# Sanofi gets CDSCO approval for Qfitlia haemophilia therapy in India 2026-10-21T15:19:57+00:00 | Governance | Indian Opinion Desk Corroboration: 3 independent outlets Sanofi Healthcare has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for Qfitlia (fitusiran), a therapy to prevent bleeding in haemophilia patients. The approval covers adults and adolescents aged 12 years and older, with or without factor VIII or IX inhibitors. Qfitlia is the first antithrombin-lowering therapy designed for routine prophylaxis, requiring as few as six injections a year for both Haemophilia A and B patients. The approval is based on data from the ATLAS phase 3 clinical programme, which showed clinically meaningful bleed protection. Parwas Mahajan, Business Head, Rare Diseases at Sanofi (India), said the therapy has the potential to significantly expand access to prophylaxis in India. ## Indian Opinion Analysis The Economic Times, BusinessLine and The Pharma Letter all report the CDSCO approval as a straightforward regulatory milestone, with near-identical facts and no critical framing. The only material difference is that The Pharma Letter, a trade publication, identifies Qfitlia as the first antithrombin-lowering therapy and gives the drug controller’s full name (DCGI), while the Indian outlets foreground patient access. The uniform coverage suggests the story carries no regulatory or political controversy. The concrete next step for Sanofi will be the therapy’s commercial launch and uptake among India’s haemophilia population. ## Coverage Coverage: 3 sources, 3 neutral - economictimes.indiatimes.com (neutral report) Straight news agency-style report with no slant - thehindubusinessline.com (neutral report) Straight news agency-style report with no slant - thepharmaletter.com (neutral report) Trade publication reporting regulatory approval without slant This brief was synthesised by AI from the 3 sources linked above, so one read covers every framing they carry. Tags: CDSCO, DCGI, haemophilia, Qfitlia, Sanofi Canonical: https://indianopinion.org/sanofi-gets-cdsco-approval-for-qfitlia-haemophilia-therapy-in-india/ License: Summary and commentary (c) Indian Opinion, reusable with attribution. Facts belong to the linked sources. Cite: https://indianopinion.org/sanofi-gets-cdsco-approval-for-qfitlia-haemophilia-therapy-in-india/#story-in-brief How this brief was made: an AI model read the reports linked above and wrote this summary and analysis, which were published automatically. Published briefs are sampled every hour by an automated quality check; the editor verifies its findings and approves corrections, and corrected briefs carry a dated correction line. Stance labels are editorial classifications of how each outlet framed this story, assigned by the same model, not ratings of the outlets. We do no original reporting. Methodology: https://indianopinion.org/ai-use-policy/