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Karnataka High Court

Dr Smt Subhalakshmi N vs State By District Appropriate ... on 9 August, 2024

Author: M.Nagaprasanna

Bench: M.Nagaprasanna

                           1



Reserved on   : 30.07.2024
Pronounced on : 09.08.2024                             R
       IN THE HIGH COURT OF KARNATAKA AT BENGALURU

         DATED THIS THE 09TH DAY OF AUGUST, 2024

                           BEFORE

         THE HON'BLE MR. JUSTICE M. NAGAPRASANNA

            CRIMINAL PETITION No.3002 OF 2024
BETWEEN:

1 . DR. SMT. SUBHALAKSHMI N.,
    W/O MANIYAN NARAYANAN
    AGED ABOUT 39 YEARS
    RESIDING AT NO.22
    KHATA NO. 862, 2ND CROSS
    ABBAIAH REDDY LAYOUT
    PROPRIETOR
    MEDIZONE MEDICAL CENTRE
    KAGGADASAPURA
    BENGALURU - 560 093.

2 . DR. MOSCOW MANI SA
    S/O SOMASUNDARAM S.,
    AGED ABOUT 46 YEARS
    RESIDING AT NO. 77,
    4TH MAIN ROAD
    VIVEKANAGAR
    FURTHER EXTENSION
    BENGALURU - 560 047.
                                           ... PETITIONERS
(BY SRI PRAVEEN S., ADVOCATE)
                            2



AND:

1.   STATE BY
     DISTRICT APPROPRIATE AUTHORITY (DAA)
     PC AND PNDT DISTRICT HEALTH AND
     FAMILY WELFARE OFFICE
     BANGALORE URBAN DISTRICT
     REPRESENTED BY SPP
     HIGH COURT OF KARNATAKA
     BENGALURU - 560 001.

2.   DR. RAVINDRANATH M.METI
     AGED ABOUT 50 YEARS
     DISTRICT HEALTH AND
     FAMILY WELFARE OFFICER
     BENGALURU URBAN DISTRICT.
                                            ... RESPONDENTS

(BY SRI B.N.JAGADEESH, ADDL. SPP)


     THIS CRIMINAL PETITION IS FILED UNDER SECTION 482 OF
CR.P.C., PRAYING TO QUASH THE CASE AND PROCEEDINGS
AGAINST THE PETITIONERS IN C.C.NO.1938/2024 IN PCR
NO.2/2024 FOR ALLEGED OFFENCES P/U/S 23, 23(1)(2),
20(1)(2)(3) OF PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC
TECHNIQUES (PROHIBITION OF SEX SELECTION) ACT, 1994,
PENDING ON THE FILE OF HONBLE MMTC-1, MAYOHALL,
BANGALORE.


     THIS CRIMINAL PETITION HAVING BEEN HEARD AND
RESERVED FOR ORDERS ON 30.07.2024, COMING ON FOR
PRONOUNCEMENT THIS DAY, THE COURT MADE THE FOLLOWING:-


CORAM:   THE HON'BLE MR JUSTICE M.NAGAPRASANNA
                                 3



                            CAV ORDER


      The petitioners, both doctors, are before this Court calling in

question proceedings in C.C.No.1938 of 2024 pending before the

Metropolitan Magistrate, Traffic Court-I, Mayo Hall, Bangalore,

pursuant to a complaint initiated by the 1st respondent under

Section 200 of the Cr.P.C., alleging offences under Sections 20(1),

(2), (3) and 23(1) and (2) of the Pre-conception and Pre-natal

Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 ('the

Act' for short).



      2. Facts, in brief, germane are as follows:-


      Both the petitioners are doctors.     The 1st petitioner is the

proprietor of the Diagnostic Centre in the name and style of

'Medizone Medical Centre' (the Centre' for short). The 2nd petitioner

is a certified registered operator of the ultrasound machine at the

Diagnostic Centre. It is the averment in the petition that the

ultrasound diagnostic procedures are conducted at the centre

between 10.30 a.m. and 11.30 a.m. and between 6.00 p.m. and

7.00 p.m. on the prescription of doctors who direct a test to be
                                  4



conducted upon the patients. When things stood thus, the 1st

respondent/Appropriate Authority under the Act, on receipt of

certain information, conduct an inspection at 4.00 p.m. on

08-12-2023 at the Centre.       At that time, it was found that the

ultrasound room, which was situated opposite the reception

counter, was open and in active mode. It is said that the lab

technician have admitted that scanning was done in the Centre.

The medical centre is closed, the scanning machine is locked. The

result of conduct of inspection and seizure of materials is filing of a

complaint before the jurisdictional Magistrate invoking Section 200

of the Cr.P.C., read with Section 28 of the Act, by registering a

crime for offences punishable as afore-quoted. The registration of

criminal case and issuance of summons is what has driven the

petitioners to this Court in the subject petition.



      3. Heard Sri S. Praveen, learned counsel appearing for the

petitioners and Sri B.N. Jagadeesh, learned Additional State Public

Prosecutor appearing for the respondents.
                                5



      4. The learned counsel appearing for the petitioners would

vehemently contend that inspection of the Centre is conducted at

4.00 p.m. when no records were displayed. The bone of contention

is that signatures of 4 patients on Form-F were missing.      Those

signatures were taken in the register.   It is not that the scanning

was done without prescriptions from respective doctors.         The

information that is filled in Form-F clearly indicates that it is

pursuant to prescriptions from doctors. The duration of pregnancy

is also indicated. He would admit that signatures of concerned

patients were not taken on the form, but they were taken in the

register. Based upon the inspection, a notice comes to be issued on

08-12-2023. The notice seeks the petitioners to reply as to why

registration should not be suspended, but on the same day seizure,

closure and locking of the scanning machine had happened.

Therefore, it was a post-decisional hearing. He would like to place

reliance upon certain guidelines issued by Government of India, in

the Ministry of Health and Family Welfare, to buttress his

submission qua the procedure adopted by the respondent in

registering and continuing with the criminal case.
                                6



     5. Per contra, the learned Additional State Public Prosecutor

would vehemently refute the submissions to contend that taking of

signatures in Form-F is mandated under the statute. It cannot be

that the patients would not sign on the document and scanning is

done. It is, therefore, necessary for the petitioners to explain or

face proceedings for having conducted the scanning without the

consent of patients. He would submit that guidelines so issued by

Government of India are adopted by the State and no separate

guidelines are notified by the State Government. He would further

contend that the petitioners should come out clean in the trial, as

they have admittedly undertaken the exercise of conducting

ultrasound scanning to determine sex of the fetus.



     6. I have given my anxious consideration to the submissions

made by the respective learned counsel and have perused the

material on record.



     7. The afore-narrated facts are not in dispute. The issue, at

this juncture, lies in a narrow compass. The 1st respondent is said

to be the Appropriate Authority under the Act to check violations of
                                    7



the Act and regulate functioning of the diagnostic centres. The

petitioners are respectively the proprietor and certified operator of

the ultrasound machine in the diagnostic centre. The diagnostic

centre of the petitioners is inspected by the 1st respondent at 4.00

p.m. on 08-12-2023 and found several irregularities in the

functioning of the Centre. The moment irregularities are found, a

complaint comes to be registered invoking Section 28 of the Act.

Since the entire issue has now sprung from the complaint, the

complaint is necessary to be noticed. It reads as follows:

                                  "....    ....    ....

             3. It is further submitted that complainant is a officer of
      Government having designation as the District Health and
      Family Welfare Officer at Bengaluru urban District, Reporting
      Letter and CTC document are herewith produce, visited with
      power given by the District Appropriate Authority under PC &
      PNDT Act under Sec.17A and 28 of the Pre-Conception and
      pre-Natal Diagnostic Techniques (Prohibition of Sex Selection)
      Act, 1994, read with Rules 18A(1)(V) of the PC & PNDT Rules,
      1996. The Delegation of power for filing of this case Delegation
      of power for authorize to inspect Dr. Ravindranath M.Meti, PC
      & PNDT the same is hereby produced for the kind perusal of
      this Hon'ble Court and marked as Annexure 'A' and 'B'.

            4. The complainant states that it is the duty of the
      Appropriate Authorities to implement the act as per Rules 12
      and to take action against all bodies upon violation of the Act
      and also against persons who have appointed/ allowed a
      person to operate without a valid qualification as mentioned in
      the Act or involved in sex selection/ determination of sex of
      the same to anyone else, as they are amount to violation of
      Act u/Sec.3A, 4, 5, 6, 29 and 30.
                             8



      5. The complainant further submits that on 08-12-2023
the District Appropriate Authority & District Inspection and
monitoring Committee visited MEDIZONE MEDICAL CENTRE,
No.22, 2nd Cross, Abhayareddy, Kaggadasapur, Bengaluru-560
093 comprising of Dr. Ravindranath M.Meti, DHO, Delegated
as DAA, Dr. NadeemAhamad, FWO, Dr. Leela Government
Radiologist, Mr. Narayana R (Case Worker PCPNDT) Bengaluru
Urban, on 08-12-2023 Friday about 4.00 p.m. The
complainant have produced panchanama hereby produced for
the kind perusal of this Hon'ble Court and marked as
Annexure-C.

      6. The DAA & DIMC, Team has inspected MEDIZONE
MEDICAL CENTRE Kaggadasapura, Bangalore and checked the
relevant registers and Form F etc., under the provision of said
Act and Rule on arrival at the premises the DIMC found that.

      7. The Ultrasound room is located opposite to the
Reception. The ultrasound room was open when team visited
the Centre and the USG machine was in the active mode.
Mis/Mrs Jenifer & Karthik (Lab Tech.) accepted that scanning
was done without generating Form F as per the PC and PNDT
Act.

       8. The USG machine present in the Diagnostics Centre
was Wipro GeVoluson P8 BT16, with serial No.VP8002800 with
single curvilinear probe.

       9. On inspection of the machine, it was found that no
images and patient details were not found and it was not store
in any media, including the USG machine.

        10. On inspection of Form B (Certificate of Registration)
1 USG machines were found with following details, Wipro
GeVoluson P8 BT16, with serial No.VP8002800 machine was
available in the Diagnostic Centre premises and staff were
unable to provide referral slips & Form-F (1) Images, Patient
Bill, Referral slips are hereby marked as Annexure-D.

      11. The complainant submits that -

      a)     The signature of the Patient was not found in
             the Form-F
                             9



            i)     The patient Signature was not found in Form-F
                   name of the patients Neelam aged: 31 years
                   Dated 13-11-2023, Ayesha aged 24 years,
                   Dated: 26-11-2023; Rashmitha aged 31 years
                   Dated 26-11-2023; Ramani aged 30 years Dated
                   27-11-2023

            The same is hereby produced for kind perusal of this
            Hon'ble Court and marked as Annexures E, F, G, H.



      b)    It is further submitted that, the complainant
            respectfully prays that this Hon'ble Court may
            kindly be pleased to permit to produce that seized
            documents before this Hon'ble Court other notice
            and Letter given by the complainant to the
            Centre. The same is hereby produced for kind
            perusal of this Hon'ble Court and marked as
            Annexure-I & J.

      c)    The complainant further submits that after
            inspecting    and   examining    the    ultrasound
            machine, District Appropriate Authority found that
            these major violations of the PCPNDT Act, that all
            the relevant records be seized and sealed.

      d)    The cause of action arose in Bangalore Urban
            Baiyappanahlli Police Station Limits. Hence, this
            Court has got jurisdiction to try this matter.

      12. It is for the submitted that, the complainant being
the Appropriate Authority file this complaint against the
accused without any mala-fide intention and misuse of power.

                       PRAYER:

      Wherefore, it is respectfully prays that this Hon'ble
Court may kindly be pleased to take cognizance non-bailable
offence punishable under Section 23, 23(1), 23(2), 20(1),
20(2), 20(3) and other relevant Sections of PC & PNDT Act and
other relevant applicable sections under IPC and secure the
accused person and punish him for having committed the said
offences, as per law, in the interest of justice."
                                   10



The complaint results in invocation of offences under Sections

20(1), (2), (3) and 23(1) and (2) of the Act.          It is necessary to

notice those provisions. Sections 20 and 23 of the Act read as

follows:

             "20. Cancellation or suspension of registration.--(1)
      The Appropriate Authority may suo motu, or on complaint, issue
      a notice to the Genetic Counselling Centre, Genetic Laboratory
      or Genetic Clinic to show cause why its registration should not
      be suspended or cancelled for the reasons mentioned in the
      notice.

            (2) If, after giving a reasonable opportunity of being
      heard to the Genetic Counselling Centre, Genetic Laboratory or
      Genetic Clinic and having regard to the advise of the Advisory
      Committee, the Appropriate Authority is satisfied that there has
      been a breach of the provisions of this Act or the rules, it may,
      without prejudice to any criminal action that it may take against
      such Centre, Laboratory or Clinic, suspend its registration for
      such period as it may think fit or cancel its registration, as the
      case may be.

             (3) Notwithstanding anything contained in sub-sections
      (1) and (2), if the Appropriate Authority is of the opinion that it
      is necessary or expedient so to do in the public interest, it may,
      for reasons to be recorded in writing, suspend the registration of
      any Genetic Counselling Centre, Genetic Laboratory or Genetic
      Clinic without issuing any such notice referred to in sub-section
      (1).
             ...                  ...                   ...

             23. Offences and penalties.--(1) Any medical
      geneticist, gynaecologist, registered medical practitioner or any
      person who owns a Genetic Counselling Centre, a Genetic
      Laboratory or a Genetic Clinic or is employed in such a Centre,
      Laboratory or Clinic and renders his professional or technical
      services to or at such a Centre, Laboratory or Clinic, whether on
      an honorary basis or otherwise, and who contravenes any of the
      provisions of this Act or rules made thereunder shall be
                                 11



     punishable with imprisonment for a term which may extend to
     three years and with fine which may extend to ten thousand
     rupees and on any subsequent conviction, with imprisonment
     which may extend to five years and with fine which may extend
     to fifty thousand rupees.

            (2) The name of the registered medical practitioner shall
     be reported by the Appropriate Authority to the State Medical
     Council concerned for taking necessary action including
     suspension of the registration if the charges are framed by the
     court and till the case is disposed of and on conviction for
     removal of his name from the register of the Council for a period
     of five years for the first offence and permanently for the
     subsequent offence.

            (3) Any person who seeks the aid of any Genetic
     Counselling Centre, Genetic Laboratory, Genetic Clinic or
     ultrasound clinic or imaging clinic or of a medical geneticist,
     gynaecologist, sonologist or imaging specialist or registered
     medical practitioner or any other person for sex selection or for
     conducting pre-natal diagnostic techniques on any pregnant
     women for the purposes other than those specified in sub-
     section (2) of Section 4, he shall be punishable with
     imprisonment for a term which may extend to three years and
     with fine which may extend to fifty thousand rupees for the first
     offence and for any subsequent offence with imprisonment
     which may extend to five years and with fine which may extend
     to one lakh rupees.

           (4) For the removal of doubts, it is hereby provided that
     the provisions of sub-section (3) shall not apply to the woman
     who was compelled to undergo such diagnostic techniques or
     such selection."


Section 20 which deals with cancellation of registration and

empowers the Appropriate Authority to issue a notice to any

diagnostic centre to show cause as to why its registration should

not be suspended or cancelled for reasons mentioned in the notice.
                                 12



After giving a reasonable opportunity of being heard, if the

Authority concerned is satisfied that there has been breach of the

provisions of the Act, it may initiate criminal action against the

Centre, suspend its registration for a period it may think fit or

cancel its registration for reasons to be recorded in writing. Section

23 which deals with offences and penalties makes any person who

would contravene the provisions of the Act to undergo punishment

stipulated therein.



      8. The Act is notified for the purpose of prohibition of sex

selection before or after conception and for regulation of pre-natal

diagnostic techniques to abolish this crude of female foeticide.

Therefore, two factors would emerge from the present proceedings

- the first being, that the diagnostic centre must be involved in

activities which would contravene the provisions of the Act, the

foundation of which is determination of sex and the other being,

prior to cancellation or suspension of registration, a reasonable

opportunity should be granted to the person whose registration is

sought to be suspended or cancelled. It is not in dispute that the 1st

respondent is the Appropriate Authority empowered to conduct
                                                    13



inspection in terms of Rule 18 of the Rules framed under the Act.

The diagnostic centre is inspected on 08-12-2023. The inspection

panchanama is drawn thereto. It reads as follows:

                                                  "¸ÀܼÀ ¥ÀAZÀ£ÁªÉÄ
       qÁ|| gÀ«ÃAzÀæ£Áxï JA.ªÉÄÃn DzÀ £Á£ÀÄ ¨ÉAUÀ¼ÀÆgÀÄ £ÀUÀgÀ f¯Éè ¨ÉAUÀ¼ÀÆgÀÄ ¥ÀƪÀð
       vÁ®ÆèPÀÄ, ¦.¹.&¦.J£ï.r.n. PÁAiÉÄÝAiÀÄ ¸ÉPÀë£ï 17(J), ¸ÉPÀë£ï 18 J(A) ªÀÄvÀÄÛ ¸ÉPÀë£ï 30 gÀAvÉ
       f¯Áè ¸ÀPÀëªÀÄ ¥Áæ¢üPÁgÀ ¥ÀævÁåAiÉÆÃf¹zÀ C¢üPÁjzÀ ªÉÄÃgÀUÉ ¢£ÁAPÀ:...gÀAzÀÄ ¨É½UÉÎ / ªÀÄzsÁåºßÀ
       / ¸ÀAeÉ 4 UÀAmÉUÉ MEDIZONE MEDICAL CENTRE Kaggadasapura,
       Bengaluru Urban District ¸ÁÌöå¤AUï ¸ÉAlgï / ¯Áå¨ÉÆÃgÉÃlj / Qè¤Pï / D¸ÀàvæU                 É É
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       / ¤AiÀĪÀÄUÀ¼À£ÀÄß G®èAX¹gÀÄvÀÛzÉ.

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1.   Ultra sound scanning              AiÀÄAvÀæ          5.
wipro Ge Voluson P8BT16 S/N
VP8002800
2. Form - F"                                             6.
3.                                                       7.
4.                                                       8.



What forms crux of the complaint is that signatures of patients were

not found in Form-F.                   Four patients are named.                         These four

patients' details are appended to the petition. The first patient is
                                14



one Neelam, aged 31 years who gets scanning done of the

pregnancy pursuant to a prescription by a doctor - Dr. Shoba

Venkat. The pregnancy is said to be of eight weeks. The next

patient is one Ayesha aged 24 years.     The prescription is by one

doctor - Dr. Asha. The pregnancy is said to be of 5 weeks. The

third patient is one Rashmita, aged 31 years, again referred by the

same Dr.Asha. Pregnancy is said to be of six weeks. The fourth

patient is one Ramani, aged 30 years referred by one Dr. Maya

V.V., The pregnancy is of 9 weeks. It is ununderstandable as to

how between five weeks and nine weeks of pregnancy the

determination of sex of the fetus can happen. It is in public domain

that sex of the fetus can be determined only after 12 to 14 weeks.

Therefore, what was carried out in the diagnostic centre was only

normal general routine pregnancy test on prescription of doctors.



     9. It is an admitted fact that forms which contained details of

the patients did not contain signatures of the patients.   It is the

contention of the learned counsel appearing for the petitioners that

those signatures are in the register.   The register and all other

documents are said to have been seized. The Additional Special
                                               15



Public Prosecutor would contend that there was no register

maintained for getting the signatures, as there is no seizure

undertaken of the register being maintained also. While the

complaint contends that there were no images in the scanning unit,

but the images are taken and seized. Though it becomes a matter

of documentation or evidence that signatures are found in the

register or otherwise, what merits consideration of the petition

notwithstanding absence of signatures is the notice that is issued.

The notice is issued on 08-12-2023. It reads as follows:


                                           " "£ÉÆÃnøï"

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                                                         ***
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                                       16




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                                            17



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The notice notices several lacunae in the maintenance of the unit.

It gives an opportunity to the petitioners to reply as to why the
                                18



registration should not be cancelled or suspended within seven days

from the date of receipt of the notice.      The registration stood

suspended on the day of the notice itself. Therefore, no time was

granted to these petitioners to submit reply to the so called show

cause notice.



     10. The learned Additional Special Public Prosecutor submits

that a show cause notice is to be issued to the petitioners and

accordingly it has been issued. There are serious lacunae in the

maintenance of diagnostic centre. If leniency is shown to these

petitioners, they would indulge in the tests of sex determination as

well as the State is on a serious look out of checking sex

determination being done illegally resulting in female foeticide. The

object of the State is laudable, as it is imperative today to check

the growth of cases of female foeticide which happen due to

determination of sex at the diagnostic centres illegally. While that

cannot be brushed aside for implementation, without compliance

with the provisions of the Act, as every diagnostic centre cannot be

painted with the same brush.
                                   19



      11. Therefore, the notice that is given to any diagnostic

centre in terms of Section 20 of the Act, it should be in furtherance

of providing an opportunity to explain with regard to the violations

of the Act, failing which, the notice would become meaningless, or

an empty formality, as they are held guilty and criminal cases are

registered even before seeking an appropriate explanation. Any act

of this kind of not providing adequate opportunity would be in

blatant violation of principles of natural justice. It is this that merits

entertainment of petition notwithstanding signatures not being

found in the Form.      If it is found in the register, it was for the

petitioners to explain as to why it was not taken in the Form and

then the criminal case could be registered against these petitioners,

as law clearly indicates that if satisfactory reply is not given by

those laboratories only then a criminal case can be registered. The

procedure cannot be deviated in the wake of any rush to implement

the provisions of the Act.



      12. It now becomes germane to notice the guidelines issued

by Government of India, Ministry of Health and Family Welfare

publishing the standard operating guidelines of District Appropriate
                                   20



Authorities. I deem it appropriate to quote certain clauses of the

guidelines,   since   the   Additional    State      Public   Prosecutor   has

admitted that the State has adopted and is following the same

guidelines, though no document to that effect is produced before

the Court. The guidelines are issued under the Act. It varies from

Code of Conduct for the Appropriate Authorities under the Act;

Guidelines    for   inspection   of    facilities;    Search    and   Seizure

operations; Guidelines for filing criminal complaints and Indicative

Checklist for inspection of facilities under the Act. I deem it

appropriate to quote them. They read as follows:


"1. Code of Conduct for the Appropriate Authorities under the Act

      ......

      8) All the Appropriate Authorities including the State,
      District and Sub-district notified under the Act, Inter-alia,
      shall observe the following conduct for Inspection and
      monitoring, namely

         •    conduct regular inspection of all the registered
              facilities once in every ninety days and shall
              preserve the inspection report as documentary
              evidence and a copy of the same be handed over to
              the owner of facility inspected and obtain
              acknowledgement in respect of the inspection

         •    place all the inspection reports once in three months
              before the Advisory Committee for follow up action
                                21



   •   maintain bimonthly progress report containing number of
       cases filed and persons convicted, registration made,
       suspended or cancelled, medical licenses cancelled,
       suspended, inspections conducted, Advisory Committee
       meetings held at the district level and quarterly progress
       report at the State level


       (a) procure the copy of the charges framed within seven
       days and in the case of doctors, the details of the charges
       framed shall be submitted within seven days of the receipt
       of copy of charges framed to the State Medical Council

       (b) procure the certified copy of the order of conviction as
       soon as possible and in the case of conviction of the
       doctors, the certified copy of the order of conviction shall be
       submitted within seven days of the receipt of copy of the
       order of conviction."

          ...                         ...                     ...

5. Guidelines for inspection of facilities.

"....
Following things need to be examined during inspection of a
Centre (indicative list not exhaustive): [Also refer to the
indicative checklist for inspection of facilities at annex 6]

          •   Board is displayed prominently on its premises with
              text in English and the local language saying,
              'Disclosure of the sex of the foetus is
              prohibited under the law' [Rule 17 (1)]

          •   Copy of the Act and Rules available on premises
              (and to be made available to clientele on demand
              for perusal) [Rule 17 (2)]

          •   Registration Certificate displayed in a conspicuous
              place (near the machine) at the place of business
              [Rule 6(2)]
                                     22



             •   Name and designation of the person using the
                 equipment is to be displayed prominently on the
                 dress/coat worn by him/her [Rule 18 (viii)]

             •   Details to be checked in the Registration
                 application, certificate and other related documents
                 (as per Form B)

      i.         Validity of certificate of registration
      ii.        Name and educational qualifications of the persons
                 authorised to use the equipment or machine
      iii.       Information about the ultrasonography machine or
                 similar equipment such as number, make model
                 including probe/s

      iv.         Prenatal diagnostic procedures approved for the
                 centre

• Details to be checked in case of facilities with portable
machine/s(portable machine to be used for indoor patients or
as a part of the mobile medical unit or MMU)

      i.         Area of operation
      ii.        Number of portable machines installed and/or used
      iii.       Make and model of the portable machine/s
      iv.        Registration of the vehicle that is the mobile
                 medical unit in which the portable machine/s is
                 available. Confirm that the registration number of
                 the vehicle is the same as the one mentioned in
                 Form B (registration certificate)
      v.         Full address of the service providers
      vi.        Availability of other services mandated by the
                 PC&PNDT law in MMU.

  •   Review of the records at the centre/facility

      i. Review of Form 'F' (Genetic clinics/Ultrasonography
             centres) [Form F at annex 7]

      a.          All the relevant points in the F form are filled and the form
                 is duly signed by the Gynaecologist / Radiologist /
                 Registered Medical Practitioner performing the procedure
                 with his/her name, seal, number as per the Act
                                 23



      b.     Copy of the F form (including the complete information
             about the pregnant woman) is sent to the Appropriate
             Authority before the 5th (date) of every succeeding month

      c.     Declaration of the pregnant woman is obtained in the
             language she understands when non-invasive techniques
             such as ultrasonography have been used

      d.     Consent letter obtained from the pregnant woman in the
             language she understands, when invasive techniques such
             as Amniocentesis have been used

      e.     Declaration is submitted by the doctor/s with time and
             date

      f.     Referral records along with the copy of films of scans are
             maintained

      g.     OPD register along with the ANC register and cash receipts

      h.     Review computer records along with the hard copies of the
             records.

The Central Supervisory Board in the meeting held on 17th
October 2005 recommended developing mechanisms so that
form F can be filled/submitted online. Subsequently, some state
governments have made it mandatory to fill 'F' forms online. In
such cases, along with online filling of the forms, a hard copy of
each form must be maintained at the centre/facility along with
the signed declaration/consent letter (as the case may be) of
the pregnant woman and the declaration of the doctor.

       ii. Review of Form 'D' (Genetic Counselling centres) [Form D
at annex 8]

      a.   All relevant points are filled

      b. Forms have been submitted by the 5th (date) of every
         month to the Appropriate Authority [Rule 9 (8)]

      iii. Review of Form 'E' (Genetic Laboratories) [Form E at
annex 9]

      a.     All relevant points are filled

      b.     Consent obtained from the pregnant woman in Form 'G'
             [at annex 10]
                               24



     c.       Forms have been submitted by the 5th (date) of every
              month to the Appropriate Authority [Rule 9 (8)].

 •   Tally Form 'F' with the OPD Register [Rule 9 (1)] to
     ensure that there is no discrepancy In the number of
     patients examined and the total number of statutory
     forms filled

 •   After the inspection, if any lapses are found, the AA is
     expected to take necessary steps to address the violation
     [Section 30 read with Rule 12 (1)]

 •   Issue a show cause notice seeking explanation as to why
     registration    of   the    centre   should    not     be
     suspended/cancelled [Section 20 (1)]. Sample format for
     issuing a show cause notice can be found at Annex 11.
     Guidelines on suspension and cancellation of registration
     are at annex 12 [Please also refer to the key sections of
     the law pertaining to inspection and issuance of show
     cause notice in the box below]

 •   If applicable, as per Section 30. complete the legal
     procedure of search, and seize the Record and the
     Ultrasonography machine [Rule 12 (1)]

 •   File a case with the Judicial Magistrate First Class /
     metropolitan magistrate [Section 28]. Sample format for
     filing a case is at annex 13."
             ...                  ...              ...

6. Search & Seizure Operations.


     How to undertake search and seizure operations?

          •   Appropriate Authorities hold the right to enter
              and search at all reasonable times any
              Genetic Laboratory / Genetic Counselling
              Centre / Ultrasonography Centre which is
              suspected to have contravened the Act and
              examine all registers, documents, receipts,
              books,    pamphlets,     advertisements      or
              machines and other equipment, and seize and
                                25



               seal these, If the AA believes that these are
               likely to furnish evidence related to a
               commission of offence [Section 30 (1) and
               Rule 12]"

               ...                    ...                       ...

9. Guidelines for Filing a Criminal Complaint.

How to file a criminal complaint under the PCPNOT Act?

As per section 28 of PCPNDT Act the Appropriate Authorities are
authorised to file a criminal complaint in the Court of Judicial
Magistrate First Class/Metropolitan Magistrate. The process of
filing a complaint case has been divided into four segments:

A) Preparatory processes prior to filing a complaint case

B) Documents to be submitted or annexed with the complaint

C) Actual filing of the case

D) General instructions

A) Preparatory Processes

•   The Appropriate Authority or any person authorised by the
    Appropriate Authority may Inspect any centre. During
    inspection if the inspecting authority finds a violation of
    Provisions of the Act, they should mention all the violations
    of the Act and draw seizure memo/Panchnama with the help
    of Independent witnesses [Rule 12]

•   Panchnama should be drawn in the presence of Panchas.
    Witnesses are only to identify seized/witnessed by them

•   if the inspecting authority finds it necessary to seal and seize
    materials, including the machine and records, this should be
    done in accordance with the law. Inspecting authority should
    supply one copy of the list of sealed & seized objects and
    obtain an acknowledgement from the owner of the centre or
    a person authorised on his/her behalf [Section 30 Rule 12
    (3)]
                                26




•   AA should issue a showcause for violations found in
    the centre and call for explanation from the owner of
    the centre Explanation should un considered in the
    Advisory    Committee     and    recommendation    for
    cancellation/suspension of the registration of centre
    should be made to Appropriate Authority Appropriate
    Authority should suspend or cancel the registration of
    centre by providing reasons for the action taken

• If AA has reason to believe that the machine or any object
  may furnish evidence of the commission of an offence then
  they may seal the machine or other objects as well in such
  cases, the reason has to be recorded in writing for such
  action being necessary in the public interest and the
  registration of the centre should be suspended without giving
  any notice in the interest of law [Section 20 (3)]

•   In other cases (except in matters of public interest), white
    suspending registration the authority should issue a show
    cause notice and call for explanation in a stipulated time.

    The explanation should be put forth for consideration of the
    Advisory Committee for deciding

       a. Cancellation of registration of centre

       b. Initiation of Court proceeding as explanation provided in
          response to the show cause notice was not found
          satisfactory

•   If the owner of the centre or the facility or the sonologist,
    assistant/employee gives any confession admitting the
    offence, it should be properly recorded in writing and duly
    signed by the owner or the person authorised on his/her
    behalf. If this is not possible then the statement recorded by
    anybody on the scene needs to be read by the owner, and if
    that too is not possible (in case disease, III-health, illiteracy,
    etc.), the same should be read to him/her and explained and
    his/her signatures to be taken on it by mentioning that
    he/she has understood the contents of the statement after it
    was read to him/her and he/she has signed the it willfully,
                                27



   fully conscious of the content and without any coercion or
   undue influence. This will be helpful for proving the case.

   The inspecting authority should draw up a detailed report of
   the inspections with accurate date and time and place and
   preferably with a site plan.

B) Documents to be submitted or annexed with the
complaint:

[Pl also refer to the indicative checklist to ascertain
completeness of legal documentation for filing a Case at annex
17. Pl. note that documents are to be submitted in original as
mentioned in the checklist]

It is necessary to submit accurate and complete
documents in the Court of Law. The following list of
documents must be submitted

a. Notification of Appropriate Authority in Government Gazette should
   be submitted in original. (Section 17(1)

b. Authorisation letter by the Appropriate Authority in case of
   inspection by authority or person authorised by Appropriate
   Authority. The letter should contain date and specific area for
   inspection, preferably with a site plan

c. Inspection report with all seizure memos

d. Show cause notice issued by Appropriate Authority (Sec
   20(1)

e. Panchnama, seated and seized documents/objects(seizure memo)
   with the list

f. Statement of centre owner

g. Explanation of centre owner

h. Recommendation of Advisory Committee

i. Order of Suspension and/or cancellation of registration

j. Any other documents which are found during inspection.
                             28



C) Actual filing of the complaint:

The complaint must be filed by the Appropriate Authority or the
officer so authorised [Sample format for filing of the complaint
at is at Annex 13]

a. During filing of the case the Appropriate Authority should take
   all the papers to the legal expert and draft a complaint in
   consonance with the facts of the inspection

b. This procedure should be followed under the guidance of the
   legal   expert   who     is   member     in   the    Advisory
   Committee/Assistant     Public   Prosecutor/District   Public
   Prosecutor/Special Public Prosecutor as the case may be and
   documents vetted by the legal expert before filing of the
   complaint

c. All factual aspects should be narrated in the complaint and
   law should not be pleaded

d. All necessary people should be made an accused and proper
   addresses should be mentioned in the complaint

e. Proper process fee should be submitted in court after the
   summoning order is passed. All necessary legal fees and
   process fee to be paid from the account of PCPNDT

f. All original documents should be submitted. One copy of the
    documents should be kept with the Appropriate Authority
    and concerned lawyer/ Public Prosecutor before submission

g. Copy of the documents should be provided to the accused as
   and when directed by the court

h. Proper RCC (Registered Complaint Case) Number should be
   obtained with the help of superintendent of the Court and
   allotment of the case should be checked. Proper next date
   should be obtained. This date and Court name and court
   proceedings should also be mentioned in the file with the
   Appropriate Authority.
                                   29



      D) General instructions:

      a.    Witnesses and Panchas should be trustworthy and
           independent so that the risk of them turning hostile during
           the trial is minimised

      b. Date and time of inspection is crucial, hence it should be
         properly cited

      c. Ensure that all points of inspection have been covered during
          inspection. Use      checklist of    inspection  to   ensure
          completeness (Annex 6)

      d. Ensure that stipulated time is given to the owner of the
         centre or facility for providing explanation and order of
         cancellation or suspension should not be passed
         during this stipulated time.

                           ....           ....          ....."


               "Indicative Checklist for Inspection of Facilities
                     Under the PCPNDT Act, 1994

A. General Information:

Date and time of inspection:           Date:               Time:

Names/designation       of     the
inspecting authority or details of
team members, if applicable:

Name:


Designation:

Name:


Designation:

Name:
                                      30




Designation:

Name of the facility:

Name of the facility owner:

Type of facility (genetic clinic,
genetic counseling centre, genetic
laboratory, ultrasonography centre,
imaging facility and combinations if
any, pl. specify)

Address of the facility(Complete):


Telephone/mobile:


E-mail"




The guidelines would direct all the appropriate authorities including

the State and District notified under the Act inter alia to observe the

conduct that is indicated under the guidelines for inspection and

monitoring. They should conduct regular inspection of all the

registered facilities once in every 90 days and preserve the

inspection report as documentary evidence and copy of the same

should be handed over to the owner of the facility inspected and

obtain an acknowledgment in respect of the inspection. This is
                                 31



indicative of the fact that the functioning of both the authorities and

the diagnostic centres would be accountable for any violation of the

Act. Guideline No.5 which deals with inspection of facilities has

various checks and balances. The details to be checked in case of

facilities with portable machines have different parameters.       The

review of the records at a centre is also indicated in the guidelines.

Form-F which is a Form that is appended to the provisions of the

Act should be checked intermittently and all the relevant points in

the Form should be filled and the Form is duly signed by the

medical practitioner performing the procedure and the Form-F

should be sent to the Appropriate Authority before 5th of every

succeeding month and to be followed several other guidelines

supra.



      13.   Guideline    No.6    deals   with   search   and   seizure

operations. The Appropriate Authorities do hold a right to enter and

search any laboratory which is suspected to have contravened the

Act, examine all the registers, seize and seal if the Appropriate

Authority believes that these are likely to furnish evidence related

to the offence. Guideline No.9 deals with filing of criminal
                                  32



complaint.   It   depicts   certain   preparatory   process   that   the

Appropriate Authority should issue a show cause notice for the

violation found in the Centre and call for explanation from the

owner and the explanation should be considered in the advisory

committee and recommendation should be made for cancellation or

suspension of registration of the Centre by the Appropriate

Authority. It is only then a criminal complaint can be registered.

The documents that are to be annexed to the criminal complaint

also bear reference in the guidelines which includes a show cause

notice issued by the Appropriate Authority under Section 20 supra.

Statement of the owner, explanation of the centre/owner and

general instructions would be indicated.        The authority should

ensure that stipulated time is given to the owner of the facility to

provide explanation and then order cancellation or suspension but

during the stipulated time, no cancellation or suspension should

take place. The checklist for inspection of facilities is also quoted

supra.



     14.     That guidelines issued by Government of India are said

to have been adopted by the State. It appears to remain only in
                                  33



paper. None of the procedures which are stipulated in the guidelines

in furtherance of the Act are followed in the case at hand.         No

doubt, a show cause notice is issued to the petitioners on 08-12-

2023. By then, the seizure had already happened and suspension

had already taken place.    But, the notice is issued as to why the

registration should not be suspended. Therefore, it is for the State

to   henceforth   adhere   to   the   guidelines   quoted   supra   and

meaningfully bring about the violations of the Act.            Leaving

loopholes in law would only form a protective veneer to the

violators of the law, if any. The loopholes should not blur the intent

behind the enactment and the rigor of provisions of the Act.

Therefore, the afore-quoted guidelines shall be strictly adhered to,

by the Authorities, while conducting inspection and registration of

criminal cases.



      15. Swinging back to the case at hand, as observed

hereinabove, the notice that is rendered on 08-12-2023 is after the

seizure and cancellation of registration. Therefore, this is not in

consonance with Section 20 of the Act. If it is not in consonance, it

would tumble down for it being in violation of law. Therefore, the
                                     34



petitioners should be permitted to reply to the said notice and

further action be taken strictly in consonance with the guidelines

and the provisions of the Act.



      16. For the aforesaid reasons, the following:


                                   ORDER

(i) Criminal Petition is allowed.

(ii) Notice dated 08-12-2023 issued by the 1st respondent stands obliterated. All consequent actions including registration of criminal case also stand quashed.

(iii) The State shall issue notice within one week from the date of receipt of the copy of this order. The petitioners shall submit their reply within one week from the receipt of notice.

(iv) The State, thereafter, is at liberty to initiate action in strict consonance with Section 20 of the Act, if need 35 arises, after submission of reply or otherwise from the hands of the petitioners.

(v) The petitioners are entitled to all consequential benefits that would flow from the quashment of the notice and all actions thereto.

'

(vi) A copy of this order shall be transmitted to the Secretary, Health and Family Welfare, Government of Karnataka, for necessary compliance. Consequently, I.A.No.1 of 2024 also stands disposed.

Sd/-

(M. NAGAPRASANNA) JUDGE bkp CT:SS