Global pharmaceutical company Roche has received a Phase 3 trial waiver from the Central Drugs Standard Control Organisation (CDSCO) for its higher dosage form of multiple sclerosis drug Ocrelizumab. According to reports from Business Standard, the 920 milligram version was approved by the neurology and psychiatry Subject Expert Committee at a meeting held on August 20. This waiver allows Roche to import and market the drug in India, building on the company's existing regulatory framework.
As reported by Business Standard, Roche had previously received a similar waiver and approval for the 300 mg version of the same drug in 2023. The company subsequently launched Ocrelizumab under the brand name Ocrevus in 2024. The drug is indicated for the treatment of relapsing forms of multiple sclerosis and primary progressive MS in adults. Multiple sclerosis is a disease of the central nervous system that causes destruction of the coating that surrounds and protects nerve fibres.
According to the SEC recommendations reported by Business Standard, the current waiver approval is subject to specific conditions. The firm must conduct a Phase 4 clinical trial in the Indian population for the proposed indications. As stated in the SEC recommendations, the company shall submit phase 4 clinical trial protocol to CDSCO within three months of grant of marketing authorisation permission. The SEC also noted that Ocrelizumab 300 mg concentrate for solution for infusion was already approved in India for similar proposed indications through intravenous administration.
As reported by Business Standard, Roche indicated that the proposed drug product is already approved in 65 countries, including the United States of America, United Kingdom, Australia, Switzerland and European Union. The company had not responded to queries at the time of reporting. The current waiver has been granted under the provisions of Rule 101 of the New Drugs and Clinical Trials Rules, 2019, which allows CDSCO to waive local clinical trials for new drugs already approved in six specified, well-regulated foreign countries.
