India SEC Recommends Phase III Waiver for Roche’s 920 mg Subcutaneous Ocrelizumab

India’s Subject Expert Committee (SEC) on Neurology and Psychiatry has recommended a waiver of the local Phase III clinical trial requirement for Roche’s 920 mg subcutaneous ocrelizumab in adults with multiple sclerosis, subject to a mandatory Phase IV study in the Indian population. The recommendation could advance the formulation toward marketing authorization in India, but it does not represent final approval.

SEC recommends Phase III waiver under Rule 101

Roche Products (India) presented a proposal to import and market ocrelizumab 920 mg/23 mL (40 mg/mL) solution for subcutaneous injection in a single-dose vial. The company requested a waiver of the local Phase III requirement and committed to conduct a Phase IV clinical trial in India.

Following deliberation at its August 20, 2026 meeting, the SEC recommended permission to import and market the product with a waiver of the local Phase III clinical trial under Rule 101 of the New Drugs and Clinical Trials Rules, 2019. The recommendation is conditional on Roche conducting a Phase IV clinical trial in the Indian population for the proposed indications.

The proposed use covers adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, as well as adults with primary progressive MS.

Subcutaneous delivery could shorten administration time

Ocrelizumab is an established CD20-directed therapy for MS. The proposed formulation offers a different route of administration from the intravenous ocrelizumab already approved in India.

The SEC noted that ocrelizumab 300 mg concentrate for IV infusion is already approved in India for the same proposed indications.

The 920 mg subcutaneous dose is administered by a healthcare professional over approximately 10 minutes, potentially reducing the administration burden compared with IV treatment, which requires a substantially longer infusion process.

The change is therefore relevant not only as a formulation update but also from a treatment-delivery perspective, particularly for patients receiving long-term, six-monthly anti-CD20 therapy.

International approvals support India’s regulatory pathway

The SEC noted that the proposed subcutaneous product had already been approved in 65 countries, including the United States, United Kingdom, Australia, Switzerland and European Union markets.

That international regulatory experience, together with the existing Indian approval of intravenous ocrelizumab, formed part of the regulatory context considered by the committee before recommending the Phase III waiver.

Phase IV evidence will be required in India

The SEC’s recommendation does not constitute final marketing authorization. If the required marketing authorization permission is subsequently granted, Roche must submit the Phase IV clinical trial protocol to CDSCO within three months. The post-marketing study must evaluate the product in the Indian population for the proposed indications.

The decision therefore represents a regulatory advance for Roche’s subcutaneous ocrelizumab program in India while retaining a requirement for India-specific post-approval evidence. The next key milestone will be formal marketing authorization, followed by submission and execution of the mandated Phase IV study.

Reference

Recommendations of the SEC (Neurology and Psychiatry) made in its 9th/26 meeting held on 20.08.2026 at CDSCO HQ New Delhi