Dr Narendra Gupta v. Union of India & Ors.

DR NARENDRA GUPTA v. UNION OF INDIA & ORS. (Writ Petition (Civil) No. 131 of 2013) APRIL 05, 2023 [DR. DHANANJAYA Y CHANDRACHUD, CJI AND J. B. PARDIWALA, J.] Directions by Supreme Court – Unnecessary Hysterecto mies – Constitution of India – Art.21 – Violation of Fundamental Rig hts of Women – Guidelines to Prevent Unnecessary Hysterectomies – A public interest litigation was filed by the petitio ner in 2013, highlighting the issue of unnecessary hysterectomie s being performed under various government healthcare schemes in vari ous States – Petitioner has brought to Supreme Court’s not ice the fact that women, who should not have been subjected to hysterecto mies and to whom alternative treatment could have been extended, wer e subjected to hysterectomies, seriously endangering the ir health in the process and also submitted that most women who were su bjected to hysterectomies of this kind belonged to the Sche duled Castes, Scheduled Tribes, or Other Backward Communities – O n

13.12.2022, Supreme Court directed the Secretary, M oHFW to examine the grievance which was raised and to file a response – From the counter affidavits filed by the Various Stat es, it emerged that there is a considerable degree of substance in the f acts which have been highlighted in the petition – In 2022, Mo HFW issued guidelines titled “Guidelines to Prevent Unnecessar y Hysterectomies,”which have been forwarded to all the States and Union Territories for compliance – The Union government also f iled the status report proposing the action plan and indicating the steps which were taken by various States while dealing wi th the performance of unnecessary hysterectomies – Held: T he right to health is an intrinsic element of the right to life u/Art . 21 and there has been a serious violation of the fundamental rights of the w omen who underwent unnecessary hysterectomies – Further, that the Guidelines which have been adopted to prevent unnec essary hysterectomies must be adopted by all the States an d Union Territories – MoHFW shall engage with all the State s and Union Territories to ensure that the Guidelines are adopte d expeditiously – All States and Union Territories directed to adopt and impl ement the Guidelines and report compliance to MoHFW and further ensu re that all public and private hospitals within their territor ies are made aware of the existence and importance of the Guideline s – All the States and Union Territories must take stringent ac tion for blacklisting hospitals once it is detected that any unnecessary hysterectomy was carried out or that the procedure was taken recourse to without the informed consent of the patient and dire cted that necessary action be taken in accordance with law – The Uni on government directed to take all necessary steps in accordance with the Guidelines to effectuate the public interest which is sought to be achieved. CIVIL ORIGINAL JURISDICTION: Writ Petition (Civil) No. 131 of 2013. Under Article 32 of The Constitution of India Ms. Aishwarya Bhati, Jayant K Sud, A.S.Gs., Dr. Manish Singhvi, S. C. Verma, Sr. Advs., Ms. Kawalpreet Kaur, Satya Mitra, Gur meet Singh Makker, Dr. Arun Kumar Yadav, Digvijay Dam, Praveena Gautam, Akshit Pradhan, A K Kaul, Abhinav Mukerji, Akshay Shrivastava, Mrs. Bihu Sharma, Ms. Pratishtha Vij, Arpit Parkash, Ms. Shubhangi Agarwal, Milind Kumar, Sumeer Sodhi, Gaurav Arora Advs. for the appearing parties. The Judgment of the Court was delivered by DR. DHANANJAYA Y CHANDRACHUD, CJI

¶1A public interest litigation has been instituted by Dr Narendra Gupta in 2013 highlighting the fact that in the States of Bihar, Chhattisgarh and Rajasthan, in particular, “unnecessary hysterectomies” were carried out under the Rashtriya Swasthya Bima Yojana as well as other government schemes related to healthcare. The petition also highlights the involvement of private hospitals in performing such hysterectomies. The Union Ministry of Health and Family Welfare1 is the first respondent, while the States of Bihar, Rajasthan and Chhattisgarh are impleaded as the second, third and fourth respondents respectively. Based on his field work, the petitioner has brought to our notice the fact that women, who should not have been subjected to hysterectomies and to whom alternative treatment could have been extended, were subjected to hysterectomies, seriously endangering their health in the process. The pet itioner also submitted that most women who were subjected to hysterect omies of this kind belonged to the Scheduled Castes, Scheduled Tribes, or Other Backward Communities.

¶2On 13 December 2022, this Court directed the Secre tary, MoHFW to examine the grievance which was raised in the petition and to file a response after collating relevant information.

¶3Before we advert to the status report which has been fi led by the Union of India, it must be recorded, at the outset, that from the counter affidavits filed by the States of Rajasthan, Bihar and Chhattisgarh, it emerges that there is a considerable degree of substanc e in the facts which have been highlighted in the petition. For instance, the affidavit filed by the State of Bihar indicates that steps were taken by the district authorities in Kishanganj, Madhubani, Samastipur and Saran to enquire into complaints regarding unnecessary hysterectomies. Finding that many of the allegations in regard to the performance of unnecessary hysterectomies were true, the State has taken consequential action. It issued a circular inter alia directing that empanelled hospitals must obtain permission from the concerned insurance provider before conducting hysterectomies on women aged forty or below. This Court has be en apprised of the fact that several hospitals have been blacklisted and de-empanelled from the Rashtriya Swasthya Bima Yojana pursuant to the investigation conducted in the state. In certain cases, First Information Reports have been filed.

¶4The State of Rajasthan has placed on the record the steps which were taken by the District Collector, Dausa for constituting committees to enquire into the alleged incidents. The State of Rajasthan framed the Rajasthan Government Clinical Establishments (Registration and Regulation) Rules 2013.The State of Chhattisgarh constituted a High 1 “MoHFW” Powered Committee which found that the hysterectomies in the state could not be termed as “wholly unneeded.”

¶5The right to health is an intrinsic element of the right to life under Article 21 of the Constitution. Life, to be enjoyed in all its diverse elements, must be based on robust conditions of health. There has been a serious violation of the fundamental rights of the women who underwent unnecessary hysterectomies.

¶6In 2022, MoHFW issued guidelines titled “Guidelines to Prevent Unnecessary Hysterectomies,” 2 which have been forwarded to all the States and Union Territories for compliance. The Gu idelines were formulated after a series of consultations with different stake holders. The Guidelines indicate that while in developed countries hysterectomies are typically conducted amongst pre-menopausal women above the age of forty-five years, in India, community based studies have consistently found rising hysterectomy rates among young women, ranging from twenty-eight to thirty-six years of age. Field based studies have indicated that unnecessary hysterectomies are performed in cases where medical or non-invasive treatment would have been sufficient. The e vidence indicates a higher risk among poor, less educated women, particularly in the rural areas.

¶7Paragraphs 5.1.3 to 5.1.5 of the affidavit filed by the Secretary, MoHFW are set out below: “5.1.3. Data from National Family Health Survey-4 (2015-16) estimates hysterectomy prevalence to be 3.6% amongst women aged 36-39 years, 9.2% amongst women aged 40-49 years and the median age for hysterectomy is 37 years.

5.1.4 Notably, two-thirds of the procedures were conducted in private facilities.

5.1.5 A working paper from the National Health Authority on early trends from AB-PMJAY indicates that 2% of the claims submitted by women were for hysterectomy. Notably, six states – 2 “Guidelines” [DR. DHANANJAYA Y CHANDRACHUD, CJI] Chhattisgarh, Uttar Pradesh, Jharkhand, Gujarat, Maharashtra and Karnataka – generated three quarters of all hysterectomy claims.”

¶8In 2019, a national consultation on unnecessary hysterectomies identified three important challenges: a. The need for appropriate clinical and population level guidelines; b. Availability of appropriate information on and treatment of gynaecological morbidity at the primary level; and c. The critical need to monitor and regulate the appropriate us e of hysterectomies, particularly for treatment of be nign gynaecological conditions and amongst younger women.

¶9Chapter 3 of the Guidelines provides guidance on prevention of unnecessary hysterectomies. It refers to the role of programme managers and also refers to the role of different levels of public he alth facilities. The Guidelines note that reporting of hysterectomies, cases conduct ed for women less than 40 years of age and the cause of the hysterectomy have to be incorporated in the existing screening checklist. To achieve this, the Guidelines propose the setting up of Hysterectomy Monitoring Committees at District, State and National levels. Chapter 3 also deals with District, State and National Hysterectomy Monitoring Committees in the following terms: “District Hysterectomy Monitoring Committees A District Hysterectomy Monitoring Committee must be set up in each district to enable effective monitoring. The committee must be set up under the chairpersonship of District CMO. NCD Nodal, District RCH Nodal Officers/ Maternal Health Nodal Offic ers, other key government personnel at the district level, representatives from FOGSI (both public and private sector), representatives from development partners etc. The monitoring committee is expected to: • Issue necessary orders to both public and private sect ors to submit a line list of all women who underwent hysterectomy every month. The line list must include information on parameters such as: • Age • Parity • Occupation • Indication of hysterectomy • Previous medical/surgical history • Hysterectomy route: • Abdominal • Vaginal • Laparoscopic • Any other surgery done along with hysterectomy: • Past treatment history: • HPE: • Every quarter the district committee must audit cases with following indications and issue necessary instructions if required: • Hysterectomy with/ without BSO in women <35 yrs. of age • Hysterectomy with BSO in women< 40 yrs. of age • All cases where no indication for doing the procedure is mentioned in the records • All cases where no records of treatment prior to hysterectomy (in papers or in history) are available • Discrepancy between mentioned indication and HPE repor t • Any severe morbidity/mortality due to hysterectomy [DR. DHANANJAYA Y CHANDRACHUD, CJI] • Annexure 3 provides detailed guidelines on how to conduct audits of hysterectomies • Arrange necessary trainings and sensitization sessions for both public and private sector professionals. State Hysterectomy Monitoring Committees A State Hysterectomy Monitoring Committee must be set up in each State to enable effective monitoring. The committee mu st be set up under the chairpersonship of State Principle Secretary. State level DPH (Director Pubtic Health) will be the nodal Officer & NCD State program officer, RCH/FW/MH programme officers will be the other key government personnel at the state l evel, representatives from FOGSI (both public and private s ector), representatives from development partners etc. The monitori ng committee is expected to meet once in every six months and review district level data to ensure that unnecessary hysterectomies can be avoided. The State Hysterectomy Monitoring Committees must also arrange necessary trainings and sensitization sessions for both public and private sector professionals and district officials. National Hysterectomy Monitoring Committees A National Hysterectomy Monitoring Committee must be set up to enable effective monitoring and ensure necessary policy decisions at the National level. The monitoring committee would comprise of officials from NCD, ICMR, MH Officers under the chairpersonship of Additional Commisssioner& Mission Director, NHM and is expected to meet once in every six months and review State level data to ensure that unnecessary hysterectomies can be avoided. The national committees must also arr ange necessary trainings and sensitization sessions for both public and private sector professionals and district officials. Most importantly national committees must review the landscape and take necessary policy decisions as required.”

¶10The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana which provides an annual health cover of Rs. 5 lakhs per famil y has been extended to cover twelve crore families across the na tion. The scheme covers the treatment of 1949 procedures, inc luding hysterectomies under 27 different specialties. As of 16 M arch 2023, 45,434 hospital admissions were authorized under this scheme for hysterectomy related treatments. Two Standard Treatment G uidelines have been developed for fourteen procedures relating to hysterectomies. The Union government has set out the details of procedures and State/ UT-wise details of authorized hospital admissions for the p urpose of hysterectomies under the Scheme.

¶11Besides setting out the provisions of the Guidelines, the status report filed by the Union government indicates the steps wh ich were taken by the States of Chhattisgarh and Bihar while deali ng with the performance of unnecessary hysterectomies.

¶12The Union government has proposed an action plan in its status report, which is set out below: “E. PROPOSED ACTION PLAN

¶10Setting Up of Grievance Portal - It is pertinent to m ention here that the Rasthriya Swasthya Bima Yojana (RSBY) has been subsumed in PMJAY with the launch of Ayushman Bhara t-Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) on 23.09.2018. The PMJAY website hosts a grievance portal for its beneficiaries. An additional grievance portal would also be maintained by National Health Authority especially designed for PMJAY beneficiaries of hysterectomies. The proposed portal will be activated for hysterect omy beneficiaries within a period of three months. Any grieva nce received on the portal will be monitored by the Nat ional Hysterectomy Monitoring Committee.

¶11Formation of Committees – The Ministry will endeavour to form a National Hysterectomy Monitoring Committee, as proposed under the Guidelines within 4 to 6 weeks. Simultaneously the states will also be continuously advised to expedite formation of the state and district level committees so that the implementati on of the National Guidelines can be properly monitored and supervised.” [DR. DHANANJAYA Y CHANDRACHUD, CJI]

¶13The Guidelines which have been adopted by MoHFW to prevent unnecessary hysterectomies must be adopted by all t he States and Union Territories. MoHFW shall engage with all the Sta tesand Union Territories to ensure that the Guidelines are adopted expeditiously. We direct that: a. All States and Union Territories shall adopt the Guidel ines within three months and report compliance to MoHFW; b. All the States and Union Territories shall implement t he Guidelines without delayand report compliance to MoHFW; and c. All the States and Union Territories shall ensure that all public and private hospitals within their territories are made aware of the existence and importance of the Guidelines. The Guidelines, for convenience of reference, are annexed to this judgment as Annexure A to facilitate compliance.

¶14Ms.Kawalpreet Kaur, counsel appearing on behalf of th e petitioner, has urged two submissions which seek to supplem ent the Guidelines. Firstly, it has been submitted that under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, where a hysterectomy is performed on a woman below the age of forty years, the requirement o f the procedure has to be certified by at least two doctors. The suggestion is that this requirement should be extended to other c ases as well, irrespective of the age of the woman undergoing a hysterectomy.

¶15Responding to the above submission of Ms Kawalpreet Kaur, Ms Aishwarya Bhati, Additional Solicitor General, submits that once the full data on hysterectomies is duly captured on the portal of MoHFW and the National, State, and District Level Committees are constituted, a considered decision will be taken by the Union of India on this aspect. The Additional Solicitor General submitted that while cert ain States already have such a procedure in place, the network of govern ment hospitals may not be adequate enough to implement such a regula tion across India even if it were made.Moreover, the ASG urged that there is a real danger that this may result in the denial of trea tment to women who are genuinely in the need of it. It has been submitted that since the situation is evolving, the Union of India would take a considered view once adequate data is available.

¶16We accept the submission.

¶17The Guidelines mandate that the National Committee should review the landscape and take necessary policy decisions, as require d, once in every six months.

¶18The second suggestion which has been urged on behalf of the petitioner is that the state should take steps for blac klisting hospitals where hysterectomies were carried out without medical nec essity and without obtaining the informed consent of the patient. In this context, it was urged that as a first line of treatment, other non-invasive me thods should be adopted and, in any event, the woman who is undergoing the hysterectomy should be properly informed about the reason and likely consequences of the hysterectomy, bearing on the health of the patient.

¶19We are in agreement with the submission that all t he States and Union Territories must take stringent action for blacklisting hospitals once it is detected that any unnecessary hysterectomy wa s carried out or that the procedure was taken recourse to without the informed consent of the patient. We direct that necessary action be tak en in accordance with law.

¶20Since steps have been taken by the Union government in framing the Guidelines in 2022 and the States of Chhattisgarh, Bihar and Rajasthan have indicated to the Court of the steps which were taken to detect unnecessary hysterectomies and to deal with them, we see no further reason to keep the petition alive.

¶21The Union government shall take all necessary step s in accordance with the Guidelines to effectuate the public interest which is sought to be achieved.

¶22We appreciate the assistance which has been rendered to the Court by Ms Kawalpreet Kaur, counsel appearing on behalf of the petitioner and Ms Aishwarya Bhati, Additional Solicitor General.

¶23The petition is disposed of in terms of the above directions.

¶24Pending applications, if any, stand disposed of. [DR. DHANANJAYA Y CHANDRACHUD, CJI]

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Ankit Gyan Directions issued. (Assisted by : Aarsh Choudhary, LCRA) [DR. DHANANJAYA Y CHANDRACHUD, CJI]