AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Durvalumab Solution for Infusion, branded as Imfinzi, for an additional therapeutic indication. The approval, granted on March 16, 2026, specifically covers the treatment of unresectable hepatocellular carcinoma in patients without prior systemic treatment.

CDSCO Approval Details

The regulatory permission from the Directorate General of Health Services, Government of India, authorizes the import for sale and distribution of Durvalumab Solution for Infusion in two dosage strengths. This approval represents a significant milestone in expanding treatment options for liver cancer patients in India.

Market Authorization Impact

The CDSCO permission paves the way for marketing Durvalumab Solution (Imfinzi) in India for the specified additional indication, subject to receipt of related statutory approvals. This regulatory milestone strengthens AstraZeneca Pharma's oncology portfolio in the Indian market by providing oncologists with an advanced therapeutic option for managing hepatocellular carcinoma.

Clinical Significance

Durvalumab's approval for unresectable hepatocellular carcinoma addresses a critical medical need in India's healthcare system. The specific indication for treatment-naive patients represents those who have not previously received systemic therapy, expanding the treatment landscape for this challenging form of liver cancer.

The company formally communicated this development to stock exchanges under Regulation 30 of SEBI Listing Obligations and Disclosure Requirements Regulation, 2015, highlighting the significance of this regulatory achievement for stakeholders.

AstraZeneca Pharma India Limited has filed a regulatory compliance certificate with stock exchanges, confirming its adherence to SEBI dematerialization regulations. The pharmaceutical company submitted the certificate to both BSE Limited and National Stock Exchange of India on March 13, 2026, through Company Secretary and Compliance Officer Tanya Sanish.

Regulatory Compliance Certificate Details

The compliance certificate was issued by Integrated Registry Management Services Private Limited, the company's Registrar and Transfer Agent, on March 3, 2026. The certificate specifically addresses compliance with Regulation 74(5) of SEBI (Depositories and Participants) Regulations, 2018, covering the period from February 1, 2026 to February 28, 2026.

Compliance Confirmations

The Registrar and Transfer Agent confirmed compliance with three key regulatory requirements within the mandated 15-day timeframe upon receipt of security certificates from depository participants:

• Securities comprised in dematerialized certificates are properly listed on relevant stock exchanges
• Physical certificates forwarded by participants have been mutilated and canceled
• Depository names have been substituted as registered owners in company records

Corporate Information

AstraZeneca Pharma India Limited operates from its corporate and registered office at Manyata Embassy Business Park, Bangalore, with manufacturing facilities located at Bellary Road, Yelahanka. The company maintains its commitment to regulatory compliance through systematic adherence to SEBI guidelines and timely submissions to stock exchanges.

The certificate submission represents standard regulatory practice, ensuring transparency in securities handling and maintaining investor confidence in the dematerialization process. The company's proactive approach to regulatory compliance demonstrates its commitment to maintaining proper corporate governance standards.