Daily Pharma News - 28 October 2026
Today's pharma news brings together drug safety, drug pricing, industry growth, and new approvals from India, China, Russia, and the United States. From a counterfeit medicine alert in India to new options for rare diseases and eye disorders, these stories show how regulation, research, and industry decisions shape everyday pharmacy practice. Here is what pharmacy students in India need to know.
CDSCO Counterfeit Defitelio Alert in India: Falsified Defibrotide Batch 24GC01A Warning
India's Central Drugs Standard Control Organisation (CDSCO) has sounded an alert over a falsified batch of Defitelio (defibrotide) 80 mg/mL, batch number 24GC01A. Acting on a World Health Organization (WHO) alert, CDSCO warned that this falsified product may be in circulation in India, even though it has no Indian authorisation. Defibrotide is a specialised medicine used in severe hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, following haematopoietic stem-cell transplantation, so any falsified version poses a serious patient-safety risk, particularly because it is given intravenously.
For pharmacy students, this story is a powerful lesson in pharmacovigilance, drug supply-chain integrity, and the role of national regulators. Counterfeit and falsified medicines are not only a legal problem; they can fail to work, cause harm, and destroy trust in the health system. Students should learn how to check batch numbers, authorisation status, and sourcing, and why suspicious products must be reported through proper regulatory channels rather than handled informally.
Supreme Court Drug Pricing Case in India: NPPA, MRP, and the Retailer Price Gap
On 27 October, the Supreme Court of India questioned the Centre over the wide gap between a medicine's maximum retail price (MRP) and the price at which retailers obtain it. The court asked why the system appeared to favour manufacturers and strongly criticised the National Pharmaceutical Pricing Authority (NPPA), reportedly calling it "totally defunct", before reserving its order. The case touches on a long-running debate in Indian pharmaceutical policy: how prices are fixed, how trade margins work, and whether patients actually benefit from the difference between MRP and procurement cost.
This is essential reading for students of pharmaceutical jurisprudence, drug pricing policy, and the Drugs (Prices Control) Order. The NPPA, working under the Department of Pharmaceuticals, regulates the prices of scheduled formulations and monitors the prices of non-scheduled medicines. Whatever the court finally orders, the hearing itself signals that drug affordability, pricing transparency, and regulator accountability will remain central questions for India's pharmacy profession.
Agilisium Asia Headquarters Moves from Chennai to Hyderabad: Telangana Pharma and Biotech Growth
Life-sciences company Agilisium plans to shift its Asia headquarters from Chennai to Hyderabad, citing Telangana's strong pharmaceutical and biotechnology ecosystem. The company is targeting $500 million in revenue and around 5,000 employees over the next five to seven years. The move underlines Hyderabad's growing position as a hub for life-sciences services, with its established Genome Valley cluster, research institutions, and manufacturing base in and around the city.
For students in South India and across the country, this is also a careers story. Growth in life-sciences services, data, and analytics creates demand for pharmacy graduates who combine domain knowledge with skills in clinical research, pharmacovigilance, regulatory affairs, and real-world data. Hyderabad's rise alongside Chennai's existing strengths shows how regional pharma ecosystems compete and collaborate, and why students should follow industry investment, not only drug approvals.
FDA Approves Berotralstat Oral Pellets (Orladeyo) for Hereditary Angioedema in Patients Aged 12 and Older
The United States Food and Drug Administration (FDA) has approved BioCryst Pharmaceuticals' 150 mg berotralstat (Orladeyo) oral pellets for preventing hereditary angioedema (HAE) attacks in patients aged 12 years and older. Berotralstat is a plasma kallikrein inhibitor taken once daily for prophylaxis, and the new pellet formulation offers an alternative for patients who cannot swallow capsules. HAE is a rare genetic disorder that causes recurrent, potentially life-threatening swelling attacks, so easier-to-take preventive options can make a real difference to adherence and quality of life.
For pharmacy students, this approval is a useful case study in formulation development and patient-centred drug design. The active ingredient is unchanged, but the dosage form is new, and that change alone can widen access for adolescents and for patients with swallowing difficulties. It also shows how rare-disease drug development works: small patient populations, high unmet need, and steady lifecycle improvements after an original approval.
FDA Approves Xbrane Lucamzi (Ranibizumab-blrz), a Lucentis Biosimilar for Retinal Diseases
The FDA has approved Lucamzi (ranibizumab-blrz), Xbrane Biopharma's biosimilar to Lucentis (ranibizumab), for retinal diseases. The approval followed delays linked to contract manufacturing, and the product is expected to widen access at a lower cost than the reference biologic. Ranibizumab is an anti-VEGF medicine injected into the eye to treat conditions such as neovascular age-related macular degeneration, diabetic macular oedema, and retinal vein occlusion, where it helps preserve vision.
Biosimilars are a key topic for Indian pharmacy students because India is one of the world's largest producers of biosimilars and generic medicines. This approval illustrates the full biosimilar journey: demonstrating similarity to the reference product, resolving manufacturing and quality issues, and then competing on access and price. As more ophthalmic biosimilars reach the market, pharmacists will need to explain interchangeability, safety monitoring, and the difference between a biosimilar and a generic to patients and prescribers.
China NMPA Accepts Sintilimab Plus GC101 for Advanced Melanoma: Innovent TIL Therapy Application
China's National Medical Products Administration (NMPA) has accepted Innovent Biologics' application for sintilimab combined with nolgileucel (GC101) tumour-infiltrating lymphocyte (TIL) therapy for unresectable or metastatic melanoma in patients who have received at least two prior therapies, including a PD-1 antibody. Sintilimab is a PD-1 inhibitor, while GC101 is a TIL cell therapy that uses a patient's own tumour-infiltrating immune cells, expanded outside the body, to attack the cancer. The combination aims to help patients whose melanoma has already progressed after standard immunotherapy.
This is an exciting development for students studying cancer immunotherapy, biologics, and cell and gene therapy. TIL therapy sits at the intersection of biotechnology, hospital pharmacy, and personalised medicine, and its progress in China shows how quickly the field is moving beyond traditional checkpoint inhibitors alone. For Indian students, it is also a reminder that oncology innovation is increasingly global, with China now a major source of novel immunotherapy applications.
R-Pharm Four-Year Viltepso (Viltolarsen) Data in Duchenne Muscular Dystrophy at World Muscle Society 2026
R-Pharm has presented four years of real-world data on viltolarsen (Viltepso) in Duchenne muscular dystrophy (DMD) at the World Muscle Society 2026 congress. The data showed motor function largely stable over the four-year period, with no nephrotoxicity observed. Viltolarsen is an antisense oligonucleotide that enables exon 53 skipping in the dystrophin gene, allowing production of a shortened but partly functional dystrophin protein in patients with DMD amenable to exon 53 skipping.
Duchenne muscular dystrophy is a rare, progressive genetic disorder that causes muscle degeneration, and long-term real-world evidence is especially valuable because clinical trials in rare diseases are often small and short. For pharmacy students, this story connects genetics, molecular pharmacology, and pharmacovigilance: exon-skipping therapy is a textbook example of precision medicine, while the four-year safety follow-up shows why kidney monitoring and long-term outcome tracking matter for oligonucleotide therapies.
Conclusion
Taken together, today's stories show a pharmacy profession pulled in three directions at once: protecting patients from falsified medicines, making genuine medicines more affordable and accessible, and delivering ever more precise therapies for rare and difficult diseases. India's counterfeit alert and the Supreme Court's pricing questions are about the foundations of trust and access, while the approvals and applications from the United States, China, and Russia are about what modern pharmacology can now achieve. For pharmacy students, the lesson is clear: stay strong on the basics of pharmacology, jurisprudence, and pharmacovigilance, and stay curious about biosimilars, immunotherapy, and cell-based treatments, because both will define your career. Keep following PharmacoLearn for daily pharma news explained simply, with the science behind the headlines.
References
- Eflip https://eflip.in/india-sounds-alert-over-counterfeit-defitelio/
- Telangana Today https://telanganatoday.com/why-is-system-helping-pharma-makers-asks-supreme-court
- Deccan Chronicle https://www.deccanchronicle.com/southern-states/telangana/agilisium-plans-to-shift-asia-headquarters-to-hyderabad-1999499
- HCPLive https://www.hcplive.com/view/fda-approves-berotralstat-oral-pellets-adults-adolescents-hae
- Life Science Focus https://www.lifesciencefocus.com/article/view/1253410/xbrane_wins_longawaited_fda_approval_for_eye_drug_biosimilar
- PharmaShots https://pharmashots.com/36767/nmpa-accepts-innovent-sintilimab-gc101-advanced-melanoma/
- GxP News https://gxpnews.net/en/2026/10/r-pharm-shared-its-experience-in-treating-duchenne-muscular-dystrophy-at-a-world-congress/
