1 IN THE HIGH COURT OF JUDICATURE AT BOMBAY CIVIL APPELLATE JURISDICTION WRIT PETITION NO. 797 OF 2011 Radiological & Imaging Association (State Chapter- Jalna), through Dr.Jignesh Gokuldas Thakker, its PC-PNDT Coordinator for the Indian Radiological & Imaging Association, having its office at C/o. Shri Sai diagnostic Centre, Post Office Road, Jalna-431 203. (Maharashtra State) … Petitioner Versus 1. Union of India Through its Secretary, Ministry of Health and Family Welfare, Having his address at Nirman Bhawan, New Delhi – 110 001. 2. State of Maharashtra Through its Secretary, Ministry of Health and Family Welfare, Having his address at Mantralaya, Mumbai- 400 021. 3. Mr. Laxmikant Deshmukh, Collector & District Magistrate, Having his address at Collectorate, Kolhapur Office, Swarajya Bhavan, Nagala Park, Kolhapur-416 003. … Respondents Dr. Jignesh Thakker- Petitioner in person. Mr. Anurag Gokhale for respondent No.1. Mr. V.D. Patil, Government Pleader for respondent No.2-State. Mr.A.A. Kumbhakoni with Mr. Amit Borkar for respondent No.3. CORAM : MOHIT S. SHAH, C.J. & SMT. R.P.SONDURBALDOTA , J. 2 Judgment Reserved on : 29 June 2011 Judgment Pronounced on : 26 August 2011 JUDGMENT (Per Chief Justice) In this petition under Article 226 of the Constitution, the petitioner- Radiological & Imaging Association (State Chapter- Jalna) (hereafter referred to as "the petitioner" or "the Association") has challenged the circular dated 14 January 2011 of Collector and District Magistrate, Kolhapur (exhibit `F') requiring the Radiologists and Sonologists to submit on-line form F under the Pre-conception and Pre-natal Diagnostic Techniques Rules, 2003. The Association has also challenged the circular dated 10 March 2010 (exhibit `A’) issued by the Collector in which reference is made to the workshop of doctors, sonologists and radiologists of Kolhapur held on 8 March 2010 and to the discussion at the said workshop for installation of SIOB (silent observer) for all the sonography machines, as a part of `save the baby’ campaign for improving sex ratio in the district. 2. The petitioner-association is a society registered under the Societies Registration Act, 1860, formed for promoting, inter alia, the study and practice of Radio-diagnosis, ultra-sound, CT, MRI and other imaging modalities. Members of the Association are medical practitioners who are imaging specialists engaged, inter alia, in foetal imaging, generally known as Sonologists/Radiologists and are governed by the provisions of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 and Rules, 1996 (for brevity, PC&PNDT Act of 1994 and Rules, 1996). 3. According to the petitioner, ultra-sonography is a diagnostic technique which utilizes sound waves and reflections 3 leading to imaging of diverse muscular or soft tissue organs/ parts of human body for detection of disorders, abnormalities or malfunctioning. It is a non-invasive technique which does not have any side effects or after effects and is, therefore, widely used in India and abroad for diagnostic examination of diverse organs and parts of the human body, including heart, liver, bladder, abdomen, kidneys, intestines, pancreas, prostate etc. Since it is non-invasive and has no radiation hazard, ultra-sonography has proved to be a boon in evaluating the foetus during pregnancy. Primary challenge 4. In this petition, the petitioner has challenged the action of Collector and District Magistrate, Kolhapur in issuing Circular dated 10 March 2010 whereby all doctors, sonologists and radiologists practicing in Kolhapur District are called upon to install device `Silent Observer’ in their sonography/ultra-sound machines. According to the petitioner, this machine and its software enables the Collector to directly review at district headquarters at Kolhapur to scan images of the patient which is illegal, against the provisions of the Act and invades privacy of the patients. It is contended that under the Rules, the ultra-sound clinics and other bodies governed by Act and the Rules are given time upto 5th day of the next month for submitting information in the format which is to be signed by the doctor and the patient. However, public notice dated 14 January 2011 (exhibit `F’) issued by the Collector and District Magistrate requiring the doctors/sonologists/radiologists to transmit form –F on-line within 24 hours is without authority of law. 4 Defence of Collector and District Magistrate 5. Collector and District Magistrate, Kolhapur has filed affidavit-in-reply dated 28 February 2011 submitting, interalia, as under:- 5.1 Vide notifications issued under Section 17 of the Act, the Collectors and District Magistrates as well as Civil Surgeons or Deans of Medical Colleges (where Civil surgeons are not available) at every district level, are appointed as appropriate authorities. Reference is made to the power conferred by the Act and the Rules on the appropriate authority for enforcement of the provisions of the Act and the Rules. 5.2 (a) The Collector and Civil Surgeon found that Kolhapur district is having the worst sex ratio 839 females per 1000 males. After understanding the magnitude of the problem and illegal use of sonography centres for sex selection test resulting in female foeticide, the Collector organized the workshop of doctors/radiologists/sonologists. (b) Kolhapur has 250 sonography centres as on 1 January, 2011 and each month more than 12000 sonography tests are being conducted on pregnant women in the district i.e. 1,50,000 tests per annum in the district. Sonography centre has to maintain, as per Section 4 and Rule 9, record of each test on the pregnant woman in form `F'. It is mandatory for the sonography centres to submit form `F' to the office of the Civil Surgeon (District Appropriate Authority) by fifth of next month. The district and sub- district appropriate authorities are required to inspect each 5 centre once in three months to check whether the sonography centre has maintained the record properly or not. It requires a lot of manpower to monitor the submission of `F’ form from all centres and its analysis for necessary action under the Act and the Rules. The overburdened district and sub-district authorities also entrusted with other public duties, find it almost impossible to carry out 100% inspection and to study and scrutinize `F’ forms being received in such large numbers every month. 5.3. The district administration came across two blatant violations of the Act viz. under-reporting and false reporting of sonography tests. (a) Under-reporting is not filling `F’ form even though sonography test is conducted on a pregnant woman, for the sole purpose of sex determination resulting in female foeticide. (b) False reporting is wrong mentioning of age of the foetus and incorrect and wrong particulars in the other relevant columns. It was noticed that even when the health, growth and other indicators of foetus is normal, many doctors/radiologists submit incorrect report of pre-natal diagnostic procedure and recommend Medical Termination of Pregnancy. Checking of `F’ form after considerable long time lag was not yielding desirable result as the appropriate authority was unable to detect the sex selection abortion being carried out. 6 (c) Study on doctors perspective on PC&PNDT Act shows that 55.9% of the doctors stated that the information submitted was absolutely false and 41.2% stated that they were not sure. Almost all, 97% of the doctors confirmed that there is demand for gender determination of foetus by patients (exhibit `M’). Several studies have shown that almost 70% of form `F' are incomplete whether deliberate or not. 6. In order to overcome these problems, the District administration evolved the impugned methods: 6.1 The on-line `F' form facilitates to fill in all 19 columns of form correctly and upload on daily basis. It also helps the district authority, namely, Civil Surgeon to analyse the monthly data expeditiously because on-line record in form `F' is readily available on computers for the analysis and, action if needed, and for corrective course for proper enforcement of the Act. This new scientific innovation of on-line `F' form is an added tool in the hands of district appropriate authorities for analysis of huge data (more than 12000 `F' forms on average per month) to take needful action. 6.2 Otherwise also, the information submitted in `F’ form in hard copy was required to be scrutinized and analysed by the District administration and as indicated above, the number of `F’ forms being received every year in Kolhapur district alone being 1.5 lakh, it was not possible for the administration to analyse the information submitted in `F’ forms in such a large number. With on-line submission of `F’ forms, it is possible for the appropriate authority to 7 analyse the data by referring to a few parameters like age of the foetus, number of children the pregnant woman already has etc. 6.3 On-line submission of `F’ form is in consonance with the spirit and object of Section 4 and Rule 9.. which already require the sonography centre to submit submission of forms `F' every month. All sonography centres, in addition to on-line submission, still keep `form `F' manually in printed form where they sign and obtain signature of the patient undergoing sonography test. 6.4. After installation of silent observer on the ultra-sound machines in the sonography centres in Kolhapur district, reporting of sonography tests of pregnant women has increased to 34%. At the hearing also, Mr. Kumbhakoni, learned counsel for the Collector and District Magistrate, Kolhapur has placed before us the statement giving details of the number of `F’ forms submitted in October 2009 and in May 2011 as under:- Month Kolhapur Rural Kolhapur City Kolhapur District October 2009 4,932 4,970 9,902 June 2010 6,618 5,290 11,908 May 2011 8,909 6,688 15,597 7. It is the specific case in the reply affidavit that the information contained in `F’ form submitted on-line is not accessible to anyone except the Collector and District Magistrate. 8. The second solution found out by the District Collector and District Magistrate, Kolhapur and Civil Surgeon is installation of silent observer (SIOB). Together with on-line submission of `F' forms, the silent observer addresses both the problems of under-reporting or false-reporting. As soon as doctor/radiologist opens the sonography 8 machine, the silent observer captures and stores the video output of each sonography test which shows the age of foetus and abnormality if any. Thus, each sonography test is counted and can be cross-checked with the `F’ form submitted on-line In case of suspected medical termination of pregnancy, the district administration can check the `F’ form and verify the truthfulness by comparing video of sonography test. For instance, in order to show that the MTP is for medical purpose and not as a result of sex selection, the age of aborted foetus is normally shown as below 12 weeks, in which case the sex is not necessary to be mentioned in the report. In order to escape from the provisions of the Act, many doctors/radiologists indulge in false reporting in form `F’ in this fashion. By cross-checking, the information submitted in `F’ form on-line with the data stored in the silent observer, it is possible for the appropriate authority to detect false reporting in form `F’ and then to track down MTP for the purpose other than the medical purpose. 9. Rule 9(6) of the PC&PNDT Rules provides that all case- related records, forms of consent, laboratory results, microscopic pictures, sonographic plates or slides, recommendations and letters shall be preserved for two years. With few exceptions, no sonography centres preserve such records except `F’ form. What the silent observer or SIOB does is, facilitate storage of video record of each sonography test. The silent observer is embedded on the ultra-sound machine which remains in the concerned sonography centre. The information stored in the said silent observer is not transmitted on-line to any authority but it remains stored in the device installed on the ultra-sound machine. It is accessed by the appropriate authority only when required in case of suspected MTP after sex selection. 9 10. In paras 10 and 31 of the affidavit-in-reply, the Collector and District Magistrate, Kolhapur (respondent No.3) has specifically stated as under:- “……….Respondent No.3 submits that petitioner has stated without ascertaining the facts and functions of SIOB that it enables the Respondent No.3 to directly review at his district level (Kolhapur District) the scanned images of a patient is not correct. The device SIOB stores the video of sonography tests of pregnant women carried out at the sonography centre and not transmitted to district server for viewing by the Collector. The SIOB is sealed in presence of the concerned doctor/Radiologist with his signature. The Appropriate Authority, whenever it deems fit, request the concerned doctor/Radiologist and his authorized person go to the centre and access the selected data on pen drive and it is being viewed by a member of Radiologist Association of Kolhapur and they offer us their observation. Hereto annexed and marked as Exh. `C’ is the protocol made for use of “silent Observer”.” 31…………….. Silent Observer is not connected to any district server, no internet is connected to Silent Observer. The appropriate authority with the help of silent observer can check for suspected centres and suspected cases like pregnant females with one or more previous girls, pregnant females with age of 35 and above. The solution also provides various medical data of the entire district that can be used for various decision making.” 11. It is further stated in the affidavit-in-reply that the Collector and District Magistrate, Kolhapur alongwith Civil Surgeon, Chairperson of Federation of Obstetric and Gynecological Societies of India and Chairperson of Radiologist Association organized a one day workshop at Kolhapur on 8 March 2010 and demonstrated the new device i.e. SIOB or popularly called the “silent observer”- to all the doctors/radiologists and sonologists present at the workshop and the object of installation of silent observer. It was also explained that this device will help the administration in solving the problem of under- reporting and false-reporting. It will protect the practitioners doing 10 ethical and legal practice and will act as a deterrent against sex selection practice resulting in female foeticide. All the doctors/radiologists present at the workshop agreed and resolved unanimously to install the silent observer (SIOB) at their own cost as concerned citizen of India to curb the illegal practice female foeticide and improving the sex ratio and it was, thereafter that the Collector and District Magistrate, Kolhapur issued letter dated 10 March 2010 (exhibit `A') appealing to all the doctors and radiologists in the district to install the silent observer at the earliest. All 250 sonography centres in Kolhapur district have installed the silent observer at their own cost and there is not a single complaint to any higher authority. Central Government stand 12. At the hearing of this writ petition, Mr.Anurag Gokhale, learned counsel for Union of India has placed on record office memorandum dated 16 June 2011 issued by the Director, Ministry of Health & Family Welfare (PNDT Division) to the learned Additional Government Advocate on the subject matter of the present petition, which reads as under:- “The undersigned is directed to refer to your letter dated 4961/LIT/2011 dated 24.5.2011 on the subject cited above and to convey that the declining child sex ratio and the reducing number of girl children in many states as per 2011 Census is a matter of great concern. 2. Tracking of pregnancy tests and detection of unreported termination of pregnancies have been a challenge for Appropriate Authorities in monitoring the activities of clinics offering diagnostic services. Clearly, it is the mandate of the Appropriate Authorities to effectively implement the PC & PNDT Act, 1994, as provided under Sub-section 4 of Section 17 of the Act. District Appropriate Authorities thus have the discretion to facilitate the mechanisms to check illegal sex 11 determination tests, including innovative strategies like the `Silent Observer’ among others. 3. This issues with the approval of competent authority.” Sd/- Director (PNDT Division) Rival Submissions 13. At the hearing of the petition, the learned advocate as well as the learned counsel for the petitioner sought discharge, as the Coordinator of the petitioner-association himself desired to argue the case. Accordingly, Dr. Jignesh G. Thakker, Coordinator of the petitioner-association made the following submissions:- (i) The impugned letter/circular of the Collector and District Magistrate, Kolhapur requiring the doctors/ radiologists /sonologists to submit form `F’ is without authority of law and not supported by any provision of the Act or the Rules. (ii) The patient gives consent for sonography test to be conducted by the concerned doctor/radiologist/sonologist and gives no consent for giving access to the information contained in the sonography test to any other person. Hence, there is invasion into the patient’s right to privacy. (iii) The sonography test is undertaken by a pregnant woman in view of faith and trust on the radiologist/sonologist/doctor that all the information relating to the test will remain confidential and private. However, the impugned actions of the Collector and District Magistrate, Kolhapur result into breach of confidentiality and privacy and therefore, constitute an offence punishable under section 72 of the Information Technology Act, 2000. 12 14. On the other hand, Mr. Kumbhakoni, learned counsel for the Collector and District Magistrate, Kolhapur, Mr. V.D. Patil, learned Government Pleader for the State of Maharashtra and Mr. Anurag Gokhale, learned counsel for respondent No.1 Union of India have opposed the petition and made the following submissions:- (i) The appropriate authorities under the Act are required to supervise and implement the provisions of the Act and the Rules and to take appropriate legal action against the use of any sex selection technique by any person at any place suo motu or otherwise and also to undertake independent investigation. The appropriate authorities also have the powers to summon any person who is in possession of any information relating to violation of possession of any Act or the Rules and to produce any document or material object relating thereto. The appropriate authorities have also power to issue search warrant for any place suspected to be indulging in sex selection techniques or prenatal sex determination. (ii) Section 4 and Rule 9 also require the ultra-sound clinic to preserve the records and documents for a period of two years and to afford all reasonable facilities for inspection of the place, equipment and records to the appropriate authority or to any other person authorized by the appropriate authority. Rule 9(8) also requires the ultra-sound clinic to submit the information in form `F’ by fifth day of the next month. Hence, requiring the ultra-sound clinics to submit `F’ forms on-line is only requiring the ultra-sound clinics to submit information in electronic form which is otherwise also required to 13 be submitted by the ultra-sound clinics in physical form. Referring to the averments made in the affidavit- in-reply as to how on-line submission of `F’ forms will help the authorities in making proper analysis of the data submitted in large numbers (almost more than 1,50,000 forms of ultra-sound test done on pregnant women in one district alone in a year, it would not be possible to make proper analysis and to enforce the Act and the Rules, if such information is not received by the appropriate authority in electronic form. (iii) Only the appropriate authority has access to this information and only the appropriate authority can assign the work of analysis to the officer authorized by the appropriate authority. Since the existing provisions of the Act and the Rules themselves require the ultra- sound clinics to give access to the information to the appropriate authorities and to the officers authorized by the appropriate authority, and the on-line information is not available on public domain, there is no question of breach of privacy right of the patient (iv) It is only on account of introduction of on-line submission of `F’ form that the authorities have been able to overcome the problem of under-reporting of `F’ forms as per the data given. The statement placed on record by the Collector and District Magistrate shows the number of `F’ forms in 250 ultra-sound centres in Kolhapur district has gone up from 9,902 in October 2009 to 15,597 in May 2011. (v) As regards the silent observer, it is submitted after referring to the relevant averments in the reply affidavit that silent observer does not transmit the information 14 stored in the device embedded on the ultra-sound machine to the office of the Collector through any district server or any other server but it very much remains within the premises of the registered ultra- sound centre. Otherwise also, the registered ultra- sound centre is required to store all its records, registers, sonography slides etc. for a period of two years. The silent observer stores images generated during the ultra sonography test, so that when the appropriate authority desires, or the officer authorized by the appropriate authority is required, to cross-check the information supplied in the `F’ form on-line, the appropriate authority or authorized officer will go to the ultra-sound centre and obtain the information stored in the silent observer in the presence of the concerned radiologist/sonologist and in the presence of another radiologist/sonologist of the District. (vi) It is submitted that there are sufficient safeguards for ensuring that there is no breach of privacy rights of the patient and that the Collector and District Magistrate welcomes any further suggestions or any other safeguards which may be made or suggested by the petitioner-Association or others. (vii) Mr. Kumbhakoni has lastly submitted that the impact of innovative measures introduced by the Collector and District Magistrate, Kolhapur is so significant that the sex ratio, which was 839 girls as to 1000 boys in the district in May 2010, has gone upto 876 girls as to 1000 boys in January 2011. It is submitted that the innovative initiatives taken by the 15 Collector and District Magistrate, Kolhapur may not be interfered with. 15. Having heard the coordinator of the petitioner- Association and the learned counsel for the respondents, we have given our anxious consideration to the rival submissions. Statutory Provisions 16. Before dealing with the submissions, we may refer to the relevant provisions of the Act and the Rules. The scheme of the PC&PNDT Act and Rules thereunder has very recently been examined by a Full Bench of this Court in Judgment dated 6 June 2011 in Writ Petition No.7869 of 2010. 17. The preamble to the Act which was initially enacted in 1994 and which underwent substantial amendments in 2003 indicates that it is an Act to provide for the prohibition of sex selection, before or after conception, and for regulations of pre-natal diagnostic techniques and for the prevention of their misuse for sex determination leading to female foeticide and for matters connected therewith or incidental thereto. 18. The Act came to be amended by Amendment Act 14 of 2003. The Statement of Objects and Reasons to the Amendment Act, inter alia, read as under :- “Amendment Act 14 of 2003 – Statement of Objects and Reasons.- The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 seeks to prohibit pre-natal diagnostic techniques for determination of sex of the foetus leading to female foeticide. During recent years, certain inadequacies and practical difficulties in the administration of the said Act have come to the notice of the 16 Government, which has necessitated amendments in the said Act. 2. The pre-natal diagnostic techniques like amniocentesis and sonography are useful for the detection of genetic or chromosomal disorders or congenital malformations or sex linked disorders, etc. However, the amniocentesis and sonography are being used on a large scale to detect the sex of the foetus and to terminate the pregnancy of the unborn child, if found to be female. Techniques are also being developed to select the sex or child before conception. These practices and techniques are considered discriminatory to the female sex and not conducive to the dignity of women. 3. The proliferation of the technologies mentioned above may, in future, precipitate a catastrophe in the form of severe imbalance in male female ratio. The State is also duty bound to intervene in such matters to uphold the welfare of the society, especially of the women and children. It is, therefore, necessary to enact and implement in letter and spirit a legislation to ban the pre conception sex selection