Shilpa Medicare Limited has announced that the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted final approval for OERIS, the company's Ondansetron Extended-Release Injection, 100 mg/mL. The approval allows the company to market and sell the injection across India.
The announcement was made on September 11, 2026.
What Is OERIS?
The Medicine and Its Approval
OERIS is the brand name for Ondansetron Extended-Release Injection, 100 mg/mL, developed by Shilpa Medicare Limited. Ondansetron is used to prevent chemotherapy-induced nausea and vomiting (CINV). The SEC under CDSCO has granted final approval for this product.
A First-of-Its-Kind Injection
Shilpa Medicare has stated that OERIS is the world's first long-acting injectable ondansetron. A single injection of OERIS provides continuous action for up to 120 hours, which is five days. Existing ondansetron formulations require repeated dosing over the same period.
What the Approval Covers
Indication
OERIS is indicated for the prevention of chemotherapy-induced nausea and vomiting. Chemotherapy is a treatment used in cancer care that can cause nausea and vomiting as side effects.
Duration of Action
One single injection of OERIS acts continuously inside the body for up to 120 hours. The company stated this removes the need for repeated daily injections or oral tablets during the five-day post-chemotherapy period.
Patent and Launch Plans
Patent Protection
Shilpa Medicare has secured patent protection for the OERIS formulation in India until the year 2039.
Launch Timeline
Following receipt of the final marketing authorisation from the drug authority, Shilpa Medicare plans to launch OERIS across hospitals and cancer centers in India.
What Management Said
Mr. Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited, stated that receiving final approval for OERIS is a key moment in the company's goal to improve cancer patient support. He stated that the company remains dedicated to making innovative, patient-first medicines that solve real medical problems and make treatments gentler.
Key Details At A Glance
| Detail | Information |
|---|---|
| Product Name | OERIS (Ondansetron Extended-Release Injection, 100 mg/mL) |
| Approval By | Subject Expert Committee (SEC), CDSCO |
| Indication | Chemotherapy-Induced Nausea and Vomiting (CINV) |
| Duration of Action | Up to 120 hours (5 days) from a single injection |
| Distinction | World's first long-acting injectable ondansetron |
| Patent In India | Until 2039 |
| Announcement Date | September 11, 2026 |
Conclusion
Shilpa Medicare Limited has received final approval from the SEC under CDSCO for OERIS, Ondansetron Extended-Release Injection, 100 mg/mL, for the prevention of chemotherapy-induced nausea and vomiting. The company has stated that OERIS is the world's first long-acting injectable ondansetron, providing up to 120 hours of action from a single dose. Patent protection for the formulation in India runs until 2039. The company plans to launch OERIS across hospitals and cancer centers in India following receipt of final marketing authorisation.