India Pharma Outlook Team | Monday, 06 October 2025
AstraZeneca Pharma India has been given the green light by the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder, branded as Enhertu.
This regulatory nod is a big move to empower clinicians with sophisticated therapeutic measures in India to tackle the most challenging cases with limited alternative treatment options. Enhertu is the first-in-class drug directed at adult patients suffering from HER2 IHC 3+ solid tumors that are unresectable or have metastasized.
In other words, pharmaceutical products are advised as a rescue plan after the first line systemic treatment and when any other plausible line of treatment is missing. The approval is testimony to AstraZeneca’s resolve to making available state-of-the-art oncological treatments to Indian patients somewhere beyond the current reach of medical science.
AstraZeneca is a multispecialty pharmaceutical company that is driven by a scientific approach and is engaged in the discovery, development, and commercial utilization of prescription drugs across four major therapeutic areas: Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Rare Diseases.
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The company's commitment to patient-centered R&D innovation allows for the drawing in of new effective treatments globally, in turn resulting in increased patient access to a broad portfolio of truly transformative therapies.
In particular, approval for import and distribution of Enhertu broadens the range of drugs available to healthcare professionals to select a case-sensitive patient-centric therapy plan thereby resulting in higher quality of treatment and better prognosis as well.
The event is a further indication of AstraZeneca’s unwavering dedication to not only providing patients in India with access to innovative medicines but also to playing a vital role in the country’s oncology care landscape transformation journey.
