Parents of SMA-affected kids in Keralam seek political support for their concerns over generic drug

Parents of children suffering from Spinal Muscular Atrophy (SMA) in Kerala are seeking political assistance to voice their concerns about the State government's decision to switch the life-saving medication for their kids with a generic drug. Spinal Muscular Atrophy (SMA) is a severe genetic disorder that affects the motor neurons in the spinal cord, leading to progressive muscle weakness and atrophy.

The life-saving drug, Risdiplam, which costs ₹5.4 lakh per bottle, has been administered to SMA-affected children in Kerala since 2021. The State government procured the patented drug at a negotiated price of about ₹1-₹1.25 lakh, to be distributed for free among children under 12, with plans to continue until they turn 25. However, the opposition-led United Democratic Front government recently decided to procure the generic version of Risdiplam manufactured by Natco Pharma, which is 97% cheaper than the patented version.

The Cure SMA Foundation of India, an advocacy organization representing those affected by SMA, along with the parents of affected children, argue that the efficacy and safety of the generic version have not been established. They emphasize that the current medication has undergone extensive long-term scientific studies, demonstrating high levels of safety and efficacy.

The parents of 118 children currently receiving the free drug report significant health improvements. They are urging authorities to maintain the existing medication until scientific study results proving the efficacy and safety of the generic drug are available.

The parents express their concern that a sudden, unannounced switch to the generic medication could negatively impact the health of their children, as the new drug has not undergone bio-equivalence or therapeutic equivalence studies. Despite submitting multiple petitions highlighting their concerns, they claim that all of them have been disregarded. Opposition leader Pinarayi Vijayan has written to Health Minister K. Muraleedharan, urging him to address the issues related to the efficacy of the new medicine.