Parents of SMA-affected children seek political support over generic drug switch in Keralam
Parents of children with Spinal Muscular Atrophy (SMA) in Keralam are seeking political support for their concerns over the State government's decision to replace the medication their children receive with a generic version. SMA is a genetic disorder that affects motor neurons and muscle strength. It can cause progressive muscle weakness and affect movement and breathing.
A section of the parents recently met Opposition leader Pinarayi Vijayan and Industries Minister P.K. Kunhalikutty. Mr Vijayan also wrote to Health Minister K. Muraleedharan, asking him to address concerns about the efficacy of the new medicine. In his letter, Mr Vijayan sought a reconsideration of the decision to cut the ₹30 crore sanctioned during the previous government's tenure for a free drug distribution scheme for children aged up to 12, with treatment to continue until they turn 25. The families say uninterrupted access to effective treatment is central to their children's care.
Children with SMA have been receiving Risdiplam, a medicine used to treat the condition, since 2021. The drug is patented by Roche Pharma and costs ₹5.4 lakh a bottle. The then Left Democratic Front government procured it at a negotiated price of about ₹1 lakh to ₹1.25 lakh and distributed it free among the children.
The United Democratic Front-led State government recently issued an order to procure a generic version manufactured by Natco Pharma. Its price is 97% lower than the patented version. Government officials say the aim is to widen access to the drug for more SMA patients.
The dispute centres on whether the cheaper generic version is clinically equivalent to the patented drug. Patient groups say any change should be backed by studies showing the same safety and efficacy.
However, the Cure SMA Foundation of India, an advocacy organisation representing people affected by the condition, and the parents of the affected children say the efficacy and safety of the generic version have not yet been established. They point out that the medicine currently being administered has been shown to have a high level of safety and efficacy through long-term scientific studies. The 118 children at present receiving the free drug are showing significant health improvements, they say.
The parents are asking the authorities to continue the same medication until scientific study results demonstrating the efficacy and safety of the generic drug are available. One parent said SMA is a neurodegenerative disease and timely, effective treatment is crucial. If the new medication lacks the same level of efficacy or safety as the current one, there is a risk that the condition of children who have already regained their health could deteriorate again, the parent said.
The parents also express concern that a sudden, unannounced switch to a generic medication, for which bio-equivalence or therapeutic equivalence studies have not been completed, could seriously affect their children's health. The parents and patients claim that multiple petitions highlighting their concerns were submitted but all were disregarded.
The issue has drawn attention to how rare-disease treatments are funded and procured. The parents are seeking political and administrative support for their demand to continue the existing medication.
