AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for an additional indication of its cancer treatment drug Durvalumab Solution for Infusion. The company announced this development through a regulatory filing dated January 31, 2026, addressed to both BSE Limited and National Stock Exchange of India Limited under SEBI Listing Regulation 30.

Drug Approval Details

The CDSCO, operating under the Directorate General of Health Services, Government of India, has granted permission for the import, sale, and distribution of Durvalumab in two formulations:

Treatment Indication and Protocol

The newly approved indication allows Durvalumab to be used in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single-agent Durvalumab. This treatment protocol is specifically indicated for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

The approval represents an expansion of the drug's therapeutic applications, potentially benefiting patients suffering from these specific types of cancer. The combination therapy approach involves both pre-operative (neoadjuvant) and post-operative (adjuvant) treatment phases.

Market Implications

This regulatory approval paves the way for AstraZeneca Pharma India to market Durvalumab Solution for Infusion in both approved formulations within the Indian market for the specified additional indication. However, the company has noted that actual marketing activities remain subject to obtaining any related statutory approvals that may still be required.

The announcement was formally communicated to stock exchanges through Chief Financial Officer & Director Bhavana Agrawal, emphasizing the company's commitment to regulatory compliance and transparency in sharing material developments with stakeholders.

AstraZeneca Pharma India Limited has announced the resignation of Ms. Sylvia Lorena Varela Ramon, Non-Executive Director, effective February 28, 2026. The pharmaceutical company communicated this development to both BSE Limited and National Stock Exchange of India Limited on January 29, 2026, in accordance with regulatory disclosure requirements.

Resignation Details and Timeline

Ms. Ramon submitted her resignation letter on January 29, 2026, stating her intention to step down from her directorial position with effect from the close of business hours on February 28, 2026. The resignation was formally communicated pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Committee Resignations

Along with her directorial position, Ms. Ramon also resigned from her committee memberships within the company. Her resignation encompasses her roles on both the Nomination and Remuneration Committee and the Stakeholder's Relationship Committee of AstraZeneca Pharma India Limited.

Company Response and Acknowledgment

The company has formally acknowledged Ms. Ramon's decision and placed on record its sincere thanks and appreciation for her contribution during her tenure. In her resignation letter, Ms. Ramon expressed gratitude to her fellow Board members and the company management for their support and guidance during her time on the Board.

The resignation letter was signed by Ms. Ramon and addressed to the Board of Directors at the company's Bangalore office. She stated that she would "remember fondly" her experience working with the board and wished the company great success in the future.

Regulatory Compliance

The announcement was made in compliance with SEBI circular SEBI/HO/CFD/PoD2/CIR/P/0155 dated November 11, 2024. Chief Financial Officer & Director Bhavana Agrawal digitally signed the regulatory filing on January 29, 2026, ensuring proper disclosure to the stock exchanges and stakeholders.