Federation of Obstetrics and Gynecological Societies of India (Fogsi) vs Union of India and Others

Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 – Pre-conception and Prenatal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996 – Indian Medical Council Act, 1956 – Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 – Petitioner-society sought direction in the nature of certiorari/mandamus for decriminalising anomalies in paperwork like incomplete ‘F’ forms/clerical mistakes/record keeping in regard of the provisions of the Act for being violative of Arts. 14, 19(1)(g) and 21 of the Constitution – Held: Though Form ‘F’ is a clerical requirement, but if any information in the form is avoided, it will result in the blantant violation of the provisions of s.4 of the Act, 1994 and may lead to a result which is prohibited u/s. 6 of the Act, 1994 – It cannot be said to be a case of clerical error as doctor has to fulfil pre-requisites for undertaking the procedure in case the conditions precedent for undertaking pre-natal diagnostic test is not specifically mentioned, it would be violative of provisions contained in s.4 – In case the indications and the information are not furnished as provided in the Form ‘F’ it would amount that condition precedent to undertake the test/procedure is absent – There is no other barometer except form ‘F’ to find out why the diagnostic test/procedure was performed – Form ‘F’ lays down the indicative list for conducting ultra-sonography during pregnancy – Further, Form ‘F’ being technical in nature gives the insight into the reasons for conducting ultra-sonography and incomplete Form ‘F’ raises the presumption of doubt against medical practitioner – Insofar as maintaining of record is concerned, they have to maintained only when the procedure or tests are conducted on pregnant woman or when patient may have been advised to use pre-conception diagnostic tools to conceive a child – The scheme of the Act makes it evident that record keeping is meant to track/monitor and regulate the use of technology that has potential of sex selection and sex determination – As the entries are mandatory and sine qua non for undertaking a test/procedure, the assertion that their fundamental rights are being violated by not providing requisite information is not germane and is without substance.

Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 – Proviso to s.4(3) – Petitioner-society contended that s.4(3) should be read down – Held: By virtue of the proviso to s. 4(3), a person conducting ultrasonography on a pregnant woman, is required to keep complete record of the same in the prescribed manner and any deficiency or inaccuracy in the same amounts to contravention of s.5 or s.6 of the Act, unless the contrary is proved by the person conducting the said ultrasonography – The aforementioned proviso to s.4(3) reflects the importance of records in such cases, as they are often the only source to ensure that an establishment is not engaged in sexdetermination – Thus, there is no substance in the contention that provision of s.4(3) be read down.

Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 – s.30 – Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996 – rr.11 and 12 – Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 – Petitioner-society contended that the action of seizure of ultra-sonography machine and sealing the premises by the competent authority cannot be said to be appropriate – Held: s. 30 of the Act enumerates the power of search and seizure and rr. 11 & 12 of the Rules provide for the power of the Appropriate Authority to seal equipment, inspect premises and conduct search and seizure – It is settled proposition that when offence is found to be committed, there can be seizure and sealing of the premises and equipment during trial as no license can be given to go on committing the offence – Such provisions of seizure/sealing, pending trial are to be found invariably in various penal legislations – The impugned provisions contained in the Act constitute reasonable restrictions to carry on any profession which cannot be said to be violative of Right to Equality enshrined u/Art.

14 or right to practise any profession u/Art. 19(1)(g) – Considering the Fundamental Duties u/Art. 51A(e) and considering that female foeticide is most inhumane act and results in reduction in sex ratio, such provisions cannot be said to be illegal and arbitrary in any manner besides there are various safeguards provided in the Act to prevent arbitrary actions – Thus, contention of the petitioner rejected – Constitution of India – Arts.19(1)(g), 14, 51A(e). Dismissing the writ petition, the Court

HELD : 1. When the Form ‘F’ is scrutinised with the provisions of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994/Preconception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996 and there cannot be any dispute with respect to serial Nos.1 and 2 wherein name and address of Genetic Laboratory and its registration number is required to be mentioned in the Form as it is necessary to have a registration under Section 18 of the Act. It cannot be said to be a clerical requirement. Patient name and her age at serial No.3 is also absolutely necessary so as to identify a person who is undergoing the test and before the age of 35 years, it cannot be conducted as provided under Section 4(3)(i). The same is as per the mandatory requirement of Section 4. Husband’s/father’s name is also necessary as per the statutory mandate for the purpose of identification of patient. Full address is also mandatory so as to ascertain the identity who is undergoing such test. In case these information are kept vague, the violation of the Act would be blatant and unchecked and offence can never be detected. Information at serial No.8 of the Form ‘F’ requires last menstrual period/weeks of pregnancy to be mentioned, same is also necessary to be mentioned as it has co-relation with the investigations and provisions of the Act and the rules framed thereunder. The column in Form at serial No.9 requires history of genetic/medical disease in the family to be specified which is as per the mandate of Section 4(3)(iv) of the Act. Form ‘F’ at serial No.10 requires indication for pre-natal diagnosis which is mandatory as per the provisions contained in Section 4(2) as except for the purposes as mentioned in Sections 4(2) and 4(3) no such tests/procedures can be performed. Thus, what is mandated by the Sections and in Rule 9 has been mentioned in the Form ‘F’. Procedure carried whether invasive or non-invasive has to be obviously mentioned and in case any laboratory tests have been recommended that is to be mentioned along with the result. The note attached to Form ‘F’ also contains the representative list of indications when ultrasound during pregnancy can be performed. Thus, though the submission that Form ‘F’ is clerical requirement urged by the petitioner-Society appears at the first blush to be worthy examination, but on close scrutiny it is found that in case any information in the Form is avoided, it will result in the blatant violation of the provisions of Section 4 and may lead to result which is prohibited under Section

6. It cannot be said to be a case of clerical error as doctor has to fulfil pre-requisites for undertaking the procedure in case the conditions precedent for undertaking pre-natal diagnostic test is not specifically mentioned, it would be violative of provisions contained in Section 4. The Form ‘F’ has to be prepared and signed by either Gynaecologist/Medical Geneticist / Radiologist / Paediatrician / Director of the Clinic/Centre/Laboratory. In case the indications and the information are not furnished as provided in the Form ‘F’ it would amount that condition precedent to undertake the test/procedure is absent. There is no other barometer except Form ‘F’ to find out why the diagnostic test/procedure was performed. In case such an important information beside others is kept vague or missing from the Form, it would defeat the very purpose of the Act and the safeguards provided thereunder and it would become impossible to check violation of provisions of the Act. It is not the clerical job to fill the form, it is condition precedent for undertaking test/procedure. With all due regards to the submission advanced on behalf of petitionerSociety that it is a clerical job, is wholly without substance but it is a responsible job of the person who is undertaking such a test i.e., the Gynaecologist/ Medical Geneticist/Radiologist/Paediatrician/Director of the Clinic/Centre/Laboratory to fill the requisite information. In case he keeps it vague, he knows fully well that he is violating the provisions of the Act and undertaking the test without existence of the conditions precedent which are mandatory to exist he cannot undertake test/procedure without filling such information in the form. There is no other way to ensure that test is undertaken on fulfilment of the prescribed conditions. There is nothing else but the record which required to be maintained and on the basis of which counter-check can be made. There is no other barometer or criteria to find out the violation of the provisions of the Act. Rule 9(4) also requires that every Genetic Clinic to fill Form ‘F’ wherein information with regard to details of the patient, referral notes with indication and case papers of the patient are required to be filled and preserved. Form ‘F’ lays down the indicative list for conducting ultrasonography during pregnancy. Form ‘F’ being technical in nature gives the insight into the reasons for conducting ultrasonography and incomplete Form ‘F’ raises the presumption of doubt against the medical practitioner. In the absence of Form ‘F’, Appropriate Authorities will have no tool to supervise the usage of ultrasound machine and shall not be able to regulate the use of the technique which is the object of the Act. [Para 59] [63-A-H; 64-A-H]

2. It is rightly contended on behalf of respondents that there are different forms for record keeping prescribed under the Act and the Rules they are important and interlinked, operate in tandem with one another. These records have to be maintained only when the procedure or tests are conducted on pregnant woman or when patient may have been advised to use preconception diagnostic tools to conceive a child. It is required for Genetic Counselling Centre advising the procedure/test with a potential of detecting or determining the sex of the foetus and referring a person to a Genetic Clinic/Imaging Centre/Ultrasound Clinic to record the details of Genetic Clinic to which patient is referred at point 15 of the Form ‘D’ along with the details of the diagnosis and relevant medical details of the person. Accordingly, Genetic Clinic/Imaging Centre/Ultrasound Clinic conducting the aforesaid referred procedure has to record the name and address of Genetic Counselling Centre with the referral slip along with the relevant medical record of the person on whom procedure/test/technique is conducted. The aforesaid record keeping procedure shall be followed by Genetic Laboratories also. The scheme of the Act makes it evident that record keeping is meant to track/monitor and regulate the use of technology that has potential of sex selection and sex determination. Section 23 is not stand-alone Section. It is rather used in the enforcement of other provisions of the Act and violations of Section 23 are often accompanied by violations of provisions of Sections 4, 5, 6 and

18 of the Act. It is submitted that non-maintenance of record in the context of sex determination is not merely a technical or procedural lapse. It is most significant piece of evidence for identifying offence and the accused. The inspection of records is crucial to identify wrong-doers as the crime of sex determination being a collusive crime given the nexus between the patients and the doctors. Accordingly, punishment is provided in Section

23 for not maintaining the records. [Para 60] [65-A-F]

3. In R. Sai Bharathi v. J. Jayalalitha it has been observed that crime is against social order, immoral and harmful act. It has also been observed by this Court that legislature can have a law to constitute an act or omission done by a person against the other as a crime. Considering the evils sought to be remedied it cannot be said that the imposition in the Act in question is disproportionate. The restrictions and the provisions of punishment have close nexus with the object sought to be achieved. It is not possible to term action as merely clerical one as that is pre-requisite for the test/procedure and that is what is intended by the Act, if it is given a go-bye under the guise of clerical error, the Act would be rendered otiose. Restriction cannot be said to be excessive and beyond what is required in the public interest, they cater to the felt need of the society and the complex issues facing people which the legislature intends to solve. [Para 77] [84-D-F]

4. It is apparent from the aforesaid discussion in Shreya Singhal v. Union of India, in a case where no reasonable standards are laid down to define guilt in a section which creates an offence, it would be arbitrary and unconstitutional. It is absolutely clear that the provisions in the Act in question cannot be termed as arbitrary or illegal or unreasonable. The provisions are not vague. A responsible doctor is supposed to know before undertaking such pre-natal diagnostic test etc. what is he undertaking and what his responsibilities are. If he cannot understand the form he is required to fill and the impact of medical findings and its consequences which is virtually the pre-requisite for undertaking a test, he is not fit to be a member of a noble medical profession. Such culpable negligence is not warranted from a doctor. It is crystal clear from the provisions of the Act which can be gathered by a person of ordinary intelligence and they can have fair notice of what is prohibited and what omission they should not make. The principles deliberated upon in Shreya Singhal case rather supports the constitutionality of the Act and the Rules framed thereunder. Considering the compelling general public interest and gender justice and declining sex ratio, there is no hesitation in upholding the validity of the provisions of Section 23(1) of the Act. [Paras 78 and 79] [86-C-F; 88-F]

5. The Act is a social welfare legislation, which was conceived in light of the skewed sex-ratio of India and to avoid the consequences of the same. A skewed sex-ratio is likely to lead to greater incidences of violence against women and increase in practices of trafficking, ‘bride-buying’ etc. The rigorous implementation of the Act is an edifice on which rests the task of saving the girl child. [Para 85] [90-E-F]

6. In the opinion of this Court, no case is made out to hold that deficiency in maintaining the record mandated by Sections 5, 6 and the proviso to Section 4(3) cannot be diluted as the aforesaid provisions have been incorporated in various columns of the Form ‘F’ and as already held that it would not be a case clerical mistake but absence of sine qua non for undertaking a diagnostic test/procedure. It cannot be said to be a case of clerical or technical lapse. Section 23(1) need not have provided for gradation of offence once offence is of non-maintenance of the record, maintenance of which itself intend to prevent female foeticide. It need not have graded offence any further difference is so blur it would not be possible to prevent crime. There need not have been any gradation of offence on the basis of actual determination of sex and non-maintenance of record as undertaking the test without the pre-requisites is totally prohibited under the Act. The non-maintenance of record is very foundation of offence. For first and second offences, gradation has been made which is quite reasonable. [Para 86] [90-G-H; 91-A-B]

7. It was also contended that action of seizure of ultrasonography machine and sealing the premises cannot be said to be appropriate. The submission is too tenuous and liable to be rejected. Section 30 of the Act enumerates the power of search and seizure and Rules 11 and 12 of the Rules provide for the power of the Appropriate Authority to seal equipment, inspect premises and conduct search and seizure. It was pointed out by the respondents that a “Standard Operational Procedure”, detailing the procedure for search and seizure has been developed by the Ministry of Health and Family Welfare. Further, regular training of Appropriate Authorities is being carried out at both the National and State level. All the States have also been directed to develop online MIS for monitoring the implementation of the Act. It is settled proposition that when offence is found to be committed, there can be seizure and sealing of the premises and equipment during trial as no license can be given to go on committing the offence. Such provisions of seizure/sealing, pending trial are to be found invariably in various penal legislations. The impugned provisions contained in the Act constitute reasonable restrictions to carry on any profession which cannot be said to be violative of Right to Equality enshrined under Article 14 or right to practise any profession under Article 19(1)(g). Considering the Fundamental Duties under Article 51A(e) and considering that female foeticide is most inhumane act and results in reduction in sex ratio, such provisions cannot be said to be illegal and arbitrary in any manner besides there are various safeguards provided in the Act to prevent arbitrary actions. [Para 90] [92-A-E]

8. Non maintenance of record is spring board for commission of offence of foeticide, not just a clerical error. In order to effectively implement the various provisions of the Act, the detailed forms in which records have to be maintained have been provided for by the Rules. These Rules are necessary for the implementation of the Act and improper maintenance of such record amounts to violation of provisions of Sections 5 and 6 of the Act, by virtue of proviso to Section 4(3) of the Act. In addition, any breach of the provisions of the Act or its Rules would attract cancellation or suspension of registration of Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, by the Appropriate Authority as provided under Section 20 of the Act. [Para 92] [92-H; 93-A-B]

9. There is no substance in the submission that provision of Section 4(3) be read down. By virtue of the proviso to Section 4(3), a person conducting ultrasonography on a pregnant woman, is required to keep complete record of the same in the prescribed manner and any deficiency or inaccuracy in the same amounts to contravention of Section 5 or Section 6 of the Act, unless the contrary is proved by the person conducting the said ultrasonography. The aforementioned proviso to Section 4(3) reflects the importance of records in such cases, as they are often the only source to ensure that an establishment is not engaged in sex-determination. [Para 93] [93-C-D]

10. In light of the nature of offences which necessitated the enactment of the Act and the grave consequences that would ensue otherwise, suspension of registration under Section 23(2) of the Act serves as a deterrent. Section 23 of the Act, which provides for penalties of offences, acts in aid of the other Sections of the Act is quite reasonable. It provides for punishment for any medical geneticist, gynecologist, registered medical practitioner or a person who owns a Genetic Counselling Centre, a Genetic Clinic or a Genetic Laboratory, and renders his professional or technical services to or at said place, whether on honorarium basis or otherwise and contravenes any provisions of the Act, or the Rules under it. [Paras 91 and 94] [92-F; 93-E]

11. Therefore, dilution of the provisions of the Act or the Rules would only defeat the purpose of the Act to prevent female foeticide, and relegate the right to life of the girl child under Article

21 of the Constitution, to a mere formality. [Para 95] [93-F] Shreya Singhal v. Union of India, (2015) 5 SCC 1 : [2015] 5 SCR 963 ; R. Sai Bharathi v. J. Jayalalitha, (2004) 2 SCC 9 : [2003] 6 Suppl. SCR 85 ; Centre for Enquiry into Health and Allied Themes (CEHAT) v. Union of India, (2001) 5 SCC 577 : [2001] 3 SCR

534 ; Voluntary Health Association of Punjab v. Union of India, (2013) 4 SCC 1 : [2013] 5 SCR 111 ; Namit Sharma v. Union of India (2013) 1 SCC 745 : [2013]

13 SCR 1 ; Hamdard Dawakhana v. The Union of India AIR 1960 SC 554 : [1960] SCR 671 ; Subramanian Swamy v. Union of India, (2016) 7 SCC 221 : [2016] 3 SCR 865 – relied on.

Suo Motu v. State of Gujarat, (2009) 1 Gujarat Law Reporter 64 ; Raj Bokaria v. Medical Council of India (W.P. (C) No.795 of 2010 in the High Court of Delhi) – approved.

Arun Bhandari v. State of U.P. (2013) 2 SCC 801 : [2013] 3 SCR 961 ; Enquiry into Health & Allied Themes (CEHAT) v. Union of India, (2003) 8 SCC

398 : [2003] 3 Suppl. SCR 593 ; Uttar Pradesh Power Corporation Ltd. v. Ayodhya Prasad Mishra (2008) 10 SCC 139 : [2008] 13 SCR 373 ; Voluntary Health Association of Punjab v. Union of India (2016) 10 SCC

265 : [2016] 8 SCR 192 ; Dr. Subhash Kashinath Mahajan v. State of Maharashtra (2018) 6 SCC 454 : [2018] 4 SCR 877 ; Gian Kaur v. State of Punjab (1996)

2 SCC 648 : [1996] 3 SCR 697 ; Nikesh Tarachand Shah v. Union of India, (2018) 11 SCC 1 : [2017] 12 SCR 358 ; P. Rathinam v. Union of India (1994) 3 SCC

394 ; State of Uttar Pradesh v. Wasif Haider, (2019) 2 SCC 303 – referred to.