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 December 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
- Union Finance Ministry permits 15 firms to import Morphine, Codeine & Thebaine with conditions
The Union Ministry of Finance has permitted 15 Pharmaceutical companies to import Morphine, Codeine, Thebaine, and their salts exclusively for manufacturing drugs or formulations meant for export. The approval, issued under Rule 54 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, allows imports subject to strict conditions, including mandatory export of finished products within 180 days, extendable up to a maximum of 270 days with approval. Unutilized quantities must be surrendered to the Government Opium and Alkaloids Works, and detailed accounting must be submitted to the Narcotics Commissioner. The notification, which also amends the import certificate format, will remain valid until December 31, 2027, aiming to regulate controlled substance imports while supporting export-oriented pharmaceutical manufacturing.
- DGFT issues updated list of PSIAs and approved instruments to ensure regulatory compliance
The Directorate General of Foreign Trade has issued an updated list of 11 empaneled Pre-Shipment Inspection Agencies following approvals granted at the 27th Inter-Ministerial Committee meeting. The update also recognizes the Handheld Radiation Survey Meter and Radionuclide Identifier (Spectrometer) as approved instruments for allotment of operational areas and countries. All approved agencies are required to update equipment mapping on the Directorate General of Foreign Trade portal and comply with conditions including valid calibration certificates, bank guarantees, and registered offices with nationalized bank accounts in India. The approvals were granted based on recommendations from the Atomic Energy Regulatory Board.
- Ministry of Health issues draft amendment to remove cough syrups from Schedule K
The Union health ministry has issued a draft amendment to the Drugs Rules, 1945 proposing the removal of cough syrups from Schedule K, which would make their sale permissible only against a valid medical prescription. The proposal follows recent child deaths linked to contaminated cough syrups and past global incidents involving toxic impurities such as diethylene glycol (DEG) and ethylene glycol (EG). The amendment seeks to delete the exemption that currently allows over-the-counter sale of cough syrups. Backed by recommendations of the Drugs Consultative Committee, the move aims to strengthen patient safety, tighten regulatory oversight, and prevent misuse and contamination of pediatric cough medicines.
- DCC suggests stakeholder consultation on use of same brand name for multiple drug formulations
The Drugs Consultative Committee has suggested conducting a stakeholder consultation to address concerns over the use of the same brand name with extensions for multiple drug formulations. The issue relates to different medicines with varying active ingredients being marketed under a common brand name, which the Committee noted could mislead consumers and increase the risk of medication errors. The matter was discussed in the Committee’s meeting following a presentation on the practice. The Committee also recalled its earlier recommendation to make the Sugam portal’s brand name database publicly accessible to help regulators and applicants identify existing or similar brand names. It reiterated that cases of identical or confusing brand names should be resolved by State Licensing Authorities to avoid market deception.
- Centre to amend Rules to act against ads of prescription-only & potent drugs by sales & distribution firms
The Government of India is considering amendments to the Drugs Rules, 1945 to curb the advertisement of prescription-only and potent drugs by sales and distribution firms, including on online platforms. The proposal follows recommendations of the Drugs Consultative Committee, which noted the growing, unchecked promotion of high-risk medicines such as antibiotics, psychotropic substances, hormonal drugs, narcotics, and lifesaving injectables. While manufacturers are already restricted from advertising drugs listed under Schedules H, H1, and X without prior central approval, similar provisions are currently absent for distributors. The move aims to extend existing safeguards to the sales and distribution level, reinforcing India’s stringent regulatory framework alongside the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, to prevent misleading and unsafe drug promotion.
- DGFT amends procedures in HBP for claiming deemed export benefits
The Directorate General of Foreign Trade has amended Chapter 7 of the Handbook of Procedures (HBP) and ANF 7A to clarify jurisdiction and streamline claims for deemed export benefits under the Foreign Trade Policy (FTP) 2023. The changes define clearer roles for Regional Authorities and Export-Oriented Units, especially for supplies to EOUs, Advance Authorization and DFIA holders. Applications for deemed export benefits must now be filed online with the jurisdictional authority, with no physical submission required. The amendments also specify payment-linked eligibility, category-wise filing restrictions, and revised procedures for Terminal Excise Duty refunds. Overall, the revisions aim to reduce ambiguity, improve administrative efficiency, and ensure smoother implementation of deemed export benefit schemes across sectors, including pharmaceuticals.
- IPC to come out with 10th edition of IP to further strengthen standards of drugs in India
The Indian Pharmacopoeia Commission is set to release the 10th edition of the Indian Pharmacopoeia (IP-2026) to further strengthen drug quality standards in India. Scheduled for release on January 2, 2026, IP-2026 will come into force from July 1, 2026, with a six-month transition period for stakeholders. The new edition introduces 121 new monographs, taking the total to 3,340, along with five new general chapters. Several chapters and excipient monographs have been harmonized with European, Japanese and US Pharmacopoeias, supporting global alignment and wider international acceptance of Indian drug standards.
- National Pharmaceutical Pricing Authority fixes retail price of 37 new drugs
The National Pharmaceutical Pricing Authority has fixed retail prices for 37 new drug formulations under the Drugs Prices Control Order (DPCO), 2013, covering therapies for Hypertension, Diabetes, Respiratory Disorders, Ophthalmic Conditions, and Mental Health. The decision includes products from companies such as Cipla, Dr Reddy’s, Torrent, Glenmark, Mankind, Emcure, and others, across multiple strengths and dosage forms. These formulations qualify as “new drugs” under Paragraph 2(1)(u) of DPCO, involving new combinations, strengths, or dosages of scheduled medicines. NPPA stated that prices were fixed as per the prescribed methodology, warning that non-compliance will attract recovery of overcharged amounts with interest under applicable laws.
- Health ministry issues draft notification with various amendments in MDR, 2017
The Ministry of Health and Family Welfare has issued a draft notification proposing multiple amendments to the Medical Devices Rules (MDR), 2017 to simplify and streamline regulatory processes. Key changes include granting perpetual validity to registration certificates and manufacturing licences for certain classes of medical devices, subject to payment of prescribed retention fees. A new Form MD-44 has been introduced for test or evaluation reports by registered medical device testing laboratories. Amendments also cover quality management system applicability, overseas manufacturing fee structures, and expanded provisions for sampling and seizure documentation. The proposed changes aim to improve regulatory clarity, ease compliance, and strengthen oversight as India continues to formalise medical device regulation.
- DoP extends timeline till Jan-16, 2026 for online submission of applications under PLI scheme for bulk drugs
The Department of Pharmaceuticals (DoP) has extended the deadline for online submission of applications under the Production Linked Incentive (PLI) scheme for bulk drugs till January 16, 2026. The extension applies to applications for manufacturing key ingredients of the Carbapenem Antibiotic Meropenem and the Antiretroviral Drug Ritonavir. Under this round, support will be provided to up to eight firms, with four applicants each for Meropenem and Ritonavir, subject to minimum annual production capacities. The PLI scheme aims to boost domestic manufacturing of critical APIs, KSMs and intermediates, reduce import dependence, and strengthen India’s pharmaceutical supply chain.
2) Approvals
- Kymera Therapeutics receives US FDA Fast Track Designation for KT-621, an oral STAT6 degrader to treat Atopic Dermatitis
Kymera Therapeutics Inc. has received Fast Track designation from the United States Food and Drug Administration (US FDA) for KT-621, a first-in-class, once-daily oral Signal Transducer and Activator of Transcription 6 (STAT6) degrader for the treatment of Moderate to Severe Atopic Dermatitis. The designation is supported by positive results from the BroADen Phase 1b trial, which demonstrated robust STAT6 degradation, biomarker modulation, clinical activity, and a favorable safety profile. The ongoing BroADen Phase 2b trial in Atopic Dermatitis is expected to report data by mid-2027, while the BREADTH Phase 2b trial in Asthma is planned to initiate in the first quarter of 2026. Fast Track status enables more frequent regulatory interactions and may allow accelerated review pathways.
- Vektor Medical receives US FDA 510(k) clearance for its next generation vMap technology to enhance connectivity
Vektor Medical has received 510(k) clearance from the United States Food and Drug Administration (US FDA) for its next generation vMap technology, expanding its non-invasive cardiac mapping capabilities. The clearance introduces new features including mapping of Atrial Flutter, direct Electrocardiogram (ECG) data streaming with electroanatomic mapping systems, three-dimensional (3D) model visualization, and classification of vMap as Software as a Medical Device (SaMD). The update enables localization of both atrial and ventricular arrhythmias using a single non-invasive solution, improving procedural interoperability and clinical workflows for electrophysiologists.
- PTC Therapeutics receives Health Canada nod for Sephience to treat children and adults living with Phenylketonuria
PTC Therapeutics Inc. has received approval from Health Canada for Sapience (sepiapterin) for the treatment of children and adults living with Phenylketonuria. The approval includes broad labelling for Hyperphenylalaninemia in adult and Paediatric patients aged one month and older who are responsive to Sepiapterin. The decision is supported by positive efficacy and safety data from the Phase 3 APHENITY trial and its long-term extension study. Sephience is indicated for use alongside a Phenylalanine-restricted diet and works by reducing blood Phenylalanine levels.
- Ajax Therapeutics receives US FDA’s Orphan Drug Designation for AJ1-11095 to treat patients with Myelofibrosis
Ajax Therapeutics Inc. has received Orphan Drug Designation from the United States Food and Drug Administration for AJ1-11095 for the treatment of Myelofibrosis, a rare and Debilitating Blood Cancer. AJ1-11095 is a first-in-class Type II Janus Kinase 2 (JAK2) inhibitor and is currently being evaluated in an ongoing Phase 1 clinical trial in patients who have previously been treated with Type I JAK2 inhibitors and shown inadequate response or loss of efficacy. The designation recognizes the significant unmet medical need in Myelofibrosis and supports the continued development of AJ1-11095 as a potential disease-modifying therapy for patients with limited treatment options.
- Alembic Pharma receives US FDA final approval for Loteprednol Etabonate & Tobramycin Ophthalmic Suspension
Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Loteprednol etabonate and Tobramycin Ophthalmic Suspension, 0.5 percent/0.3 percent, in 5 milliliter and 10 milliliter pack sizes. The product is therapeutically equivalent to Zylet Ophthalmic suspension of Bausch and Lomb Incorporated and is indicated for steroid-responsive inflammatory ocular conditions where superficial bacterial infection or risk of infection exists. The application was granted Competitive Generic Therapy designation, making Alembic eligible for 180 days of exclusivity upon commercialization.
- Lupin receives US FDA approval for biosimilar Armlupeg
Lupin Limited has received approval from the United States Food and Drug Administration for Armlupeg (Pegfilgrastim-unne), its first biosimilar, indicated for reducing Febrile Neutropenia in Cancer patients and improving survival following Myelosuppressive Radiation exposure. Armlupeg is approved as a biosimilar to Neulasta and will be manufactured at Lupin’s biotech facility in Pune, which was inspected by the US FDA prior to approval. The approval marks a key milestone in Lupin’s biologics strategy, strengthening its presence in the US biosimilars market.
- US FDA approves AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab for 1st-line treatment of patients with HER2-positive Metastatic Breast Cancer
The US Food and Drug Administration has granted 510(k) marketing clearance to Zephyrus Innovations for its VaporShield Closed System Transfer Device (CSTD). VaporShield is designed to protect healthcare workers from exposure to hazardous drugs during subcutaneous and intramuscular injections, addressing gaps under USP <800> requirements. The device provides a fully closed system from drug preparation to disposal while incorporating auto-retractable syringe features to prevent needlestick injuries. Zephyrus said the clearance enables safer handling of hazardous medicines, with potential to protect millions of healthcare workers globally, as demand for CSTDs continues to grow.
3) International Pharma News
- Lupin Manufacturing Solutions and PolyPeptide enter strategic alliance to scale global peptide supply chain
Lupin Manufacturing Solutions, a subsidiary of Lupin Limited, has entered a long-term strategic alliance with PolyPeptide Group AG, a global Contract Development and Manufacturing Organization specializing in peptide-based Active Pharmaceutical Ingredients. The partnership aims to strengthen global peptide supply chains, enhance operational efficiency, and support the growing demand for peptide therapeutics, including treatments for Metabolic Diseases. Under the alliance, the companies will expand sourcing options, integrate procurement and supply planning, and ensure consistent quality and reliable global service delivery.
- Johns Hopkins University with Great Learning to launch AI in healthcare program
Johns Hopkins University has partnered with Great Learning to launch a 10-week online AI in Healthcare program aimed at healthcare, pharmaceutical, biotech and health tech professionals. Designed by Johns Hopkins faculty, the program focuses on practical applications of artificial intelligence in areas such as diagnostics, hospital operations, epidemiology, drug discovery and personalized medicine, without requiring prior coding knowledge. The curriculum includes real-world use cases, and guidance on managing electronic health records and scaling AI projects. The initiative comes amid rapid growth in the global AI-healthcare market and seeks to build data-driven, patient-centric healthcare systems.
- High-level Kenyan delegation to discuss investments, regulatory landscape with Indian pharma industry
A high-level delegation from Kenya, led by Lee Kinyanjui, will visit India to engage with the Indian pharmaceutical industry on investments and the regulatory environment. The discussions come as African nations seek to boost local drug manufacturing and reduce import dependence. Kenya, positioned as a gateway to East and Central Africa, offers access to over 400 million consumers through regional trade blocs and is supported by strong infrastructure and Special Economic Zones. The visit aims to deepen India Kenya pharmaceutical collaboration amid currency volatility in Africa, which has raised import costs and affected demand for medicines.
- Indian Pharma industry exports remain in positive territory despite tariff concerns
India’s pharmaceutical industry is continuing to strengthen its global position despite tariff concerns, with Pharmexcil now ranking among the world’s top five export promotion councils and moving from fifth to fourth place. Pharmaceutical exports reached USD 30.46 billion, driven largely by generics, which contribute USD 16 billion. The US and Europe together account for 50–53 per cent of exports, reflecting sustained trust in Indian medicines. At the CPHI & PMEC India event, Pharmexcil Chairman Namit Joshi said that although there were initial concerns under Section 232 tariff provisions, no duties have been imposed, and exports remain on a growth trajectory.
- Afghanistan initiates talk with Pharmexcil to strengthen bilateral cooperation in Indian pharma sector
Afghanistan has initiated focused discussions with the Pharmaceuticals Export Promotion Council of India to strengthen bilateral cooperation in the pharmaceutical sector following a high-level ministerial visit to India, the talks center on long-term medicine supply, investment opportunities, and easing trade challenges such as visa issues, transport corridors, and use of the Chabahar Port. Afghan officials are keen to engage Indian pharma companies and explore local manufacturing prospects. As part of the engagement, a USD 100 Million Memorandum of Understanding was signed between Zydus Lifesciences and Afghanistan’s Raoufi International Group, covering medicine exports and future local manufacturing.
- Max Healthcare and Monash University sign MoU to advance research and academic collaboration
Max Healthcare and Monash University have signed a Memorandum of Understanding to strengthen long-term collaboration in medical research, training, and academic exchange. The partnership combines Max Healthcare’s clinical expertise with Monash University’s global research capabilities, with an initial focus on advancing research in triple-negative Breast Cancer, a highly aggressive and hard-to-treat subtype. The collaboration will span laboratory research, clinical studies, joint publications, and staff and student exchange programs across communicable and non-communicable diseases.
- WHO issues global guideline on the use of GLP-1 medicines in treating obesity
The World Health Organization has issued its first global guideline on the use of GLP-1 medicines for treating obesity, recognizing the condition as a chronic, relapsing disease affecting over one billion people worldwide. The guidance provides conditional recommendations for the long-term use of GLP-1 therapies in adults, alongside intensive behavioral interventions such as diet and physical activity. While acknowledging their proven efficacy, WHO cautioned about high costs, limited long-term safety data, health-system readiness, and equity concerns. The guideline stresses that medicines alone are insufficient and calls for comprehensive, lifelong, person-centered care, population-level prevention policies, and urgent action to improve affordability, access, and regulated supply to prevent widening health disparities.
- Lilly’s Retatrutide Shows Up to 71.2 lbs Weight Loss in Phase 3 Trial
Eli Lilly and Company announced positive results from its Phase 3 TRIUMPH-4 clinical trial of Retatrutide, an experimental once-weekly drug that targets three hormone receptors (GLP-1, GIP and glucagon). In people with Obesity and Knee Osteoarthritis, the highest dose of Retatrutide led to an average weight loss of about 28.7 % of body weight, which is roughly 71.2 pounds over 68 weeks. The treatment also substantially reduced Osteoarthritis pain and improved physical function, with many participants experiencing large drops in pain scores. Both the 9 mg and 12 mg doses met the trial’s main effectiveness and safety goals.
5) Domestic Pharma News
- Novo Nordisk announces launch of Ozempic in India
Novo Nordisk has announced the launch of Ozempic (injectable semaglutide) in India for the treatment of adults with Uncontrolled Type 2 Diabetes Mellitus. Ozempic is a once-weekly Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA), indicated as an adjunct to diet and exercise. The launch addresses a significant public health need, with India home to over 101 million people living with Diabetes and a high burden of Obesity and Prediabetes. Ozempic has demonstrated effectively Glycated Haemoglobin (HbA1c) reduction, meaningful weight loss, and Cardiovascular and Kidney protection. Available in 0.25 milligram, 0.5 milligram, and 1 milligram FlexTouch pens, the therapy supports long-term, physician-guided diabetes management.
- IPC 2025 to accelerate Pharm Futura integrating AI into pharmacy education to prepare future-ready professionals
The Indian Pharmaceutical Congress 2025, scheduled to be held in Bengaluru from December 19 to 21, will focus on accelerating the Pharm Futura movement by integrating Artificial Intelligence into pharmacy education. Aligned with the theme “AI and Technology in Pharma: Educate, Innovate, Empower,” the initiative aims to prepare future pharmacists for a digital-first healthcare ecosystem. The program highlights the use of Artificial Intelligence in clinical decision-making, drug discovery, patient counselling, pharmacogenomics, and personalized medicine. It also emphasizes training students to use Clinical Decision Support Systems to enhance patient safety. While acknowledging challenges such as implementation costs, faculty training, and ethical concerns, the initiative underlines the need for future-ready, patient-centric pharmacy professionals.
- KPCMA urges state govt to revise D Pharm fees
The Karnataka Pharmacy College of Management Association has urged the Karnataka government to revise the Diploma in Pharmacy fee from INR 14,300 to (Rupees Fourteen Thousand Three Hundred) to INR 40,000 (Rupees Forty Thousand) per annum from the academic year 2025–26, citing rising operational and compliance costs. The association stated that the existing fee is inadequate to cover faculty salaries, laboratory maintenance, consumables, accreditation requirements, and infrastructure upgrades. It also requested continuation of the consensual seat matrix for Diploma in Pharmacy admissions to avoid disruption for institutions and students.
- India to co-host 2nd WHO Global Summit on Traditional Medicine in New Delhi
India will co-host the 2nd World Health Organization Global Summit on Traditional Medicine in New Delhi from December 17 to 19, 2025, in collaboration with the World Health Organization. Announced by the Union Ministry of Ayush, the summit will bring together global policymakers, researchers, and experts to discuss innovation, evidence-based practices, and future strategies in traditional medicine. A curtain raiser program was held on December 8, chaired by the Union Minister of Ayush, highlighting India’s growing leadership in the sector. The summit will feature ministerial dialogues, scientific sessions, exhibitions, and knowledge-sharing initiatives aimed at strengthening the integration of traditional medicine into public health systems worldwide.
- Zydus introduces biosimilar Denosumab 120 mg Subcutaneous protecting bone health in Cancer Patients
Zydus Lifesciences Ltd. has launched Zyrifa, a biosimilar of Denosumab 120 mg Subcutaneous (SC), aimed at protecting bone health in Cancer patients with skeletal metastases. Denosumab, a monoclonal antibody, is widely used to prevent skeletal-related complications such as fractures, pain, spinal cord compression and loss of mobility in advanced Cancers. Zyrifa is indicated for patients with bone metastases arising from breast, prostate, lung, kidney, thyroid, myeloma, head and neck, and other solid tumors. Priced at INR 12,495 (Rupees Twelve Thousand Four Hundred Ninety-Five), the launch seeks to improve access and affordability of critical supportive oncology care.
- Sun Pharma introduces Ilumya in India for treatment of moderate-to-severe Plaque Psoriasis
Sun Pharmaceutical Industries has launched Ilumya (tildrakizumab) in India for the treatment of moderate-to-severe Plaque Psoriasis, expanding access to its global portfolio of innovative biologics. Ilumya, an IL-23 inhibitor already available in 35 countries, has shown strong and sustained efficacy with a favorable safety profile. In an Indian clinical study involving 115 patients, a high proportion achieved significant skin clearance and improvement in quality of life, with good tolerability and no immunogenicity concerns. The therapy offers long-term disease control with simplified dosing, addressing unmet needs among Indian patients who remain inadequately managed on conventional treatments.
- Maarga Mind Care expand to Gurgaon, targets 25 mental health hospitals across India by 2030
Maarga Mind Care has expanded to North India with the launch of its new center in Gurgaon, marking a key milestone in its national growth strategy. The Bengaluru-based mental healthcare provider aims to establish 25 dedicated mental health hospitals across India by 2030, with a planned investment of around INR 300 Crore (Rupees Three Hundred Crore). The Gurgaon facility will provide a wide range of services including psychiatry, de-addiction, rehabilitation, neuromodulation therapies, counselling, inpatient care and emergency support, focusing on accessible, evidence-based and compassionate treatment to address India’s widening mental health care gap.
6) Innovations
- AIIMS Bhopal hosts mobile robotic simulation system to spread awareness and orientation for faculty and students
All India Institute of Medical Sciences Bhopal hosted the Xi Experience Centre, a mobile robotic-assisted surgery sensitization platform developed by Intuitive, to enhance awareness and orientation among faculty, students, and healthcare professionals. The initiative aimed to promote understanding and future adoption of advanced minimally invasive surgical technologies in central India. The program provided hands-on exposure to robotic-assisted surgery, highlighting its applications across Urology, Gynaecology, General Surgery, and Oncology. The Xi Experience Centre showcased features of the da Vinci robotic-assisted surgery system, including three-dimensional vision, wristed instruments, and real-time imaging. The initiative supports decentralized access to advanced surgical care in Tier 2 and Tier 3 cities and strengthens preparedness for future integration in government hospitals.
- Germany’s Healy World brings material-science led digital wellness innovation to India.
Germany-based Healy World has entered the Indian market with Zero Hertz, a material-science-driven digital wellness innovation aimed at supporting everyday well-being amid rising digital exposure. Unlike gadgets or wearables, Zero Hertz integrates Electromagnetic Field (EMF) and Radio Frequency (RF) shielding directly into fabrics used in daily life. The proprietary material is designed to block low-frequency electromagnetic fields and significantly reduce RF exposure, while remaining breathable and skin-friendly. Making its global debut in India, the launch includes a cap, sleep mask, and full-body blanket for work, rest, and recovery.
- mAbxience and HP drive the use of AI in biomanufacturing and biosimilar development
mAbxience and HP Inc. have launched a pioneering project to apply artificial intelligence in biomanufacturing and biosimilar development. The collaboration focuses on creating a digital twin of monoclonal antibody production processes, using real manufacturing data and advanced neural network models to improve predictability, consistency, and efficiency. The AI-driven solution enables simulation and optimization of cell culture stages, helping increase yields while reducing variability. The initiative strengthens mAbxience’s position as a cost-competitive biomanufacturing partner and supports broader access to high-quality biologic medicines through smarter, data-driven production.
- Hiro Pharma Consulting’s AI-enabled reliability assurance method for Pharmacovigilance systems receives Japanese paten
Hiro Pharma Consulting (R) Co., Ltd. has received a Japanese patent for its AI-enabled reliability assurance methodology for pharmacovigilance systems, marking the country’s first patent dedicated to validating AI-driven PV platforms. The patented AI-PV Hiro Pharma Validation Method provides a structured approach to Good Pharmacovigilance Practice (GVP) compliant computerized system validation, ensuring accuracy, audit readiness, and continuous verification of AI functions. Recognised by the Japan Patent Office for its novelty, the method supports global regulatory compliance across major regulatory agencies.
- Ophthalmologists back AI-powered screening as a game-changer in preventing blindness
AI-powered screening and advanced data analytics are transforming eye care in India by enabling early detection, personalised treatment, and prevention of vision loss. Using technologies such as ultra-widefield retinal imaging, optical coherence tomography, and AI models trained on large retinal datasets, Ophthalmologists can identify diseases like diabetic retinopathy, glaucoma, and age-related macular degeneration at early stages. AI supports faster referrals, predictive treatment planning, reduced unnecessary interventions, and expanded telemedicine access, especially in underserved areas. This shift from reactive treatment to lifelong vision preservation has the potential to significantly reduce preventable blindness.
- Cannabis derivatives could provide new ovarian Cancer Treatments
Researchers from Khon Kaen University in Thailand have reported that Cannabis derived compounds cannabidiol (CBD) and delta-9-Tetrahydrocannabinol (THC) show promising anti-cancer activity against Ovarian Cancer in laboratory studies. Experiments on two Ovarian Cancer cell lines, including one resistant to platinum-based chemotherapy, showed that both compounds reduced Cancer cell growth and colony formation. When used together in a 1:1 ratio, CBD and THC demonstrated stronger effects and also inhibited Cancer cell migration, a key factor in Metastasis. The compounds had minimal impact on healthy cells, suggesting a favorable safety profile.
- SmartWinnr launches medical simulation center of excellence to advance AI readiness in pharma and medtech
SmartWinnr has launched a medical simulation center of excellence to enhance AI readiness and compliance in pharma and medtech training. The center integrates experienced life sciences professionals with AI specialists to ensure simulations mirror real-world medical conversations, clinical contexts and regulatory requirements. By embedding medical, behavioral and sales expertise into AI-driven role-play simulations, the platform aims to improve representative confidence, message recall and field readiness. Early pilots showed significant gains in confidence and learning outcomes. The initiative reinforces SmartWinnr’s focus on responsible, domain-specific AI and plans to expand expertise and therapy coverage in the coming year.
- Intas collaborates with Integri Medical to launch India’s first needle-free injection system for IVF and gynaecology
Intas Pharmaceuticals has partnered exclusively with Integri Medical to introduce India’s first needle-free injection system (N-FIS) for IVF and Gynaecology treatments. The collaboration makes Intas the only company in the country to offer needle-free drug delivery in reproductive care, aiming to significantly reduce pain, anxiety, and treatment fatigue associated with frequent injections. Using a high-pressure jet stream mechanism, N-FIS delivers medication through the skin without needles, minimizing tissue trauma and contamination risk. With India’s rapidly growing IVF market, the initiative is expected to improve treatment experience and compliance for hundreds of thousands of women, setting a new benchmark in patient-centric innovation.
4) Trends
- Researchers demonstrate environmental and climate shape regional patterns of Allergic Sensitization
An international research team has demonstrated that environment and climate significantly shape regional patterns of Allergic Sensitization using molecular Immunoglobulin E (IgE) profiling. In a population-based study of 1,000 adults across five climatically distinct cities in Turkiye, researchers identified region-specific IgE reactivity patterns using high-resolution allergen microarray diagnostics. The study revealed clear differences in Sensitization linked to local climate, altitude, and environmental exposure, with Kayseri showing notably lower rates of Sensitization and Allergic symptoms. The findings highlight that molecular allergology provides deeper insight than conventional extract-based testing and can support more precise diagnosis, prevention strategies, and region-specific allergy management, even where clinical symptoms are absent.
- World Health Organization issues first global guideline on Infertility
The World Health Organization has released its first global guideline on Infertility, urging countries to make fertility care safer, more affordable, and equitable. Infertility affects nearly one in six people of reproductive age, yet access to Diagnosis and treatment remains limited, with high out-of-pocket costs forcing many to forgo care. The guideline sets out 40 recommendations covering prevention, Diagnosis, and treatment, and calls for fertility services to be integrated into national health systems. It emphasises prevention through early awareness, addressing risk factors such as untreated infections and tobacco use, and promoting healthy lifestyles. The guideline also outlines stepwise, evidence-based clinical pathways and highlights the need for psychosocial support and rights-based, gender-equitable reproductive health policies.
- Study by researchers presented at Radiological Society of North America meeting shows Obesity speeds development of Alzheimer’s Disease
A study presented at the Radiological Society of North America annual meeting shows that Obesity may significantly accelerate the development of Alzheimer’s disease. Researchers analyzing five-year data from over 400 participants found that Alzheimer’s-related blood biomarkers increased 29% to 95% faster in individuals with Obesity compared to non-obese participants. While baseline tests showed lower biomarker levels in obese individuals due to blood dilution, longitudinal analysis revealed a higher and faster-growing disease burden over time. The findings suggest blood biomarkers may be more sensitive than brain imaging in tracking Obesity’s impact on Alzheimer’s pathology. Researchers noted that addressing Obesity, a major modifiable risk factor, could potentially delay disease onset and improve prevention and treatment strategies.
- Oral semaglutide for weight loss could be a game-changer for Obesity care in India
New data presented at Obesity Week 2025 suggests that an investigational oral semaglutide (25 mg) pill could match injectable versions in delivering meaningful weight loss and cardiometabolic benefits. The daily pill showed comparable reductions in body weight, along with improvements in blood pressure, cholesterol, and blood sugar, with the strongest effects seen in patients achieving over 15% weight loss. Benefits were consistent across women regardless of menopausal status, and most participants reported better physical function. Indian experts note that an oral option could significantly improve acceptance and access, especially among patients hesitant about injections.
- Most countries make progress towards universal health coverage, but major challenges remain, WHO–World Bank report finds
A joint World Health Organization and World Bank Global Monitoring Report 2025 finds that most countries have made progress towards Universal Health Coverage (UHC) since 2000, but major gaps remain. Global health service coverage improved significantly, while the proportion of people facing financial hardship from health expenses declined. Despite this, an estimated 4.6 billion people still lack access to essential health services, and 2.1 billion face financial hardship, driven largely by out-of-pocket spending on medicines. The poorest populations continue to bear the greatest burden. Progress has slowed since 2015, and without stronger political commitment and investment, achieving UHC by 2030 remains unlikely.
7) Law and Order Briefs
- AICDF demands action against 16 marketing firms in WB for violation of norms
The All-India Chemists & Distributors Federation has urged the Ministry of Health and Family Welfare and West Bengal’s drug control authorities to take immediate action against 16 pharmaceutical marketing and manufacturing firms for alleged regulatory violations. AICDF claims the companies failed to submit mandatory brand registration and price compliance details, including Form V filings with the National Pharmaceutical Pricing Authority, rendering certain products illegal for sale. The federation expressed concern over weak enforcement despite repeated complaints, warning that continued non-compliance threatens public health and supply-chain integrity, and called for swift, impartial action to deter licensed offenders.
- Parliamentary Panel recommends measures to expedite approvals and innovation in medical devices sector
The Parliamentary Standing Committee on Health and Family Welfare has recommended key reforms to speed up approvals and boost innovation in India’s medical devices sector. It urged the Department of Health to ensure complete digitisation and automation of licensing through a unified platform linking central and state authorities under the Central Drugs Standard Control Organisation. The Panel called for a single comprehensive query system, time-bound conditional approvals especially for devices with CE or US FDA certifications and stronger performance monitoring to curb delays. It also suggested leveraging AI to identify bottlenecks and setting up a dedicated facilitation cell for startups under MedTech Mitra, to create a more predictable, transparent, and innovation-friendly regulatory ecosystem.
- Madras HC directs health ministry to form panel to review safety & efficacy of Pioglitazone & Sitagliptin
The Madras High Court has directed the Ministry of Health and Family Welfare to constitute a panel of medical experts to review the safety and efficacy of Pioglitazone and Sitagliptin, two widely used Diabetes medicines. The court ordered a joint inquiry, with both parties to be heard on the same day and asked the expert panel to recommend the most suitable drug for Indian patients. The review must be completed within three months, underscoring the public health and cost implications for millions of Diabetes Patients. The direction follows concerns over conflicting opinions and alleged lapses in the earlier process involving the Indian Council of Medical Research.
- Biocon Biologics inks settlement and license agreement to commercialize Biosimilar Aflibercept Worldwide
Biocon Biologics has entered into a global settlement and license agreement with Regeneron and Bayer to commercialize its biosimilar aflibercept, Yesafili (40 mg/ml), across Europe and the rest of the world. The agreement follows an earlier settlement covering the US and Canada and resolves all pending litigation. Yesafili, a VEGF inhibitor for multiple Ophthalmic conditions, is set to launch in the UK in January 2026 and other markets from March 2026. The product has already received approvals from the European Commission and the Medicines and Healthcare products Regulatory Agency, strengthening Biocon Biologics’ global Ophthalmology portfolio.
- AIOCD seeks PM’s intervention to stop illegal e-pharmacies & withdraw proposed regulations GSR 817 & 220
The All-India Organization of Chemists and Druggists has sought the intervention of the Prime Minister to curb illegal operations of e-pharmacies and quick-commerce platforms and to withdraw the proposed drug regulations GSR 817 and GSR 220. The organization alleged that several online platforms are selling medicines, including antibiotics, without statutory licenses, qualified pharmacists, or proper patient records, in violation of the Drugs and Cosmetics Act, 1940, the Pharmacy Act, and Telemedicine Practice Guidelines. AIOCD warned that such practices aggravate Antimicrobial Resistance and pose serious public health risks. It urged immediate closure of illegal platforms, withdrawal of the proposed regulations, inquiry into online doctor-on-call models, and strict enforcement of existing pharmacy laws.
- Telangana DCA raids unlicensed fertility centre, issues show cause notices to 180 retail shops in two-day crackdown
The Telangana Drugs Control Administration carried out a two-day enforcement drive to curb illegal drug sales and protect patient safety. Authorities issued show cause notices to 180 retail medical shops for violations such as selling prescription medicines without valid prescriptions, stocking expired drugs, and operating without registered pharmacists. In a separate action, officials raided an unlicensed fertility centre in Hanamkonda and seized medicines, including steroids and hormone preparations. Samples were collected for analysis, and further action will be taken under the Drugs and Cosmetics Act, 1940.
- Faridabad court sentences chemist to three years rigorous imprisonment for unlicensed drug sales
A Faridabad court has sentenced Mausim, proprietor of Riyaz Medicos, to three years of rigorous imprisonment for operating an unlicensed medical store and illegally selling Allopathic Medicines, in violation of the Drugs and Cosmetics Act, 1940. The conviction followed a 2019 FDA raid that seized 81 varieties of medicines stocked without a valid license. The court rejected the defense claim that the accused was not present during the raid, holding him responsible as the shop’s proprietor. Along with imprisonment, the court-imposed fines totaling INR 1,20,000 (Rupees One Lakh Twenty Thousand Only). The ruling reinforces strict enforcement against unauthorized drug sales to protect public health.