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 July 2025. This newsletter aims to cover local, regional, and global news as well as regulatory updates, new government initiatives, and technological advancements etc.
Regulatory Update
• DCGI asks states to monitor NDMA impurity level in ranitidine to monitor and reduce shelf life
The Drugs Controller General of India (DCGI) has asked State and Union Territory drug regulators to direct ranitidine manufacturers to monitor N-nitrosodimethylamine (NDMA) impurity levels in both the active pharmaceutical ingredient (API) and final formulations. This follows recommendations from the Drugs Technical Advisory Board (DTAB), which advised risk-based measures such as reducing the drug’s shelf life. NDMA, classified as a probable human carcinogen, has raised global safety concerns, leading to the withdrawal of ranitidine products in the United States and European Union. The Indian Council of Medical Research (ICMR) has been requested to conduct further studies to assess long-term safety.
• CDSCO switches over to online submission of clinical trial applications for CGTP
The Central Drugs Standard Control Organisation (CDSCO) has mandated online submission of clinical trial applications for Cell and Gene Therapeutic Products (CGTP), ending offline submissions from July 10, 2025. Applications for Phase I, II, and III trials must now be filed via the Sugam online portal. CDSCO has also released user manuals and video tutorials to aid applicants. This digitization aligns with CDSCO’s broader e-governance initiatives.
• DCC asks DCGI to constitute sub-committee to look into issues raised by consumers on drug labelling
The Drugs Consultative Committee (DCC) has recommended the constitution of a sub-committee by the Drugs Controller General of India (DCGI) to address consumer grievances related to drug labelling and packaging. Concerns include illegible expiry dates, inadequate font sizes, and lack of distinguishing marks on generic medicines. The sub-committee will also examine the feasibility of regulating suppliers of packaging materials and incorporating Braille or QR code-based voice assistance for visually impaired users.
• Microbial contamination limits in Schedule M to be amended to match with WHO standards
The Drugs Consultative Committee (DCC) has proposed amending Schedule M of the Drugs and Cosmetics Act, 1940 to align microbial contamination limits for ‘Grade A’ cleanroom areas with World Health Organisation (WHO) standards outlined in Technical Report Series (TRS) 1044 Annexure II. Currently, a mismatch exists in the contamination limits specified in Schedule M and WHO guidance, potentially affecting uniform regulatory practices. Harmonising these limits will streamline regulatory approvals, enhance environmental monitoring standards, and align Indian manufacturing practices with international benchmarks, improving global acceptance of Indian pharmaceutical products.
• DCC approves amendment to licensing rules for Stem Cell and Gene Therapy product
The Drugs Consultative Committee (DCC) has approved amendments to Forms 27D, 27DA, 28D, and 28DA under the Drugs Rules, 1945, to facilitate manufacturing licenses for stem cell-derived products, Gene therapy products, and xenografts. The move allows manufacturers to apply through the State Licensing Authorities (SLA) and the Central Licenses Approval Authority (CLAA).
• CDSCO revises guidance document on export NOC for unapproved, approved new drugs
The Central Drugs Standard Control Organisation (CDSCO) has revised its guidance document on the issuance of No Objection Certificates (NOCs) for the manufacture of unapproved or approved new drugs for export purposes. Notably, for unapproved fixed-dose combinations (FDCs), exporters may now submit approval from a Stringent Regulatory Authority (SRA)—such as the United States, European Union Member States, Canada, Japan, Australia, or Switzerland—if approval from the importing country’s National Regulatory Authority (NRA) is unavailable. The document also outlines requirements for New Chemical Entities (NCEs), introduces a two-step NOC application process, and specifies conditions for handling unexported stock based on residual shelf life.
• DCC agrees with proposal to amend entry on liquid antiseptics under Schedule K
The Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945 to revise the exemptions under Schedule K for liquid antiseptics. These exempt certain household and hospital-use liquid antiseptics from sale license requirements under specific conditions, including manufacture by licensed entities and absence of controlled substances. This move aims to streamline regulation while ensuring safety standards.
• NPPA releases draft ceiling price of six scheduled formulations
The National Pharmaceutical Pricing Authority (NPPA) has issued draft ceiling prices for six scheduled formulations listed under the National List of Essential Medicines (NLEM), 2022. These include povidone iodine ointment 10%, DPT (Diphtheria, Pertussis, Tetanus) vaccine, paracetamol injection 150 mg/ml, sodium nitroprusside injection, ipratropium respirator solution, and diltiazem modified-release capsules. Proposed price reductions range from 5% to nearly 39%, aiming to improve affordability of essential drugs.
• Commerce Ministry amends export rules for Pharma Grade Sugar: shipment and buyer details made optional
The Ministry of Commerce and Industry has amended the export authorization process for pharma grade sugar under the Foreign Trade Policy (FTP) 2023. Changes to ANF-2N, the application form for restricted items, make shipment and buyer details optional at the application stage, allowing exporters to update these before actual shipment. The Directorate General of Foreign Trade (DGFT) has allocated a one-time export quota of 25,000 metric tonnes (MT) for the current sugar season, ending September 30, 2025, exclusively for bona fide pharmaceutical exporters. Compliance requires a valid drug manufacturing license, membership of Pharmexcil, and National Accreditation Board for Testing and Calibration Laboratories (NABL) quality certification.
• DCC asks SLAs to implement various regulatory decisions of CDSCO with priority for uniformity
The Drugs Consultative Committee (DCC) has urged State Licensing Authorities (SLAs) to prioritise the uniform implementation of key regulatory decisions of the Central Drugs Standard Control Organisation (CDSCO). These include revised Schedule M manufacturing standards, prior CDSCO approval for new drugs, product licenses without Bioavailability/Bioequivalence (BA/BE) data for certain drugs, and actions from Risk Based Inspections (RBIs). Other measures involve the State Drug Regulatory Index, Rule 84AB compliance, strengthening drug testing labs, onboarding the Online National Drugs Licensing System (ONDLS), and tackling spurious/Not of Standard Quality (NSQ) drugs. Only 16 States/UTs have joined ONDLS so far.
Approvals
• US FDA Approves LEO Pharma’s Anzupgo cream for Chronic Hand Eczema
The United States Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream by LEO Pharma for the topical treatment of moderate-to-severe Chronic Hand Eczema (CHE) in adults unresponsive to or unsuitable for corticosteroids. The approval strengthens LEO Pharma’s dermatology portfolio and marks a key step in its US market expansion.
• Caliway receives US FDA clearance to proceed with SUPREME- 01 Phase 3 study of CBL-514 for reducing Abdominal Subcutaneous Fat
Caliway Biopharmaceuticals has received clearance from the United States Food and Drug Administration (US FDA) to proceed with SUPREME-01, a global, multicenter Phase 3 study evaluating CBL-514 for the reduction of abdominal subcutaneous fat. The study will enroll 300 participants across 29 sites in the US and Canada. CBL-514 is a first-in-class, small-molecule injectable drug designed to induce adipocyte apoptosis, targeting fat reduction without systemic side effects. The trial’s primary endpoints include MRI-measured fat volume and the Patient Reported-Abdominal Fat Rating Scale (PR-AFRS).
• Lupin’s arm receives GMP certification from Australia’s TGA
Lupin Limited’s wholly owned subsidiary, Lupin Manufacturing Solutions (LMS), has received Good Manufacturing Practice (GMP) certification from the Therapeutic Goods Administration (TGA), Australia, for its Active Pharmaceutical Ingredient (API) manufacturing facility in Dabhasa, Gujarat. LMS provides pharmaceutical Contract Development and Manufacturing Organization (CDMO) services and focuses on API production. This certification reflects compliance with international quality and regulatory standards, bolstering Lupin’s global presence and operational credibility in regulated markets like Australia.
• Fujifilm Pharma’s liposomal formulation of gemcitabine FF- 10832 receives US FDA’s Orphan Drug designation to treat Biliary Tract Cancer
Fujifilm Pharmaceuticals USA, Inc. has received Orphan Drug designation from the United States Food and Drug Administration (US FDA) for FF-10832, an investigational liposomal formulation of gemcitabine, aimed at treating Biliary Tract Cancer (BTC). This designation supports the development of therapies for rare diseases, offering benefits such as seven years of market exclusivity. FF-10832, currently in Phase 2a trials, has shown promise in early studies and aims to improve treatment outcomes by enhancing drug delivery and plasma half-life.
• AstraZeneca Pharma India gets CDSCO approval for treating Endometrial Cancer in the country
AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute durvalumab solution for infusion for two new indications targeting Endometrial Cancer. The drug, in combination with carboplatin and paclitaxel, is now approved as first-line treatment for adults with advanced or recurrent Endometrial Cancer, followed by maintenance with durvalumab and olaparib in patients with mismatch repair proficient (pMMR) disease. Based on the DUO-E study, the combination significantly reduced the risk of disease progression.
• Solid Biosciences gets US FDA IND & Health Canada CTA approvals for SGT-501 to treat Catecholaminergic Polymorphic ventricular Tachycardia
Solid Biosciences has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) and Clinical Trial Application (CTA) approval from Health Canada for its gene therapy candidate SGT-501 to treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), a rare and potentially fatal inherited cardiac condition. SGT-501, based on adeno-associated virus delivery of the CASQ2 gene, aims to stabilize calcium regulation in heart muscle cells, targeting the disease’s root cause. A Phase 1b trial is expected to begin in Q4 2025. The therapy holds Orphan Drug and Rare Paediatric Disease designations.
• EMA committee recommends marketing approval for Biogen’s Zurzuvae to treat women with Postpartum Depression
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for Biogen’s Zurzuvae (zuranolone) to treat Postpartum Depression (PPD) in adult women. If approved by the European Commission, Zurzuvae will become the first treatment in the European Union specifically indicated for PPD. The once-daily, 14-day oral treatment has shown rapid and sustained symptom improvement in the SKYLARK study. Zurzuvae was approved by the US Food and Drug Administration (FDA) in 2023 and is jointly developed by Biogen and Sage Therapeutics.
• KalVista Pharmaceuticals receives UK MKRA marketing authorization for sebetralstat to treat Hereditary Angioedema Attacks
KalVista Pharmaceuticals has received marketing authorization from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for Ekterly (sebetralstat), the first and only oral on-demand treatment for Hereditary Angioedema (HAE) attacks in patients aged 12 and older. The approval is based on the Phase 3 KONFIDENT trial, which demonstrated Ekterly’s effectiveness and safety. Ekterly also received Orphan Drug status in the UK, granting up to 10 years of market exclusivity. The treatment was recently approved by the US Food and Drug Administration (FDA) and is under regulatory review in the European Union, Japan, and other global market.
• UK MHRA approves Biogen Netherlands’ Tofersen to treat rare inherited form of Motor Neurone Disease
The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has approved Tofersen (Qalsody) on 22nd July 2025 for treating adults with Amyotrophic Lateral Sclerosis (ALS) linked to mutations in the SOD1 (superoxide dismutase 1) gene, a rare inherited form of Motor Neurone Disease (MND). Developed by Biogen Netherlands B.V., tofersen is administered via lumbar puncture and works by reducing harmful protein levels caused by the faulty gene. The approval was granted under the International Recognition Procedure (IRP).
• UK MHRA approves ALK’s EUR neffy, a needle-free Anaphylaxis treatment of adults and children in UK
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved ALK’s EURneffy 2 mg, the first needle-free adrenaline nasal spray for emergency treatment of anaphylaxis in adults and children (≥30 kg). EURneffy, developed under license from US-based ARS Pharmaceuticals, offers a user-friendly, needle-free alternative to Adrenaline Auto-Injectors (AAIs), with improved temperature stability and a longer shelf life. The approval is based on data from over 700 participants, showing no serious adverse events. This innovation may significantly improve patient adherence and emergency response in allergy treatment across the UK, Europe’s largest Anaphylaxis market.
• AB Science receives several European countries approval to initiate the confirmatory phase 3 study of masitinib in ALS
AB Science SA has received approval from Spain, Greece, and Slovenia to initiate its confirmatory Phase 3 clinical trial (study AB23005) of masitinib in Amyotrophic Lateral Sclerosis (ALS) under Step 2 of the Clinical Trials Information System (CTIS). This follows the validation of its harmonized protocol by the European Medicines Agency (EMA) and prior approval from the US Food and Drug Administration (FDA).
• US FDA grants Fast Track status to Solid Biosciences’ gene therapy for CPVT
Solid Biosciences has received Fast Track designation from the US Food and Drug Administration (FDA) for SGT-501, its investigational Adeno-Associated Virus (AAV)-based gene therapy for treating Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). SGT-501 delivers a functional copy of the cardiac calsequestrin 2 (CASQ2) gene to stabilize the ryanodine receptor 2 (RYR2), aiming to correct calcium dysregulation that causes abnormal heart rhythms in CPV.
• Anixa Biosciences’ Breast Cancer vaccine technology receives US patent
Anixa Biosciences, in collaboration with Cleveland Clinic, has been granted US Patent No. 12,370,244 for its investigational Breast Cancer vaccine. The vaccine targets alpha-lactalbumin, a protein present during lactation and in certain Breast Cancers, aiming to stimulate an immune response while sparing healthy tissue. Designed to prevent Triple-Negative Breast Cancer (TNBC), an aggressive subtype with limited treatment options, the vaccine addresses a critical unmet need. As no vaccine for breast cancer has been approved by the US Food and Drug Administration (FDA), this development marks a significant step forward in preventive oncology.
• Lupin receives US FDA approvals for Liraglutide and Glucagon injectable products
Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Applications for Liraglutide injection single-patient-use prefilled pens and Glucagon for injection vials. Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India. Liraglutide injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Victoza injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk Inc. It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults and paediatric patients aged 10 years and older, with Type 2 Diabetes Mellitus.
International Pharma News
• Asahi Kasei to Build New Plant to Boost Planova Virus Filter Production
Asahi Kasei Life Science, a division of Asahi Kasei, will build a new spinning plant in Nobeoka City, Miyazaki, Japan, to expand production of its Planova Virus Removal Filters. The facility, supported by Japan’s Ministry of Economy, Trade, and Industry (METI), will be the company’s fourth spinning plant for hollow-fiber cellulose membrane filters, with construction starting in July 2026 and operations in January 2030. The expansion aims to meet rising global demand for virus filtration in biopharmaceutical manufacturing, particularly for plasma-derived therapeutics and biologics.
• Lupin launches Loteprednol Etabonate Ophthalmic Suspension, 0.5% in the US
Lupin Limited has launched Loteprednol Etabonate 0.5%, ophthalmic suspension in the United States, a bioequivalent version of Lotemax by Bausch & Lomb. The ophthalmic suspension is indicated for treating steroid-responsive inflammatory conditions affecting the eye, including allergic conjunctivitis, herpes zoster keratitis, iritis, and post-operative inflammation following ocular surgery. The product addresses inflammation of the conjunctiva, cornea, and anterior segment of the globe.
• Samsung Bioepis releases whitepaper titled ‘Solving the biosimilar void in Europe’; proposes measures to improve practices that hinder healthy market competition
Samsung Bioepis Co. Ltd. has released a whitepaper titled ‘Solving the Biosimilar Void in Europe’, outlining policy recommendations to strengthen biosimilar adoption and market sustainability. Despite €56 billion in cost savings over 11 years, biosimilars in Europe face hurdles such as inadequate Health Technology Assessment (HTA), aggressive price controls, single-winner tender systems, and weak prescriber incentives. The whitepaper calls for tailored HTA, free market-driven pricing, multi-winner tenders, and physician-pharmacist education to foster fair competition and ensure long-term access. The aim is to position biosimilars not just as cost-saving tools, but as enablers of patient-centric care.
• Saudi Arabia Seeks Strategic Partnerships with Indian Pharma & Medical Device Firms
Saudi Arabia is inviting Indian pharmaceutical and Medical Device Companies to explore strategic partnerships and investments in its rapidly expanding healthcare sector under the Vision 2030 framework. The Embassy of India in Riyadh, in coordination with the Public Investment Fund (PIF), will host a webinar on August 18, 2025, to present opportunities in local manufacturing, regulatory guidance, and procurement mechanisms. Focus areas include Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), small molecule drugs, biologics, and advanced medical devices.
• Akeso announces China NMPA accepts sNDA for ivonescimab in combo with chemotherapy to treat Advanced Squamous NSCLC
Akeso, Inc. announced that China’s National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab, a PD-1/VEGF bispecific antibody, in combination with chemotherapy for first-line treatment of Advanced Squamous Non-Small Cell Lung Cancer (sq-NSCLC). This follows promising results from the Phase III HARMONi-6 trial. Ivonescimab has shown superiority over existing PD-1 therapies and is under evaluation in over 12 global registrational trials across multiple cancers. The drug forms a key part of Akeso’s “IO+ADC” strategy in immuno-oncology, supporting its ambition to lead in the development of innovative cancer immunotherapies.
• Elpis Biopharma inks MoU with National Cancer Centre Singapore to conduct translational cell therapy research in Singapore
Elpis Biopharmaceuticals has signed a Memorandum of Understanding (MoU) with the National Cancer Centre Singapore (NCCS) to advance translational research and clinical trials for Bispecific Armored CAR-T Cell Therapies targeting Solid Tumors such as Colorectal, Pancreatic, and Ovarian Cancers. While CAR-T therapy is currently approved for blood cancers, this collaboration seeks to expand its use to solid tumors. Elpis will contribute advanced technologies including bispecific antibodies and mRNA display tools, while NCCS will provide clinical expertise and infrastructure. This partnership aims to accelerate the clinical translation of next-generation immunotherapies to address unmet cancer treatment needs in the region.
• WHO includes ArkBio’ Pediatric RSV Drug, ziresovir in PADO-RSV priority list
Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced that its Pediatric Respiratory Syncytial Virus (RSV) drug, ziresovir (10 mg), has been included in the Pediatric Drug Optimization for Respiratory Syncytial Virus (PADO-RSV) priority list by the World Health Organization (WHO) and the Global Accelerator for Pediatric Formulations (GAP-f). Ziresovir is the first and only RSV antiviral from China to be listed and the only product in the antiviral category selected. Recognized for its clinical value, child-friendly design, and safety, the drug targets a major global health need, especially in low- and middle-income countries, and ArkBio plans to expand its global clinical development and accessibility.
• Fangzhou and Novo Nordisk Signed Collaboration Memorandum to Establish a New Ecosystem for Health Management
Fangzhou Inc., China’s leading online Chronic Disease Management platform, has signed a Memorandum of Understanding (MoU) with Novo Nordisk, a global healthcare company, at the 3rd China International Supply Chain Expo in Beijing. The partnership aims to integrate artificial intelligence, innovative treatment solutions, and pharmaceutical services to improve the management of chronic diseases like Diabetes and Obesity. By combining Novo Nordisk’s expertise in treatment with Fangzhou’s digital healthcare ecosystem, the initiative will offer medication guidance, efficacy tracking, and health education.
• Cryoviva launches Stem Cell Collection Services in the Philippines
Cryoviva Lifesciences has partnered with Life Keep Philippines to launch stem cell and umbilical cord blood collection services near Metro Manila. A new facility is being set up at Salwalk Medicity with Cryoviva’s support. This marks part of the company’s Southeast Asia expansion, alongside India, Thailand, Singapore, and Vietnam. The project is led by Dr. Ramon Atienza and Dr. Felicidad Calip, with backing from CSD Ventures. Cryoviva offers cryopreservation of cord blood, lining, and amnion tissue, using semi-automated processing. Group Chief Executive Officer (CEO) Dr. Alok Khullar sees this as a key step in strengthening regional access to advanced therapies and innovation.
• Gilead receives positive CHMP opinions under accelerated review from EMA for twice-yearly Lenacapavir for HIV prevention
Gilead Sciences, Inc. has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) under accelerated review for its twice-yearly injectable HIV-1 capsid inhibitor, Lenacapavir (trade name Yeytuo), for pre-exposure prophylaxis (PrEP) in adults and adolescents at high risk of HIV-1 acquisition. If approved by the European Commission, it will be available across the European Union and select European Economic Area countries, with an extra year of market exclusivity. Supported by Phase 3 PURPOSE trials showing superior HIV prevention compared to daily oral PrEP, the opinion also facilitates World Health Organization (WHO) prequalification and access in low- and lower-middle-income countries.
• AstraZeneca to invest $50 billion in America for medicines manufacturing and R&D
AstraZeneca has announced a USD 50 billion investment in the United States by 2030, aimed at boosting medicines manufacturing and research and development. The centerpiece will be a multi-billion-dollar manufacturing facility in Virginia, the company’s largest global investment, producing drug substances for its weight management and metabolic portfolio, including Oral Glucagon-like Peptide-1 (GLP-1), Baxdrostat, Oral Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), and combination small molecule products. Additional projects include expanding R&D centres and next-generation manufacturing sites across multiple US states.
• Karnataka and Germany sign MoU to strengthen ties in life sciences start-ups
The Government of Karnataka has signed a five-year Memorandum of Understanding (MoU) with the German state of Bavaria to strengthen collaboration in biotechnology, medical technology, artificial intelligence (AI), quantum technology, higher education, and skill development. The partnership will include joint innovation hubs, co-funded Biotech Research and Development (R&D) grants, and initiatives in climate-friendly pharma manufacturing, precision medicine, and AI for drug discovery. Germany, the 9th-largest investor in India, has a strong life sciences presence in Karnataka, with companies like Merck, Siemens, and BASF operating in the state. The collaboration aims to boost start-ups, green manufacturing, and advanced R&D in life sciences.
Domestic Pharma News
• Zeno Health launches nationwide e-commerce platform to deliver Quality, Affordable Medicines across 23,000+ Pin Codes
Zeno Health, a leading Indian omnichannel pharmacy, has launched a nationwide e-commerce platform to deliver affordable, high-quality medicines across over 23,000 PIN codes. Addressing India’s healthcare access gap and high out-of-pocket spending (39.4% per household), Zeno offers direct procurement from WHO-GMP (World Health Organization – Good Manufacturing Practices) and FDA-certified manufacturers, enabling lower prices. With 60,000+ stock-keeping units (SKUs), air shipment to 7,000 PIN codes, and a no-questions-asked return policy, it ensures convenience, reliability, and reach. This initiative strengthens Zeno’s hybrid model, supporting its goal to redefine healthcare access across India.
• Fortis and Agilus expand rapid genomic testing capabilities with launch of second Genexus System
Fortis Memorial Research Institute (FMRI), Gurugram, in collaboration with Agilus Diagnostics, has launched its second Genexus System, enhancing India’s rapid genomic testing capabilities. The Genexus platform, based on Next-Generation Sequencing (NGS), delivers crucial test results such as liquid biopsy in 24 hours, myeloid NGS in 72 hours, and Minimal Residual Disease (MRD) testing within 5 days—far faster than traditional methods. This speed has enabled early targeted treatments for over 40% of patients and reduced early mortality rates in Blood Cancer cases. The expansion aims to scale precision oncology by integrating AI-enabled genomics and multidisciplinary tumor boards.
• UP leads way ahead in setting up of Jan Aushadhi Kendras
Uttar Pradesh leads the country in the establishment of Jan Aushadhi Kendras (JAKs), accounting for over 20% of the total 16,912 low-cost generic medicine outlets set up nationwide as of June 30, 2025. Of these, 3,550 are in Uttar Pradesh, with 2,004 opened in the last five years. The scheme, aimed at making medicines 50% to 80% cheaper, has saved citizens approximately ₹38,000 crore over 11 years and generated self-employment for over 16,000 people, including 6,800 women entrepreneurs.
• Torrent Pharma extends Shelcal brand into the Adult Nutrition Powder Segment
Torrent Pharmaceuticals has launched Shelcal Total, a daily nutrition powder for adults, expanding its well-known Shelcal brand. The supplement combines protein, calcium, magnesium, vitamin D3, vitamin K2, glucosamine, and bamboo shoot extract to support bone, joint, and overall health. It is made with vegetarian ingredients and contains no added sugar, colors, or flavors.
• CIPMMA calls on Union government to exempt Pharma Marketers from quality liability
The Consortium of Indian Pharmaceutical Marketers and Manufacturers Associations (CIPMMA) has urged the Union government to exempt Pharma Marketers from quality and regulatory liabilities, arguing that marketers are not involved in manufacturing. This resolution was passed during its 15th general body meeting, along with four others—calling for a reduction in Active Pharmaceutical Ingredient (API) prices, concessional electricity charges for MSME (Micro, Small & Medium Enterprises) Udyam Certificate holders, a uniform 5% GST (Goods and Services Tax) on all pharma products, and a complete ban on online pharma trade in Tamil Nadu.
• CMRI Kolkata launches free Cervical Cancer vaccination clinic to safeguard girls and young women
The Calcutta Medical Research Institute (CMRI), Kolkata, has launched a free Cervical Cancer vaccination clinic for girls and young women aged 9 to 26, offering Human Papillomavirus (HPV) vaccines and gynecologist consultations every Wednesday and Thursday. This initiative by CMRI aims to increase access to HPV vaccination, raise awareness, and prevent cervical cancer—India’s second most common cancer in women. The clinic provides Quadrivalent and Nine-Valent vaccines, aligned with World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines. This move supports public health goals under the “Cervical Cancer Mukt Bharat” campaign.
• Corona Remedies acquires seven brands in Cardiology & Women’s Healthcare from the pharmaceutical division of Bayer in India
Corona Remedies Limited has acquired seven pharmaceutical brands from Bayer’s India division, effective July 16, 2025. The acquisition includes Noklot in the cardiology segment and Fostine, Luprofact, Menodac, Ovidac, Spye, and Vageston in women’s healthcare. This move marks Corona Remedies’ entry into the anti-platelet market, valued at Rs. 1,507 crore with 8% growth, and strengthens its position in the gonadotrophin and progesterone hormone market, valued at Rs. 1,862 crore, primarily for infertility and pregnancy care.
• Nitin Gadkari launches Gadkari Trust Diagnostic Centre with AMTZ’s Medical Equipment to serve underprivileged communities
Union Minister for Road Transport & Highways, Nitin Gadkari, has inaugurated the Swargiya Bhanutai Gadkari Memorial Diagnostic Centre in Nagpur to provide affordable or free diagnostic services to underprivileged communities. The 6,000 sq ft facility offers Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scans, dialysis, blood tests, and digital X-rays, all using medical equipment manufactured in India at the Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam. Certified by the Central Drugs Standard Control Organisation (CDSCO), Atomic Energy Regulatory Board (AERB), and Bureau of Indian Standards (BIS), the centre showcases India’s growing capabilities in medical technology.
• ICMR to hold workshop on clinical trials from Sept 15- 19 in Pune to empower ethical excellence in clinical research
The Indian Council of Medical Research (ICMR), along with KEM Hospital & Research Centre and ICMR-National Institute of Translational Virology & AIDS Research, will host a five-day national workshop on clinical trials from September 15–19 in Pune. Titled “Regulatory and Operational Aspects of Clinical Trials,” the program aims to enhance ethical and scientific excellence in research. With a focus on regulatory frameworks, trial conduct, and patient safety, the workshop will train 25 selected clinical researchers through expert-led sessions and site visits. It is seen as a vital step in strengthening India’s clinical research standards.
Innovations
• Biocon Foundation and IISc on World Head & Neck Cancer Day called for Oral Cancer Elimination
Biocon Foundation and the Indian Institute of Science (IISc) marked World Head & Neck Cancer Day with the 6th edition of Oral Cancer Task Force (OCTF) Annual Meeting. IISc will now lead OCTF as its Secretariat, focusing on AI-led diagnostics and bioinformatics. A mobile-based AI tool for early detection was unveiled, developed with support from government and academic institutions. Updated Indian Clinical Practice Guidelines were also released. Experts emphasized the need for early detection, technological scaling, and tobacco control. India bears a third of global oral cancer cases, underlining the urgency for prevention and accessible care, especially in low- and middle-income countries.
• NIH unveils ultra-high-resolution MRI scanner to map microscopic brain structures in living humans
Researchers supported by the National Institutes of Health (NIH) have developed the Connectome 2.0, a next-generation human magnetic resonance imaging (MRI) scanner capable of mapping microscopic brain structures in living individuals. Unlike conventional MRI, this system fits snugly around the head and uses an expanded number of channels to deliver near single-micron resolution. It enables detailed, non-invasive exploration of brain circuitry vital for understanding cognition, behavior, and neurological disorders. Backed by The BRAIN Initiative, this advance supports efforts to build a wiring diagram of the human brain and represents a major leap in precision neuroscience.
• India’s medical expertise in robotic surgeries draws patients from across the world
India is rapidly emerging as a global leader in robotic-assisted transplant surgeries, attracting international patients seeking precision care at affordable costs. Hospitals like Fortis Bengaluru are pioneering innovations like the TREAT programme, which enables simultaneous robotic surgeries for both kidney donor and recipient—an Indian first. Surgeons across India are performing robotic kidney, liver, and heart transplants with outcomes matching international standards. Backed by government support, cost-effectiveness, and skilled talent, robotic surgery is becoming a major pillar of India’s growing medical tourism sector.
• Veeda Lifesciences inks partnership with Mango Sciences to bring AI innovation in clinical trials services
Veeda Lifesciences, a global Contract Research Organization (CRO), has partnered with Boston-based healthcare AI company Mango Sciences by investing in its AI-driven platform, Querent. This strategic alliance aims to transform Veeda into an AI-led oncology drug development organization by enhancing patient identification, recruitment diversity, and trial efficiency across Europe and India. The integration of Large Language Models (LLMs) and Generative AI will improve trial design, data analytics, and real-world evidence generation. This move reflects Veeda’s ongoing commitment to digital transformation and its goal to modernize clinical trials with global representation.
• DevsHealth and FNDR unveil the first fully AI-designed antiviral compound targeting Dengue
DevsHealth and the Foundation for Neglected Diseases Research (FNDR) have announced DHFLV_003B, the world’s first fully artificial intelligence (AI)-designed antiviral compound targeting Dengue. Created using DevsHealth OS, a proprietary AI platform, and this drug was developed entirely in silico, drastically reducing development timelines. Early testing at FNDR’s biosafety facility in Bengaluru showed strong inhibition of Dengue Virus replication. The compound is now undergoing optimization to enhance its efficacy and target related viruses like Zika and West Nile.
• Genomill Health’s Bridge Capture technology detects key mutations from blood samples in Metastatic Colorectal Cancer Patients
Genomill Health, a biotechnology company pioneering simplified targeted library preparation for Next-Generation Sequencing (NGS), has announced the results of a pilot study published in Scientific Reports, demonstrating the high sensitivity of its Bridge Capture technology for mutation profiling in cell-free DNA of Metastatic Colorectal Cancer patients. The study shows that Bridge Capture matches the sensitivity of droplet digital polymerase chain reaction (ddPCR)—a gold standard in the field—while offering unlimited panel scalability and a simple, cost-efficient workflow that enables decentralized NGS testing.
• TrioTree offers AI-powered voice-to-structured-data system in partner clinics, redefining clinical documentation
TrioTree Technologies has deployed an AI and Natural Language Processing (NLP)-powered voice-to-structured-data system across partner clinics, revolutionizing clinical documentation. The tool captures doctor-patient conversations in real time, supports over 178 languages, and directly integrates structured data into Hospital Information Systems (HIS) without disrupting workflows. Beyond outpatient use, it also enables AI-assisted operation theater documentation, converting free-form surgical notes into standardized formats. TrioTree’s recognition as an authorized integrator for Oman’s National Health Insurance Platform (Dhamani), regulated by the Financial Services Authority (FSA), further demonstrates its adaptability to global healthcare standard.
• Apollo Hospitals and Siemens Healthineers team-up to advance innovation in Liver Healthcare
Apollo Hospitals and Siemens Healthineers have partnered under a Master Research Agreement to advance Liver Disease Diagnostics using artificial intelligence and quantitative ultrasound imaging. The initiative aims to improve patient outcomes through early detection, risk stratification, and monitoring of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), earlier referred to as Non-Alcoholic Fatty Liver Disease (NAFLD). MASLD prevalence in India is estimated at 9%–32%, particularly affecting individuals who are overweight, obese, or diabetic. This collaboration will support the development of AI-driven clinical tools for cost-effective, non-invasive diagnostics, aligning with national health goals to tackle rising liver and cardiovascular disease risks.
• Nanyang Biologics bags first prize at the SuperAI Genesis Competition for breakthrough in AI-powered drug discovery
Nanyang Biologics (NYB.AI) won first prize at the inaugural SuperAI Genesis Startup Competition, selected from over 700 global startups for its breakthrough in AI-powered drug discovery. The platform delivers 25% higher accuracy, 64× improvement in hit-rate, and reduces processing time dramatically. With backing from Fischer Medical Ventures and industry leaders like NVIDIA and Johnson & Johnson Innovation – JLABS, NYB.AI is set to revolutionize pharma and nutraceutical research.
Trends
• CII–MediBuddy report maps corporate India’s Digital Health Readiness
MediBuddy, in collaboration with the Confederation of Indian Industry (CII), has released the second edition of its corporate wellness report titled Workplace Health Reimagined: Corporate India’s Readiness for Digital Health Leadership. The report maps how organisations are transitioning from one-time health initiatives to always-on, digital-first wellness ecosystems. It reveals that over 70% of employees face at least one lifestyle-related health risk, while only 20% of employers offer regular health screenings. Driven by Artificial Intelligence (AI), mobile platforms, and public initiatives like the Ayushman Bharat Digital Mission (ABDM), this shift highlights the role of technology in shaping future-ready, inclusive healthcare systems.
• WHO & UNICEF data shows global childhood vaccination coverage holds steady yet over 14 million infants remain unvaccinated
According to new data from the World Health Organization (WHO) and United Nations Children’s Fund (UNICEF), global childhood vaccination coverage remained stable in 2024, with 89% of infants receiving at least one dose of the diphtheria, tetanus, and pertussis (DTP) vaccine, and 85% completing all three doses. However, 14.3 million infants—termed “zero-dose” children—received no vaccines at all. While low-income countries supported by Gavi, the Vaccine Alliance saw progress, ongoing challenges such as conflict, misinformation, and funding shortfalls threaten gains. WHO and UNICEF urge global efforts to reach all children and sustain immunization equity.
• WHO releases new guidelines recommending injectable Lenacapavir for HIV prevention
The World Health Organization (WHO) has issued new guidelines recommending injectable Lenacapavir (LEN) as a twice-yearly pre-exposure prophylaxis (PrEP) option for HIV prevention. Announced at the IAS 2025 Conference, this long-acting injectable offers a promising alternative to daily oral medication, particularly for individuals facing stigma or limited healthcare access. The guidelines also highlight simplified HIV testing, long-acting treatments like Cabotegravir and Rilpivirine (CAB/RPV), and integration of HIV services with noncommunicable disease care. WHO has urged countries to implement these measures swiftly to reduce infections and promote equitable healthcare access
Law and Order Briefs
• KPRDO concerned over JAKs selling other branded generic drugs in violation of Clause 2.4 of PMBI agreement
The Karnataka Pharma Retailers & Distributors Organization (KPRDO) has raised concerns over violations by Janaushadhi Kendras (JAKs) in Karnataka, alleging they are selling other branded generic drugs in breach of Clause 2.4 of the Pharmaceuticals & Medical Devices Bureau of India (PMBI) agreement. KPRDO claims this undermines the core mission of Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) to provide affordable, quality medicines.KPRDO has urged authorities to allow licensed pharmacies to stock PMBI medicines and ensure accountability to protect patients and uphold scheme integrity.
• PETA India raises objection against inclusion of IISC scientist for inspection of Palamur Biosciences’ facility
The People for the Ethical Treatment of Animals (PETA) India has raised an objection in the Delhi High Court against the Committee for the Purpose of Control and Supervision of Experiments on Animals’ (CCSEA) recommendation to include a senior scientist from the Indian Institute of Science (IISC) in the court-appointed inspection team for Palamur Biosciences. PETA India alleged that the IISC has previously been accused of animal cruelty and that the CCSEA failed to disclose this to the Court. It also claimed that the expert, a core committee member of the CCSEA, was incorrectly presented as an independent expert.
• Delhi High Court refuses to direct Zydus to disclose manufacturing process of Sigrima
The Delhi High Court has rejected a plea by F. Hoffmann-La Roche seeking directions to Zydus Lifesciences to disclose the manufacturing process of its Breast Cancer Drug Sigrima. Roche alleged that Sigrima infringed its process patent for Pertuzumab (marketed as Perjeta). However, the Court held that Roche failed to meet the statutory requirements under Section 104A of the Patents Act, 1970, which allows shifting the burden of proof in process patent infringement cases. It noted that Roche had not shown that Sigrima was identical to the patented product and had not performed analytical or reverse engineering studies.
• Sun Pharma settles Leqselvi litigation with Incyte Corporation
Sun Pharmaceutical Industries Limited has reached a settlement with Incyte Corporation in the litigation concerning Leqselvi (deuruxolitinib) in the United States. Both companies have agreed to dismiss the ongoing case in the U.S. District Court of New Jersey and release all claims related to the dispute. As part of the agreement, Incyte has granted Sun Pharma a limited, non-exclusive license to manufacture and market deuruxolitinib for select Non-Hematology-Oncology indications, including alopecia areata, in the U.S. Sun Pharma will make an upfront payment and ongoing royalty payments.
• Telangana DCA issues show cause notices to 149 medical shops for selling illicit abortion kits
The Drug Control Administration (DCA) of Telangana has issued show cause notices to 149 medical shops for the illegal sale of abortion kits during a statewide enforcement drive. These kits, containing drugs like mifepristone and misoprostol—classified under Schedule H—require prescription and strict medical supervision under the Medical Termination of Pregnancy (MTP) Act, 2002 and MTP Rules, 2003. Violations included selling without prescriptions, improper record-keeping, and absence of pharmacists. The DCA warned of severe health risks from unsupervised use and vowed strict legal action under the Drugs and Cosmetics Act, 1940.
• BDCDA urges CCI action against misleading ads by unregulated online pharmacies
The Bangalore District Druggists and Chemists Association (BDCDA) has urged the Competition Commission of India (CCI) to take action against anti-competitive and non-compliant pharmaceutical advertisements by unregulated online pharmacies. These digital platforms, including Medplus and its affiliates, are accused of violating pharmaceutical advertising norms through social media and mobile apps, encouraging self-medication and risking public health. BDCDA warned that these practices threaten ethical pharmacy standards, promote counterfeit medicines, and undermine the role of licensed pharmacists. It has called for legal action under the Competition Act and the formation of a multi-agency digital monitoring cell.