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 May 2026. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
- CDSCO Directs States to Intensify Oversight of GLP-1 Weight Loss Drugs
Central Drugs Standard Control Organisation (CDSCO) has directed State Licensing Authorities (SLAs) to strengthen monitoring of the supply chain and promotional activities related to glucagon-like peptide-1 (GLP-1) receptor agonist-based weight loss and diabetes medicines. The regulator has called for strict action against unauthorized distribution, non-compliant dispensing practices, misleading advertisements, and violations of approved indications and labelling requirements. The directive follows nationwide inspections of online pharmacies, wholesalers, retail outlets, and wellness clinics amid growing demand for GLP-1 therapies such as semaglutide, liraglutide, and tirzepatide. CDSCO emphasized that these medicines should only be used under medical supervision due to potential safety risks and urged stakeholders to comply with the Drugs and Cosmetics Act, 1940 and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
- CDSCO Introduces Parallel Review Process for Clinical Trial Applications
Central Drugs Standard Control Organisation (CDSCO) has introduced a parallel submission and review mechanism for clinical trial applications, allowing sponsors and Clinical Research Organisations (CROs) to simultaneously submit clinical trial protocols and related documents to both CDSCO and the concerned Ethics Committees. Under the revised process, Ethics Committees can independently review applications without waiting for prior approval from the Central Licensing Authority. The initiative is aimed at reducing approval timelines, improving regulatory efficiency, and accelerating the initiation of clinical trials. The reform complements recent amendments to the New Drugs and Clinical Trials Rules, 2019, which seek to simplify regulatory procedures, reduce administrative burden, and facilitate faster clinical research and pharmaceutical development in India, ultimately supporting quicker patient access to innovative therapies.
- CDSCO to reject long-pending online applications after three reminders
The Central Drugs Standard Control Organisation (CDSCO) has announced that long-pending applications submitted through the Sugam portal will be rejected if applicants fail to respond after three reminder notices and a final disposal communication. The move is aimed at reducing application backlogs and improving regulatory efficiency across divisions including new drugs, biologics, medical devices, cosmetics, clinical trials, and ethics committees. Under the structured mechanism introduced in January 2026, applicants receive three reminders at 30-day intervals, followed by a final notice before rejection and forfeiture of fees. CDSCO has advised stakeholders to promptly address pending queries to avoid cancellation of applications and ensure smoother processing of regulatory submissions.
2) Approvals
- Lupin Secures Chinese Approval for Oseltamivir Phosphate Oral Suspension
Lupin Limited has received approval from China’s National Medical Products Administration (NMPA) for its oseltamivir phosphate oral suspension (6 mg/mL), developed in partnership with Yabao Pharmaceuticals. The approval marks Lupin’s first product entry into China and represents significant milestone in the company’s global expansion strategy. The oral suspension is indicated for the treatment and prevention of influenza A and B, with a particular focus on paediatric patients. Through this partnership, Lupin aims to expand access to affordable, high-quality influenza therapies in one of the world’s largest pharmaceutical markets while strengthening its presence in the paediatric healthcare segment.
- US FDA accepts Transpire Bio’s ANDA filing for generic high-strength Trelegy Ellipta
Transpire Bio Inc. announced that the United States Food and Drug Administration (US FDA) has accepted its Abbreviated New Drug Application (ANDA) for a generic version of high-strength Trelegy Ellipta (200 mcg/62.5 mcg/25 mcg). The inhalation therapy is indicated for Asthma and Chronic Obstructive Pulmonary Disease (COPD) maintenance treatment. The company stated that the filing includes a Paragraph IV certification under the Hatch-Waxman Act and may qualify for 180 days of market exclusivity upon approval as a potential first-to-file applicant.
- US FDA approves Immgolis and Immgolis Intri, biosimilars to Simponi and Simponi Aria
Accord BioPharma, Inc. announced that the United States Food and Drug Administration (US FDA) has approved Immgolis and Immgolis Intri, biosimilars to Simponi and Simponi Aria, for the treatment of Rheumatoid Arthritis and Ulcerative Colitis. The products are the first golimumab biosimilars approved in the United States and have also received interchangeable designation for specific indications. The biosimilars will be commercialized in the United States by Accord BioPharma during the fourth quarter of 2026.
- US FDA Grants Priority Review to Bayer’s Sevabertinib for First-Line HER2-Mutant NSCLC Treatment
Bayer announced that the United States Food and Drug Administration (US FDA) has granted Priority Review status to Sevabertinib for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring HER2 (ERBB2) tyrosine kinase domain activating mutations. The regulatory submission is supported by data from the ongoing Phase I/II SOHO-01 study evaluating the therapy in treatment-naïve patients. Sevabertinib previously received accelerated approval in the United States in 2025 for previously treated HER2-mutant NSCLC and has also been approved in China. The Priority Review designation may expedite regulatory evaluation of the therapy, which is being developed to address the limited treatment options available for patients with HER2-mutant lung cancer.
- Sunrise Group gets US FDA clearance for rechargeable at-home sleep test; marking a major advancement in sleep testing technology
Sunrise Group has received United States Food and Drug Administration (US FDA) clearance for Sunrise Air, a next-generation rechargeable home sleep testing device designed for the diagnosis of obstructive sleep apnoea (OSA). The device combines mandibular jaw movement monitoring with additional sensors for airflow, oxygen saturation, pulse rate, and snoring analysis, supported by Artificial Intelligence (AI)-based algorithms to generate comprehensive sleep assessment reports. Designed for multi-night testing, the lightweight and rechargeable solution aims to improve access to sleep disorder diagnosis outside traditional sleep laboratories. The clearance supports Sunrise Group’s efforts to expand patient-friendly, clinically robust sleep care solutions.
3) International Pharma News
- WHO Member States Extend Negotiations on Pandemic Agreement’s PABS Framework
WHO Member States have agreed to extend negotiations on the Pathogen Access and Benefit Sharing (PABS) annex, a critical component of the WHO Pandemic Agreement aimed at ensuring equitable access to pathogens, vaccines, diagnostics, and therapeutics during future pandemics. While significant progress was made during the latest Intergovernmental Working Group (IGWG) discussions, countries concluded that additional time is needed to finalize the framework. The outcome will be presented to the 79th World Health Assembly, with further negotiations scheduled for July 2026 and potential completion by May 2027. The PABS mechanism is considered essential for strengthening global pandemic preparedness, response, and equitable benefit-sharing among countries.
- Roche to Acquire AI-Driven Digital Pathology Firm PathAI for USD 1.05 Billion
Roche has entered into a definitive agreement to acquire PathAI for up to USD 1.05 billion (One Billion and Fifty Million Dollars), including milestone-based payments. The acquisition is aimed at strengthening Roche’s digital pathology and precision medicine capabilities through Artificial Intelligence (AI)-enabled diagnostic solutions. PathAI’s technology supports automated pathology workflows, high-resolution digital imaging, biomarker discovery, and companion diagnostics development. Roche stated that the acquisition builds on its existing partnership with PathAI and will enhance oncology diagnostics and biopharma services globally. Following completion of the transaction, expected in the second half of 2026 subject to regulatory approvals, PathAI will become part of Roche’s diagnostics division, further expanding the company’s AI-driven healthcare portfolio.
- WHO Opens Applications for 2027 Update of Essential Medicines Lists
The World Health Organization (WHO) has opened the application process for the 2027 revision of its Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), with submissions accepted until November 6, 2026. The WHO Expert Committee will review applications during its 26th meeting in Geneva in May 2027. The biennial update process evaluates medicines based on efficacy, safety, disease burden, resource utilization, and implementation feasibility. The WHO Model Lists serve as a key reference for more than 150 countries in developing national essential medicines lists and supporting procurement decisions aimed at advancing universal health coverage and access to essential healthcare.
4) Domestic Pharma News
- DCGI to inaugurate 11th Pharmac South 2026 on June 4 in Chennai
The 11th edition of Pharmac South 2026, a major pharmaceutical trade exhibition and conference in South India, will be inaugurated by the Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, on June 4 at the Chennai Trade Centre. Organized by the Indian Drug Manufacturers’ Association Tamil Nadu state board in collaboration with Orbit Exhibitors, the two-day event is expected to witness participation from over 150 companies. The conference will feature technical and regulatory sessions focusing on revised Schedule M implementation, digital healthcare regulations, pharmaceutical exports, quality standards, branding, and negotiation strategies. Industry experts and regulatory officials from the Central Drugs Standard Control Organisation (CDSCO) and Indian Pharmacopoeia Commission (IPC) are also scheduled to participate in the event.
- US FDA and Telangana DCA bolster global pharma safety at second regulatory forum
The United States Food and Drug Administration (US FDA) and Telangana Drugs Control Administration (DCA) convened the Second Regulatory Forum in Hyderabad to strengthen cooperation on pharmaceutical quality and global supply chain safety. The forum focused on advanced Good Manufacturing Practices (GMP), inspection procedures, revised Schedule M implementation, and oversight of sterile manufacturing facilities. Telangana officials also highlighted the state’s participation in the ‘Observed Inspection’ model, under which DCA inspectors join US FDA-led audits to enhance regulatory capabilities. Discussions further addressed emerging public health concerns such as Antimicrobial Resistance (AMR) and contamination risks in liquid oral products. The collaboration aims to align inspection standards, strengthen regulatory enforcement, and ensure the safety, quality, and efficacy of pharmaceutical products manufactured in Telangana for global markets.
- Danone India and Government of UP introduce Iron-Anthem to drive anaemia awareness
Danone India, in partnership with the Government of Uttar Pradesh, has launched the “India ka Iron Up karenge” campaign to raise awareness about iron deficiency and anaemia among children and families. Developed with the Directorate of Family Welfare, Uttar Pradesh, the campaign features a 40-second awareness film highlighting the importance of regular iron intake through relatable school lunchbox scenarios and child-led messaging. The initiative aims to encourage healthier nutritional habits and promote preventive healthcare through simple dietary interventions. By focusing on participation and awareness rather than instruction alone, the campaign seeks to improve public understanding of iron deficiency and support better child growth, health, and development outcomes across communities.
- Apollo HomeCare and Apollo AyurVAID Partner to Strengthen Post-Discharge Transition Care
Apollo HomeCare and Apollo AyurVAID have launched an integrated Transition Care service aimed at improving patient recovery between hospital discharge and return to home. The initiative provides clinically monitored step-down care facilities offering nursing support, physiotherapy, rehabilitation, nutritional guidance, and selective Ayurvedic therapies based on patient recovery needs. The collaboration adopts a joint clinical evaluation model, integrating modern medicine with Ayurveda to develop personalized transition care plans. Currently operational in Bengaluru, Chennai, and Delhi, the service is designed for both domestic and international patients recovering from major treatments. The partnership seeks to reduce post-discharge complications, improve continuity of care, and minimise hospital readmissions through structured recovery support.
- NIMHANS, Karnataka govt & Himalaya Wellness Company scale-up of community-based suicide prevention initiatives
National Institute of Mental Health and Neurosciences (NIMHANS), the Government of Karnataka, and Himalaya Wellness Company have expanded Project SURAKSHA, a community-based suicide prevention initiative, across the entire Ramanagara district following the successful completion of its three-year pilot phase in Channapattana. Aligned with India’s National Suicide Prevention Strategy and the World Health Organization (WHO) LIVE LIFE framework, the programme focuses on early identification, referral, and risk management of vulnerable individuals through trained community networks. The initiative has engaged nearly 800 trained stakeholders and reached over 6,000 people. Karnataka has also approved the first phase of implementation in Bellary district, supporting broader mental health and suicide prevention efforts across the state.
5) Innovations
- IBA introduces myQA StarTrack³ for fast, high resolution linac QA with a single detector setup
IBA has launched myQA StarTrack³, an advanced quality assurance (QA) solution designed for linear accelerator (linac) beam verification in radiation therapy. The system features a high-resolution 2D ionization chamber array capable of delivering water tank-equivalent accuracy while enabling rapid beam profile assessment across multiple photon and electron energies. The solution supports machine QA workflows through a single detector setup, reducing operational complexity and improving efficiency. It also includes a web-based software platform for centralized QA data management and real-time beam analysis. According to IBA, the innovation aims to help medical physics teams achieve faster, consistent, and reliable QA processes while supporting safer radiotherapy treatment delivery.
- Laxmi Dental introduces AI-connected platform for remote patient dental monitoring to minimise clinic visits and avoid treatment delays
Laxmi Dental Limited has launched ‘i Scope360’, an Artificial Intelligence (AI)-connected remote dental monitoring platform designed to improve treatment continuity and reduce dependence on physical clinic visits. The platform integrates three modules- iTrack, iHealth, and iTrack Live to enable remote aligner tracking, oral health assessment, and virtual consultations through smartphone-based guided scans. Developed and manufactured in India, the solution aims to address challenges such as fragmented workflows, delayed interventions, and inconsistent patient compliance in dental care. According to the company, the platform can reduce follow-up visits by 30–50% and improve treatment compliance by 20–30%. The launch also reflects the growing adoption of digital orthodontics and connected dental care systems globally.
- Samsung Galaxy Watch Demonstrates AI-Based Fainting Prediction Capability
Samsung Electronics, in collaboration with Chung-Ang University Gwangmyeong Hospital, has validated the ability of Galaxy Watch to predict vasovagal syncope (VVS), a common fainting condition, using Artificial Intelligence (AI)-driven biosignal analysis. The clinical study analysed heart rate variability data collected through the smartwatch’s photoplethysmography (PPG) sensor during induced fainting tests involving 132 patients. According to the findings, the AI model predicted fainting episodes up to five minutes in advance with 84.6 per cent accuracy. The research, published in the European Heart Journal, Digital Health, is described as the world’s first demonstration of a commercial smartwatch providing early syncope prediction. Samsung stated that the development supports the shift towards preventive and personalized digital healthcare solutions.
- Parexel Launches ParexelAI to Accelerate Clinical Development Processes
Parexel has launched ParexelAI, a proprietary suite of Artificial Intelligence (AI)-enabled services designed to improve speed, quality, and efficiency across the clinical development lifecycle. The platform integrates AI capabilities with human oversight to support functions ranging from early-stage clinical research to post-market surveillance. According to the company, ParexelAI has already reduced site selection timelines by 50 per cent, clinical study report preparation time by 30 per cent, and pharmacovigilance processing timelines by 20 per cent. The launch also strengthens Parexel’s AI-driven partnerships in regulatory automation, patient identification, and safety monitoring. The company stated that the platform aims to accelerate clinical trials while maintaining regulatory compliance, patient safety, and scientific accuracy through a human-led AI approach.
- ZenMD Launches AI-Powered Clinical Intelligence Platform for Indian Healthcare
ZenMD has officially launched in India, introducing an Artificial Intelligence (AI)-powered clinical intelligence platform designed to support doctors and healthcare institutions. The platform integrates four core solutions, ZenScribe, ZenNotes, ZenConsult, and ZenScan to streamline clinical documentation, decision support, and medical imaging analysis across more than 80 medical specialties. Built specifically for Indian healthcare settings, the platform includes a proprietary hallucination correction layer to validate AI-generated outputs and enhance reliability. According to the company, the solution aims to reduce administrative burden, improve clinical efficiency, and support evidence-based decision-making.
- Labcorp Launches AI-Powered MyLabcorp App for Personalized Health Insights
Labcorp has launched MyLabcorp, an Artificial Intelligence (AI)-powered mobile application designed to help users better understand laboratory test results and monitor health trends over time. The platform combines lab results, AI-generated explanations, and clinically reviewed educational content within a secure, personalized environment. Powered in part by OpenAI’s advanced reasoning models, the app enables users to receive real-time insights on test results, access health information across multiple therapeutic areas, and manage appointments, billing, and laboratory services. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform aims to improve health literacy, support informed discussions with healthcare providers, and enhance patient engagement through data-driven, personalized healthcare insights.
6) Trends
- CarePay Survey Highlights Financing Gaps in Elective Healthcare Treatment Adoption
CarePay has reported that financing constraints remain a major barrier to treatment adoption in India’s elective healthcare and wellness sector. Based on a nationwide survey of over 3,100 clinics across segments including in vitro fertilization (IVF), dermatology, cosmetology, and dental care, the study found that many patients discontinue treatment plans after consultation due to liquidity challenges rather than lack of intent. The survey also highlighted growing demand for No-Cost Equated Monthly Instalment (EMI) options, particularly in high-value treatment categories. According to the findings, embedded multi-lender financing solutions can help reduce patient drop-offs, accelerate treatment decisions, and improve conversion rates, reflecting a broader shift toward flexible payment models in India’s expanding wellness and elective healthcare market.
- New evidence confirms malaria vaccine saves child lives and will have high impact in wider rollout
A new study published in The Lancet has confirmed that the RTS,S malaria vaccine significantly reduces child mortality in Africa. Data from the Malaria Vaccine Implementation Programme (2019–2023) in Ghana, Kenya, and Malawi showed that approximately one in eight child deaths was prevented among vaccine-eligible children over a four-year period. The findings reinforce the public health value of WHO-recommended malaria vaccines and suggest similar or greater benefits in other high-burden African countries. The evaluation also found that malaria vaccination did not negatively affect uptake of other childhood vaccines or malaria prevention measures such as insecticide-treated nets. Currently, 25 African countries have incorporated malaria vaccines into their immunization programmes, targeting over 10 million children annually. WHO emphasized that wider vaccine deployment, alongside existing malaria prevention and treatment strategies, could save tens of thousands of children’s lives each year, although additional funding is needed to support broader rollout and sustained coverage.
- Study Highlights Comparable CAR T-Cell Therapy Outcomes Across Accredited and Non-Accredited Centres
Research presented at the 2026 ASCO Annual Meeting, with participation from Florida Cancer Specialists & Research Institute (FCS), found that CAR T-cell therapy delivered at accredited and non-accredited centres demonstrated comparable quality and safety outcomes. The study evaluated over 6,800 adult patients with diffuse large B-cell lymphoma and reported no statistically significant differences in early safety outcomes, time to next treatment, or post-treatment resource utilization between the two settings. Findings suggest that proximity and accessibility of treatment centres play a critical role in improving patient access and experience without compromising clinical outcomes. The study supports broader availability of advanced cellular therapies closer to patients’ homes, potentially reducing travel burdens while maintaining high standards of care. Researchers emphasized that expanding access to CAR T-cell therapy through qualified non-accredited centres could help address geographical barriers and improve equitable access to innovative cancer treatments.
7) Law and Order Briefs
- Central drug regulator cannot prosecute pharma unit under Chapter IV of D&C Act: Himachal High Court
Himachal Pradesh High Court has quashed criminal proceedings initiated by the Central Drugs Standard Control Organisation (CDSCO) against Salus Pharmaceuticals, ruling that prosecution under Chapter IV of the Drugs and Cosmetics Act, 1940 falls within the jurisdiction of state authorities and not the Central government, except where specifically authorised by law. The Court held that matters relating to the manufacture, sale, and distribution of drugs are primarily regulated by state governments under the Act. It also noted procedural deficiencies in the prosecution, including the omission of authorised personnel responsible for testing activities. The ruling is expected to have implications for regulatory enforcement actions and may influence discussions around the scope of central and state powers under the Drugs and Cosmetics Act.
- CCI clears super-specialty hospitals of antitrust violations, rejects ‘aftermarket monopoly’ claims
The Competition Commission of India (CCI) has closed its long-running investigation into hospital practices, ruling that major super-specialty hospitals did not violate Section 4 of the Competition Act. The Commission rejected claims that hospitals operate as “aftermarket monopolies,” recognizing healthcare delivery as an integrated care ecosystem rather than separate markets for medicines, diagnostics, and consumables. CCI noted that patients have access to pre-admission cost estimates, provider comparisons, and second opinions, enabling informed choices. The regulator also confirmed compliance with applicable pricing regulations and found no abuse of dominant position. The decision has been welcomed by the Association of Healthcare Providers of India (AHPI).
- IPA Opposes New DCGI Recruitment Rules, Alleges Conflict with Statutory Provisions
Indian Pharmaceutical Association (IPA) has urged the Union Health Ministry to withdraw the Recruitment Rules, 2026 for the post of Drugs Controller General of India (DCGI), alleging that the revised eligibility criteria conflict with provisions of the Drugs and Cosmetics Act and Rules. The association contends that allowing candidates from non-pharmacy and non-pharmaceutical science backgrounds could dilute the technical expertise required for India’s apex drug regulatory position. IPA has also raised concerns regarding deputation eligibility criteria, which it says may exclude qualified state regulatory officers. Similar objections have been voiced by regulatory officers’ and drug inspectors’ associations, which have called for maintaining pharmacy-specific qualifications and regulatory experience for appointments to the DCGI post.
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