply with the provisions of the Act
and the Rules and which is not only cumbersome but also leaves their
patients nonplussed on seeing the proclamations in their clinic in
compliance of the Act and the Rules as if it is a genetic clinic. We were
informed that owing thereto several doctors are opting not to keep a
ultrasound machine or other such alternate portable equipment in their
clinics, much to their handicap and to the inconvenience of their patients.
22. The learned ASG defending the challenge argued (i) that the
fountainhead for the amendments of the year 2014 to the Rules is the
judgment of this Court in K.L. Sehgal’s case; ii) attention was invited to
Section 16 of the Act prescribing the functions of the Central Supervisory W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 29 of 83
Board constituted under the Act and the minutes of the meetings of the
Board leading to the amendment; iii) the amendments of the year 2014 do
not become retrospective by requiring those practising ultrasonography to
either take the competency test or undergo six months training; iv) attention
was drawn to Statement of Objections & Reasons of the PNDT Act; v) that
as per the Act, any person can open a genetic clinic, provided a qualified
person is employed therein; vi) that the explanation to Section 2(d) of the
Act applies to a place other than vehicle also; vii) that the challenge in all
the petitions is to the six months training and none should have any
objection to obtaining an added qualification; viii) that the wisdom of the
policy is not to be gone into by the court; (ix) that the un-amended Rule
3(3)(1)(b) also provided for training though none was prescribed and the
amendment is intended to end un-channelised system of training of
sonologist; and, (x) better training will raise standards.
23. The written submissions filed have also been perused.
DISCUSSION.
24. We had during the hearing enquired from the counsels whether it is
technically possible to fit/load ultrasound machine with a device/programme
disabling the use thereof for sex determination or for scanning uterus. W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 30 of 83
25. We were however told that the same is not possible.
26. We had further enquired whether the respondents are open to taking a
declaration, from medical practitioners though desirous of or in need of
using an ultrasound machine, portable or otherwise, for purposes other than
sex determination, to the effect that the same will not be used for scanning
uterus or otherwise for sex determination and to exempt such practitioners
from the provisions of the Act/Rules relating to training/competency test/
maintenance of records etc, though otherwise remaining liable for surprise
inspections/raids etc and penalties for violations of the Act.
27. However no such concession was forthcoming from the side of the
Government; rather the learned ASG suggested that the subject is a sensitive
one which is seized of by the Supreme Court.
28. We have considered the controversy in totality.
29. We must say, we have been left wondering, what, the questions as
have been raised before us, have to do with prevention of misuse of prenatal
diagnostic techniques for sex determination, which was/is the only
purpose / objective of the enactment of PNDT Act. For meeting the said
objective/purpose, we fail to understand what difference it makes, whether
the sonologist or imaging specialist i.e. a person who can use and operate an W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 31 of 83
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. The PNDT Act does not owe its enactment to the poor or useless or
inaccurate diagnostic reports of ultrasound tests and resultant need to
prescribe the qualifications of persons who can operate, use, read and report
the outcome of the said diagnostic procedure. If it was felt that for practising
medicine with the aid of an ultrasound machine, none of the medical
qualifications contained in the Schedule to the MCI Act are sufficient or that
only those with one or more of the said qualifications are competent to so
practise, the MCI Act was/is in existence to serve the said purpose and there
was no need for a new enactment to serve the said purpose. The PNDT Act
owes its existence solely to the falling ratio of female child as against the
male child and the cause whereof was found to be misuse of pre-natal
diagnostic techniques for sex determination, in turn leading to female
foeticide.
30. A perusal of the Statement of Objects & Reasons of the PNDT Act
indeed shows that it was intended to prohibit pre-natal diagnostic techniques
for determination of sex of foetus leading to female foeticide and to prevent
abuse of techniques discriminatory against female sex and affecting dignity W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 32 of 83
and status of women, by regulating the use of such techniques and to
provide deterrent punishment to stop such inhuman act. The enactment was
to achieve the objectives of:
(i) prohibition of the misuse of pre-natal diagnostic
techniques for determination of sex of foetus, leading to
female foeticide;
(ii) prohibition of advertisement of pre-natal diagnostic
techniques for detection or determination of sex;
(iii) permission and regulation of the use of pre-natal
diagnostic techniques for the purpose of detection of
specific genetic abnormalities or disorders;
(iv) permitting the use of such techniques only under certain
conditions by the registered institutions; and
(v) punishment for violation of the provisions of the proposed
legislation.
The preamble of the Act is as under:
An Act to provide for the prohibition of sex selection, before or
after conception, and for regulation of pre-natal diagnostic
techniques for the purposes of detecting genetic abnormalities or
metabolic disorders or chromosomal abnormalities or certain
congenital malformations or sex-linked disorders and for the
prevention of their misuse for sex determination leading to female
foeticide and for matters connected therewith or incidental
thereto.
31. An overview of the PNDT Act also shows all provisions thereof to be
to serve the purpose/objective only of preventing misuse of pre-natal
diagnostic techniques for sex determination. The PNDT Act is found by us
to have been enacted (i) to prohibit/make sex determination and sex
selection an offence; (ii) to prohibit sale of ultrasound and other machines W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 33 of 83
capable of sex selection save to persons registered under the Act; (iii) to
prohibit conduct/use of pre-natal diagnostic techniques except for detection
of prescribed abnormalities and to prescribe the conditions (including
maintenance of records) subject to which the prenatal diagnostic techniques
shall be used for such limited purpose; (iv) to constitute Central Supervisor
and State Supervisory Boards to advise the Central Government on policy
matters relating to use of pre-diagnostic techniques and against their
misuse, to monitor implementation of the Act and recommend changes in
the Act and the Rules, to create public awareness, to lay down code of
conduct to be observed in places where ultrasound machines are kept etc.;
(v) to constitute Appropriate Authorities to grant registration under the Act
and to enforce the provisions of the Act. Though Section 32 of the Act
empowering the Central Government to make Rules for carrying out the
provisions of the Act empowers the Central Government to make rules to
provide for the minimum qualification for the persons employed at Genetic
Counselling Centres, Genetic Laboratory or Genetic Clinic i.e. a place
where ultrasound or like machine is kept but that in our opinion would only
entitle the Central Government to provide that only persons holding any of
the medical qualifications recognised by MCI, will be so employed (because W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 34 of 83
ultrasound and like machines are medical tools) but would not entitle the
Central Government to prescribe or coin new or additional qualifications.
We say so because that is not the provision in the Act and the Rules under
Section 32 can be made only for carrying out the provisions of the Act.
Once the PNDT Act is not found to be dealing with medical education, the
power to make rule prescribing minimum qualification cannot be
understood as a power to establish a qualification but has to be necessarily
understood as power to prescribe only those qualifications which are
recognised by MCI. This is more so since the Act in Section 2(m) and (p)
expressly refers to qualifications recognized by MCI.
32. We are unable to find any provision in the PNDT Act empowering
any of the bodies constituted thereunder i.e. the Central Supervisory Board
or the State Supervisory Boards or the Appropriate Authorities or the
Advisory Committees or even the Central Government to prescribe the
qualifications for practising medicine with the aid of an ultrasound machine
or to prescribe the nature and content i.e. curriculum of the said
qualification or the duration of the qualification. The task of prescribing the
education and training without which a person cannot practise in the field of
medicine is a highly technical and important task requiring in depth W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 35 of 83
knowledge of what all practise in that field of medicine entails as it is then
only that that the person before being permitted to practise therein can be
equipped therewith. It is inconceivable that without any whisper even in any
of the provisions of the Act in this regard, the Act could be intended to be or
can be held to be concerned with prescribing the qualification and course
content of that qualification for practising medicine with the aid of or
through the medium of ultrasound machine. The said power cannot be
generally inferred. In contradistinction, the MCI Act, enacted to provide for
the reconstitution of the Medical Council of India and the maintenance of a
Medical Register for India and for matters connected therewith, a) in sub
Sections 10A, 10B, 11, 12, 13, 14 and 20 makes detailed provisions qua
medical qualifications which are/can be recognised, b) vide Section 15,
permits names of any those holding recognised medical qualifications to be
entered in the Medical Register to be maintained and confers right in them
only to practise medicine, c) vide Section 16 empowers the MCI to ensure
that the medical colleges/institutions are imparting requisite medical
education and holding examinations in the courses for which recognition
has been given to them, d) vide Section 19 provides for withdrawal of
recognition, e) vide Section 19A empowers MCI to prescribe minimumW.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 36 of 83
standards of medical education, f) vide Section 20A empowers the MCI to
prescribe the professional conduct, etiquette and code of ethics to be
followed by medical practitioners, and so on. The Schedules to the MCI Act
are found to give detailed description of recognised medical qualifications.
33. Not only so, even if the concern sought to be addressed by the PNDT
Act were to be held to include use of ultrasound machines only by those
who are educationally equipped and trained therefor, it belies logic, why the
prescription in the Act in this regard would be confined to use of ultrasound
machines only for pre-natal diagnostic procedures when it is undisputed that
the said machines are used for other diagnostic procedures as well. There is
not mention whatsoever thereof in the Act or the Rules (though interestingly
mention thereof is made in the Six Months Training Rules). It cannot be
that though the MCI recognised medical qualifications educate and train for
use of ultrasound machine qua other diagnostic procedures but not qua prenatal.
Certainly the legislature cannot be presumed to be so arbitrary as to,
while addressing the concern of not allowing use of ultrasound machines by
those who are not qualified therefor, address it qua one of the diagnostic
procedures only and not others. It further cannot be presumed that though
MCI is competent to prescribe and regulate award of medical qualifications W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 37 of 83
to enable a person to prescribe medicines and treatment to and even to
conduct surgery on patients but not to do the same to enable a person to
diagnose with the aid of ultrasound machine. In this regard it is also worth
noting that under Section 10A of the MCI Act, the power of the Central
Government to grant permission for establishment of medical colleges and
for opening a new or higher course of study or training including a post
graduate course of study or training, is “notwithstanding anything contained
in this Act or any other law for the time being in force”.
34. We are therefore unable to comprehend the purport of the impugned
provisions prescribing the qualification of persons who can use and operate
the ultrasound machines and like. It is not as if prior to the coming into
force of the PNDT Act the ultrasound machines were in the hands of
persons other than „Doctors‟. Even in diagnostic centres where „technicians‟
were operating the ultrasound machines, they were under the control and
supervision of „Doctors‟ and it was the „Doctors‟ who were preparing and
signing the reports of ultrasound diagnosis/test. It was the „Doctors‟ only
who were misusing the same for sex determination, as is evident from
reports in the news media of the stray cases detected of violation of the Act.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 38 of 83
35. Section 16 of the PNDT Act prescribing the functions of the Central
Supervisory Board constituted under Section 7 of the Act prescribes one of
the functions as, to create public awareness against the practice of
preconception sex selection and prenatal determination of sex of foetus
leading to female foeticide. We find the Supreme Court also to have, in
orders reported in (2001) 5 SCC 577, (2003) 8 SCC 398 and (2003) 8 SCC
410 in Centre For Enquiry into Health and Allied Themes (CEHAT) Vs.
UOI as well as in orders reported in (2013) 4 SCC 1, (2014) 16 SCC 426
and (2015) 9 SCC 740 in Voluntary Health Association of Punjab Vs.
UOI, repeatedly emphasised the need to sensitise the people and create
public awareness against the practise of prenatal determination of sex and
female foeticide.
36. Therefrom the legislative intent appears to be to allow use of
ultrasound machines only by those who can be sensitised to the issue.
Though to us it appears that the issue is a moralistic and not a legal one and
such sensitisation is not dependent upon literacy and there appears to be no
basis for presuming that the ultrasound machines prior to the coming into
force of PNDT Act were in the hands of persons who could not even be so
sensitised or for apprehension that they will be so in future, but we still fail W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 39 of 83
to see any nexus between the provisions of the PNDT Act and the aim and
objective of enactment thereof on the one hand and the impugned PNDT
Rule and the Six Months Training Rules with which we are concerned in
these petitions, on the other hand
37. We are of the opinion that for the purposes of prevention of sex
determination through ultrasound machines or other radiological techniques,
it matters not whether the ultrasound machine is in the hands of an MBBS
or an MBBS with six months training or an MBBS with one year experience
who has cleared the competency test or in the hands of MD radiologist /
obstetrics. The qualification of MBBS itself is a highly sought after
qualification, to secure which one has to first appear in a competitive
examination for admission to a medical college and thereafter has to
undergo the rigours of passing the MBBS examination. By no stretch of
imagination can it be said that an MBBS qualified person lacks education or
understanding to be not able to comprehend the fatal consequence of female
foeticide as a result of sex determination or the morality behind the same.
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. To W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 40 of 83
make an as educated a person as a „Doctor‟ understand the ill effects of sex
determination and that use thereof for the purposes of female foeticide is a
crime, there is no need to require him either to undergo post-graduation or a
six months training or gain a one year experience or pass a competency test.
By doing so, he will not be less likely to break the said law than he would
be without the same. It is not as if holding a medical qualification
recognised by MCI does not have any concern with the conduct/behaviour
of the holder thereof. The holder thereof is required to abide by the
standards of professional conduct and etiquette and code of ethics
prescribed by MCI in exercise of power under Section 20A of the MCI Act.
Moreover, when the holder of medical qualification is capable of being
sensitised with the code of conduct/etiquette/ethics, he/she can certainly be
sensitised to the issue of PNDT without being required to undergo any
training/experience.
38. We are constrained to observe that in the matter of the said
legislation, the destination appears to have been forgotten during the journey
from September, 1991 when the Pre-natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Bill, 1991 was first introduced in the
Lok Sabha to the enactment of the PNDT Act and the Rules and the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 41 of 83
amendments thereto.
39. The result thereof is evident. Inspite of the law having been enacted
nearly quarter of a century back, the child sex ratio continues to fall as
admitted by the Union of India in its counter affidavit filed in the year 2014
in WP(C) No. 3184/2014. A surfing of the internet does not show any
improvement thereafter either. The PNDT Act, clearly has failed to serve
the purpose.
40. One of the reasons therefor, as far as we can gauge is the unnecessary
emphasis on regulating and enforcing those provisions which do not serve
the aim and objective of the Act and at the expense of detection of
violations of the prohibitions imposed by the Act and which appear to
continue unabated. The entire enforcement machinery created under the Act
appears to be engrossed in the mammoth paper work of registration of
ultrasound machines and other diagnostic tools, even if in use of medical
professionals for non prenatal diagnosis and of ensuring that the records
required to be maintained by the registrants are maintained. In all this
exercise, there appears to be little time left for identifying those misusing
the ultrasound machine for sex determination and who are going undetected. W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 42 of 83
41. We now proceed to deal with the rival contentions, to answer the
following:
A. Interpretation of Section 2(p) of the PNDT Act, i.e. who is
authorised to operate and use a ultrasound machine.
B. Whether Rule 3(3)(1)(b) of the PNDT Rules (after the amendment
w.e.f.09.01.2014) is inconsistent with Section 2(p) of the PNDT
Act and if so to what effect.
C. Whether Rule 3(3)(1)(b) of the PNDT Rules (after the amendment
w.e.f. 09.01.2014), to the extent it requires 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, is arbitrary and if so to what effect.
42. We may at the outset notice the difference in the stand qua the
interpretation of Section 2(p) between the petitioner in WP(C) No.
6968/2011 and the petitioners in the other two petitions. While according to
petitioner in WP(C) No. 6968/2011, which represents Doctors with
postgraduate degrees in radio-diagnosis, it is only the Doctors with
postgraduate degrees in radio-diagnosis who are competent to install, use,
operate and report on diagnosis with ultrasound machines and have been
doing so in the past and the PNDT Act has for the first time entitled even W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 43 of 83
those without postgraduate degrees i.e. mere MBBS to do so, the petitioners
in other two petitions who represent the general body of Doctors, not
necessarily holding postgraduate degree in radio-diagnosis, controvert.
However since we have not been shown and have ourselves not been able to
find any bar under the MCI Act or any other law/rule/regulation, to
using/operating ultrasound machine save with a postgraduate degree in radio
diagnosis, we proceed to interpret Section 2(p) literally.
43. Section 2(p) was subject matter of interpretation in K.L. Sehgal supra
on which heavy reliance has been placed by the respondent Union of India
in its counter affidavits as hereinabove recorded. It was the contention of
the GNCTD in that case that the word “or” between the words “...Indian
Medical Council Act, 1956 (102 of 1956)” and “who possess a postgraduate
qualification...” in Section 2(p) of the PNDT Act has to be read as
“and”. This Court however rejected the said contention reasoning (a) that a
plain reading of Section 2(p) shows that a person possessing one of the
medical qualifications recognised under the MCI Act is a sonologist and the
word “or” only makes possessing of the post-graduate qualification in ultrasonography
or imaging techniques or radiology an alternative qualification;
(b) that though prior to the insertion of Section 2(p) certain amendments W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 44 of 83
were proposed and in which instead of the word “or” the words “and / or”
existed but in the ultimate enactment the word “and” was dropped meaning
that the definition as was incorporated requires a post-graduate qualification
only in the alternative; (c) that the understanding of the definition in Section
2(p) is also reflected in Regulation 3(3)(1)(b) (as it stood then i.e. prior to
amendment w.e.f. 09.01.2014) which enabled a sonologist or a imaging
specialist or a radiologist or registered medical practitioner having postgraduate
decree or diploma or six months training or one year experience in
sonography or image screening to set up a genetic clinic / ultrasound clinic /
imaging centre; (d) that if the word “or” is read as “and”, then the words
which indicate that the person should be possessing one of the medical
qualifications recognised under the MCI Act would be rendered redundant;
(e) that to accept the argument that the word “or” should be read as “and”
would be reading too many words into Section 2(p) of the PNDT Act, which
is not simply permissible; (f) that MCI also in its letter dated 4th May, 2009
to one of the petitioners had intimated that a person who either has a MBBS
degree or a further specialisation qualification would be able to run an
ultrasound clinic provided he or she undergoes six months training in ultrasonography.W.P.(C)
Nos.6968/2011, 2721/2014 & 3184/2014 Page 45 of 83
44. Union of India and GNCTD were parties to K.L. Sehgal and accepted
the said judgment and allowed it to attain finality. They have now also not
assailed the interpretation of Section 2(p) of PNDT Act therein. Rather,
both in their respective counter affidavits have relied heavily thereon. The
contention of the petitioners in WP(C)No. 2721/2014 and WP(C) No.
3184/2014 also is that qualification of MBBS or any medical qualification
recognized under the MCI Act is enough to operate/use an ultrasound
machine. It is only the petitioner in WP(C) No. 6968/2011 which contends
that only those with postgraduate degree in radio-diagnosis can do so;
however it has been unable to show any requirement of MCI in this regard.
We have already hereinabove held 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. We have
not been told or are able to comprehend as to how, to serve the said purpose
it is relevant whether the ultrasound machine is in hands of a person having
qualification of MBBS or of a person holding qualification of M.D. (RadioDiagnosis).
If MCI, which is the specialist body in the field of medicine, is
of the opinion that persons having MBBS qualification are entitled to W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 46 of 83
practise medicine with use of ultrasound machine, we need look no further.
In this light of the matter we do not feel the need to consider the correctness
of the interpretation of Section 2(p) in K.L. Sehgal supra. We also do not
find the amendment of Rule 3(3)(1)(b) w.e.f. 09.01.2014 i.e. after K.L.
Sehgal, to have any effect thereon. Suffice it is to state that literally,
Section 2(p) enables a person who possesses any one of the medical
qualification recognised by MCI to be a sonologist or imaging specialist.
45. We will next take up the question, whether the Rule 3(3)(1)(b) of the
PNDT Rules as amended w.e.f. 09.01.2014 is contrary to the PNDT Act.
46. Rule 3(3)(1)(b) prescribes the qualifications of those who can set up
or those who can be employed in a genetic clinic, ultrasound clinic or a
imaging centre. The word employee is defined in Rule 2(b) as a person
working in or employed by a genetic clinic or an ultrasound clinic or an
imaging centre including those working on part-time, contractual,
consultancy, honorary or on any other basis.
47. The Act defines genetic clinic and genetic laboratory in Section 2(d)
and (e) thereof as under:
(d) Genetic Clinic means a clinic, institute, hospital, nursing
home or any place, by whatever name called, which is used for
conducting pre-natal diagnostic procedures;W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 47 of 83
Explanation- For the purposes of this clause, „Genetic
Clinic‟ includes a vehicle, where ultrasound machine or
imaging machine or scanner or other equipment capable
of determining sex of the foetus or a portable equipment
which has the potential for detection of sex during
pregnancy or selection of sex before conception, is used.
(e) 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;
The terms „ultrasound clinic‟ and „imaging centre‟ used in Rule
3(3)(1)(b) are not defined in the Act or the Rules.
48. „Pre-natal diagnostic procedures‟ [used in Section 2(d)], „prenatal
diagnostic techniques‟ and „prenatal diagnostic test‟ are defined in Section
2(i) (j) and (k) of the PNDT Act as under:
(i) pre-natal diagnostic procedures means all gynecological or
obstetrical or medical procedures such as ultrasonography
foetoscopy, taking or removing samples of amniotic fluid,
chorionic villi, embryo, blood or any other tissue or fluid of a
man, or of woman before or after conception, for being sent to a
Genetic Laboratory or Genetic Clinic for conducting any type
of analysis or pre-natal diagnostic tests for selection of sex
before or after conception;
(j) pre-natal diagnostic techniques includes all pre-natal
diagnostic procedures and pre-natal diagnostic tests;
(k) pre-natal diagnostic test means ultrasonography or any test
or analysis of amniotic fluid, chorionic villi, blood or any tissue W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 48 of 83
of a pregnant woman or conceptus conducted to detect genetic
or metabolic disorders or chromosomal abnormalities or
congenital anomalies or haemoglobinopathies or sex-linked
diseases;
49. Though the words ultrasound clinic/imaging centre are not defined as
aforesaid but it follows from a conjoint reading of definitions aforesaid that
any clinic/institute/hospital/nursing home or other place, though not
proclaiming itself to be carrying out pre-natal diagnostic procedure and thus
not a genetic clinic but having ultrasound or other machines „capable of‟
viewing/imaging the foetus and other organs of human body for selection of
sex before or after conception, would be covered thereby.
50. We may in this regard highlight that the definition of genetic clinic in
Section 2(d) of the Act, as per the Explanation thereto includes a place
where ultrasound or imaging machine „capable of‟ determining sex of the
foetus or having potential for detection of sex during pregnancy or selection
of sex before conception is used. The explanation being „inclusive‟, cannot
be confined to vehicle. This becomes further evident from Section 18(1),
which also uses the word „capable of‟ and is as under:
18. Registration of Genetic Counselling Centres, Genetic
Laboratories or Genetic Clinics:
(1) No person shall open any Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic, including clinic, W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 49 of 83
laboratory or centre having ultrasound or imaging machine
or scanner or any other technology capable of undertaking
determination of sex of foetus and sex selection, or render
services to any of them, after the commencement of the Prenatal
Diagnostic Techniques (Regulation and Prevention of
Misuse) Amendment Act, 2002 unless such centre,
laboratory or clinic is duly registered under the Act.
51. The Act thus takes within its sweep all places/vehicles where
ultrasound machine or other machine are kept, whether for prenatal
diagnostic procedures or not, if they are capable of sex determination. We
will deal further with this aspect in the discussion under question „C‟ framed
by us in para 41 above.
52. That brings us back to, whether Rule 3(3)(1)(b) is inconsistent with
Section 2(p) for the reason of expanding the definition of sonologist as
given in Section 2(p) of the Act.
53. Rule 3(3)(1)(b) prescribes the qualifications for setting up of or for
employment in a genetic clinic /ultrasound clinic/imaging centre.
54. Though the PNDT Act in Section 2(p) defines the words sonologist or
imaging specialist but there is thus nothing in the Act to indicate what a
sonologist or imaging specialist as defined in the PNDT Act can do or what
he/she is prohibited from doing. There is absolutely nothing in the Act
entitling a sonologist or imaging specialist, as defined therein, to use/operate W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 50 of 83
a ultrasound machine or imaging machine or to set up a genetic clinic /
ultrasound clinic/imaging clinic. In fact the word sonologist, besides in
Section 2(p), is used only at two other places in the Act i.e. in Section
16A(2)(f)(v) while prescribing the categories of persons from whom
members of the State Advisory Board are to be appointed and in Section
23(3) while prescribing the punishment for a person who approaches any
Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic or
Ultrasound Clinic or Imaging Clinic or a medical geneticist, gynaecologist,
sonologist or imaging specialist or registered medical practitioner or any
other person for sex selection. The word imaging specialist is used only in
Section 23(3). The said provisions do not vest any right in sonologist or
imaging specialist as defined in Section 2(p) to set up or seek employment
in a place having ultrasound or like machine. On the contrary the Act, by
Section 32(2)(i) empowers the Central Government to make rules providing
for the minimum qualification for persons employed in genetic clinic and
which as aforesaid would include ultrasound clinic and imaging clinic and
in exercise of which power Rule 3(3)(1)(b) has been enacted.
55. The question thus, of Rule 3(3)(1)(b) being inconsistent with Section
2 (p) does not arise.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 51 of 83
56. We may at this stage deal with the contention of senior counsel for
the petitioner in WP(C)No.2721/2014 of the words “registered medical
practitioner” in Rule 3(3)(1)(b) referring to registered medical practitioner
as defined in Rule 2 (ee) of the Drugs and Cosmetics Rules, 1945. We do
not find any merit therein because „registered medical practitioner‟ is
defined in Section 2(m) of the Act as under:
(m) registered medical practitioner means a medical
practitioner who possesses any recognised medical
qualification as defined in clause (h) of section 2 of the Indian
Medical Council Act, 1956, (102 of 1956), and whose name has
been entered in a State Medical Register;
and Rule 2(f) is as under:
2.(f) words and expressions used herein and not defined in these
rules but defined in the Act, shall have the meanings,
respectively, assigned to them in the Act.
57. That brings us to question „C‟ framed by us in para 41 above. There
are two limbs of it i.e. whether the insistence in Rule 3(3)(1)(b) read with
Rule 6(2) of the Six Months Training Rules on six months training or one
year experience coupled with passing the competency test is arbitrary, and if
not, whether the insistence thereon even for those intending to or using the
ultrasound machines or imaging machines for purposes other than pre-natal
diagnostic procedures is arbitrary. W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 52 of 83
58. Rule 3(3)(1)(b) refers to a Sonologist or Imaging Specialist and which
words, in terms of Rule 2(f) supra would take their colour from their
definition of Sonologist or Imaging Specialist in Section 2(p) of the Act. In
this context the challenge in W.P.(C) No.6968/2011 to Section 2(p)
becomes relevant. It remains unrebutted that in the Schedule to the MCI
Act there is no “post-graduate qualification, in ultrasonography or imaging
techniques” referred to in Section 2(p). The reference certainly cannot be to
any such qualification which is not recognised by MCI. Section 2(p) thus
indeed is faulty to the said extent and none can claim under Rule 3(3)(1)(b)
on the basis of having a postgraduate qualification in ultrasonography or
imaging techniques, till such qualification is included in the schedule to the
MCI Act.
59. Rule 3(3)(1)(b), even prior to amendment with effect from 9th
January, 2014, referred to six months training or one year experience in
sonography or image screening. There admittedly was no prescribed six
months training or prescription for one year experience. It however appears
that registrations under the PNDT Act were being granted on the basis of
training / experience with any other person registered under the Act and
certificate issued by that person and there was a lot of arbitrariness as was W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 53 of 83
noticed in K.L. Sehgal supra. However since in the absence of any
prescription, the reference to six months training or one year experience
was not an impediment to anyone obtaining registration, the occasion for
challenging the same did not arise. It was rather the grievance of the
petitioner in W.P.(C) No.6968/2011 that taking advantage of the faulty
definition of Sonologist or Imaging Specialist as aforesaid in Section 2(p)
and the absence of any prescription / rules regarding six months training and
one year experience, those not competent to set up a ultrasound clinics, had
obtained registrations under the Act, defeating rather than serving the
purpose of the Act.
60. However upon the framing of Six Months Training Rules and the
amendment of Rule 3(3)(1)(b) with effect from 9th January, 2014, the cause
of action as per contentions aforesaid has accrued.
61. The respondent UOI has attributed the said amendments solely to
K.L. Sehgal.
62. Since the respondents in their counter affidavits have extensively
referred to K.L. Sehgal, notice at this stage may be taken thereof. The
learned Single Judge was therein concerned with rejection of the application
of doctors of two well-known established radiology / ultrasound clinics of W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 54 of 83
Delhi for grant / renewal of their registration under the PNDT Act. This
Court in the judgment took notice of the stand of the MCI (i) that the
recognised medical qualification as defined under Section 2(h) of the MCI
Act means any of those medical qualification included in the Schedule to
the MCI Act; (ii) that the MCI had framed the Post-Graduate Medical
Education Regulations, 2000; (iii) that as per Rule 10 of the said
Regulations, the period of training for the award of degree of Directorate of
Medicine (MD) / Master of Surgery (MS) consists of three completed years
including the period of examination; (iv) that for award of a post-graduate
diploma, there is to be two completed years training, including the period of
examination; (v) that the specialities in which post-graduate degrees /
diplomas can be awarded are prescribed in the Schedule to the Regulations;
(vi) that the said Schedule includes qualification of MD with speciality in
radio-diagnosis; (vii) that the Schedule also includes diplomas in radiodiagnosis,
radiotherapy and radiological sciences; (viii) that the institutes
from where the petitioners in that case claimed to have undergone training
were not included in the Schedule or in the list of institutes recognised /
permitted by MCI to conduct any post-graduate courses in radio-diagnosis
or ultrasound; and, (ix) that the petitioners thus could not claim to be having W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 55 of 83
six months training or one year experience.
63. It was also noticed in K.L. Sehgal that MCI did not appear to be
itself aware of medical colleges which provide training in ultra-sonography
and diagnostic ultrasound and that there was uncertainity in applying the
PNDT Act and the Rules and that none of the authorities were clear, what
should be minimum criteria regarding training, where the training should be
provided, whether the criteria should be made prospective and so on. It was
however observed that these were technical aspects on which the views of
the experts rather than of the Court are relevant and that the Court in
exercise of jurisdiction under Article 226 of the Constitution lacks the
competence to determine such technical issues. This Court lamented on the
disconcerting state of affairs resulting in mushrooming growth of diagnostic
clinics and ineffective regulation thereof. It was directed that to avoid any
confusion, the requirements in terms of qualification, training and
experience to be recognised and registered as a sonologist should be
incorporated in the PNDT Act and further explicated under the PNDT
Rules.
64. It would thus be evident that this Court in K.L. Sehgal did not return
any findings on which the respondent no.1 could have based its amendment W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 56 of 83
with effect from 9th January, 2014. The justification of the amendment
thereon is thus misconceived.
65. Else, the challenge thereto in these petitions has not been met. No
source of power from any of the provisions of the PNDT Act has been
shown, to in exercise of power under Section 32, lay down and prescribe the
course and training and content thereof to practise medicine with aid of
ultrasound machine and to prohibit those, who by virtue of their name
entered in the Medical Register under Section 15 of the MCI Act entitled to
so practise, from so practising without undergoing the said six months
course or experience coupled with passing the competency test.
66. Sections 3, 3B and 4 of the PNDT Act are as under:
3. Regulation of Genetic Counselling Centres, Genetic
Laboratories and Genetic Clinics.- On and from the
commencement of this Act,--
(1) no Genetic Counselling Centre, Genetic Laboratory or
Genetic Clinic unless registered under this Act, shall conduct or
associate with, or help in, conducting activities relating to prenatal
diagnostic techniques;
(2) no Genetic Counselling Centre or Genetic Laboratory or
Genetic Clinic shall employ or cause to be employed or take
services of any person, whether on honorary basis or on
payment who does not possess qualifications as may be
prescribed;
(3) no medical geneticist, gynaecologist, paediatrician,
registered medical practitioner or any other person shall
conduct or cause to be conducted or aid in conducting by
himself or through any other person, any pre-natal diagnostic W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 57 of 83
techniques at a place other than a place registered under this
Act;
.......
3B. Prohibition on sale of ultrasound machines, etc., to
persons, laboratories, clinics, etc. not registered under the
Act.- No person shall sell any ultrasound machine or imaging
machine or scanner or any other equipment capable of
detecting sex of foetus to any Genetic Counselling Centre,
Genetic Laboratory, Genetic Clinic or any other person not
registered under the Act.
4. Regulation of pre-natal diagnostic techniques.- On and
from the commencement of this Act,--
(1) no place including a registered Genetic Counselling Centre
or Genetic Laboratory or Genetic Clinic shall be used or
caused to be used by any person for conducting pre-natal
diagnostic techniques except for the purposes specified in
clause (2) and after satisfying any of the conditions specified in
clause (3);
(2) No pre-natal diagnostic techniques shall be conducted
except for the purposes of detection of any of the following
abnormalities, namely:--
(i) Chromosomal abnormalities;
(ii) Genetic metabolic diseases;
(iii) Haemoglobinopathies;
(iv) Sex-linked genetic diseases;
(v) Congenital anomalies;
(vi) Any other abnormalities or diseases as may be
specified by the Central Supervisory Board;
67. The aforesaid provisions of the Act read with Section 18(1) thereof
reproduced earlier prohibit doing of activities mentioned therein without
registration under the PNDT Act and the PNDT Rules inter alia lay down
the conditions for such registration. Registration under the Act and the
Rules is thus a licence to carry on the activities which are prohibited by the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 58 of 83
Act.
68. The said activities which are prohibited by the Act save with licence
in accordance with Rules, we have no doubt are activities of practise of
„medicine‟ defined in Section 2(f) of the MCI Act as under:
“2(f). "medicine" means modern scientific medicine in
all its branches and includes surgery and obstetrics,
but does not include veterinary medicine and surgery”
and the licence granted is a “medical qualification” which confers on the
grantee / recipient, the right to practise the said field of medicine and in
which he / she cannot practise without such registration / licence.
69. The MCI Act, vide Section 10A(1)(b)(i) thereof prohibits a medical
college from opening a new or higher course of study or „training‟ which
would enable a student of such course or training to qualify himself for the
award of any recognized medical qualification and which is defined in
Section (h) thereof as a qualification included in the Schedules to the said
Act. It is not the case that the six months training under the Six Months
Training Rules framed therefor under the PNDT Act has been included in
the Schedules to the MCI Act. It is thus not a recognized qualification. W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 59 of 83
70. The Indian Medical Degrees Act, 1916 vide Section 2 thereof
describes „western medical science‟ as western method of allopathic
medicine, obstetrics and surgery but not including Homeopathy or
Ayurvedic or Unani System of medicine. Section 3 of the said Act provides
that the right to confer degrees, diplomas, licences, certificates or other
documents stating or implying that the holder, grantee or recipient thereof is
qualified to practise western medical science is only of the authorities
specified in Schedule thereto. Section 4 thereof prohibits unauthorized
conferment of degrees, diplomas, licences, certificates or other document
stating or implying that holder thereof is qualified to practise western
medical science.
71. In our opinion, the activities prohibited by the PNDT Act save with
licence / registration under the said Act and Rules framed thereunder, are
activities of practise of western medical science within the meaning of the
Indian Medical Degrees Act and the Appropriate Authority constituted
under the PNDT Act which has been empowered to grant registration /
licence thereunder having not been included in the Schedule to the Indian
Medical Degrees Act, the registration / licence granted by the Appropriate
Authority under the PNDT Act cannot thus confer a right to practise what is W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 60 of 83
prohibited by PNDT Act. On the contrary, as aforesaid a person holding a
qualification recognized under the MCI Act was / is entitled to practise what
has been taken away / prohibited by the PNDT Act. We agree with the
petitioners that the MCI is the sole repository of education in western
medical science which includes training and the training if any required for
conducting prenatal diagnostic procedures has to be by inclusion in the
Schedules to the MCI Act. The Supreme Court in MCI Vs. State of
Karnataka (1998) 6 SCC 131 reiterated in Dr. Preeti Srivastava Vs. The
State of Maharashtra (1999) 7 SCC 120 held that fixation of admission
capacity in medical colleges/institutions is the exclusive function of MCI
and the same has a direct nexus with co-ordination and determination of
standards in medical education. Though undoubtedly the permission under
the MCI Act, for establishment of a medical college is not applicable to
Central Government (see Explanation 1 to Section 10A) and permission for
starling a new course of study or training is to be granted by the Central
Government but the MCI having been constituted under the MCI Act as the
expert body to make recommendations to the Central Government, we are
of the view that the need even if felt for six months training as under the
PNDT Act, should be fulfilled within the confines of the MCI Act. We do W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 61 of 83
not find any representation of the MCI in the Supervisory Boards or in the
Appropriate Authorities or Advisory Committees constituted under the
PNDT Act to advise the Central Government on policy matters thereunder
and implementation thereof. Though the respondent UOI claims to have
constituted MCI before the amendment of 9th January, 2014 but the said
consultation cannot be a substitute for the procedure required to be followed
under the MCI Act.
72. The purport of our above discussion is to again highlight that the
essential provisions of the PNDT Act i.e. those directly concerned to serve
the aim and objective thereof, appear to have been diluted and / or lost their
effectiveness in the midst of provisions which do not appear to have any
nexus to the aim and objective of the Act, leading to the child sex ratio
continuing to fall except in some metropolitan cities.
73. There is no denying the fact that ultrasound machines today are used
for diagnosis of ailments of a large number of organs in the human body and
the use thereof is not limited to pre-natal diagnostic procedures.
74. Though the PNDT Act is concerned with use of ultrasound machines
only in pre-natal diagnostic procedures and not with use thereof for other
diagnostic procedures and there is merit in the grievance of the petitioners,W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 62 of 83
of the Doctors using the ultrasound machines for other diagnostic
procedures having also been brought in the purview of the Act and being
required to comply with cumbersome requirements thereof, to their
detriment and cost, but at the same time the reason for the net of the Act
having been spread far and wide to encompass all ultrasound machines,
because an ultrasound machine even though not intended for prenatal
diagnostic procedures being „capable of‟ use therefor, cannot be said to be
baseless. We are therefore unable to confine the operation of the PNDT Act
only to those proclaiming to run a genetic clinic and hold that all those
places including vehicles where ultrasound or like machine „capable of‟ sex
determination is kept would be a genetic clinic and within the ambit of the
Act.
75. It was to balance the said conflicting interests that we had enquired of
the technical solution if any, to prevent use of ultrasound machines not
intended for prenatal diagnostic procedures, therefor and suggested, though
registering all users of ultrasound machines but exempting those furnishing
declaration not to use the same for prenatal diagnostic procedures from
complying with other requirements of the Act but remaining liable for
inspection and penalties etc. if found to be violating.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 63 of 83
76. Though we were told that neither was / is possible but we find that a
Division Bench of the High Court of Bombay in Radiological and Imaging
Association (State Chapter-Jalna) Vs. Union of India
MANU/MH/1050/2011 was concerned with a challenge to a circular dated
10th March, 2010 of the District Magistrate Kolhapur whereby all Doctors,
Sonologists and Radiologists were called upon to install device “silent
observer” in their ultrasound machines, on the ground that the same invaded
privacy of the patients and was also contrary to the provisions of the PNDT
Act and the Rules which merely required the doctors to maintain records. It
was the defence of the District Magistrate, Kolhapur that the requirement
for maintaining records and the provision for inspection thereof by the
authorities was failing to check the child sex ratio which was continuing to
fall and the “silent observer” if installed in the ultrasound machines will
capture and store the video record of each sonography test enabling the
authorities to effectively check violations. The Central Government also
supported the said stand. The High Court found that the images stored in
the “silent observer” remain part of the ultrasound machine on which “silent
observer” is embedded and enables the authorities under the Act to detect
violation of the PNDT Act by removing the “silent observer” from the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 64 of 83
ultrasound machine and accessing the sonographies done with the
ultrasound machine on a computer. The challenge on the ground of breach
of privacy was negatived reasoning that the doctors were in any case
required to maintain the record and the petition was dismissed. We also
find that during the hearing of another petition before the Bombay High
Court impugning the ban on use of portable ultrasound machines and as
reported in the judgment therein i.e. Radiological and Imaging Association
(State Chapter) Vs. Union of India MANU/MH/1436/2011, the Advocate
General for the State of Maharashtra stated that the order as issued by the
District Magistrate, Kolhapur was applicable to the entire State of
Maharashtra and the advocate appearing for the Ministry of Health, Union
of India also stated that the said direction for installation of “silent observer”
is in accordance with law and directions to the said effect shall be issued
with respect to the rest of the country as well. We yet further find another
Division Bench of the Bombay High Court in Writ Petition Lodging
No.2059/2012 titled Dr. Rajendra G. Goyal Vs. State of Maharashtra to
have vide order dated 17th September, 2012 stayed the ban on use of
portable ultrasound machines subject to installation of “silent observer”
therein.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 65 of 83
77. We are at a loss why neither party informed us of the same and rather
inspite of our specific enquiry ruled out such a solution. In our opinion the
installation of silent observer on ultrasound machines offers perfect
balancing of the need to prevent misuse of ultrasound machines for sex
determination and the need to not burden the doctors desirous of using
ultrasound machines for procedures other than pre-natal with unnecessary
paper work and displaying warnings in their clinics as required to be
displayed by genetic clinics.
78. We further find that a Division Bench of the High Court of Kerala in
Qualified Private Medical Practitioners and Hospitals Association Vs.
State of Kerala MANU/KE/0330/2006 was concerned with petitions for a
declaration that the laboratories and clinics which do not conduct pre-natal
diagnostic tests using ultrasonography will not come within the purview of
the PNDT Act and for a direction not to insist for registration of all
ultrasound scanning centres irrespective of the fact whether they are
conducting pre-natal diagnostic tests using ultrasonography or not. It was
contended before the Court that only institutions which use ultrasonography
for the purpose of pre-natal diagnostic tests will come within the purview of
the Act and only such institutions are required to register with the W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 66 of 83
Authorities under the Act and the direction to all ultrasound clinics in the
city to resister was bad. The respondents of course relied upon the order of
the Supreme Court in CEHAT to contend that all clinics with ultrasound
machines require registration irrespective of the fact whether the machines
were used for any pre-natal detection or not. The High Court held that
though Section 18 of the Act compels registration of Genetic Counselling
Centres, Genetic Laboratories or Genetic Clinics without which no person
can open any such centre, laboratory or clinic but the expression "Genetic
Counselling Centre" as defined under Section 2(c) makes it clear that only
those institutes, hospitals or nursing homes which provide for genetic
counselling to patients come within the ambit of the expression "Genetic
Counselling Centre". Further, on a reading of the definition in Section 2(d)
of a genetic clinic it was held that only those clinics, institutes, hospitals or
nursing homes which conduct pre-natal diagnosis would be covered. It was
thus held that those hospitals, nursing homes or clinics not conducting any
pre-natal diagnostic procedures though having a ultrasound machine would
not be Genetic Counselling Centres or genetic clinics within the meaning of
the Act. It was further held on a interpretation of Section 4(1) that the
legislature however has extended the prohibition contained therein even to W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 67 of 83
unregistered counselling centres or diagnostic centres or genetic clinics i.e.
even institutions which may not require registration will still be governed by
the restrictive provisions and cannot indulge in any activities contrary to the
legislative mandate imposed under Section 4 and the prohibitions contained
therein equally apply to all such institutions. It was further held that with a
view to prevent misuse of any pre-natal diagnostic techniques except for the
purpose of genetic or metabolic diseases etc., the authorities would be free
to conduct inquiries or to hold inspections at places where such device is
available and to take action in case any person or institution is found to have
indulged in activities contrary to the provisions of the Act. We do not find
the matter to have been taken to the Supreme Court.
79. We also find the High Court of Punjab and Haryana in Medscan
Diagnostic Imaging Centre Vs. State Appropriate Authority
MANU/PH/3702/2014, though concerned with a challenge to an order of
seizure of MRI and CT scan gadgets under the PNDT Act to have observed
that mere possession of a machine or a gadget capable of detection of sex
cannot be an offence under the Act. It was held that this would set new
restrictions which will be disastrous for an ordinary clinic which is not
registered as a genetic clinic but has an MRI or CT scan for the purposes of W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 68 of 83
determination of other abnormalities that may have no reference at all to
performance of sex determination. It was held that possession of equipment
ought not to be taken as possession of equipment which could be used for
sex determination. The Court took notice of the poor detection of violations
of the Act but observed that the same cannot be a ground for punishing mere
possession of the machine without any charge of having conducted sex
determination with the aid thereof. LPA No.696/2015 preferred thereagainst
was dismissed vide judgment dated 7th May, 2015. We again do not find the
matter to have been taken to the Supreme Court.
80. From the above, it appears that there is no uniformity in the
implementation of the Act and the Rules across the country and no attempt
even towards the same has been made.
81. We have hereinabove on an analysis of the provisions of the PNDT
Act held that the same is not concerned with formulating education or
qualifications for practising medicine with the aid of ultrasound machine.
The power of the Central Government under Section 32 to make rule
providing for minimum qualifications of persons employed at genetic clinic
has to be interpreted in the said light. The rule making power under a
statute cannot travel beyond the Act. There is no provision in the Act W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 69 of 83
providing for imparting of education including training or formulating
curriculum thereof or to hold competency test, as a pre-requisite to
registration under the Act entitling a person to practise medicine with the
aid of ultrasound machine.
82. In the absence of any such provision in the Act, no such power can be
conferred by the Central Government on itself in the guise of making rules.
Supreme Court in Academy of Nutrition Improvement supra cited by the
senior counsel for the petitioner reiterated that conferment of rule making
power by an Act does not enable the rule making authority to make a rule
which travels beyond the scope of enabling Act.
83. A Division Bench of this Court, in Indraprastha Gas Ltd. Vs.
Petroleum & Natural Gas Regulatory Board (PNGRB)
MANU/DE/2313/2012, for the detailed reasons given therein and need to
repeat which herein is not felt, held that the Petroleum & Natural Gas
Regulatory Board Act, 2006 does not confer any power on the PNGRB to
fix /regulate price of gas as had been done vide the order of the PNGRB
impugned in that proceeding and accordingly held the regulations framed by
the PNGRB empowering it to fix the price to be beyond the competence of
PNGRB and ultra vires the PNGRB Act. Reliance in the judgment was W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 70 of 83
placed on (i) various dicta of the courts that price fixation is a legislative
function, to be performed by a statutory authority in furtherance of the
provisions of the relevant laws; (ii) U.P. Power Corporation Limited Vs.
National Thermal Power Corporation Ltd. (2009) 6 SCC 235 holding that
regulatory provisions are required to be applied having regard to the nature,
textual content and situational context of each statute; and, (iii) DLF Qutab
Enclave Complex Educational Charitable Trust Vs. State of Haryana
(2003) 5 SCC 622 holding that a Regulatory Act must be construed having
regard to the purpose it seeks to achieve and a statutory authority cannot ask
for something which is not contemplated under the statute.
84. The appeal against the aforesaid judgment of this Court, was
dismissed by the Supreme Court vide judgment reported as Petroleum &
Natural Gas Regulatory Board Vs. Indraprastha Gas Ltd. (2015) 9 SCC
209. Supreme Court also proceeded to examine whether a reading of
provisions of the Act showed a conferment of power to fix price and not
finding so, upheld the judgment of this Court. The contention, that PNGRB
having been established under a statute, to regulate, a power to regulate
price should be inferred, was negatived.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 71 of 83
85. We are humbly of the view that just like price fixation is a legislative
function, similarly, education, particularly higher education as in the field of
medicine is a legislative function to be performed by a statutory authority in
furtherance of the provisions of the relevant law, just like the MCI
constituted under the MCI Act, All India Council of Technical Education
(AICTE) constituted under the All India Council for Technical Education
Act, 1987, universities constituted under the University Grants Commission
Act, 1956 etc. are performing. In the PNDT Act with which we are
concerned, though Statutory Authorities viz. Supervisory Boards,
Appropriate Authorities and Advisory Committees have been constituted
but not empowered to regulate education in the field of medicine with the
aid of ultrasound machine. The Central Government, in our view, in
exercise of its rule making power under the said Act cannot do so. Supreme
Court, in Professor Yashpal Vs. State of Chhatisgarh (2005) 5 SCC 420
held that it is the responsibility of Parliament to ensure that proper standards
are maintained in institutions for higher education.
86. In the field of medicine, we find that the Supreme Court in Hamdard
Dawakhana Vs. Union of India AIR 1960 SC 554 concerned with the
challenge to Section 3(d) of the Drug and Magic Remedies (Objectionable W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 72 of 83
Advertisements) Act, 1954 prohibiting taking any part in the publication of
any advertisement referring to any drug in terms which suggests the
“diagnosis, cure, mitigation, treatment or prevention of any general disease
or any other diseases or condition which may be specified in the Rules made
under the Act” held that the delegation to the Administrative Authority
without the Parliament establishing any criteria, standards or principles on
which a particular disease is to be specified thereunder was beyond the
permissible boundaries of valid delegation. It was held that the words, “or
any other disease or condition which may be specified under the Rules made
under the Act”, confer uncanalised, uncontrolled power to the executive and
is ultra vires.
87. We also find that the Supreme Court in Godde Venkateswara Rao
Vs. Government of Andhra Pradesh AIR 1966 SC 828 was concerned with
a challenge to an order of the Government of Andhra Pradesh under Section
72 of the Andhra Pradesh Panchayat Samithis and Zilla Parishads Act, 1959
on the ground of being inconsistent with the provisions of the Act. It was
held that the government in exercise of the rule making power under the Act
can only makes Rules for carrying out the purpose of the Act and cannot
under the guise of the said Rules convert an authority with power to W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 73 of 83
establish a Primary Health Centre into only a recommendatory body and
cannot vest in itself a power which under the Act vests in another body.
The Rules to the extent they transferred the power of the Panchayat Samithi
to the Government, being inconsistent with the provisions of the Act, were
held, must yield to the Act.
88. The matter, in our view is placed beyond any pale of controversy by
the two decisions of the Supreme Court relating to the profession of law.
Supreme Court in Indian Council of Legal Aid and Advice Vs. Bar
Council of India (1995) 1 SCC 732 was concerned with the challenge to the
Rule introduced by the Bar Council of India prohibiting enrolment as an
Advocate of those who had completed the age of 45 years. The Bar Council
of India justified the said Rule as the sentinel of professional conduct and
the same being necessary for maintaining standards and traced its power to
make such a Rule to laying down the conditions subject to which an
Advocate shall have right to practise and the circumstances under which a
person shall be deemed to practice as an Advocate. It was however held
that the power thereunder was to lay down the conditions applicable to an
Advocate i.e. a person who has already been enrolled as an Advocate and
did not entitle the Bar Council of India to bar the entry into the legal W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 74 of 83
profession of persons who had completed 45 years of age. It was further
held that the Parliament while enacting the Advocates Act, 1961 had
provided the basic substantive matters, viz. eligibility for entry into the
profession, disqualification for enrolment and had nowhere restricted the
entry of those who had completed the age of 45 years as Advocates and the
Bar Council of India in the guise of making a Rule could not introduce an
additional condition for entry into the profession. Accordingly, the Rule
was held to be beyond the rule making power and ultra vires the Act.
89. In another case namely V. Sudeer Vs. Bar Council of India (1999) 3
SCC 176, the Supreme Court was concerned with the Bar Council of India
Training Rules, 1995 as amended by the Resolution of the Bar Council of
India in the meeting held on 19th July, 1998, relating to training of entrants
of the legal profession. It was the contention of the petitioners that after
having successfully completed their legal education by getting requisite law
degrees from the Universities, their right to practise law as available to them
under the Advocates Act could not be taken away by requiring them to
undergo training. It was also the contention that the Rules were totally
unworkable, highly unreasonable and discriminatory and violative of Article
14 of the Constitution of India. Finding that under the Advocates Act, not W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 75 of 83
having undergone pre-enrolment training was not a disqualification for
enrolment and further not finding any legislative intention in the Advocates
Act requiring a law graduate seeking enrolment as an Advocate under the
Act to undergo any pre-enrolment training as a condition for enrolment and
further finding that under the Advocates Act a person on acquiring a
qualification mentioned therein was qualified to be an Advocate, it was held
that the general rule making power did not take into its sweep the power to
provide pre-enrolment training and examination for applicants who were
seeking enrolment as Advocates. It was further held that the power of Bar
Council of India over legal education did not extend to laying down preenrolment
training. On an analysis of the provisions of the Advocates Act,
it was also held that enrolment of Advocates is a task of State Bar Council
and not of Bar Council of India and it was axiomatically held that Bar
Council of India could not exercise a rule making power thereover. It was
explained that the rule making power has to take colour from the statutory
function and cannot enable to impose additional restrictions.
90. We respectfully add that the position here is identical. The MCI Act,
vide Section 15 thereof confers a right on the person holding a recognised
medical qualification and whose name is entered in the Medical Register W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 76 of 83
maintained thereunder, to practise medicine. The said right is taken away
by the impugned Rules made under the PNDT Act which is not enacted to
address the issues of education in the field of medicine and does not contain
any statutory provisions therefor, by requiring such person to undergo
training. The same has but to be held to be not permissible.
91. Supreme Court in Kunj Behari Lal Butail Vs. State of H.P. (2000) 3
SCC 40 also held that in exercise of delegated power to legislate
circumscribed by the expression – “for carrying out the purposes of this
Act”, the State Government cannot bring within the net of the Rules what
has been excluded by the Act itself. It was further held that the legislature
cannot delegate its essential legislative functions which consist in the
determination or choosing of the legislative policy or of enacting that policy
into a binding rule of conduct. It was explained that it was very common to
the legislature to provide for a general rule making power to carry out the
purpose of the Act but while testing the validity of the said Rules, the object
and purpose of the enactment is to be found out and only if the Rules fall
within the limits prescribed by the parent Act would they be valid. It was
further held that the rule making power cannot be exercised to bring into
existence substantive rights or obligations or disabilities not contemplated W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 77 of 83
by the provisions of the Act itself. This was reiterated in Global Energy Ltd.
Vs. Central Electricity Regulatory Commission (2009) 15 SCC 570.
92. In the context of interplay between PNDT Act, and MCI Act
reference with benefit can be made to Bharathidasan University Vs. All
India Council for Technical Education (2001) 8 SCC 676 concerned with
a need for University created under the Bharathidasan University Act, 1981
to seek the prior approval of the All India Council for the Technical
Education for imparting technical education. It was held that when the
AICTE Act does not contain any evidence of any intention to belittle and
destroy the authority or autonomy of other statutory bodies having their own
assigned roles to perform, merely activated by some assumed objects or
desirabilities, the AICTE could not intervene. On a perusal of the
provisions of the AICTE Act, it was found that AICTE was not intended to
be an authority either superior to or to supervise the Universities and was
thus held not entitled to make a Regulation in the exercise of its regulation
making power, compelling the Universities to seek its prior approval. It was
further held that the fact that the Regulations had been laid before the
legislature (as is the case with the impugned Rules), did not confer them
with any more sanctity or impunity.W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 78 of 83
93. In our opinion, the position herein is identical. There is nothing in the
PNDT Act to show that it interferes in any manner with the MCI Act. What
has been permitted by the MCI Act i.e. a right to practise medicine upon
acquiring a qualification recognised under the MCI Act and having the
name entered in the Medical Register, cannot be taken away by making a
Rule under the PNDT Act requiring such persons to undergo training.
94. We therefore hold that the power of the Central Government in
exercise of Rule making power under Section 32(2)(i) of the PNDT Act to
provide minimum qualifications for persons employed at Genetic Clinics etc
does not extended to creating any new qualifications. Central Government
thereunder cannot prescribe qualifications other than those recognised by
MCI. If the Central Government is of the view that a qualification of MBBS
does not educate/equip a person to practise medicine with aid of ultrasound
machine, it can prescribe any other qualification viz. M.D. (Radiology)/
M.D. (Obstetrics), M.D.(Gynaecology) as the minimum qualification under
Section 32(2)(i) of PNDT Act. If the Central Government is of the view that
none of the qualifications recognised by MCI so equip a person, the remedy
therefor is to prescribe such qualification under the MCI Act.
95. Though in our opinion, MCI under Section 20A of the MCI Act is fully W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 79 of 83
empowered also to prescribe the professional conduct to be observed by
persons working in places where ultrasound machines are used but the Act
having made, what was earlier not an offence, an offence, the Central
Government in exercise of power under Section 32 would in our view be
entitled to prescribe such conduct. However the same, again in view of
above cannot take the form of a training or course required to be undergone
before registration under the PNDT Act but in the form of „Do‟s‟ and
„Don‟ts‟ and of which patients visiting Genetic Clinics can also be made
aware by requiring such clinics to display the same prominently and press
releases etc.
96. Though we have on an interpretation of the provisions of the PNDT
Act held hereinabove that for proper implementation and enforcement of the
Act all places having ultrasound or like machines „capable of‟ sex
determination require registration under the Act but at the same time we are
unable to interpret the provisions of Sections 4,18,29 of PNDT Act and
Rules 2(2), 3(2), 9 of the PNDT Rules requiring Genetic Clinics etc to
comply with requirements mentioned therein, as extending to those places
where a ultrasound of like machine „capable of‟ sex determination exists but
not for conducting prenatal diagnostic procedures. To interpret/hold W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 80 of 83
otherwise would tantamount to extending the application of the PNDT Act
to persons and places for whom/which it was not intended. We find merit in
the contention of petitioners that ultrasound as a diagnostic tool has
application for procedures other than pre-natal also and requiring places
having ultrasound machines „capable of‟ determining sex but not intended
and used for prenatal diagnostic procedure to also comply with requirements
of a genetic clinic serves no purpose. We are afraid, it may raise cost of
medical treatment and put a unnecessary strain on doctor-patient
relationship. Supreme Court recently in Lal Shah Baba Dargah Trust Vs.
Magnum Developers MANU/SC/1437/2015 reiterated Mangin Vs. IRC
(1971) 1 All ER 179 (PC) laying down that the object of the construction of
a Statue being to ascertain the will of the legislature, it may be presumed
that neither injustice nor absurdity was intended – if therefore a literal
interpretation would produce such a result and the language admits of an
interpretation which would avoid it, then such an interpretation may be
adopted. We are of the view the language of the Act and the Rules permits
an interpretation, though making registration mandatory for possessing a
ultrasound or like machine „capable of‟ determining sex but not mandating
fulfilment of the provisions of the Act and the Rules for use thereof for W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 81 of 83
prenatal diagnostic procedures, if not used therefor.
97. We, in this respect concur with the view aforesaid of the High Courts
of Bombay, Kerala and Punjab and Haryana and adopt the same.
98. We accordingly dispose of these petitions with the following
declarations / directions:
(i) 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;
(ii) 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;
(iii) However, if the person seeking registration (a) makes a
declaration in the form to be prescribed by the Central W.P.(C) Nos.6968/2011, 2721/2014 & 3184/2014 Page 82 of 83
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;
(iv) 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;
(v) 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; and,
(vi) 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.
No costs.
RAJIV SAHAI ENDLAW, J.
CHIEF JUSTICE
FEBRUARY 17, 2016
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