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Maharashtra FDA Seizes ₹11.19 Lakh Reactin Plus Stock from Cipla Facility

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Maharashtra FDA Seizes ₹11.19 Lakh Reactin Plus Stock from Cipla Facility

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carrying and Forwarding (C&F) unit in Pune, citing serious irregularities in the packaging, storage, record-keeping and recall of Reactin Plus Tablets handled at the facility.

The regulator’s action targets compliance lapses at the C&F unit rather than the manufacturing process itself, according to the details of the order. Cipla has pushed back against the decision, stating that the matter is currently sub judice and is likely to be examined further through legal proceedings.

The company has also issued a clarification distancing the issue from product integrity, asserting that the FDA’s action does not allege any concerns relating to the safety, quality or efficacy of Cipla’s products. The case adds to the scrutiny Indian pharmaceutical companies have faced recently over storage and distribution compliance, even as manufacturing standards remain unaffected.

Written by: Arundhuti Chatterjee

Graphics by: Pramit Hazra

Department of Pharmaceuticals Reopens ₹5,000 Crore Pharma Innovation Scheme for Second Round of Applications

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Department of Pharmaceuticals Reopens ₹5,000 Crore Pharma Innovation Scheme for Second Round of Applications

India’s Department of Pharmaceuticals has opened a fresh application window for its flagship Promotion of Research and Innovation in Pharma & MedTech (PRIP) initiative, offering startups, MSMEs, and established manufacturers a renewed shot at government-backed funding for cutting-edge drug and device development.

The scheme, backed by a ₹5,000 crore outlay, is structured to support two distinct stages of innovation. Early-stage applicants working on technologies rated between Readiness Levels 1 and 3 can pursue up to ₹5 crore per project, beginning with a brief concept submission before advancing to a full application if shortlisted. Companies with more mature technologies, spanning Readiness Levels 4 through 6, can apply directly for larger grants of up to ₹100 crore — though funding is capped at 35 percent of total project costs, with applicants expected to cover the remainder.

Officials noted that the portal for submissions will go live in mid-September, and that participants from the scheme’s first round should not resubmit previously considered projects. Priority funding areas include novel chemical and biological medicines, complex generics and biosimilars, and next-generation medical devices — among them AI-driven diagnostic software, genetic-testing equipment, surgical robotics, and telemedicine-enabled tools.

First rolled out in 2023, PRIP was designed to strengthen India’s research infrastructure in pharmaceuticals and build a stronger talent pipeline in emerging fields like artificial intelligence. The programme also connects participants with mentorship resources through associated platforms aimed at helping viable innovations reach commercial markets.

Queries about eligibility or the application process can be directed to the scheme’s dedicated support email.

Written By: Sayan Das 

Graphics by: Pramit Hazra

​Bioforum the Data Masters Expands Global Footprint with New Office and GCC in Bengaluru, India

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​Bioforum the Data Masters Expands Global Footprint with New Office and GCC in Bengaluru, India

Bioforum the Data Masters, a leading global biometric Contract Research Organization (CRO), announced the opening of its new office and Global Capability Center (GCC) in Bengaluru. The launch represents one of the largest growth initiatives in the company’s history, significantly broadening its worldwide delivery infrastructure.

​The new India GCC integrates key technical capabilities, including clinical data management, statistical programming, clinical coding, validation, clinical standards, and technology solutions. Serving as an integral hub within Bioforum’s global delivery network, the facility strengthens the organization’s follow-the-sun operational model and expands its Functional Service Provider (FSP) delivery model to support biopharmaceutical clients across time zones.

​“Our Global Capability Center in Bangalore significantly strengthens our ability to support complex global programs, expand our FSP delivery capabilities, and provide clients with the expertise and flexibility they need as their programs grow,” said Amir Malka, CEO and Co-Founder of Bioforum.

​The strategic move highlights India’s evolving position as a high-value hub for clinical data science and innovation.

​“India’s role in clinical development has fundamentally changed, from a delivery location to a strategic capability,” added Dr. Santhosh Kumar, Senior Vice President, India and GCC at Bioforum.

​The Bengaluru GCC enhances Bioforum’s capacity to deliver agile, high-quality data solutions for clinical trials worldwide, reinforcing its commitment to end-to-end biometrics excellence and scalable partner support.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

40,468 Lives Screened: Alembic Pharmaceuticals Earns Asia Book of Records Recognition

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40,468 Lives Screened: Alembic Pharmaceuticals Earns Asia Book of Records Recognition

Alembic Pharmaceuticals Limited has been recognized by the Asia Book of Records for conducting one of the largest blood pressure screening initiatives in the region, screening 40,468 patients over a two-week period. The nationwide effort brought together 2,174 doctors across India, united by a shared commitment to advancing community health.

The initiative reflects Alembic’s ongoing dedication to preventive healthcare, offering citizens across the country easy access to vital health checks that can help detect hypertension early and encourage timely medical intervention. Blood pressure, often called a “silent” risk factor for cardiovascular disease, remains a significant public health concern in India, making large-scale screening drives like this one especially valuable.

Speaking on the achievement, an Alembic spokesperson expressed pride in the collective effort of the medical community, noting that the milestone was made possible only through the participation and dedication of doctors nationwide.

Alembic Pharmaceuticals remains committed to initiatives that promote accessible, preventive healthcare for communities across India.

Written by: Arundhuti Chatterjee

Graphics by: Pramit Hazra

Cipla’s Pithampur Facility Receives 7 FDA Observations Following Inspection

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Cipla’s Pithampur Facility Receives 7 FDA Observations Following Inspection

Cipla Limited  announced the conclusion of a routine Current Good Manufacturing Practice (cGMP) inspection conducted by the United States Food and Drug Administration (US FDA) at its manufacturing facility located in Pithampur, Madhya Pradesh.

​The inspection concluded with the US FDA issuing a Form 483 containing seven procedural observations. The audit focused on evaluating standard operating procedures, quality control systems, and regulatory compliance protocols across the plant’s production lines.

​Cipla is thoroughly reviewing the observations and is preparing a comprehensive Corrective and Preventive Action (CAPA) response. The company will submit its detailed response to the US FDA within the stipulated 15-business-day timeframe and is committed to working closely with the regulatory agency to address all highlighted items promptly.

​”Quality and regulatory compliance remain the foundational pillars of Cipla’s global operations,” the company said in a statement. “We view continuous regulatory feedback as a vital component of maintaining highest-in-class manufacturing standards.”

​The Pithampur unit is a strategic site supporting Cipla’s global portfolio. The company does not anticipate any immediate disruption to product supplies or commercial operations and maintains full commitment to delivering safe, high-quality medicines to patients worldwide.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Roche Wins FDA Clearance for New Blood Test to Detect Alzheimer’s Disease

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Roche Wins FDA Clearance for New Blood Test to Detect Alzheimer’s Disease

Roche has secured U.S. Food and Drug Administration clearance for Elecsys pTau217, a plasma-based blood test designed to help physicians detect amyloid pathology linked to Alzheimer’s disease. The test targets adults aged 55 and above who present with cognitive decline symptoms, giving both primary care providers and specialists a shared diagnostic tool built on identical validated thresholds.

Co-developed with Eli Lilly and Company, ElecsyspTau217 stands out as the only FDA-cleared single-biomarker blood test capable of both confirming and ruling out amyloid pathology across care settings using one consistent cutoff standard—an approach Roche calls its “Power of One” strategy.

Dan Malarek, President and CEO of Roche Diagnostics North America, called the clearance a milestone that could bring diagnostic evaluation closer to patients and strengthen clinicians’ confidence in charting next steps. Carole Ho of Lilly Neuroscience emphasized the collaboration’s goal: narrowing the gap between symptom onset and diagnostic answers for families affected by the disease.

Roughly three-quarters of people living with dementia remain undiagnosed, and existing detection methods—PET scans and cerebrospinal fluid testing—are often expensive, invasive, and limited to specialty settings. Elecsys pTau217 offers a less invasive alternative that fits into current lab workflows, potentially identifying patients earlier and flagging who needs further imaging or specialist referral.

The test returns positive, intermediate, or negative results and is built to run on Roche’s existing network of more than 4,500 cobas laboratory instruments across the U.S., allowing rapid rollout without new equipment investment. Notably, this marks the fourth FDA-cleared blood-based Alzheimer’s biomarker test overall—and the second cleared within the same week—reflecting accelerating momentum toward accessible, blood-based neurological diagnostics.

Written By: Sayan Das 

Graphics by: Pramit Hazra

FDA Grants Approval to Johnson & Johnson’s IMAAVY for Warm Autoimmune Hemolytic Anemia

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FDA Grants Approval to Johnson & Johnson’s IMAAVY for Warm Autoimmune Hemolytic Anemia

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY® (nipocalimab-aahu) as the first therapy specifically indicated for the treatment of warm autoimmune hemolytic anemia (wAIHA). The approval extends to adult and pediatric patients aged 12 years and older who are currently or previously treated with corticosteroids.

wAIHA is a rare, antibody-driven condition that causes premature destruction of red blood cells. IMAAVY functions as an immunoselective neonatal Fc receptor (FcRn) blocker, engineered to selectively reduce disease-driving IgG autoantibodies while preserving essential B-cell immune function.

The FDA decision is supported by robust data from the pivotal Phase 2/3 ENERGY clinical study. In the trial, approximately three times as many patients treated with the approved dose of IMAAVY achieved a durable hemoglobin response compared to those on placebo at 24 weeks, demonstrating meaningful and sustained disease control.

“Today’s announcement marks the second approval for IMAAVY and is an extraordinary milestone for people living with warm autoimmune hemolytic anemia, an underserved community that has waited far too long for an FDA-approved treatment,” said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head at Johnson & Johnson. “As the first approved therapy for wAIHA, IMAAVY has the potential to redefine disease management, particularly for people with uncontrolled disease.”

This regulatory milestone strengthens the clinical utility of FcRn-targeted therapies across serious antibody-driven autoimmune conditions. IMAAVY provides a much-needed, targeted therapeutic option designed to address the underlying mechanism of hemolytic anemia and improve long-term outcomes for patients navigating this challenging disorder.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

FDA Approves World’s First Combined Glucose-Ketone Wearable Monitor

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FDA Approves World’s First Combined Glucose-Ketone Wearable Monitor

The U.S. Food and Drug Administration has granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, approved for use in patients aged two and above with diabetes. This marks a significant milestone: it is the first FDA-cleared wearable in the country capable of continuously tracking ketone levels, and the first device anywhere to combine real-time glucose and ketone monitoring within one wearable sensor.

CDRH Director Michelle Tarver highlighted the device’s potential to give families and clinicians a critical head start against dangerous ketone spikes, framing the clearance as a meaningful advance in patient safety.

Roughly 40 million Americans currently manage diabetes, with an estimated 2.1 million living with type 1 diabetes, a population particularly vulnerable to diabetic ketoacidosis (DKA) — a fast-developing, potentially fatal complication triggered by excess ketone production. Previously, ketone testing relied on isolated point-in-time readings. The Libre Duo 10 Day instead samples interstitial fluid every 60 seconds across its 10-day wear cycle, transmitting trend data to a paired smartphone and issuing alerts when ketone levels climb toward risk thresholds.

Supporting clinical evidence came from six studies spanning over 600 participants, confirming the sensor’s ability to detect meaningful ketone shifts — including early rises preceding DKA onset — alongside reliable glucose tracking.

The product received Breakthrough Device designation ahead of its review and was authorized through the De Novo pathway, alongside newly established special controls governing labeling and performance standards for this novel device category.

This is a sensitive health-related topic — if you or someone you know needs personalized guidance on diabetes management or DKA risk, please consult a healthcare provider.

Written By: Sayan Das 

Graphics by: Pramit Hazra

Lundbeck and EVERSANA Enter Strategic Partnership to Advance AI-Powered Commercialization Across U.S. Operations

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Lundbeck and EVERSANA Enter Strategic Partnership to Advance AI-Powered Commercialization Across U.S. Operations

Lundbeck, a global biopharmaceutical leader focused exclusively on brain health, and EVERSANA®, a leading global provider of commercial services to the life sciences sector, have announced a strategic partnership to scale AI-powered commercialization across Lundbeck’s U.S. commercial organization.

​The expanded collaboration builds on initial successful deployments and broadens Lundbeck’s integration of EVERSANA’s AI Agency platform. By leveraging agentic AI orchestration, workflow automation, and human oversight, the platform establishes an operating model designed to accelerate strategic planning, content generation, and omnichannelengagement while strictly adhering to life sciences governance and medical, legal, and regulatory (MLR) compliance.

​Under the partnership, Lundbeck will scale these capabilities across multiple key commercial functions, including marketing, medical communications, market access, and media operations. The initiative directly supports Lundbeck’s “Focused Innovator” strategy and ambition to build “bionic capabilities” combining artificial intelligence with deep human domain expertise to streamline operations and enhance speed-to-market.

​Executive leadership from both organizations emphasized that the alliance moves beyond isolated AI pilot programs into enterprise-level commercial execution. By embedding compliance and scientific rigor into AI workflows, the partnership aims to enhance operational agility, reduce cycle times, and ultimately deliver greater value and essential therapies to patients living with neurological and psychiatric disorders.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Montage Laboratories Commences Construction of Manufacturing Unit 3 to Expand Production Footprint

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Montage Laboratories Commences Construction of Manufacturing Unit 3 to Expand Production Footprint

Montage Laboratories Pvt. Ltd., a manufacturer of pharmaceutical formulations, has performed the Bhoomi Pujan(groundbreaking ceremony) for its upcoming manufacturing facility, Unit 3. The milestone marks a new phase in the company’s infrastructure and capacity expansion roadmap.

​The new unit is designed to enhance Montage Laboratories’ manufacturing capabilities and strengthen its production capacity to meet the growing domestic and global demand for quality-driven formulations. The facility will operate under Current Good Manufacturing Practice (cGMP) standards, expanding on the company’s existing operations in Himmatnagar.

​Company leadership, stakeholders, and team members attended the groundbreaking ceremony. The management highlighted that this strategic investment is a vital step toward scaling up operations, enhancing technical infrastructure, and reinforcing the company’s long-standing commitment to delivering high-quality, affordable healthcare solutions.

​Construction and development work for Unit 3 will commence immediately, with further details on production lines and project timelines to be announced as development progresses.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

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