Shilpa Medicare gets CDSCO nod for 120-hour OERIS India

What happened and why it matters

Shilpa Medicare has received final marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for OERIS, an extended-release ondansetron injection. The company said the decision strengthens its specialty pharmaceutical portfolio in oncology-supportive care. OERIS targets chemotherapy-induced nausea and vomiting (CINV), a high-frequency complication for patients receiving moderately or highly emetogenic chemotherapy. The key differentiator is duration: the product is designed to provide antiemetic action for up to 120 hours after a single administration. If adopted in clinical practice, that dosing interval could reduce repeat injections compared with standard ondansetron regimens.

CDSCO and SEC: how the approval came through

The authorization followed review by the Subject Expert Committee (SEC) under CDSCO, after Shilpa completed Phase III clinical trials. The company described the Phase III program as multicenter, randomized, double-blind, and non-inferiority in design. Trial outcomes presented by the company focused on both efficacy and safety over a 120-hour post-chemotherapy window. Based on the company’s update, the regulatory process progressed from clinical completion and SEC review to final marketing authorization. Shilpa also indicated it plans an immediate commercial launch across India following this approval.

Phase III trial design and topline results

Shilpa reported that the Phase III study enrolled 240 patients in India who were receiving moderately or highly emetogenic chemotherapy. The trial compared OERIS with multiple doses of conventional ondansetron injections. The company reported a complete response rate of 89% in the OERIS arm versus 82% in the standard ondansetron arm over 120 hours after chemotherapy. It also stated that no serious or severe adverse events were reported in the study. Shilpa described the safety profile as comparable or better than conventional therapy.

What is OERIS and how it is positioned

OERIS is described as the world’s first extended-release ondansetron injectable formulation. Shilpa’s positioning is built around sustained action for up to 120 hours, or five days, after a single dose. The company said this could reduce the need for repeat injections compared with standard formulations. From an operational standpoint, the company highlighted potential benefits in patient convenience and healthcare staff efficiency because dosing could be once every five days in the stated use-case. The product is referred to as OERIS (also cited as OERIS™) and the clinical program is referenced as SMLINJ011.

Product specifications disclosed by the company

The company shared key product details including the composition, strength, duration of action, and patent timeline in India. These specifications frame how OERIS may be prescribed and how long Shilpa expects protection for the formulation in the domestic market.

Commercial launch plan in India

Shilpa said it plans to initiate the commercial launch across India immediately upon receipt of the final marketing authorization. The company’s comments connect launch timing directly to the regulatory decision, rather than a phased rollout. The approval also aligns with earlier expectations referenced in the provided context, which had pointed to approval in 1HFY27 and an India launch in FY27. With marketing authorization now reported as granted, the near-term focus shifts to product availability, hospital adoption, and oncology-center uptake.

Global regulatory and market context cited

Alongside India, Shilpa has discussed broader ambitions for OERIS. The company has stated plans to pursue global registration and commercialization through the 505(b)(2) pathway in the United States and other key markets. In the same context, the product roadmap referenced Europe Phase 3 and a U.S. filing to follow. The company also cited the global market size for ondansetron as approximately USD 375 million. These datapoints provide context for why Shilpa is prioritizing a long-acting version of a widely used supportive-care molecule.

Dividend update alongside the drug milestone

Separately, Shilpa Medicare declared a dividend of ₹0.60 per equity share for the financial year ended March 31, 2026. The dividend was declared during the company’s 39th Annual General Meeting held on September 11, 2026. While unrelated to OERIS clinically, dividend declarations often matter to shareholders tracking capital return alongside R and D milestones.

Stock snapshot mentioned in the update

The provided context also included a market price reference for Shilpa Medicare Ltd. As of September 9, 2026, the stock was cited at ₹960.60, with a previous close of ₹959.90. The company is listed on NSE as SHILPAMED and on BSE as 530549, as referenced in the material. Stock prices can react to regulatory milestones, but this update only provides the quoted levels without attributing any move to the OERIS news.

Why this matters for investors and the oncology-supportive care space

For Shilpa Medicare, the CDSCO marketing authorization adds a commercial-stage specialty product with an explicit differentiation on duration of effect. The Phase III dataset described by the company highlights an efficacy outcome (complete response) over the same 120-hour window that the formulation is designed to cover. Patent protection in India until 2039 is also a key commercial detail because it suggests a longer runway for the specific formulation, subject to market and competitive dynamics. The next set of watchpoints, based on the disclosed roadmap, includes execution of the India launch and progress on regulatory filings and clinical work outside India.

Conclusion

Shilpa Medicare’s final CDSCO marketing authorization for OERIS positions the company to launch a 120-hour extended-release ondansetron injection in India for CINV. The company has linked the approval to an immediate launch plan and has also outlined steps for global registration through the 505(b)(2) pathway in the U.S. and other markets.