Kerala SMA Treatment Programme Faces Backlash Over Generic Drug Switch and Bottle Labelling

Spinal Muscular Atrophy treatment in Kerala has run into a controversy after the state government replaced the branded medicine Risdiplam with a cheaper generic alternative called Natsmart. SMA is a rare genetic disorder that weakens muscles and impairs breathing. Roche Pharmaceuticals launched Risdiplam, marketed as Evrysdi, in India in July 2021 as the first at-home oral treatment for the condition. While the drug proved effective, its high cost made it out of reach for most families.

Programme Expansion and Costs

Kerala became the first state to provide Risdiplam free of charge through government hospitals in 2022, initially covering children under 12. In 2026, the state allocated ₹30 crore in its budget to expand coverage to genetically confirmed SMA Type 2 patients up to age 25. Currently, 109 children with SMA Type 1 and Type 2 below age 12 receive the medication for free. A single bottle of Evrysdi previously cost ₹6.3 lakh, though the state obtained it at a negotiated price of ₹5.4 lakh. With Roche offering 11 free bottles for every four purchased under a patient assistance programme, the state's annual expenditure reached about ₹23 crore for an estimated requirement of 2,500 bottles.

The Generic Alternative

To manage this rising financial burden, a technical experts committee evaluated Natsmart, a generic version of Risdiplam made by Natco Pharma following a Delhi High Court verdict. While Evrysdi maintenance can cost up to ₹70 lakh annually, Natsmart costs under ₹5 lakh per year, with a bottle priced at ₹15,900 compared to the current Evrysdi price of ₹4.44 lakh. The state government cleared Natsmart in February 2026. Parents and advocacy groups like the Cure SMA Foundation of India have urged a return to the branded version, arguing that the generic lacks dedicated paediatric clinical studies and could reverse children's progress. Public health experts have defended the switch as necessary for wide access, noting that the Central Drugs Standard Control Organisation approved Natsmart without requiring a bioequivalence study, which WHO guidelines permit for identical oral solutions.

The Labelling Controversy

The debate escalated last week when the generic drug was first dispensed at SAT Hospital in Thiruvananthapuram. Parents noticed a sticker on the bottle marked 'Physicians' sample/for clinical trials', sparking fears that trial drugs were being used on children. Authorities clarified that these specific sample bottles were sourced directly from Natco due to delayed government supplies, but the incident has drawn reactions from political parties including the CPI(M). SAT Hospital authorities have planned a meeting with families to address their concerns and clear up misgivings about the labelling issue.

Context

Spinal Muscular Atrophy is a severe progressive condition that requires continuous, long-term pharmaceutical management to maintain motor and respiratory functions. State-funded healthcare programmes frequently balance high patient needs against strict budget limits when choosing between patented drugs and less expensive generic equivalents.