Kerala High Court: In a case that challenged the constitutionality of various provisions of the Kerala Clinical Establishments Act (Registration and Regulation), 2018 (the ‘Act’), the Division Bench of Sushrut Arvind Dharmadhikari* and Syam Kumar V.M., JJ. , dismissed the writ appeals and held that the Act and its Rules were neither unconstitutional nor arbitrary, but rather a carefully designed social welfare legislation to safeguard patient rights, ensure transparency, and maintain minimum standards of healthcare facilities.
Background:
The appellants challenged the provisions of the Act and the Kerala Clinical Establishments (Registration and Regulation) Rules, 2018 (the ‘Rules’) made thereunder. They contended that these provisions and requirements were arbitrary, impractical, and ultra vires the parent legislation, and lacked adequate statutory safeguards or definitions. The lack of clarity regarding what constituted a ‘type of service’ or a ‘package’, made compliance impossible and invited arbitrary enforcement, thereby violating Articles 14 and 19(1)(g) of the Constitution. They also alleged that the blanket application of Section 47 of the Act, which mandated ‘safe transport’ for victims in emergencies, was impractical.
The appellants argued that publishing the details pertaining to doctors and other staff on a public platform could lead to its misuse by competing institutions for poaching or other unfair practices, thereby affecting the operational integrity and competitive standing of the hospital. They alleged that by merely granting the liberty to raise practical difficulties before the Government, the Single Judge refused to adjudicate the validity of the impugned provisions, which left it to the Government’s discretion to address the difficulties faced by hospitals, thereby undermining the appellants’ fundamental rights under Articles 14, 19(1)(g), and 21 of the Constitution.
However, the State Attorney submitted that there is always a presumption in favour of the constitutionality of a statute. He contended that the appellants had misconceived the scope of the authority’s powers under the Act, and that the provisions of the Act and the Rules did not confer un-canalized or unguided powers on the statutory authorities, thereby making the alleged chance of misuse imaginary. He argued that the possibility or chance of abuse or misuse of a statutory provision should not be a guiding factor when considering the constitutionality or validity of a statute.
The State Attorney further submitted that the difficulties in implementation were imaginary, misconceived, and misplaced. It is a trite law that hardship, by itself, in implementing the provisions of an Act does not constitute grounds for declaring the said provision unconstitutional. If a Parliamentary Act is valid and constitutional, it cannot be held ultra vires merely because a party faces some difficulty in implementing the same.
He also stated that the details and data of the staff collected by the Council was stored in the State Data Center and managed by the Government of Kerala, and could only be accessed by the State Administrator, the District Registering Authority concerned, and the clinical establishment itself. Moreover, the details and data entered by the respective clinical establishments in the official portal were secure and would remain confidential.
Issues:
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Whether the Act (particularly Sections 16(2), 39(2), and 39(3), along with the allied rules and forms) is unconstitutional, ultra vires, arbitrary, or illegal?
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Whether the impugned Rules and Schedules are ultra vires the Constitution as well as the Act?
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Whether the Single Judge erred in sustaining the framework and in applying comparative and constitutional standards as provided under the Act?
Analysis:
A. On the constitutionality of the Act
The Court opined that the doctrine of presumption of constitutionality holds that a law passed by a competent legislature is presumed to be constitutional unless proven otherwise. The burden of proof lies with the party challenging the law to clearly demonstrate that it violates a constitutional provision. The Court observed that the Act does not create new constraints; rather, it operationalises the constitutional duties through a registration-cum-standards regime, a transparency mandate, and enforceable minimum requirements for emergency care and stabilisation.
B. On the plea of vagueness of Section 39
The Court rejected the plea of vagueness as raised by the appellants while challenging Section 39 and observed that the terms ‘types of service’ and ‘package rates’ were well-understood in Indian healthcare administration as there was a baseline package for common procedures with defined inclusions and exclusions. The Act does not require clairvoyant pre-pricing of every possible clinical contingency; it just mandates good faith baseline tariffs for identifiable services and packages, with itemized billing for add-ons, complications, and extended stays.
C. On the plea of privacy violation
The Court followed K.S. Puttaswamy (Privacy-9J.) v. Union of India, (2017) 10 SCC 1, and observed that regarding the details of the staff and the alleged privacy violation, the regulator’s need to verify minimum staffing, competence, and 24×7 coverage was axiomatic in a standards-based regime. The data was to be furnished to the registering authority for oversight, and there was no mandate to publish personal information publicly. The Court further observed that the concerns regarding ‘poaching’ or RTI disclosure could not override patient safety.
D. On the aspect of ‘safe transfer’ under Section 47
The Court noted that on the emergency stabilisation and ‘safe transfer’, while compliance may be challenging for small clinics, Section 47 of the Act mirrors World Health Organisation stabilization guidelines and EMTALA duties: screen, stabilise within capacity, and ensure safe transfer. The prohibition against refusal to provide treatment due to inability to make immediate payment vindicates Article 21 of the Constitution.
E. On the challenge to ultra vires
The Court opined that categorisation by bed strength was a rational proxy for capacity and risk profile, as it informed fees, inspection frequency, staffing minima, and equipment requirements. Form 2A’s particulars were ancillary to registration and standards verification. The Rules and Schedules did not supplant the Act, rather they implemented it, and accordingly, the Court declined the challenge.
F. On the issue of Arbitrariness
The Court observed that the impugned provisions addressed recognised harms, restrictive and unfair trade practice of billing, understaffing, denial of emergency care, and afforded procedural safeguards. They were neither capricious nor excessive, and therefore, not arbitrary.
G. Clarification of ‘package rates’ (Section 39)
The Court explained that ‘package rates’ referred to baseline tariffs for commonly performed procedures with standard inclusions. Unforeseen complications, management of co-morbidities, extended ICU stays, and high-end consumables might be billed separately, provided there is disclosure and clinical justification.
H. Clarification of staff data (Form 2A)
The Court directed that the authority must frame guidelines on confidentiality, purpose limitation, access control, and retention, and the publication of the staff data to the public was not required unless specifically authorised by law.
I. Compliance with Section 47
The Court observed that compliance with Section 47 was capacity graded. All establishments must provide first aid and stabilization to the extent feasible and ensure safe transfer, including communication, documentation, and transport. No establishment must deny initial lifesaving aid on account of non-payment or lapses in documentation.
Decision:
The Court upheld the validity of the impugned Sections 16, 39, and 47 of the Act, along with the allied Rules and Schedules. It was held that the provisions are neither vague nor disproportionate and are in conformity with global standards. Therefore, the Court affirmed the decision of the Single Judge and dismissed the writ appeals.
Further, the Court also issued the following guidelines:
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Capacity-Graded Emergency Care – Every clinical establishment must provide immediate screening and stabilization of emergency patients, and arrange safe transfer to a higher center if necessary, with proper documentation and communication. No establishment must deny life-saving aid due to non-payment of advance or lack of documents. Upon discharge, hospitals must hand over the discharge summary along with all investigation reports.
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Transparency and Public Display – Each clinical establishment must prominently display, in Malayalam and English, at the reception/admission desk and on its website, the services offered, baseline and package rates with itemisation for unforeseen procedures, key facility details, a summary of patients’ rights, and the contact details of the Grievance Officer along with District Registering Authority/DMO helpline details. Any change in services, rates, or grievance contact details must be promptly updated, with the date of revision clearly indicated.
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Patient Information Brochure – Every hospital must provide a brochure in Malayalam and English outlining key details including services offered, treatment rates and packages, deposit/refund rules, insurance and claim procedures, billing and discharge policies, ambulance/transport charges, emergency care protocols, and grievance redressal mechanisms.
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Grievance Redress Mechanism – Every clinical establishment must maintain a Grievance Desk/Helpline and a Complaint register to register complaints with a unique reference number. All complaints must be resolved within seven working days, with unresolved or serious matters escalated to the District Registering Authority/DMO.
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Compliance with the Act – Every clinical establishment must submit an undertaking of compliance with Sections 39 and 47 of the Act within 30 days of this judgment to the District Registering Authority, which shall conduct verification audits within 60 days.
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Patient Remedies – Patients can pursue remedies for service deficiencies before the Consumer Disputes Redressal Commission, lodge complaints with local police, escalate serious grievances to the Chief Secretary or State Police Chief, and seek assistance from Legal Services Authorities.
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Language and Accessibility – All mandatory displays, notices, and brochures must be in Malayalam and English and prominently visible at reception areas, other key locations, and on the establishment’s website homepage.
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Non-Compliance – Non-compliance with the guidelines will invite action under the Act, including suspension or cancellation of registration and penalties, in addition to other patient remedies.
[Kerala Private Hospitals Assn. v. State of Kerala, WA No. 1621 of 2025, decided on 26-11-2025]
*Judgment authored by: Justice Sushrut Arvind Dharmadhikari
Advocates who appeared in this case:
For the Appellants: V.V. Asokan (SR); K. Anand, T.K. Sreekala, S. Parvathi, Nikitha Susan Paulson, Uthara Asokan, K.I. Mayankutty Mather (SR.), Advocates.
For the Respondents: Government Pleader N. Manoj Kumar, State Attorney S. Kannan, Senior G.P. Ajith Joy.
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