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

In recent months, India’s healthcare and pharmaceutical sectors have witnessed a continued emphasis on strengthening regulatory frameworks, enhancing quality assurance, and expanding access to healthcare services. Policy developments reflect a concerted effort to address public health priorities while fostering a more resilient and innovation-oriented ecosystem.

Key measures include national frameworks for responsible adoption of artificial intelligence in healthcare and targeted regulatory interventions addressing risks in pharmaceutical distribution and marketing practices. At the same time, policymakers have also proposed streamlining processes for ethics committee registrations and post-approval changes for drugs, alongside efforts to establish a policy framework for refurbished medical devices. Judicial developments have further clarified issues relating to regulatory overlap, trademark protection, and patent enforcement and revocation.

In this edition of ‘Checking the Pulse’, we examine key policy and regulatory developments in the Indian healthcare and pharmaceutical sector from February 2026 to March 2026.

1. Ministry of Health and Family Welfare launches SAHI and BODH to strengthen responsible adoption of AI in healthcare

On February 17, 2026, the Union Minister of Health and Family Welfare, launched 2 (two) national digital health initiatives - the Strategy for Artificial Intelligence in Healthcare for India (“SAHI”) and the Benchmarking Open Data Platform for Health AI (“BODH”) at the India Artificial Intelligence Impact Summit 2026. [1]  The initiatives aim to support safe, ethical, and evidence-based adoption of artificial intelligence (“AI”) technologies within India’s healthcare ecosystem.

SAHI is intended to serve as a national governance framework for integrating AI into healthcare systems. It sets out recommendations across areas such as risk-based governance of AI tools, data quality and representativeness, interoperability with digital health infrastructure, workforce readiness, and innovation-supportive regulatory mechanisms. SAHI also emphasises alignment with India’s digital health architecture, including the Ayushman Bharat Digital Mission and the eSanjeevani platform, while operating within the broader legal framework established under the Digital Personal Data Protection Act, 2023 and related health data governance policies.

Further, BODH has been developed by the Indian Institute of Technology, Kanpur in collaboration with the National Health Authority to provide a national benchmarking platform for the independent evaluation of AI-based healthcare solutions. The platform enables developers to test and validate AI models against anonymised health datasets within a secure environment, without direct access to underlying data. AI systems are assessed on parameters such as accuracy, reliability, and potential bias, with the objective of supporting the safe deployment of validated AI tools in clinical and public health settings.

Together, SAHI and BODH signal a balanced approach to integrating AI in healthcare and combining innovation with necessary safeguards. Their effective implementation will be important for enabling safe, reliable, and equitable adoption of AI across India’s healthcare system.

2. Central Drugs Standard Control Organisation intensifies regulatory surveillance over GLP-1 weight loss drug supply chain

On March 24, 2026, the Central Drugs Standard Control Organisation (“CDSCO”) issued a press release stating that the Drugs Controller General of India (“DCGI”) has intensified regulatory surveillance over the supply chain of glucagon-like peptide-1 (“GLP-1”) based weight loss drugs to curb unauthorized sale. [2]  The action follows the increasing availability of generic variants of such drugs across retail pharmacies, online platforms, wholesalers, and wellness clinics.

The regulatory surveillance included coordinated inspections conducted in collaboration with state regulators. A total of 49 (forty-nine) entities, including online pharmacy warehouses, wholesalers, retailers, and wellness clinics, were audited to identify violations relating to unauthorized sale, improper prescription practices, and misleading marketing, with notices issued to non-compliant entities. 

The initiative reinforces that GLP-1 drugs are approved in India only for use under prescription by qualified specialists, including endocrinologists and internal medicine practitioners, and for certain indications by cardiologists. The enhanced surveillance is intended to strengthen compliance across the pharmaceutical supply chain and mitigate risks arising from unsupervised use, with the regulator indicating that continued non-compliance may attract enforcement action, including licence cancellation, penalties, and prosecution.

1. Ministry of Health and Family Welfare constitutes an expert committee to frame a comprehensive policy on the regulation of refurbished medical devices

In February 2026, the Ministry of Health and Family Welfare (“MoHFW”) constituted an expert committee (“Committee”) to frame a comprehensive policy for the regulation of refurbished medical devices in India. [3] 

The Committee comprises representatives from MoHFW, the Directorate General of Health Services, the CDSCO, the Department of Pharmaceuticals (“DoP”), and industry stakeholders. Its mandate includes defining the scope of refurbished medical devices that may be permitted for use in India, developing a framework to assess their safety, performance, and remaining useful life, and recommending guidelines for disposal and waste management once such devices reach the end of their lifecycle.

The Committee’s constitution follows regulatory uncertainty arising from differing positions taken by authorities on the import of refurbished medical equipment. In November 2025, an expert committee under the Ministry of Environment, Forest and Climate Change permitted the import of certain used high-end medical devices under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. Subsequently, CDSCO clarified to customs authorities that refurbished medical devices cannot be imported for sale or distribution in India in the absence of an explicit regulatory pathway under the Medical Devices Rules, 2017 (“MD Rules”), resulting in uncertainty for importers and healthcare providers.

Refurbished medical devices, including diagnostic imaging equipment and robotic surgical systems, are generally available at significantly lower prices than new devices and are often used by hospitals seeking cost-effective access to advanced medical technology. At the same time, concerns have been raised regarding safety standards and the potential impact of such imports on domestic manufacturing.

2. MoHFW proposes removal of provisional registration requirement for Ethics Committees for biomedical and health research

Pursuant to a notification dated February 2, 2026, MoHFW has proposed amendments to the New Drugs and Clinical Trials Rules, 2019 (“NDCT Rules”) to streamline the registration process for Ethics Committees for biomedical and health research (“Draft Amendment”) .[4]

The Draft Amendment proposes omission of sub-rule (3) under Rule 17 of the NDCT Rules, thereby removing the requirement for provisional registration of Ethics Committees for biomedical and health research. Consequentially, sub-rule (4) is proposed to be substituted to provide that, upon receipt of an application in Form CT-01, the designated authority shall directly scrutinise the application and, if satisfied, grant final registration in Form CT-03, or reject the application with reasons recorded in writing.

The Draft Amendment seeks to replace the existing two-stage registration process (provisional and final) with a single-step registration mechanism for Ethics Committees involved in biomedical and health research. This is expected to reduce procedural timelines and administrative burden, while maintaining regulatory oversight through scrutiny at the initial stage.

3. MoHFW proposes framework for post-approval changes under NDCT Rules

Pursuant to a notification dated February 2, 2026, MoHFW has proposed amendments to the NDCT Rules to introduce a structured framework governing post-approval changes to new drugs (“Proposed Amendment”). [5]

The Proposed Amendment seeks to insert provisions under Rule 77 and Rule 82 of the NDCT Rules, requiring manufacturers or their authorised agents to notify the licensing authority of changes relating to manufacturing processes, excipients, packaging, shelf life, specifications, testing, or documentation. Such changes are proposed to be classified into 3 (three) categories based on their potential impact on product quality:

• Major changes (Level I): Changes with a significant potential to adversely affect the identity, strength, quality, purity, or potency of a drug, requiring prior approval from the licensing authority;
• Moderate changes (Level II): Changes with a moderate potential to adversely affect the identity, strength, quality, purity, or potency of a drug, requiring prior approval from the licensing authority; and
• Minor changes (Level III): Changes with minimal potential impact, which may be implemented without prior approval (except for changes relating to shelf life), subject to annual reporting to the licensing authority.

The Proposed Amendment seeks to introduce a risk-based regulatory approach for lifecycle management of approved drugs, aligning with global regulatory practices and addressing the current absence of an explicit framework for post-approval changes under the existing NDCT Rules.

4. Drugs Technical Advisory Board approves proposal to incorporate Good Distribution Practices under Drugs and Cosmetics Rules

On February 16, 2026, the Drugs Technical Advisory Board (“DTAB”) approved a proposal to amend the Drugs and Cosmetics Rules, 1945 (“D&C Rules”) to incorporate guidelines on Good Distribution Practices (“GDP”) for pharmaceutical products (“Proposed Framework”). [6]  The Proposed Framework seeks to provide regulatory approval to Draft Guidelines on GDP for Pharmaceutical Products (“GDP Guidelines”) issued by CDSCO.

The GDP Guidelines are intended to regulate the storage, transportation, and distribution of pharmaceutical products across the supply chain, ensuring that product quality is maintained from manufacture to retail. The Proposed Framework is aligned with the World Health Organization technical guidance and is expected to apply to entities involved in the manufacture for sale, distribution, stocking, and sale of drugs.

The Proposed Framework provides for inclusion of GDP Guidelines as a schedule under the D&C Rules to render such practices legally enforceable, addressing longstanding concerns regarding the handling and storage of pharmaceutical products during transit. The measure is also aimed at strengthening regulatory oversight and mitigating risks associated with substandard or improperly handled medicines in the supply chain.

5. Drugs Technical Advisory Board recommends prior intimation route for import of drugs for testing purposes

In its 93rd meeting held on February 16, 2026, DTAB recommended streamlining the regulatory process for import of drugs for examination, testing, or analysis under the D&C Rules .[7]

DTAB noted that the regulatory framework has been recently amended to introduce a prior intimation mechanism (in lieu of prior approval) for the manufacture of certain categories of drugs for analytical and pre-clinical testing under the NDCT Rules. 

In this regard, DTAB recommended introducing a similar prior intimation system for licensed manufacturers seeking to import drugs for analytical and non-clinical testing purposes, in place of the existing requirement of prior permission from the CDSCO. This proposed relaxation would, however, exclude certain high-risk categories of drugs, including sex hormones, cytotoxic drugs, beta-lactam antibiotics, and narcotic and psychotropic substances.

This recommendation is aimed at reducing procedural timelines and improving ease of doing business for manufacturers engaged in research and development activities, while continuing to maintain regulatory oversight for sensitive drug categories.

1. Delhi High Court directs consultation between regulators on veg/ non-veg labelling requirement for cosmetics

On February 17, 2026, the Delhi High Court (“Delhi HC”) passed an order in a writ petition filed by Reckitt Benckiser (India) Limited (“Reckitt”), challenging the requirement to display vegetarian and non-vegetarian symbols on cosmetic and toiletry products. [8]  The petition relates to Rule 6(8) of the Legal Metrology (Packaged Commodities) Rules, 2011 (“Legal Metrology Rules”), which mandates that packages of certain products, including soaps, shampoos, and toothpastes, bear a green dot for vegetarian products and a red or brown dot for non-vegetarian products.

Reckitt argued that toiletries fall within the definition of ‘cosmetics’ and are accordingly governed by the D&C Act and regulated by the DCGI, rather than the legal metrology authorities. Reckitt relied on deliberations of the DTAB, which had previously declined to recommend mandatory vegetarian or non-vegetarian labelling for cosmetics and instead supported a voluntary advisory approach.

Taking note of the apparent inconsistency between the mandatory labelling requirement under the Legal Metrology Rules and the position of the drug regulatory authorities, the Delhi HC directed that: (a) a joint consultation shall be convened between the DCGI and the Director of Legal Metrology, with participation from relevant stakeholders; and (b) a joint affidavit setting out the position of both authorities shall be filed prior to the next hearing.

2. Madras High Court stays observation declaring ‘VAPO’ as publici juris in trademark dispute

On February 17, 2026, the Madras High Court (“Madras HC”) granted interim relief to The Procter & Gamble Company (“P&G”) in appeals arising from trademark rectification proceedings concerning the use of the term ‘VAPO’. [9]  The dispute relates to competing marks used for medicated balm products, including ‘Vicks VapoRub’ and a rival mark ‘Vaporin’ registered by IPI India Private Limited (“IPI India”).

The appeals challenged a single judge’s order which, inter alia, characterised the term ‘VAPO’ as publici juris, i.e., a term common to trade and not capable of exclusive appropriation. P&G contended that such a finding could adversely affect its trademark rights and dilute the distinctiveness associated with its established branding. IPI India, on the other hand, relied on its registered mark and opposed interference with its use.

The Madras HC limited its intervention to the impugned observation and stayed the finding that ‘VAPO’ is publici juris, noting that the issue requires further examination. It clarified that no injunction was granted against IPI India’s use of its registered mark and that the interim order was confined to the reasoning adopted in the earlier judgment. The matter is scheduled for further hearing, with the interim order preserving the status quo pending adjudication.

3. Bombay High Court grants permanent injunction in pharmaceutical trademark dispute involving ‘ZERODOL’

On February 23, 2026, the Bombay High Court (“Bombay HC”) granted a permanent injunction in favour of Ipca Laboratories Limited (“Ipca”) restraining the use of the mark ‘ZEKODOL-P’ by Rikon Pharmaceuticals Private Limited (“Rikon”), holding that it infringed the registered trademark ‘ZERODOL’ .[10]

Ipca contended that ‘ZERODOL’ is a coined and distinctive mark used for pharmaceutical preparations and has acquired significant goodwill through long-standing use. It was argued that Rikon’s mark ‘ZEKODOL-P’ was phonetically, visually, and structurally similar and used in respect of identical goods, namely pain relief medications. 

The Bombay HC held that the competing marks were deceptively similar and created an overall impression of near identity, particularly given the common suffix ‘DOL’ and minimal distinction in prefixes. Emphasising the heightened standard applicable to pharmaceutical products, Bombay HC observed that even a remote likelihood of confusion must be avoided due to potential risks to public health. Bombay HC accordingly granted a permanent injunction and, while declining damages for lack of proof of actual loss, awarded costs of INR 1,500,000 (Indian Rupees One Million and Five Hundred Thousand) in favour of Ipca.

4. Delhi High Court holds patent revocation petition maintainable despite patent expiry and parallel invalidity defence

On February 24, 2026, the Delhi HC held that a patent revocation petition under the Patents Act, 1970 (“Patents Act”) may continue even after the expiry of the patent and may coexist with an invalidity defence raised in an infringement suit. [11]  The dispute arose from a revocation petition filed by Macleods Pharmaceuticals Limited (“Macleods”) challenging Indian Patent No. IN 243301 relating to the diabetes drug linagliptin, owned by Boehringer Ingelheim Pharma GmbH & Co. KG. (“Boehringer”). Boehringer argued that the revocation proceedings should terminate because Macleods had already raised an invalidity defence in a parallel infringement suit and the patent had expired during the pendency of the dispute.

The Delhi HC rejected these arguments and clarified that an invalidity defence under Section 107 of the Patents Act operates only as a defence in personam in an infringement suit, whereas a revocation petition under Section 64 of the Patents Act is a separate statutory remedy that operates in rem. 

Addressing the effect of patent expiry, Delhi HC held that revocation under Section 64 of the Patents Act operates retrospectively from the date of grant and invalidates the patent ab initio. Consequently, a revocation petition may remain maintainable even after expiry of the patent where questions such as damages or accounts of profits for past infringement remain in issue. Delhi HC therefore upheld the maintainability of the revocation proceedings and dismissed Boehringer’s appeal.