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Natco’s Generic SMA Drug Approved; Kerala Row Over Labels
Sentiment: NeutralHigh Priority
What Happened?
Natco Pharma's generic drug for spinal muscular atrophy has been approved, but controversy arose in Kerala over labels indicating 'Clinical Trial'. Parents expressed concerns about the drug's use.
Key points
- Natco's risdiplam powder for oral solution was approved by Telangana's FDA.
- The drug's approval was granted on April 7, 2025.
- Parents raised concerns over labels stating 'Physician Sample/Clinical Trial'.
- Natco's generic version costs ₹15,900 compared to Roche's ₹6 lakh.
- The Kerala government previously supplied Roche's branded medicine for free.
Key insights
- The controversy highlights the importance of clear labeling in pharmaceuticals.
- Switching to Natco's generic drug may increase access to treatment for more patients.
- Parents' concerns reflect the need for transparency in drug approvals.
Why it matters
The approval of Natco's drug could significantly reduce treatment costs for SMA in Kerala.
Entities
Natco Pharma· CompanySMA· DiseaseKerala· StateTelangana State Food and Drug Administration· OrganizationRoche· Company
Source
Times of India
