AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organization (CDSCO) to import and sell Trastuzumab deruxtecan for an additional indication, specifically for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. The approval, granted on June 10, 2026, covers the 100 mg/5mL vial lyophilized powder for concentrate for solution for infusion under the brand name Enhertu®. This regulatory clearance allows the company to market the drug in India for the specified indication, subject to the receipt of related statutory approvals.

Regulatory Approval Details

The authorization from the Directorate General of Health Services, Government of India, permits AstraZeneca Pharma India to import for sale and distribution of the drug. The approval specifically targets the use of Trastuzumab deruxtecan in combination with pertuzumab.

Significance of the Approval

The regulatory green light represents a key step in expanding the availability of Enhertu® to the Indian market for this specific patient group. The approval underscores AstraZeneca Pharma India's continued efforts to broaden its pharmaceutical offerings in the country through the necessary regulatory channels.

Promoter AstraZeneca Pharmaceuticals AB has confirmed that it did not create any encumbrance on its shares in AstraZeneca Pharma India Limited during the financial year 2025-26. The declaration, submitted to the stock exchanges, assures stakeholders that the shares held by the promoter remain free from any such charges or liabilities. This disclosure is significant as it provides transparency regarding the promoter's holding structure and compliance with regulatory norms.

The declaration was made under Regulation 31(4) of the SEBI (Substantial Acquisition of Shares and Takeovers) Regulations, 2011. This regulation requires promoters to disclose any encumbrance on their holdings annually. The filing covers the period from April 1, 2025, to March 31, 2026. The document explicitly states that the promoter has not, directly or indirectly, made any encumbrance on the shares during this timeframe.

The confirmation was signed by Lars-Johan Cederbrant, Director and Authorised Signatory of AstraZeneca Pharmaceuticals AB. The letter was addressed to the Managers of Listing at both BSE Limited and National Stock Exchange of India Ltd. The promoter requested the exchanges to place the declaration on record. The filing was dated April 2, 2026, and originated from Sweden.