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 seen a continued push towards regulatory strengthening, quality standardisation, and innovation-driven growth. The policy momentum reflects a sustained commitment to advancing patient safety, improving affordability, and fostering a more accountable industry landscape.

A series of initiatives, from reinforcing global good manufacturing practices compliance and encouraging indigenous research and development, to tightening pricing oversight and enhancing regulatory clarity across drugs and medical devices, signals the government’s focus on building a system that is both resilient and future ready. Parallel efforts to promote ethical practices and streamline approval pathways further underline a shift towards transparency and balancing stakeholder responsibilities.

Together, these developments mark an ongoing effort to shape a more robust, competitive, and patient-centric healthcare ecosystem in India.

In this edition of ‘Checking the Pulse’, we examine key policy and regulatory updates from October 2025 and November 2025.

1.Department of Pharmaceuticals invites applications for research and innovation projects under the PRIP scheme

On October 1, 2025, the Department of Pharmaceuticals, Government of India, opened the application window for research and innovation projects under its Promotion of Research and Innovation in Pharma med-tech sector scheme (“PRIP”). The scheme aims to transform the Indian pharma med-tech sector from cost-based competitiveness to innovation-based growth. With an approved outlay of INR 50,000,000,000 (Indian Rupees Fifty Billion), PRIP is expected to support approximately 300 (three hundred) projects involving total research and development investment of approximately INR 110,000,000,000 (Indian Rupees One Hundred and Ten Billion) in new medicines, complex generics, biosimilars and novel medical devices.1

PRIP aims to provide assistance to the following projects:

(a) Early-stage projects: For early-stage projects, Micro, Small and Medium Enterprises (“MSMEs”) and startups may apply for projects costing up to INR 90,000,000 (Indian Rupees Ninety Million) for assistance of up to INR 50,000,000 (Indian Rupees Fifty Million). The scale of financial assistance is 100% (one hundred percent) for cost up to INR 10,000,000 (Indian Rupees Ten Million) and 50% (fifty percent) of additional cost beyond INR 10,000,000 (Indian Rupees Ten Million), subject to a maximum cap of INR 50,000,000 (Indian Rupees Fifty Million).

(b) Later stage projects: For projects which are in the later stages of development - industry, MSMEs and startups may apply for assistance of up to 35% (thirty five percent) of the total project cost, subject to a maximum cap of INR 1,000,000,000 (Indian Rupees One Billion).

(c) Strategic priority areas projects: For projects in strategic priority innovation areas such as rare diseases and anti-microbial resistance, the scheme provides assistance of up to 50% (fifty percent) of the total project cost, subject to a maximum cap of INR 1,000,000,000 (Indian Rupees One Billion).

The scheme is expected to promote industry-academia linkage for research and development in priority areas and inculcate the culture of quality research in the pharmaceutical and medical technology sectors.

2. Anusandhan Foundation launches the mission for advancement of medical technology in high-impact areas

On October 25, 2025, the Anusandhan National Research Foundation, in collaboration with the Indian Council of Medical Research and the Bill & Melinda Gates Foundation, launched the ‘Mission for Advancement in High-Impact Areas - Medical Technology’ (“MAHA-MT”). This initiative aims to accelerate innovation in India's medical technology sector, reduce reliance on high-cost imports, and promote equitable access to affordable and high-quality medical technologies aligned with national health priorities.[2]

MAHA-MT will provide milestone-linked funding support to a wide range of entities, including academic and research and development institutions, hospitals, startups, MSMEs, medical technology industry, and inter-institutional or industry-academia collaborations. Each selected project will receive funding ranging from INR 50,000,000 (Indian Rupees Fifty Million) to INR 250,000,000 (Indian Rupees Two Hundred and Fifty Million), with exceptional cases eligible for funding up to INR 500,000,000 (Indian Rupees Five Hundred Million). MAHA-MT operates with a total budgeted outlay of INR 7,500,000,000 (Indian Rupees Seven Billion and Five Hundred Million) over a period of 5 (five) years.

MAHA-MT will support development and commercialization of a broad spectrum of innovative medical devices and in-vitro diagnostics, including high-end frontier technologies such as advanced diagnostic imaging, robotics, artificial intelligence (“AI”)/ machine learning (“ML”) enabled platforms and devices. Projects aligned with national health priorities such as tuberculosis, cancer, neonatal care, and primary healthcare will be prioritized.

In addition to financial assistance, MAHA-MT will provide further support through several national initiatives. ‘Patent Mitra’, an online patent filing and maintenance system of India, will provide intellectual property protection and technology transfer support. MAHA-MT will offer regulatory guidance and facilitate clearances from relevant regulatory bodies. A clinical trial network will support clinical validation and evidence generation. Further, expert mentorship from industry professionals will assist selected projects in transitioning from concept to market.

3. National Pharmaceutical Pricing Authority issues ceiling-price order for selected scheduled formulations

On November 4, 2025, the National Pharmaceutical Pricing Authority under the Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals) issued a notification (“Price Control Notification”) fixing ceiling prices for certain scheduled formulations under the Drugs (Prices Control) Order, 2013 (“DPCO”). The Price Control Notification supersedes the earlier order dated March 27, 2025, only with respect to the specified formulation packs included in the table, except for actions already taken before the supersession.[3]

The Price Control Notification specifies ceiling prices (exclusive of goods and services tax, if applicable) for 6 (six) formulations, including riboflavin, peritoneal dialysis solution, ethyl alcohol, and human normal immunoglobulin intended for infusion. The dosage forms, strengths, and unit-wise ceiling prices are provided in the tabular format in the Price Control Notification. Manufacturers selling the scheduled formulations above the notified ceiling prices are required to revise prices downward, while manufacturers selling below the ceiling prices must maintain existing maximum retail prices as per paragraph 13(2) of DPCO.

Price Control Notification reiterates key responsibilities for manufacturers and supply-chain stakeholders. Manufacturers must:

(a) publish revised prices through the integrated pharmaceutical database management system in Form V and share the updated lists with state drug controllers and dealers;

(b) seek prior price approval before introducing any new scheduled formulation under paragraph 2(1)(u);

(c) file quarterly returns in Form III covering production, import, and sales data; and

(d) provide 6 (six) months’ advance notice in Form IV before discontinuing any scheduled product.

Additionally, retailers and dealers are required to display the latest price and supplementary price lists prominently at the point of sale, ensuring transparency and consumer awareness. Non-compliance with the specified ceiling prices and conditions will result in liability to deposit the overcharged amount along with interest under DPCO, read with the Essential Commodities Act, 1955.

4.CDSCO asks procurement agencies to mandate Indian licence as technical requirement

Central Drugs Standard Control Organisation (“CDSCO”) has issued a circular, dated November 17, 2025, directing all procurement agencies, including public hospitals and institutions, to mandatorily require a valid Indian manufacturing or import licence for medical devices as per the Medical Devices Rules, 2017 (“MD Rules”). The circular was issued by the Drugs Controller General of India.[4]

CDSCO clarified that certain procurement entities were insisting on foreign regulatory certifications, such as the Food and Drug Administration of the United States or European conformity approvals, as part of technical-bid criteria. The circular states that Indian licensing under the MD Rules must be treated as a non-negotiable prerequisite, and any foreign certification may only be sought in addition to, and not in substitution of, CDSCO or state licensing authority approval. The circular thereby clarified that no medical device may be sold or distributed in India without the requisite licence.

1.MoHFW issues draft amendments to the Drugs Rules to debar applicants submitting misleading or forged information

On October 28, 2025, the Ministry of Health and Family Welfare (“MoHFW”) issued a notification proposing amendments to the Drugs Rules to establish a debarment framework for applicants submitting misleading, fake, or fabricated documents and information in product marketing approval applications (“Proposed Amendment”).[1]

The Proposed Amendment introduces new rules (Rules 29B, 66B, 84F, 93A, 122DBA, 122Q and 150L) across different chapters of the Drugs Rules, incorporating multiple debarment provisions for pharmaceutical establishments, imports, cosmetics, and medical devices. It empowers the licensing authority to debar applicants found guilty of violations, like fabrication, misleading, fake or forged documents, for such period as they deem fit.

The debarment framework provided in the Proposed Amendment includes due process protections, requiring the licensing authority to provide applicants with an opportunity to show-cause in writing before imposing debarment. Aggrieved applicants may appeal to the state government within 30 (thirty) days from the date of receiving the debarment order, or within 60 (sixty) days in cases involving imports or manufacture of new drugs for clinical trials or marketing approvals.

The Proposed Amendment has been introduced after a recommendation by the Drugs Technical Advisory Board (“DTAB”) made during its 91st meeting in August 2024, which recommended that applicants submitting forged, fabricated, or misleading data be debarred from the licensing process in addition to suspension or cancellation of product approvals. Previously, such violations were actionable only under the Indian Penal Code, 1860, requiring lengthy criminal investigations and prosecution. The incorporation of explicit debarment provisions within the Drugs Rules is thereby aimed at enabling the regulatory authorities to address data integrity violations more expeditiously.

2. The draft Drugs, Medical Devices and Cosmetics Act is expected to be presented in Parliament during the winter session

The draft of the Drugs, Medical Devices and Cosmetics Act (“Draft Act”), which has been under development for nearly 3 (three) years to replace the existing Drugs and Cosmetics Act, 1940, is expected to be presented in the parliament during the upcoming winter session. The Draft Act was recently discussed at a high-level meeting of MoHFW, chaired by the Union Health Minister J. P. Nadda.[2]

One of the major reasons behind the introduction of the Draft Act is the repeated complaints and concerns flagged by health regulators across the globe, including WHO, over serious quality lapses by Indian drug manufacturers.

The Draft Act provides for the following:

(a) Grant of statutory power to CDSCO to (i) ensure strict quality checks and surveillance of drugs, medical devices, and cosmetics manufactured in India for both domestic use and export; and (ii) take immediate action against fake or substandard medicines.

(b) Prohibit any person from selling, keeping stock or exhibiting or offering for sale or distribute any drug by online mode, except under and in accordance with a license or permission issued by CDSCO.

(c) Constitution of Medical Devices Technical Advisory Board (“MDTAB”) to advise the central government and the state governments on technical matters pertaining to medical devices arising out of administration of the Draft Act.

(d) Establish a ‘Drugs, Medical Devices and Cosmetics Consultative Committee’ to advise the central government, the state governments, MDTAB and DTAB, on any matter tending to secure uniformity in the country in the administration of the Draft Act and the rules made thereunder.

The Draft Act is being developed in line with international standards to ensure accountability and transparency at every stage from manufacturing to market distribution.

3. CDSCO invites comments to ensure a level playing field in new drug approval process.

On October 8, 2025, CDSCO issued a notice inviting comments from pharmaceutical manufacturers, research organizations, and other stakeholders to ensure a level playing field for the approval of new drugs in India. The notice was issued by the new drugs division of CDSCO, flagging concerns over the disparity in regulatory burden between first-time applicants and subsequent applicants seeking approval for the same new drug.[3]

As per the New Drugs and Clinical Trials Rules, 2019 (“NDCT Rules”), applicants are generally required to conduct local clinical trials in the Indian population for drugs approved abroad. However, certain provisions, like Rules 75 and 80 of the NDCT Rules, allow for waivers under specific conditions. Under Rules 75 and 80 of the NDCT Rules, CDSCO may waive the requirement for local clinical trials where adequate Indian population data already exists for the same drug, including data generated by another applicant. In such cases, subsequent applicants are required to submit only bioequivalence study data for obtaining approval.

CDSCO observed that in many cases, multiple applicants submit protocols for clinical trials and bioequivalence studies for the same drug. While permission is granted to all, often only one applicant proceeds with the full clinical trial and bioequivalence study. Once that applicant secures approval based on the submitted data, other applicants can obtain approval for the same drug by submitting only bioequivalence study data without conducting their own clinical trials. 

This practice creates an uneven playing field, as the first applicant bears the full cost and regulatory burden of conducting clinical trials, while subsequent applicants benefit from a significantly reduced compliance pathway. CDSCO stated that it will deliberate on the matter with stakeholders and concerned departments to introduce a fair system that promotes innovation, ethical practices, and equitable regulatory standards for all applicants.

1. CDSCO releases draft guidance document on medical device software to align India’s regulatory framework with global standards

On October 21, 2025, CDSCO released a draft guidance document on medical device software (“Draft Guidance”) for stakeholder comments.[8]The Draft Guidance seeks to bring regulatory clarity on the scope and classification of software regulated as medical devices under the MD Rules, particularly in the context of standalone software and emerging technologies such as AI and ML.

The Draft Guidance does not introduce a new regulatory framework but consolidates existing regulatory principles and aligns India’s approach with internationally accepted risk-based regulatory models. It applies to software products that fall within the definition of a ‘medical device’ under the MD Rules and broadly covers the following:

(a) software that is embedded in, or drives, a physical medical device; and

(b) standalone software intended for medical purposes.

As per the Draft Guidance, software as a medical device (“SaMD”) is defined as standalone software that is intended to perform one or more medical purposes without being part of a physical medical device. It delivers a medical purpose on its own and is intended to generate new medical information for purposes such as diagnosis, prevention, monitoring, prediction, or treatment of a disease or condition. Such software may operate on general-purpose computing platforms, including mobile devices and cloud-based systems, and may interface with other medical devices or software, without controlling their functioning.

Additionally, the Draft Guidance clarifies that not all software used in a healthcare setting qualifies as a medical device. A software that does not have an independent medical purpose and does not generate new medical information falls outside the scope of regulation under the MD Rules. This includes:

(a) software used solely for data encryption, transmission, storage or archiving;

(b) software intended to monitor the performance, servicing or maintenance of a medical device; and

(c) image management systems used for storage, display or sharing of digitised medical images.

The Draft Guidance adopts a risk-based approach for classification of SaMD in line with the MD Rules. SaMD is required to be classified into Class A (low risk) to Class D (high risk) based on the following factors:

(a) the significance of the information provided by the software for healthcare decision-making, whether it merely informs, actively drives, or directly enables diagnosis or treatment; and

(b) the healthcare situation or condition for which the software is intended to be used, categorised as non-serious, serious or critical.

By clarifying the boundary between regulated medical device software and unregulated health informational technology systems, and by adopting a structured risk-based classification framework, the Draft Guidance is expected to assist manufacturers and importers in navigating licensing and compliance requirements under the MD Rules more effectively.

2. Department of Consumer Affairs Exempts Medical Devices from Legal Metrology (Packaged Commodities) Rules, 2025

On October 23, 2025, the Department of Consumer Affairs, under the Ministry of Consumer Affairs, Food and Public Distribution, notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025 ("Amendment Rules").[9] The Amendment Rules introduce significant reforms to harmonise the packaging and labelling requirements for medical devices with those under the MD Rules, thereby eliminating the dual compliance burden that previously existed.

The key changes introduced by the Amendment Rules are:

(a) Amendment to Rule 2(h): The Amendment Rules insert a new proviso to Rule 2(h) of the Legal Metrology (Packaged Commodities) Rules, 2011 ("LM Rules"), which defines ‘pre-packaged commodity’. The proviso clarifies that for packages containing medical devices, the provisions of the MD Rules shall apply for making declarations at any place on the label. This ensures that medical device manufacturers and importers need only comply with the MD Rules for all labelling declarations, rather than navigating overlapping requirements under both regulatory frameworks.

(b) Amendment to Rule 7: The Amendment Rules insert two new provisos to Rule 7 of the LM Rules, which prescribe the height and width of numerals and letters for declarations on packaged commodities. The first proviso specifies that for packages containing medical devices, the provisions of the MD Rules shall prevail for the height and width of numerals and letters used for making declarations. The second proviso clarifies that the requirement of making declarations on the principal display panel as per the LM Rules is not mandatory for medical devices; instead, such declarations may be made as per the MD Rules. 

(c) Amendment to Rule 33: Rule 33 of the LM Rules, which provides for certain relaxations in compliance, has been renumbered as sub-rule (1). The Amendment Rules insert a new sub-rule (2), which explicitly states that the relaxation under Rule 33 shall not apply where the MD Rules are applicable. This amendment eliminates any ambiguity regarding the interplay between the two regulatory regimes and ensures that medical device manufacturers cannot seek relaxations under the LM Rules when the MD Rules govern their products.

Prior to this amendment, medical device manufacturers and importers faced a significant compliance burden, as packages containing medical devices were required to comply with both the LM Rules (governing consumer packaged commodities) and the MD Rules (governing medical device-specific requirements). This dual regulatory framework created jurisdictional overlap, resulting in conflicting interpretations by inspectors and enforcement authorities, increased compliance costs, and operational inefficiencies. 

The Amendment Rules address this challenge by creating a clear regulatory hierarchy: where medical devices are concerned, the MD Rules shall prevail in their entirety. This harmonisation simplifies the regulatory landscape, reduces the time and cost associated with dual compliance, and provides legal certainty to industry stakeholders. Manufacturers can now streamline their packaging and labelling processes by adhering to a single, specialised set of standards under the MD Rules, thereby accelerating product approvals and market entry. 

1. Delhi High Court restrains Alchem International from infringing the trademarks of Alkem Laboratories

The Delhi High Court (“Delhi HC”) has restrained Alchem International Private Limited (“Alchem International”) from using the trademark 'ALCHEM', finding it deceptively similar to Alkem Laboratories Limited's (“Alkem Laboratories”) registered mark 'ALKEM'. The interim order was passed on October 10, 2025, by hon’ble Justice Amit Bansal in a trademark infringement suit filed by Alkem Laboratories against Alchem International.[10]

Alkem Laboratories has used the mark 'ALKEM' as part of its corporate identity and branding since incorporation and holds trademark registrations under multiple classes, with the earliest dating back to 1973. Alkem Laboratories contended that Alchem International's increasing use of 'ALCHEM' for consumer-facing products, online advertising and expanded trade channels was likely to cause confusion and amounted to trademark infringement and passing off.

On the other hand, Alchem International, incorporated in 1982, began using 'ALCHEM' in 1985, asserting that the mark was coined from the words ‘alkaloids and chemicals’. They argued that Alkem Laboratories’ inaction for years amounted to acquiescence and that the claim was barred by limitation.

Hon’ble Justice Bansal observed that the marks 'ALKEM' and 'ALCHEM' are phonetically identical and visually and structurally deceptively similar. The Delhi HC held that Alkem Laboratories was the prior adopter and registered proprietor of the mark 'ALKEM', and that Alchem International's continued use of a similar mark for similar products did not appear to be bona fide. Delhi HC emphasized that such similarity in the pharmaceutical sector could have public health implications.

Addressing the defence of acquiescence claimed by Alchem International, the Delhi HC observed that Alkem Laboratories could not be said to have ‘slept over its rights’, since Alchem International's business initially focused only on bulk drugs and active pharmaceutical ingredients and became a competitor only in 2018, when it expanded into the retail pharmaceutical and nutraceutical market, posing a real threat of consumer confusion.^[11]

2. Supreme Court rejects petition seeking CBI probe into child deaths linked to contaminated cough syrup

On October 10, 2025, the hon’ble Supreme Court of India (“SC”) dismissed a Public Interest Litigation (“PIL”) seeking a Central Bureau of Investigation probe into the deaths of children in Madhya Pradesh allegedly due to consumption of contaminated cough syrup.[12] The order was passed by a bench comprising Hon’ble Chief Justice of India B.R. Gavai and Hon’ble Justice K. Vinod Chandran. 

The PIL called for urgent intervention to overhaul India’s drug safety and recall framework, arguing that recurring incidents involving substandard medicines highlight systemic regulatory lapses. It sought nationwide corrective measures to ensure effective monitoring, immediate recalls, and public health safeguards. 

During the hearing, Solicitor General Tushar Mehta opposed the plea, submitting that the state governments of Madhya Pradesh and Tamil Nadu had already initiated necessary action, including investigation and regulatory measures. He further contended that the petition was based primarily on media reports and should not be entertained at this stage. 

Observing that ongoing investigations and regulatory actions were underway, the SC declined to interfere and dismissed the PIL, leaving state authorities and drug regulators to continue their inquiry into the incident and ensure accountability, while highlighting the need for vigilance in matters involving public health.[1]

• [1] Please refer here:
   https://www.pib.gov.in/PressReleasePage.aspx?PRID=2173970&reg=3&lang=2
• [2] Please refer here:
   https://www.pib.gov.in/PressReleasePage.aspx?PRID=2182432.
   
• [3] Please refer here:
  https://nppa.gov.in/uploads/tender/22c5c14f5123814d5ead47f777b03a33.pdf.
   
• [4] Refer to the circular below:
   https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCircularFile/Circular-17-11-2025.pdf.
   
• [5] Please refer here:
  https://www.legalitysimplified.com/wp-content/uploads/2025/10/False-and-Fabricated-data_Draft-Notification.pdf.
   
• [6] Please refer here:
  https://pharma.economictimes.indiatimes.com/news/policy-and-regulations/centre-to-bring-law-for-strict-quality-checks-surveillance-of-drugs-and-cosmetics/124593168.
   
• [7] Please refer here: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM0ODA=.
   
• [8] Please refer here: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Draft%20guidance%20document%20on%20Medical%20Device%20Software%2021%2010%202025.pdf.
   
• [9] Please refer here:
  https://consumeraffairs.gov.in/public/upload/files/267107_1761404707.pdf
   
• [10] https://medicaldialogues.in/pdf_upload/abl10102025sc10502018184842-625758-304569.pdf
   
• [11] Please refer here:
  https://www.livelaw.in/high-court/delhi-high-court/delhi-high-court-restrains-alchem-international-from-infringing-trademark-of-alkem-labs-explains-concept-of-acquiescence-306823.
   
• [12] Please refer here:
  https://api.sci.gov.in/supremecourt/2025/58104/58104_2025_1_38_64918_Order_10-Oct-2025.pdf
   
• [13] Please refer here:
  https://timesofindia.indiatimes.com/india/cough-syrup-deaths-sc-rejects-pil-seeking-cbi-probe-drug-safety-review-toll-at-21-in-mp/articleshow/124446424.cms.