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 months of August and September 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 Health Ministry launches State Health Regulatory Excellence Index
The Union Health Ministry has launched the State Health Regulatory Excellence Index (SHRESTH), a first-of-its-kind initiative to benchmark and strengthen state drug regulatory systems through transparent, data-driven evaluation. Developed by the Central Drugs Standard Control Organization (CDSCO), the index will rank states in two categories :- Manufacturing States and Distribution States/Union Territories based on parameters like human resources, infrastructure, licensing, surveillance, and responsiveness. SHRESTH aims to harmonize regulatory processes, improve drug safety, and foster cross-learning among states. Data submission and scoring will be conducted monthly, with the index serving as a roadmap for regulatory maturity and consistent quality assurance nationwide.
• CMHA notifies classifications and categories of Mental Health Establishments
The Central Mental Health Authority (CMHA) has amended the Mental Healthcare Regulations, 2025, introducing formal classifications and categories for mental health establishments across India. The new framework mandates registration of institutions under five categories: (a) standalone mental health establishments, (b) psychiatric departments of medical colleges, (c) psychiatric wards in multi-specialty hospitals, (d) standalone de-addiction centers, and (e) centers for psychosocial rehabilitation. Each category specifies the type of in-patient and outpatient services permitted, ranging from crisis intervention and integrated care to de-addiction and long-term rehabilitation.
• Health Ministry amends Drugs Rules to include qualitative data of excipients in QR codes
The Union health ministry has amended the Drugs Rules, 1945 to require inclusion of qualitative details of excipients in barcodes or Quick Response (QR) codes on drug formulations from March 1, 2026. Issued as the Drugs (2nd Amendment) Rules, 2025, the change aims to help patients and healthcare providers identify excipients especially for those allergic to substances like parabens before use. Currently, Rule 96 mandates QR codes to capture product identifiers, brand and generic names, manufacturer details, batch number, manufacturing/expiry dates, and license number.
• Ayush Ministry & FSSAI jointly release official list of approved “Ayurveda Ahar” products
The Union Ministry of Ayush and the Food Safety and Standards Authority of India (FSSAI) have jointly released the first official list of approved “Ayurveda Ahar” products, marking a major step in integrating Ayurvedic dietary principles into mainstream food regulation. The list, based on authentic texts under Schedule A, includes over 90 traditional preparations with details on ingredients and uses. The Ayurveda Medicine Manufacturers Organization of India (AMMOI) is promoting these products as part of preventive health, emphasizing digestive health and immunity. The initiative is expected to boost Indian manufacturers, encourage startups, and open global markets for traditional wellness-based foods.
• Bureau of Indian Standards issues 6 months extension for certification of medical devices
The Bureau of Indian Standards (BIS) has extended the deadline for certification of certain medical devices under its Quality Control Order by six months. The extension follows industry requests for more time to comply with stringent safety and quality norms. After the extended deadlines, selling non-certified products would be illegal. BIS certification is mandatory for some categories of medical devices to make sure the product is of requisite quality and can be used in the treatment of the patient safely.
• Andhra Pradesh Govt. approves simplified license renewal process for pharmacists
The Government of Andhra Pradesh has approved modifications proposed by the Andhra Pradesh Pharmacy Council (APPC) to streamline the pharmacist license renewal process. Under the new rules, pharmacists will no longer need to provide detailed employment histories from the time of registration; instead, only their current employment or non-employment status will be required. The revised checklists I and II were cleared following a review of APPC’s proposals, with implementation directed by the Registrar in Vijayawada. The move is expected to ease administrative burdens and make renewals more efficient for pharmacists across the state.
• Karnataka Health Department brings AYUSH medicines and testing labs under FSDA purview
The Karnataka government has ordered the merger of the AYUSH (Ayurveda, Unani, Siddha, and Homeopathy) Drug Licensing Authority, Drug Enforcement Division, and Drug Testing Laboratories with the State Food and Drug Administration (FDA). This integration brings all AYUSH regulation under the broader drugs control department, creating a unified authority for licensing, enforcement, and quality testing of both allopathic and AYUSH medicines. With NABL-accredited FDA labs in Bengaluru, Hubballi, and Belagavi now handling AYUSH testing, the move is expected to strengthen quality control, streamline approvals, and ensure uniform oversight. Karnataka follows states like Gujarat, Maharashtra, Goa, and Kerala in adopting this model to enhance compliance, accountability, and consumer safety.
• CDSCO launches online dual-use NOC system with one-year validity
The Central Drugs Standard Control Organisation (CDSCO) has introduced a new online system through the Sugam Portal for granting dual use No Objection Certificates (NOCs) for drugs imported in bulk for non-medicinal use. Effective August 31, 2025, the system allows permissions valid for one year, reducing compliance burdens for industries such as pharmaceuticals, food, and animal feed. The guidance document issued under Rule 43 of the Drugs and Cosmetics Rules, 1945, provides clarity on documentation, eligibility, and timelines. From September, only registered and approved users will be allowed to apply.
• CDSCO Achieves 97% Digitization, Enhances Transparency in Drug Regulation: DCGI
Drugs Controller General of India (DCGI) has said that 97% of operations at the Central Drugs Standard Control Organization (CDSCO) are now digital. Individual dashboard system for CDSCO team members has been set up enabling real-time tracking of pending files, ensuring faster processing and accountability across the regulatory chain. CDSCO has launched a State Regulatory Index, a ranking system that scores states on regulatory performance. This initiative is aimed at ensuring healthy competition among states and pushing for regulatory compliance in accordance with PIC/S, harmonization and capacity building among state regulators.
• CDSCO excludes Voglibose 0.2 mg and Metformin Hcl 500mg from list of 35 drugs declared as new drugs in April.
The Drugs Controller General of India (DCGI) recently published a list of 35 unapproved Fixed Dose Combinations (FDCs) that had been licensed earlier by various State and Union Territory drug controllers. Some state authorities (SLAs) granted manufacturing licenses for certain FDCs without DCGI approval, even though they qualified as “new drugs.” The DCGI issued show cause notices to manufacturers, after which many voluntarily surrendered licenses or had them cancelled by the SLAs. The DCGI also flagged that inconsistent enforcement by SLAs has led to non-uniform application of national drug laws, which must be corrected.
• PCI once again opens portal for institutes to submit additional information for approval
The Pharmacy Council of India (PCI) opened its portal for submission of additional information in connection with applications from the pharmacy institutions for section 12 approvals for the academic session 2025-26. Under Section 12 of the Act, the PCI grants approval to the pharmacy courses and examination for the registration of pharmacists in the country. The Pharmacy Council of India repeatedly reopened its portal for institutions to submit additional information for 2025-26 approvals, but many failed to comply. PCI warned that incomplete submissions would lead to “Not to make admission” status and possible rejection of applications for the academic session.
2) Approvals
• USFDA grants fast track designation to AAVantgarde Bio’s AAVB-039 to treat Stargardt Disease
The United States Food and Drug Administration (USFDA) have granted Fast Track Designation to AAVantgarde Bio’s investigational gene therapy AAVB-039 for Stargardt Disease, a leading cause of vision loss in children and young adults. AAVB-039 delivers the full-length ABCA4 protein to address the genetic root of the disease, which currently has no approved treatment. The designation, which follows clearance of the Investigational New Drug (IND) application, allows accelerated development and review. AAVB-039 is now being evaluated in the phase 1/2 CELESTE trial for safety, tolerability, and early efficacy. This milestone highlights its potential as a transformative therapy for inherited Retinal Diseases.
• USFDA approves Novo Nordisk’s Wegovy to treat Metabolic Dysfunction-Associated Steatohepatitis
The United States Food and Drug Administration (USFDA) have granted accelerated approval for Novo Nordisk’s Wegovy (Semaglutide 2.4 mg) to treat Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) in adults with moderate to advanced Liver Fibrosis (stages F2–F3). Wegovy is now the first and only glucagon-like peptide-1 (GLP-1) therapy approved for MASH, in addition to its existing benefits in weight loss and cardiovascular health. Approval was based on part 1 of the phase 3 ESSENCE trial, which showed significant improvement in Liver Fibrosis and resolution of Steatohepatitis compared with placebo.
• UK MHRA approves Aventis Pharma Teplizumab to delay progression of type 1 Diabetes
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Teplizumab (Tzield), developed by Aventis Pharma Limited, as the first immunotherapy for type 1Diabetes. Teplizumab is indicated for adults and children aged 8 years and above with Stage 2 type 1Diabetes, delaying progression to Stage 3 by an average of three years. Administered as a 14-day intravenous infusion, the therapy represents a major step in early intervention for high-risk patients. The MHRA will continue to monitor safety and effectiveness through its Yellow Card scheme.
• Madrigal Pharma’s Rezdiffra gets European Commission’s conditional marketing nod to treat MASH with moderate to advanced Liver Fibrosis
The European Commission (EC) has granted conditional marketing authorization to Madrigal Pharmaceuticals’ Rezdiffra for treating adults with Noncirrhotic Metabolic Dysfunction Associated Steatohepatitis (MASH) with moderate to advanced Liver Fibrosis. Rezdiffra is now the first and only approved therapy for MASH in the European Union, addressing a major unmet need as MASH is the fastest-growing cause of Liver Transplantation in Europe. Approval was based on positive phase 3 MAESTRO-NASH trial results, showing both fibrosis reduction and disease resolution.
• USFDA grants fast track designation to Altimmune’s Pemvidutide to treat Alcohol Use Disorder
The United States Food and Drug Administration (USFDA) have granted Fast Track designation to Altimmune’s Pemvidutide for the treatment of Alcohol Use Disorder (AUD). Pemvidutide is a novel peptide-based dual receptor agonist targeting glucagon-like peptide-1 (GLP-1) and glucagon receptors, designed to address both alcohol cravings and comorbidities such as Liver Steatosis and Obesity. The designation aims to accelerate development and review of therapies addressing serious unmet needs. A phase 2 trial, RECLAIM, is enrolling 100 patients to evaluate Pemvidutide effect on heavy drinking days, World Health Organization (WHO) risk levels, and biomarkers of alcohol intake. This recognition highlights Pemvidutide’s potential to expand treatment options for AUD.
• NYSDOH grants Quanterix Accelerator Laboratory a clinical laboratory permit in the Clinical Chemistry category
Quanterix Corporation announced that the New York State Department of Health (NYSDOH) has granted its Accelerator Laboratory a clinical laboratory permit in the Clinical Chemistry category. This approval expands advanced biomarker research and deepens collaborations with clinical, pharmaceutical, and research partners. With this the Quanterix Accelerator Laboratory is now fully certified under the Clinical Laboratory Improvement Amendments (CLIA) program across all 50 states, enabling nationwide clinical testing and biomarker analysis. The facility uses Simoa technology to support clinical trials and custom assay development. Operating under the Lucent Diagnostics brand, it will now broaden its test menu and deliver expanded biomarker-driven diagnostics.
• Zydus gets USFDA approval for Diltiazem Hydrochloride tablets
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Diltiazem Hydrochloride tablets in strengths of 30 mg, 90 mg, and 120 mg. The tablets are indicated for the treatment of Angina, High Blood Pressure, Chronic Stable Angina, and Angina due to Coronary artery spasm. Diltiazem belongs to the class of calcium-channel blockers and helps relax the heart muscles and blood vessels. The approval strengthens Zydus’ portfolio of cardiovascular drugs in the US market.
• Alembic Pharma Gets USFDA approval for Generic Acne Drug Tretinoin Cream
Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) to market its generic Tretinoin Cream 0.025% in the US. The product is the generic equivalent of Retin-A Cream 0.025% by Bausch Health US, LLC, and is indicated for the treatment of Acne Vulgaris. The market for Tretinoin Cream 0.025% in the US is valued at approximately USD 94 million, offering Alembic significant revenue potential with this launch.
• Indoco Remedies receives USFDA approval for Rivaroxaban Tablets
ndoco Remedies Ltd. has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market Rivaroxaban tablets USP in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg. These are generic equivalents of Janssen Pharmaceuticals’ Xarelto tablets, widely prescribed for the treatment of Venous Thromboembolism (VTE). This milestone underscores Indoco capabilities in delivering high-quality products and supports its growth strategy in the competitive United States generics market.
• USFDA Grants Fast Track Designation to NRx Pharma’s NRX-100 for Suicidal Depression
The United States Food and Drug Administration (USFDA) has granted Fast Track designation to NRx Pharmaceuticals’ NRX-100, an intravenous formulation of ketamine, for the treatment of Suicidal ideation in patients with Depression, including Bipolar Depression. This designation expands NRX-100’s scope beyond its earlier 2017 approval in combination therapy. The decision recognizes its potential to address critical unmet medical needs, supported by clinical trials showing significant reductions in Suicidality. NRX-100 also qualifies for the Commissioner’s National Priority Voucher and Accelerated Approval Program, potentially expediting regulatory review. The preservative-free formulation further ensures long-term stability and enhanced patient safety.
• Lupin receives USFDA approval for Risperidone long-acting injectable, with 180-day CGT exclusivity
Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Risperidone extended-release injectable suspension, available in 25 mg, 37.5 mg, and 50 mg vials. The approval includes 180 days of Competitive Generic Therapy (CGT) exclusivity and marks the first product developed using its subsidiary Nanomi B.V.’s Long-Acting Injectable (LAI) platform. Nanomi’s advanced microsphere technology ensures sustained drug release, improved injectability, and consistent therapeutic outcomes. This milestone strengthens Lupin’s position in complex injectables and supports its broader strategy to expand specialty and novel product offerings across therapeutic areas.
• Mankind gets CDSCO nod for Phase 1 clinical trials for molecule to treat Autoimmune Disorders.
Mankind Pharma has received approval from the Central Drugs Standard Control Organization (CDSCO) to initiate a Phase 1 clinical trial of MKP11093, a novel molecule being developed for the treatment of Autoimmune Disorders such as Rheumatoid Arthritis, Ulcerative Colitis, Plaque Psoriasis, and Alopecia. selectively targets Janus Kinase-1 (JAK1), a key enzyme in the JAK family (JAK1, JAK2, JAK3, TYK2), and works by inhibiting the JAK/STAT signaling pathway, thereby reducing the activity of multiple pro-inflammatory cytokines involved in Autoimmune Diseases.
• Takeda’s Vonvendi receives USFDA expanded indication approval to treat adults and children with Von Willebrand Disease
The United States Food and Drug Administration (USFDA) has approved Takeda’s Biologics License Application (sBLA) for Vonvendi [von Willebrand factor (Recombinant)] expanding the indication to include routine Prophylaxis to reduce the frequency of bleeding episodes in adults with Von Willebrand Disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative management of bleeding in Paediatric patients with VWD. Vonvendi is a recombinant von Willebrand factor used to treat and prevent bleeding in patients with von Willebrand Disease, including routine Prophylaxis for adults. It has a long half-life, and most bleeds require only one infusion. FDA approval expands its use, supported by positive clinical trial results and real-world data.
• Sobi and Lonis receives EU approval for Tryngolza in FCS
The European Union has approved Tryngolza (Olezarsen) 80 mg for treating Familial Chylomicronemia Syndrome (FCS), a rare genetic disorder causing extremely high triglyceride levels and risk of life-threatening Acute Pancreatitis. Approval was based on positive Phase 3 Balance study data showing significant and sustained reductions in Triglycerides at six and twelve months, along with substantial reduction in Pancreatitis events.
• Qiagen Launches FDA-Cleared QI Astat-Dx Rise for High-Throughput Syndromic Testing
Qiagen N.V. has announced the launch of QIAstat-Dx Rise, a higher-throughput version of its QIAstat-Dx automated syndromic testing system, designed to provide unmatched scalability with an easy workflow for customers worldwide. The system has received clearance from the U.S. Food and Drug Administration (USFDA) and is aimed at hospitals and reference laboratories seeking advanced automation, including cartridge loading/unloading, urgent sample prioritization, and minimal hands-on time. This marks Qiagen’s third FDA-cleared QIAstat-Dx product in 2025, further building on the strong customer response to its lower-throughput version.
• USFDA Grants Fast Track Designation to Greenwich Life Sciences GLSI-100 for HER2-Positive Breast Cancer
The United States Food and Drug Administration (USFDA) has granted Fast Track designation to GLSI-100, Greenwich Life Sciences peptide immunotherapy, for HLA-A*02 Breast Cancer patients who have completed standard HER2/neu-targeted therapy. Fast Track status enables frequent FDA interaction, rolling Biologic License Application (BLA) submissions, and potential accelerated approval to expedite access. In a Phase IIb trial, GLSI-100 achieved an 80% or greater reduction in Cancer recurrence over five years, with strong immune responses, no serious adverse events, and a favorable safety profile. The ongoing Phase III FLAMINGO-01 trial will further evaluate safety and efficacy, positioning GLSI-100 as a promising therapy to prevent metastatic recurrence in HER2-positive Breast Cancer.
• Johnson & Johnson’s Tremfya receives US FDA approval to treat Paediatric Plaque Psoriasis and active Psoriatic Arthritis.
The United States Food and Drug Administration (USFDA) has approved Johnson & Johnson’s Tremfya (guselkumab) for the treatment of children aged six years and older who weigh at least 40 kg and have moderate to severe Plaque Psoriasis or active Psoriatic Arthritis. This makes Tremfya the first and only IL-23 inhibitor approved for these Paediatric indications, building on earlier adult approvals in 2017 and 2020. The approval is based on data from the phase 3 PROTOSTAR study and supportive adult trials, which showed significant improvement in skin clearance and symptom relief. This approval provides an important new treatment option for children affected by these chronic immune-mediated diseases.
3) International Pharma News
• Zomedica Corporation and VerticalVet partner to deliver advanced Veterinary technologies to independent practices.
Zomedica Corporation has entered a two-year strategic partnership with VerticalVet, a leading Group Purchasing Organization (GPO) supporting over 2,600 independent Veterinary practices in the United States. Under the agreement, Zomedica becomes a preferred provider of advanced Veterinary solutions, giving VerticalVet members access to technologies such as PulseVet shock wave therapy, VETGuardian remote monitoring, Assisi targeted pulsed electromagnetic field therapy devices, and Vetigel hemostatic gel. The collaboration aims to enhance clinical outcomes, improve operational efficiency.
• Apriori Bio enters research collaboration with Francis Crick Institute
Apriori Bio, a biotechnology company focused on developing variant-resilient vaccines, has entered research collaboration with the Francis Crick Institute to study immune responses and improve vaccine design against emerging viral threats. The partnership will leverage data from the Crick’s Legacy Study and Apriori’s artificial intelligence platform, Octavia, to predict viral evolution and design vaccines that elicit stronger and broader immune protection. By combining cutting-edge research with artificial intelligence, the collaboration aims to enhance global seasonal strain selection and improve vaccine effectiveness across diverse populations, contributing to preparedness against future pandemics.
• Sartorius Stedim Biotech & Nanotein Technologies partner to advance cell therapy manufacturing.
Sartorius Stedim Biotech has partnered with Nanotein Technologies, investing up to USD 3 million for a minority stake to support the commercialization of Nanotein’s NanoSpark platform. Under an exclusive distribution agreement, Sartorius will globally offer NanoSpark STEM-T and NanoSpark GROW-NK soluble activators, designed to improve expansion and quality of T cells and natural killer cells used in cell therapies, including CAR-T and NK-based Cancer Treatments. The collaboration aims to provide feeder-free, consistent, and scalable solutions to address key challenges in immune cell manufacturing, while jointly developing new products for the expanding cell and gene therapy market.
• American Lung Association promotes biomarker testing to improve lives of people with Lung Cancer.
The American Lung Association is expanding its Biomarker Education and Awareness for Testing (BEAT) Lung Cancer initiative to increase access to biomarker testing, a critical tool for tailoring Lung Cancer treatment. Biomarker testing, also called molecular or genomic testing, identifies tumor DNA and protein changes such as PD-L1 levels to guide targeted therapies and immunotherapy. Despite its benefits, testing remains underused, with only 14% of eligible Black patients and 26% of eligible white patients receiving it. The campaign aims to raise awareness, reduce insurance barriers, and provide patient navigation services to improve equity and outcomes in Lung Cancer care.
• Boehringer Ingelheim and AnGes sign manufacturing agreement for HGF gene therapy product.
Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes Inc. for the drug substance of its investigation into Hepatocyte Growth Factor (HGF) gene therapy for Peripheral Arterial Disease (PAD). The agreement follows AnGes’ recent completion of clinical trials and preparations for a Biologics License Application (BLA) with the United States Food and Drug Administration (USFDA) Manufactured at Boehringer’s Vienna site using proprietary microbial technology, the plasmid DNA therapy aims to reduce ulceration and amputations in PAD patients. With 200 million people affected globally, the collaboration supports regulatory milestones and advances patient access to innovative gene therapies.
• Pirbright Institute and GALVmed partner to develop safer Rift Valley Fever Vaccine
The Pirbright Institute, through its Centre for Veterinary Vaccine Innovation and Manufacturing (CVIM), has partnered with GALVmed to develop and deliver a safer, more effective vaccine against Rift Valley fever (RVF) for low and middle income countries, particularly in Africa. The replication-incompetent viral-vectored candidate addresses safety issues in existing vaccines, which can cause abortion or foetal malformations in pregnant livestock. RVF, a Mosquito-Borne Zoonotic Disease, causes high mortality and abortion in cattle, sheep, and goats, with significant socioeconomic losses, and can also infect humans. The collaboration aims to transition the vaccine from lab to field, ensuring broader protection and improved farmer livelihoods.
• Lupin announces global licensing deal with Sandoz Group AG for Ranibizumab Bio-similar
Lupin Limited has partnered with Switzerland-based Sandoz Group AG to jointly commercialize its bio similar Ranibizumab, used in treating serious eye conditions such as Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), Proliferative Diabetic Retinopathy (PDR), Macular Edema following Retinal Vein Occlusion (RVO), and Choroidal Neovascularization (CNV). Under the agreement, Lupin will manage manufacturing and regulatory submissions, while Sandoz will oversee commercialization across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia, with exclusive or semi-exclusive rights in designated markets. A separate agreement also grants Sandoz sole rights in Canada.
• Angle announces collaboration with Myriad Genetics for molecular analysis
Angle plc, a global leader in liquid biopsy technologies, has announced collaboration with Myriad Genetics Inc. to explore the use of Parsortix-derived circulating tumor cell, DNA alongside Myriad’s existing tissue-based diagnostic tests. Under the agreement, Cancer patient blood samples will be processed using Angle’s Parsortix system to capture intact Cancer cells for downstream molecular analysis, with results compared against matched tissue samples. The initiative could broaden access to actionable genomic data through simple blood tests, enhancing precision oncology and patient treatment options.
• Cosmo Pharma and Takeda renew strategic manufacturing pact for global supply of oral treatment for Ulcerative Colitis
Cosmo Pharmaceuticals N.V. has renewed its multi-year strategic manufacturing and supply agreement with Takeda for the global production of Mesalazine MMX 1200 mg (marketed as Lialda in the US and Mezavant in Europe), an oral once-daily treatment for Ulcerative Colitis. The renewal reinforces Cosmo’s role as a trusted contract development and manufacturing partner. Its Lainate, Italy site, certified under ISO 13485 and approved by multiple regulators, has supported global pharma players for over 30 years with efficient, high-quality, and sustainable production. Cosmo said the partnership aligns with its Vision 2030 strategy to expand innovation, scale partnerships, and strengthen its CDMO leadership worldwide.
• WHO designates new WHO-Listed Authorities to expand global access to quality medical products.
The World Health Organization (WHO) has designated Health Canada, Japan’s Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) as WHO-Listed Authorities (WLAs), a status granted to regulators that meet the highest international standards for medical products. This brings the total to 39 WLAs worldwide. The Republic of Korea’s Ministry of Food and Drug Safety (MFDS) also had its scope expanded to cover all regulatory functions. The move strengthens reliance, harmonization and collaboration, particularly benefiting low- and middle-income countries with limited regulatory capacity.
• Servier enters agreement with Kaerus Bioscience to acquire potential treatment for Fragile X Syndrome, the most common genetic cause of ASD.
Servier has announced an agreement with Kaerus Bioscience to acquire KER-0193, a potential treatment for Fragile X Syndrome (FXS), the most common genetic cause of Autism Spectrum Disorder (ASD). KER-0193, an orally bioavailable small molecule modulator of BK channels, specifically targets the abnormal channel function linked to the genetic cause of FXS. The candidate has successfully completed a Phase 1 clinical study and has been granted both Orphan Drug Designation and Rare Paediatric Disease Designation by the United States Food and Drug Administration (USFDA). FXS is a rare neurodevelopmental disorder characterized by a wide range of cognitive and behavioural challenges.
• Aptar Pharma and Dianosic partner to advance the ARIS platform to treat Chronic Allergic Rhinitis and Chronic Rhinosinusitis.
Aptar Pharma announced an exclusive partnership agreement with Dianosic, pioneering intranasal therapeutic solutions, for the development of an Active Resorbable Intranasal Scaffold (ARIS) technology platform is aimed at addressing the significant unmet needs of delivering drugs locally over extended periods for the treatment of Chronic Allergic Rhinitis (CAR) and Chronic Rhinosinusitis (CRS). This collaboration would additionally explore nose-to-brain (N2B) opportunities, especially in Neuropsychiatric and Neurodegenerative Diseases. Under the agreement, Aptar Pharma will invest in Dianosic and be part of its strategic committee, while promoting the technology to its customers and exploring opportunities to complement the platform with Aptar’s suite of comprehensive services.
• Novartis is to acquire New York-based clinical-stage biopharma company, Tourmaline Bio.
Novartis to acquire Tourmaline Bio, Inc. (Tourmaline) which is focused on developing Pacibekitug, an anti-IL-6 mAb as a treatment option for Atherosclerotic Cardiovascular Disease. Novartis will acquire a phase 3 ready asset which will complement its existing cardiovascular disease portfolio. Novartis will, through an indirect wholly owned subsidiary, commence a tender offer to purchase all outstanding shares of Tourmaline common stock. Holders of Tourmaline common stock would receive USD 48 per share in cash at closing. Following completion of the tender offer, Novartis expects to merge the acquiring subsidiary with and into Tourmaline, resulting in Tourmaline becoming an indirect wholly owned subsidiary of Novartis.
• Mycenax Biotech Partners with Spera Pharma to Strengthen ADC Manufacturing Services.
Mycenax Biotech Inc. has entered into a strategic alliance with Spera Pharma Inc., to deliver integrated manufacturing solutions for Antibody-Drug Conjugates (ADC) and bioconjugates. The collaboration combines Mycenax’s end-to-end biologics capabilities and Spera’s expertise in high-potent fill-finish and CMC development, offering a comprehensive platform covering payload synthesis, drug substance production, formulation, and aseptic manufacturing. The partnership aims to accelerate time-to-market for ADC developers with a cost-effective, turnkey solution tailored to global clients. Both companies, recognized for regulatory compliance and technical excellence, position the alliance as a seamless, one-stop ADC development and manufacturing solution.
• WHO updates Essential Medicines Lists with New Cancer and Diabetes Treatments.
The World Health Organization (WHO) has released updated editions of its Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), adding 20 new medicines for adults and 15 for children. Key additions include GLP-1 agonists like semaglutide, dulaglutide, and tirzepatide for Diabetes and Obesity, and immunotherapies such as pembrolizumab, atezolizumab, and cemiplimab for Cancer. The list now includes 523 adult and 374 paediatric medicines. WHO emphasized addressing high drug prices, promoting generic competition, and improving access in low-resource settings. The updates aim to expand equitable access to effective treatments for major global diseases.
• CitiusTech acquires Health Data Movers to strengthen Epic Systems integration.
CitiusTech has acquired Health Data Movers, a Best in KLAS healthcare technology services firm specializing in Epic Systems, Workday, and ServiceNow. The deal enhances CitiusTech’s ability to embed AI, automation, and advanced analytics directly into core healthcare platforms, minimizing change management risks while improving efficiency and patient care. With Epic serving as the backbone of many health systems, this acquisition enables seamless integration of emerging technologies like AI scribes and cloud-based solutions into clinical workflows. The combined expertise positions CitiusTech as a strong strategic partner for healthcare providers seeking to accelerate digital transformation.
4) Domestic Pharma News
• Gujarat FDCA receives rupees thirty-two crores from state govt. to expand Surat drug testing lab.
The Gujarat Food and Drug Control Administration (FDCA) has received INR 32,00,00,000/- (Rupees Thirty-Two Crores Only) from the state government to expand its drug testing laboratory in Surat, strengthening the state’s pharmaceutical quality control infrastructure. The 2,500-square-meter facility is moving into the equipment procurement phase, with the Gujarat Medical Services Corporation Limited (GMSCL) handling tenders via the Government e-Marketplace. In addition, a new drug testing lab is being developed in Rajkot, while another major facility is planned in Ahmedabad or Gandhinagar. Together with the upgraded Vadodara microbiological lab the largest of its kind in Asia these initiatives position Gujarat as an emerging hub for drug quality testing in India.
• Himachal government installs state’s first da Vinci robotic-assisted surgery facility at AIMSS.
The Himachal Pradesh government has inaugurated the state’s first da Vinci robotic-assisted surgery facility at the Atal Institute of Medical Super Specialities (AIMSS), Shimla. Installed in the urology department, the facility marks a major step in expanding access to advanced surgical technologies beyond metro cities. The initiative includes recruiting specialist robotic surgeons and plans to expand robotic systems across other government medical colleges. The da Vinci system enables minimally invasive procedures with enhanced precision, safety, and faster recovery, positioning AIMSS as a hub for advanced surgical care, training, and research in the region.
• Odisha govt. notifies OPDC to propel state as a pharma hub in eastern India.
The Government of Odisha has officially notified the creation of the Odisha Pharmaceutical Development Cell (OPDC) to spearhead the state’s ambition of becoming a leading pharmaceutical hub in eastern India. Operating under the Chief Minister’s Office and chaired by the Chief Secretary, the OPDC will attract investments in formulations, active pharmaceutical ingredients medical devices, and biotechnology. Plans include organizing a National Pharma Conclave in Bhubaneswar ahead of the Make-in-Odisha Conclave 2025 and developing an Integrated Lifesciences Park. Backed by recent regulatory infrastructure such as the Central Drugs Testing Laboratory (CDTL) and the Central Drugs Standard Control Organization (CDSCO) sub-zonal office, Odisha aims to consolidate its strong talent pool and industry potential.
• Pfizer launches PCV20 for adults in India to offer broad protection against Pneumococcal Disease.
Pfizer has introduced its 20-valent Pneumococcal Conjugate Vaccine (PCV20) for adults in India, offering broad protection against 20 serotypes responsible for invasive and non-invasive Pneumococcal Diseases. The single-dose vaccine eliminates the need for a second dose and is particularly beneficial for adults over 50 years and individuals with chronic conditions such as Asthma, Chronic obstructive Pulmonary Disease, Kidney Disease, and Diabetes. PCV20 supports timely immunization, reducing the risk of hospitalization and mortality. This launch underscores Pfizer’s 25-year leadership in pneumococcal vaccine innovation and its commitment to advancing preventive healthcare in India.
• Cohance Lifesciences pumps in Rs. 23 crores to progress on its cGMP Oligonucleotide unit at Hyderabad.
Cohance Lifesciences has invested INR 23,00,00,000/- (Rupees Twenty-Three Crores Only to advance its new current Good Manufacturing Practice (cGMP) Oligonucleotide building block facility in Hyderabad. The unit will provide up to 700 kg annual capacity with ISO Class 8 clean rooms and RH-controlled areas, ensuring high standards for complex nucleoside and nucleic acid synthesis. This strategic expansion strengthens Cohance integrated platform, enabling scale-up from research to commercial manufacturing of Oligonucleotide based therapeutics. Customer audits are scheduled in coming quarters, with GMP validations expected by 2026. The investment complements Cohance’s recent USD 10 million expansions in the United States for bio conjugation capabilities.
• FPME inaugurates new Mumbai office urges reforms to strengthen India’s pharma export ecosystem.
The Federation of Pharma Merchant Exporters (FPME) has inaugurated its new office in Mumbai, where key stakeholders gathered to discuss pressing issues affecting India’s pharmaceutical export sector. In a detailed discussion, FPME identified several urgent policy and operational hurdles that threaten to undermine the competitiveness of India’s pharmaceutical exports, particularly those undertaken by merchant exporters, who account for approximately 30% of the country’s USD 25 billion pharma exports.
• Kerala IPA launches upskilling programmes for pharmacy professionals
The Kerala branch of the Indian Pharmaceutical Association (IPA) has announced a series of one-year educational and training programmes to upskill pharmacy students, working pharmacists, and teachers. Key initiatives include an industry orientation course for final-year B. Pharm and M. Pharm students, combining online learning with hands-on training in pharma industries in Tamil Nadu and Karnataka. Other programmes will cover patient counseling, pedagogy training for pharmacy teachers, and regulatory affairs, with expert sessions from Tamil Nadu IPA. A major highlight will be the Pharmacy Students Congress in Kochi this September. IPA said these initiatives aim to bridge academic industry gaps, enhance patient care, and raise professional standards in Kerala’s pharma sector.
• Apollo Ayur VAID partners with JNTBGRI for Ayurveda-based herbal drug R&D.
Apollo Ayur VAID, India’s leading chain of precision Ayurveda hospitals, has signed a three-year Memorandum of Understanding (MoU) with the Jawaharlal Nehru Tropical Botanic Garden and Research Institute (JNTBGRI), an autonomous research body under the Kerala State Council for Science, Technology and Environment (KSCSTE), will focus on developing and standardizing Ayurveda-based herbal drugs. Joint initiatives will include in silico drug design, raw herb authentication, phytochemical and pharmacological validation, and translational research that links discovery with clinical practice. Both institutions will also work on funding proposals, knowledge exchange, and scientific dissemination to build a credible, evidence-based Ayurveda ecosystem.
• IDMA Telangana to host AI-Driven Pharma Innovation Summit 2025 in Hyderabad.
The Indian Drug Manufacturers’ Association (IDMA) Telangana State Board has announced the AI-Driven Pharma Innovation Summit 2025, to be held on November 13–14 in Hyderabad. With the theme “Empowering Pharmaceutical Innovation through AI, Smart Manufacturing & Digital Technologies,” the national-level event will serve as a platform for knowledge-sharing and collaboration among industry leaders, regulatory experts, start-ups, and academicians. Organized in collaboration with Pharmabharath, Operant Pharmacy Federation (OPF), and Chronicle Pharmabiz, the summit will showcase applications of AI in formulation development, manufacturing, quality management, and regulatory compliance. The event will feature top CXOs, R&D leaders, exhibitions, and sponsorship opportunities for companies to highlight digital innovation.
• Maharashtra FDA expands blood bank infrastructure for consistent, safe blood & blood components.
The Maharashtra Food and Drug Administration (FDA) has expanded the blood bank infrastructure by granting licenses to 26 more blood banks taking the total count of blood banks to 392 in the past one year. Maharashtra FDA had licensed 23 more blood banks. Mumbai needs an estimated 1,000 to 1,400 units of blood daily. Maharashtra FDA has also initiated a blood banks inspection drive across the state to ensure safe blood and its components. The national blood policy has mandated blood banks to attempt 100% component separation.
• Botanic Healthcare Invests Rs. 25 Crore in Dedicated Liposomal Manufacturing Facility in Hyderabad.
Botanic Healthcare has inaugurated its LipsoBio facility in Hyderabad with an investment of over INR 25,00,00,000/- (Rupees Twenty-Five Crores Only) , marking a major step in liposomal delivery technologies to improve bioavailability and effectiveness in health and wellness products. With a raw material capacity of 8,500 MT annually, the facility will produce liposomal vitamins, minerals, botanically enriched beadlets, and customized formulations using its patent-filed DFS (Dietary Fiber Stabilized) Technology. Serving both domestic and global markets across Asia-Pacific, North America, and Europe, LipsoBio strengthens Botanic’s innovation pipeline with products like LipoGlo, LipoQ10, and Lipomac, reinforcing its global leadership in nutraceutical delivery solutions.
• Fujifilm India strengthens public health at CHC Dholera with installation of DR X-ray system.
Fujifilm India has inaugurated a digital radiology (DR) X-ray facility at the Community Health Centre (CHC) in Dholera, Gujarat, under its Corporate Social Responsibility (CSR) initiative. The center aims to provide advanced diagnostic and preventive healthcare to the city’s expanding industrial workforce and nearby villages. As Dholera develops into a major industrial and smart city hub, this facility will serve as the first central DR X-ray hub in the region, offering early TB screening, sputum collection, and regular health camps.
• Apollo Hospitals announce major acquisition and new oncology centre.
Apollo Hospitals Enterprise Ltd (AHEL) has announced two major initiatives to strengthen its leadership in specialized healthcare. The company will acquire a 31% equity stake in its subsidiary Apollo Health and Lifestyle Ltd (AHLL) from the International Finance Corporation (IFC) for INR 12,540.68 Million (Rupees Twelve Thousand Five Hundred Forty Point Six Eight Million) , pending approval from the Competition Commission of India. Additionally, AHEL will invest INR 5,730 Million (Five Thousand Seven Hundred Thirty Million) only to establish a new comprehensive oncology center in Gurugram, featuring a Proton Beam Therapy System. The facility will expand Cancer treatment capacity by 350 patients annually.
• Pharmexcil in talks with stakeholders to launch online logistics platform to streamline logistics operations.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is in discussions with stakeholders to launch an online logistics platform aimed at streamlining fragmented operations and improving transparency among exporters, importers, service providers, and regulators. The platform is expected to offer compliance management, competitive bidding, warehousing and insurance booking, route optimization, digital documentation, real-time tracking, and feedback systems. The initiative complements the recent launch of the National Accreditation Body for Cold Chain Management (NAB-CCM), which focuses on training and compliance in pharmaceutical cold chain logistics. Experts emphasize that advanced warehousing, predictive analytics, AI, and blockchain will be key to ensuring quality, safety, and efficiency in India’s pharma supply chain.
5) Innovations
• Dry chemistry-based point of care testing sets new standard for reliability & accessibility in Diagnostics.
Dry chemistry-based Point of Care Testing (POCT) is emerging as a game-changer in India’s healthcare sector, offering reliable diagnostics without the need for water, refrigeration, or extensive infrastructure. According to Fujifilm India, this technology ensures faster clinical decisions, reduces turnaround time, and minimizes human error, making it ideal for primary care centers, mobile units, and critical care settings. Its compact analyzers and stable reagents improve cost efficiency and support integration with the Ayushman Bharat Digital Mission. By strengthening decentralized diagnostics, POCT promises better disease monitoring, timely interventions and inclusive healthcare delivery across underserved regions.
• Klotho Neurosciences begins manufacturing of KLTO-202 product candidate using AAVnerGene’s platform technology.
Klotho Neurosciences has signed a binding agreement with AAVnerGene to manufacture its KLTO-202 gene therapy candidate using AAVnerGene’s advanced AAVone and Athena platform technologies. These systems promise higher purity, faster production, and safer tissue-targeted delivery compared to the traditional “triple transfection” method. KLTO-202, derived from the patented “Anti-Aging” Klotho gene, is being developed to treat neurodegenerative and age-related disorders such as ALS, Alzheimer’s, and Parkinson’s Disease.
• Zeus Hygia launches Metaberine, a green-process enriched Berberine with superior bioavailability.
Zeus Hygia Lifesciences has unveiled Metaberine, the world’s first green-process enriched Berberine developed using its proprietary Biosolve Technology. Conventional Berberine extracts suffer from poor bioavailability (less than 2% absorption), high dosage requirements (500–1500 mg/day), delayed action, and gastrointestinal side effects. Metaberine addresses these issues with enhanced solubility, faster onset, and reduced side effects at a much lower dose of 200 mg/day. Produced via a 100% aqueous process, it is suitable for capsules, sachets, and other applications. Backed by proprietary data and upcoming clinical trials, Metaberine targets B2B partners globally in pharma, nutraceutical, and functional food industries, offering a potent, natural, and affordable solution for metabolic health management.
• HCGMCC partners with Qure.ai to deploy AI-powered imaging for early lung disease detection.
HCG Manavata Cancer Centre (HCGMCC), Nashik, has partnered with health-tech innovator Qure.ai to deploy AI-powered imaging solutions for early detection and structured management of lung diseases, including suspected Lung Cancer. The hospital will implement qXR (AI-enabled Chest X-ray) and qCT (AI-enabled Chest CT), supported by qTrack, Qure.ai’s disease tracking platform, to enable real-time risk identification and faster, more accurate diagnosis. A dedicated Incidental Pulmonary Nodule (IPN) Clinic has also been launched to ensure structured follow-up for high-risk patients. The collaboration, supported by Johnson & Johnson MedTech, aims to democratize lung health in India.
• STEER World with its 200 kg/hr continuous Granulation using Patented Integraal system to accelerate pharm manufacturing.
STEER World has successfully showcased its Patented Integraal Continuous Granulation System, achieving a landmark 200 kg/hour continuous production of metformin granules. This breakthrough represents a new benchmark in oral solid dosage manufacturing, combining scalability, efficiency, and sustainability. The system reduces conversion costs by over 50%, cuts energy use and carbon footprint, and streamlines quality compliance, enabling affordable medicines with faster output. With potential scalability to 500+ kg/hour, Integraal offers manufacturers a transformative pathway to high-volume, cost-effective, and eco-friendly pharmaceutical production. This innovation marks a paradigm shift in pharma manufacturing economics and performance.
• Eli Lilly Launches TuneLab AI Platform to Support Biotech Drug Discovery.
Eli Lilly and Company has launched Lilly TuneLab, an AI/ML-powered drug discovery platform that provides biotech companies access to predictive models trained on decades of Lilly’s proprietary research data, representing an investment of over USD 1 Billion (United States Dollars One Billion Only) TuneLab offers drug disposition, safety, and preclinical datasets covering hundreds of thousands of molecules, enabling smaller biotechs to leverage capabilities typically reserved for large pharma. The platform uses federated learning to preserve data privacy, allowing partners to contribute training data without direct exposure. Developed with global tech partners, TuneLab is part of Lilly’s Catalyze360 initiative, complementing capital, labs, and R&D expertise. The platform aims to accelerate AI-driven innovation in drug discovery, especially for early-stage biotech companies.
• CLIRNET Launches specialized AI Agents to Enhance Clinical Decision-Making.
CLIRNET, India’s largest doctor network, has launched a suite of AI agents designed to provide healthcare professionals with instant, evidence-based clinical support across India, the Middle East, and Africa. The tools include a Drug-to-Drug Interaction (DDI) Agent, a Differential Diagnosis (DDx) Agent, a MedSearch Agent for summarising peer-reviewed studies, and a MedInfo Agent for disease insights and preventive care. Powered by Retrieval-Augmented Generation (RAG) and Genetic-Pareto Prompt Evolution (GEPA), the agents reduce hallucinations and continuously improve through expert feedback. With a network of 650,000 doctors, CLIRNET aims to bridge advanced AI with frontline medicine, enabling safer decisions, fewer errors, and improved patient outcomes. More specialized agents are in development to meet emerging healthcare needs.
• Korber and Pepperl+Fuchs pave the way for seamless PAS-X MES deployment on HMI systems.
Korber is expanding its partner network in the field of (HMI) with Pepperl+Fuchs. The two companies have jointly developed a recommendation that significantly simplifies installation and rollout. Pepperl+Fuchs offers mobile devices and smartphones in explosion-proof designs, specifically developed for safe use in hazardous areas, enabling flexible data capture and mobile communication. Pepperl+Fuchs’ VisuNet Human Machine Interfaces (HMI) family offers modular, explosion-proof solutions for safe, efficient operations in hazardous and hygienic environments, supported by mobile devices and user-friendly peripherals. Their partnership with Korber integrates VisuNet with PAS-X MES, enhancing process safety, workflow integration, and long-term reliability in regulated production.
6) Trends
• Phantom limb study reveals brain retains lost Limb’s control center.
A groundbreaking study by the National Institutes of Health (NIH) and University College London has shown that the brain’s representation of a lost limb can persist for years after surgical amputation, challenging the long-standing theory of cortical remapping in brain plasticity. Using functional magnetic resonance imaging scans before and after amputations, researchers found minimal differences in brain activity, suggesting the brain retains its control map of the missing limb. This finding deepens understanding of Phantom Limb Syndrome and opens new directions for developing neuroprosthetics, brain-computer interface technologies, and more effective pain treatments.
• Study shows restricted blood flow speeds tumor growth by aging immune system.
A new study from NYU Langone Health reveals that restricted blood flow, or ischemia, can accelerate tumors growth by prematurely aging the immune system. Published in JACC-Cardio-Oncology, the research shows that mice with peripheral ischemia in the legs developed breast tumors that grew twice as fast as those without restricted blood flow. The study found that ischemia reprograms bone marrow stem cells to favor myeloid cells, which weaken Anti-Cancer immunity, while reducing lymphocyte output. These changes, which mirror aging, make the immune system more tolerant of Cancer. The findings highlight the link between cardiovascular disease and Cancer progression, suggesting new strategies such as earlier Cancer screening for patients with peripheral Artery Disease and exploring inflammation-modulating therapies.
• Study suggests Heat Waves accelerate ageing in humans.
A long-term study from NYU Langone Health and the University of Hong Kong, published in Nature Climate Change, shows that repeated heat wave exposure can accelerate biological ageing, with health impacts comparable to smoking, alcohol, or poor diet. Tracking 25,000 people in Taiwan over 15 years, researchers found that four additional heat wave days in two years increased biological age by nine days, while manual workers showed even higher acceleration. Heat waves were linked to DNA damage, organ stress, and premature immune system aging. The findings underscore the global health risks of rising extreme temperatures due to climate change, suggesting the need for early screening, better prevention strategies, and greater adaptation measures worldwide.
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• Patients will receive medicines 3-6 months faster under 10-Year Health Plan, as regulators set out plans.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have outlined how the government’s new 10-Year Health Plan will allow National Health Service (NHS) patients in England to access new medicines 3–6 months faster. Under a joint information-sharing agreement, pharmaceutical companies will register early with both agencies, enabling parallel reviews of licensing and value assessments. The integrated pathway aims to reduce administrative costs by 25%, streamline regulatory and Health Technology Assessment (HTA) requirements, and boost the UK’s life sciences sector. The initiative also supports faster adoption of biosimilars and reinforces the UK’s position as a hub for innovation and investment.
• Healthcare providers consider AI, automation and data-driven care as top priorities, says CII- EY HealthTech Survey.
The digital momentum shift towards IT innovation is Significant which is clearly visible in budget allotment by 20–25% over the next 2–3 years. Healthcare providers are also leaning into AI with a clear focus on enhancing visibility of clinical data and generating meaningful insights to assist doctors. This comes with a vision for long-term capability gains. Building of IT capability, digital investments, Business Intelligence tools and data lakes are the primary focus for investors. Healthcare service providers identify capability building and IT team upskilling as their biggest digital challenge, underscoring the sector’s need for a more digitally fluent workforce, same is the situation in integrating data and driving adoption of business intelligence (BI) tools.
• WHO COPCORD Survey Finds 1 in 6 Indians Live with Arthritis.
The WHO COPCORD (Community Oriented Programme for Control of Rheumatic Diseases) India survey, covering over 56,000 people across rural and urban areas, revealed that one in six Indians (195 million) suffer from Arthritis related pain, with women making up two-thirds of the cases. The findings, discussed at a national meeting organized by AIIMS Delhi and the Center for Rheumatic Diseases (CRD) Pune, highlighted that Arthritis has surpassed Diabetes and Hypertension as the most common self-reported illness in India.
7) Law and Order Briefs
• AIOCD urges urgent action against illegal online sale of prescription medicines.
The All-India Organization of Chemists and Druggists (AIOCD), representing 12.4 lakh chemists, have urged Union Home Minister Amit Shah to act against illegal e-pharmacies and quick commerce platforms like Zepto and Blinkit. Despite legal restrictions, these platforms allegedly deliver Schedule H/H1/X medicines without valid prescriptions, raising risks of drug abuse, ghost prescriptions, and misuse of habit-forming drugs such as Pregabalin. AIOCD warned of rising youth addiction and unfair practices undermining offline chemists. The body has demanded an immediate ban on such sales and strict enforcement of the Drugs & Cosmetics Act.
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• RDCA seeks Delhi CM’s intervention to revoke two recent directives that cause economic hardships to traders.
The Retail Distribution Chemist Alliance (RDCA) has appealed to Delhi Chief Minister Rekha Gupta to revoke two recent directives that it says are causing economic hardship to small traders. The first mandates compulsory enrolment of pharmacies under the Health Facility Registry (HFR) of the Ayushman Bharat Digital Mission (ABDM), which RDCA argues lacks statutory backing under the Drugs and Cosmetics Act, 1940 or the Pharmacy Act, 1948. The second, issued by the District Magistrate (South), requires CCTV installation in pharmacies, raising concerns over privacy, cost burden, and unequal application. RDCA has urged the government to keep enrolment voluntary, withdraw the CCTV order, ensure uniform regulation across sectors, and hold stakeholder consultations before imposing new compliance measures.
• Delhi DCA issues advisory chemist associations on misuse of Pregabalin & Tapentadol formulations.
The Drug Control Administration (DCA) of the Government of NCT of Delhi has issued an advisory to chemist associations warning against the over-the-counter sale of Pregabalin (anticonvulsant and neuropathic pain medication) and Tapentadol (a synthetic opioid analgesic). The advisory, digitally signed by Kamal Ranjan Chawla, Head of Office and Controlling Authority, highlights their growing misuse for intoxication and addiction. Retail chemists have been instructed to maintain proper stock records and comply with the Drugs Rules, 1945, with strict action promised against violators.
• SC lifted the stay it granted over the omission of Rule 170 of Drugs and Cosmetics rules, 1945.
The Supreme Court has lifted its earlier stay on the AYUSH Ministry’s notification deleting Rule 170 of the Drugs and Cosmetics Rules, 1945, which required prior approval from licensing authorities before advertising Ayurvedic, Siddha, and Unani (ASU) drugs. The Court had stayed the omission in August 2024 citing regulatory concerns, but the amendment has now been allowed to take effect. The removal of Rule 170 has raised concerns about misleading advertisements and their potential risks to patient safety.
• Delhi HC rules in favour of Mankind Pharma, removes “Unkind” trademark.
The Delhi High Court, in Mankind Pharma Ltd. v. Ram Kumar trading as M/s Dr. Kumars Pharmaceuticals, ruled in favour of Mankind Pharma, granting heightened protection to its “Kind” family of marks. Justice Tejas Karia held that while “Kind” may not be inherently distinctive, its continuous use since 1986 had conferred secondary meaning and strong consumer association with Mankind’s products. The Court found “Unkind” deceptively similar both phonetically and visually, with the prefix “Un” insufficient to avoid confusion, particularly in pharmaceuticals where errors could endanger health. Declaring the adoption dishonest and aimed at exploiting goodwill, the Court ordered removal of “Unkind” from the Register under Sections 11 and 57 of the Trademarks Act 1999.
• GSK to receive $370 million settlement as part of Patent litigation related to mRNA COVID-19 vaccines.
GSK announced it will receive a USD 370 Million (United States Dollars Three Hundred Seventy Million Only) upfront settlement following the mRNA patent settlement between CureVac and BioNTech. The agreement also grants GSK a 1% royalty on US sales of influenza, COVID-19, and related combination mRNA vaccines made by BioNTech and Pfizer from 2025 onwards of the upfront amount, USD 320 Million (United States Dollars Three Hundred Twenty Million Only) will be paid in cash, while the remainder is linked to amendments reducing future royalties owed by GSK on its own mRNA products. If BioNTech’s acquisition of CureVac is completed, GSK will be entitled to an additional USD 130 Million (United States Dollars One Hundred Thirty Million Only) in cash, 1% royalties on non-US sales, and reduced milestone payments.
• Supreme Court Questions Centre on Enforcement of Pharma Marketing Code.
The Supreme Court has asked the Centre whether the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024 is being effectively enforced. The query came while hearing a petition filed by the Federation of Medical and Sales Representatives Association of India (FMRAI), which has long demanded a legally binding code. The Court noted concerns that the regime may be a “toothless tiger.” While the Department of Pharmaceuticals has reprimanded AbbVie Healthcare India for unethical marketing practices, FMRAI alleges that such actions remain limited to warnings, with bribery and freebies continuing unchecked in the industry.
• ToolGen Sues Lonza in Netherlands Over CRISPR Patent Infringement.
ToolGen, has filed a Patent infringement lawsuit against Lonza Netherlands BV in the Hague District Court, alleging unauthorized use of its CRISPR Cas9 RNP source technology (EP 4 357 457) in the production of CASGEVY, the world’s first gene-editing therapy for Sickle Cell Disease and Beta-Thalassemia. ToolGen claims Lonza’s use of its platform which optimizes Cas9 protein and guide RNA delivery violates its patent rights. CASGEVY, developed by Vertex, is approved in the US, UK, and EU and manufactured at Lonza’s Dutch facility.
• Delhi HC appointed three-member team to conduct inspection on Palamur Biosciences’ facility.
The Delhi High Court has appointed a three-member team, including experts from the Committee for Control and Supervision of Experiments on Animals (CCSEA) and the Centre for Cellular and Molecular Biology (CCMB), to conduct a fresh inspection of Telangana based Palamur Biosciences following allegations of animal abuse by People for the Ethical Treatment of Animals (PETA) India. Earlier inspections had led to conflicting findings, one citing cruelty and lapses, another clearing the facility, which PETA claimed was biased. The Court directed completion within three weeks, with independent oversight. While the company agreed to rectify issues, PETA seeks license revocation and closure.
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