Kerala High Court Upholds Clinical Establishments Act, Dismisses Challenges by Medical Bodies

Ernakulam, Kerala – The Kerala High Court, in a significant judgment delivered on June 23, 2025, by the Honourable Mr. Justice Harisankar V.Menon , has upheld the constitutional validity of the Kerala Clinical Establishments (Registration and Regulation) Act, 2018, and the rules framed thereunder. The Court dismissed a batch of writ petitions filed by various medical associations challenging several provisions of the Act as unconstitutional, arbitrary, and unenforceable.

The petitioners included prominent bodies such as the Kerala Private Hospitals Association, the Indian Medical Association (Kerala State Branch), the Indian Dental Association, the Medical Laboratory Owners Association, and the Kerala Private Clinics Association. They contended that the Act, aimed at regulating clinical establishments to ensure public health standards, imposed unreasonable restrictions and vested unbridled powers in statutory authorities.

Background of the Challenge

The Kerala Clinical Establishments (Registration and Regulation) Act, 2018, was enacted to prescribe standards for facilities and services provided by clinical establishments, thereby improving public health. The Act covers a wide range of institutions, including hospitals, maternity homes, nursing homes, clinics, and laboratories.

The petitioners challenged various provisions concerning: * Registration requirements and data submission. * Display of "fee rate" and "package rate" for services. * Mandatory emergency treatment and safe transport of patients. * Powers of inspection, suspension, and cancellation of registration. * Penalties for non-compliance. * The inclusion of "dentistry" within the Act's purview. * The composition of the State Council and Executive Committee.

Key Arguments from Petitioners and Respondents

Petitioners' Contentions:

The primary arguments advanced by the petitioners, through senior counsel Sri. Kurian George Kannanthanam, Sri. George Poonthottam, and Sri. K.I. Mayankutty Mather, among others, included:

* Vagueness and Arbitrariness: Terms like "fee rate," "package rate," and "imminent danger to public health" were alleged to be undefined, leading to potential misuse by authorities.

* Unbridled Powers: Provisions related to suspension/cancellation of registration (Sections 14(3), 25) were claimed to grant excessive and unguided powers.

* Impracticality: Requirements such as emergency treatment (Section 47) and data submission were deemed impractical, especially for rural establishments.

* Privacy Concerns: Certain rules (Rule 24(7)(3)) were argued to invade patient privacy.

* Legislative Competence: The inclusion of "dentistry" was challenged, arguing it was not covered by the corresponding Central Act and that dentists were already regulated under the Dentists Act, 1948. It was also argued that the State could not enact this law due to the existence of a Central Act on the subject adopted by other states under Article 252.

* Procedural Fairness: Concerns were raised about the lack of opportunity for correction before cancellation and the inclusion of patient welfare representatives in expert bodies.

State's Defence:

Sri. Manoj Kumar, the State Attorney, representing the State of Kerala, countered that: * The Act's primary objective is to safeguard public health, ensure patient safety, promote transparency, and uphold ethical standards in clinical practice. * There is a presumption in favour of a statute's constitutionality, and courts do not examine the wisdom of the legislature but only look for violations of constitutional provisions. * Public interest in health must prevail over private interests. * The mere possibility of abuse of power is not a ground to strike down a statute. * Cancellation of registration and other regulatory actions are subject to due process of law, including notices and hearings. * The requirement to display rates was also in line with directions from the Apex Court.

Court's Reasoning and Key Findings

Justice Harisankar V.Menon meticulously examined the constitutional and legal arguments. The Court's reasoning pivoted on several key principles:

1. Legislative Competence: The Court affirmed the State of Kerala's legislative competence to enact the law under Entry 6 of List II (Public health and sanitation; hospitals and dispensaries) of the Seventh Schedule to the Constitution. The argument that the Central Clinical Establishments (Registration and Regulation) Act, 2010 (Central Act 23 of 2010), enacted under Article 252 at the request of some states, precluded Kerala from legislating was rejected. The Court clarified that Article 252 allows other states to adopt such central legislation by choice, but does not bar them from enacting their own laws on subjects within their legislative domain.

2. Grounds for Judicial Review of Legislation: Relying on the Supreme Court's decision in State of A.P. and Others v. McDowell & Co. and Others [(1996) 3 SCC 709] , the High Court reiterated that a law can be struck down only on two grounds: (1) lack of legislative competence, and (2) violation of any fundamental rights or other constitutional provisions.

"No enactment can be struck down by just saying that it is arbitrary or unreasonable. Some or other constitutional infirmity has to be found before invalidating an Act."

The Court found no such infirmity in the challenged Act.

3. Public Health as a Constitutional Mandate: The judgment emphasized the State's duty under Article 47 of the Constitution to improve public health, noting that "Right to health is integral to right to life" as held in State of Punjab and Others v. Mohinder Singh Chawla [(1997) 2 SCC 83] . The Court also cited State of Punjab v. Shiv Ram and Others [(2005) 7 SCC 1] on the growing need for external regulation in the medical profession due to commercialization.

4. On Display of Fee Rates (Section 39): The challenge to Section 39, requiring the display of "fee rate" and "package rate," was dismissed. The Court noted that the Supreme Court (in W.P(C) No.648 of 2020) and a Division Bench of the Kerala High Court (in Sabu P. Joseph v. State of Kerala [2021 (4) KHC 225] ) had already issued directions supporting such transparency. Some petitioners were parties to the earlier High Court case.

5. On Powers of Suspension/Cancellation (Sections 14 & 25): The Court found that the powers to suspend or cancel registration under Section 25 are not unbridled. Cancellation requires satisfaction of specific conditions (non-compliance or harmful acts), issuance of a show-cause notice, and a reasonable opportunity of hearing. The order takes effect after the appeal period or dismissal of appeal. The proviso allowing immediate restraint in cases of "imminent danger" requires reasons to be recorded in writing.

"A reading of the afore would show that the cancellation of registration is not merely for the asking, as portrayed by the petitioners." The Court also highlighted the availability of appellate (Section 34) and revisional (Section 35) remedies.

6. On Composition of State Council (Section 3): The inclusion of a representative from patient welfare organizations in the State Council and Executive Committee was deemed non-arbitrary, promoting inclusiveness alongside representatives from medical associations.

7. On Inclusion of Dentistry (Section 2(j)): The Court held that "dentistry" is a specialized department of medical science and falls within "modern medicine." The definition of "recognised system of medicine" in Section 2(j) explicitly includes "Modern Medicine (including dentistry)." The Court found no lack of legislative competence in this inclusion.

"From all the above, it is quite clear that dentistry is part of “modern medicine”, and it is made clear through the definition of dentistry under Section 2(j) of the Act."

Liberty to Address Practical Difficulties

While dismissing the writ petitions and upholding the Act, Justice Menon acknowledged the practical difficulties that clinical establishments might face in implementing certain provisions.

"Though, I have held that merely on account of the arbitrariness of a statute, the same do not require to be declared unconstitutional, I am of the opinion that liberty is to be granted to the petitioners to point out the practical difficulties faced by them before the Government and it is for the Government to consider the practical difficulties... and to adopt such remedial measures, which it deems fit..."

Conclusion

The Kerala High Court's decision robustly affirms the State's power to regulate clinical establishments to ensure public health and patient safety. By dismissing the challenges, the Court has reinforced the regulatory framework established by the 2018 Act. While the Act stands, the liberty granted to medical establishments to approach the government with practical implementation issues offers a pathway for addressing operational concerns within the legal framework. This judgment is a significant pronouncement on the balance between regulatory oversight and the operational autonomy of healthcare providers in Kerala.