This article is written by Sankalpita Pal, currently pursuing BBA.LL.B (Hons) from Symbiosis Law School, Pune. This article attempts to throw light on the issue of unauthorized surgeries performed by people without a proper medical degree through case analysis.

Introduction

In 2018 the Uttarakhand High Court provided an insight into the one of the less talked about subjects in medico-legal cases i.e. unauthorised surgeries and the legality of surgeries done by people who don’t even hold an MBBS degree. In Ahmad Nabi v State of Uttarakhand and others, the Uttarakhand High Court finally cleared a few cues as it has passed a few directions for the State Government to follow. The court also passed an order that mandated hospitals and small-scale clinical establishments to strictly follow all the directives and rules under the Clinical Establishment (Registration and Regulation) Act, 2010. The case was decided by a Division Bench.

• Case no.: Writ Petition (PIL) No. 120 of 2016
• Decided on: August 14, 2018
• Coram: Acting Chief Justice Rajiv Sharma and Justice Manoj Tiwari

This article will provide an overview of the case and the necessary implications of the directives passed by the Uttarakhand High Court.

Overview of the case facts

The petitioner Ahmad Nabi filed a complaint against two hospitals namely Public Hospital Sarkari Road Kela Khera and BD Hospital Doraha Bazpur. This complaint was filed much before the actual Public Interest Litigation of 2016. In the complaint, the petitioner alleged both these hospitals were owned and run by medical practitioners who don’t really hold a proper medical degree. He also furnished proof that the hospitals were not even registered under the Clinical Establishments (Registration and Regulations) Act, 2010. 

Nabi further stated that the surgical operations were conducted by fake or possibly inexperienced people posing as surgeons who have no medical degree. Thus, paying heed to Nabi’s grave allegations the Chief Medical Officers of both the hospitals were issued notices respectively in March 2016. An enquiry was conducted with regard to the qualifications of the medical practitioners and the registration status of the hospitals and a report was filed.

After a thorough investigation was done Nabi’s allegations, in fact, turned out to be true. At the time in BD Hospital around 10 patients were admitted for surgery. However, there were no ‘doctors’ found at the hospital who held a bona fide MBBS degree. A similar scenario was found in the Public Hospital in Sarkari Rd Kela Khera. Consequently, both the hospitals were sealed. 

Subsequently, the court noted that even though the hospitals were not fully legally registered as required by the statute (Uttarakhand Clinical Establishments (Registration and Regulation) Rules, 2013); the State had provided them with provisional registration status. The Provisional status of registration was granted on the basis of 2 doctors who had a degree. It was later found out that these doctors didn’t really have an MBBS degree. One of them had a degree in BHMS (Homeopathic Medicine) and the other had a degree in BUMS (Unani Medicine). 

Petitioner’s contentions

The petitioner contended that the State government was negligent and had facilitated the violation of their own statute. The State was supposed to adhere to the mandates under the Uttarakhand Clinical Establishments (Registration and Regulation) Rules, 2013. Since the State granted provisional registration to the hospitals which facilitated the flourishing of the illegal establishments there was a violation of the Operational Guidelines for Clinical Establishment Act and Clinical Establishment Act Standard for Hospital (Levels 1A & 1B). 

State’s response

In response to the above contention, the state government issued an affidavit stating that necessary instructions were issued by the Chief Medical Officers to medical officers in both the hospitals.

Furthermore, the state explained as to why there was a non-compliance of Clinical Establishments (Registrations and Regulation) rules. The state informed that they received a request from the Indian Medical Association in which concerned authorities were required to keep the provisions under the Act in abeyance, as it would lead to the rise in expenditure of the patient by a significant percentage. Thus, Nainital’s District Magistrate had requested the Secretary (State of Uttarakhand) to keep all kinds of the registration procedure and documentation pending till the matter was reviewed.

Rules and provisions

• Section 2(c), Section 2(m), Section 8, Section 10, Section 11, Section 12, Section 32, Section 41, Section 45 and Section 52 of Clinical Establishments (Registration and Regulation) Act, 2010
• Operational Guidelines for Clinical Establishment Act and Clinical Establishment Act Standard for Hospital (Levels 1A & 1B)
• Clinical Establishments (Registration and Regulation) Rules, 2015 (passed by the central government)
• Rule 3 and Rule 13 of the Uttarakhand Clinical Establishments (Registration and Regulation) Rules, 2013 (passed by the state government)

Analysis of the court’s decision

The Uttarakhand High Court provided a very convincing statement. The Court observed that “once any legislative enactment is made it is the duty of the State to implement and carry it out in letter and spirit.” Later on to the court’s astonishment, it was further recorded that surgeries were, in fact, being performed by people with no formal degree in medicine. The evidence that backed up this fact was irrefutable. It is evident that the life and safety of unsuspecting patients admitted at the hospitals were at jeopardy.

It is to be noted that para 37 of the judgment mentions that life and safety of the patients of supreme consideration. The judgment also mentioned categorically that, “Right to life circumscribes Right to safety as well and medical facilities must be provided by duly qualified doctors. Also, the hospitals must contain all types of latest machinery needed to support the health sector. The Courts also noted a no. of cases where patients at private hospitals were overcharged and concluded that such shouldn’t be the case. The Court also stated that the rates of diagnostic tests, prescribed medicines and blood reports etc shall be available at a reasonable price. Unnecessary exorbitant prices put the patient and his/her family under a lot of financial pressure.

In the preceding paragraph of the judgment (para 36) the court stated that the fact that the surgeries in these two hospitals were performed by doctors having B.H.M.S. or Homeopathic medicine degree and B.U.M.S. or Unani Medicine Degree respectively. Surgical procedures are complex and a series of the necessary procedures has to be followed. On top of that, the hospital housed 10 patients admitted for surgery.

Furthermore, in paragraph 38, the court mentioned that it doesn’t make sense for the State Government to keep the enforcement of the said Act at abeyance. The enforcement of a valid Statute cannot be restricted by the state government; it is better to have no laws at all than to restrict the enforcement of one. It was also pointed out that the State of Uttarakhand also  adopted a certain set of standards with regard to medical infrastructure that needs to be followed mandatorily as provided under the Clinical Establishment Act Standard for Hospital (Level 1A & 1B).” These standards were also violated by the alleged hospitals.

Moving forward to paragraph 39, the court elaborated on what all equipment is supposed to be present in hospitals. The Standards laid down under the Clinical Establishment Act Standard for Hospital (Level 1A & 1B), a set of categorization of hospitals are provided which have to attain the minimum standards. The Standards provide that there should be proper segregation and collection of waste along with its responsible disposal as per law. Medical Records must be maintained in a physical and digital format. This is another important requirement as this helps in keeping a record of the medical history of a person that can be required for various purposes. The records must be kept confidential until an inevitable circumstance requires the hospital to reveal the records to the third party. The security and integrity of records must be maintained. Every patient admitted must be registered even if they are admitted for a short while. 

One of the most important constitutional references made by the court was that Article 47 of the Constitution puts an obligation on the State to maintain a standard for public health care by strictly applying the existing statutes in order to regulate the functioning of clinical establishments. It is the primary duty of the State to look after the public health facilities as every citizen has a Right to life (Article 21). Hence, with the objective to fulfil this responsibility, the Government must regulate what all clinical establishments are getting registered and also keep a check on the ones running without being registered. The State’s negligence or the unscrupulousness of its officials can facilitate illegal medical institutions to escape the law and harm public health. 

This act provides the definition of the collective term of “Clinical Establishment”. It also assigns the scope of ‘clinical establishment’. This term circumscribes hospitals, nursing homes, maternity homes, dispensaries, small-scale clinics etc or even any institution that offers services, and facilities that require real diagnosis and treatment of illness, care for injury etc. it also includes any governmental clinical establishment. Such establishments are wholly owned, controlled and managed solely by the government (few facilities and services may be outsourced); it can also be run by a trust or a corporation which is duly registered under the Central or the State Act.

Directives issued by the court

Lastly, para 40 which was the concluding part of the judgment. The Uttarakhand High Court issued a few mandatory direction:

• The Court mandated that it is the state’s responsibility to seal all kinds of clinical establishments if found to be not registered as required under the Clinical Establishments (Registration and Regulation) Act, 2010. 
• The state government must also ensure that all the running clinical establishments which are already registered under the 2010 Act, follow the Operational Guidelines for Clinical Establishments Act. The registered establishments are also required to strictly follow the standards laid down under the Clinical Establishment Act Standard for Hospital (Level 1A & 1B).
• The court had also observed that more often than not a lot of hospitals and clinics put their patients through unnecessary diagnostic tests. Thus, on account of such situations, the court directed that clinical establishments throughout Uttarakhand don’t put patients through unnecessary diagnostic tests. Only tests required to diagnose the actual clinical condition is permitted.
• Patients shouldn’t be forced to buy branded products when readily available generic medicines have the same effect. Thus, doctors practicing general medicine across the state of Uttarakhand (including government doctors) are required to prescribe only generic medicines.
• The state must set the rates at which various diagnostic tests or procedures etc are to be extended by clinical establishments. 
• The ITUs (Intensive Care Unit) is an important unit in every hospital. The outer wall of ITUs (one of its sides) shall have transparent glass having cloth curtains. This would enable the attendants of the patient to see the patient from afar. The attendants must be informed about the health/condition of the patient after every 12 hours.

Conclusion

In conclusion, it is a known fact that statistically, our country is already outshining itself in the pharmaceutical market at the global strata. If only Governments adhere to the mandates under Clinical Establishments (Registration and Regulation) Act, 2010 and strive to uphold the objective of the Act, then India’s Clinical sector can do wonders. 

It is clear that the whole objective behind the implementation of the standards laid down in this Act was to systematize the clinical establishments in India. The Act also aims at stringently compelling the medical care sector to adhere to certain standards and equip themselves with the best machinery. India is expected to fulfil these objectives. However, at present, the analysis of the facts of the Ahmad Nabi case shows that the Act is grossly violated not only by clinical establishments but also the State governments are at fault. Oftentimes an unauthorized surgery may lead to fatal consequences. Unregistered hospitals are set up for profit. The Act was passed in order to prevent this ad ministerial lacuna and brought all the clinical establishments under the government’s vigilance. There is still some hope and India still has a long way to go.

References

• http://www.legalservicesindia.com/law/article/1061/27/People-Without-A-Degree-Performing-Surgeries-Uttarakhand-HC-Directs-State-To-Seal-Hospitals-Not-Adhering-To-Clinical-Establishment-Act
• https://www.mondaq.com/india/healthcare/446404/an-overview-of-the-clinical-establishments-registration-and-regulation-act-2010
• http://clinicalestablishments.gov.in/En/1061-act-page.aspx

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