India's SEC recommends Phase 3 trial waiver for Roche's subcutaneous ocrelizumab in multiple sclerosis
核心洞察
India's Subject Expert Committee recommended a local Phase 3 trial waiver for Roche's 920 mg subcutaneous ocrelizumab, subject to a Phase 4 trial commitment in the Indian population.
The waiver applies to relapsing forms of MS and primary progressive MS in adults, with the 300 mg IV formulation already approved in India since 2023.
Ocrelizumab is approved in 65 countries including the US, UK, Australia, Switzerland and the EU, and Roche must submit a Phase 4 protocol within three months of marketing authorization.
The Subject Expert Committee (SEC) for neurology and psychiatry, which advises India's Central Drugs Standard Control Organisation (CDSCO), has recommended granting Roche permission to import and market its subcutaneous ocrelizumab formulation for multiple sclerosis (搜索) (MS), with a waiver of the local Phase 3 clinical trial subject to conditions. The recommendation, made at a meeting held on August 20, 2026, covers ocrelizumab 920 mg solution for subcutaneous injection in a single-dose vial (r-DNA origin) [920 mg/23 mL (40 mg/mL)].
The application, submitted by Roche Products (India), seeks import of the drug for indications including relapsing forms of MS — to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults — as well as primary progressive MS in adults. The SEC noted that ocrelizumab 300 mg concentrate for solution for infusion (r-DNA origin) [300 mg/10 mL (30 mg/mL)] has already been approved in India for these indications through intravenous (IV) administration.
Waiver Conditions and Phase 4 Commitment
The waiver was granted under the provisions of Rule 101 of the New Drugs and Clinical Trials Rules, 2019, which permits the CDSCO to waive local clinical trials for new drugs already approved in six specified, well-regulated foreign countries. The Committee observed that the proposed drug product is already approved in 65 countries, including the United States, United Kingdom, Australia, Switzerland and the European Union.
The approval is conditional. "After detailed deliberation, the committee recommended for grant of permission to import and market drug product ocrelizumab 920 mg solution for injection in a single-dose vial (r-DNA origin) [920 mg/23 mL (40 mg/mL)] (subcutaneous) for the proposed indications with waiver of local phase III clinical trial under the provisions of Rule 101 of the New Drugs and Clinical Trials Rules, 2019, subject to the condition that the firm shall conduct a phase IV clinical trial in the Indian population for the proposed indications," the Committee stated. Roche must submit the Phase 4 clinical trial protocol to CDSCO within three months of the grant of marketing authorization permission.
Clinical Profile and Market Context
Ocrelizumab is a humanised monoclonal antibody marketed by Roche under the brand name Ocrevus Zunovo in the United States and Ocrevus SC in other markets. Roche launched Ocrevus in India in February 2024, describing it as the only monoclonal antibody drug approved for the treatment of both relapsing-remitting multiple sclerosis (搜索) (RRMS) and primary-progressive multiple sclerosis (PPMS), with more than 10 years of clinical and real-world data indicating that over 80% of people with RRMS and over 33% of people with PPMS treated with Ocrevus showed no signs of disability progression.
According to the Multiple Sclerosis (搜索) Society of India (MSSI), the crude prevalence of the disease in India stands at 8–9 people per one lakh population, with the approximate number of persons with MS in the country close to 1.8 lakh. The Society notes that an increase in the number of practising neurologists and the easy and affordable availability of magnetic resonance imaging (MRI) has led to a rise in reported MS prevalence, though no centralized Registry of Persons with MS exists in the country.
6Wresearch, a commercial strategy and growth advisory firm headquartered in New Delhi, observed in April 2026 that the multiple sclerosis (搜索) market in India is rapidly transforming from a high-unmet-need therapeutic area to a more accessible and technologically driven sector, with companies including Novartis, Biogen, Sanofi and Roche among the leading market players.