Sudha Hospitals Rep. by Managing Partner - Dr. K. Sudhakar vs The Director of Medical & Rural Health Services, Chennai & Others

Sudha Hospitals Rep. by Managing Partner - Dr.K.Sudhakar, 181, Perundurai Road, Erode 638011.

..Petitioner in the both the petitions

Vs.

1. The Director of Medical & Rural Health Services, No.258, DMS Complex, Anna Salai, Teynampet, Chennai 600 018.

..1st Respondent in the both the petitions

2. Joint Director of Health Services & District Enforcement Officer, The Tamil Nadu Clinical Establishments (Regulation) Act, Government Hospital, Erode 638011.

...2nd Respondent in WP.No.18572 of 2022

https://www.mhc.tn.gov.in/judis 1/25 W.P.No.18572 and 18573 of 2022 2. Joint Director of Health Services & District Appropriate Authority, PC & PNDT Act, 1994, Government Hospital, Erode 638011.

...2nd Respondent in WP.No.18573 of 2022

Prayer in WP.No.18572 of 2022:- This Writ Petition is filed under Article 226 of the Constitution of India, seeking for a Writ of Certiorari to call for the entire records of the respondents which culminated in the impugned order of the second respondent in Na.Ka.No.5698/S2/2022, dated 14.07.2022 under Sec.5(2) & 6(1) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and quash the same.

Prayer in WP.No.18573 of 2022:- This Writ Petition is filed under Article 226 of the Constitution of India, seeking for a Writ of Certiorari to call for the entire records of the respondents which culminated in the impugned order of the second respondent in Na.Ka.No.5698/S2/2022, dated 14.07.2022 under Sec.20(3) of Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 and quash the same as arbitrary, illegal and unsustainable and further direct the respondents to de-seal and handover all the 10 ultra sound scan machines which were functioning at the aforementioned 3 hospitals of the petitioner.

For Petitioner : Mr.A.L.Somayaji, Senior Counsel

for Mr.V.P.Sengottuvel

For Respondents : Mr.J.Ravindran, AAG

assisted by Mr.B.Vijay, AGP and

Mr.T.Seenivasan, Spl.G.P.

https://www.mhc.tn.gov.in/judis 2/25 W.P.No.18572 and 18573 of 2022

COMMON ORDER

These Writ Petitions have been filed challenging the impugned orders both dated 14.07.2022 passed under Section 20(3) of Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 and Section 5(2) & 6(1) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997. The following directions are passed under the impugned orders:- a) The petitioner's Registration as a Clinical Establishment has been suspended under the provisions of Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997. b) The petitioner Hospitals have been prohibited from admitting new patients. c) The petitioner Hospitals have been directed to discharge the existing patients within a period of two weeks. d) The petitioner's registration under the Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, has been ordered to be suspended by exercising powers under Section 20(3) of the said Act. e) The petitioner has been prohibited from scanning their https://www.mhc.tn.gov.in/judis 3/25 W.P.No.18572 and 18573 of 2022

patients by using their medical equipments in their

Hospitals.

WP.No.18572 of 2022 has been filed challenging the order passed under the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and WP.No.18573 of 2022 has been filed challenging the order passed under the Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.

2. The petitioner Hospitals claim that they are running three Hospitals for the past 35 years in the city of Erode and they have an unblemished track record. The impugned orders have been passed under the respective enactments making serious allegations against the petitioner Hospitals for the alleged violations committed by them in their Fertility Centre.

3. According to the respondents, as seen from the impugned orders, only based on the preliminary investigation and in public interest, the petitioner's registration under the two enactments has been suspended. https://www.mhc.tn.gov.in/judis 4/25 W.P.No.18572 and 18573 of 2022 4. The petitioner denies the contentions of the respondents under the impugned orders and has challenged the same on the following grounds:-

a) The impugned orders of the second respondent

in not allowing to admit any new patients in the Hospital and to discharge patients, who are undergoing treatment, directly affects the petitioner's right to carry on medical profession as guaranteed under Article 19(1)(g) of the Constitution of India. According to them, there is no provision conferred under the Act to issue such directions.

b) The impugned orders do not record the reasons

for the formation of opinion on the part of the second respondent for dispensing with the issuance of notice under Section 5(1-A) of the Act in public interest.

c) The second respondent, while issuing the

impugned orders, has to record the reasons for dispensing with the issuance of notice before suspension of registration and form an opinion on the basis of such valid reasons that it is necessary or expedient to do so. https://www.mhc.tn.gov.in/judis 5/25 W.P.No.18572 and 18573 of 2022

d) It is mandatory to give reasonable opportunity

of hearing under Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and the competent authority should be satisfied that there has been breach of any of the provisions of the Act or the Rules made thereunder or the conditions of registration while issuing the impugned orders, which are drastic in nature, affecting the fundamental rights of the petitioner guaranteed under the Constitution of India.

e) The impugned orders are liable to be set aside

on the ground of non-disclosure of reasons for passing the drastic impugned orders.

f) The impugned orders of the second respondent

passed under Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and Section 20(3) of Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, without assigning https://www.mhc.tn.gov.in/judis 6/25 W.P.No.18572 and 18573 of 2022 any reasons or violations alleged to have been committed by the petitioner herein, are unsustainable.

g) The respondents failed to see that the

registration of the license granted under Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, cannot be suspended or cancelled for any other reasons not falling within the scope of the said Act, and hence, the impugned orders are unsustainable.

h) The second respondent and the Committee

constituted by the first respondent, inspected the Fertility Centre at Door No.181, Perundurai Road, Erode during June 2022 and conducted investigation with respect to only 2 ultra sound scan machines. While that being so, the action initiated by the second respondent to seize and seal the ultra sound scan machines in the Multi Specialty Hospital and Mother and Child Care Centre, is wholly illegal.

i) The order of the second respondent suspending

the licenses of the petitioner herein for all its 10 Ultra Sound https://www.mhc.tn.gov.in/judis 7/25 W.P.No.18572 and 18573 of 2022 Scanning Machines functioning at its three Hospitals for unsustainable allegation made against the petitioner's Fertility Center is wholly illegal and unsustainable.

j) Directing the petitioner to submit their

explanation to the appropriate authority through the second respondent within a period of two weeks, is nothing but an eye wash, as the second respondent had already concluded in the impugned proceedings regarding non following of the procedures, pursuant to the enquiry report. Having pre- determined the issue, it is of no avail to direct the petitioner to submit an explanation.

k) The respondents committed an illegality of

seizing the Ultra sound scan machines functioning in all the 3 hospitals, without furnishing a copy of the inspection report submitted pursuant to the preliminary enquiry.

l) The second respondent failed to see that the

arbitrary action of seizing and sealing the ultra sound scan machines at the Multi Specialty Hospital and Mother and https://www.mhc.tn.gov.in/judis 8/25 W.P.No.18572 and 18573 of 2022 Child Care Centre, would cause serious medical complications leading to mortality and morbidity, as there are several critical inpatients in the ICU of the Multi Speciality Hospital and critical new born babies in NICU of Mother and Child Care Center, as they may require urgent Ultra sound examination.

5. A counter affidavit has been filed by the respondents questioning the maintainability of the Writ Petition on the ground that, being an appealable order, as per the statutory provisions of the respective enactments, the petitioner ought not to have filed these writ petitions, instead they ought to have filed statutory appeals under the provisions of the respective enactments.

6. According to the respondents, the illegalities and violations committed by the petitioner Hospitals are as follows: a) A leading Tamil News Daily on 03.06.2022 published a news item stating that an Ooctye was retrieved from a teenage girl by creating fake documents and adopting unethical medical practice. The serious abuse and misuse of https://www.mhc.tn.gov.in/judis 9/25 W.P.No.18572 and 18573 of 2022 license by the petitioner Hospital was telecasted in various news Channels across the State. A team was formed by the State Appropriate Authority to investigate the illegality committed by the petitioner Hospital in regard to ART procedure. The investigation conducted by the team has revealed startling facts of unethical medical practice of the petitioner Hospital for Oocyte retrieval.

b) The investigation team of the respondents has

noticed gross violation of the provisions of the Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 by the petitioner Hospital, for the procedures carried out on a teenage girl of 16 years from Soorampatti, Erode. The Inspector of Police, Erode has registered an FIR in Crime No.279 of 2022 against the parents of the teenage girl and broker (tout), who were involved in the illegal extraction of Ooctye from the under aged girl and the person, who had fabricated the Aadhar Card of the child for illegal Ooctye retrieval.

c) The victim minor girl with false identity of

https://www.mhc.tn.gov.in/judis 10/25 W.P.No.18572 and 18573 of 2022 Bhanu Mahalingam was stimulated for Ovulation at Sudha Hospital, Erode on 05.05.2022 for Ooctye retrieval. The Hospital Management had initially mentioned the age of the victim as 23 years in the case sheet and later it was manipulated as 27 years to escape from the clutches of law.

In order to prove the age of the victim girl, Aadhaar No.5641 6521 1544 was produced with no QR code and the back side of the Aadhaar had also not been verified by the counselor of the Hospital. Moreover, the copy of the Aadhaar submitted to the Hospital was not verified with the originals.

d) The Hospital Authorities were aware that the

Identity produced by the victim was fake. The victim was stimulated with harmone injection at M/s.Sudha Hospital, Erode and then, she was sent to Salem Branch Hospital for retrieval of 9 Ooctyes. The Ooctyes were retrieved from the victim by a team of Doctors (Dr.Lakshmi, OG & Dr.Janaki, MD, DA) on 17.05.2022. It is learnt that the retrieval of 9 Ooctyes were kept in frozen condition in M/s.Sudha Hospital at Salem. The retrieved Ovum was kept under https://www.mhc.tn.gov.in/judis 11/25 W.P.No.18572 and 18573 of 2022 frozen condition.

e) As per the Act, Hospital should obtain consent

from the donor woman and her husband for Ooctye retrieval.

However, examination of the Hospital records revealed that Consent Form contains victim signature alone. But the petitioner Hospital had proceeded with the procedures without obtaining consent from the husband of the donor.

f) The petitioner has violated the provisions of the

Assisted Reproductive Technology (Regulation) Act, which came into force on 25.01.2022.

g) According to the respondents, the age of the

Ooctye donor must not be less than 21 or more than 35 years. However, the victim being a minor girl, aged below 21 years, the Ooctye retrieval form her is not legally permissible, but the petitioner had violated the provisions of law. https://www.mhc.tn.gov.in/judis 12/25 W.P.No.18572 and 18573 of 2022 Apart from the above mentioned alleged violations, the respondents have also mentioned other ancillary violations committed by the petitioner in paragraph 18 of the counter affidavit.

7. With regard to the contention of the petitioner Hospital that the principles of natural justice have been violated and no opportunity of hearing was granted to the petitioner, the respondents have stated that since the petitioner has violated the ethical practice of Assisted Reproductive Technology (Regulation) Act and misused the privileges under that Act for pecuniary gains and only in the interest of public, on receiving complaints, the impugned orders have been passed, which according to them is legal. Further, according to respondents, since public interest is involved and to prevent the petitioner Hospitals from committing further violations, there was no necessity for the respondents to give an opportunity of hearing as they are legally entitled to pass the impugned order as per the proviso to Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and Section 20(3) of Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994. https://www.mhc.tn.gov.in/judis 13/25 W.P.No.18572 and 18573 of 2022 8. Mr.A.L.Somayaji, learned Senior Counsel appearing for Mr.V.P.Sengottuvel, learned counsel for the petitioner would reiterate the contentions mentioned in the affidavit filed in support of the Writ Petitions and would submit that as per both the enactments, opportunity of hearing ought to have been given to the petitioner before passing such drastic impugned orders.

9. Learned Senior Counsel drew attention of this Court to the respective impugned orders and would submit that the allegations made in the counter affidavit filed before this Court have not been disclosed in the said impugned orders and therefore the proviso to Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and Section 20(3) of Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 cannot be applied by the respondents and they cannot contend that no opportunity of hearing need be given to the petitioner and no reasons need to be given for passing the impugned orders. https://www.mhc.tn.gov.in/judis 14/25 W.P.No.18572 and 18573 of 2022 10. However, Mr.J.Ravindran, learned Additional Advocate General assisted by Mr.B.Vijay, learned Additional Government Pleader and Mr.T.Seenivasan, learned Special Government Pleader, appearing for the respondents would reiterate the contentions of the respondents found in their counter affidavit as extracted supra and submit that only based on several complaints received from the public, such a drastic action has been taken against the petitioner Hospitals as per the proviso to Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and Section 20(3) of Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.

11. After hearing the submissions of the learned Senior Counsel appearing for the petitioner and learned Additional Advocate General appearing for the respondents, this Court suggested to the learned Additional Advocate General as to whether the respondents will be agreeable to depute a panel of Doctors in the Government Service, who may be allowed to supervise the petitioner Hospitals and simultaneously grant an opportunity of hearing to the petitioner with regard to the serious allegations made against them in the counter affidavit, after impugned orders are quashed and remanded for fresh consideration. However, the https://www.mhc.tn.gov.in/judis 15/25 W.P.No.18572 and 18573 of 2022 same was flatly refused by the learned Additional Advocate General.

Learned Additional Advocate General further submitted that under the impugned orders, the petitioner has been given an opportunity to submit their explanation and therefore the petitioners right to defend the impugned action has not been defeated.

12. At the same time, it is also fairly admitted by the learned Additional Advocate General that there are no previous bad antecedents against the petitioner Hospitals except the present incidents.

13. Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and Section 20(3) of Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, under which the impugned orders are passed are extracted hereunder:-

The Tamil Nadu Clinical Establishments (Regulation) Act, 1997 "5.(1) Where the holder of a certificate of registration of a clinical establishment has been convicted under any of the provisions of this Act for three times in the aggregate, the

competent authority shall cancel the certificate of

registration and the clinical establishment shall not be

permitted to apply for fresh registration.

https://www.mhc.tn.gov.in/judis 16/25 W.P.No.18572 and 18573 of 2022 (1-A) The competent authority, may suo motu or on complaint issue a notice to any clinical establishment to show cause why its registration under this Act 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 clinical establishment, the competent authority is satisfied that there has been a breach of any of the provisions of this Act or the Rules made thereunder or the conditions of registration, it may, without prejudice to any other action that it may take against such clinical establishment suspend its registration for such period as it may think fit or cancel its registration.

Provided that where the competent 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 clinical establishment without issuing any notice."

The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 "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 https://www.mhc.tn.gov.in/judis 17/25 W.P.No.18572 and 18573 of 2022 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 advice 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)"

14. As seen from the above Sections under both the statutes, only under extraordinary circumstances in public interest, by reasons recorded in writing, suspension of registration under the the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and the Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, https://www.mhc.tn.gov.in/judis 18/25 W.P.No.18572 and 18573 of 2022 1994 is permissible without granting an opportunity of hearing to the petitioner. Both the aforementioned Sections make it clear that under normal circumstances, a reasonable opportunity of hearing has to be given and the competent authority must be satisfied that there is a breach of Act or Rules and only thereafter, the registration of an establishment under the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and the Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, can be suspended.

15. In the case on hand, the allegations levelled against the petitioner, which are reflected in the counter affidavit filed by the respondents, do not find a place in the impugned orders. They have also not been recorded in writing in the impugned orders. Mere bald allegations without recording specific instances of violations said to have been committed by the petitioner, is not sufficient. While exercising the power of suspension under the proviso of the respective sections under the respective enactments, the respondents must record in writing the specific instances of violations committed by the petitioner. But as seen from the impugned orders, the specific instances of violations have not been recorded in writing, which in the considered view of this Court, is https://www.mhc.tn.gov.in/judis 19/25 W.P.No.18572 and 18573 of 2022 mandatory. Only based on mere bald allegations and by merely stating that it is in public interest, the impugned orders have been passed by the respondents, which is unsustainable even if the respondents claim that the said orders have been passed only by exercising powers available to them as per the proviso to Section 5(2) of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and Section 20(3) of the Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.

16. The seizing and sealing of the ultra sound scan machines at the Multi Specialty Hospital and Mother and Child Care Centre of the petitioner would cause serious medical ramifications leading to mortality and morbidity, as there may be several critical inpatients in the ICU of the Multi Speciality Hospital and critical new born babies in NICU of Mother and Child Care Center, who may require urgent Ultra sound examination.

17. The petitioner has been running 3 Hospitals in the city of Erode for the past 35 years and they claim that they have an unblemished track record. Being an old Hospital, which has lasted for 35 years, several https://www.mhc.tn.gov.in/judis 20/25 W.P.No.18572 and 18573 of 2022 patients may be taking both outpatient and inpatient treatments and in some cases life saving operations may have to be performed on an emergency. Under the impugned orders, without granting an opportunity of hearing the petitioner has been directed not to admit new patients and they have also been directed to discharge the existing patients within a period of two weeks, without granting an opportunity of hearing to them, which in the considered view of this Court affects the petitioner's right to carry on medical profession as guaranteed under Article 19(1)(g) of the Constitution of India. Unless an opportunity of fair hearing was granted to the petitioner, the actual truth may not come out. There may be several news paper reports reporting instances of violations that is said to have taken place in the petitioner Hospitals. But that cannot be used as a piece of evidence, unless it is substantiated by oral and documentary evidence.

18. The drastic action taken against the petitioner under the impugned orders without affording any opportunity of hearing to the petitioner that too when the petitioner Hospitals are in existence for 35 years and have been giving treatment to several patients is unsustainable.

No specific instances of violations alleged to have been committed by the petitioner, is reflected in the impugned orders, though the respondents in https://www.mhc.tn.gov.in/judis 21/25 W.P.No.18572 and 18573 of 2022 the counter affidavit filed before this Court have given specific instances.

19. The respondents have also stated in the counter affidavit that the Writ petitions are not maintainable since alternative statutory appealable remedy is available to the petitioners under the respective enactments. However, the impugned orders are passed without affording an opportunity of hearing to the petitioner and when the proviso to the respective sections also makes it clear that the alleged violations committed by the petitioner have to be recorded in writing, the petitioner's right to approach this Court on the ground of violation of principles of natural justice, is certainly maintainable.

20. For the foregoing reasons, the impugned orders dated 14.07.2022 passed by the second respondent, are quashed and the matter is remanded back to the second respondent for fresh consideration on merits and in accordance with law. The second respondent is directed to pass final orders after affording a fair hearing to the petitioner including granting them the right of personal hearing and also permitting them to produce all necessary documents/records / witnesses, in support of their case, within a period of twelve weeks from the date of receipt of a https://www.mhc.tn.gov.in/judis 22/25 W.P.No.18572 and 18573 of 2022 copy of this order. The respondents are directed to de-seal the medical equipments which were sealed under the impugned orders, within a period of three days from the date of receipt of a copy of this order.

However, in public interest, the respondents are at liberty to depute a panel of Doctors during the period of the enquiry whenever they deem fit to do so to the petitioner Hospitals to supervise their functioning without causing disturbance to the patients and report any violations under the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 as well as the Pre Conception and Pre Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 to the competent authorities under the respective enactments.

21. With the aforesaid directions, the Writ Petitions are disposed of. No costs. Consequently, connected miscellaneous petitions are closed.

21.07.2022

Note : Issue order copy on 25.07.2022 Index : Yes/No Speaking order : Yes/No pvs/vsi2 https://www.mhc.tn.gov.in/judis 23/25 W.P.No.18572 and 18573 of 2022 To 1. The Director of Medical & Rural Health Services, No.258, DMS Complex, Anna Salai, Teynampet, Chennai 600 018.

2. The Joint Director of Health Services & District Enforcement Officer, The Tamil Nadu Clinical Establishments (Regulation) Act, Government Hospital, Erode 638011. https://www.mhc.tn.gov.in/judis 24/25 W.P.No.18572 and 18573 of 2022

ABDUL QUDDHOSE, J.

vsi2

W.P.No.18572 and 18573 of 2022

21.07.2022

https://www.mhc.tn.gov.in/judis 25/25