In this issue of Noverra Partners Pharma and Healthcare Insight we have made an effort to include all the pertinent developments in the pharmaceuticals and healthcare sector during the month of February 2026. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
1) Regulatory Update
- PCI asks institutions to submit SIF for 2026-27 by February 27
The Pharmacy Council of India (PCI) has reopened its portal, giving existing pharmacy institutions a final opportunity to submit the Standard Inspection Format (SIF) for the 2026-27 academic session by February 27, following a Supreme Court order dated on February 6 extending the deadline by three weeks. Institutions that missed prior windows in October – November 2025 are urged to act early to avoid server delays due to high traffic. Under PCI’s revised schedule, SIF submissions before November 1 qualify for the current session starting August 1 (with admissions until August 15); later ones shift to the next-to-next acadamic year. This ensures compliance for PCI code issuance and student admissions nationwide.
- DGFT extends deadline for filing Annual RoDTEP Return till March 31, 2026
The Directorate General of Foreign Trade (DGFT) has extended the deadline for filing the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Return (ARR) for Financial Year (FY) 2023–24 until March 31, 2026, with a composition fee of ₹15,000. The extension, issued under the Foreign Trade Policy (FTP) 2023, aims to promote ease of doing business and support exporters. Failure to file by the extended deadline may attract action under the Handbook of Procedures (HBP) 2023, including denial of RoDTEP benefits. The RoDTEP scheme provides refunds embedded duties and taxes not covered under Goods and Services Tax (GST), enhancing the global competitiveness of Indian exports.
- Health Ministry proposes to do away with provisional registration of ethics committees under NDCT Rules
The Ministry of Health and Family Welfare has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 to streamline regulatory procedures and improve ease of doing business in India’s pharmaceutical sector. The draft notification proposes eliminating the provisional registration of Ethics Committees, which currently allows a two-year provisional certificate before final registration. Under the proposed changes, authorities will directly review applications submitted in Form CT-01 and grant final registration in Form CT-03 if requirements are satisfied. The draft also outlines new provisions for post-approval changes in drug manufacturing, classifying them into major, moderate and minor quality changes with corresponding regulatory requirements. These amendments aim to simplify approvals, accelerate clinical research and reduce the regulatory burden on pharmaceutical companies.
- DGFT invites suggestions on ‘The Digital Trade Facilitation Bill, 2026’ from pharma exporters.
The Directorate General of Foreign Trade (DGFT) has invited stakeholder comments on the draft Digital Trade Facilitation Bill, 2026, following the Union Budget 2025–26 announcement to operationalize BharatTradeNet as a Digital Public Infrastructure for trade. The proposed legislation aims to grant statutory recognition and enforceability to electronic trade documents, enable trusted digital verification mechanisms, and facilitate secure cross-border exchange of trade records. The Bill will complement the Information Technology Act and the Consumer Protection Act, without overriding data protection laws. Stakeholders, including pharma exporters, have been given 30 days to submit their comments. The move seeks to enhance digital interoperability, trade transparency, and ease of doing business.
- NPPA asks companies to revise MRPs of 17 drugs following basic customs duty (BCD) exemption.
The National Pharmaceutical Pricing Authority (NPPA) has directed manufacturers and marketers of 17 life-saving cancer drugs exempted from Basic Customs Duty (BCD) in the Union Budget 2026–27 to revise their Maximum Retail Prices (MRP) and pass on the benefit to consumers. The exemption, notified by the Ministry of Finance, increases the total number of BCD-exempt drugs to 129. As per the Drugs Prices Control Order (DPCO), 2013, MRPs must reflect reductions in duties and taxes. Companies are required to submit revised pricing details in Form V and issue updated price lists. While the industry welcomed the move, patient groups argued that deeper measures may be needed to improve the affordability of patented medicines.
- DGFT amends import policy on penicillin, 6-APA & Amoxycillin and their salts to boost trade
The Directorate General of Foreign Trade (DGFT) has amended the import policy for key antibiotics including Penicillin, 6-Aminopenicillanic Acid (6-APA), and Amoxycillin and their salts to regulate imports and support domestic trade. Under the revised policy, imports of Penicillin G-potassium, Amoxycillin trihydrate, and 6-APA below specified Minimum Import Price (MIP) thresholds have been classified as “Restricted.” However, the MIP condition will not apply to imports by 100% Export Oriented Units in Special Economic Zones or under the Advance Authorization scheme, provided the inputs are not diverted to the Domestic Tariff Area. The amendments were issued under the Foreign Trade Policy 2023 to streamline antibiotic imports while ensuring regulatory compliance and trade balance.
- CDSCO directs manufacturers of Doxycycline & Carbimazole to add new side effects in package information
The Central Drugs Standard Control Organization (CDSCO) has directed state and Union Territory regulators to instruct manufacturers of Doxycycline and Carbimazole formulations to update their prescribing information leaflets with newly identified adverse drug reactions. Based on recommendations from the Indian Pharmacopoeia Commission (IPC) under the Pharmacovigilance Program of India (PvPI), Doxycycline labels must include central nervous system side effects such as restlessness, anxiety, irritability, nervousness, and dizziness. Carbimazole labels must add “agranulocytosis,” a potentially life-threatening condition. The decision follows Subject Expert Committee reviews and reflects strengthened pharmacovigilance measures to enhance drug safety awareness and ensure updated risk communication to healthcare professionals and patients.
- Government proposes amendment of rules to allow drug imports through Navi Mumbai International Airport
The Union Ministry of Health and Family Welfare (MoHFW) has proposed a draft amendment to the Drugs Rules, 1945 to allow the Navi Mumbai International Airport (NMIA), Maharashtra, to be authorised as an entry point for the import of drugs. Once finalised, NMIA would become the 12th airport in India permitted for drug imports by air. The proposal, issued after consultation with the Drugs Technical Advisory Board (DTAB), has been published for public comments for 30 days before final notification. The amendment seeks to modify Rule 43A of the Drugs Rules to include NMIA alongside existing authorised airports such as Chennai, Delhi, Mumbai, Hyderabad, and Bengaluru, aiming to strengthen pharmaceutical import logistics and cargo handling capacity in the country.
2) Approvals
- WHO prequalifies Biological E’s novel oral polio vaccine type 2 to strengthen global outbreak response
The World Health Organization (WHO) has prequalified a novel oral polio vaccine type 2 (nOPV2) manufactured by Biological E Limited, strengthening global vaccine supply for controlling poliovirus type 2 outbreaks. WHO prequalification confirms that the vaccine meets international standards for quality, safety, and efficacy, enabling procurement by United Nations agencies such as UNICEF for global immunization programs. The vaccine, developed to address circulating vaccine-derived poliovirus type 2 (cVDPV2), offers improved genetic stability compared to earlier oral vaccines, reducing the risk of new outbreaks. The additional prequalification also expands the global manufacturing base for nOPV2, supporting faster and more sustainable responses to polio outbreaks worldwide.
- Alembic Pharma gets U.S. FDA nod for generic Antifungal Drug
Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. The product is therapeutically equivalent to Jublia, and is indicated for the topical treatment of Onychomycosis of the toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes. Alembic was among the first applicants to submit a substantially complete ANDA with a Paragraph IV certification, which may allow the company to benefit from 180-day generic drug exclusivity, subject to regulatory provisions.
- Lupin receives European approval for biosimilar Ranibizumab
Lupin Limited has received approval from the European Commission for its biosimilar ranibizumab, Ranluspec, available in vial and pre-filled syringe formulations. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Ranibizumab is a recombinant humanized monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A) and is indicated for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, proliferative diabetic retinopathy, macular edema following retinal vein occlusion, and choroidal neovascularization. Lupin’s biosimilar ranibizumab will be commercialized by Sandoz across the European Union, excluding Germany, while in France it will be marketed by Sandoz and Biogaran.
- Vanda Pharmaceuticals Inc. receives US Food and Drug Administration approval for Bysanti
The US Food and Drug Administration has approved Bysanti (milsaperidone) tablets for the treatment of Schizophrenia in adults and for acute manic or mixed episodes associated with bipolar I disorder. Bysanti is a new chemical entity (NCE) and an atypical antipsychotic that demonstrated bioequivalence to iloperidone, leveraging established efficacy and safety data from extensive clinical use. The approval marks Vanda’s second new drug clearance within two months and strengthens its behavioural health portfolio. Commercial launch is anticipated in Q3 2026, with regulatory data exclusivity and US patent protection extending through 2044, supporting long-term market presence.
- Hologic receives US FDA approval for Aptima HPV assay for primary screening option; expands cervical health portfolio
Hologic Inc. has received US Food and Drug Administration approval for its Aptima Human Papillomavirus (HPV) assay as a primary screening option using clinician-collected samples. The Aptima HPV assay is the only US Food and Drug Administration-approved messenger ribonucleic acid (mRNA)-based test designed to detect high-risk HPV infections most likely to progress to Cervical Cancer. The approval expands Hologic’s Cervical Cancer screening portfolio to include Pap testing, co-testing (Pap + HPV), and HPV primary screening. Backed by real-world evidence involving over 650,000 women, the assay demonstrated clinically comparable sensitivity to DNA-based tests, strengthening screening flexibility and preventive care options in the United States.
- Zydus receives US FDA tentative approval for dapagliflozin tablets, 5 mg and 10 mg
Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, 5 mg and 10 mg, the generic version of Farxiga. Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The tablets will be manufactured at the company’s formulation manufacturing facility located at the Special Economic Zone (SEZ) in Ahmedabad.
- UK MHRA approves Jazz Pharmaceuticals’ Zanidatamab for the treatment of Biliary Tract Cancer
The UK Medicines and Healthcare Products Regulatory Agency has approved Zanidatamab (Ziihera), developed by Jazz Pharmaceuticals plc, for the treatment of adults with unresectable or metastatic Biliary Tract Cancer expressing high levels of HER2, following progression after prior therapy. Approved via the International Recognition Procedure, Zanidatamab is administered intravenously every two weeks. In a clinical study involving 80 patients, approximately 52% of HER2-positive patients experienced tumour shrinkage or disappearance after a median follow-up of 34 months. The approval addresses an unmet clinical need and introduces a targeted treatment option for advanced biliary tract cancer in the United Kingdom.
- EU recommends approval of AstraZeneca’s Imfinzi perioperative regimen for patients with early gastric and gastroesophageal cancers
AstraZeneca announced that Imfinzi (durvalumab) in combination with standard FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) has been recommended for approval in the European Union (EU) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The regimen is intended for the treatment of adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. The recommendation is based on results from the MATTERHORN Phase III trial, which showed a 29% reduction in the risk of disease progression, recurrence or death and a 22% reduction in the risk of death compared with chemotherapy alone. If approved, the regimen could become the first immunotherapy-based perioperative treatment for this patient population in the EU.
3) International Pharma News
- Lupin inks license & supply agreement with Spektus to commercialize novel antidepressant DeslaFlex in Canada
Lupin Limited has signed a license and supply agreement with Spektus Pharma to commercialize the novel antidepressant DeslaFlex in Canada. The drug, developed using Spektus’ proprietary FlexiTab oral drug-delivery platform, is designed for the treatment of Major Depressive Disorder (MDD). The partnership combines Lupin’s established commercial presence in the Canadian market with Spektus’s expertise in developing differentiated formulations. According to the companies, the collaboration aims to expand treatment options for patients while strengthening Lupin’s central nervous system (CNS) portfolio. The agreement also supports Lupin’s strategy to expand its specialty medicines business and introduce innovative therapies in international markets.
- GCCL and MICS sign MoU to collaborate on multinational clinical trial services
GCCL Co., Ltd. and Medicover Integrated Clinical Services (MICS) have signed a Memorandum of Understanding (MoU) to collaborate on multinational clinical trial services across Europe, the United States, and the Asia-Pacific region. The partnership aims to enhance cross-regional coordination, streamline sample analysis, strengthen project management, and jointly expand market presence. By combining MICS’s European and US network with GCCL’s analytical and project management expertise in Asia, the collaboration seeks to improve operational efficiency and deliver integrated, end-to-end clinical trial solutions for global pharmaceutical, biotechnology, and medtech clients.
- India, Brazil sign MoU to strengthen cooperation in pharma and medical products regulation
India and Brazil have signed a Memorandum of Understanding (MoU) to strengthen cooperation in the regulation of pharmaceutical and medical products. The agreement was exchanged between the Central Drugs Standard Control Organization (CDSCO) of India and Brazil’s Brazilian Health Regulatory Agency (ANVISA). The MoU establishes a framework for information exchange, regulatory cooperation, and capacity building related to pharmaceuticals, biological products, medical devices, and pharmaceutical ingredients. The collaboration aims to enhance regulatory convergence improve oversight of medical products, and support access to safe, effective, and quality-assured medicines. The initiative is also expected to strengthen India–Brazil supply chains and healthcare cooperation while promoting best regulatory practices between the two countries.
- Bavarian Nordic receives USD 22.5 million contract for its Mpox and Smallpox vaccine from the Government of Canada
Bavarian Nordic A/S has received a USD 22.5 million order from the Public Health Agency of Canada (PHAC) for its mpox and smallpox vaccine, MVA-BN. The order is part of a 10-year framework agreement signed in 2022 to support Canada’s public health preparedness against viral threats. Under the contract, bulk vaccine manufacturing will take place in 2026, while filling and supply of the final drug product will occur later. The MVA-BN vaccine is the only non-replicating mpox vaccine approved in several jurisdictions, including the United States, Canada, the European Union, the United Kingdom, Switzerland, Singapore and Mexico. The collaboration aims to strengthen global readiness against infectious diseases such as mpox and smallpox.
- LifeScan partners with i-SENS to launch OneTouch brand for a continuous glucose monitoring system
LifeScan has partnered with i-SENS to develop and launch a continuous glucose monitoring (CGM) system under the OneTouch Vita brand, marking a significant expansion of LifeScan’s diabetes care portfolio. The collaboration combines LifeScan’s global distribution network and established OneTouch brand with i-SENS’s advanced biosensor and electrochemical technology. The companies plan to introduce the CGM products in Germany, Ireland, Portugal, and Belgium by early 2027, with further global expansion planned later. The partnership aims to strengthen LifeScan’s position in the glucose management market and improve diabetes care by providing advanced monitoring solutions.
- Sobi completes acquisition of Arthrosi Therapeutics, strengthening pipeline for the potential treatment of Gout
Swedish Orphan Biovitrum AB (Sobi) has completed the acquisition of Arthrosi Therapeutics, strengthening its pipeline for the treatment of Gout. Through the transaction, Sobi acquired all outstanding shares of Arthrosi, a biotechnology company developing Pozdeutinurad (AR882), an investigational once-daily oral URAT1 inhibitor currently being evaluated in two global Phase 3 clinical trials for progressive and tophaceous gout. The candidate drug has previously shown promising results in Phase 2 studies, demonstrating sustained reduction in serum uric acid and improvement in gout-related symptoms.
- WHO validates elimination of trachoma as a public health problem in Libya
The World Health Organization (WHO) has validated the elimination of trachoma as a public health problem in Libya, marking a significant public health milestone in the Eastern Mediterranean Region. Libya becomes the 28th country globally and the 8th in the region to achieve this status. The success follows sustained surveillance, surgical interventions for trichiasis, and strengthened eye health services under the National Prevention of Blindness Programme, supported by WHO and international partners. Despite political instability and humanitarian challenges, Libya met WHO elimination thresholds, reinforcing global progress toward neglected tropical disease targets under the 2021–2030 roadmap.
- Pfizer launches cost-savings program on TrumpRx lowering drug costs for millions of Americans
Pfizer Inc. has launched a cost-savings initiative on the TrumpRx platform to make over 30 medicines available to American patients at significant discounts. Under the program, uninsured and self-paying insured patients may receive savings averaging 50%, with discounts up to 85% on selected primary care and specialty brands. The initiative aligns with Pfizer’s Most Favored Nation (MFN) agreement with the US government aimed at improving affordability while sustaining pharmaceutical innovation. In partnership with GoodRx Holdings Inc., patients can access coupons usable at most US pharmacies or opt for home delivery, expanding pricing transparency and consumer choice in the United States.
- Galderma launches OBT hyaluronic acid injectables Restylane Defyne and Refyne in Japan
Galderma has launched Restylane Defyne and Restylane Refyne, the first Optimal Balance Technology (OBT)-based hyaluronic acid injectables authorized in Japan for the correction of moderate to severe facial wrinkles and folds. Designed for injection into the mid-to-deep dermis, the products aim to restore natural facial expressions while maintaining flexibility and structural support. Restylane Refyne provides a softer, flexible gel for delicate facial areas, while Restylane Defyne offers enhanced support for deeper wrinkles and jawline contouring. Their approval was supported by Phase III clinical studies demonstrating significant improvement in wrinkle severity for up to 12 months. The launch expands Galderma’s Restylane portfolio in Japan and supports the company’s growth strategy in the region’s rapidly expanding aesthetics market.
4) Domestic Pharma News
- TNCDA urges state govt to abolish ‘double taxation’ on pharmacies
The Tamil Nadu Chemists and Druggists Association (TNCDA) has urged the Tamil Nadu government to abolish what it describes as “Double Taxation” on pharmacies caused by overlapping licensing requirements. In a letter to the Municipal Administration Minister, the association said several municipalities are imposing annual trade license fees on pharmacies despite traders already paying professional taxes and holding mandatory drug licenses. TNCDA argued that these additional local body charges create financial and administrative burdens for pharmacy businesses. Representing around 50,000 wholesalers and retailers in the state, the association requested the government to introduce a uniform policy to remove redundant licensing fees and simplify regulatory procedures for pharmacy traders.
- Zynova Shalby launches advanced oncology department for patient-centric cancer care
Zynova Shalby Multi-Specialty Hospital has launched a dedicated oncology department in Mumbai to provide comprehensive cancer care amid the rising burden of cancer cases in India. The new department offers end-to-end oncology services, including cancer screening, advanced imaging, biopsy procedures, chemotherapy, immunotherapy, and targeted therapy. The initiative aims to strengthen early detection, accurate diagnosis, and coordinated treatment, which are critical for improving survival rates and patient outcomes. The department will be led by a multidisciplinary team of oncology specialists to ensure evidence-based and personalized treatment for patients. The hospital stated that the initiative is part of its efforts to expand specialized healthcare services and improve access to quality cancer treatment.
- Cipla Foundation and Tata IISc Medical School to set up Centre for Pulmonary Medicine in Bengaluru
Cipla Foundation has partnered with the Indian Institute of Science (IISc) and the Tata IISc Medical School to establish the Cipla Foundation Centre for Pulmonary Medicine in Bengaluru. The center aims to strengthen respiratory care, research, and medical training in India, addressing the growing burden of lung diseases. It will focus on advanced diagnostics, outpatient and inpatient care, and critical care facilities, while supporting research in conditions such as chronic obstructive pulmonary disease, asthma, and interstitial lung disease. The initiative will also promote interdisciplinary research, including AI-based lung diagnostics, pharmacogenomics, and biomarker discovery, along with training programmes for pulmonologists and healthcare professionals to improve respiratory healthcare outcomes in the country.
- IPC signs MoUs with GSPC, QCI & HITES to strengthen Pharmacovigilance and quality assurance
The Indian Pharmacopoeia Commission (IPC) has signed Memorandam of Understanding (MoUs) with the Goa State Pharmacy Council (GSPC), Quality Council of India (QCI), and HLL Infra Tech Services Limited (HITES) to strengthen drug safety, quality assurance, and professional capacity building in India. The collaborations will focus on promoting the National Formulary of India, enhancing Adverse Drug Reaction (ADR) reporting under the Pharmacovigilance Program of India (PvPI), and conducting training and awareness programs for pharmacists. The partnerships also aim to support ADR Monitoring Centers and improve reporting systems across healthcare facilities, reinforcing IPC’s commitment to uniform medicine quality standards and improved patient safety nationwide.
- BDCDA urges Karnataka govt to constitute committee of retired drug controllers for monitoring DC department
The Bangalore District Chemists and Druggists Association (BDCDA) has urged the Karnataka government to establish an honorary committee of retired Drugs Controllers, Additional Drugs Controllers, and Deputy Drugs Controllers to support monitoring and implementation of geo-tagging compliance in the state’s drug control department. The association noted that enforcement officials are facing severe manpower shortages, affecting statutory duties such as inspections, sampling, and prosecution. It also proposed restructuring the enforcement mechanism by separating food licensing and drug administration functions and placing enforcement activities under an Indian Police Service (IPS)-led framework. According to BDCDA, such reforms would strengthen regulatory oversight, improve operational efficiency, and enhance coordination in addressing antimicrobial resistance (AMR) and drug misuse.
- BDMAI’s e-marketing portal to promote Indian pharma products and services in domestic, global markets
The Bulk Drug Manufacturers Association of India (BDMAI) has launched an e-marketing portal to promote Indian active pharmaceutical ingredients (APIs), intermediates, pellets, impurities, and contract development and manufacturing organization and contract research and manufacturing services in domestic and global markets. Designed as a one-stop digital marketplace, the platform enhances visibility and connectivity for bulk drug manufacturers. The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has encouraged members to register as buyers and use the portal for sourcing APIs. Featuring product-based search tools and an integrated enquiry system, the initiative aims to strengthen India’s bulk drug ecosystem and global competitiveness.
- Grace Cancer Foundation inks MoU with Government of Meghalaya, expands footprint to North East
The Grace Cancer Foundation (GCF) has signed a Memorandum of Understanding (MoU) with the Government of Meghalaya to expand its cancer awareness and screening programs in the North-Eastern region of India. Under the collaboration, free cancer screening initiatives will be rolled out in Meghalaya and Tripura starting February 2026, focusing on early detection and awareness in underserved communities. The initiative follows an appeal by the Governor of Telangana to extend the foundation’s services to the North-East. The program aims to strengthen early diagnosis, patient support, and community-level cancer awareness in the region.
5) Innovations
- Amrita unveils ‘MedSum’, AI tool to cut doctor paperwork and improve patient communication
Amrita Vishwa Vidyapeetham has unveiled MedSum, an artificial intelligence-powered clinical assistant designed to convert doctor–patient conversations into structured medical records, prescriptions, and multilingual patient summaries. Developed by its School of Artificial Intelligence in collaboration with Amrita Hospitals and Amrita Technologies, the tool reduces the documentation burden and enhances patient understanding. Powered by BharatGen’s Param-17B large language model, MedSum generates real-time, hospital-ready clinical notes and voice-based summaries in multiple Indian languages. Currently deployed across several specialties, the platform supports improved clinical efficiency and patient communication, marking a significant step toward sovereign, India-built AI solutions in healthcare.
- Remidio Takes India’s AI success story global at India AI Impact Summit 2026
Remidio Innovative Solutions showcased its AI-powered eye screening technology at the India AI Impact Summit 2026, highlighting India’s growing role in global healthcare innovation. The company’s artificial intelligence platform has screened over 16 million people across more than 55 countries, including 1.3 million AI-based screenings, significantly reducing screening costs from INR 2,000 to INR 60 per test. Remidio’s technology detects major causes of blindness such as diabetic retinopathy, glaucoma, and age-related macular degeneration in a single scan and is deployed across several Indian states and leading hospitals. The system has received Central Drugs Standard Control Organization (CDSCO) approval and CE certification, and is also advancing research in oculomics, using retinal imaging to identify early indicators of systemic diseases.
- Samsung Health announces ‘Find Care’ feature in partnership with PharmEasy and Tata 1mg
Samsung Electronics has introduced the ‘Find Care’ feature within Samsung Health through a partnership with PharmEasy and Tata 1mg. The integrated feature enables users to order medicines, book diagnostic tests, and consult doctors directly within the Samsung Health app, eliminating the need to switch between platforms. This update aims to enhance digital healthcare convenience and accessibility. By combining wellness tracking with on-demand healthcare services, the initiative strengthens the digital health ecosystem and reflects the growing convergence between consumer technology and healthcare delivery in India.
- Zydus launches ‘PEPAIR’, India’s first drug-free handheld device for respiratory health
Zydus Lifesciences has launched PEPAIR, a drug-free handheld device designed to support respiratory health and improve airway clearance in patients with chronic lung conditions. The device is India’s first Oscillating Positive Expiratory Pressure (OPEP) device and is aimed at helping patients with chronic obstructive pulmonary disease, asthma, and bronchiectasis. PEPAIR works by creating pressure and vibrations during exhalation to loosen mucus, open airways, and promote effective mucus clearance. Developed in partnership with AeroDel Technology Innovations, the device features a patented three-resistance system and aims to improve respiratory care accessibility for patients in India.
- BPL Medical Technologies launches India’s first AI‑integrated mobile cancer screening bus
BPL Medical Technologies has powered India’s first AI-enabled mobile cancer screening unit, aimed at expanding access to early cancer detection services in underserved regions. The mobile screening bus, launched at the Basavatarakam Indo‑American Cancer Hospital & Research Institute in Hyderabad, is equipped with AI-integrated digital radiography and digital mammography systems. The unit enables high-quality imaging and cancer screening in community settings, particularly in rural and low-access areas where diagnostic infrastructure is limited. Designed to support preventive healthcare programmers, the initiative focuses on the early identification of breast and other cancers, helping improve patient outcomes through timely diagnosis and treatment.
- Median Technologies collaborates with Tempus to expand access to Eyonis LCS software as a medical device in the United States
Median Technologies has entered into a non-exclusive distribution agreement with Tempus AI to expand access to its artificial intelligence-based lung cancer screening software, Eyonis LCS, in the United States. The collaboration follows the US Food and Drug Administration (FDA) 510(k) clearance of Eyonis LCS and aims to integrate the software into clinical workflows through the Tempus Pixel platform. The software as a medical device (SaMD) uses artificial intelligence to detect and characterize lung cancer in low-dose computed tomography scans with high sensitivity and specificity, supporting earlier diagnosis and improved screening efficiency. Under the agreement, Tempus AI will distribute the solution to imaging providers across the United States while supporting implementation and workflow integration, with plans for future expansion into European markets.
6) Trends
- MedLegal Review 2026 in its 18th edition notes clinical errors outpaced by ‘paperwork errors’
The 18th edition of MedLegal Review 2026, hosted by the Institute of Medicine & Law in collaboration with the D. Y. Patil (University) School of Law, highlighted key medico-legal trends in India’s healthcare sector. The review found that procedural and documentation errors now outnumber clinical errors in legal cases against healthcare providers. It also noted rising compensation awarded by courts and an increase in criminal proceedings against doctors and hospital administrators. According to data from the Ministry of Consumer Affairs’ e-Jagriti portal, over 65,000 cases have been filed against doctors and hospitals in consumer courts, placing healthcare among the top sectors facing litigation. The review further indicated that the Digital Personal Data Protection Act could create new legal and privacy challenges for healthcare providers.
- National conference highlights future of integrative healthcare through ‘Yoga Samyog’
The National Conference on Naturopathy 2026, held in New Delhi in February, highlighted the growing emphasis on integrating Yoga and Naturopathy into preventive and rehabilitative healthcare. Organized by the Morarji Desai National Institute of Yoga (MDNIY) and the Central Council for Research in Yoga & Naturopathy (CCRYN) under the Ministry of AYUSH, the conference focused on strengthening evidence-based traditional medicine. Experts discussed research on Yoga’s therapeutic role in managing lifestyle disorders such as diabetes, obesity, and insomnia, while also exploring its applications in neurophysiology and women’s health. The event emphasized scientific validation, interdisciplinary collaboration, and policy support to bridge traditional AYUSH systems with modern medical practices for improving public health outcomes.
- One in two people facing cataract blindness need access to life-changing surgery
The World Health Organization (WHO) has called on countries to strengthen efforts to expand access to cataract surgery, warning that nearly one in two people suffering from cataract-related blindness worldwide still lack access to treatment. According to a study published in The Lancet Global Health, cataracts affect over 94 million people globally, making them one of the leading causes of preventable blindness. Although global cataract surgery coverage has increased by about 15% over the past two decades, further acceleration is needed to achieve the World Health Assembly target of a 30% increase by 2030. WHO highlighted major barriers such as shortages of trained eye-care professionals, high treatment costs, and unequal access, particularly affecting women and populations in low-resource regions.
- AIOCD hails budget 2026-27 as a visionary roadmap for patient welfare and pharma innovation
The All-India Organization of Chemists and Druggists (AIOCD) praised the Union Budget 2026–27 as a balanced roadmap that combines industrial growth with patient welfare. Key highlights include exemption from Basic Customs Duty (BCD) on 36 life-saving medicines, addition of 37 new drugs, and 13 patient assistance programmes to reduce treatment costs. The budget also unveiled the ₹10,000 crore Biopharma Shakti initiative to boost biologics and biosimilars, alongside plans for new National Institutes of Pharmaceutical Education and Research (NIPERs) and 1,000 accredited clinical trial sites. With support for AYUSH through Ayurvedic AIIMS and testing labs, the budget emphasizes innovation, affordability, and integrative healthcare, aligning with India’s vision of “Viksit Bharat” by 2047.
- Study highlights Limitations of HbA1c Test for Diabetes Diagnosis in South Asians
Recent research published in The Lancet Regional Health – Southeast Asia indicates that the widely used glycated haemoglobin (HbA1c) test may not always provide accurate diabetes diagnosis and monitoring for South Asian populations, including India. Researchers found that conditions such as anaemia, haemoglobinopathies, and glucose-6-phosphate dehydrogenase (G6PD) deficiency can alter HbA1c levels by affecting haemoglobin concentration and red blood cell lifespan. This may result in misclassification of diabetes status or delayed diagnosis. The study suggests that relying solely on HbA1c could underestimate the true burden of diabetes in the region. Experts recommend combining HbA1c testing with other diagnostic approaches such as the Oral Glucose Tolerance Test (OGTT) and Self-Monitoring of Blood Glucose (SMBG) to improve diagnostic accuracy.
7) Law and Order Briefs
- Madras HC directs TN SPC to conduct council elections through online mode
The Madras High Court directed the Tamil Nadu State Pharmacy Council to conduct future council elections through online voting, marking the first judicial directive in India mandating digital elections for a pharmacy council. The order was issued by Justice P. T. Asha in response to a petition filed by the Indian Pharmacists Association challenging the costly and time-consuming paper-ballot system. The court instructed the Tamil Nadu government to amend the Tamil Nadu Pharmacy Council Rules, 1953 within eight months, suggesting reference to the Indian Veterinary Council Rules, 1985, which already allow online voting. The directive will apply to the 2030 council elections, aiming to improve transparency, reduce costs, and increase pharmacist participation.
- Novo Sues Hims & Hers Over Compounded Version of Oral Wegovy Pill
Novo Nordisk has filed a lawsuit against Hims & Hers Health alleging patent infringement related to a compounded oral version of its obesity drug Wegovy. The dispute arose after Hims launched a compounded semaglutide pill priced at about USD 49 per month, significantly cheaper than Novo Nordisk’s branded product. Novo Nordisk claims the drug violates patents protecting semaglutide and is seeking hundreds of millions of dollars in damages. Shortly after the lawsuit and regulatory scrutiny, Hims withdrew the pill from its platform. The case highlights growing tensions in the rapidly expanding GLP-1 (Glucagon-Like Peptide-1) weight-loss drug market and increasing legal and regulatory scrutiny of compounded versions of patented medicines.
- AbbVie sued US health agencies over inclusion of Botox in drug price negotiation program
AbbVie has filed a lawsuit against the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services over the inclusion of its blockbuster drug Botox in the Medicare Drug Price Negotiation Program established under the Inflation Reduction Act (IRA). AbbVie argues that Botox should be excluded because it contains human serum albumin derived from blood plasma, which qualifies it as a plasma-derived product exempt from the program. The company claims the government’s decision violates statutory exclusions and constitutional protections, including free speech and property rights. AbbVie is seeking to halt the price negotiation process, which aims to reduce prescription drug costs for Medicare beneficiaries.
- SC asks Gujarat Pollution Control Board to decide Piramal Pharma’s Dahej plant reopening plea
The Supreme Court of India has directed the Gujarat Pollution Control Board (GPCB) to decide within one week on a plea by Piramal Pharma seeking relief regarding its Dahej manufacturing facility in Gujarat. The direction came while hearing a dispute related to the plant’s closure over alleged environmental violations, including the improper discharge of hazardous waste. A bench led by Justice Surya Kant asked the pollution control authority to take a prompt decision on the company’s representation. The Dahej unit is a key production site for pharmaceutical intermediates used in manufacturing the inhalation anaesthetic Sevoflurane. The court’s direction aims to ensure a timely regulatory decision on the plant’s operational status.
- AIOCD seeks PM’s intervention to halt illegal e-pharmacies by withdrawing GSR 220(E) & GSR 817(E)
The All-India Organization of Chemists and Druggists (AIOCD) has urged Prime Minister Narendra Modi to take immediate action against illegal e-pharmacies operating across India. Representing over 13 lakh licensed pharmacies, the association warned that the unchecked growth of online medicine sales without a clear legal framework poses serious risks to drug safety and public health. The body cited the U.S. Drug Enforcement Administration’s “Operation Meltdown,” which shut down over 200 illegal pharmacy domains linked to India, as a warning of potential criminal misuse. AIOCD also demanded the withdrawal of government notifications GSR 220(E) and GSR 817(E), alleging they are being misused by e-pharmacy operators and could contribute to issues such as antimicrobial resistance and circulation of substandard drugs.
- SC allows Zydus to sell cancer drug biosimilar; asks Bristol Myers to map patents
The Supreme Court of India has allowed Zydus Lifesciences to manufacture and sell its biosimilar version of the cancer drug Nivolumab, despite objections from Bristol Myers Squibb. The US pharmaceutical company had sought to restrain Zydus, alleging that the biosimilar infringed its patent covering Nivolumab, marketed globally as Opdivo. However, the court declined to halt the launch, noting that the drug had already entered the market. At the same time, the court directed Bristol Myers Squibb to conduct a detailed product-to-patent mapping exercise to determine whether Zydus’ product violates its patent claims. The ruling highlights the balance between intellectual property protection and access to affordable life-saving medicines in India.
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