On 1 October 2026, the Food Safety and Drugs Administration (“FDA”), issued a circular mandating all government, private and trust hospitals, nursing homes, clinics, day-care centres, diagnostic centres, and entities in the pharmaceutical supply chain licensed by the FDA, including C&F agents, stockists, distributors, wholesalers and retailers, in the State of Karnataka to disclose the “Landing/Base Price” of all medicines, medical devices and consumables in bills from 1 November 2026 (“Circular”).
Cyril Amarchand Mangaldas represented the Private Hospitals and Nursing Homes Association (PHANA) and others before the High Court of Karnataka in W.P. No. 33279/2026, challenging the Circular.
The writ petition challenges the Circular as being without jurisdiction, unconstitutional, arbitrary, and contrary to the statutory framework governing healthcare institutions. The principal grounds urged, inter alia, are: (i) The FDA has no statutory authority to regulate hospitals or impose obligations upon them through a circular. (ii) The Circular seeks to derive authority from the Clinical Establishments (Registration and Regulation) Act, 2010 and the Rules thereunder, which have not been adopted by the State of Karnataka under Article 252 of the Constitution of India. (iii) The requirement to disclose “Landing/ Base Price” is not present in any statute or rules, including the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder, the Karnataka Private Medical Establishments Act, 2007, the Legal Metrology (Packaged Commodities) Rules, 2011 etc. (iv) The FDA did not have the power to impose substantive obligations through a mere circular, despite no statute prescribing the same. (v) The Circular violates Article
The interim relief sought was not only on the grounds of unconstitutionality of the Circular but also the fact that compliance with the Circular would require healthcare establishments to establish entirely new billing processes, procure and deploy new software systems, train administrative and billing personnel, and implement these changes across hospitals, nursing homes, clinics and diagnostic centres within a period of one month. Given the scale of the operational changes involved, compliance within the prescribed timeline was impractical and would cause significant disruption to the functioning of healthcare institutions, requiring immediate intervention by the Court.
The Additional Advocate General appearing for the State contended that no prejudice would be caused if interim relief was declined and contended that the Circular merely required disclosure of the “Landing/Base Price”. On behalf of the Petitioners, this submission was opposed on the ground that the Circular is non-est in law.
Upon instructions, the Additional Advocate General gave an undertaking that the Circular would not be implemented until the next date of hearing. Based on this, the High Court has granted an interim order directing that the Circular shall not be insisted upon until the next date of hearing and adjourned the matter to 12 November 2026 for consideration of interim relief.
The team was led by Lomesh Kiran Nidumuri, Partner (Head—Disputes, South India); with Twinkle J Chadwa and Prashasti Bhat, Senior Associates; and Ajay T.K and Prajwal V, Associates; before the High Court of Karnataka.
Biplab Lenin, Partner; Priyam Rajkumar, Principal Associate-Designate; and Shriya Pandita, Associate; provided strategic inputs on the pharmaceutical and healthcare regulatory framework, drug pricing regime and industry-specific implications arising from the Circular.
