Checking The Pulse - Recent Legal Developments In The Indian Healthcare And Pharma Sector

In the past couple of months, India’s healthcare and pharmaceutical sectors have undergone a series of structural reforms and policy adjustments, highlighting a clear focus on enhancing patient-centricity, strengthening quality standards, and streamlining regulatory compliance.

Recent developments indicate a sustained effort to strengthen and modernise India’s healthcare and pharmaceutical regulatory framework. These include revisions to national drug quality standards, reforms to drug procurement under public health schemes, announcement of a trade agreement between India and the European Union, and healthcare-specific measures proposed in the Union Budget for 2026–27. In parallel, regulatory initiatives in the medical devices sector reflect an increasing emphasis on risk-based oversight, digitisation of regulatory approvals, and support for innovation, while continuing to prioritise patient safety.

Collectively, these developments signal a sustained effort towards a more predictable, transparent, and patient-centric healthcare ecosystem in India.

In this edition of Checking the Pulse, we examine key policy, regulatory, and judicial updates from December 2025 and January 2026.

1. Union Government releases 10th edition of Indian Pharmacopoeia to update national drug standards

On January 2, 2026, the Indian Pharmacopoeia Commission, under the Ministry of Health and Family Welfare (“MoHFW”), published the Indian Pharmacopoeia 2026 (“IP 2026”), thereby marking the 10^th (tenth) edition of India’s official compendium of drug quality standards under the Drugs and Cosmetics Act, 1940 (“DCA”). [1]  IP 2026 supersedes the previous edition of the Indian Pharmacopoeia and prescribes authoritative and legally enforceable standards for drugs manufactured, distributed, and marketed in India. Additionally, the introduction pages to the IP 2026 clarify that any monographs not included in this edition shall continue to remain valid, unless specifically withdrawn.

IP 2026 incorporates 121 (one hundred and twenty-one) new monographs, thereby expanding coverage across therapeutic categories and reinforcing quality benchmarks for medicines. The updated standards under IP 2026 include drug substances, pharmaceutical dosage forms, biological and biotechnology-derived products, vaccines, immunosera, radiopharmaceuticals, herbal products, and blood and blood components.

A significant regulatory development in IP 2026 is the first-time inclusion of monographs for blood and blood component products in compliance with the Drugs Rules, 1945. These monographs introduce detailed standards to strengthen quality assurance and standardization in transfusion-related articles in IP 2026.

The IP 2026 has been structured across 4 (four) volumes, consolidating general notices, monographs, and reference data amongst others to improve usability for regulators, manufacturers, quality professionals, and laboratories. It also reflects continued efforts towards harmonization of Indian drug standards with international pharmacopeial standards and practices through global collaboration.

As India’s official book of drug standards, IP 2026 plays a central role in licensing, inspection, quality control, and regulatory enforcement under the DCA. Further, it underscores the Central Government’s ongoing focus on updating pharmaceutical quality standards in line with scientific advances, public health needs, and international best practices.

2. Government introduces Drug Procurement Policy in Central Government Health Scheme to strengthen medicine supply and quality

On January 15, 2026, the MoHFW issued a comprehensive Drug Procurement Policy for the Central Government Health Scheme (“CGHS”), thereby replacing the previous approaches to medicine sourcing and supply under the CGHS (“DP Policy”). [2]  The DP Policy has been circulated as an office memorandum for adoption by all CGHS establishments across the country.

CGHS is a flagship healthcare programme administered by the Central Government that provides comprehensive healthcare to Central Government employees, pensioners, members of the parliament, former members of the parliament and their dependents in CGHS-covered cities. The CGHS covers a wide range of services, including outpatient consultations, diagnostic tests, hospitalization, and medicines, and seeks to ensure cashless or reimbursable healthcare access for its beneficiaries. Presently, 4.2 million (four million and two hundred thousand) beneficiaries are covered by CGHS in 81 (eighty one) cities through 350 (three hundred and fifty) wellness centers.

The objective of the DP Policy is to ensure an uninterrupted, quality-assured, cost-effective, and transparent supply of medicines to CGHS beneficiaries across the country. It standardizes the drug procurement process by laying down detailed procedures covering the selection of drugs, formulation of the CGHS formulary, and eligibility criteria for inclusion in the CGHS database of medicines.

The DP Policy provides that bulk procurement of drugs shall be undertaken by the competent authority only through central agencies such as the Medical Stores Organization and the Pharmaceuticals and Medical Devices Bureau of India, while also permitting local procurement only in cases of urgency. It further mandates the maintenance of buffer stocks and the enforcement of strict quality assurance requirements, including compliance with IP 2026 standards and Good Manufacturing Practices (GMP) prescribed by World Health Organization.

To ensure uniform and effective implementation of these objectives, the MoHFW has directed the Directorate of CGHS to issue subsequent operational orders, guidelines, and clarifications applicable across all CGHS dispensaries.

3. MoHFW notifies amendments to New Drugs and Clinical Trials Rules to streamline research approvals and reduce regulatory timelines

On January 20, 2026, and January 21, 2026, the MoHFW notified the New Drugs and Clinical Trials (Amendment) Rules, 2026 [3],  and the New Drugs and Clinical Trials (Second Amendment) Rules, 2026  [4]  respectively, (collectively, “NDCT Amendment Rules”), thereby amending the New Drugs and Clinical Trials Rules, 2019 (“NDCT Rules”) under the DCA.

The NDCT Amendment Rules seek to simplify regulatory processes, reduce approval timelines, and facilitate research and development activities, particularly at the pre-clinical and bioavailability/ bioequivalence (“BA/ BE”) study stages. At the same time, the proposed changes continue to retain safeguards relating to patient safety, ethics oversight, and regulatory supervision.

The key changes introduced by the NDCT Amendment Rules are:

(a) Introduction of prior-intimation framework for manufacturing of new drugs and unapproved active pharmaceutical ingredients: Rule 52 of the NDCT Rules, governing the manufacture of new drugs and investigational new drugs for clinical trials, BA/ BE studies, examination, test and analysis, has been amended to replace references to ‘permission’ with ‘permission or prior-intimation’. Consequential amendments have been carried out across Rules 54 to 58 and Rules 60 to 64 to align conditions of manufacture, record-keeping, suspension, cancellation, and appeal mechanisms with the new prior-intimation framework.

As per the amended Rule 52(1), manufacturers carrying out analytical or non-clinical testing of new drugs or investigational new drugs (other than specified high-risk categories) may now begin manufacturing after submitting an online prior-intimation application in Form CT-10 and receiving an acknowledgement from the Central Licensing Authority (“CLA”).

Similarly, as per the amended Rule 59(1), manufacturers of pharmaceutical formulations and active pharmaceutical ingredients (“APIs”) undertaking the same activities may commence manufacturing after submitting prior-intimation applications in Form CT-12 and Form CT-13, respectively, and receiving acknowledgement from the CLA.

The NDCT Amendment Rules materially change the application of the NDCT Rules by creating a dual regulatory pathway. Manufacturers can now manufacture limited quantities of drugs for research, testing, and analysis, and initiate low-risk bioavailability and bioequivalence studies upon submitting an online intimation to the Central Drugs Standard Control Organization (“CDSCO”) through the SUGAM portal and receiving acknowledgement of the notice of intent. For higher-risk categories, including psychotropic and narcotic drugs, permission from CDSCO remains mandatory.

(b) Reduction of statutory timelines for grant of manufacturing permissions: Under Rules 53 and 60 of the NDCT Rules, which govern permissions for manufacture of new drugs, investigational new drugs, and unapproved APIs respectively, the timelines for grant of manufacturing permissions have been significantly reduced from 90 (ninety) to 45 (forty-five) working days. This reduction accelerates regulatory processing for applicants who fall under the permission-based framework.

(c) Introduction of prior-intimation framework for specific export-oriented BA/ BE studies: A new proviso has been inserted under Rule 31 of the NDCT Rules to permit initiation of certain single-dose, two-period, two-sequence, two-treatment BA/ BE studies in healthy adult human volunteers for export purposes only, upon submission of an online prior-intimation in Form CT-05 and its acknowledgement by the CLA. This pathway applies only to oral dosage forms of drugs already approved in India or in specified foreign jurisdictions and expressly excludes certain drugs such as cytotoxic, hormone, narcotic and psychotropic substances. Additional safeguards include mandatory prior approval by a registered Ethics Committee (“EC”), minimum sample size requirement of 18 (eighteen) subjects, and enhanced record-keeping obligations by ECs. This amendment facilitates faster commencement of export-focused BA/ BE studies while preserving ethical oversight and participant safety.

Further, to operationalize the BA/ BE prior-intimation route, corresponding amendments have been made to Rules 33, 35, 36, 37, and 38 of the NDCT Rules, extending references to ‘permissions’ to include ‘acknowledgements of prior-intimation’. These changes ensure that requirements relating to fees, validity periods, extensions, reporting obligations, inspections, and compliance apply uniformly to both permission-based and prior-intimation-based BA/ BE studies.

1. Parliamentary Standing Committee recommends strengthening of drug price regulation framework

On December 1, 2025, the Parliamentary Standing Committee on Chemicals and Fertilizers (“Standing Committee”) presented its report titled ‘Price Rise of Medicines in the Pharmaceutical Sector Impacting the Lives of Ordinary Citizens Adversely - A Review’ before the Lok Sabha (“Report”). [5]  The Report recommends significant reforms to India’s drug price regulation framework, including strengthening the statutory powers of the National Pharmaceutical Pricing Authority (“NPPA”) to improve drug affordability and strengthen regulatory oversight in the pharmaceutical sector.

The NPPA is the primary authority responsible for regulating drug prices in India under the Drugs (Prices Control) Order, 2013. Under the current framework, the NPPA is empowered to fix ceiling prices only for medicines listed in the National List of Essential Medicines (“NLEM”). Medicines falling outside the NLEM, including several widely prescribed formulations and fixed-dose combinations (“FDCs”), are not subject to direct price control and are regulated only through a statutory cap of 10% (ten percent) on annual increases in maximum retail price (“MRP”).

In the Report, the Standing Committee observed that this regulatory structure has resulted in significant gaps in price regulation, particularly in relation to non-scheduled medicines, such as Sucralfate and Rifabutin. It noted that manufacturers determine launch prices for such medicines without regulatory oversight and that, in the absence of an initial price fixation mechanism, the post-launch price increase cap alone has limited effectiveness in addressing the affordability concerns for patients.

The Report also highlighted concerns relating to wide and opaque trade margins across the pharmaceutical supply chain. It noted the absence of a transparent and institutionalized mechanism to monitor price-to-stockist data, which restricts the ability of regulators and the public to assess the pricing practices across manufacturers, distributors, and retailers. In this context, the Report emphasized that the trade margins should be regulated through a permanent, legally supported system, instead of temporary or ad-hoc measures, particularly for high-value and life-saving medicines such as anti-cancer drugs.

Further, the Standing Committee expressed concerns regarding fixed dose combinations which remain largely outside the price control framework despite being widely prescribed. It noted that the exclusion of such formulations from price regulation raises issues of affordability as well as rational drug use. It also observed the absence of a statutory mechanism enabling systematic cost audits of medicines, which constrains the NPPA’s ability to assess the justification for high MRPs, particularly for high-value and critical medicines such as anti-cancer drugs.

2. India–European Union Trade Deal expected to strengthen pharmaceutical and healthcare market access and regulatory cooperation

On January 27, 2026, India and the European Union (“EU”) concluded negotiations on a comprehensive Free Trade Agreement (“FTA”), by releasing a factsheet outlining the broad contours of the FTA (“FTA Factsheet”). [6]  While the FTA is yet to be released to the public, the FTA Factsheet signals a significant forward-looking shift in trade, regulatory cooperation, and market access across key sectors, including pharmaceuticals, medical devices, and healthcare services, against the backdrop of a combined India–EU market estimated at approximately USD 24 trillion (United States Dollars Twenty Four Trillion) around the time of release of the FTA Factsheet.

From a healthcare and life sciences perspective, the FTA is expected to reduce tariff barriers, improve regulatory predictability, and facilitate closer alignment between Indian and EU regulatory frameworks, thereby enhancing bilateral trade and investment flows in the sector.

The FTA Factsheet sets out several crucial changes such as:

(a) Improved market access for pharmaceuticals and medical products: As per the FTA Factsheet, the FTA is expected to progressively eliminate or reduce tariffs of up to 6.7% (six point seven percent) across 99.1% (ninety nine point one percent) of trade lines covering medical instruments, appliances, and vital healthcare supplies. This is likely to enable cost-competitive entry of Indian medical devices, such as measuring and testing instruments, lenses, and spectacles, into the EU market.

(b)  Zero-duty access and regulatory certainty for pharmaceutical exports: The FTA Factsheet indicates that the FTA delivers preferential access across 97% (ninety seven percent) of tariff lines, covering 99.5% (ninety nine point five percent) of India’s export value, which is expected to include APIs, bulk drugs, and finished formulations. Given that India is among the world’s largest suppliers of cost-effective generics, the FTA is likely to enhance the competitiveness of Indian pharmaceutical exports in the EU by removing residual tariff barriers and offering greater regulatory predictability.

(c) Regulatory cooperation and convergence in healthcare standards: A key pillar of the proposed trade deal is enhanced regulatory cooperation, including commitments towards transparency, stakeholder consultation, and information exchange between regulators. In the pharmaceutical and medical devices context, this is expected to facilitate greater dialogue between Indian authorities and EU regulators on technical standards, quality requirements, and conformity assessment procedures. Over time, such cooperation may reduce duplicative compliance burdens and improve clarity for manufacturers navigating both jurisdictions. 

Collectively, the proposed tariff liberalization, regulatory alignment, and market-access commitments under the India–EU FTA are expected to create meaningful opportunities for Indian pharmaceutical and medical device manufacturers to integrate more deeply into European value chains. At a time when the EU is seeking diversified and resilient supply sources, Indian healthcare companies are well positioned to leverage the FTA to expand exports, deepen regulatory collaboration, and strengthen India’s role as a trusted global healthcare supplier.

3. Union Budget 2026-2027 announces Biopharma SHAKTI and other relief measures for healthcare sector

On February 1, 2026, the Union Minister for Finance and Corporate Affairs presented the Union Budget 2026-2027 (“Budget”), announcing several initiatives for India's healthcare and pharmaceutical sector. [7]  The Budget places emphasis on biologics and biosimilar manufacturing, healthcare workforce expansion, medical value tourism, traditional medicine, and public health infrastructure, reflecting a continued focus on long-term capacity creation and regulatory strengthening. The following are the proposed initiatives announced in the Budget:

(a) Biopharma SHAKTI: The Budget proposes the launch of Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation) (“Biopharma SHAKTI Scheme”) with an outlay of INR 100 billion (Indian Rupees One Hundred Billion) over the next 5 (five) years. 

The Biopharma SHAKTI Scheme aims to provide for the establishment of 3 (three) new National Institutes of Pharmaceutical Education and Research (“NIPER”) along with the upgradation of the existing 7 (seven) NIPERs. To further strengthen India's position as a preferred destination for clinical research, the Biopharma SHAKTI Scheme aims to create a network of over 1,000 (one thousand) accredited India Clinical Trials sites across the country.

(b) Customs duty exemptions on life-saving medicines: The Budget proposes to exempt 17 (seventeen) drugs and medicines such as Ribociclib, Tremelimumab, Tislelizumab, and Venetoclax from basic customs duty, to ease the burden on patients, particularly those undergoing cancer treatment. Additionally, 7 (seven) further rare diseases, including Cystinosis, Hereditary Angioedema, and Primary Immune Deficiency Disorder, have been added to the list of medicines eligible for import duty exemptions.

(c) Customs duty policy changes: The Budget proposed the extension of basic customs duty exemption/ concessional rates on import of goods related to the healthcare and pharmaceutical sector, including medical and surgical instruments, which were due to expire on March 31, 2026, up to March 31, 2028.

(d) Customs process reforms and ease of doing business: Recognizing that India's role and share in global trade is poised for a major leap, the Budget proposes that the approvals required for cargo clearance from various government agencies shall be seamlessly processed through a single and interconnected digital window by the end of the financial year.

The healthcare and pharmaceutical announcements in the Budget collectively mark a significant step toward building a robust, innovation-driven, and globally competitive pharmaceutical and biopharmaceutical sector in India.

1. MoHFW publishes Draft Notification proposing significant amendments to the Medical Devices Rules, 2017

On December 4, 2025, the MoHFW, after consultation with the Drugs Technical Advisory Board, issued a draft notification proposing amendments to the Medical Devices Rules, 2017 (“MD Rules”) to be introduced through the Medical Devices (Amendment) Rules, 2024 (“MD Amendment Rules”). [8]  The MD Amendment Rules seek to streamline the regulatory processes for medical devices by rationalizing licensing requirements, improving regulatory clarity for Class A (Non-Sterile and Non-Measuring) medical devices (“Class A Medical Devices”), and strengthening post-market oversight.

The proposed changes focus on easing compliance for manufacturers and importers while enhancing transparency through enhanced documentation, testing, and inspection mechanisms under the existing regulatory framework.

The key changes proposed to be introduced by the MD Amendment Rules are:

(a) Introduction of registration numbers for Class A Medical Devices: The MD Amendment Rules insert references to ‘Registration Number’ or ‘Reg. No.’ for Class A Medical Devices, particularly in Rule 44 (labelling of medical devices) and (a)      Rule 45 (exemption of labelling requirements for export of medical devices). Manufacturers and importers shall mention ‘Registration Number’ or ‘Reg. No.’ on labels and import documents.

These changes formally acknowledge that Class A medical devices follow a registration-based process. As a result, the labelling requirements are now aligned with the registration system under the MD Rules.

(b) Rationalization of inspection, record-keeping, and testing obligations: The MD Amendment Rules introduce several procedural refinements to inspection and testing mechanisms. Rule 85 (conditions of registration) is amended to mandate that registration certificate holders furnish test or evaluation reports of medical devices in the newly introduced Form MD-44. Form MD-44 requires detailed disclosures relating to batch numbers, raw materials, and testing protocols amongst other details. Additionally, Rule 85(ix) is amended to require the registration certificate holder to maintain an inspection book in Form MD-11.

Further, Form MD-11 (Inspection Book) is amended to expressly include registration holders alongside licensees, make references to registration numbers wherever applicable, and remove the requirement of digital signatures. Additionally, Forms MD-36, MD-37, and MD-38 are updated to introduce standardized tables that capture detailed sample information about medical devices.

The MD Amendment Rules are expected to significantly reduce regulatory friction for the manufacturers and importers by eliminating periodic license renewals and enhancing certainty around the validity of regulatory approvals. Collectively, these reforms simplify compliance, enhance regulatory predictability, and ensure the effective implementation of the MD Rules, while also maintaining safeguards for quality, safety, and performance of medical devices.

2. CDSCO introduces online risk classification module to streamline medical device approvals

On December 4, 2025, CDSCO issued a circular introducing a new risk classification module (“Classification Module”) on the CDSCO Online System for Medical Devices (“Online Portal”) to streamline regulatory approvals under the MD Rules. [9]  The Classification Module became operational with effect from November 27, 2025. It applies to medical devices other than in vitro diagnostic (“IVD”) medical devices and is intended to simplify the process of obtaining an official risk classification for devices that are not already included in the existing CDSCO classification lists.

The revised mechanism enables applicants to submit requests for risk classification under MD Rules directly through the Online Portal, thereby replacing the earlier manual mechanisms. This is particularly relevant for manufacturers or importers of novel or less commonly marketed medical devices, where ambiguity regarding the appropriate risk class often leads to procedural delays at the licensing stage. The introduction of the Classification Module forms part of CDSCO’s broader efforts to digitize regulatory processes and improve transparency and predictability.

Under the MD Rules, medical devices (other than IVDs) are classified into four risk-based categories in accordance with Rule 4 of chapter II read with Part I of the First Schedule. These include: (a) Class A (low-risk medical devices); (b) Class B (low to moderate-risk medical devices); (c) Class C (moderate to high-risk medical devices); and (d) Class D (high-risk medical devices).

IVD medical devices are classified separately under Part II of the First Schedule. The CLA is empowered under the MD Rules to determine the appropriate risk classification of a medical device having regard to its intended use, mode of action, duration of use, degree of invasiveness, and other prescribed parameters. The CLA may also update classification lists or reclassify devices as regulatory understanding and technological developments evolve.

3. CDSCO and Indian Council of Medical Research release MedTech Mitra handbook for IVD medical device innovators

On December 5, 2025, the CDSCO, in collaboration with the Indian Council of Medical Research (“ICMR”), released the MedTech Mitra In Vitro Diagnostic Innovators Handbook (“Handbook”) to support innovators and developers in navigating the regulatory and clinical requirements applicable to IVD medical devices. [10]  The Handbook is intended to operate within, and complement, the regulatory framework prescribed under the MD Rules and does not introduce a separate regulatory regime.

The Handbook consolidates regulatory expectations, best practices, and internationally harmonized standards into a single guidance document, with the objective of enabling innovators to integrate regulatory and quality considerations at an early stage of product development. It is particularly targeted at early-stage developers and first-time manufacturers who may lack familiarity with India’s medical device regulatory ecosystem, particularly in relation to IVDs.

Structurally, the Handbook is organized into 6 (six) chapters and provides a step-by-step roadmap that guides innovators through each stage of the IVD product lifecycle, beginning with the identification of unmet clinical needs and progressing through product development, validation, regulatory approval, and commercialization.

A key feature of the Handbook is the inclusion of chapter-wise ‘To-Do Lists’, which translate regulatory and quality requirements into actionable compliance steps for innovators and manufacturers to ensure that their IVD devices meet the required safety, efficacy, and quality standards mandated by regulatory authorities. These chapter-wise checklists address, inter alia: (a) determination of device classification under the MD Rules; (b) performance evaluation and validation requirements for IVDs; (c) risk management and safety assessment; (d) quality management system compliance, including alignment with applicable standards; and (e) post-market surveillance and vigilance obligations.

By presenting regulatory requirements in a structured and sequential manner, the Handbook seeks to reduce ambiguity, minimize avoidable regulatory missteps, and improve the readiness of IVD products for subsequent market entry. It also encourages alignment with globally accepted principles which can facilitate potential access to international markets for Indian IVD innovations.

The release of the Handbook forms part of the broader MedTech Mitra initiative, jointly spearheaded by CDSCO and ICMR under the guidance of NITI Aayog (the policy think tank of the Government of India), which aims to strengthen India’s medical technology ecosystem, particularly in the IVD segment.

1. Delhi High Court permits manufacture and export of Semaglutide while restraining domestic sales until patent expiry

The Delhi High Court (“Delhi HC”) passed an interim order in a suit concerning the manufacture and commercialization of semaglutide in India. [11]  The order was passed on December 2, 2025, in a patent infringement suit filed by Novo Nordisk against Dr. Reddy’s Laboratories Limited (“Dr. Reddy’s”). The proceedings formed part of a broader global patent dispute involving semaglutide and were heard in the context of parallel proceedings pending before Delhi HC, involving Sun Pharmaceutical Industries Limited (“Sun Pharma”).

Novo Nordisk, a global healthcare company, holds patent over semaglutide, a glucagon-like peptide-1 analogue used in the treatment of diabetes and weight management therapies, which is globally marketed as Ozempic, Wegovy and Rybelsus. It was alleged by Novo Nordisk that certain Indian pharmaceutical companies, including Dr. Reddy’s was dealing with semaglutide in quantities and in a manner indicative of intended commercial exploitation in India, rather than for research, development, or regulatory purposes.

Accordingly, Novo Nordisk sought interim relief restraining Dr. Reddy’s from manufacturing, selling, or otherwise dealing in semaglutide-based products in India, relying on its subsisting patent rights, which are scheduled to expire on March 26, 2026.

During the course of hearing, Delhi HC also took note of developments in separate and parallel proceedings involving Sun Pharma. In those proceedings, Sun Pharma furnished a categorical undertaking before the court that it would not market or sell its semaglutide product in the Indian market until the expiry of Novo Nordisk’s patent. Based on this undertaking, the Delhi HC permitted Sun Pharma to continue manufacturing semaglutide for the purpose of exporting to jurisdictions where Novo Nordisk does not hold corresponding patent protection. Sun Pharma was further directed to file an affidavit reaffirming its undertaking and to place on record details of exports undertaken.

In the proceedings against Dr. Reddy’s, the Delhi HC adopted a similar reasoning and formulated an interim arrangement, thereby permitting Dr. Reddy’s to manufacture semaglutide-based products in India and export them to countries where Novo Nordisk does not have a patent registration. Dr. Reddy’s has also been directed to place on record details such as quantity and value of products manufactured and sold. Accordingly, the Delhi HC sought to preserve Novo Nordisk’s patent rights under the Patents Act, 1970, while simultaneously allowing limited manufacturing and export activities that did not prima facie infringe the patentee’s exclusive rights within India.

2. Supreme Court examines regulatory oversight of private hospitals under Kerala Clinical Establishments framework

The Hon’ble Supreme Court of India (“SC”) is presently hearing an appeal challenging the Kerala Clinical Establishments (Registration and Regulation) Act, 2018 (“Kerala CE Act”) and the rules framed thereunder, particularly the provisions mandating transparency and minimum standards for clinical establishments. [12]  The appeal arises from a decision of the Kerala High Court (“Kerala HC”) dated November 26, 2025, which upheld key provisions of the Kerala CE Act requiring private hospitals to display treatment fee structures and charges, provide emergency medical care, and maintain patient-related information in both Malayalam and English, observing that such measures promote accountability and enable informed decision-making by patients.

The Kerala Private Hospitals Association (“Hospitals Association”) and other petitioners argued that the mandatory requirements under the provisions of the Kerala CE Act interfere with their freedom to conduct business and amounts to over-regulation. They argued that the Kerala CE Act imposed uniform standards on unequal establishments, ignoring differences in size, specialty, and cost structures which made the enforcement actions and penalties disproportionate.

The Kerala HC rejected challenges by the Hospitals Association and held that the legislation gives effect to constitutional and welfare obligations by prescribing minimum operational standards, transparency norms and emergency care obligations for private hospitals and clinics. The Kerala HC further held that denial of life-saving care on grounds of non-payment is prohibited, while mandating the maintenance of robust patient information and grievance redressal mechanisms.

The SC has issued notice on the appeal and sought responses from the Central and State Governments and has declined to stay the operation and enforcement of the impugned provisions, thereby requiring private hospitals to continue with registration and compliance under the existing regulatory framework. The proceedings reflect ongoing judicial scrutiny over questions of regulatory transparency, patient rights, and enforceability of welfare-oriented health legislation in private clinical hospitals.

3. Delhi HC restores ban on fixed-dose combination drugs under Section 26A of the DCA

The Delhi HC restored the Central Government’s notifications prohibiting the manufacture, sale and distribution of certain FDC drugs used in the treatment of Type II diabetes mellitus. [13]  The judgment was passed on January 9, 2026, by a division bench, in the appeals challenging the 2019 judgment by a single judge bench that set aside the statutory ban.

The impugned notifications had been issued by the Central Government under Section 26A of the DCA, which empowers the government to prohibit drugs if their use is likely to involve risk to human beings or if they lack therapeutic justification. The banned FDCs comprised specific combinations of glimepiride, pioglitazone and metformin in defined strengths. The single judge bench had interfered with the notifications on the ground that the government had not demonstrated concrete or proven harm arising from the use of the drugs.

Allowing the appeals, the division bench held that the single judge bench erred in setting aside the notifications and restoring the manufacture and sale of the FDCs. The Delhi HC clarified that the statutory threshold under Section 26A does not require the Central Government to establish actual or proven injury to human health. It is sufficient if the government forms a reasoned opinion, based on expert material, that continued use of a drug is likely to pose a risk to human beings or lacks therapeutic justification.

The division bench emphasized that decisions taken under Section 26A are preventive in nature and are intended to protect public health. In matters involving drug safety, courts must accord due deference to expert regulatory assessments and should not substitute their own views unless the decision is shown to be arbitrary or without any rational basis. The Delhi HC also observed that regulatory action under Section 26A is not punitive but precautionary, aimed at preventing potential harm before it manifests. Accordingly, the Delhi HC upheld the validity of the government notifications and restored the ban on the specified FDC products.

4. Delhi HC permits Zydus Lifesciences to market Nivolumab biosimilar in patent dispute with E.R. Squibb

The Delhi HC allowed Zydus Lifesciences Limited (“Zydus”) to manufacture and sell its biosimilar version of the anti-cancer drug, ZRC-3276, in India, thereby modifying an earlier injunction that had restrained such sales. [14]  The judgment was passed on January 12, 2026, by a division bench in a patent infringement suit filed by E.R. Squibb & Sons (“Squibb”) against Zydus.

Squibb has been the holder of an Indian patent covering nivolumab, a monoclonal antibody used in cancer immunotherapy and marketed globally as Opdivo and in India as Opdyta. Squibb alleged that Zydus’s manufacture and proposed sale of its biosimilar infringed its subsisting patent rights, and sought interim relief restraining Zydus from manufacturing, selling, importing, or otherwise dealing in its biosimilar product, ZRC-3276, during the pendency of the suit. Accepting this contention, in July 2025, a single judge bench of Delhi HC had granted an interim injunction, preventing Zydus from commercializing the biosimilar in India.

Zydus challenged the injunction before a division bench, contending that the interim order had been passed without a proper assessment of whether its biosimilar product actually fell within the scope of Squibb’s patent claims.

Allowing the appeal, the division bench vacated the interim injunction and permitted Zydus to manufacture and sell its nivolumab biosimilar in India for the remaining term of the patent, which is noted to expire on May 2, 2026. The Delhi HC noted that no detailed product-to-claim mapping had been placed before the bench to prima facieestablish infringement, which is a critical consideration when granting interim relief in patent matters involving complex biologic products.

The Delhi HC also emphasized public interest considerations. It observed that nivolumab is an essential and life-saving cancer therapy, and that only a limited period remained before the patent was due to expire. In these circumstances, the balance of convenience favored permitting market access to the biosimilar, particularly where affordability and availability were a concern.

At the same time, the court sought to safeguard Squibb’s interests by directing Zydus to maintain detailed and audited accounts of all sales and revenues arising from ZRC-3276. This would enable appropriate monetary compensation to be determined in favor of Squibb, if it ultimately succeeds in the infringement suit.

The decision reflects Delhi HC’s continued effort to balance patent enforcement with public health considerations, particularly in cases involving biosimilars and critical therapies. It underscores that interim injunctions in pharmaceutical patent disputes are not automatic and must be carefully assessed based on technical complexity, proximity to patent expiry, and the broader public interest in terms of access to essential medicines.