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 November 2025. 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
• DoP mulls exemption of 84 more drugs from public procurement rules that restrict global tender
The Department of Pharmaceuticals (DoP) is considering adding 84 more drug formulations to the list exempted from Global Tender Enquiry (GTE) restrictions under the General Financial Rules (GFR), 2017, allowing global procurement for tenders up to Rupees Two Hundred Crore (Rs. 200 crore). The list includes patented and proprietary medicines, unlaunched products, and formulations requested by the Director General Armed Forces Medical Services (DGAFMS) and the Indian Council of Medical Research (ICMR). Domestic manufacturers have been asked to submit objections by December 5, 2025. This follows earlier exemptions by the Department of Expenditure (DoE), which allowed global tendering for 128 drugs and vaccines until March 31, 2027. The move aims to ensure access to critical drugs while mapping domestic manufacturing capacity.
• CDSCO asks procurement agencies to mandate Indian license as technical requirement
The Central Drugs Standard Control Organisation (CDSCO) has instructed all procurement agencies, including hospitals, to make licenses issued by Indian licensing authorities a mandatory requirement for purchasing medical devices. The directive follows reports that some agencies are insisting on United States and European certifications as part of technical bid conditions. CDSCO clarified that such foreign certifications may be added only after ensuring compliance with Indian licensing requirements under the Medical Devices Rules, 2017. The circular reiterates that no medical device can be sold in India without a valid license issued by the State or Union Territory Licensing Authorities for Class A and B manufacturing and all sales, or by the CDSCO as the Central Licensing Authority for Class C and D manufacturing and imports.
• DCGI directs state regulators to mandate display of PvPI’s QR code in pharmacy premises
The Drugs Controller General (India) has directed all State and Union Territory drug licensing authorities to ensure that retail and wholesale pharmacies display a Quick Response (QR) code for reporting adverse drug reactions under the Pharmacovigilance Programme of India (PvPI). The instruction follows the decisions of the 16th PvPI Working Group Meeting held on June 18, 2025. Pharmacies must place the designated QR code and the PvPI toll-free number prominently to support reporting through the PvPI Adverse Drug Reaction Monitoring System (ADRMS). The DCGI has asked regulators to widely disseminate the circular and enforce compliance. The Indian Pharmacopoeia Commission earlier introduced this QR-based reporting platform to encourage public and healthcare professional participation in adverse drug reaction reporting.
• Panel asks DoP to come out with pharmaceutical policy for affordable pricing of medicines
The Parliamentary Standing Committee on Chemicals and Fertilisers has recommended that the Department of Pharmaceuticals (DoP) develop a pharmaceutical policy focused on ensuring affordable prices for both scheduled and non-scheduled medicines. During its review of rising drug prices, the Committee was informed that the DoP has conducted stakeholder consultations on various provisions of the Drugs Prices Control Order (DPCO), 2013, and is examining submitted recommendations. The Panel expressed concern over delays in decisions on Trade Margin Rationalisation (TMR), noting that essential medicines have become unaffordable for many. It also suggested stronger controls on multinational companies and a mechanism to supply medicines at Price to Stockist (PTS) under the Pradhan Mantri Jan Aushadhi Yojana (PMJAY). The Committee urged the DoP and the National Pharmaceutical Pricing Authority to review TMR implementation to improve affordability.
• CDSCO updates list of Class A non-sterile and non-measuring devices
The Central Drugs Standard Control Organization (CDSCO) has expanded its list of Class A non-sterile and non-measuring medical devices to 1,069 items, up from the earlier list of around 803. These devices are exempt from licensing requirements under the Medical Devices Rules (MDR), 2017, but manufacturers and importers must obtain registration numbers through the CDSCO Online System under Chapter IIIB. The updated list includes items such as reusable surgical probes, abdominal supports, acupressure devices, audiometric equipment, adhesive pads, incontinence products, ambulance stretchers, birthing tables, cervical pillows, and various cushions. CDSCO noted that intended uses listed are for guidance and may vary if aligned with the classification. The list is dynamic and subject to revision. Variants with measuring functions or sterile versions are excluded. Classification follows MDR Rule 4, which defines Class A as low-risk devices.
• Dept of Consumer Affairs launches online portal to recognise Pvt labs as approved test centres
The Department of Consumer Affairs has launched a new online portal enabling private laboratories, industries, and testing facilities to apply for recognition as Government Approved Test Centers (GATC) under the Legal Metrology framework. The initiative aims to expand verification capacity for weighing and measuring instruments used in trade, improving efficiency, reducing delays, and strengthening consumer protection. Private labs recognized as GATCs will verify instruments used across healthcare, transport, infrastructure, and energy sectors. Applications are open until 30 November 2025, with mandatory requirements for qualified staff, calibration systems aligned with national standards, and an online fee of Rupees Two Lakh (Rs. 2 lakh) per instrument category.
2) Approvals
• Zydus receives US FDA tentative approval for Olaparib tablets, 100 mg and 150 mg
Zydus Lifesciences Limited has received tentative approval from the US Food and Drug Administration (FDA) for its Olaparib tablets in 100 mg and 150 mg strengths, referencing the US-RLD (United States Reference Listed Drug) Lynparza. Olaparib is used to treat specific Ovarian, Breast, Pancreatic, and Prostate Cancers in patients with BRCA or other Homologous Recombination RRepair (HRR) gene mutations. The approved tablets will be manufactured at Zydus’ SEZ facility.
• US FDA approves Darzalex Faspro for adult patients with high-risk Smouldering Multiple Myeloma
Halozyme Therapeutics announced that Johnson & Johnson has received US Food and Drug Administration (FDA) approval for a new indication for Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) co-formulated with Enhanze, as a single-agent treatment for adults with High-Risk Smouldering Multiple Myeloma (HR-SMM). Darzalex Faspro becomes the first and only approved therapy for HR-SMM, enabling earlier intervention before progression to active multiple myeloma. Smouldering multiple myeloma is genomically identical to active disease, with around 15% of new US Multiple Myeloma Diagnoses in 2025 classified as Smouldering. About half of HR-SMM patients progress within two years. The approval is based on the phase 3 AQUILA study evaluating Darzalex Faspro versus active monitoring.
• Alembic Pharma receives US FDA final approval for Sumatriptan injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, single dose Autoinjector System
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for sumatriptan injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, in a single-dose Autoinjector System. The product is therapeutically equivalent to GlaxoSmithKline’s reference listed drug, Imitrex STATdose System. Sumatriptan injection is indicated in adults for the acute treatment of Migraine with or without aura, and for the acute treatment of Cluster Headache. This marks Alembic’s first drug device combination product.
• Medical Microinstruments receives US FDA’s IDE approval for first robotic-enabled Microsurgical study in Alzheimer’s patients
Medical Microinstruments Inc. (MMI) has received US Food and Drug Administration (FDA) approval for an Investigational Device Exemption (IDE) to begin a clinical study evaluating a novel Microsurgical Intervention for Alzheimer’s disease. The REMIND study (Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease) will assess the safety and effectiveness of the Symani Surgical System in re-establishing lymphatic drainage pathways in the deep cervical lymph nodes (dCLNs) of patients with Alzheimer’s and documented Lymphatic obstruction. The primary endpoint is device-related serious adverse events within 30 days, with additional biomarker, imaging, and cognitive assessments tracked for six months. This first-of-its-kind robotic super microsurgical approach may enable improved clearance of amyloid beta and tau proteins.
• Alembic Pharma receives US FDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Alembic Pharmaceuticals has received final US Food & Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Dexlansoprazole delayed-release capsules in 30 mg and 60 mg strengths. The product is the generic equivalent of Takeda’s Dexilant and is used in patients aged 12 and above for healing Erosive Esophagitis (EE), maintaining healed EE with heartburn relief, and treating Symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).
• Health Canada approves AbbVie’s Lupron Depot new strength for the treatment of advanced Prostate Cancer
AbbVie has received Health Canada approval for a new 6-month, 45 mg Lupron Depot (Leuprolide acetate) strength for treating advanced Prostate Cancer. With this addition, Lupron Depot is now available in four dosing options: 7.5 mg (1-month), 22.5 mg (3-month), 30 mg (4-month), and 45 mg (6-month). The therapy has been used in Canada for 36 years. Clinicians noted that the extended-release 6-month option may reduce administration burden for patients. Prostate Cancer remains the most common Cancer among Canadian men, accounting for one in five new cases. AbbVie stated that the approval reinforces its long-term commitment to improving treatment options and advancing care for patients with advanced prostate cancer.
3) International Pharma News
• Mesoblast and BMT CTN to initiate pivotal trial of Ryoncil as part of first-line regimen in adults with severe acute GvHD refractory to steroids
Mesoblast Limited will collaborate with the NIH-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to initiate a pivotal phase 3 trial of Ryoncil (remestemcel-L-rknd) as part of the first-line regimen for adults with severe acute graft versus host disease (aGvHD) refractory to corticosteroids. The partnership aims to extend the treatment already FDA-approved for children and adolescents to adults, who face high mortality and low response rates with current therapies such as Ruxolitinib. In Expanded Access use, Ryoncil showed 76% survival at Day 100 in patients aged 12 and older who failed Ruxolitinib or other second-line agents.
• Solventum to acquire privately held bioscience company, Acera Surgical for up to $850 million
Solventum has entered into a definitive agreement to acquire Acera Surgical, a privately held bioscience company specializing in engineered materials for regenerative wound care, for United States Dollars Seven Hundred Twenty-Five Million (US$ 725 million) in cash plus up to United States Dollars One Hundred Twenty-Five Million (US$ 125 million) in milestone-based payments. Founded in 2013, Acera uses proprietary electrospinning technology to develop Synthetic soft tissue repair solutions, including its Restrata products used for complex wounds in acute care settings. Solventum expects the acquisition to accelerate adoption of Restrata through its global footprint and specialized wound care sales network.
• Philips & Cortechs.ai extend partnership to advance quantitative neuroimaging and strengthen Philips’ leadership in precision diagnostics in neurology
Royal Philips has expanded its partnership with Cortechs.ai to integrate Cortechs.ai’s AI-enabled quantitative neuroimaging analytics directly into Philips’ MR systems. The collaboration aims to deliver faster, more objective, and reproducible insights for Neurological Diagnosis by combining Philips’ MR technologies with Cortechs.ai’s advanced post-processing software. Philips highlighted that AI-driven quantitative reports can improve workflow efficiency, diagnostic consistency, and patient care. Their NeuroQuant solutions are already available on Philips’ Advanced Visualization Workspace. The extended partnership reinforces Philips’ commitment to precision diagnostics in neurology and Cortechs.ai’s mission to enhance early detection and disease monitoring through AI in radiology.
• GSK & LTZ announce strategic collaboration to advance novel myeloid cell engagers in Oncology
GSK and LTZ Therapeutics have entered a strategic research collaboration to develop up to four first-in-class Myeloid Cell Engagers (MCEs) for Haematologic Cancers and Solid Tumors. The agreement gives GSK an exclusive option to license global development and commercial rights to the pre-clinical candidates. MCEs are emerging immuno-oncology therapies designed to harness myeloid cells major tissue-resident immune cells to recognize and kill tumor cells with a potentially favourable safety profile. LTZ’s platform has shown promising pre-clinical activity across multiple tumor types.
• OneOncology, Cancer Specialists of North Florida partner to enhance delivery of Cancer care services across North Florida region
OneOncology, a physician-led national platform that supports independent medical specialty practices, has partnered with Cancer Specialists of North Florida (CSNF) to strengthen Cancer care delivery across the North Florida region. CSNF, which includes 39 physicians, 19 advanced practice providers, 4 pharmacists and over 520 staff, treats 42,000 patients annually across 13 clinics. The partnership will allow CSNF to retain provider ownership while accessing OneOncology’s precision medicine tools, clinical technology, research opportunities and capital for expansion. CSNF recently opened a new state-of-the-art Jacksonville clinic featuring PET/CT (Positron Emission Tomography/Computed Tomography) and MRI (Magnetic Resonance Imaging) services. Both organizations stated that the collaboration will expand access to integrated, high-quality, and affordable Cancer care across North Florida.
• Moleculin Biotech inks research & material transfer agreement with University of North Carolina to evaluate Annamycin for treatment of Pancreatic Cancer
Moleculin Biotech has entered into a research and material transfer agreement with the University of North Carolina at Chapel Hill (UNC) to conduct preclinical studies evaluating Annamycin for treating Pancreatic Cancer. Under the agreement, Moleculin will supply Annamycin while UNC will conduct the planned preclinical research. Zamboni, will study its tumor-targeting ability in PDAC GEMM models, comparing Liposomal and free Annamycin with Doxil and free Doxorubicin. The studies aim to assess how novel agents and modalities can enhance delivery of Annamycin to Pancreatic tumors. Moleculin highlighted Annamycin’s high affinity for the pancreas and the relevance of Topoisomerase II upregulation in Pancreatic Cancer. The drug already holds Fast Track and Orphan Drug Designations for AML and soft tissue sarcoma and is currently in a pivotal phase 2B/3 global trial for relapsed/refractory AML.
• GenomOncology collaborates with Glioblastoma Foundation to speed up Glioblastoma Brain Cancer Treatment
GenomOncology has partnered with the Glioblastoma Foundation to accelerate genomic testing for Glioblastoma, one of the most aggressive Brain Cancers. The collaboration enables the Foundation’s new genomic testing laboratory to use GenomOncology’s Pathology Workbench (PWB) platform, which integrates complex molecular data into unified clinical reports. Within two weeks of contract signing, the lab became operational, offering DNA panel testing, RNA fusion analysis, and whole-genome sequencing methylation testing, including MGMT (O-6-methylguanine-DNA methyltransferase) methylation status, an important predictor of resistance to temozolomide therapy. The partnership aims to provide oncologists with automated variant interpretation, therapy matching, and comprehensive genomic insights, supporting precision oncology and faster, personalized treatment decisions for glioblastoma patients.
4) Domestic Pharma News
• NCISM grants permission to 31 new Ayurveda Medical Colleges in AY 2025-26
The National Commission for Indian System of Medicine (NCISM) has granted Letters of Intent or Permission to 31 entities up to November 19, 2025, for establishing new Ayurveda medical colleges for the 2025–26 academic year, adding over 2,600 undergraduate Bachelor of Ayurvedic Medicine and Surgery (BAMS) seats. Permission was denied to 17 colleges, and one institution allowed permanent withdrawal. These approvals come in addition to 536 institutes already permitted for UG and PG Ayurveda education. Of the new approvals, 21 institutions are from Maharashtra, four from Madhya Pradesh, and one each from Karnataka, Bihar, Chhattisgarh, Haryana, and Uttar Pradesh. Maharashtra also has the highest number of UG and PG Ayurveda institutes. The rise in Ayush institutions aligns with broader government initiatives under the National Ayush Mission.
• Ayurveda Medicines Manufacturers Organization of India welcomes NCERT’s landmark decision to integrate Ayurveda into middle school science curriculum
The National Council of Educational Research and Training (NCERT) has integrated detailed chapters on Ayurveda into the science curriculum for Classes 6 to 8, aligning with the National Education Policy (NEP) 2020 and its focus on Indian Knowledge Systems (IKS). Class 6 introduces fundamental Ayurvedic concepts such as the 20 opposing qualities (Gunas). Class 7 expands on healthy food habits, lifestyle practices, and practical herbal medicines, while Class 8 covers lifestyle disciplines including Dinacharya and Ritucharya under the chapter Ayurveda Balance of Body, Mind, and Environment.
• AstraZeneca Pharma India and Sun Pharma partner to help patients living with Hyperkalaemia in India
AstraZeneca Pharma India and Sun Pharmaceutical Industries have entered a second brand partnership to expand access to sodium zirconium cyclosilicate (SZC), an effective treatment for Hyperkalaemia, across India. Under the agreement, both companies will market SZC under separate brand names: AstraZeneca as Lokelma and Sun Pharma as Gimliand. AstraZeneca will retain intellectual property rights, marketing authorization, and import licence. Leaders from both companies noted that the collaboration aims to improve early screening, diagnosis, and treatment for Hyperkalaemia, particularly among patients with Chronic Kidney Disease and Heart Failure.
• Govt aims to set up more AMRIT Pharmacies across the country, says Union health minister
Union health minister J. P. Nadda announced that the government aims to expand AMRIT (Affordable Medicines and Reliable Implants for Treatment) Pharmacies to every medical college and district hospital in India to ensure broader access to affordable medicines. Speaking at the 10th anniversary celebration of AMRIT in New Delhi, he inaugurated 10 new outlets and launched AMRIT ITes Eco Green Version 2.0 to enhance operational efficiency. AMRIT has grown to over 255 pharmacies, with a target of 500 nationwide, offering 50–90% discounts on essential medicines.
• IPC signs MoU with TNPC to promote safe and rational use of medicines
The Indian Pharmacopoeia Commission (IPC) has signed a Memorandum of Understanding (MoU) with the Tamil Nadu Pharmacy Council (TNPC) to promote the safe and rational use of medicines across the state. The collaboration focuses on strengthening pharmacists’ involvement in Adverse Drug Reaction (ADR) reporting under the Pharmacovigilance Programme of India (PvPI) and increasing the adoption of the National Formulary of India (NFI) in healthcare institutions. IPC, which also publishes the Indian Pharmacopoeia (IP), will provide technical expertise, while TNPC will coordinate pharmacist participation. The MoU includes joint awareness programmes on Pharmacovigilance, Materiovigilance, and medicine safety, along with annual observance of National Pharmacovigilance Week in Tamil Nadu.
• Panel asks DoP to keep control over prices of stents and monitor overcharging
The Parliamentary Standing Committee on Chemicals and Fertilisers has urged the Department of Pharmaceuticals (DoP) and the National Pharmaceutical Pricing Authority (NPPA) to address rising stent prices and strengthen monitoring to prevent overcharging. The panel noted that prices of Bare Metal Stents (BMS) and Drug Eluting Stents (DES) have increased by around 44% and 29%, respectively, since their initial ceiling prices were set in 2017 under the Drugs Prices Control Order (DPCO), 2013. The Committee asked NPPA to ensure compliance with fixed prices and report corrective steps.
• BOHECO opens Cannabis Leaf-Based Wellness Clinic & Store bridging Ayurveda with modern science
Bombay Hemp Company (BOHECO) has launched its largest Holistic Health & Wellness Clinic & Store in Bengaluru, in partnership with Soulgoal Artisan, offering Cannabis-leaf–based Ayurvedic wellness solutions. The flagship center on Brigade Road integrates doctor-led consultations, research-backed formulations, therapies, and immersive brand experiences. BOHECO aims to bridge Ayurveda with modern scientific evidence, supported by its decade long research and collaborations with CSIR-NBRI, the National Institute of Ayurveda, and Tata Memorial Centre on studies involving pain, sleep, and cancer management. The company’s offerings span pain relief, stress, sleep, and skincare, prescribed through its doctor network and virtual clinics. BOHECO stated that the new center marks a step forward in India’s evolving medical cannabis landscape amid rising acceptance of plant-based therapies.
• KSRPO alerts state govt about increasing sales of Schedule-H, H-1 & X drugs by fake Ayush doctors
The Karnataka State Registered Pharmacist Organization (KSRPO) has warned the state government about rising sales of Schedule-H, Schedule-H-1 and Schedule-X medicines by fake Ayush practitioners in Jiraal Kalgudi village of Koppal district. The local chemists and druggists’ association has sought action to protect public health. KSRPO president Ashokaswamy Heroor stated that unqualified Ayush practitioners are selling Allopathic medicines nationwide, while drug regulators struggle to curb the issue. He explained that Schedule-H and Schedule-X medicines require prescriptions, registers, and licensed pharmacy outlets under the Drugs and Cosmetics Act and Rules. However, fake doctors are selling these drugs without licenses, creating legal issues for licensed pharmacists.
5) Innovations
• Bry-Air Launches P80x advanced Dehumidifier based on MOF technology, for the pharmaceutical industry
Bry-Air has launched the P80x Dehumidifier, a major innovation for the pharmaceutical industry featuring its MIRACLE Next-Gen Rotor powered by advanced Metal-Organic Framework (MOF) technology. MOFs, recently recognized with a Nobel Prize in Chemistry, outperform traditional silica gel desiccants used for decades. The P80x delivers over 25% higher performance, operates at significantly lower regeneration temperatures (60–80°C vs. 120–140°C), and offers up to 50% energy savings. It is also designed for integration with heat pump systems, supporting Net Zero processing. With these capabilities, the P80x sets a new benchmark in dehumidification efficiency, sustainability, and HVAC industry performance, particularly for pharmaceutical applications.
• Glenmark launches world’s first Nebulized triple therapy for COPD
Glenmark Pharmaceuticals has launched the world’s first Nebulized fixed-dose triple therapy for Chronic Obstructive Pulmonary Disease (COPD), introducing Nebzmart GFB Smartules and Glenmark Airz FB Smartules. The therapies combine Glycopyrronium, Formoterol, and Budesonide to address airway obstruction, inflammation, and declining lung function in a single nebulized dose, offering a simpler option for patients who struggle with inhalers. Glenmark stated that innovation reinforces its leadership in respiratory care. Clinical studies in India showed rapid improvement in lung function, better control of breathlessness, and a strong safety profile. The launch marks a significant advancement in COPD management and supports Glenmark’s broader focus on Respiratory, Dermatology, and Oncology therapies across global markets.
• Dr. Lal PathLabs launches India’s first Complement Testing Lab
Dr. Lal PathLabs has launched India’s first dedicated Complement Testing Laboratory, bringing globally benchmarked complement assays to the country and strengthening its position in Autoimmune Diagnostics. The facility introduces several functional and antibody-based tests such as C1q, C5, Factor B, Factor H antibody, AH50, and C1 INH functional many of which are available in India for the first time. Complement testing helps identify immune dysfunction that contributes to Autoimmune, kidney, and recurrent infection-related disorders. The complement system regulates infection control and tissue protection, and its malfunction can lead to conditions such as lupus, C3 glomerulopathy, atypical haemolytic uremic syndrome, vasculitis, and rheumatoid arthritis.
• Harbour BioMed & Evinova China enter strategic AI collaboration to accelerate AI-enabled drug development
Harbour BioMed (HBM) and Evinova China have entered a strategic AI collaboration to accelerate AI-enabled drug development. The partnership will apply artificial intelligence and digital technologies to improve the efficiency of innovative biologics R&D. Both companies aim to build an open ecosystem to support AI-driven drug discovery and clinical development. Harbour BioMed, known for its Harbour Mice technology platform and pipeline in immunology and Oncology, expects the collaboration to enhance clinical study efficiency and speed up delivery of novel therapies. Evinova China, leveraging digital transformation insights from global pharma leaders, will contribute its AI-powered clinical development solutions. Together, the companies plan to advance China-originated breakthrough assets toward global markets.
• Biomarkers, AI & next-gen diagnostics offer new hope in India’s Cancer battle
India’s Cancer care landscape is rapidly evolving with the adoption of biomarkers, next-generation sequencing diagnostics, and artificial intelligence (AI) tools, enabling earlier detection and more precise treatment decisions. Clinicians highlight the urgent need for widespread screening, improved awareness, and stronger primary healthcare systems to identify Cancers at an early stage. Experts note that technologies such as immunotherapy, Targeted therapy, and precision Oncology are improving outcomes, while AI-driven diagnostics offer faster, personalized insights. However, affordability and delayed diagnosis remain major barriers. With rising cases of Breast, Cervical, Oral, and Colorectal Cancers, hospitals are expanding home-based oncology and palliative programs to improve continuity of care, particularly in Tier-2 regions.
• Mindbowser bolsters its AWS partnership with EHRConnect to offer secure cloud solution for global healthcare sector
Mindbowser has announced that its flagship healthcare integration platform, EHRConnect, is now available on the Amazon Web Services (AWS) Marketplace, marking its first product listing on the platform. EHRConnect is a zero-code, HIPAA-ready solution that enables health systems, digital health companies, payers, labs, and wearable-tech providers to exchange clinical data within hours. Deployed entirely inside a customer’s AWS environment, it keeps all protected health information within their own account while delivering faster deployments and significant cost savings. The platform features more than 150 pre-built healthcare nodes, integrates with AWS services, and connects seamlessly with major EHR systems including Epic, Cerner, and Athenahealth. Its AI-first workflow engine automates data routing, mapping, enrichment, and anomaly detection.
6) Trends
• World Health Organization issues guidance to address drastic global health financing cuts
The World Health Organization (WHO) has issued new guidance to help countries manage the severe impact of sudden cuts in external health funding, which is projected to decline by 30–40% in 2025 compared with 2023. WHO’s document, “Responding to the health financing emergency: immediate measures and longer-term shifts,” outlines policy options to maintain essential health services amid major disruptions affecting maternal care, vaccination, emergency preparedness, and disease surveillance. Survey data from 108 low- and middle-income countries show service reductions of up to 70% and widespread health worker job losses. WHO urges governments to prioritize health spending, protect essential services, improve efficiency, and integrate externally funded programmes into primary healthcare models. Several countries, including Nigeria, Kenya, Ghana, South Africa, and Uganda, have already taken steps to strengthen health budgets and sustain services.
• WHO launches global guidelines on Diabetes during pregnancy on World Diabetes Day
The World Health Organization (WHO) has issued its first global guidelines for managing Diabetes during pregnancy, a condition affecting one in six pregnancies worldwide. The recommendations aim to prevent severe complications such as pre-eclampsia, stillbirth, and birth injuries, and to reduce long-term risks of Type 2 Diabetes and Cardiometabolic Diseases for mothers and children. The guidelines outline 27 recommendations, including individualized diet and activity advice, regular blood glucose monitoring, tailored medication regimens for different types of Diabetes, and multidisciplinary care for women with pre-existing Diabetes. Released on World Diabetes Day 2025, under the theme “Diabetes across life stages,” the guidelines emphasize integrating Diabetes care into routine antenatal services and ensuring equitable access to essential care, particularly in low- and middle-income countries.
• LISSUN study reports 68% parents insist on mandatory mental and emotional health counselling in schools
LISSUN has released findings from a pan-India survey of 10,000 individuals examining parental awareness of children’s mental health. The study shows that 68% of parents want schools to introduce mandatory and regular counselling sessions at an early age. However, 48% of parents remain unsure about identifying signs of mental illness in their children, reflecting a critical awareness gap. Parents cited major factors affecting children’s mental wellbeing, including social media and peer pressure (35.8%), academic pressure (27.4%), bullying (20.8%) and family stress (11.3%). The survey also highlighted increasing concerns around depression, ADHD (Attention-Deficit/Hyperactivity Disorder) and learning disabilities. Many parents recommended appointing dedicated school counsellors and conducting regular awareness programs.
• New WHO report urges bold steps for equitable access to novel TB Vaccines
A new World Health Organization (WHO) report launched at the G20 Health Ministers Meeting calls for bold financing and access strategies to ensure equitable rollout of novel TB Vaccines for adolescents and adults in high-burden countries. The report identifies key barriers in supply, financing and demand, projecting that global demand may exceed 3 billion regimens between 2030–2040, with early supply gaps likely. It outlines six priority actions, including catalytic financing, country-level evidence generation, market transparency, regional manufacturing, and coordinated planning. With TB causing over a million deaths yearly, WHO emphasizes urgent global collaboration to secure timely, affordable, and sustainable vaccine access.
• IARC, WHO Academy, and other WHO partners launch new comprehensive learning program on screening, Diagnosis, and management of Cervical Precancer
On World Cervical Cancer Elimination Day, the International Agency for Research on Cancer (IARC) and the World Health Organization (WHO), along with WHO Academy partners, launched a new free learning program on screening, Diagnosis, and management of Cervical Precancer. Available on the WHO Academy online platform, the program is designed for service providers including frontline health workers, policymakers, program managers, and advocates, supporting the WHO Cervical Cancer Elimination Initiative. IARC reported that more than 660,000 women were diagnosed with Cervical Cancer in 2022, with nearly 350,000 deaths. The training aims to strengthen workforce capacity to help countries reach the 90–70–90 targets by 2030. The program includes five modules with e-learning and on-site practical guidance, building on IARC’s existing training resources.
• Indian pharmaceutical market records healthy 5-year CAGR of over 10 per cent
The Indian Pharmaceutical Market (IPM) has posted a strong five-year Compound Annual Growth Rate (CAGR) of 10.02% for the period ending September 2025, according to the latest IQVIA Market Feedback Report. Despite global economic fluctuations, the market has expanded steadily, supported by rising health awareness, broader access to healthcare, and a stable regulatory environment. Chronic therapies for Cardiovascular Diseases, Diabetes, and CNS disorders continue to outperform acute therapies. Sun Pharma retained the top position in MAT sales, followed by Abbott and Cipla. Cardiac Therapies and Anti-Infectives contributed most to overall value, while Antineoplastics/Immunomodulators recorded the highest monthly growth at 24.6%.
7) Law and Order Briefs
• Centre brings IPC under the jurisdiction of CAT to address service-related grievances
The Union Ministry of Personnel has notified that the Indian Pharmacopoeia Commission (IPC), Ghaziabad, will come under the jurisdiction of the Central Administrative Tribunal (CAT) to address employee service-related grievances. This was done by amending the Administrative Tribunals Act, 1985, applying Section 14(3), which empowers CAT to handle recruitment and service matters of autonomous bodies. From October 29, 2025, IPC employees can approach CAT for disputes, ensuring faster resolution and improved efficiency. CAT, established to adjudicate service-related complaints in central government organizations, has 19 benches and a 91.18% case disposal.
• Health ministry to amend D&C Rules to issue licenses to marketers to ensure quality & safety of drugs
The Union health ministry’s Drugs Consultative Committee (DCC) has recommended amending the Drugs & Cosmetics (D&C) Rules to mandate licensing for pharmaceutical marketers, ensuring greater accountability for drug quality and safety. The DCC noted that marketers currently operate without regulatory oversight, and their details are often unavailable for communication or compliance checks. The Committee proposed that no marketer should market any drug without obtaining a license from the licensing authority, with conditions incorporated into the Rules. Industry experts have long argued that marketing firm many of which outsource manufacturing, must share responsibility for product quality, safety, efficacy, and storage across distribution channels.
• Govt to bring law for strict quality checks, monitoring of drugs, cosmetics
The Indian government is preparing to replace the nearly 85-year-old Drugs and Cosmetics Act, 1940 with a new Drugs, Medical Devices and Cosmetics Act 2025. Under the draft law, the Central Drugs Standard Control Organization (CDSCO) will receive formal statutory powers to more strictly monitor and enforce quality standards for drugs, medical devices, and cosmetics. For the first time, CDSCO could take immediate action against fake or sub-standard products without lengthy procedures. The law aims to digitize licensing, improve coordination with state regulators, strengthen testing labs, and ensure accountability across manufacture-to-market stages. The move follows global quality concerns and recent incidents involving contaminated medicines.
• Pfizer files lawsuit against Metsera and its directors & Novo Nordisk in the Delaware Court of Chancery for breach of merger agreement
Pfizer has filed a lawsuit in the Delaware Court of Chancery against Metsera, its board, and Novo Nordisk, alleging breach of contract, breach of fiduciary duty, and tortious interference related to Metsera’s merger agreement with Pfizer. Pfizer claims Novo Nordisk’s competing offer cannot be a “Superior Proposal” due to high regulatory risk and an unprecedented structure intended to evade antitrust review. In contrast, Pfizer’s acquisition has already secured all regulatory approvals, including early termination of the HSR waiting period. Pfizer also argues that Novo Nordisk’s proposed special dividend violates Delaware law and that Metsera’s directors acted improperly. Pfizer seeks a restraining order, injunctive relief, and damages to enforce the merger agreement.
• Mumbai EOW initiates probe against Medikabazaar current board members and partners for corporate fraud
The Mumbai Police Economic Offences Wing (EOW) has initiated a probe into alleged corporate fraud at Boston Ivy Healthcare Pvt Ltd, operator of B2B medical-supplies platform Medikabazaar. A case has been registered against the company’s current board members and foreign investor partners, including Healthquad, Creaegis, Ackerman Van Haaren and Kois Invest over alleged diversion of more than Rupees Two Hundred Sixty-Four Crore (Rs. 264 crores). The FIR, filed by founders and 13% shareholders Vivek Tiwari and Ketan Malkan, accuses the directors of cheating, criminal breach of trust and conspiracy under multiple sections of the Bharatiya Nyaya Sanhita (BNS), 2023. The complaint alleges wrongful board removal of the founders, undervalued ESOP share allotments, and fund siphoning facilitated by senior executives and investor representatives.
• Cardiol Therapeutics wins US patent protection for heart-disease drug platform
Cardiol Therapeutics has received a US Notice of Allowance for a patent covering its cannabidiol-based therapies CardiolRx and CRD-38 for treating a broad range of inflammatory and Fibrotic Heart Diseases. The patent, once issued, will secure protection through October 2040 for conditions including Myocarditis, Pericarditis, Heart Failure, Inflammatory Cardiomyopathy, Atherosclerosis, and Cardiac Toxicity from Cancer Drugs. CEO David Elsley said the allowance strengthens the company’s competitive position as it advances late-stage programs. The decision follows positive Phase II results in acute myocarditis. Cardiol continues two major clinical programs in recurrent pericarditis (MAVERIC) and acute myocarditis (ARCHER), while progressing CRD-38 for heart failure.
• Delhi High Court dismisses Artura Pharma’s application related to territorial jurisdiction
The Delhi High Court dismissed Chennai-based Artura Pharmaceuticals’ application seeking return of a trademark infringement suit filed by Sun Pharma for lack of territorial jurisdiction, while reserving Artura’s right to raise the issue during trial. Sun Pharma had sought injunctions
over alleged deceptive marks Pepfix and Neovital, against its Pepfiz and Revital marks. The Court found that questions of fact such as the functionality of Artura’s websites, enquiries originating from Delhi, and exposure of Delhi consumers require trial evidence. It noted Artura’s claims of manufacture for export and limited domestic sales, and Sun Pharma’s contention that product listings on PharmaHopers (a business-to-business directory) and the company website support Delhi jurisdiction. The territorial issue will be decided as a preliminary issue at trial.
Leave a Reply