Shilpa Medicare has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for marketing authorization of OERIS.

 

The anti-nausea jab is Ondansetron Extended-Release Injection (100 mg/mL), a novel injectable designed to provide anti-nausea protection for up to five days from a single dose.

 

The company said OERIS is designed to be the world’s first extended-release ondansetron injectable formulation, with sustained antiemetic action for up to 120 hours. The approval marks a first-of-its-kind authorization in India and globally, according to the company.

 

OERIS is intended for the prophylaxis and control of chemotherapy-induced nausea and vomiting (CINV) in patients undergoing moderately-to-highly emetogenic chemotherapy.

 

The SEC’s decision follows the successful completion of a multicenter, randomized, double-blind Phase III clinical trial evaluating the safety and efficacy of the formulation.

 

The extended-release formulation could reduce the need for repeated injections, allowing patients to receive a single dose once every five days. Shilpa Medicare said the approach is expected to improve patient convenience while also reducing the workload for healthcare staff.

 

OERIS will be launched in India and is protected by an Indian patent until 2039. Following receipt of the final marketing authorization from CDSCO, the company plans to begin its commercial launch across the country.

 

Commenting on the development, Shilpa Medicare Managing Director Vishnukant Bhutada said: "Final approval from SEC for grant of marketing authorization for OERIS, marks a pivotal moment in our journey to redefine supportive cancer care. 

 

"It underscores our dedication to developing complex, patient-first formulations that address real clinical gaps. This milestone further solidifies our differentiated oncology portfolio and propels us closer to our vision of becoming a globally recognized leader in specialty pharmaceuticals and advanced drug delivery systems.”