Zydus Lifesciences has secured a significant regulatory milestone with the High Court granting permission to manufacture semaglutide, a key medication used in diabetes treatment and weight management. The court order also authorizes the pharmaceutical company to export the drug to specific international markets.

Regulatory Approval Details

The High Court's decision enables Zydus Lifesciences to enter the manufacturing of semaglutide, which represents an important addition to the company's pharmaceutical portfolio. The approval encompasses both domestic manufacturing rights and export authorization to certain nations, positioning the company to serve select international markets.

Strategic Implications

This regulatory clearance positions Zydus Lifesciences to participate in the growing diabetes care market through semaglutide production. The export authorization particularly enhances the company's potential to expand its international pharmaceutical business operations in the diabetes and metabolic health treatment segment.

The court's permission marks a notable development for Zydus Lifesciences in strengthening its presence in the specialized therapeutic area of diabetes care and weight management solutions.

Zydus Lifesciences Limited has signed an exclusive agreement with Myriad Genetics, a leader in molecular diagnostic testing and precision medicine, to launch cancer-risk assessment diagnostic tests in India. The partnership was announced through a press release dated December 19, 2025.

Agreement Details

Under the exclusive agreement, Zydus will introduce three key diagnostic tests to the Indian market:

These globally trusted tests have been widely adopted in North America, Europe, and major global cancer centres, and will now empower Indian oncologists with cutting-edge genomic decision-support tools.

Test Specifications and Applications

The MyRisk Test analyzes 63 clinically significant genes including BRCA1, BRCA2, PALB2, ATM, TP53, MLH1, and MSH2, covering cancer types like breast, ovarian, lung, pancreatic, colorectal, endometrial, prostate, gastric, and melanoma. The test includes a Risk Score that combines genetic and clinical data to predict 5-year and lifetime breast cancer risk.

The MyChoice HRD Plus Test determines HRD status based on genomic alterations in BRCA1 and BRCA2 genes and Genomic Instability Score using Myriad's proprietary algorithm. This enables healthcare professionals to identify patients with advanced ovarian cancer who are more likely to respond to targeted therapies.

The Prolaris Test is an RNA-based gene expression test that quantifies tumour aggressiveness and provides patient-specific risk scores, helping clinicians determine treatment approaches and 10-year risk of metastasis.

Management Commentary

Dr. Sharvil P. Patel, Managing Director of Zydus, stated that the agreement marks a major step in expanding access to precision diagnostic tests for cancer treatment in India. He emphasized that the tests will help doctors develop personalized treatment plans, predict disease progression, and streamline clinical workflows.

"This collaboration with Myriad Genetics will strengthen clinician education and diagnostic infrastructure so that patients benefit from earlier, more accurate risk assessment and more confident treatment planning," Dr. Patel added.

Brian Donnelly, Chief Commercial Officer for Myriad Genetics, described the collaboration as an important step forward in expanding precision oncology across India, noting that Myriad tests aim to empower clinicians with actionable information for personalized care.

Market Impact

The partnership addresses the increasing incidence of cancers globally and in India specifically. With rising prostate cancer incidence in India, the Prolaris Test offers a clinically validated tool for personalized therapy decisions. The collaboration is expected to make personalized, evidence-based cancer care accessible to patients across India's healthcare system.