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Maharashtra FDA Withdraws Drug License Cancellation Order for Cipla C&F Unit Following Bombay High Court Rebuke

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Maharashtra FDA Withdraws Drug License Cancellation Order for Cipla C&F Unit Following Bombay High Court Rebuke

In a major regulatory development, the Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelingthe drug sale license of Cipla Pharma & Life Sciences Ltd’sCarrying and Forwarding (C&F) unit in Wadki, Pune. The decision follows sharp reprimands from the Bombay High Court, which ruled that the state regulator acted in a “high-handed” manner and in direct violation of the principles of natural justice.

​The division bench, comprising Acting Chief Justice RavindraGhuge and Justice Gautam Ankhad, intervened after Ciplachallenged the FDA’s sudden cancellation. The court observed that the regulatory authority had gone “overboard” in enforcing punitive measures without adhering to the required statutory procedures and fair hearing norms.

​The initial cancellation order, slated to take effect from August 27, was issued by the Maharashtra FDA citing alleged irregularities regarding the packaging, storage, and recall protocol of Reactin Plus Tablets handled at the Wadkidistribution facility.

​Following the High Court’s intervention and strong rebuke, the FDA consented to withdraw the cancellation order forthwith. The regulator has stated that it will issue a fresh show-cause notice to Cipla Pharma & Life Sciences Ltd, allowing the company due opportunity to respond before any formal, reasoned order is passed.

​This judicial intervention safeguards the distribution operations of essential pharmaceutical supplies while reinforcing the necessity for statutory authorities to uphold due process. Ciplacontinues to maintain that it adheres strictly to standard regulatory compliance and quality assurance protocols across its supply chain network.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Orsini Partners with Priovant to Support Access to New Dermatomyositis Therapy LISRAYA

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Orsini Partners with Priovant to Support Access to New Dermatomyositis Therapy LISRAYA

Orsini, a specialty pharmacy known for its work in rare disease care, has been named a specialty pharmacy partner for LISRAYA (brepocitinib), a newly approved oral treatment from Priovant Therapeutics for adults living with dermatomyositis. The once-daily medication is notable as the first targeted therapy cleared for this rare and often debilitating autoimmune condition.

Dermatomyositis affects the skin and muscles, causing painful rashes and progressive weakness, and can extend to the lungs, heart, and digestive system. Because treatment options have historically been limited, the approval marks a meaningful shift for patients and their care teams.

LISRAYA’s approval is supported by findings from the VALOR trial, described as the largest placebo-controlled study conducted in dermatomyositis to date. Trial participants who received the therapy showed measurable improvement across several disease indicators, including muscle strength, skin symptoms, overall functioning, and the ability to reduce steroid use.

Orsini leadership expressed enthusiasm about supporting patients through this new option, framing the collaboration as an opportunity to ease access to a therapy long awaited by the dermatomyositis community. Priovant’s leadership echoed that sentiment, pointing to Orsini’s established track record with rare disease therapies as key to ensuring patients transition smoothly onto treatment.

Founded in 1987, Orsini specializes in connecting patients with advanced and rare disease therapies through pharmacy distribution, clinical support, patient services, and home infusion care. The company holds accreditation from ACHC, URAC, and NABP, including URAC’s Rare Disease Pharmacy Center of Excellence recognition.

LISRAYA carries a boxed warning covering risks of serious infection, mortality, malignancy, major cardiovascular events, and thrombosis. Prescribers and patients are advised to consult the full prescribing information before starting therapy.

Written By: Sayan Das 

Graphics by: Pramit Hazra

‘Shwas Kavach’ Initiative Gains Government Recognition for AI-Enabled Last-Mile Medical Oxygen Network

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‘Shwas Kavach’ Initiative Gains Government Recognition for AI-Enabled Last-Mile Medical Oxygen Network

Shwas Kavach, an initiative aimed at strengthening India’s last-mile medical oxygen supply, has received recognition and support from the Office of the Principal Scientific Adviser (PSA) to the Government of India. The project was formally endorsed on the government’s Manthan platform on 8th May 2026 as an AI-enabled, decentralized model for delivering oxygen to healthcare facilities across the country.

The initiative is being developed by CPDMED at the Indian Institute of Science, Bengaluru, together with Newttorr Pumps and Systems Private Limited. It proposes an AI-linked network covering all 778 districts in India, connecting government and military healthcare facilities down to the primary health centre level, supported by a round-the-clock toll-free helpline linking healthcare facilities and oxygen resources. Central to the plan are containerised, IoT-enabled oxygen cylinder filling units to be set up at district drug warehouses, allowing real-time monitoring of purity, pressure, volume and pricing. Once fully implemented, the network is expected to establish approximately 60,165 cylinder banks across district and taluka hospitals, community and primary health centres, along with military, air force and naval hospitals.

The initiative draws on lessons from the pandemic years, when large-scale investment in oxygen generation infrastructure was not enough for timely access to healthcare, especially in rural areas, as supply chains remained concentrated in urban centres. Many home-based patients are reported to have gone without oxygen in time, with such cases often left undocumented.

Shwas Kavach is positioned as a preparedness framework for future health emergencies, built to keep medical oxygen consistently available, accessible, affordable and accountable, down to the village level. Newttorr has also piloted what it describes as India’s first IoT-enabled oxygen cylinder filling station under its Oxy Aid brand.

Special thanks to Mr. Mallikarjun Dandinawar for his valuable support and contribution. 

Written By: Sayan Das

Graphics by: Pramit Hazra

India’s First AYUSH University to Build 100-Acre Permanent Campus in Kurukshetra, Haryana

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India’s First AYUSH University to Build 100-Acre Permanent Campus in Kurukshetra, Haryana

The Ministry of Ayush announced the development of the permanent campus for India’s first dedicated AYUSH University, sprawling across nearly 100 acres in Fatehpurvillage, Kurukshetra, Haryana. First announced in 2017, the landmark institution stands as the nation’s premier university exclusively dedicated to education, research, and healthcare across all five AYUSH systems: Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy.

​The comprehensive project will be executed in three distinct phases to establish a world-class holistic healthcare ecosystem. The Phase 1 development, valued at ₹465 crore, is scheduled for completion within 30 months. This initial phase will feature a state-of-the-art Research & Innovation Centre, an AyurvedicPostgraduate College, a central library, and student hostels, alongside sustainable green infrastructure equipped with solar power generation and rainwater harvesting systems.

​Across its full development lifecycle, the university complex will house extensive clinical facilities, including a dedicated 250-bed Ayurveda hospital alongside separate 50-bed multi-specialty hospitals for each of the other AYUSH disciplines.

​The institution is already making a tangible impact on community health, currently recording more than 450 daily outpatient department (OPD) visits. The establishment of this integrated, modern campus reinforces India’s commitment to advancing traditional medicine systems through evidence-based research, specialized education, and accessible patient care.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Pfizer-BioNTech’s Updated COVID-19 Vaccine Gets FDA Nod for 2026-2027

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Pfizer-BioNTech’s Updated COVID-19 Vaccine Gets FDA Nod for 2026-2027

Pfizer Inc. and BioNTech SE said Thursday that U.S. regulators have cleared their refreshed COVID-19 shot, giving American providers a strain-matched option just as the fall respiratory season approaches. The Food and Drug Administration signed off on a supplemental license application covering the 2026-2027 version of COMIRNATY, now formulated to target the XFG lineage rather than earlier circulating strains.

The newly authorized shot, branded COMIRNATY XFG, is cleared for adults 65 and older, along with anyone between 5 and 64 who carries an underlying health condition that raises their risk of serious COVID-19 illness. Regulators based their decision on an accumulated evidentiary record spanning clinical trials, laboratory data, and years of real-world use, layered with fresh manufacturing and non-clinical findings. That newer data indicated the reformulated vaccine triggered a robust immune reaction not only against XFG itself but against related descendants circulating this year, including XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1.

Choosing XFG as the season’s target strain follows direction the FDA issued earlier this year identifying it as the composition best suited to U.S. vaccination efforts heading into fall 2026. With sign-off secured, the companies said doses would begin moving to pharmacies, hospitals and clinics nationwide right away, with broad availability expected within days.

COMIRNATY’s mRNA platform, jointly advanced by the two companies, has now been administered in excess of five billion doses worldwide since its introduction, a track record the companies point to as evidence of a consistent safety and effectiveness profile built on continuous pharmacovigilance and manufacturing oversight.

Written By: Sayan Das 

Graphics by: Pramit Hazra

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

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