Following a dispute in the state of Kerala regarding the generic for Spinal Muscular Atrophy (SMA) from Natco Pharma, regulatory clarifications indicate that the conflict arose due to the labels on the free bottles provided.
The words 'Physician Sample/Clinical Trial' caused concern among parents, who believed their children were receiving medication intended for clinical trials rather than an authorized drug for regular treatment.
The company acknowledged that the free vials were labeled 'Physician Sample/Clinical trials only,' but stated that they were provided as samples under a framework agreement, not for conducting clinical trials. The company also reported that its generic Rizdiplam, priced at 15,900 Indian Rupees compared to 6 lakh for the Roche product, met all regulatory requirements.
Authorities at SAT Hospital confirmed that the distributed medicine was an approved generic form.