Politics · India Bureau
Kerala hospital defends free SMA drug distribution as approved generic
Authorities at a Kerala hospital have dismissed concerns raised by parents of children with spinal muscular atrophy, clarifying that the medication distributed free of cost is an approved generic formulation, not an experimental drug.
LSN India ·
Hospital officials at SAT Hospital in Kerala have pushed back against allegations that they distributed an unapproved experimental drug to children with spinal muscular atrophy (SMA), stating the medication is a legally approved generic version of Risdiplam.
The controversy emerged after parents of SMA patients expressed concerns about the nature of the treatment provided at the hospital's clinic. Hospital authorities have since clarified that the drug in question is the generic formulation of Risdiplam, the patented original medication developed by pharmaceutical company Roche.
According to the hospital, the generic version is manufactured by Indian pharmaceutical firm Natco Pharma and has received regulatory approval from India's drug regulatory bodies. The medication has been provided to patients at no cost as part of the hospital's treatment programme.
Experts cited in the matter have characterized the row as unwarranted, suggesting that concerns about the drug's status appear to stem from a misunderstanding regarding the difference between approved generics and experimental formulations. The distinction is significant, as approved generics undergo rigorous testing and regulatory scrutiny before distribution, whereas experimental drugs remain in trial phases.
The hospital has reiterated its commitment to providing safe, approved treatments to SMA patients seeking care at its facility.