Shilpa Medicare received final marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for OERIS, an extended-release ondansetron injection. The company’s Co Managing Director announced the SEC’s final approval, marking a significant milestone in enhancing supportive cancer treatment.

The Subject Expert Committee (SEC) under the CDSCO granted the authorization following the successful completion of Phase III trials. These multicenter, randomized, double-blind trials evaluated the safety and efficacy of the formulation for chemotherapy-induced nausea and vomiting (CINV).

Product Specifications

OERIS is designed as the world’s first extended-release ondansetron injectable formulation. It provides sustained antiemetic action for up to 120 hours (5 days) after a single administration. This duration significantly reduces the need for repeat injections compared to standard formulations.

Clinical and Commercial Outlook

The formulation aims to enhance patient convenience and optimize healthcare staff efficiency by requiring only one dose every five days. Shilpa plans to initiate the commercial launch across India immediately upon receipt of this final marketing authorization.

What the Numbers Show

The patent protection extending until 2039 provides a long-term exclusivity window for this novel complex injectable. This extended period allows for substantial revenue realization potential before generic competition can enter the market, supporting the company’s strategy in high-value specialty therapeutics.

Shilpa Medicare declared a dividend of ₹0.60 per equity share for the financial year ended March 31, 2026, during its 39th Annual General Meeting held on September 11, 2026.

The meeting, conducted via Video Conferencing and Other Audio-Visual Means from the company’s registered office, saw shareholders adopt the audited standalone and consolidated financial statements for FY26. The statutory and secretarial auditor reports were unqualified, with no adverse observations noted.

Key Resolutions Passed

Shareholders approved several ordinary resolutions during the proceedings:

Mr. Sharath Reddy Kalakota (DIN: 03603460), who retired by rotation, offered himself for re-appointment and was subsequently appointed. The board also approved the payment of commission to Mr. Madhav Vishnukant Bhutada (DIN: 08222055), a Non-Executive Director of Shilpa Biologicals Private Limited, a material subsidiary of the company.

Meeting Proceedings

Mr. Omprakash Inani, Chairman, chaired the meeting, which commenced at 11:00 am and concluded at 11:57 am. Ms. Ritu Tiwary, Company Secretary and Compliance Officer, confirmed the presence of the requisite quorum, including key managerial personnel, auditors, and committee chairpersons.

The total number of shareholders as on the record date of September 4, 2026, was 80,572. Of these, 48 members participated through the video conference platform. The Chairman and Managing Director addressed members on the company’s performance and future outlook.

An insta-poll was conducted for 15 minutes following the conclusion of the AGM to allow members who had not voted via remote e-voting to cast their ballots. The combined results of e-voting and insta-poll, along with the Scrutinizer’s Report, will be declared to stock exchanges within the regulatory timeline.