Dr Narendra Gupta Versus Union Of India & ORS.

SUPREME COURT REPORTS [2023] 6 S.C.R.

[2023] 6 S.C.R. 992 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 Hysterectomies - Constitution of India - Art.

21 - Violation of Fundamental Rights of Women - Guidelines to Prevent Unnecessary Hysterectomies - A public interest litigation was filed by the petitioner in 2013, highlighting the issue of unnecessary hysterectomies being performed under various government healthcare schemes in various States - Petitioner has brought to Supreme Court's 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 and also submitted that most women who were subjected to hysterectomies of this kind belonged to the Scheduled Castes, Scheduled Tribes, or Other Backward Communities - On 13.12.

2022, Supreme Court directed the Secretary, MoHFW to examine the grievance which was raised and to file a response - From the counter affidavits filed by the Various States, it emerged that there is a considerable degree of substance in the facts which have been highlighted in the petition - In 2022, MoHFW issued guidelines titled "Guidelines to Prevent Unnecessary Hysterectomies," which have been forwarded to all the States and Union Territories for compliance - The Union government also filed the status report proposing the action plan and indicating the steps which were taken by various States while dealing with the performance of unnecessary hysterectomies - Held: The right to health is an intrinsic element of the right to life u/Art.

DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

hysterectomies must be adopted by all the States and Union Territories - MoHFW shall engage with all the States and Union Territories to ensure that the Guidelines are adopted expeditiously - All States and Union Territories directed to adopt and implement the Guidelines and report compliance to MoHFW and further ensure that all public and private hospitals within their territories are made aware of the existence and importance of the Guidelines - All the States and Union Territories must take stringent action 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 directed that necessary action be taken in accordance with law - The Union 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, Gurmeet 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

1. A 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,

SUPREME COURT REPORTS [2023] 6 S.C.R.

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 petitioner also submitted that most women who were subjected to hysterectomies of this kind belonged to the Scheduled Castes, Scheduled Tribes, or Other Backward Communities.

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

3. Before we advert to the status report which has been filed 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 substance 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 been apprised of the fact that several hospitals have been blacklisted and deempanelled from the Rashtriya Swasthya Bima Yojana pursuant to the investigation conducted in the state. In certain cases, First Information Reports have been filed.

4. The 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"

DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI] Powered Committee which found that the hysterectomies in the state could not be termed as "wholly unneeded."

5. The 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.

6. In 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 Guidelines 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 evidence indicates a higher risk among poor, less educated women, particularly in the rural areas.

7. Paragraphs 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"

SUPREME COURT REPORTS [2023] 6 S.C.R.

Chhattisgarh, Uttar Pradesh, Jharkhand, Gujarat, Maharashtra and Karnataka - generated three quarters of all hysterectomy claims."

8. In 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 use of hysterectomies, particularly for treatment of benign gynaecological conditions and amongst younger women.

9. Chapter 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 health facilities. The Guidelines note that reporting of hysterectomies, cases conducted 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 Officers, 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 sectors to submit a line list of all women who underwent

DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI] 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 report • Any severe morbidity/mortality due to hysterectomy

SUPREME COURT REPORTS [2023] 6 S.C.R.

• 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 must 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 level, representatives from FOGSI (both public and private sector), representatives from development partners etc.

The monitoring 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 arrange 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."

10. The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana which provides an annual health cover of Rs. 5 lakhs per family has

DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI] been extended to cover twelve crore families across the nation. The scheme covers the treatment of 1949 procedures, including hysterectomies under 27 different specialties. As of 16 March 2023, 45,434 hospital admissions were authorized under this scheme for hysterectomy related treatments. Two Standard Treatment Guidelines 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 purpose of hysterectomies under the Scheme.

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

12. The Union government has proposed an action plan in its status report, which is set out below:

"E. PROPOSED ACTION PLAN

10. Setting Up of Grievance Portal - It is pertinent to mention here that the Rasthriya Swasthya Bima Yojana (RSBY) has been subsumed in PMJAY with the launch of Ayushman BharatPradhan 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 hysterectomy beneficiaries within a period of three months. Any grievance received on the portal will be monitored by the National Hysterectomy Monitoring Committee.

11. Formation 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 implementation of the National Guidelines can be properly monitored and supervised."

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13. The Guidelines which have been adopted by MoHFW to prevent unnecessary hysterectomies must be adopted by all the States and Union Territories. MoHFW shall engage with all the Statesand Union Territories to ensure that the Guidelines are adopted expeditiously. We direct that:

a.

All States and Union Territories shall adopt the Guidelines within three months and report compliance to MoHFW; b.

All the States and Union Territories shall implement the 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.

14. Ms.Kawalpreet Kaur, counsel appearing on behalf of the petitioner, has urged two submissions which seek to supplement 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 of the procedure has to be certified by at least two doctors. The suggestion is that this requirement should be extended to other cases as well, irrespective of the age of the woman undergoing a hysterectomy.

15. Responding 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 certain States already have such a procedure in place, the network of government hospitals may not be adequate enough to implement such a regulation 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 treatment to women who are genuinely in the need of it. It has been submitted that since the

DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI] situation is evolving, the Union of India would take a considered view once adequate data is available.

16. We accept the submission.

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

18. The second suggestion which has been urged on behalf of the petitioner is that the state should take steps for blacklisting hospitals where hysterectomies were carried out without medical necessity 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 methods 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.

19. We are in agreement with the submission that all the States and Union Territories must take stringent action 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. We direct that necessary action be taken in accordance with law.

20. Since 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.

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

22. We 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.

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

24. Pending applications, if any, stand disposed of.

SUPREME COURT REPORTS [2023] 6 S.C.R.

DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI]

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI]

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI]

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI]

SUPREME COURT REPORTS [2023] 6 S.C.R.

DR NARENDRA GUPTA v. UNION OF INDIA & ORS.

[DR. DHANANJAYA Y CHANDRACHUD, CJI] Ankit Gyan Directions issued.

(Assisted by : Aarsh Choudhary, LCRA)