| |APRIL 20269ONESOURCE PARTNER WINS USFDA NOD FOR GENERIC SEMAGLUTIDE DRUGCDSCO PRIOR INTIMATION MECHANISM SPEEDS UP DRUG TESTING IN INDIAICMR PALLIATIVE CARE STUDY AIMS TO EXPAND ACCESS IN INDIAONCOLOGY DRUGMAKERS SEE GAP BETWEEN INNOVATION AND REAL-WORLD CARE GAPNCR'S FAKE MOUNJARO PROBLEM IS BIGGER THAN YOU THINKOneSource Speciality Pharma has said that its partner, Orbicular Pharmaceutical Technologies, along with a US-based front-end partner, has received tentative approval from the U.S. Food and Drug Administration for a generic version of semaglutide injection, a widely used treatment for diabetes.The approval relates to an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic, a leading drug used to manage type 2 diabetes and, increasingly, for weight loss. A tentative approval means the product has met the regulator's standards for drug safety, quality, and effectiveness, but cannot yet be launched commercially due to existing patent protection barriers.OneSource acted as the contract development and manufacturing organization (CDMO) partner for the product. The company supported the process with its manufacturing capabilities, including work carried out at its USFDA-approved facility in Bengaluru. This highlights its growing role in handling complex injectable drugs for global markets. POIndia's CDSCO prior intimation mechanism is now live, marking a shift in how drug makers begin early-stage manufacturing for research.The Central Drugs Standard Control Organisation has rolled out the system from April 21, 2026, replacing the older requirement of securing a test license before producing small batches of new or investigational drugs.Under the updated New Drugs and Clinical Trials Rules 2019, pharmaceutical companies can start manufacturing limited quantities for testing and analysis by simply submitting an online intimation. POIndia is set to take a major step toward improving end-of-life support as the Indian Council of Medical Research rolls out a palliative care study across multiple states.Announced today, this initiative aims to address a long-standing gap in the country's healthcare system, where access to pain relief and supportive care remains extremely limited for millions.The ICMR palliative care study will focus on building practical models that can be integrated into public hospitals and scaled nationwide. POIndian oncology medicine manufacturers are witnessing a clear disconnect between rapid scientific innovation -- including NCR's fake Mounjaro problem is growing fast--and most people don't see it coming.In fact, it is no longer limited to shady corners of the market. It's now tied to a Rs 70 lakh cache of counterfeit injections recently uncovered, pointing to a much larger issue beneath the surface.Demand for Mounjaro has surged across India, driven by its growing reputation as a powerful weight-loss and diabetes drug.That demand has created the perfect opening for counterfeit versions to quietly enter the market. These fake injections are not just being sold at suspiciously low prices--they are often priced close to the real product, making them harder to question. POtargeted therapies, biosimilars, next-generation sequencing (NGS), minimal residual disease assays, and immuno-oncology treatments and their on-ground implementation in clinical settings, especially in resource-constrained environments.This gap threatens to limit the benefits of precision medicine for the vast majority of cancer patients in India, where diagnostic access, referral pathways, and affordability remain uneven. PO
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