A Division Bench of the Kerala High Court dismissed two writ appeals filed by the Kerala Private Hospitals Association (KPHA) and the Indian Medical Association (IMA) challenging the constitutionality of Sections 16, 39, and 47 of the Kerala Clinical Establishments (Registration and Regulation) Act, 2018 and the 2018 Rules.
The bench of Justice Sushrut Arvind Dharmadhikari and Justice Syam Kumar V.M. held that these provisions are neither vague nor disproportionate and are in conformity with global standards
The appeals arose from a single-judge judgment dated June 23, 2025, that had upheld the regulatory framework introduced to standardise facilities, ensure transparency in pricing, and improve public health standards across clinical establishments in Kerala.
Appellants (private hospitals) argued that several provisions of the Act were vague and impractical, particularly the requirements to publish treatment rates and package costs, disclose detailed staff information, fulfil emergency care and transport obligations, and provide extensive documentation for registration. They contended that the Act failed to define key terms like “type of service” and “package,” making compliance difficult. They also raised concerns that publishing staff details could lead to privacy issues and potential poaching by competitors.
The State defended the Act as a public-health measure enacted under Entry 6 of List II, stressing that it was designed to ensure patient safety, ethical clinical practice, and transparency. It clarified that hospitals were not required to adopt uniform pricing, but only to publish the rates they themselves charge. The State also pointed out that many hospitals already display staff information voluntarily, and that the Act’s data-collection mechanisms maintain confidentiality by restricting access to authorised officials through secure government systems.
Upholding the single-judge decision, the High Court reiterated the strong presumption of constitutionality attached to welfare legislation designed to improve healthcare quality and ensure patient rights. The Bench emphasised that the appellants’ grievances, although framed as constitutional objections, were primarily rooted in administrative inconvenience, perceived burdens, and apprehensions of future misuse, none of which are valid grounds for striking down a statute.
Referring to R.K. Garg v. Union of India, (1981) (4) SCC 675, Rajbala v. State of Haryana, (2016) 2 SCC 445, and others, the Court held that the petitioners had failed to show any violation of Articles 14 or 19(1)(g). It emphasised that mere hardship in complying with a statute is not a ground to strike it down and that regulatory oversight in the healthcare sector is essential for ensuring minimum standards and patient protection.
The Court also analysed the alleged vagueness of Sections 39(2) and 39(3) requiring publication of fee rates and package rates. It held that the statutory obligation merely requires establishments to display their own actual rates, not a uniform, government-prescribed tariff. This, the Court observed, promotes transparency and enables patients to make informed decisions while simultaneously curbing overcharging. The argument that medical services vary too widely for advance display of rates was rejected on the ground that variability does not render the requirement arbitrary; it merely means that hospitals must display the prices they themselves adopt. The Bench found no vagueness in the statutory language, concluding that the provision serves the legitimate objective of patient protection.
On the grievance regarding Clause 12 of Form II, which seeks details of medical employees, the Court held that such information is neither excessive nor violative of privacy. The Court accepted the State’s submission that the information is stored securely in a government-controlled data system and accessible only to authorised officials.
The Court also held that the provision, which mandates safe transport for emergency patients, is essential to the legislature’s intent of strengthening emergency response in healthcare. It declined to accept the appellants’ argument that smaller hospitals lack the infrastructure to comply, stating that public health obligations cannot be diluted based on individual institutional limitations.
The Bench also rejected the challenge to the registration framework under Section 16, noting that the statute clearly prohibits operation of any clinical establishment without registration and provides fair procedural safeguards, including show-cause notices, opportunities for representation, and appellate remedies. The Court clarified that the statute mandates registration and that administrative formats or schedules do not dilute this requirement.
Ultimately, the Court held that the petitioners had failed to demonstrate any constitutional infirmity in the impugned provisions. It reaffirmed that judicial review does not extend to evaluating the wisdom of policy choices made by the legislature, especially in complex domains like healthcare regulation. The Bench found that the Act strikes a balance between institutional autonomy and public interest, aligns with Directive Principles, particularly Article 47.
Finding no arbitrariness or illegality in the provisions under challenge, the Division Bench dismissed both appeals and affirmed the validity of the Act and the Rules.
The Court has also issued the following guidelines to ensure the effective implementation of the Act:
1. Capacity-Graded Emergency Care: Every clinical establishment must screen and stabilise emergency patients within its capacity and ensure safe, documented transfer to higher centres. They shall never deny life-saving aid for want of payment or documents. Hospitals must provide all investigation reports and records along with the discharge summary at the time of discharge.
2. Transparency and Public Display: Each establishment must prominently display its services, baseline and package rates, facilities, patient rights, and grievance officer details in Malayalam and English at admission areas and on its website.
3. Patient Information Brochure: A patient information brochure in Malayalam and English must be provided at admission and online on the website, detailing services, rates, billing policies, insurance procedures, discharge steps, emergency protocols, and grievance mechanisms.
4. Grievance Redress Mechanism: A dedicated grievance desk or helpline must be maintained, issuing acknowledgements with unique reference numbers and attempting to resolve complaints within seven working days. Serious or unresolved complaints must be escalated to the District Medical Officer or District Registering Authority for further action. Hospitals must maintain a physical or electronic complaint register that is readily available for inspection by authorities.
5. Updates and Accuracy: All displayed rate lists, brochures and website information must be kept current, and any change in services, rates or grievance contacts must be promptly updated with the revision date clearly shown.
6. Compliance Requirements: Every clinical establishment must file an undertaking of compliance with Sections 39 and 47 and these directions within 30 days, and the District Registering Authority must conduct verification audits within 60 days and periodically thereafter, taking action for any deficiencies.
7. Patient Remedies: Patients may pursue remedies before the Consumer Commission, approach the police in cases involving fraud or cheating, escalate serious complaints to the Chief Secretary or State Police Chief, and seek help from Legal Services Authorities, with establishments required to cooperate fully and issue receipts for all payments and complaints.
8. Language and Accessibility: All mandatory notices, displays, brochures, and website information must be in clear Malayalam and English.
9. Non-Compliance: Non-compliance with these directions will attract regulatory action under the Act, including suspension or cancellation of registration and imposition of penalties, in addition to any civil, criminal, or constitutional remedies available to patients.
The Court has also directed the Chief Secretary, Government of Kerala, and the State Police Chief to issue appropriate notifications/orders and ensure strict compliance with the directions of the Court and procedures & directions given in the Act. They has also been directed to file detailed compliance reportwithin 30 days.
Appearances
Appellants- Sri V.V. Asokan, Senior Advocate Assisted by Sri K. Anand, Sri K.I. Mayankutty Mather, Senior Advocate Assisted by Smt. T.K. Sreekala, Smt. S. Parvathi, Smt. Nikitha Susan Paulson, Smt. Uthara Asokan.
Respondents- Shri N. Manoj Kumar, Government Pleader / State Attorney, Shri S. Kannan, Senior Government Pleader, Sri Ajith Joy.
