DR NARENDRA GUPTA versus UNION OF INDIA & ORS. on 5 April 2023

1. A public interest litigation has been instituted by Dr NarendraGupta in 2013 highlighting the fact that in the States of Bihar, Chhattisgarhand Rajasthan, in particular, “unnecessary hysterectomies” were carriedout under the Rashtriya Swasthya Bima Yojana as well as othergovernment schemes related to healthcare. The petition also highlightsthe involvement of private hospitals in performing such hysterectomies.The Union Ministry of Health and Family Welfare[1] is the first respondent, AB

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Awhile the States of Bihar, Rajasthan and Chhattisgarh are impleaded asthe second, third and fourth respondents respectively. Based on his fieldwork, the petitioner has brought to our notice the fact that women, whoshould not have been subjected to hysterectomies and to whom alternativetreatment could have been extended, were subjected to hysterectomies,Bseriously endangering their health in the process. The petitioner alsosubmitted that most women who were subjected to hysterectomies ofthis kind belonged to the Scheduled Castes, Scheduled Tribes, or OtherBackward Communities.

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

3. Before we advert to the status report which has been filed bythe Union of India, it must be recorded, at the outset, that from thecounter affidavits filed by the States of Rajasthan, Bihar and Chhattisgarh,Dit emerges that there is a considerable degree of substance in the factswhich have been highlighted in the petition. For instance, the affidavitfiled by the State of Bihar indicates that steps were taken by the districtauthorities in Kishanganj, Madhubani, Samastipur and Saran to enquireinto complaints regarding unnecessary hysterectomies. Finding that manyEof the allegations in regard to the performance of unnecessaryhysterectomies were true, the State has taken consequential action. Itissued a circular inter alia directing that empanelled hospitals must obtainpermission from the concerned insurance provider before conductinghysterectomies on women aged forty or below. This Court has beenapprised of the fact that several hospitals have been blacklisted and de-Fempanelled from the Rashtriya Swasthya Bima Yojana pursuant to theinvestigation conducted in the state. In certain cases, First InformationReports have been filed.

4. The State of Rajasthan has placed on the record the stepswhich were taken by the District Collector, Dausa for constitutingGcommittees to enquire into the alleged incidents. The State of Rajasthanframed the Rajasthan Government Clinical Establishments (Registrationand Regulation) Rules 2013.The State of Chhattisgarh constituted a High Powered Committee which found that the hysterectomies in the statecould not be termed as “wholly unneeded.”

5. The right to health is an intrinsic element of the right to lifeunder Article 21 of the Constitution. Life, to be enjoyed in all its diverseelements, must be based on robust conditions of health. There has beena serious violation of the fundamental rights of the women who underwentunnecessary hysterectomies.

6. In 2022, MoHFW issued guidelines titled “Guidelines to PreventUnnecessary Hysterectomies,”[2] which have been forwarded to all theStates and Union Territories for compliance. The Guidelines wereformulated after a series of consultations with different stake holders.The Guidelines indicate that while in developed countries hysterectomiesare typically conducted amongst pre-menopausal women above the ageof forty-five years, in India, community based studies have consistentlyfound rising hysterectomy rates among young women, ranging fromtwenty-eight to thirty-six years of age. Field based studies have indicatedthat unnecessary hysterectomies are performed in cases where medicalor non-invasive treatment would have been sufficient. The evidenceindicates a higher risk among poor, less educated women, particularly inthe 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 womenaged 36-39 years, 9.2% amongst women aged 40-49 years andthe median age for hysterectomy is 37 years.

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

5.1.5 A working paper from the National Health Authority on earlytrends from AB-PMJAY indicates that 2% of the claims submittedby women were for hysterectomy. Notably, six states –

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AChhattisgarh, Uttar Pradesh, Jharkhand, Gujarat, Maharashtra andKarnataka – generated three quarters of all hysterectomy claims.”

8. In 2019, a national consultation on unnecessary hysterectomiesidentified three important challenges:

Ba.The need for appropriate clinical and population levelguidelines; b.Availability of appropriate information on and treatment ofgynaecological morbidity at the primary level; and C

c.The critical need to monitor and regulate the appropriate useof hysterectomies, particularly for treatment of benigngynaecological conditions and amongst younger women.

9. Chapter 3 of the Guidelines provides guidance on prevention ofunnecessary hysterectomies. It refers to the role of programme managersDand also refers to the role of different levels of public health facilities.The Guidelines note that reporting of hysterectomies, cases conductedfor women less than 40 years of age and the cause of the hysterectomyhave to be incorporated in the existing screening checklist. To achievethis, the Guidelines propose the setting up of Hysterectomy MonitoringECommittees at District, State and National levels. Chapter 3 also dealswith District, State and National Hysterectomy Monitoring Committeesin the following terms:

“District Hysterectomy Monitoring Committees A District Hysterectomy Monitoring Committee must be set up inFeach district to enable effective monitoring. The committee mustbe 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, representativesfrom FOGSI (both public and private sector), representatives fromGdevelopment partners etc. The monitoring committee is expectedto:

•Issue necessary orders to both public and private sectorsto submit a line list of all women who underwent H

hysterectomy every month. The line list must includeinformation 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 withfollowing indications and issue necessary instructions if required:

•Hysterectomy with/ without BSO in women <35 yrs. ofage •Hysterectomy with BSO in women< 40 yrs. of age •All cases where no indication for doing the procedure ismentioned in the records •All cases where no records of treatment prior tohysterectomy (in papers or in history) are available •Discrepancy between mentioned indication and HPE report •Any severe morbidity/mortality due to hysterectomy A

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A•Annexure 3 provides detailed guidelines on how to conductaudits of hysterectomies •Arrange necessary trainings and sensitization sessions forboth public and private sector professionals.

BState Hysterectomy Monitoring Committees

A State Hysterectomy Monitoring Committee must be set up ineach State to enable effective monitoring. The committee mustbe set up under the chairpersonship of State Principle Secretary.State level DPH (Director Pubtic Health) will be the nodal OfficerC& NCD State program officer, RCH/FW/MH programme officerswill be the other key government personnel at the state level,representatives from FOGSI (both public and private sector),representatives from development partners etc. The monitoringcommittee is expected to meet once in every six months and reviewDdistrict level data to ensure that unnecessary hysterectomies canbe avoided. The State Hysterectomy Monitoring Committees mustalso arrange necessary trainings and sensitization sessions for bothpublic and private sector professionals and district officials.

National Hysterectomy Monitoring Committees E

A National Hysterectomy Monitoring Committee must be set upto enable effective monitoring and ensure necessary policydecisions at the National level. The monitoring committee wouldcomprise of officials from NCD, ICMR, MH Officers under thechairpersonship of Additional Commisssioner& Mission Director,FNHM and is expected to meet once in every six months andreview State level data to ensure that unnecessary hysterectomiescan be avoided. The national committees must also arrangenecessary trainings and sensitization sessions for both public andprivate sector professionals and district officials. Most importantlyGnational committees must review the landscape and take necessarypolicy decisions as required.”

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

been extended to cover twelve crore families across the nation. Thescheme covers the treatment of 1949 procedures, includinghysterectomies under 27 different specialties. As of 16 March 2023,45,434 hospital admissions were authorized under this scheme forhysterectomy related treatments. Two Standard Treatment Guidelineshave 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 ofhysterectomies under the Scheme.

11. Besides setting out the provisions of the Guidelines, the statusreport filed by the Union government indicates the steps which weretaken by the States of Chhattisgarh and Bihar while dealing with theperformance of unnecessary hysterectomies.

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

“E. PROPOSED ACTION PLAN

10. Setting Up of Grievance Portal - It is pertinent to mentionhere that the Rasthriya Swasthya Bima Yojana (RSBY) has beensubsumed in PMJAY with the launch of Ayushman Bharat-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 NationalHealth Authority especially designed for PMJAY beneficiaries ofhysterectomies.

The proposed portal will be activated for hysterectomybeneficiaries within a period of three months. Any grievancereceived on the portal will be monitored by the NationalHysterectomy Monitoring Committee.

11. Formation of Committees – The Ministry will endeavour toform a National Hysterectomy Monitoring Committee, as proposedunder the Guidelines within 4 to 6 weeks. Simultaneously the stateswill also be continuously advised to expedite formation of the stateand district level committees so that the implementation of theNational Guidelines can be properly monitored and supervised.”

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A13. The Guidelines which have been adopted by MoHFW toprevent unnecessary hysterectomies must be adopted by all the Statesand Union Territories. MoHFW shall engage with all the StatesandUnion Territories to ensure that the Guidelines are adopted expeditiously.We direct that:B

a.All States and Union Territories shall adopt the Guidelineswithin three months and report compliance to MoHFW; C

b.All the States and Union Territories shall implement theGuidelines without delayand report compliance to MoHFW;and

c.All the States and Union Territories shall ensure that all publicand private hospitals within their territories are made awareof the existence and importance of the Guidelines.

The Guidelines, for convenience of reference, are annexed to thisDjudgment as Annexure A to facilitate compliance.

14. Ms.Kawalpreet Kaur, counsel appearing on behalf of thepetitioner, has urged two submissions which seek to supplement theGuidelines. Firstly, it has been submitted that under the Ayushman BharatEPradhan Mantri Jan Arogya Yojana, where a hysterectomy is performedon a woman below the age of forty years, the requirement of theprocedure has to be certified by at least two doctors. The suggestion isthat this requirement should be extended to other cases as well,irrespective of the age of the woman undergoing a hysterectomy.

F15. Responding to the above submission of Ms Kawalpreet Kaur,Ms Aishwarya Bhati, Additional Solicitor General, submits that once thefull data on hysterectomies is duly captured on the portal of MoHFWand 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 StatesGalready have such a procedure in place, the network of governmenthospitals may not be adequate enough to implement such a regulationacross India even if it were made.Moreover, the ASG urged that there isa real danger that this may result in the denial of treatment to womenwho are genuinely in the need of it. It has been submitted that since the H

situation is evolving, the Union of India would take a considered viewonce adequate data is available.

16. We accept the submission.

17. The Guidelines mandate that the National Committee shouldreview 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 thepetitioner is that the state should take steps for blacklisting hospitalswhere hysterectomies were carried out without medical necessity andwithout obtaining the informed consent of the patient. In this context, itwas urged that as a first line of treatment, other non-invasive methodsshould be adopted and, in any event, the woman who is undergoing thehysterectomy should be properly informed about the reason and likelyconsequences of the hysterectomy, bearing on the health of the patient.

19. We are in agreement with the submission that all the Statesand Union Territories must take stringent action for blacklisting hospitalsonce it is detected that any unnecessary hysterectomy was carried outor that the procedure was taken recourse to without the informed consentof the patient. We direct that necessary action be taken in accordancewith law.

20. Since steps have been taken by the Union government inframing the Guidelines in 2022 and the States of Chhattisgarh, Bihar andRajasthan have indicated to the Court of the steps which were taken todetect unnecessary hysterectomies and to deal with them, we see nofurther reason to keep the petition alive.

21. The Union government shall take all necessary steps inaccordance with the Guidelines to effectuate the public interest which issought to be achieved.

22. We appreciate the assistance which has been rendered to theCourt by Ms Kawalpreet Kaur, counsel appearing on behalf of thepetitioner 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.

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DR NARENDRA GUPTA v. UNION OF INDIA & ORS.1045[DR. DHANANJAYA Y CHANDRACHUD, CJI]ABCDEFGAnkit GyanDirections issued.(Assisted by : Aarsh Choudhary, LCRA)H