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 October 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
• Central Drugs Standard Control Organization asks States to ensure testing of raw materials before manufacturing
India’s Central Drugs Standard Control Organization (CDSCO) has mandated stricter oversight of pharmaceutical raw materials after fatal incidents linked to toxic cough syrups. State drug authorities must now ensure drug makers use approved, high-quality ingredients and thoroughly test each batch including excipients before medicines go to market. The move responds to findings that some manufacturers used industrial-grade, unlicensed materials from unreliable sources, posing serious health risks. The Central Drugs Standard Control Organization (CDSCO) wants all manufacturers to implement rigorous vendor verification and maintain comprehensive records of material testing, with state regulators monitoring compliance and reporting on enforcement actions taken.
• Central Drugs Standard Control Organization issues clarification on approval of combi-packs of certain injections
The Central Drugs Standard Control Organisation (CDSCO) has clarified that combi-packs of lyophilised dry powder for injection or IV infusion, approved by the regulator for over four years and used with prescribed diluents, will not be treated as new drugs. Such products may be approved by State Licensing Authorities (SLA) without additional CDSCO permission. However, combi-packs using different diluents will fall under the new drug category, requiring approval as per the New Drugs and Clinical Trials (NDCT) Rules, 2019
• Central Drugs Standard Control Organization issues new directive on manufacturing licenses for Class A, B & IVD medical devices
The Central Drugs Standard Control Organization (CDSCO) issued a new directive to streamline licensing for Class A, B, and IVD medical devices under the Medical Devices Rules (MDR), 2017, emphasizing the mandatory role of the Central Licensing Authority (CLA) in device classification prior to licensing. The directive mandates that SLAs refer to the Central Drugs Standard Control Organization (CDSCO) classification list and obtain prior Central Licensing Authority (CLA) approval for unlisted, investigational, or new IVD devices. It aims to prevent licensing of unclassified or incorrectly classified devices, ensuring safety and compliance.
• CDSCO switches submission of PACs for clinical trial applications for CGTP to online only mode
The Central Drugs Standard Control Organization (CDSCO) has announced that all Post Approval Change (PAC) submissions for clinical trial applications related to Cell and Gene Therapy Products (CGTPs) must now be made exclusively online through the Sugam portal. The move, effective October 24, 2025, marks a further step in CDSCO’s ongoing digitization initiative to streamline regulatory submissions. Applicants can now submit Form CT-06 for PACs online. This digital transformation aims to promote uniformity, transparency, and efficiency in India’s regulatory framework and aligns with broader e-governance objectives through the Online National Drugs Licensing System (ONDLS).
• Centre to amend Rules related to liquid antiseptics under Schedule K
The Union Ministry of Health and Family Welfare has proposed amendments to Schedule K of the Drugs Rules, 1945 to exempt liquid antiseptics for household use from sale license requirements and hospital-grade antiseptics from retail sale licensing. Manufacturers will be required to clearly label products as either “For household use” or “For hospital and other than household use.” The draft divides the existing entry (Serial No. 39) into two separate categories and follows recommendations from the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB). The Ministry will consider objections and suggestions within 30 days of the draft notification’s publication.
• Commerce ministry extends RoDTEP Scheme for pharma exporters till March 2026
The Ministry of Commerce & Industry has extended the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme for pharma exporters till March 2026, as per a notification issued by the Directorate General of Foreign Trade (DGFT). The extension allows continued remission of embedded taxes on electricity, fuel, and logistics, easing cost pressures on exporters. Existing RoDTEP rates and item eligibility will remain unchanged across DTA units, SEZs, EOUs, and AA holders. The scheme’s operation will remain within the budgetary framework of FTP 2023.
• India’s Pharma reforms target global credibility
The Union Health Ministry published the proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, in the Gazette of India. The amendments aim to simplify the requirements and procedures for obtaining test licenses and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies highlights of the proposed amendments include significant changes to the licensing process. For test license applications, the existing license system is being transitioned to a simpler notification or intimation mechanism. Applicants will no longer be required to wait for a formal test license; instead, they can proceed after intimating the Central Licensing Authority (CLA). Furthermore, the statutory processing time for test license applications will be reduced from 90 days to 45 days.
• Health ministry issues draft amendment to move preparations with higher alcoholic content under Schedule H1
The Union Health Ministry has proposed amending Schedule K of the Drugs Rules, 1945, to move oral formulations with alcohol content above 12% v/v and pack size over 30 ml to Schedule H1 for stricter regulation. This aims to curb misuse of products like Aromatic Cardamom Tincture (84–87% alcohol in 100 ml packs), which are cheap and often consumed as liquor, posing public health risks. The proposal, supported by the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), removes exemptions under Schedule K and limits pack sizes to 30 ml. Draft rules will be open for public objections for 30 days after Gazette publication, after which the Central Government will consider them for implementation.
2) Approvals
• Lupin receives U.S. Food and Drug Administration (FDA) approval for Rivaroxaban for oral suspension.
Lupin Limited today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its abbreviated New Drug Application for Rivaroxaban for oral suspension, 1 mg/mL which is bioequivalent to Xarelto for oral suspension, 1 mg/mL of Janssen Pharmaceuticals, Inc. Rivaroxaban for oral suspension is indicated for treatment of Venous Thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment; Treatment of thromboprophylaxis in Pediatric patients 2 years and older with Congenital heart disease after the Fontan procedure.
• Precision NeuroMed granted Orphan Drug Designation by U.S. Food and Drug Administration (FDA) for treatment of Glioblastoma Multiforme (GBM)
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational therapy for Glioblastoma (GBM) of Precision NeuroMed (PNM), a clinical-stage biotechnology company pioneering advanced drug delivery technologies for Central Nervous System (CNS) diseases. Despite advancements in understanding the genetics of Glioblastoma (GBM) and identifying novel drug targets, the Blood Brain Barrier (BBB) remains a significant obstacle, severely limiting the effectiveness of many potential therapies delivered through the bloodstream. The five-year survival rate for patients is just 5%, with an average life expectancy of 12 to 18 months following diagnosis. Standard treatment consists of maximal tumor resection followed by radiation therapy with temozolomide with no major innovations since the approval of temozolomide for glioblastoma in 2005.
• Boehringer Ingelheim’s Jascayd receives U.S. Food and Drug Administration (FDA) approval for oral treatment option for adults with Idiopathic Pulmonary Fibrosis (IPF)
Boehringer Ingelheim’s Jascayd tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for Idiopathic Pulmonary Fibrosis (IPF) in adult patients. Jascayd is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. Idiopathic Pulmonary Fibrosis (IPF) is a progressive disease, causing a continuous decline in lung function. Approval is based on results from two clinical trials, which showed reduction in Forced Vital Capacity decline with JASCAYD versus placebo in adults with Idiopathic Pulmonary Fibrosis (IPF). This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung function in Idiopathic Pulmonary Fibrosis (IPF) patients.
• U.S. Food and Drug Administration (FDA) grant fast track designation for AJ201, a First-in-Class therapy for Kenndy’s Disease
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AJ201, the first-in-class for therapy for Spinal and Bulbar Muscular Atrophy (SBMA). This recognition reinforces AJ201’s potential to address the unmet needs of patients with Spinal and Bulbar Muscular Atrophy (SBMA). AnnJi Pharmaceutical Co., Ltd. remain committed to advancing AJ201 into Phase 3 development and to working closely with the FDA to potentially deliver the first approved treatment. Spinal and Bulbar Muscular Atrophy (SBMA), is a rare X-linked inherited Neuromuscular Disorder caused by CAG repeat expansion in the androgen receptor (AR) gene. The resulting mutant AR protein contributes to muscle and neuron degeneration through mechanisms involving Cellular toxicity, Oxidative Stress, and Neuroinflammation.
• US Food & Drug Administration (FDA) approves Roche’s Tecentriq plus Lurbinectedin as first-line maintenance therapy for extensive-stage Small Cell Lung Cancer
The US Food & Drug Administration (FDA) has approved Roche’s Tecentriq (atezolizumab) in combination with Lurbinectedin as a first-line maintenance treatment for patients with extensive-stage Small Cell Lung Cancer. This approval offers a new treatment option aimed at improving patient outcomes after initial therapy. Tecentriq is a programmed death-ligand 1 (PD-L1) inhibitor that enhances immune response against Cancer cells, while lurbinectedin acts as a chemotherapeutic agent. The combination targets Extensive-Stage disease to delay progression and improve survival, representing a significant advancement in Lung Cancer therapeutics according to regulatory approval.
• EMA grants Orphan Drug Designation to Ribo’s siRNA therapeutic RBD1016 for Hepatitis Delta Virus infection
The European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to RBD1016, an siRNA-based therapeutic developed by Suzhou Ribo Life Science Co., Ltd. and Ribocure Pharmaceuticals AB, for the treatment of Hepatitis D Virus (HDV) infection. RBD1016, designed using Ribo’s GalNAc-based RiboGalSTAR platform, selectively targets key viral factors involved in HDV infection and is currently in Phase II global clinical trials. The ODD status provides regulatory and commercial incentives to accelerate development for this rare and severe liver disease, which affects an estimated 12–20 million people worldwide.
• U.S. Food and Drug Administration (FDA) approve Bayer’s Lynkuet to treat moderate to severe vasomotor symptoms due to Menopause
The U.S. Food and Drug Administration (FDA) approved Bayer’s Lynkuet (elinzanetant), the first dual neurokinin (NK1 and NK3) receptor antagonist, for treating moderate to severe vasomotor symptoms due to Menopause. Lynkuet is a once-daily, non-hormonal capsule that works by inhibiting Substance P and Neurokinin B signaling on KNDy neurons, modulating thermoregulation. Approval is based on three Phase III clinical trials (OASIS 1, 2, and 3), demonstrating significant reductions in frequency and severity of hot flashes, with safety established over up to 52 weeks. Lynkuet offers a hormone-free alternative for women not suitable for hormone therapy.
• Alembic Pharmaceuticals receives US FDA approval for Ticagrelor Tablets, 60 mg
Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg, the generic equivalent of AstraZeneca’s Brilinta. The drug is used to reduce the risk of Cardiovascular Death, Myocardial Infarction, and Stroke in patients with acute coronary syndrome or a history of heart attack. It also helps prevent stent thrombosis and first-time cardiac events in high-risk patients. With an estimated market size of USD 236 million (IQVIA, June 2025), this approval strengthens Alembic’s US portfolio, taking its total ANDA approvals to 227, including 206 final approvals.
3) International Pharma News
• Novartis to launch direct-to-patient platform for Cosentyx in the US
Novartis has announced plans to launch a direct-to-patient (DTP) platform in the United States starting November 1, 2025, enabling cash-paying patients prescribed Cosentyx (secukinumab) to purchase the drug at a 55% discount off its list price. The initiative aims to enhance affordability and patient access by bypassing intermediaries such as insurers and pharmacy benefit managers. The DTP model will act as proof of concept for future direct-selling initiatives across Novartis’ portfolio, with the company also exploring direct-to-business sales to large employers.
• Pfizer reaches landmark agreement with US government to lower drug costs for American patients
Pfizer Inc. announced an agreement with the Trump Administration that will ensure US patients pay lower prices for their prescription medicines while strengthening America’s role as the global leader in biopharmaceutical innovation. Pfizer has voluntarily agreed to implement measures designed to ensure Americans receive comparable drug prices to those available in other developed countries and pricing newly launched medicines at parity with other key developed markets. Pfizer will also participate in a direct purchasing platform, TrumpRx.gov, that will allow American patients to purchase medicines from Pfizer at a significant discount.
• Piramal Partners with IntoCell to explore opportunities in ADC development
Piramal Pharma Solutions, a global Contract Development and Manufacturing Organization (CDMO), has signed a Memorandum of Understanding (MOU) to solidify its strategic partnership and explore potential collaboration opportunities in ADC development with IntoCell Inc., a Korean biotechnology company specializing in innovative Antibody-Drug Conjugate (ADC) linker and payload platform technologies. IntoCell will explore licensing opportunities for its proprietary drug-linker technologies with Piramal’s clients. In exchange, Piramal will offer comprehensive contract research, development, and manufacturing of bioconjugates, including ADCs, to IntoCell and its client base. Through this agreement, Piramal can now offer clients a broader range of payload-linkers, and faster bioconjugate development times, thereby improving its service offerings and competitiveness in this specialized field.
• India and Russia pharma ties deepen as Putin calls for boost in Indian drug imports
Trade agreement between India and Russian President Vladimir Putin. The Russian President has directed his government to ramp up imports of Indian pharmaceuticals and agricultural products. With pharmaceuticals currently representing a USD 5 Billion (United States Dollars Five Billion Only) surplus. This move presents a significant opportunity for Indian drug manufacturers to expand their presence in the Russian pharmaceutical market. The announcement followed a recent high-level bilateral meeting in India between Health Minister JP Nadda and Russian Deputy Prime Minister Dmitry Nikolaevich Patrushev. This strategic initiative aims to rebalance trade and deepen economic ties between the two countries in the pharmaceutical and agricultural sectors.
• WHO and the European Union launch collaboration to advance digitized health systems in sub-Saharan Africa
The World Health Organization (WHO) and the European Union (EU) have launched a new collaboration to accelerate the digital transformation of health systems in sub-Saharan Africa through wider adoption of WHO’s Global Digital Health Certification Network (GDHCN). Announced at the World Health Summit 2025, the EUR 8 Million (Euros Eight Million Only) initiative (2025–2028) aims to enhance pandemic preparedness and streamline digital health credentialing across borders. Building on the EU’s Digital COVID Certificate model, GDHCN enables secure verification of vaccination and health records internationally. The partnership aligns with the EU-AU Health Partnership under the EU Global Gateway strategy, supporting countries to build trusted, interoperable, and privacy-protected digital health systems for future resilience.
• Pharmexcil to lead business delegation to Egypt, Algeria, and Morocco to boost exports
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) will lead a business delegation to Egypt, Algeria, and Morocco from January 12–21, 2026, to strengthen India’s pharmaceutical presence in Africa, one of the fastest-growing markets for generic medicines. India’s pharma exports stood at USD 30.46 (United States Dollars Thirty and Forty-Six Cents Only). in FY 2025, with Africa accounting for USD 3,933 million (United States Dollars Three Billion Nine Hundred Thirty-Three Million). or 12.91% of total exports. The delegation will organize Buyer-Seller Meets (BSMs) and hold discussions with trade associations, health ministries, and regulatory bodies to explore partnerships and regulatory collaborations. Director General Raja Bhanu stated that the proposal has been submitted under the Market Access Initiative (MAI) Scheme, aiming to deepen bilateral trade and enhance affordable healthcare access across Africa.
• Maldives becomes the first country to achieve ‘triple elimination’ of mother-to-child transmission of HIV, syphilis & Hepatitis B
The World Health Organization (WHO) has validated the Maldives as the first country in the world to achieve ‘triple elimination’ of mother-to-child transmission of Human Immunodeficiency Virus (HIV), syphilis, and Hepatitis B. The milestone follows the Maldives’ earlier validations for HIV and syphilis elimination and its recent success in eliminating Hepatitis B transmission. WHO praised the achievement as a result of strong political will, universal health coverage, and sustained investment in maternal and child health. Over 95% of pregnant women in the Maldives receive antenatal care and testing, with nearly universal Hepatitis B immunization at birth. The country recorded zero cases of HIV and syphilis in newborns in 2022–2023. WHO will continue supporting Maldives to sustain and build on this historic public health success.
• New Zealand’s pharma growth complements ongoing FTA negotiations with India to boost pharma trade.
New Zealand’s growing pharmaceutical sector, supported by ongoing Free Trade Agreement (FTA) negotiations with India, is expected to enhance bilateral pharma trade. Both countries have identified pharmaceuticals as a priority area, focusing on streamlining regulatory approvals and assessing manufacturing quality to facilitate the entry of Indian generics into New Zealand. The country’s pharma market is projected to rise from USD 1.10 Billion (United States Dollars One Billion One Hundred Million Only) to USD 1.60 Billion (United States Dollars One Billion Six Hundred Million Only) at a CAGR of 8.5%.The next round of FTA negotiations will be held in New Delhi to further strengthen collaboration and expand market access for pharmaceutical manufacturers from both nations.
• GSK & Spero announce positive PIVOT-PO phase III trial of tebipenem HBr, an investigational oral treatment for complicated Urinary Tract Infections
GSK and Spero Therapeutics announced positive Phase III results from the PIVOT-PO trial of tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The trial demonstrated non-inferiority of oral tebipenem HBr to intravenous imipenem-cilastatin, achieving comparable efficacy and safety outcomes. If approved, it would become the first oral carbapenem antibiotic in the US, offering a home-based alternative to hospital IV therapy and addressing a key gap in treating multidrug-resistant infections. GSK plans to file for Food and Drug Administration approval in Q4 2025.
• 16th annual meeting of the WHO International Regulatory Cooperation for Herbal Medicines held in Jakarta, Indonesia
The World Health Organization’s International Regulatory Cooperation for Herbal Medicines (WHO-IRCH) held its annual meeting in Jakarta, Indonesia, hosted by the Indonesian Food and Drug Authority (BPOM). The event brought together regulators, policymakers, and researchers from 22 member countries and 31 observers to strengthen cooperation on the quality, safety, and efficacy of herbal medicines. Discussions covered key areas such as safety regulation, quality control, and standardization, along with updates on the WHO Global Traditional Medicine Strategy 2025–2034 and the WHO International Herbal Pharmacopoeia. The meeting outcomes will feed into the 2nd WHO Traditional Medicine Global Summit, scheduled in New Delhi in December 2025.
4) Domestic Pharma News
• Reliance General Insurance partners with Mayfair We Care to redefine borderless healthcare
Reliance General Insurance has entered a strategic partnership with UK-based Mayfair We Care Ltd to provide seamless, borderless healthcare and emergency assistance for its policyholders worldwide. As part of the agreement, Mayfair will operate a 24×7 multilingual Alarm Centre offering round-the-clock medical and travel-related support to Reliance General customers abroad. Services include cashless and reimbursement claims, medical referrals, tele-assistance, evacuation, repatriation, and travel coordination. Effective from August 1, 2025, for an initial term of three years, the partnership reflects a long-term commitment to delivering innovative, customer-centric solutions.
• NIMHANS sets up National Tobacco Testing Lab for comprehensive chemical and toxicological analysis
The National Institute of Mental Health and Neurosciences (NIMHANS) has established the National Tobacco Testing Lab (NTTL), the fourth such facility in India, marking a key advancement in tobacco product testing and public health research. The laboratory is equipped to conduct comprehensive chemical and toxicological analyses of tobacco products, supporting regulatory enforcement and scientific evaluation under national and international standards. The facility was inaugurated by officials from the Ministry of Health and Family Welfare and NIMHANS leadership. This initiative strengthens tobacco control measures, enhances research capacity for monitoring harmful substances, and reinforces NIMHANS’ commitment to healthcare innovation and evidence-based policymaking aimed at reducing the health burden of tobacco consumption in India.
• Medanta introduces UNITY VCS system for advanced eye care
Medanta, has introduced the UNITY Vitreoretinal Cataract System (VCS), becoming the first institute in the country to use this advanced Ophthalmic system. The UNITY VCS combines intelligent fluidics, real-time sensing, and advanced phaco technology to enhance precision, safety, and efficiency in cataract and vitreoretinal surgeries. Its UNITY 4D Phaco enables twice as fast nucleus removal with less energy, while the HYPERVIT 30K Vitrectomy Probe ensures superior precision with minimal retinal traction.
• IPC signs MoU with UPPC to promote rational use of medicines
The Indian Pharmacopoeia Commission (IPC) has signed an MoU with the Uttar Pradesh Pharmacy Council (UPPC) to promote the rational use of medicines and enhance pharmacists’ professional competence. Under the agreement, pharmacists registering with the UPPC must now subscribe to the National Formulary of India (NFI), published by IPC. The NFI provides evidence-based information on drug usage, dosage, indications, contraindications, and clinical guidance to ensure the safe and effective use of medicines. The collaboration aims to empower pharmacists as key contributors to patient safety and evidence-based practice.
• Apollo AyurVAID and HCAH SuVitas launch Centre for Precision Ayurveda and Integrative Medicine in Hyderabad
Apollo AyurVAID Hospitals has entered Telangana with the launch of the AyurVAID HCAH Centre for Precision Ayurveda and Integrative Medicine in partnership with HCAH SuVitas at Somajiguda, Hyderabad. The new center focuses on integrative rehabilitation and recovery for patients with chronic and complex conditions such as Stroke, Traumatic brain injury, and Neurodegenerative or Musculoskeletal disorders. It also provides precision Ayurveda treatments across specialties including Metabolic, Gynecology, Dermatology, and Mental Health, along with Para-Surgical Care for Anorectal and wound-related conditions. The 115-bed facility, including 20 Ayurvedic treatment beds, combines modern rehabilitation with traditional Ayurveda. Apollo AyurVAID plans to open three more hospitals in the region over the next five years.
• IPA & KDPMA to hold workshop on BA/BE on November 22 in Bengaluru
The Indian Pharmaceutical Association (Karnataka State Branch) and Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) will hold a one-day workshop on Bioavailability and Bioequivalence (BA/BE) titled “Managing Regulatory Changes in Solid Oral Dosage Forms Technical Insights” on November 22, 2025, at the Grand Magrath Hotel, Bengaluru. The event aims to update the industry on regulatory changes under Rules 74 and 78 of the Drugs and Cosmetics Act, 1940, concerning submission of bioequivalence data for license applications. Experts from leading pharma companies and CROs will discuss BA/BE regulations, study design, excipient quality, DEG contamination, and AI’s role in BE prediction. The workshop seeks to strengthen regulatory compliance, quality standards, and industry–academia collaboration in India.
• Hikal launches state-of-the-art high potency API laboratory at its Integrated Innovation Centre, Pune
Hikal Ltd. has inaugurated a state-of-the-art High Potency Active Pharmaceutical Ingredient (HPAPI) Laboratory at its Integrated Innovation Centre in Pune. The cGMP-compliant facility, designed to meet Occupational Exposure Band 5 (OEB-5) standards, strengthens Hikal’s CDMO capabilities for developing complex oncology and specialty molecules, including ADCs, PDCs, and PROTACs. Equipped with isolators, in-lab analytical tools like HPLC and GC, and advanced containment systems, the lab ensures safety and precision from raw material dispensing to final packaging.
• Alembic Pharma & Amlan International launch MinerTox-Z and MinerTox-A in India
Alembic Pharmaceuticals Ltd., in collaboration with Amlan International, has launched MinerTox-Z and MinerTox-A in India advanced feed additive solutions designed to protect poultry against toxins and improve farm productivity. MinerTox-Z provides rapid, broad-spectrum protection against fungal and bacterial toxins, while MinerTox-A offers long-lasting mycotoxin binding. Both products also enhance immunity and bird performance, reducing hidden economic losses for farmers.
• Eli Lilly to invest over USD 1 billion in new contract manufacturing in India
Eli Lilly and Company has announced plans to invest over USD 1.00 Billion (United States Dollars One Billion Only) contract manufacturing operations in India, aimed at expanding global access to its innovative medicines. As part of this initiative, Lilly will also establish a manufacturing and quality hub in Hyderabad, offering advanced technical capabilities and oversight for its India-based contract manufacturing network. Recruitment will begin immediately across roles in engineering, chemistry, analytics, and quality management.
• AI to dominate discussions at 74th IPC to be held in Bengaluru from December 19 to 21
The 74th Indian Pharmaceutical Congress (IPC), to be held in Bengaluru from December 19–21, 2025, will spotlight the transformative impact of Artificial Intelligence (AI) on the pharmaceutical industry. Industry experts will discuss how AI-driven technologies like machine learning, NLP, and generative models are reshaping drug discovery, R&D efficiency, and personalized healthcare. Harish K Jain, chairman of the local organising committee, noted that AI can cut costs, reduce timelines, and improve patient outcomes in an industry where success rates are below 10%.
5) Innovations
• Epigenica AB launches the groundbreaking EpiFinder GenomePro
Epigenica AB, a Swedish epigenomics company, has launched the EpiFinder GenomePro, an advanced platform that enables simultaneous, high-throughput analysis of histone post-translational modifications (hPTMs) and DNA Methylation. The next-generation system enhances the earlier EpiFinder Genome platform with optimized reagents, shorter workflows, and the capacity to analyze 24 samples per run, producing 192 genome-wide ChIP-Seq profiles with minimal input and lower cost per sample. Featuring flexible assay design and an open-source data analysis pipeline, EpiFinder GenomePro allows researchers to explore epigenetic mechanisms underlying disease, biomarker discovery, and precision medicine.
• CollPlant announces positive results from non-clinical studies of its photocurable regenerative dermal and soft tissue filler
CollPlant announced positive outcomes from non-clinical studies of its photocurable regenerative dermal and soft tissue filler designed for aesthetic and reconstructive applications. The studies confirmed the filler’s safety, biocompatibility, and efficacy in promoting tissue regeneration. This innovative product leverages recombinant human collagen (rhCollagen) technology combined with photocurable properties to enhance precision and durability in soft tissue augmentation. Offering potential advantages in minimally invasive procedures, the filler aims to improve patient outcomes.
• Qureight AI model Vascul8 offers new hope for Pulmonary Vascular disease patients
Qureight’s AI-powered imaging platform, Vascul8, has been validated in a peer-reviewed study, marking a significant advancement in managing pulmonary vascular disorders. The study demonstrated Vascul8’s ability to predict disease severity and identify patients at risk of residual pulmonary hypertension (PH) after surgery for chronic thromboembolic pulmonary hypertension (CTEPH). Traditionally, residual PH is assessed through invasive right heart catheterisation, but Vascul8 enables accurate screening using routine CT scans. The findings expand Vascul8’s potential beyond fibrotic lung disease to pulmonary vascular disorders.
• Stem cell liver model reproduces rare immune drug reactions
Researchers at Cincinnati Children’s Hospital Medical Center, in collaboration with Roche, have developed a next-generation human liver organoid microarray platform. This platform predicts which drugs might trigger harmful immune responses in some patients, offering a potential for safer, more personalized drug development. The study presents a miniaturized, fully human liver model developed from stem cells and a patient’s own immune cells. This system serves as an advanced tool to investigate why some medications lead to severe immune-related liver injuries in certain individuals. This model helps explain the variability in drug-induced liver damage. This approach moves closer to personalized drug safety testing, enabling better prediction and understanding drug reactions linked to liver injury, improving patient-specific treatment outcomes.
• Lupin Digital Health launches AI-powered Cardiometabolic wellness platform, VITALYFE
Lupin Digital Health has launched VITALYFE, an AI-powered cardiometabolic wellness platform designed to help India’s working professionals reclaim their heart health. Built on the foundation of LYFE, India’s first Central Drugs Standard Control Organization (CDSCO) approved Class C software medical device for critical cardiac conditions, VITALYFE extends hospital-grade cardiac expertise to preventive wellness. Developed with Cardiometabolic expertise, it uses artificial intelligence, behavioural science, and computer-vision technology to identify early risks and provide personalized interventions.
• Fujifilm India brings advanced wet chemistry technology to India with FW500
Fujifilm India has launched the FW500 Clinical Chemistry Analyzer, expanding its in-vitro diagnostics portfolio by integrating over four decades of dry chemistry expertise with Wako’s globally trusted biochemistry reagents. The analyzer delivers accuracy, speed, and efficiency, processing up to 200 tests per hour with 95 sample and 72 reagent positions. Designed for mid-sized laboratories, it features continuous sample loading and temperature-controlled reagents. The FW500 also promotes sustainability through low water usage and reusable cuvettes, supported by intelligent software for real-time monitoring and remote access.
• Philips and Nicolab collaborate to advance stroke care in India
Philips is expanding its collaboration with Nicolab, a company specializing in AI-powered stroke care, to advance stroke management in India. The partnership combines Philips’ imaging expertise with Nicolab’s StrokeViewer AI platform the first cloud-based solution in India with regulatory clearance for CT Perfusion analysis. The integration with Philips’ Azurion image guided therapy platform enables real time imaging, faster diagnosis, and improved treatment precision. With nearly 1.8 million new stroke cases annually, the initiative aims to strengthen clinical workflows, speed decision making, and enhance access to life-saving care, including in Tier 2 and 3 cities. Executives from both companies emphasized their shared commitment to using AI-driven technology to improve recovery outcomes and expand equitable stroke treatment access.
• Bayosthiti AI and Narayana Health partner to build India’s first AI-powered Heart Disease Predictor
Bayosthiti AI has partnered with Narayana Health to develop India’s first AI-powered Heart Disease Predictor. The project will study transcriptomic data from over 12,000 participants at the Narayana Institute of Cardiac Sciences, Bengaluru, using Bayosthiti’s BIRT (Barcode-Integrated Reverse Transcription) technology. This approach sequences complete RNA profiles to train AI models capable of identifying cellular activity patterns that indicate coronary artery disease before traditional tests detect it. With 65 million Indians affected and existing diagnostics based on Western data, the collaboration aims to create tools tailored to Indian biology.
• SSO Cancer Hospital in partnership with EPIC Hospital launches Qure.ai’s AI tool for early cancer detection
Specialty Surgical Oncology (SSO) Cancer Hospital, in partnership with EPIC Multispecialty Hospital, Ahmedabad, has launched Qure.ai’s AI tool for early cancer detection, integrating it into oncology workflows to speed up diagnosis and improve outcomes. The launch was part of the Seminar on Surgical Innovations in Cancer, which showcased how AI and robotic-assisted surgery are redefining precision and accessibility in cancer care. The AI system identifies minute abnormalities such as lung nodules or liver lesions, enabling diagnosis months earlier than traditional methods. Already deployed at SSO, Qure.ai tools detect pulmonary nodules from chest X-rays and link patients directly to specialists.
6) Trends
• WHO releases new reports on new tests and treatments in development for Bacterial Infections
The World Health Organization (WHO) released its latest reports on antibacterial agents in clinical and preclinical development and diagnostics to detect and identify priority bacteria listed in the WHO Bacterial Priority Pathogens List (BPPL). The number of antibacterials in the clinical pipeline decreased from 97 in 2023 to 90 in 2025, of which 50 are traditional and 40 are non-traditional approaches. Only 15 qualify as innovative and 5 are effective against “critical” bacteria. The preclinical pipeline has 232 programs across 148 groups, mostly small firms. The diagnostics report highlights gaps such as lack of multiplex platforms, limited biomarker tests, and inadequate point-of-care tools. WHO stressed the urgent need for investment in R&D and affordable diagnostic platforms.
• Indian Ayurveda economy valued at USD 43 billion, poised for major growth
Secretary of the Ministry of Ayush speaking at the Kerala Health Tourism and Global Ayurveda Summit & Expo 2025, organized by the Confederation of Indian Industry (CII), Kotecha emphasized that Ayurveda and traditional health systems in India are on the verge of a transformative era. Speaking at the Kerala Health Tourism and Global Ayurveda Summit & Expo 2025, organized by the Confederation of Indian Industry (CII), Kotecha emphasized that Ayurveda and traditional health systems in India are on the verge of a transformative era. Kotecha commended Kerala’s pioneering leadership in Ayurveda and labeled the state as a model for the rest of the country.
• New MediBuddy Data Shows Early Metabolic Risks Emerging Among Professionals Aged 30–40
MediBuddy, India’s largest digital healthcare company, has released a study highlighting a sharp rise in metabolic and lifestyle-related risk factors among professionals aged 30 to 40. Data from 14,192 individuals aged 30 to 40 years showed 59% were obese and 19% overweight, indicating a high BMI burden. Dyslipidemia was prevalent, with 38% having borderline or high triglycerides, 30% with borderline or high total cholesterol, and 45% showing low HDL. Glycaemia analysis found 25% pre-diabetic and 7% diabetic, with some showing high blood pressure. Compared with national data (Obesity 28.6%, Diabetes 11.4% per ICMR–INDIAB 2021), the findings indicate earlier onset of metabolic risks among urban professionals, highlighting the 30s as a critical decade for managing Weight, Cholesterol, and Glucose-related health issues.
• Metabolic syndrome significantly increases Gynaecological Cancer risk among Indian women
The Indian Council of Medical Research (ICMR) revealed that women suffering from Metabolic Syndrome (MeS) face a significantly higher risk of developing Gynaecological Cancers, including Ovarian, Endometrial, Cervical, Vaginal, and Vulvar Cancers. Metabolic Syndrome is defined by a cluster of metabolic abnormalities Obesity, High Blood Sugar, Hypertension, Elevated Triglycerides, and low HDL Cholesterol. Data shows 35% of adult women in the country now live with MeS, whereas 26% of men, with rates climbing further with age. Researchers from ICMR’s National Institute of Reproductive and Child Health (NIRRCH) in Mumbai found that women diagnosed with MeS are nearly three times more likely to develop Ovarian Cancer and almost twice as likely to suffer from Uterine (endometrial) Cancer.
• EASO algorithm recommends Semaglutide for Obesity mgmt in patients with Cardiovascular Disease, Diabetes, and Heart failure
The European Association for the Study of Obesity (EASO) algorithm recommends semaglutide as the preferred Obesity Management Medication (OMM) for patients with Cardiovascular Disease due to its proven ability to reduce Major Adverse Cardiovascular Events (MACE). For heart failure, both Semaglutide and Tirzepatide are considered first-line treatments. Semaglutide is also recommended for patients with Obesity and Knee Osteoarthritis for pain reduction, and alongside Tirzepatide for Type 2 diabetes or Prediabetes Remission. The algorithm emphasizes continuous Obesity management with pharmacotherapy and lifestyle interventions, recognizing Obesity as a chronic, relapsing disease requiring long-term care.
• New study ranks physical side effects of common antidepressants
A study by King’s College London and the University of Oxford analyzed data from 151 clinical trials involving 30 antidepressants and over 58,000 patients, ranking the physical side effects such as Weight change, Heart Rate, Blood Pressure, Cholesterol, and Blood Glucose. Older drugs like Amitriptyline and Venlafaxine caused significant Weight gain and increased Heart rate and Blood pressure, while SSRIs such as sertraline, fluoxetine, and citalopram exhibited fewer physical side effects. The study highlighted the importance of tailoring antidepressant choice to individual patient health profiles, emphasizing continued use should be under medical advice despite side effect risks.
• Metropolis Healthcare study reveals 46% of tested individuals show vitamin D deficiency across India
Metropolis Healthcare has released a nationwide analysis of over 22 lakh vitamin D test results collected between 2019 and January 2025, revealing that 46.5% of individuals across India showed vitamin D deficiency, while another 26% had insufficient levels. South India recorded the highest deficiency at 51.6%, followed by Central India at 48.1% and North India at 44.9%. The North-East reported the lowest at 36.9%. National deficiency rates have gradually declined from around 51% in 2019–20 to 43% in 2023–24. Teenagers showed the highest deficiency at 66.9%, while gender differences have narrowed. Metropolis emphasized the need for preventive diagnostics, awareness, and nutritional interventions to address widespread vitamin D inadequacy across the country.
• HCL Healthcare new study urges mental health first-aid in Indian workplaces
HCL Healthcare, a leading employer-health provider, has released a study titled “Demystifying Mental Health at the Workplace,” based on over 4,200 emotional-wellness consultations across five major Indian employers. The findings show 84% of employees experience persistent low mood or depressive thoughts, 59% have moderate to severe anxiety, 50% sleep less than seven hours nightly, and 21% of those under 25 report suicidal ideation. Women accounted for 54% of consultations, and 85% of cases involved employees under 40. Key stressors include self-esteem issues (34%), relationship and family stress (27%), and career pressures (14%). The report urges companies to integrate mental health first-aid, leadership involvement, digital and on-site support, and evidence-based frameworks to enhance resilience, productivity, and employee well-being.
7) Law and Order Briefs
• SC petition demands CBI probe into deaths of 14 children from contaminated cough syrup in MP
A Supreme Court petition demands a CBI probe into the deaths of 14 children in Madhya Pradesh’s Chhindwara district after consuming contaminated Coldrif cough syrup, manufactured by Tamil Nadu-based Sresan Pharma. The syrup was found to contain 46.28% Diethylene Glycol (DEG), a toxic industrial solvent banned in pharmaceuticals. Children suffered Acute Renal Failure, leading to fatalities. The plea seeks nationwide bans, compulsory testing of syrup-based medicines, and compensation for affected families, citing the constitutional right to health and life. The case has propelled arrests, bans in multiple states, and calls for National Pharmacovigilance Portal for real-time drug safety monitoring.
• FSDA Cracks Down on Illegal Codeine Syrup Network
The Food Safety and Drug Administration (FSDA) has busted an illegal distribution network involved in the sale of codeine-based cough syrups being misused as intoxicants. Acting on leads from Eidika Life Sciences officials raided Shyam Pharma in Aminabad, which was later sealed after its proprietor, failed to respond to inspection calls. Investigations revealed forged invoices showing fake sales to Vinod Pharma in Sultanpur, whose owner denied any such transactions. Authorities confirmed that the syrups were sold illegally through cash deals, bypassing licensed supply chains. The FSDA stated that this operation is part of a statewide crackdown on narcotic-containing medicines being diverted for substance abuse.
• No relief to Jamp India, VS International over copyright infringement of Jubilant Generic’s Product Dossiers
The Allahabad High Court upheld an interim injunction restraining Jamp India Pharmaceuticals and VS International from using Jubilant Generics’ product dossiers, holding that the dossiers are protectable ‘literary works’ under the Copyright Act. The Court affirmed the territorial and inherent jurisdiction of the Gautam Budh Nagar Commercial Court under Section 62(2) of the Copyright Act and Section 20(c) of the CPC, rejecting objections on composite suit and arbitration. It also held that urgent interim relief was justified without pre-institution mediation under Section 12-A of the Commercial Courts Act. The Court noted that Jamp’s license was limited to Canada, and any unauthorized use or technology transfer in India constituted copyright infringement.
• Supreme Court rejects Roche’s appeal against Natco Pharma in Spinal Muscular Atrophy Drug dispute
The Supreme Court of India has dismissed Roche’s petition challenging the Delhi High Court’s order that permitted Natco Pharma to launch a generic version of Risdiplam, used in treating Spinal Muscular Atrophy (SMA). The Court upheld the concurrent findings of both the single judge and the Commercial Appellate Division of the Delhi High Court, which had denied Roche’s request for an injunction. With this, Roche’s final interim-stage challenge stands closed, and the matter will now proceed to trial.
• Delhi High Court Restrains Alchem from Using “ALCHEM” Mark Similar to Alkem’s “ALKEM”
The Delhi High Court has restrained Alchem International Pvt. Ltd. from using the trademark “ALCHEM,” finding it phonetically and visually similar to Alkem Laboratories Ltd.’s registered mark “ALKEM.” The Court held that Alchem’s use constituted trademark infringement and passing off. Alkem, which has used “ALKEM” since 1973, argued that Alchem became a competitor only after expanding its business in 2018. The Court rejected Alchem’s defence of acquiescence, noting that Alkem’s prior tolerance arose from the defendant’s limited operations, which later created a real risk of consumer confusion and market dilution. The injunction applies to the retail sale of pharmaceutical and medicinal products.
• Centre plans new law for stricter quality checks and surveillance of drugs, medical devices, and cosmetics
The Indian government is drafting the ‘Drugs, Medical Devices and Cosmetics Act, 2025’ to strengthen the legal framework for quality testing, market surveillance, and regulation of drugs, medical devices, and cosmetics. This move aims to address repeated quality lapses flagged globally. The new law will replace the Drugs and Cosmetics Act of 1940, granting statutory powers to the Central Drugs Standard Control Organization (CDSCO) for stringent quality control, immediate action against fake or substandard products, digitizing licensing, and enhancing coordination and testing capacities, aligning with international standards.
• Delhi HC asks companies to file chart with details of banned FDCs
The Delhi High Court has directed pharmaceutical companies challenging the ban on Fixed Dose Combinations (FDCs) to file a comprehensive chart detailing each banned formulation, corresponding government notifications, and related writ petition numbers within six weeks. The direction, issued by a Division Bench of Chief Justice Devendra Kumar Upadhyaya and Justice Tushar Rao Gedela on October 9, 2025, aims to streamline hearings in nearly 55 petitions filed by 27 companies against the Centre’s FDC prohibitions under Section 26A of the Drugs and Cosmetics Act, 1940. The bans, issued in June 2023 and August 2024, affected over 170 FDCs including common cold, cough,
and pain relief medicines. The matter is next listed for January 13, 2026.