Another contention canvassed by the counsel for the petitioner that the impugned action suspending the licence of the diagnostic clinic of the petitioner for an indefinite period is impermissible which virtually amounts to cancellation of the licence of the Genetic Centre of the petitioner is also misconceived since the suspension of licence of the petitioner is only till decision in the criminal case is taken by the Criminal Court.
The observations made by the Full Bench as well as the Division Benches of this Court referred to hereinabove conclude all the challenges raised by the petitioner in the present petition. The observations made by the Division Bench in Malpani Infertility Clinic Pvt. Ltd. & others (supra) clearly show that the Division Bench in view of the fact that prosecution was launched against the petitioner in the said case, it was held to be sufficient reason for the authorities to take recourse to sub-section (3) of section 20 of the Act. In the instant case, the petitioner having admitted the existence of deficiency and inaccuracy in keeping and maintaining the record including Form `F' has resulted in contravention of the provisions contained in section 5 or 6 and, therefore, would amount to an offence and can be treated to be sufficient reason for the appropriate authority to invoke the provisions of sub-section (3) of section 20 of the Act in the larger public interest and, therefore, the action of suspension of registration of the Genetic Centre of the petitioner is sustainable in law till such time contrary is proved by the petitioner. Similarly, in the instant case also, the prosecution has been launched against the petitioner, though at a subsequent stage, which is pending before the competent criminal Court. The contentions canvassed by the learned counsel for the
2. The petitioner is challenging the legality and propriety of notice/order dated 21.6.2011 passed by the respondent no.3 and order dated 9.11.2011 passed by the respondent no.4. Similarly, a direction is sought against the respondent nos.2 and 3 to release and/or return to the petitioner sonography machine seized vide order dated 21.6.2011. SUBMISSIONS OF THE PETITIONER :
3. Mr.Thorat, the learned counsel for the petitioner, has submitted that the action of the respondent-authorities is wholly illegal, incorrect and, therefore, cannot be sustained in law. It is contended that the provisions of the proviso to sub-section (3) of section 4 of the Act require the Doctor to keep a record in the clinic as prescribed under the Rules, failing which it can be presumed that the provisions of sections 5 and 6 are contravened by such Doctor. It is submitted that before drawing presumption of contravention of section 5 or 6, opportunity must be given to the Doctor to disprove the said presumption as per the scheme of sub- section (3) of section 4 of the Act. The scheme of the Act, therefore, provides that before the said presumption is drawn, the Doctor conducting sonography on a pregnant woman is required to be given a chance to put 3/38
krs wp11059.11 forth his defence regarding maintenance of the record and it is only thereafter the authorities are entitled to consider whether there is a violation of section 5 or 6 of the Act. It is contended that if the appropriate authority is satisfied by the explanation of the Doctor, it may not be necessary to proceed against such Doctor by initiating criminal proceedings or take action of suspension of licence.
4. Mr.Thorat has contended that section 20 of the Act provides for cancellation or suspension of licence. Sub-section (1) of section 20 specially provides that the appropriate authority may suo motu or on complaint, issue a notice to the Genetic Clinic to show cause why its registration should not be suspended or cancelled. Sub-section (2) of section 20 further provides that after giving reasonable opportunity of being heard to the Genetic Clinic and having regard to the advice of the Advisory Committee, if the appropriate authority is satisfied that there has been a breach of the provisions of the Act or the Rules, it may, without prejudice to any criminal action that it may take against such Centre, Clinic or Laboratory suspend its registration for such period as it may think fit or cancel its registration, as the case may be. Mr.Thorat, therefore, contended that sub-sections (1) and (2) of section 20 4/38
krs wp11059.11 substantiates the contention canvassed by the petitioner that as per the scheme of the Act, it is necessary to first afford a reasonable opportunity of being heard to the Doctor and it is only thereafter action, if any, either of suspension or cancellation of licence can be taken.
5. The counsel for the petitioner has submitted that sub-section (3) of section 20 is an exception to the rule of giving reasonable opportunity of hearing to the Genetic Centre/Doctor provided as per sub-sections (1) and (2) of section 20. However, though the appropriate authority is vested with the emergency powers stipulated in sub-section (3) and can suspend the licence if it is necessary or expedient to do so in public interest, it must record reasons in writing and it is only thereafter, it is entitled to suspend the registration of any Genetic Counselling Centre, etc., without issuing such notice.
6. It is submitted that in the hand-book prepared and published by Union of India which is in the form of guidelines, it is stipulated that though the appropriate authority has a right to suspend the registration of Genetic Laboratory, Clinic or Centre, without issuing a notice, however, such power should be exercised as an exception rather than a rule and 5/38
krs wp11059.11 only when it is essential in the public interest to do so. In the instant case, the appropriate authority has not given or recorded any reason before suspending the licence or obtained advice of the Advisory Committee.
7. Mr.Thorat further submitted that the provisions of section 20 though empower the appropriate authority to suspend the registration, such suspension can only be for the specific period. Even otherwise, the term "suspension" denotes that the validity of the registration is put in abeyance for a temporary period and not for an indefinite period. In the instant case, the appropriate authority suspended the licence for an indefinite period which amounts to cancellation of the same which is not permissible in law.
8. Mr.Thorat has submitted that the scheme envisaged under the Act and the Rules made thereunder suggests two different actions and two different punishments. It prescribes strict compliance by the Doctor conducting ultrasound sonography on a pregnant woman to keep the record strictly as per the format provided. However, while maintaining the record, if some mistake is committed due to inadvertence which is not of a serious nature, it may not attract punishment of cancellation of 6/38
krs wp11059.11 licence and, therefore, under the provisions of the Act, lesser punishment of suspension of licence for a limited period for minor and/or clerical mistakes is provided. Similarly, for serious lapses committed by the Doctor in this regard, harsh punishment like cancellation of licence is also provided under the Act. It is contended that in many cases of similar type, the authority has suspended the licence for a limited period of one month or so in case of minor violations of the provisions of the Act. The counsel for the petitioner has contended that the appropriate authority in Navi Mumbai which has taken action against the petitioner has used different yardstick while taking action in respect of other Doctors who had committed similar lapses. It is contended that the appropriate authority in the case of Dr.Parulekar' Hospital situated at Airoli, Navi Mumbai, where similar allegations were made regarding not filling `F' form properly issued show cause notice dated 26.7.2011 to the said hospital asking it to show cause as to why action of suspension should not be taken. It is, therefore, submitted that the normal rule as per the scheme of the Act is to issue show cause notice before taking action of suspension and it is only in exceptional situation show cause notice contemplated under sub-sections of section 20 of the Act can be dispensed with and that too after recording reasons in writing. It is contended that in the instant 7/38
krs wp11059.11 case, the appropriate authority has not complied with the mandatory requirement prescribed under sub-section (3) of section 20 of the Act and, therefore, the impugned order is not sustainable in law. Even otherwise, the order of suspension which was issued by the appropriate authority for an indefinite period amounts to cancellation and the said action which is impermissible and, therefore, the same deserves to be quashed and set aside. In order to substantiate this contention, reliance is placed on the decision of a single Judge of this Court sitting at Aurangabad Bench in Writ Petition No.9573 of 2011 (Tirupati Diagnostic Centre v. The District Appropriate Authority @ Civil Surgeon, General Hospital Jalna) rendered on 22.3.2012.
9. Mr.Thorat further submitted that without prejudice to the above referred contention advanced by him, even if it is assumed that there was a breach of rule on the part of the petitioner and there is a power to suspend the licence under section 23 of the Act. In the instant case, the suspension of licence has taken place in June 2011 and is being continued for a more than one year. Since the appropriate authority does not have power of suspending the licence for an indefinite period, such action, therefore, is not sustainable in law and liable to be quashed and set aside. 8/38
krs wp11059.11 Similarly, since the licence can be suspended only for a limited period, ultrasound machine, therefore, can only be seized by the appropriate authority for a specific period only. It is submitted that if the order of suspension is unsustainable in law and is liable to be quashed and set aside, necessary consequence is that the appropriate authority must return ultrasound machine to the petitioner. It is submitted that when the ultrasound machine was attached and sealed, no indication was given to the petitioner that the appropriate authority was about to file a criminal case against the petitioner and, therefore, seizure of machine cannot be considered as a part of muddemal property and is required to be released.
10. It is contended that ultrasound machine is used only by two specialists i.e. Gynaecologist or Radiologist. Both these specialists are very busy in their respective professions and, therefore, they are required to rely upon their subordinate staff for up-keep of the clinic, laboratory, etc., including maintenance of record required as per the provisions of the Act. It is submitted that there is no nexus between the provisions of the Act and the object to be achieved by the Act. The object is to see that no professional should conduct sex determination test for the purpose of female foeticide and, therefore, harsh punishment like suspension, 9/38
krs wp11059.11 cancellation of licence and/or conviction is provided, whereas for committing minor violation or error in filling up the form and/or maintaining the record, awarding of such punishment is unreasonable, arbitrary and, therefore, violative of Article 14 of the Constitution of India.
11. Mr.Thorat has submitted that without prejudice to the legal submissions made by him, even on merit of the matter, it will be seen that there is no irregularity committed by the petitioner. At no point of time, the petitioner has admitted his guilt and solitary sentence in the Appeal Memo cannot be read in isolation to treat the same as admission of the petitioner of not keeping the record as per the Rules. It is submitted that rule 9 is the only rule which deals with maintenance and preservation of the record and it is nowhere stipulated in the said rule that it casts a duty of maintaining `F' register. It does not stipulate the manner in which the said register is required to be maintained by the Doctor. It is contended that for the mistake committed by the Doctor who has referred the patient, the blame cannot be put on the Radiologist and/or Gynaecologist. Mr.Thorat, therefore, contended that the action of the appropriate authority is wholly unwarranted, misconceived and liable to be quashed 10/38
krs wp11059.11 and set aside.
SUBMISSIONS OF THE RESPONDENT NO.3:
12. Mr.Marne, the learned counsel for the respondent no.3, has contended that the appropriate authority on noticing discrepancies as mentioned in the order of suspension thought it fit in larger public interest to exercise power under section 20(3) of the Act for ordering immediate suspension of registration. In the instant case, it is pertinent to note that there is no prejudice as such caused to the petitioner because of non- issuance of the show cause notice or for not granting hearing to the petitioner by the appropriate authority, since in the appeal filed by the petitioner before the appropriate authority, the petitioner has admitted the existence of discrepancies/irregularities mentioned in the suspension order. It is, therefore, contended that even if show cause notices would have been issued to the petitioner, beyond contending that the discrepancies are of minor nature committed by the petitioner by mistake, there was nothing that the petitioner could have stated in his defence.
13. Mr.Marne has contended that the Act nowhere makes it 11/38
krs wp11059.11 mandatory for the appropriate authority to obtain advice of the Advisory Committee. Under section 17(4)(a), the appropriate authority has wide powers to suspend or cancel without obtaining any advice. Under section 17(4)(i), the recommendations of the Advisory Committee are to be considered only if action is taken on the basis of the complaint. In the present case, the action is taken by the appropriate authority suo motu and not on any complaint and, therefore, it was not required to obtain advice of the Advisory Committee.
14. The learned counsel for the respondent no.3 has submitted that the contention canvassed by the petitioner that the appropriate authority has not recorded reasons is also not correct. In the order of suspension, the appropriate authority has recorded the reasons why it was suspending the registration. The petitioner has admitted the existence of the said discrepancies as mentioned in the order of suspension. Since the petitioner has admitted the existence of discrepancies mentioned in the order of suspension, the authorities were justified in exercising the power under section 20(3) of the Act. It is submitted that the petitioner having admitted the existence of the discrepancy, it is not open for the petitioner to state that reasons were not sufficient to take action of suspension of 12/38
krs wp11059.11 registration/licence. The learned counsel for the respondent no.3 further contended that the contention canvassed by the counsel for the petitioner that the order of suspension is for an indefinite period and, therefore, bad in law is also incorrect. The order of suspension of registration of the petitioner would continue till final decision of the criminal case/s lodged against the petitioner is taken by the competent criminal Court.
15. The counsel for the respondent no.3 has further submitted that the Act and or the Rules made thereunder nowhere stipulates two types of violations, major and minor ones. On the contrary, the proviso to sub- section (3) of section 4 raises an automatic presumption of contravention of the provisions of section 5 or section 6 of the Act in case of any deficiency or inaccuracy in keeping complete record as prescribed in the Rules. It is mandatory under rule 9 to maintain and preserve various records. Maintenance of record in Form `F' is a vital condition before subjecting a pregnant woman to ultrasonography test. In Form `F', it is mandatory for a pregnant woman to declare that she does not want to know the sex of her foetus. It is also mandatory for the Doctor to declare that while conducting ultrasonography/image scanning, he did not disclose sex of foetus in any manner. In the present case, there is an 13/38
krs wp11059.11 admitted violation of this condition and, therefore, by no stretch of imagination, it can be treated as a minor irregularity. It is submitted that if non-maintenance of record in Form `F' is permitted, it would open a door for Doctors to determine and disclose sex of foetus as there would be no record of tests performed on pregnant woman. In any case, it is for the criminal Court to consider and decide the nature of violation of the provisions of the Act and the Rules on the basis of evidence adduced by the parties. In the instant case, since the discrepancy about not maintaining complete record is admitted by the petitioner, the action of suspension is sustainable in law and it is open for the petitioner to prove that the petitioner did not determine the sex of the foetus nor disclosed about it to anyone. It is, therefore, contended that the action taken by the appropriate authority is sustainable in law and the petition is liable to be dismissed.
SUBMISSIONS OF THE RESPONDENT NO.5:
16. Mr.Sethna, the learned counsel for the respondent no.5, has contended that the petitioner seeks to challenge the impugned action taken by the appropriate authority, including that of suspension of its 14/38
krs wp11059.11 centre's licence mainly on three grounds which, according to the petitioner, is contrary to the mandate under section 20 of the Act which are as under:-
(i) no opportunity to show cause or being heard was given to the petitioner;
(ii) no approval of the Advisory Committee was obtained; and (iii) the suspension of licence was in complete violation of the principles of natural justice and, hence, contrary to section 20.
17. It is submitted that there is no violation whatsoever of any of the statutory provisions by the respondents as alleged. Section 20(3) is a non obstante provision. Therefore, independent and de hors to what is stated in sub-clauses (1) and (2) of section 20, the appropriate authority is duly and statutorily empowered to take appropriate action without issuing any notice referred to in section 20(1) provided such action of suspension of the Centre's registration is in public interest.
18. It is contended that in the present case, as provided under section 21, the appropriate authority has suo motu initiated the action of sealing 15/38
krs wp11059.11 the sonography machines and suspending the Centre's licence. The reasons for taking such actions have been duly recorded in the impugned order dated 21.6.2011. Those relate to the discrepancies and irregularities in maintenance of Form `F' which is a form statutorily required to be filled and maintained at all times by the Centre, inter alia, under rule 9 of the Rules of 1996. The irregularities and discrepancies have been enumerated in the impugned order. The learned counsel for the respondent no.5 has submitted that the petitioner himself has admitted the existence of irregularities and discrepancies as recorded in the order. The Appellate Authority has also in its order dated 9.11.2011 considered the seriousness of the violation which included non-filing of declaration in Form `F'.
19. The counsel for the respondent no.5 has further contended that section 17 of the Act sets out the functions of the appropriate authority and section 17(4)(a) includes the power to suspend/cancel registration of a Genetic Clinic. It is contended that section 9 of the Act clearly mandates that record shall be maintained and preserved for a period of two years or such period as may be prescribed and shall be made available at all times for inspection of the appropriate authority. Rule 9 16/38
krs wp11059.11 also provides in detail the manner in which the records are to be maintained, including all details as specified in Form `F'. Rule 18 of the Rules prescribes code of conduct to be observed by persons working at genetic centres which, inter alia, include to ensure that no provisions of the Act and the Rules are violated in any manner.
20. The learned counsel for the respondent no.5 has submitted that maintenance of Form `F' is a statutory requirement under the provisions of the Act and the Rules, any breach thereof will, therefore, lead to contravention of the provisions of sections 5 and 6 of the Act as provided under section 4 of the Act. There is no mention either in the provisions of the Act or the Rules distinguishing between minor and/or major offences. Hence, the contention of the petitioner of not maintaining Form `F' is a minor irregularity which is totally misconceived and contrary to the statutory scheme of the Act.
21. The counsel for the respondent no.5, in order to substantiate the contention canvassed by him, placed reliance on the decision of a Division Bench of this Court in Imaging Association v. Union of India and Ors. in Writ Petition No.797 of 2011 decided on 26.8.2011. Reliance 17/38
krs wp11059.11 is also placed by the learned counsel on the decision of a Full Bench of this Court in Dr.(Mrs.) Suhasini Umesh Karanjikar v. Kolhapur Municipal Corporation (2011 (4) All M.R. 804). The learned counsel further placed reliance on the decision of a Division Bench of this Court in Radiological & Imaging Association (State Chapter), through Dr.Jignesh Gokuldas Thakker v. Union of India & Ors. (Writ Petition (L) No.1939 of 2011) decided on 17.11.2011.
22. In this Writ Petition, a Civil Application, being Civil Application No.251 of 2012, has been filed by the applicant for intervention. Heard Mr.Warunjikar, the learned counsel for the applicant in the Civil Application. Civil Application No.251 of 2012 for intervention is allowed.
23. Mr.Warunjikar, the learned counsel for the applicant in Civil Application No.251 of 2012 for intervention, has submitted that the applicant adopts the contentions canvassed by the respondents and prays that the Writ Petition be dismissed.
CONSIDERATION AND CONCLUSIONS:
18/38
krs wp11059.11
24. Considered the contentions canvassed by the learned respective counsel for the petitioner as well as the respondents, perused the relevant provisions of the Act and the Rules as well as the decisions cited by the parties. The petitioner, in this petition, inter alia, challenged the order dated 21.6.2011 passed by the appropriate authority-cum-Medical Officer of Navi Mumbai Municipal Corporation as well as the order dated 9.11.2011 passed by the appellate authority.
25. The petitioner has challenged the action of sealing of sonography machine/s and suspension of licence of the petitioner's centre on the following grounds:-
(i) The order of suspension of registration is passed by the appropriate authority without following the procedure laid down under section 20(1) and (2) of the Act.
(ii) That the powers conferred under section 20(3) of the Act is an extraordinary power required to be exercised in an exceptional circumstance and that too after recording reasons. The impugned action is in violation of the provisions of section 20(3) of the Act.
19/38
krs wp11059.11 (iii) It was mandatory to obtain advice of the Advisory Committee before taking action of suspension of registration under section 20 of the Act.
(iv) Suspension of licence cannot be for an indefinite period. (v) The irregularities and discrepancies being of a minor nature do not warrant suspension of registration and seizure of ultrasonography machine.
26. Before we consider the issues raised by the petitioner, in the light of the provisions of the Act, it will be expedient to take into consideration the objectives of the Act. The Legislature enacted the Act to provide for the prohibition of sex selection before or after conception, and for regulation of pre-natal diagnostic techniques for the purposes of detecting genetic abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex-linked disorders and for the prevention of their misuse for sex determination leading to female foeticide. The intention of the Legislature is to prohibit pre-natal diagnostic techniques for determination of sex of the foetus leading to female foeticide since abuse of such techniques is discriminatory against the female sex and affects the dignity and status of women. The intention 20/38
krs wp11059.11 behind the legislation is to regulate the use of such techniques and to provide deterrent punishment to stop such inhuman act. Clause (2) of the Statement of Objects and Reasons of the Act reads thus:- "(2) The Bill, inter alia, provides for:--
(i) prohibition of the misuse of pre-natal diagnostic techniques for determination of sex of foetus, leading to female foeticide;
(ii) prohibition of advertisement of pre-natal diagnostic techniques for detection or determination of sex;
(iii) permission and regulation of the use of pre-natal diagnostic techniques for the purpose of detection of specific genetic abnormalities or disorders;
(iv) permitting the use of such techniques only under certain conditions by the registered institutions; and (v) punishment for violation of the provisions of the proposed legislation."
27. It will be appropriate to consider section 4 of the Act in the light 21/38
krs wp11059.11 of the Statement of Objects and Reasons of the Act. Section 4 provides regulation of pre-natal diagnostic techniques. Sub-section (1) contemplates that no place including a registered Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall be used or caused to be used by any person for conducting pre-natal diagnostic techniques except for the purposes specified in sub-section (2) and after satisfying any of the conditions specified in sub-section (3).
28. Sub-section (2) of section 4 contemplates that no pre-natal diagnostic techniques shall be conducted except for the purposes of detection of any of the following abnormalities, namely:-- "(i) chromosomal abnormalities;
(ii) genetic metabolic diseases;
(iii) heamoglobinopathies;
(iv) sex-linked genetic diseases;
(v) congenital anomalies;
(vi) any other abnormalities or diseases as may
be specified by the Central Supervisory
Board."
22/38
krs wp11059.11 Whereas sub-section (3) of section 4 mandates that no pre-natal diagnostic techniques shall be used or conducted unless the person qualified to do so is satisfied for reasons to be recorded in writing that any of the following conditions are fulfilled, namely:- "(i) age of the pregnant woman is above thirty-five years;
(ii) the pregnant woman has undergone two or more spontaneous abortions or foetal loss;
(iii) the pregnant woman had been exposed to
potentially teratogenic agents such as, drugs, radiation, infection or chemicals;
(iv) the pregnant woman or her spouse has a family history of mental retardation or physical deformities such as, spasticity or any other genetic disease; (v) any other condition as may be specified by the Board."
29. Proviso to sub-section (3) further stipulates that the person conducting ultrasonography on a pregnant woman shall keep complete 23/38
krs wp11059.11 record thereof in the clinic in such manner, as may be prescribed, and any deficiency or inaccuracy found therein shall amount to contravention of provisions of section 5 or section 6 unless contrary is proved by the person conducting such ultrasonography. The scheme of section 4 clearly demonstrates that the person qualified (Doctor) can conduct pre-natal diagnostic techniques except for the purposes specified in sub-section (2) of section 4 provided he/she is satisfied for the reasons to be recorded in writing that any of the conditions mentioned in sub-section (3) of section 4 are fulfilled. The proviso to sub-section (3) makes it mandatory for the Doctor conducting ultrasonography on a pregnant woman to keep complete record thereof in the clinic in such manner as prescribed under the provisions of the Act and the Rules particularly as provided under rule 9 of the Rules of 1996 which provides the procedure and manner pertaining to the maintenance and preservation of records of Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres, etc. Considering the object of the Act, the maintenance and preservation of records as per rule 9 is an important statutory duty cast upon the person (Doctor) conducting ultrasonography on a pregnant woman and, therefore, any deficiency or inaccuracy found in this regard amounts to contravention of the provisions of section 5 or 6 24/38
krs wp11059.11 of the Act unless contrary is proved by the person (Doctor) conducting such ultrasonography. The safeguards provided in section 4 of the Act are with the object to prohibit pre-natal diagnostic techniques for determination of sex of the foetus leading to female foeticide and, therefore, the person (Doctor) conducting ultrasonography on a pregnant woman is required to scrupulously follow every aspect of sub-sections (1), (2) and (3) of section 4 as well as rule 9 of the Rules.
30. It is important to note that in order to prohibit abuse of these pre- natal diagnostic techniques, the Legislature has incorporated a proviso to sub-section (3) of section 4 of the Act which stipulates that any deficiency or inaccuracy found in maintaining and preserving complete record in a manner prescribed by the person conducting ultrasonography on a pregnant woman shall amount to contravention of the provisions of section 5 or section 6 unless contrary is proved by the person conducting such ultrasonography. This provision, in our view, is completely consistent with the objectives of the Act and has been introduced to prohibit abuse of the pre-natal diagnostic techniques by the person conducting ultrasonography on a pregnant woman. In the instant case, it is not in dispute that the petitioner has admitted the existence of 25/38
krs wp11059.11 deficiency or inaccuracy in maintaining and preserving the complete record which includes Form `F' and, therefore, as per the scheme of section 4 of the Act, it amounts to an offence since the same is in contravention of the provisions of sections 5 and 6 of the Act unless contrary is proved by the petitioner who has conducted ultrasonography. The contention of the petitioner that the discrepancy was of a minor nature is wholly misconceived. Neither the provisions of the Act nor that of the Rules provide or define minor or major deficiencies or inaccuracies. On the other hand, it requires strict compliance of every provision of the Act and the Rules. Considering the objectives to be achieved, strict punishment is provided for violating the condition prescribed under the Act. The contentions canvassed by the petitioner, in this regard, therefore, are devoid of substance and are rejected.
31. Section 20 of the Act deals with the power of the appropriate authority to cancel or suspend the registration of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic and procedure to be followed by the appropriate authority in this regard. It is no doubt true that sub-section (1) of section 20 requires the appropriate authority to issue a notice to the Genetic Counselling Centre, Genetic Laboratory or 26/38
krs wp11059.11 Genetic Clinic, etc., to show cause why its registration should not be suspended or cancelled for the reasons mentioned in the notice. Similarly, sub-section (2) of section 20 contemplates giving of reasonable opportunity of hearing to the Genetic Counselling Centre, etc., and having regard to the advice of the Advisory Committee and if the appropriate authority is satisfied that there is a breach of the provisions of the Act or the Rules, it is legally entitled, without prejudice to take any criminal action for such period as it may think fit, or cancel its registration, as the case may be. Whereas sub-section (3) of section 20 starts with the non obstante clause and contemplates that if the appropriate authority is of the opinion that it is necessary or expedient in the larger public interest, it can suspend the registration of the Genetic Counselling Centre without issuing any notice referred to in sub-section (1), after recording reasons in writing for invoking this extraordinary power. Sub-section (3) gives extraordinary power to the appropriate authority in the larger public interest to be used in exceptional circumstances when the appropriate authority is of the opinion that it is necessary or expedient to do so and that too after recording reasons. In the instant case, the impugned order dated 21.6.2011 passed by the respondent no.3 in exercise of power under section 23 of the Act whereby 27/38
krs wp11059.11 the licence of the diagnostic centre of the petitioner came to be suspended mentions reasons. Those are as follows:-
"During the inspection the following discrepancies/irregularities were observed:
1. "F" form register is not kept in prescribed form and not updated.
2. No signature of Radiologist and patients on few F forms.
3. Monthly reports available without "F" forms check list.
4. In month of June, 2011, total 37 F forms are available, but in F Form register only 23
patients' details were updated.
5. Referral slips are available but not in proper form (no letter head and no. reg. no. of
referring doctor)."
32. It is, therefore, clear that in the instant case, the appropriate authority, in fact, has given reasons for exercising extraordinary power 28/38
krs wp11059.11 under sub-section (3) of section 20 of the Act for suspending the licence of the diagnostic centre of the petitioner and, therefore, the contentions canvassed by the counsel for the petitioner, in this regard, are also unfounded.
33. It is no doubt true that in the normal circumstances, as contended by the counsel for the petitioner, the appropriate authority is expected to issue show cause notice to the Genetic Counselling centre, etc., and is also expected to give reasonable opportunity of hearing to the Genetic Counselling Centre, Laboratory, etc., before taking action of suspending or cancellation of registration of Genetic Counselling Centre, etc., having regard to the advice of the Advisory Committee. However, the exercise of power under sub-section (3) of section 20 of the Act by the appropriate authority is warranted in exceptional situation and that too in order to protect the larger public interest and after recording reasons and is not guided by the procedure stipulated in sub-sections (1) and (2) of section 20 of the Act as per the scheme of sub-section (3) of section 20 of the Act, hence, the contention canvassed by the learned counsel for the petitioner that the impugned action is bad in law being violative of the principles of natural justice is misconceived for the reasons recorded 29/38
krs wp11059.11 hereinabove.
34. Another contention canvassed by the counsel for the petitioner that the impugned action suspending the licence of the diagnostic clinic of the petitioner for an indefinite period is impermissible which virtually amounts to cancellation of the licence of the Genetic Centre of the petitioner is also misconceived since the suspension of licence of the petitioner is only till decision in the criminal case is taken by the Criminal Court.
35. We want to reiterate the scheme of the relevant provisions of the Act which are attracted in the present case. Section 4 deals with regulation of pre-natal diagnostic techniques whereas section 17(4) deals with the functions to be performed by the Appropriate Authority. Clause (a) of sub-section (4) of section 17 demonstrates that one of the functions required to be performed by the Appropriate Authority is to grant, suspend or cancel registration of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic. Sub-sections (1), (2) and (3) of section 20 deal with the procedure to be followed by the Appropriate Authority while cancelling or suspending the registration of Genetic Counselling 30/38
krs wp11059.11 Centre, Laboratory or Clinic. In the normal course, the Appropriate Authority is requited to follow the procedure stipulated under sub- sections (1) and (2) of section 20 of the Act before cancelling or suspending the registration whereas sub-section (3) of section 20 clothes the Appropriate Authority with extraordinary powers to be used in an exceptional situation when the Appropriate Authority is of the opinion that it is expedient in public interest to suspend the registration of the Genetic Centre after recording reasons therefor, without issuing any notice referred to in sub-section (1). Similarly, rule 9 of the Rules of 1996 deals with the manner in which the record Genetic Counselling Centre is required to be maintained and preserved. The proviso to sub- section (3) of section 4 provides that the person conducting ultrasonography on a pregnant woman shall keep complete record thereof in the clinic in the manner prescribed under rule 9 of the Rules and any deficiency or inaccuracy found in this regard shall amount to contravention of the provisions of section 5 or section 6 and would amount to an offence unless contrary is proved by the person conducting such ultrasonography.
36. The relevant observations made by the Full Bench of this Court in 31/38
krs wp11059.11 Dr.(Mrs.) Suhasini Umesh Karanjkar, through her Constituted Attorney Dr. Umesh Murlidhar Karanjkar (supra) read thus:- "24. A bare perusal of the aforesaid statutory provisions, both in the Act and in the Rules framed thereunder, makes it abundantly clear that an ultra sonography test on a pregnant woman is considered to be an important part of a pre-natal diagnostic test or pre-natal diagnostic procedure, which cannot be conducted except for the purpose of Section 4(2). The person conducting ultra sonography on a
pregnant woman has to maintain a complete record thereof in the manner prescribed in the Rules and a deficiency or inaccuracy in maintaining such records would amount to an offence, unless the person
conducting such sonography is able to show that
there was no deficiency or inaccuracy. ..............................."
The above observations made by the Full Bench clearly demonstrate that 32/38
krs wp11059.11 the ultrasonography test on a pregnant woman is an important part of pre- natal diagnostic test which cannot be conducted except for the purpose of section 4(2) of the Act and the person conducting such ultrasonography test has to maintain complete record thereof in the manner prescribed in the Rules and any deficiency or inaccuracy in maintaining such records would amount to an offence unless the person conducting such ultrasonography is able to show that there was no deficiency or inaccuracy. The law declared by the Full Bench is squarely applicable in the present case and the issue involved stands covered by the said decision. However, the decision of the learned single Judge of this Court sitting at Aurangabad Bench rendered on 3.5.2012 in Criminal Application No.757 of 2012 in view of the decision of the Full Bench, in our view, does not further the case of the petitioner. Similarly, the decision cited by the counsel for the petitioner dated 22.3.2012 rendered in Writ Petition No.9573 of 2011 by the learned single Judge of this Court sitting at Aurangabad Bench also does not help the petitioner.
37. The observations made by the Division Bench in Radiological & Imaging Association (State Chapter-Nalna), through Dr.Jignesh Gokuldas Thakker v. Union of India & Ors. (Writ Petition No.797 of 201) in 33/38
krs wp11059.11 paragraphs 25 and 26 read thus:-
"25. A bare perusal of the aforesaid statutory provisions, both in the Act and in the Rules framed thereunder, makes it abundantly clear that an ultra sonography test on a pregnant woman is considered to be an important part of a pre-natal diagnostic test or pre-natal diagnostic procedure, which cannot be conducted except for the purpose of section 4(2). The person conducting ultra sonography on a
pregnant woman has to maintain a complete record thereof in the manner prescribed in the Rules and a deficiency or inaccuracy in maintaining such records would amount to an offence, unless the person
conducting such sonography is able to shows that there was no deficiency or inaccuracy.
26. In our opinion, the aforesaid provisions of the Act and the Rules make it amply clear that the
persons running the sonography clinic/sonography 34/38
krs wp11059.11 centre etc. are required to store, maintain and
preserve the complete records including the sonography plates or slides for a period of two years from the date of pre-natal diagnostic techniques procedure/test and that in the event of legal
proceedings, such records, letter etc. have to be preserved in light of the legal proceedings. The sonography clinic is also required to send a complete report in respect of a pre-conception of pregnancy related procedure for technical procedure or test conducted by them in respect of each month for the perusal of the concerned appropriate authority. As per Rule 11(1) the Clinic is also duty bound to afford all reasonable facilities for inspection of equipments and records to the appropriate authority or any other person authorized by the appropriate authority and such authority/authorized officer has also been
vested with the power to search, seal and seize such equipments/records. All these provisions are required to be read with the express power conferred 35/38
krs wp11059.11 by section 17(4) of the Act which empowers the
appropriate authority to take immediate action in case of breach of the provisions of the Act or the Rules."
38. Rule 9(1) requires that every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, etc., shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedure or pre-natal diagnostic tests, the names of their spouse or father and the date on which they first reported for such counselling, procedure or test. Sub-rule (4) of rule 9 stipulates the record to be maintained by every Genetic Clinic, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form `F'. In the instant case, the petitioner has admitted existence of discrepancies, irregularities in maintenance of Form `F' which has undoubtedly resulted in causing deficiency or inaccuracy in maintaining and preserving the record and, therefore, as per proviso to sub-section (3) of section 4 of the Act, resulted in contravention the provisions of section 5 or 6 of the Act and would amount to an offence, unless contrary is proved by the petitioner who has conducted such ultrasonography test.
36/38
krs wp11059.11
39. The observations made by the Full Bench as well as the Division Benches of this Court referred to hereinabove conclude all the challenges raised by the petitioner in the present petition. The observations made by the Division Bench in Malpani Infertility Clinic Pvt. Ltd. & others (supra) clearly show that the Division Bench in view of the fact that prosecution was launched against the petitioner in the said case, it was held to be sufficient reason for the authorities to take recourse to sub-section (3) of section 20 of the Act. In the instant case, the petitioner having admitted the existence of deficiency and inaccuracy in keeping and maintaining the record including Form `F' has resulted in contravention of the provisions contained in section 5 or 6 and, therefore, would amount to an offence and can be treated to be sufficient reason for the appropriate authority to invoke the provisions of sub-section (3) of section 20 of the Act in the larger public interest and, therefore, the action of suspension of registration of the Genetic Centre of the petitioner is sustainable in law till such time contrary is proved by the petitioner. Similarly, in the instant case also, the prosecution has been launched against the petitioner, though at a subsequent stage, which is pending before the competent criminal Court. The contentions canvassed by the learned counsel for the 37/38
krs wp11059.11 petitioner, in this regard, therefore, suffer from lack of merit and, therefore, the same are rejected.
40. In view of the above settled legal position, the impugned orders passed by the Appropriate Authorities are neither arbitrary nor violative of Article 14 of the Constitution and are sustainable in law and it is for the petitioner to prove before the criminal Court that there was no deficiency or inaccuracy in maintaining and preserving the complete record of the clinic. The petition suffers from lack of merit and the same is dismissed. (D. D. SINHA, J.)
(SMT.V.K.TAHILRAMANI,J.)
Suundaresan
38/38
Print Page
The observations made by the Full Bench as well as the Division Benches of this Court referred to hereinabove conclude all the challenges raised by the petitioner in the present petition. The observations made by the Division Bench in Malpani Infertility Clinic Pvt. Ltd. & others (supra) clearly show that the Division Bench in view of the fact that prosecution was launched against the petitioner in the said case, it was held to be sufficient reason for the authorities to take recourse to sub-section (3) of section 20 of the Act. In the instant case, the petitioner having admitted the existence of deficiency and inaccuracy in keeping and maintaining the record including Form `F' has resulted in contravention of the provisions contained in section 5 or 6 and, therefore, would amount to an offence and can be treated to be sufficient reason for the appropriate authority to invoke the provisions of sub-section (3) of section 20 of the Act in the larger public interest and, therefore, the action of suspension of registration of the Genetic Centre of the petitioner is sustainable in law till such time contrary is proved by the petitioner. Similarly, in the instant case also, the prosecution has been launched against the petitioner, though at a subsequent stage, which is pending before the competent criminal Court. The contentions canvassed by the learned counsel for the
petitioner, in this regard, therefore, suffer from lack of merit and, therefore, the same are rejected.
Bombay High Court
Dr.Sujit Govind Dange vs State Of Maharashtra on 16 August, 2012
Bench: D.D. Sinha, V.K. Tahilramani
2. The petitioner is challenging the legality and propriety of notice/order dated 21.6.2011 passed by the respondent no.3 and order dated 9.11.2011 passed by the respondent no.4. Similarly, a direction is sought against the respondent nos.2 and 3 to release and/or return to the petitioner sonography machine seized vide order dated 21.6.2011. SUBMISSIONS OF THE PETITIONER :
3. Mr.Thorat, the learned counsel for the petitioner, has submitted that the action of the respondent-authorities is wholly illegal, incorrect and, therefore, cannot be sustained in law. It is contended that the provisions of the proviso to sub-section (3) of section 4 of the Act require the Doctor to keep a record in the clinic as prescribed under the Rules, failing which it can be presumed that the provisions of sections 5 and 6 are contravened by such Doctor. It is submitted that before drawing presumption of contravention of section 5 or 6, opportunity must be given to the Doctor to disprove the said presumption as per the scheme of sub- section (3) of section 4 of the Act. The scheme of the Act, therefore, provides that before the said presumption is drawn, the Doctor conducting sonography on a pregnant woman is required to be given a chance to put 3/38
krs wp11059.11 forth his defence regarding maintenance of the record and it is only thereafter the authorities are entitled to consider whether there is a violation of section 5 or 6 of the Act. It is contended that if the appropriate authority is satisfied by the explanation of the Doctor, it may not be necessary to proceed against such Doctor by initiating criminal proceedings or take action of suspension of licence.
4. Mr.Thorat has contended that section 20 of the Act provides for cancellation or suspension of licence. Sub-section (1) of section 20 specially provides that the appropriate authority may suo motu or on complaint, issue a notice to the Genetic Clinic to show cause why its registration should not be suspended or cancelled. Sub-section (2) of section 20 further provides that after giving reasonable opportunity of being heard to the Genetic Clinic and having regard to the advice of the Advisory Committee, if the appropriate authority is satisfied that there has been a breach of the provisions of the Act or the Rules, it may, without prejudice to any criminal action that it may take against such Centre, Clinic or Laboratory suspend its registration for such period as it may think fit or cancel its registration, as the case may be. Mr.Thorat, therefore, contended that sub-sections (1) and (2) of section 20 4/38
krs wp11059.11 substantiates the contention canvassed by the petitioner that as per the scheme of the Act, it is necessary to first afford a reasonable opportunity of being heard to the Doctor and it is only thereafter action, if any, either of suspension or cancellation of licence can be taken.
5. The counsel for the petitioner has submitted that sub-section (3) of section 20 is an exception to the rule of giving reasonable opportunity of hearing to the Genetic Centre/Doctor provided as per sub-sections (1) and (2) of section 20. However, though the appropriate authority is vested with the emergency powers stipulated in sub-section (3) and can suspend the licence if it is necessary or expedient to do so in public interest, it must record reasons in writing and it is only thereafter, it is entitled to suspend the registration of any Genetic Counselling Centre, etc., without issuing such notice.
6. It is submitted that in the hand-book prepared and published by Union of India which is in the form of guidelines, it is stipulated that though the appropriate authority has a right to suspend the registration of Genetic Laboratory, Clinic or Centre, without issuing a notice, however, such power should be exercised as an exception rather than a rule and 5/38
krs wp11059.11 only when it is essential in the public interest to do so. In the instant case, the appropriate authority has not given or recorded any reason before suspending the licence or obtained advice of the Advisory Committee.
7. Mr.Thorat further submitted that the provisions of section 20 though empower the appropriate authority to suspend the registration, such suspension can only be for the specific period. Even otherwise, the term "suspension" denotes that the validity of the registration is put in abeyance for a temporary period and not for an indefinite period. In the instant case, the appropriate authority suspended the licence for an indefinite period which amounts to cancellation of the same which is not permissible in law.
8. Mr.Thorat has submitted that the scheme envisaged under the Act and the Rules made thereunder suggests two different actions and two different punishments. It prescribes strict compliance by the Doctor conducting ultrasound sonography on a pregnant woman to keep the record strictly as per the format provided. However, while maintaining the record, if some mistake is committed due to inadvertence which is not of a serious nature, it may not attract punishment of cancellation of 6/38
krs wp11059.11 licence and, therefore, under the provisions of the Act, lesser punishment of suspension of licence for a limited period for minor and/or clerical mistakes is provided. Similarly, for serious lapses committed by the Doctor in this regard, harsh punishment like cancellation of licence is also provided under the Act. It is contended that in many cases of similar type, the authority has suspended the licence for a limited period of one month or so in case of minor violations of the provisions of the Act. The counsel for the petitioner has contended that the appropriate authority in Navi Mumbai which has taken action against the petitioner has used different yardstick while taking action in respect of other Doctors who had committed similar lapses. It is contended that the appropriate authority in the case of Dr.Parulekar' Hospital situated at Airoli, Navi Mumbai, where similar allegations were made regarding not filling `F' form properly issued show cause notice dated 26.7.2011 to the said hospital asking it to show cause as to why action of suspension should not be taken. It is, therefore, submitted that the normal rule as per the scheme of the Act is to issue show cause notice before taking action of suspension and it is only in exceptional situation show cause notice contemplated under sub-sections of section 20 of the Act can be dispensed with and that too after recording reasons in writing. It is contended that in the instant 7/38
krs wp11059.11 case, the appropriate authority has not complied with the mandatory requirement prescribed under sub-section (3) of section 20 of the Act and, therefore, the impugned order is not sustainable in law. Even otherwise, the order of suspension which was issued by the appropriate authority for an indefinite period amounts to cancellation and the said action which is impermissible and, therefore, the same deserves to be quashed and set aside. In order to substantiate this contention, reliance is placed on the decision of a single Judge of this Court sitting at Aurangabad Bench in Writ Petition No.9573 of 2011 (Tirupati Diagnostic Centre v. The District Appropriate Authority @ Civil Surgeon, General Hospital Jalna) rendered on 22.3.2012.
9. Mr.Thorat further submitted that without prejudice to the above referred contention advanced by him, even if it is assumed that there was a breach of rule on the part of the petitioner and there is a power to suspend the licence under section 23 of the Act. In the instant case, the suspension of licence has taken place in June 2011 and is being continued for a more than one year. Since the appropriate authority does not have power of suspending the licence for an indefinite period, such action, therefore, is not sustainable in law and liable to be quashed and set aside. 8/38
krs wp11059.11 Similarly, since the licence can be suspended only for a limited period, ultrasound machine, therefore, can only be seized by the appropriate authority for a specific period only. It is submitted that if the order of suspension is unsustainable in law and is liable to be quashed and set aside, necessary consequence is that the appropriate authority must return ultrasound machine to the petitioner. It is submitted that when the ultrasound machine was attached and sealed, no indication was given to the petitioner that the appropriate authority was about to file a criminal case against the petitioner and, therefore, seizure of machine cannot be considered as a part of muddemal property and is required to be released.
10. It is contended that ultrasound machine is used only by two specialists i.e. Gynaecologist or Radiologist. Both these specialists are very busy in their respective professions and, therefore, they are required to rely upon their subordinate staff for up-keep of the clinic, laboratory, etc., including maintenance of record required as per the provisions of the Act. It is submitted that there is no nexus between the provisions of the Act and the object to be achieved by the Act. The object is to see that no professional should conduct sex determination test for the purpose of female foeticide and, therefore, harsh punishment like suspension, 9/38
krs wp11059.11 cancellation of licence and/or conviction is provided, whereas for committing minor violation or error in filling up the form and/or maintaining the record, awarding of such punishment is unreasonable, arbitrary and, therefore, violative of Article 14 of the Constitution of India.
11. Mr.Thorat has submitted that without prejudice to the legal submissions made by him, even on merit of the matter, it will be seen that there is no irregularity committed by the petitioner. At no point of time, the petitioner has admitted his guilt and solitary sentence in the Appeal Memo cannot be read in isolation to treat the same as admission of the petitioner of not keeping the record as per the Rules. It is submitted that rule 9 is the only rule which deals with maintenance and preservation of the record and it is nowhere stipulated in the said rule that it casts a duty of maintaining `F' register. It does not stipulate the manner in which the said register is required to be maintained by the Doctor. It is contended that for the mistake committed by the Doctor who has referred the patient, the blame cannot be put on the Radiologist and/or Gynaecologist. Mr.Thorat, therefore, contended that the action of the appropriate authority is wholly unwarranted, misconceived and liable to be quashed 10/38
krs wp11059.11 and set aside.
SUBMISSIONS OF THE RESPONDENT NO.3:
12. Mr.Marne, the learned counsel for the respondent no.3, has contended that the appropriate authority on noticing discrepancies as mentioned in the order of suspension thought it fit in larger public interest to exercise power under section 20(3) of the Act for ordering immediate suspension of registration. In the instant case, it is pertinent to note that there is no prejudice as such caused to the petitioner because of non- issuance of the show cause notice or for not granting hearing to the petitioner by the appropriate authority, since in the appeal filed by the petitioner before the appropriate authority, the petitioner has admitted the existence of discrepancies/irregularities mentioned in the suspension order. It is, therefore, contended that even if show cause notices would have been issued to the petitioner, beyond contending that the discrepancies are of minor nature committed by the petitioner by mistake, there was nothing that the petitioner could have stated in his defence.
13. Mr.Marne has contended that the Act nowhere makes it 11/38
krs wp11059.11 mandatory for the appropriate authority to obtain advice of the Advisory Committee. Under section 17(4)(a), the appropriate authority has wide powers to suspend or cancel without obtaining any advice. Under section 17(4)(i), the recommendations of the Advisory Committee are to be considered only if action is taken on the basis of the complaint. In the present case, the action is taken by the appropriate authority suo motu and not on any complaint and, therefore, it was not required to obtain advice of the Advisory Committee.
14. The learned counsel for the respondent no.3 has submitted that the contention canvassed by the petitioner that the appropriate authority has not recorded reasons is also not correct. In the order of suspension, the appropriate authority has recorded the reasons why it was suspending the registration. The petitioner has admitted the existence of the said discrepancies as mentioned in the order of suspension. Since the petitioner has admitted the existence of discrepancies mentioned in the order of suspension, the authorities were justified in exercising the power under section 20(3) of the Act. It is submitted that the petitioner having admitted the existence of the discrepancy, it is not open for the petitioner to state that reasons were not sufficient to take action of suspension of 12/38
krs wp11059.11 registration/licence. The learned counsel for the respondent no.3 further contended that the contention canvassed by the counsel for the petitioner that the order of suspension is for an indefinite period and, therefore, bad in law is also incorrect. The order of suspension of registration of the petitioner would continue till final decision of the criminal case/s lodged against the petitioner is taken by the competent criminal Court.
15. The counsel for the respondent no.3 has further submitted that the Act and or the Rules made thereunder nowhere stipulates two types of violations, major and minor ones. On the contrary, the proviso to sub- section (3) of section 4 raises an automatic presumption of contravention of the provisions of section 5 or section 6 of the Act in case of any deficiency or inaccuracy in keeping complete record as prescribed in the Rules. It is mandatory under rule 9 to maintain and preserve various records. Maintenance of record in Form `F' is a vital condition before subjecting a pregnant woman to ultrasonography test. In Form `F', it is mandatory for a pregnant woman to declare that she does not want to know the sex of her foetus. It is also mandatory for the Doctor to declare that while conducting ultrasonography/image scanning, he did not disclose sex of foetus in any manner. In the present case, there is an 13/38
krs wp11059.11 admitted violation of this condition and, therefore, by no stretch of imagination, it can be treated as a minor irregularity. It is submitted that if non-maintenance of record in Form `F' is permitted, it would open a door for Doctors to determine and disclose sex of foetus as there would be no record of tests performed on pregnant woman. In any case, it is for the criminal Court to consider and decide the nature of violation of the provisions of the Act and the Rules on the basis of evidence adduced by the parties. In the instant case, since the discrepancy about not maintaining complete record is admitted by the petitioner, the action of suspension is sustainable in law and it is open for the petitioner to prove that the petitioner did not determine the sex of the foetus nor disclosed about it to anyone. It is, therefore, contended that the action taken by the appropriate authority is sustainable in law and the petition is liable to be dismissed.
SUBMISSIONS OF THE RESPONDENT NO.5:
16. Mr.Sethna, the learned counsel for the respondent no.5, has contended that the petitioner seeks to challenge the impugned action taken by the appropriate authority, including that of suspension of its 14/38
krs wp11059.11 centre's licence mainly on three grounds which, according to the petitioner, is contrary to the mandate under section 20 of the Act which are as under:-
(i) no opportunity to show cause or being heard was given to the petitioner;
(ii) no approval of the Advisory Committee was obtained; and (iii) the suspension of licence was in complete violation of the principles of natural justice and, hence, contrary to section 20.
17. It is submitted that there is no violation whatsoever of any of the statutory provisions by the respondents as alleged. Section 20(3) is a non obstante provision. Therefore, independent and de hors to what is stated in sub-clauses (1) and (2) of section 20, the appropriate authority is duly and statutorily empowered to take appropriate action without issuing any notice referred to in section 20(1) provided such action of suspension of the Centre's registration is in public interest.
18. It is contended that in the present case, as provided under section 21, the appropriate authority has suo motu initiated the action of sealing 15/38
krs wp11059.11 the sonography machines and suspending the Centre's licence. The reasons for taking such actions have been duly recorded in the impugned order dated 21.6.2011. Those relate to the discrepancies and irregularities in maintenance of Form `F' which is a form statutorily required to be filled and maintained at all times by the Centre, inter alia, under rule 9 of the Rules of 1996. The irregularities and discrepancies have been enumerated in the impugned order. The learned counsel for the respondent no.5 has submitted that the petitioner himself has admitted the existence of irregularities and discrepancies as recorded in the order. The Appellate Authority has also in its order dated 9.11.2011 considered the seriousness of the violation which included non-filing of declaration in Form `F'.
19. The counsel for the respondent no.5 has further contended that section 17 of the Act sets out the functions of the appropriate authority and section 17(4)(a) includes the power to suspend/cancel registration of a Genetic Clinic. It is contended that section 9 of the Act clearly mandates that record shall be maintained and preserved for a period of two years or such period as may be prescribed and shall be made available at all times for inspection of the appropriate authority. Rule 9 16/38
krs wp11059.11 also provides in detail the manner in which the records are to be maintained, including all details as specified in Form `F'. Rule 18 of the Rules prescribes code of conduct to be observed by persons working at genetic centres which, inter alia, include to ensure that no provisions of the Act and the Rules are violated in any manner.
20. The learned counsel for the respondent no.5 has submitted that maintenance of Form `F' is a statutory requirement under the provisions of the Act and the Rules, any breach thereof will, therefore, lead to contravention of the provisions of sections 5 and 6 of the Act as provided under section 4 of the Act. There is no mention either in the provisions of the Act or the Rules distinguishing between minor and/or major offences. Hence, the contention of the petitioner of not maintaining Form `F' is a minor irregularity which is totally misconceived and contrary to the statutory scheme of the Act.
21. The counsel for the respondent no.5, in order to substantiate the contention canvassed by him, placed reliance on the decision of a Division Bench of this Court in Imaging Association v. Union of India and Ors. in Writ Petition No.797 of 2011 decided on 26.8.2011. Reliance 17/38
krs wp11059.11 is also placed by the learned counsel on the decision of a Full Bench of this Court in Dr.(Mrs.) Suhasini Umesh Karanjikar v. Kolhapur Municipal Corporation (2011 (4) All M.R. 804). The learned counsel further placed reliance on the decision of a Division Bench of this Court in Radiological & Imaging Association (State Chapter), through Dr.Jignesh Gokuldas Thakker v. Union of India & Ors. (Writ Petition (L) No.1939 of 2011) decided on 17.11.2011.
22. In this Writ Petition, a Civil Application, being Civil Application No.251 of 2012, has been filed by the applicant for intervention. Heard Mr.Warunjikar, the learned counsel for the applicant in the Civil Application. Civil Application No.251 of 2012 for intervention is allowed.
23. Mr.Warunjikar, the learned counsel for the applicant in Civil Application No.251 of 2012 for intervention, has submitted that the applicant adopts the contentions canvassed by the respondents and prays that the Writ Petition be dismissed.
CONSIDERATION AND CONCLUSIONS:
18/38
krs wp11059.11
24. Considered the contentions canvassed by the learned respective counsel for the petitioner as well as the respondents, perused the relevant provisions of the Act and the Rules as well as the decisions cited by the parties. The petitioner, in this petition, inter alia, challenged the order dated 21.6.2011 passed by the appropriate authority-cum-Medical Officer of Navi Mumbai Municipal Corporation as well as the order dated 9.11.2011 passed by the appellate authority.
25. The petitioner has challenged the action of sealing of sonography machine/s and suspension of licence of the petitioner's centre on the following grounds:-
(i) The order of suspension of registration is passed by the appropriate authority without following the procedure laid down under section 20(1) and (2) of the Act.
(ii) That the powers conferred under section 20(3) of the Act is an extraordinary power required to be exercised in an exceptional circumstance and that too after recording reasons. The impugned action is in violation of the provisions of section 20(3) of the Act.
19/38
krs wp11059.11 (iii) It was mandatory to obtain advice of the Advisory Committee before taking action of suspension of registration under section 20 of the Act.
(iv) Suspension of licence cannot be for an indefinite period. (v) The irregularities and discrepancies being of a minor nature do not warrant suspension of registration and seizure of ultrasonography machine.
26. Before we consider the issues raised by the petitioner, in the light of the provisions of the Act, it will be expedient to take into consideration the objectives of the Act. The Legislature enacted the Act to provide for the prohibition of sex selection before or after conception, and for regulation of pre-natal diagnostic techniques for the purposes of detecting genetic abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex-linked disorders and for the prevention of their misuse for sex determination leading to female foeticide. The intention of the Legislature is to prohibit pre-natal diagnostic techniques for determination of sex of the foetus leading to female foeticide since abuse of such techniques is discriminatory against the female sex and affects the dignity and status of women. The intention 20/38
krs wp11059.11 behind the legislation is to regulate the use of such techniques and to provide deterrent punishment to stop such inhuman act. Clause (2) of the Statement of Objects and Reasons of the Act reads thus:- "(2) The Bill, inter alia, provides for:--
(i) prohibition of the misuse of pre-natal diagnostic techniques for determination of sex of foetus, leading to female foeticide;
(ii) prohibition of advertisement of pre-natal diagnostic techniques for detection or determination of sex;
(iii) permission and regulation of the use of pre-natal diagnostic techniques for the purpose of detection of specific genetic abnormalities or disorders;
(iv) permitting the use of such techniques only under certain conditions by the registered institutions; and (v) punishment for violation of the provisions of the proposed legislation."
27. It will be appropriate to consider section 4 of the Act in the light 21/38
krs wp11059.11 of the Statement of Objects and Reasons of the Act. Section 4 provides regulation of pre-natal diagnostic techniques. Sub-section (1) contemplates that no place including a registered Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall be used or caused to be used by any person for conducting pre-natal diagnostic techniques except for the purposes specified in sub-section (2) and after satisfying any of the conditions specified in sub-section (3).
28. Sub-section (2) of section 4 contemplates that no pre-natal diagnostic techniques shall be conducted except for the purposes of detection of any of the following abnormalities, namely:-- "(i) chromosomal abnormalities;
(ii) genetic metabolic diseases;
(iii) heamoglobinopathies;
(iv) sex-linked genetic diseases;
(v) congenital anomalies;
(vi) any other abnormalities or diseases as may
be specified by the Central Supervisory
Board."
22/38
krs wp11059.11 Whereas sub-section (3) of section 4 mandates that no pre-natal diagnostic techniques shall be used or conducted unless the person qualified to do so is satisfied for reasons to be recorded in writing that any of the following conditions are fulfilled, namely:- "(i) age of the pregnant woman is above thirty-five years;
(ii) the pregnant woman has undergone two or more spontaneous abortions or foetal loss;
(iii) the pregnant woman had been exposed to
potentially teratogenic agents such as, drugs, radiation, infection or chemicals;
(iv) the pregnant woman or her spouse has a family history of mental retardation or physical deformities such as, spasticity or any other genetic disease; (v) any other condition as may be specified by the Board."
29. Proviso to sub-section (3) further stipulates that the person conducting ultrasonography on a pregnant woman shall keep complete 23/38
krs wp11059.11 record thereof in the clinic in such manner, as may be prescribed, and any deficiency or inaccuracy found therein shall amount to contravention of provisions of section 5 or section 6 unless contrary is proved by the person conducting such ultrasonography. The scheme of section 4 clearly demonstrates that the person qualified (Doctor) can conduct pre-natal diagnostic techniques except for the purposes specified in sub-section (2) of section 4 provided he/she is satisfied for the reasons to be recorded in writing that any of the conditions mentioned in sub-section (3) of section 4 are fulfilled. The proviso to sub-section (3) makes it mandatory for the Doctor conducting ultrasonography on a pregnant woman to keep complete record thereof in the clinic in such manner as prescribed under the provisions of the Act and the Rules particularly as provided under rule 9 of the Rules of 1996 which provides the procedure and manner pertaining to the maintenance and preservation of records of Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres, etc. Considering the object of the Act, the maintenance and preservation of records as per rule 9 is an important statutory duty cast upon the person (Doctor) conducting ultrasonography on a pregnant woman and, therefore, any deficiency or inaccuracy found in this regard amounts to contravention of the provisions of section 5 or 6 24/38
krs wp11059.11 of the Act unless contrary is proved by the person (Doctor) conducting such ultrasonography. The safeguards provided in section 4 of the Act are with the object to prohibit pre-natal diagnostic techniques for determination of sex of the foetus leading to female foeticide and, therefore, the person (Doctor) conducting ultrasonography on a pregnant woman is required to scrupulously follow every aspect of sub-sections (1), (2) and (3) of section 4 as well as rule 9 of the Rules.
30. It is important to note that in order to prohibit abuse of these pre- natal diagnostic techniques, the Legislature has incorporated a proviso to sub-section (3) of section 4 of the Act which stipulates that any deficiency or inaccuracy found in maintaining and preserving complete record in a manner prescribed by the person conducting ultrasonography on a pregnant woman shall amount to contravention of the provisions of section 5 or section 6 unless contrary is proved by the person conducting such ultrasonography. This provision, in our view, is completely consistent with the objectives of the Act and has been introduced to prohibit abuse of the pre-natal diagnostic techniques by the person conducting ultrasonography on a pregnant woman. In the instant case, it is not in dispute that the petitioner has admitted the existence of 25/38
krs wp11059.11 deficiency or inaccuracy in maintaining and preserving the complete record which includes Form `F' and, therefore, as per the scheme of section 4 of the Act, it amounts to an offence since the same is in contravention of the provisions of sections 5 and 6 of the Act unless contrary is proved by the petitioner who has conducted ultrasonography. The contention of the petitioner that the discrepancy was of a minor nature is wholly misconceived. Neither the provisions of the Act nor that of the Rules provide or define minor or major deficiencies or inaccuracies. On the other hand, it requires strict compliance of every provision of the Act and the Rules. Considering the objectives to be achieved, strict punishment is provided for violating the condition prescribed under the Act. The contentions canvassed by the petitioner, in this regard, therefore, are devoid of substance and are rejected.
31. Section 20 of the Act deals with the power of the appropriate authority to cancel or suspend the registration of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic and procedure to be followed by the appropriate authority in this regard. It is no doubt true that sub-section (1) of section 20 requires the appropriate authority to issue a notice to the Genetic Counselling Centre, Genetic Laboratory or 26/38
krs wp11059.11 Genetic Clinic, etc., to show cause why its registration should not be suspended or cancelled for the reasons mentioned in the notice. Similarly, sub-section (2) of section 20 contemplates giving of reasonable opportunity of hearing to the Genetic Counselling Centre, etc., and having regard to the advice of the Advisory Committee and if the appropriate authority is satisfied that there is a breach of the provisions of the Act or the Rules, it is legally entitled, without prejudice to take any criminal action for such period as it may think fit, or cancel its registration, as the case may be. Whereas sub-section (3) of section 20 starts with the non obstante clause and contemplates that if the appropriate authority is of the opinion that it is necessary or expedient in the larger public interest, it can suspend the registration of the Genetic Counselling Centre without issuing any notice referred to in sub-section (1), after recording reasons in writing for invoking this extraordinary power. Sub-section (3) gives extraordinary power to the appropriate authority in the larger public interest to be used in exceptional circumstances when the appropriate authority is of the opinion that it is necessary or expedient to do so and that too after recording reasons. In the instant case, the impugned order dated 21.6.2011 passed by the respondent no.3 in exercise of power under section 23 of the Act whereby 27/38
krs wp11059.11 the licence of the diagnostic centre of the petitioner came to be suspended mentions reasons. Those are as follows:-
"During the inspection the following discrepancies/irregularities were observed:
1. "F" form register is not kept in prescribed form and not updated.
2. No signature of Radiologist and patients on few F forms.
3. Monthly reports available without "F" forms check list.
4. In month of June, 2011, total 37 F forms are available, but in F Form register only 23
patients' details were updated.
5. Referral slips are available but not in proper form (no letter head and no. reg. no. of
referring doctor)."
32. It is, therefore, clear that in the instant case, the appropriate authority, in fact, has given reasons for exercising extraordinary power 28/38
krs wp11059.11 under sub-section (3) of section 20 of the Act for suspending the licence of the diagnostic centre of the petitioner and, therefore, the contentions canvassed by the counsel for the petitioner, in this regard, are also unfounded.
33. It is no doubt true that in the normal circumstances, as contended by the counsel for the petitioner, the appropriate authority is expected to issue show cause notice to the Genetic Counselling centre, etc., and is also expected to give reasonable opportunity of hearing to the Genetic Counselling Centre, Laboratory, etc., before taking action of suspending or cancellation of registration of Genetic Counselling Centre, etc., having regard to the advice of the Advisory Committee. However, the exercise of power under sub-section (3) of section 20 of the Act by the appropriate authority is warranted in exceptional situation and that too in order to protect the larger public interest and after recording reasons and is not guided by the procedure stipulated in sub-sections (1) and (2) of section 20 of the Act as per the scheme of sub-section (3) of section 20 of the Act, hence, the contention canvassed by the learned counsel for the petitioner that the impugned action is bad in law being violative of the principles of natural justice is misconceived for the reasons recorded 29/38
krs wp11059.11 hereinabove.
34. Another contention canvassed by the counsel for the petitioner that the impugned action suspending the licence of the diagnostic clinic of the petitioner for an indefinite period is impermissible which virtually amounts to cancellation of the licence of the Genetic Centre of the petitioner is also misconceived since the suspension of licence of the petitioner is only till decision in the criminal case is taken by the Criminal Court.
35. We want to reiterate the scheme of the relevant provisions of the Act which are attracted in the present case. Section 4 deals with regulation of pre-natal diagnostic techniques whereas section 17(4) deals with the functions to be performed by the Appropriate Authority. Clause (a) of sub-section (4) of section 17 demonstrates that one of the functions required to be performed by the Appropriate Authority is to grant, suspend or cancel registration of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic. Sub-sections (1), (2) and (3) of section 20 deal with the procedure to be followed by the Appropriate Authority while cancelling or suspending the registration of Genetic Counselling 30/38
krs wp11059.11 Centre, Laboratory or Clinic. In the normal course, the Appropriate Authority is requited to follow the procedure stipulated under sub- sections (1) and (2) of section 20 of the Act before cancelling or suspending the registration whereas sub-section (3) of section 20 clothes the Appropriate Authority with extraordinary powers to be used in an exceptional situation when the Appropriate Authority is of the opinion that it is expedient in public interest to suspend the registration of the Genetic Centre after recording reasons therefor, without issuing any notice referred to in sub-section (1). Similarly, rule 9 of the Rules of 1996 deals with the manner in which the record Genetic Counselling Centre is required to be maintained and preserved. The proviso to sub- section (3) of section 4 provides that the person conducting ultrasonography on a pregnant woman shall keep complete record thereof in the clinic in the manner prescribed under rule 9 of the Rules and any deficiency or inaccuracy found in this regard shall amount to contravention of the provisions of section 5 or section 6 and would amount to an offence unless contrary is proved by the person conducting such ultrasonography.
36. The relevant observations made by the Full Bench of this Court in 31/38
krs wp11059.11 Dr.(Mrs.) Suhasini Umesh Karanjkar, through her Constituted Attorney Dr. Umesh Murlidhar Karanjkar (supra) read thus:- "24. A bare perusal of the aforesaid statutory provisions, both in the Act and in the Rules framed thereunder, makes it abundantly clear that an ultra sonography test on a pregnant woman is considered to be an important part of a pre-natal diagnostic test or pre-natal diagnostic procedure, which cannot be conducted except for the purpose of Section 4(2). The person conducting ultra sonography on a
pregnant woman has to maintain a complete record thereof in the manner prescribed in the Rules and a deficiency or inaccuracy in maintaining such records would amount to an offence, unless the person
conducting such sonography is able to show that
there was no deficiency or inaccuracy. ..............................."
The above observations made by the Full Bench clearly demonstrate that 32/38
krs wp11059.11 the ultrasonography test on a pregnant woman is an important part of pre- natal diagnostic test which cannot be conducted except for the purpose of section 4(2) of the Act and the person conducting such ultrasonography test has to maintain complete record thereof in the manner prescribed in the Rules and any deficiency or inaccuracy in maintaining such records would amount to an offence unless the person conducting such ultrasonography is able to show that there was no deficiency or inaccuracy. The law declared by the Full Bench is squarely applicable in the present case and the issue involved stands covered by the said decision. However, the decision of the learned single Judge of this Court sitting at Aurangabad Bench rendered on 3.5.2012 in Criminal Application No.757 of 2012 in view of the decision of the Full Bench, in our view, does not further the case of the petitioner. Similarly, the decision cited by the counsel for the petitioner dated 22.3.2012 rendered in Writ Petition No.9573 of 2011 by the learned single Judge of this Court sitting at Aurangabad Bench also does not help the petitioner.
37. The observations made by the Division Bench in Radiological & Imaging Association (State Chapter-Nalna), through Dr.Jignesh Gokuldas Thakker v. Union of India & Ors. (Writ Petition No.797 of 201) in 33/38
krs wp11059.11 paragraphs 25 and 26 read thus:-
"25. A bare perusal of the aforesaid statutory provisions, both in the Act and in the Rules framed thereunder, makes it abundantly clear that an ultra sonography test on a pregnant woman is considered to be an important part of a pre-natal diagnostic test or pre-natal diagnostic procedure, which cannot be conducted except for the purpose of section 4(2). The person conducting ultra sonography on a
pregnant woman has to maintain a complete record thereof in the manner prescribed in the Rules and a deficiency or inaccuracy in maintaining such records would amount to an offence, unless the person
conducting such sonography is able to shows that there was no deficiency or inaccuracy.
26. In our opinion, the aforesaid provisions of the Act and the Rules make it amply clear that the
persons running the sonography clinic/sonography 34/38
krs wp11059.11 centre etc. are required to store, maintain and
preserve the complete records including the sonography plates or slides for a period of two years from the date of pre-natal diagnostic techniques procedure/test and that in the event of legal
proceedings, such records, letter etc. have to be preserved in light of the legal proceedings. The sonography clinic is also required to send a complete report in respect of a pre-conception of pregnancy related procedure for technical procedure or test conducted by them in respect of each month for the perusal of the concerned appropriate authority. As per Rule 11(1) the Clinic is also duty bound to afford all reasonable facilities for inspection of equipments and records to the appropriate authority or any other person authorized by the appropriate authority and such authority/authorized officer has also been
vested with the power to search, seal and seize such equipments/records. All these provisions are required to be read with the express power conferred 35/38
krs wp11059.11 by section 17(4) of the Act which empowers the
appropriate authority to take immediate action in case of breach of the provisions of the Act or the Rules."
38. Rule 9(1) requires that every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, etc., shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedure or pre-natal diagnostic tests, the names of their spouse or father and the date on which they first reported for such counselling, procedure or test. Sub-rule (4) of rule 9 stipulates the record to be maintained by every Genetic Clinic, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form `F'. In the instant case, the petitioner has admitted existence of discrepancies, irregularities in maintenance of Form `F' which has undoubtedly resulted in causing deficiency or inaccuracy in maintaining and preserving the record and, therefore, as per proviso to sub-section (3) of section 4 of the Act, resulted in contravention the provisions of section 5 or 6 of the Act and would amount to an offence, unless contrary is proved by the petitioner who has conducted such ultrasonography test.
36/38
krs wp11059.11
39. The observations made by the Full Bench as well as the Division Benches of this Court referred to hereinabove conclude all the challenges raised by the petitioner in the present petition. The observations made by the Division Bench in Malpani Infertility Clinic Pvt. Ltd. & others (supra) clearly show that the Division Bench in view of the fact that prosecution was launched against the petitioner in the said case, it was held to be sufficient reason for the authorities to take recourse to sub-section (3) of section 20 of the Act. In the instant case, the petitioner having admitted the existence of deficiency and inaccuracy in keeping and maintaining the record including Form `F' has resulted in contravention of the provisions contained in section 5 or 6 and, therefore, would amount to an offence and can be treated to be sufficient reason for the appropriate authority to invoke the provisions of sub-section (3) of section 20 of the Act in the larger public interest and, therefore, the action of suspension of registration of the Genetic Centre of the petitioner is sustainable in law till such time contrary is proved by the petitioner. Similarly, in the instant case also, the prosecution has been launched against the petitioner, though at a subsequent stage, which is pending before the competent criminal Court. The contentions canvassed by the learned counsel for the 37/38
krs wp11059.11 petitioner, in this regard, therefore, suffer from lack of merit and, therefore, the same are rejected.
40. In view of the above settled legal position, the impugned orders passed by the Appropriate Authorities are neither arbitrary nor violative of Article 14 of the Constitution and are sustainable in law and it is for the petitioner to prove before the criminal Court that there was no deficiency or inaccuracy in maintaining and preserving the complete record of the clinic. The petition suffers from lack of merit and the same is dismissed. (D. D. SINHA, J.)
(SMT.V.K.TAHILRAMANI,J.)
Suundaresan
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