Generic SMA treatment to continue despite objections

Health Minister K Muraleedharan has confirmed the continuation of administering a cheaper generic version of risdiplam to treat children with spinal muscular atrophy (SMA), despite objections raised by parents, opposition leaders, and former health ministers. The generic medicine, Natco Pharma's Natsmart, has received regulatory approval and is being supplied following recommendations from an expert committee.

Muraleedharan maintains that there is no evidence indicating the generic medicine is inferior to the more expensive branded formulation, manufactured by Roche. The decision to replace Evrysdi with the cheaper generic formulation, under the Kerala United Against Rare Disease programme, has sparked controversy. Parents and opposition leaders question whether sufficient evidence exists to establish therapeutic equivalence between the two formulations, particularly after bottles supplied through Sree Avittom Thirunal Hospital in Thiruvananthapuram were found to have misleading labels.

The government has agreed to investigate allegations of improper labelling upon receipt of a formal complaint. Hospital authorities deny that children were part of unauthorised clinical trials, stating that the medicine distributed was an approved generic formulation. Former health ministers have called for a comprehensive investigation into the distribution and procurement of the disputed bottles.