UNION OF INDIA versus INDIAN RADIOLOGICAL AND IMAGING ASSOCIATION AND ORS. ETC. ETC. on 14 March 2018

O R D E R

1. We have heard learned counsel for the contesting parties andconsidered the written submissions tendered, for the purpose of evaluatingthe grant of interim relief.

2. In Voluntary Health Association of Punjab v Union ofIndia[1], this Court by a judgment dated 8 November 2016 issuedcomprehensive directions for the purpose of effective implementationof the provisions of the Pre-conception and Pre-natal DiagnosticTechniques (Prohibition of Sex Selection) Act, 1994[2]. The directionsissued by this Court are extracted below:

“33. Keeping in view the deliberations made from time totime and regard being had to the purpose of the Act andthe far reaching impact of the problem, we think itappropriate to issue the following directions in addition tothe directions issued in the earlier order:- (a) All the States and the Union Territories in India shall maintaina centralized database of civil registration records from allregistration units so that information can be made availablefrom the website regarding the number of boys and girls beingborn.

(b) The information that shall be displayed on the website shallcontain the birth information for each District, Municipality,Corporation or Gram Panchayat sothat a visual comparison ofboys and girls born can be immediately seen.

(c) The statutory authorities if not constituted as envisaged underthe Act shall be constituted forthwith and the competentauthorities shall take steps for there constitution of the statutorybodies so that they can become immediately functional afterexpiry of the term. That apart, they shall meet regularly sothat the provisions of the Act can be implemented in realityand the effectiveness of the legislation is felt and realized inthe society.

1Writ Petition (c) No. 349 of 2006

2PCPNDT Act

A

B

C

D

E

F

G

H

A(d) The provisions contained in Sections 22 and 23 shall be strictlyadhered to. Section 23(2) shall be duly complied with and itshall be reported by the authorities so that the State MedicalCouncil takes necessary action after the intimation is givenunder the said provision. The Appropriate Authorities who havebeen appointed under Section 17(1) and 17(2) shall be impartedBperiodical training to carry out the functions as required undervarious provisions of the Act.

(e) If there has been violation of any of the provisions of the Actor the Rules, proper action has to be taken by the authoritiesunder the Act so that the legally inapposite acts are immediatelyCcurbed.

(f) The Courts which deal with the complaints under the Act shallbe fast tracked and the concerned High Courts shall issueappropriate directions in that regard.

D(g) The judicial officers who are to deal with these cases underthe Act shall be periodically imparted training in the JudicialAcademies or Training Institutes, as the case may be, so thatthey can be sensitive and develop the requisite sensitivity asprojected in the objects and reasons of the Act and its variousprovisions and in view of the need of the society.E(h) The Director of Prosecution or, if the said post is not there, theLegal Remembrancer or the Law Secretary shall take stockof things with regard to the lodging of prosecution so that thepurpose of the Act is subserved.

(I) The Courts that deal with the complaints under the Act shallFdeal with the matters in promptitude and submit the quarterlyreport to the High Courts through the concerned Sessions andDistrict Judge.

(j) The learned Chief Justices of each of the High Courts in thecountry are requested to constitute a Committee of threeGJudges that can periodically oversee the progress of the cases.

(k) The awareness campaigns with regard to the provisions of theAct as well as the social awareness shall be undertaken as perthe direction No.9.8 in the order dated March 4,2013 passed inVoluntary Health Association of Punjab (supra).H

(l) The State Legal Services Authorities of the States shall giveemphasis on this campaign during the spread of legal aid andinvolve the para-legal volunteers.

(m) The Union of India and the States shall see to it that appropriatedirections are issued to the authorities of All India Radio andDoordarshan functioning in various States to give wide publicitypertaining to the saving of the girl child and the grave dangersthe society shall face because of female foeticide.

(n) All the appropriate authorities including the States and districtsnotified under the Act shall submit quarterly progress report tothe Government of India through the State Government andmaintain Form H for keeping the information of all registrationsreadily available as per sub-rule 6 of Rule 18A of the Rules.

(o) The States and Union Territories shall implement thePre-conceptionand Pre-natal Diagnostic Techniques(Prohibition of Sex Selection)(Six Months Training) Rules, 2014forthwith considering that the training provided therein isimperative for realising the objects and purpose of this Act.

(p) As the Union of India and some States framed incentiveschemes for the girl child, the States that have not framed suchschemes, may introduce suchschemes.”(Emphasis supplied)

3. The PCPNDT Act was enacted by Parliament, as itsPreamble indicates, to prohibit sex-selection, and to regulate pre-nataldiagnostic techniques so as to prevent their misuse for sexdetermination. The Preamble reads thus:

“An Act to provide for the regulation of the use of pre-nataldiagnostic techniques for the purpose of detecting genetic ormetabolic disorders or chromosomal abnormalities or certaincongenital malformations or sex linked disorders and for theprevention of the misuse of such techniques for the purpose ofpre-natal sex determination leading to female foeticide; and, formatters connected there with or incidental thereto.”

4. The intent of Parliament in enacting the law is clarified in theStatement of Objects and Reasons which accompanied the introductionof the Bill. Insofar as it is material to the present controversy, theStatement of Objects and Reasons reads thus:

A

B

C

D

E

F

G

H

A“Introduction:

B

C

In the recent past Pre-natal Diagnostic Centres sprang up in theurban areas of the country using pre-natal diagnostic techniquesfor determination of sex of the foetus. Such centres became verypopular and their growth was tremendous as the female child isnot welcomed with open arms in most of the Indian families. Theresult was that such centres became centres of female foeticide.Such abuse of the technique is against the female sex and affectsthe dignity and status of women. Various Organisation workingfor the welfare and uplift of the women raised their heads againstsuch an abuse.”

Statement of Objects and Reasons

D

It is proposed to prohibit pre-natal diagnostic techniques fordetermination of sex of the foetus leading to female foeticide.Such abuse of techniques is determination against the female sexand affects the dignity and status of women. A legislation isrequired to regulate the use of such techniques and to providedeterrent punishment to stop such inhuman act.

E

The Bill, inter alia provides for:-

(i) prohibition of the misuse of pre-natal diagnostic techniques fordetermination of sex of foetus, leading to female foeticide; F

(ii) prohibition of advertisement of pre-natal diagnostic techniquesfor detection or determination of sex;

(iii) permission and regulation of the use of pre-natal diagnostictechniques for the purpose of detection of specific geneticabnormalities or disorders;

(iv) permitting the use of such techniques only under certainGconditions by the registered institutions; and

(v) punishment for violation of the provisions of the proposedlegislation.

H

2. The Bill seeks to achieve the above objectives.”

5. The comprehensivedirections issued by this Court in its decisionin Voluntary Health Association of Punjab (Supra)must be read asintegral to the enforcement of a law which has been enacted byParliament to curb a grave social evil and to render the statutory provisionstruly effective to curb the mischief which was sought to be addressedby enacting the law. More specifically, in its judgmentdated 8 November 2016, this Court has required the states and theUnion territories to implement the Pre-conception and Pre-natalDiagnostic Techniques (Prohibition of Sex Selection) (Six MonthsTraining) Rules, 2014 forthwith. The decision explains that the provisionfor training required under the above subordinate legislation, is imperativeto realise the objects and purposes of the Act.

6. The impact of the directions which have been issued by thisCourt is negated by a judgment rendered by a Division Bench of theDelhi High Court on 17 February 2016 in a batch of cases includingIndian Radiological and Imaging Association (IRIA) v Union ofIndia[3], Indian Medical Association v Union of India[4 ]andSonological Society of India v Union of India[5].Before the Delhi HighCourt, there was a challenge to the provisions of Rule 3(3)(1)(b) of thePCPNDT Rules,1996 and Rule 6of the Six Months Training Rules asamended by a notification dated 9 January 2014. Rule 3.3(1)(b), whichwas in challenge reads as follows:

“3.3(1) Any person having adequate space and being oremploying….

(a) …

(b) …a Sonologist, Imaging Specialist, Radiologist or RegisteredMedical Practitioner having Post Graduate degree or diploma orsix 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.”

Rule 6 of the Pre-conception and Pre-natal Diagnostic Techniques(Prohibition of Sex Selection) (Six Months Training) Rules, 2014 is in thefollowing terms:

3Writ Petition (C) No. 6968 of 2011

4Writ Petition (C) No. 2721 of 2014

5Writ Petition (C) No. 3184 of 2014

A

B

C

D

E

F

G

H

A“6. Eligibility for training.-

(1) Any registered medical practitioner shall be eligible forundertaking the said six months training.

(2) The existing registered medical practitioners, who areBconducting ultrasound procedures in a Genetic Clinic orUltrasound Clinic or Imaging Centre on the basis of one yearexperience or six months training are exempted from undertakingthe said training provided they are able to qualify the competencybased assessment specified in Schedule II and in case of failureto clear the said competency based exam, they shall be requiredCto undertake the complete six months training, as provided underthese rules, for the purpose of renewal of registrations.”

Rule 6(2) provides for an exemption to existing registeredmedical practitioners conducting ultrasound procedures in a genetic orultrasound clinic or imaging centre subject to qualifying in theDcompetencybased assessment.

7. The Delhi High Court has inter alia held that it was unable tofind any provision in the PCPNDT Act empowering any of the bodiesconstituted under the law or even the Central government to prescribequalifications for practicing medicine with the aid of an ultrasoundEimaging equipment or to prescribe the nature and content of the curriculumor duration of the qualification. While disposing of the batch of writpetitions, the Delhi High Court has issued the following directions:

(i) “that Section 2(p) of the PNDT Act defining a Sonologist orImaging Specialist, is bad to the extent it includes personsFpossessing a postgraduate qualification in ultrasonography orimaging techniques – because there is no such qualificationrecognized by MCI and the PNDT Act does not empowerthe statutory bodies constituted thereunder or the CentralGovernment to devise and coin new qualification; G

(ii) We hold that all places including vehicles where ultrasoundmachine or imaging machine or scanner or other equipmentcapable of determining sex of the foetus or has the potentialof detection of sex during pregnancy or selection of sex beforeconception, require registration under the Act; H

(iii) However, if the person seeking registration (a) makes adeclaration in the form to be prescribed by the CentralSupervisory Board to the effect that the said machine orequipment is not intended for conducting pre-natal diagnosticprocedures; (b) gives an undertaking to not use or allow theuse of the same for pre-natal diagnostic procedures; and, (c)has a “silent observer” or any other equipment installed onthe ultrasound machines, as may be prescribed by the CentralSupervisory Board, capable of storing images of eachsonography tests done therewith, such person would beexempt from complying with the provisions of the Act andthe Rules with respect to Genetic Clinics, Genetic Laboratoryor Genetic Counselling Centres;

(iv) If however for any technical reasons, the Central SupervisoryBoard is of the view that such “silent observer” cannot beinstalled or would not serve the purpose, then the CentralSupervisory Board would prescribe other conditions whichsuch registrant would require to fulfil, to remain exempt asaforesaid;

(v) However, such registrants would otherwise remain bound bythe prohibitory and penal provisions of the Act and wouldfurther remain liable to give inspection of the “silent observer”or other such equipment and their places, from time to timeand in such manner as may be prescribed by the CentralSupervisory Board; and

(vi) Rule 3(3)(1)(b) of the PNDT Rules (as it stands after theamendment with effect from 9th January, 2014) is ultra viresthe PNDT Act to the extent it requires a person desirous ofsetting up a Genetic Clinic / Ultrasound Clinic / ImagingCentre to undergo six months training imparted in the mannerprescribed in the Six Months Training Rules.”

8. Prima facie, the High Court has erred in its finding that thereis an absence of statutory power. Sub-section 1 of Section 32 of thePCPNDT Act confers rule making power upon Central Government for“carrying out the provisions of the Act”. Illustratively, sub Section 2 ofSection 32 stipulates that the rules may provide for:

A

B

C

D

E

F

G

H

A“(i) the minimum qualifications for persons employed at aregistered Genetic Counselling Centre, Genetic Laboratory orGenetic Clinic under clause (1) of section 3.”

The above provision refers to minimum qualifications required ofpersons employed at registered genetic counselling centres, geneticBlaboratories or genetic clinicsunder Section 3(2). Hence, it would benecessary to understand the import of Section 3 which reads thus:

“3. Regulation of Genetic Counselling Centres, GeneticLaboratories and Genetic Clinics.- COn and from the commencement of this Act,—

(1) no Genetic Counselling Centre, Genetic Laboratory orGenetic Clinic unless registered under this Act, shall conduct orassociate with, or help in, conducting activities relating topre-natal diagnostic techniques; D

(2) no Genetic Counselling Centre, Genetic Laboratory orGenetic Clinic shall employ or cause to be employed any personwho does not possess the prescribed qualifications;

(3) no medical geneticist, gynaecologist, paediatrician, registeredmedical practitioner or any other person shall conduct or cause toEbe conducted or aid in conducting by himself or through any otherperson, any pre-natal diagnostic techniques at a place other thana place registered under this Act.”

The expression ‘genetic counselling centre’ has been defined inFSection 2(c) as follows:

“(c) “Genetic Counselling Centre” means an institute, hospital,nursing home or any place, by whatever name called, whichprovides for genetic counselling to patients”

The expression ‘genetic laboratory’ is defined in Section 2(e) asGfollows:

(e) “Genetic Laboratory” means a laboratory and includes a placewhere facilities are provided for conducting analysis or tests ofsamples received from Genetic Clinic for pre-natal diagnostic test”

H

The expression ‘genetic clinic’ is defined in Section 2(d) asfollows:

“(d) “Genetic Clinic” means a clinic, institute, hospital, nursinghome or any place, by whatever name called, which is used forconducting pre-natal diagnostic procedures”

Under Section 2(d), ‘genetic clinic’ is defined with reference tothe place which is used for conducting pre-natal diagnostic procedures.‘Genetic laboratory’ in Section 2(e) includes a place where facilities areprovided for conducting analysis or tests of samples received from agenetic clinic for a pre-natal diagnostic test.

The expression ‘pre-natal diagnostic procedures’ is defined inSection 2(i) as follows:

“(i) “pre-natal diagnostic procedures” means all gynaecologicalor obstetrical or medical procedures such as ultrasonographyfoetoscopy, taking or removing samples of amniotic fluid, chorionicvilli, blood or any tissue of a pregnant woman for being sent to aGenetic Laboratory or Genetic Clinic for conducting pre-nataldiagnostic test”

Both Sections 2(i) and Section 2(k) contain a specific referenceto ultrasonography. The expression ‘sonologist or imaging specialist’ isdefined in Section 2(p) as follows:

“(p) sonologist or imaging specialist” means a person whopossesses any one of the medical qualifications recognised underthe Indian Medical Council Act, 1956 (105 of 1956) or whopossesses a post-graduate qualification in ultrasonography orimaging techniques or radiology”

Section 4 provides thus:

“4. Regulation of pre-natal diagnostic techniques.- On and fromthe commencement of this Act,—

(1) no place including a registered Genetic Counselling Centre orGenetic Laboratory or Genetic Clinic shall be used or caused tobe used by any person for conducting pre-natal diagnostictechniques except for the purposes specified in clause (2) andafter satisfying any of the conditions specified in clause (3); A

B

C

D

E

F

G

H

A(2) no pre-natal diagnostic techniques shall be conducted exceptfor the purposes of detection of any of the following abnormalities,namely:—

(i) chromosomal abnormalities;

(ii) genetic metabolic diseases;

(iii) haemoglobinopathies;

B

(iv) sex-linked genetic diseases;

(v) congenital anomalies;

(vi) any other abnormalities or diseases as may be specifiedby the Central Supervisory Board; C[(3) no pre-natal diagnostic techniques shall be used or conductedunless the person qualified to do so is satisfied that any of thefollowing conditions are fulfilled, namely:—

(i) age of the pregnant woman is above thirty-five years;

(ii) the pregnant woman has undergone two or moreDspontaneous abortions or foetal loss;

(iii) the pregnant woman had been exposed to potentiallyteratogenic agents such as drugs, radiation, infection orchemicals;

(iv) the pregnant woman or her spouse has a family history ofEmental retardation or physical deformities such as, spasticityor any other genetic disease;

(v) any other condition as may be specified by the CentralSupervisory Board; Provided that the person conducting ultrasonography on a pregnantFwoman shall keep complete record thereof in the clinic in suchmanner, as may be prescribed, and any deficiency or inaccuracyfound therein shall amount to contravention of the provisions ofsection 5 or section 6 unless contrary is proved by the personconducting such ultrasonography;

(4) no person including a relative or husband of the pregnant womanGshall seek or encourage the conduct of any pre-natal diagnostictechniques on her except for the purpose specified in clause (2).

(5) no person including a relative or husband of a woman shallseek or encourage the conduct of any sex-selection technique onher or him or both.]”

H

Section 4(2) specifies exceptional situations in which a pre-nataldiagnostic test may be conducted to detect certain specifiedabnormalities. Section 4(3) provides that no pre-natal diagnostic test shallbe used or conducted unless the person qualifiedto do so, is satisfied forreasons to be recorded in writing that specific conditions (which havebeen laid down) are fulfilled. Section 5(2) contains a prohibition on thedisclosure to a pregnant woman or to a relative of the sex of the foetus.Section 6 contains a prohibition on the determination of sex and on sexselection.

9. Prima facie,these provisions indicate that Parliament hasconferred upon the Central government rule making authority to specifyminimum qualification for persons to be employed at genetic counsellingcentres, laboratories and clinics. Specification of qualifications, in ourview,should be read in a purposive sense which will fulfil the object ofthe law. Even on a plain and natural construction of the words used byParliament, specification of qualifications must necessarily comprehendthe power to prescribe training. The rationale for this is that the trainingwould sensitize the person concernedto the salutary object and purposeof the legislation which has been enacted by Parliament to deal with aserious social evil and be conscious of the misuse of sex-selection tests.Pre-natal diagnostic procedures are susceptible to grave misuse.

10. Parliament which has the unquestioned authority andlegislative competence to frame the law considered it necessary toempower the Central government to frame rules to govern thequalifications of persons employed in genetic counselling centres,laboratories and clinics. The wisdom of the legislature in adopting thepolicy cannot be substituted by the court in the exercise of the power ofjudicial review.Prima facie the judgment of the Delhi High Court hastrenched upon an area of legislative policy. Judicial review cannotextend to reappreciating the efficacy of a legislative policy adopted in alaw which has been enacted by the competent legislature. Both theIndian Medical Council Act, 1956 and the PCPNDT Act are enacted byParliament. Parliament has the legislative competence to do so. TheTraining Rules 2014 were made by the Central Government in exerciseof the power conferred by Parliament. Prima facie, the rules areneither ultra vires the parent legislation nor do they suffer frommanifest arbitrariness.

A

B

CD

EF

G

H

A11. For the reasons that we have indicated, we are of the viewthat the judgment of the Delhi High Court needs to be stayed during thependency of these proceedings. The judgment of the High Court squarelyimpinges upon the directions issued by this Court in Voluntary HealthAssociation of Punjab. We direct in consequence that the judgment ofthis Court in Voluntary Health Association of Punjab shall be strictlyBenforced by all states and union territories untrammelled by any order ofany High Court or any other court.

12. Pending final disposal, there shall be a stay of the operation ofthe judgment and order of the Delhi High Court dated 17 February 2016.The interlocutory applications are disposed of accordingly.

C

Kalpana K. Tripathy

IAs disposed of.

D

E

F

G

H