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This current edition of our Life Sciences and Healthcare Newsletter highlights key developments in the regulatory, policy and industry space that have taken place during January 2026. There has been significant and meaningful activity across pharmaceutical, medical devices and food regulation, notably the introduction of a prior intimation mechanism under the NDCT Rules, the operationalization of the drugs compounding regime, the publication of the latest Indian Pharmacopoeia edition, the revised FSSAI inventory compliance norms, and various digital health initiatives by the National Health Authority.
In addition, we review a recent decision of the Delhi High Court on the patentability of diagnostic procedures, which has far-reaching implications for the MedTech, biotech, and AI-diagnostic industries. We trust this edition will serve as a useful reference as you navigate the evolving regulatory landscape.
Pharmaceuticals
Draft NDCT Rules Proposes Bioequivalence exemptions for equivalent Intravenous and Injectable New Drugs
The Ministry of Health and Family Welfare ("MoHFW") has published a draft amendment to the New Drugs and Clinical Trials Rules, 2019 ("NDCT Rules") on January 20, 2026, introducing a modification to Table 2 of the Second Schedule. The draft amendment seeks to exempt bioequivalence ("BE") studies for intravenous infusions and aqueous injectable solutions, if the excipients in the test formulation are qualitatively and quantitatively identical to those in the reference formulation. The draft amendment was made after consultation with the Drugs Technical Advisory Board ("DTAB"). Stakeholders are invited to submit objections or suggestions within 30 days, with the final amendment to be notified on a date to be separately notified. The amendment aims to waive the need for BE testing when the chemical equivalence of the formulation makes the testing unnecessary.
NDCT Amendment Rules, 2026, introduces a prior intimation mechanism to reduce approval timelines
Following a public consultation which was initiated by the draft issued on August 27, 2025, the MoHFW has notified the New Drugs and Clinical Trials (Amendment) Rules, 2026. One of the significant changes introduced through this amendment is the 'prior intimation' mechanism, which permits manufacturers to commence the manufacture of new drugs and investigational new drugs for analytical and non-clinical testing purposes upon submitting an online intimation to the Central Licensing Authority ("CLA") and receiving an acknowledgement, without the need to await formal prior permission. This facility, however, does not extend to sex hormones, cytotoxic drugs, beta lactams, biologics with live microorganisms, or narcotics and psychotropic drugs, all of which continue to require formal prior permission. The prior permission route also remains applicable for clinical trials, bioavailability or BE studies or for examination, test and analysis.
The amendment also shortens the regulatory timelines, by reducing several approval periods from 90 to 45 working days and standardizing various provisions to include both permissions and prior intimations in the provisions dealing with manufacture, record-keeping, labeling, suspension, cancellation, and appeals. The corresponding statutory forms CT-10, CT-12 and CT-13 have also been amended accordingly. The amendment will come into effect 45 days after the date of its publication in the Official Gazette. The amendment will help ease procedural burdens, accelerate early-stage drug development, and improve regulatory efficiency.
IP 2026 released with 121 new monographs
The Indian Pharmacopoeia 2026 ("IP 2026") was released by the Union Health Minister Shri J.P. Nadda on January 2, 2026. IP 2026 is published by the Indian Pharmacopoeia Commission, established under the Drugs and Cosmetics Act, 1940. The 10th edition is a major milestone in improving the quality, safety, and efficacy of medicines. The IP 2026 includes 121 new monographs, taking the total number of monographs to 3,340, with an emphasis on anti-tubercular, anti-diabetic, anti-cancer medicines, and iron supplements used under various National Health Programmes. Notably, this edition marks a milestone with the inclusion of 20 blood component monographs on transfusion medicine for the first time, which is aligned with the Drugs and Cosmetics (Second Amendment) Rules, 2020. The Minister highlighted the remarkable international advancement achieved by India in pharmacovigilance, moving from the 123rd rank (2009-2014) to the 8th rank in the world (2025) in terms of contribution to the pharmacovigilance database of the World Health Organization.
Mandatory Blue Strip Labeling for Antimicrobial Drugs
On January 21, 2026. the MoHFW published a draft amendment to the Drugs Rules, 1945 ("Drugs Rules"). The amendment to Rule 96 of the Drugs Rules stipulates that antimicrobial drug products shall be required to bear a prominent blue vertical strip on the left side throughout the body of the labeling. This visual marker, recommended by the DTAB, aims to assist patients and healthcare professionals in identifying anti-infectives to curb irrational use and tackle antimicrobial resistance. Stakeholders are invited to submit objections or suggestions within 30 days.
Inclusion of Pregabalin to Schedule H1 of the Drugs Rules
The MoHFW has published a draft notification on January 21, 2026, proposing to include Pregabalin as the 51st drug in Schedule H1 of the Drugs Rules. This inclusion aims to curb systemic abuse by strictly following prescription and dispensing requirements, such as maintain records of prescriber and patient and retaining prescriptions for a minimum period of 3 years by pharmacists, as per Rule 65 of the Drugs Rules. The draft amendment is open to public feedback for a period of 30 days and will come into effect 3 months after its final publication in the Official Gazette.
Drugs and Cosmetics (Compounding of Offences) Rules, 2025 has been Operationalized
The Central Drugs Standard Control Organization ("CDSCO") through a Public Notice dated January 1, 2026, has operationalized the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 which came into force on April 24, 2025. The framework provides for a Central Compounding Authority that shall settle compoundable offences, such as discrepancies in record-keeping, minor technical or procedural lapses, and labeling errors, which is in line with the decriminalization policy of the Jan Vishwas Act, 2023. Offenders may resolve violations by filing applications in the prescribed format along with compounding fees, which has to be paid within 30 days of the order allowing the compounding of offenses, thereby obtaining immunity from prosecution. Although this initiative aims to promote ease of doing business, the official FAQs make it clear that the grant of immunity is discretionary and may be revoked if material facts were misrepresented during the compounding process.
Medical Devices
Risk Classification for Oncology-related Medical Devices
CDSCO released a risk classification list for medical devices pertaining to oncology under the Medical Devices Rules, 2017, through a notice on January 2, 2026. This move provides a mandatory roadmap for manufacturers and importers by categorizing 77 different oncology-related medical devices into risk categories from Class A (low risk) to Class D (high risk), which determines the level of regulatory oversight required for each device. Key categories of devices include radiation therapy equipment, imaging and diagnostic devices, ablation systems, hyperthermia treatment systems, drug delivery devices, surgical instruments and artificial intelligence ("AI") and machine learning technologies.
Government Initiatives
NHA Releases AB PM-JAY Compendium of Best Practices for 2025-26
The National Health Authority ("NHA") has released the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana ("AB PM-JAY") Compendium of Best Practices for 2025-26, that provides a strategic framework for improving universal health coverage through state-level innovations that can be replicated. The compendium puts together the best practices on 9 themes: beneficiary identification and enrollment, information, education, and communication, hospital operations, treatment innovations, claim management, audit and compliance, capacity building, grievance redressal, and fund utilization. By synthesizing successful models in beneficiary outreach and digital health integration, the compendium provides a roadmap for improving the portability of cashless benefits across the Ayushman Bharat ecosystem.
Chintan Shivir Organised to Strengthen Implementation of AB PM-JAY and ABDM
The NHA organized a strategic two-day Chintan Shivir in Bhubaneswar, Odisha on January 19 and 20, 2026, to improve the implementation of AB PM-JAY and Ayushman Bharat Digital Mission through innovation, digitalization, and inclusive healthcare. During the Shivir, NHA signed three Memorandum of Understanding with Bhashini, the Indian Institute of Sciences, Bangalore and National Accreditation Board for Hospitals and Healthcare Providers ("NABH")- Quality Control of India ("QCI"). These partnerships will help improve multilingual support for digital healthcare services, strengthen AI-driven diagnostic integration and improve quality and accreditation standards. The NHA also released the Health Benefit Package Manual - Part 2, which is an important resource manual for empaneled healthcare providers to ensure accurate hospital billing, claim submission, and compliance with clinical standards. For healthcare establishments, these developments indicate an improvement in the use of digital protocols and more rigorous quality benchmarks for public-private healthcare partnerships.
Accreditation
NABH Issues Revised Occupancy Norms to Support Small and Mid-Sized HCOs
The NABH has notified a strategic shift in its accreditation criteria on January 20, 2026, replacing the static 30% average minimum bed occupancy standard with a tiered, graduated scale. According to the new standards, Health Care Organizations ("HCOs") are required to comply with a minimum of 20% occupancy for the final assessment, 25% for surveillance or the first renewal, and 30% for subsequent cycles. This change will be applicable to both accreditation and certification schemes, as long as the hospital has been functional for 6 months and has been following NABH standards for at least 3 months. In addition, the notification gives a crucial reprieve to standalone day-care centers, particularly those providing chemotherapy, fertility, and dialysis services, to include day-care beds as census beds for calculating occupancy. The notification also gives a formula to calculate average bed occupancy.
Revised NABH-QCI eligibility criteria for CGHS Empanelment
NABH has released a notification on January 12, 2026, regarding the processing of applications by hospitals for empanelment under the Central Government Health Scheme ("CGHS") that were received on or after December 22, 2025. The notification advises that such applications would be strictly processed according to the new criteria, which include NABH accreditation, NABH entry-level certification, or NABH-QCI recommendation, as per the category and location of the healthcare facility. The notification breaks down the CGHS empanelment eligibility criteria based on facility type (Multi-Specialty, Single-Specialty, Super-Specialty, Diagnostic Laboratories and more), and the accreditation standards for Tier 1 cities versus Tier 2/3 cities and for North-Eastern states, Jammu & Kashmir, and Ladakh.
Food Laws
FSSAI Issues Draft Amendment Mandating Daily Production Records and FIFO/FEFO Compliance
The Food Safety and Standards Authority of India ("FSSAI") published the Draft Food Safety and Standards (Licensing and Registration of Food Business) Amendment Regulations, 2026 on January 23, 2026. The Draft Amendment proposes two key changes, firstly, manufacturing food businesses will be required to maintain daily records of production and raw material utilization, though this obligation will not apply to non-manufacturing food businesses. Second, all licensed food business operators will be required to follow First-In-First-Out ("FIFO") and First-Expire-First-Out ("FEFO") inventory management principles when storing raw materials, ingredients, work-in-progress, and processed, cooked, or packaged food products, with retailers being expressly exempted from this requirement. Stakeholders may submit their objections or suggestions within 30 days of the notification being published.
Key Judgment
Hirotsu Bio Science v. Assistant Controller of Patents and Designs C.A.(COMM.IPD-PAT) 45/2023
Introduction
The Delhi High Court upheld the rejection of a patent application for a novel cancer diagnostic method by the Patent Office. The case involves Hirotsu Bio Science Inc. ("Appellant"), seeking to patent a system that uses the olfactory sensitivity of nematodes (Caenorhabditis elegans) to identify cancer in biological samples. The ruling clarifies that under Section 3(i) of the Patents Act, 1970 ("Patents Act"), even highly sensitive laboratory screening tests are not eligible for being patented as they fall under the category of diagnostic methods.
Factual Background
The Appellant's technology, N-NOSE®, utilizes the chemotaxis behaviour of nematodes, which exhibit attraction to urine of cancer patients and avoidance of healthy subjects' urine. The method allegedly has a sensitivity of 100% and a specificity of 95% and claims the ability to detect early-stage cancers (Stage 0-1) and multiple types of cancers (gastric, colorectal, pancreatic, breast, and lung cancers) that existing tumor markers miss.
The Appellant filed the patent application in July 2016, and the Assistant Controller of Patents (the "Respondent") rejected it in August 2023. The rejection was based on Section 3(i) of the Patents Act, which prohibits the patenting of diagnostic methods. The Appellant appealed against the rejection before the Delhi High Court.
The Appellant's Submissions
The Appellant argued that the term "detection" is different from "diagnosis", since diagnosis requires medical interpretation and clinical judgment to link symptoms with diseases. The Appellant's method simply performs in vitro detection by identifying cancer-specific odor responses without specifying cancer type. Claims 1-4 explicitly specify an 'in vitro method' fully performed outside the human body on biological materials.
The Appellant argued that the claims constitute the legal monopoly, while the Complete Specification ("Specification"), simply provides explanatory background. The Appellant relied on precedents that Specifications cannot expand or restrict claims. While the Specification mentioned "diagnosis" for contextual purposes, the claims are strictly limited to in vitro detection without any diagnostic step.
The Appellant relied on EMD Millipore Corporation v. Assistant Controller of Patents and Designs (2025:DHC:8928) to argue that the exclusion under Section 3(i) is not a blanket prohibition against all inventions related to diagnosis; rather, only methods directly involving medical professional judgment or physical intervention performed on the human body are excluded.
Additionally, the Appellant cited The Chinese University of Hong Kong and Sequenom, Inc. v. The Assistant Controller of Patents and Designs (2023 SCC OnLine Mad 6372) to argue that the assessment should focus on whether the test is 'inherently and per se capable of identifying' a disease and that the scope of the word 'diagnostic' in Section 3(i) should be restricted to in vivo processes.
Highlighting real-world application, the Appellant asserted that the method has already been commercialized in Japan to provide cancer risk information rather than medical diagnosis.
Consequently, the Appellant suggested amending Claim 1 to specify that the results are for preliminary screening purposes only and not for definitive medical diagnosis.
The Respondent's Submissions
The Respondent argued that the method meets all four steps in the diagnostic process: (i) data collection, (ii) comparison with standards, (iii) identifying deviations or symptoms, and (iv) attribution to clinical picture. The Specification repeatedly refers to the invention as a "cancer diagnosis system" that can accurately detect cancer, identify various types of cancer, and detect early-stage cancers. This representation is not consistent with the Appellant's characterization of the invention as merely preliminary screening, as claims cannot be interpreted in a manner that contradicts the Specifications.
The Respondent relied upon Natera Inc. and Anr. v. Assistant Controller of Patents and Designs, (2025:DHC:8937) to argue the manner in which diagnosis is performed would not be patentable and that Section 3(i) does not make any distinction between in vivo or in vitro processes.
Furthermore, the Respondent relied upon Sequenom Inc. and Anr. v. the Controller of Patents (2025:DHC:8926), to argue that if a test has high sensitivity and specificity (e.g., ≥95%) it leads to a definitive result or conformity and therefore constitutes a diagnosis. Ultimately, the Respondent maintained that Section 3(i) excludes both in vivo and in vitro methods, as no such distinction exists in the statute. And the word "diagnostic" under the Patents Act includes both positive and negative diagnoses, and a test does not need to be "definitive" to be excluded; provided it identifies the disease or disorder.
Judicial Analysis and Findings
The Court decided to take a functional view regarding what the method does, rather than what it is called. It concluded that the method falls within the meaning of "diagnosis" under Section 3(i) since it satisfied all diagnostic test steps: collecting sample, measuring chemotaxis, repetitive analysis, and linking positive results to cancer presence or risk.
It reinforced that Section 3(i) is a broad public-policy exclusion, and the term 'diagnostic' covers both in vivo and in vitro processes, thereby rejecting the argument that in vitro methods make the invention patentable.
The Court emphasized that high accuracy has relevance to diagnostic character, since the method has 95-100% sensitivity/specificity and capability to detect Stage 0-1 cancers which existing markers fail to catch, the method was per se capable of identifying disease, not merely indicating further testing needs. The Court held methods achieving such accuracy provide actionable disease identification, qualifying as diagnostic even if it is labelled 'screening.'
The Court rejected the Appellant's genus-species analogy, insisting the claims must be read in line with the Specification, which describes the technology as a 'cancer diagnosis system' of high accuracy. It rejected the proposed amendment to the claim as it would be inconsistent with the Specification's diagnostic characterization.
The Court also held it is immaterial who carries out the diagnostic process. Section 3(i) is not restricted to only physician-performed methods, as doing so would allow fully automated diagnostic methods to become patentable.
Conclusion
The Court dismissed the appeal on the grounds that the cancer detection method is a non-patentable diagnostic process under Section 3(i) of the Patents Act. The ruling clearly shows that purpose triumphs over nomenclature, and if a method can identify pathology with a sufficient level of accuracy, it is diagnostic, regardless of whether it is labelled detection or screening, performed autonomously, or conducted in vitro. Although diagnostic methods and processes are excluded under Section 3(i), the ruling has maintained the patentability of diagnostic products, tools, and devices.
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