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), a serious genetic disorder, in Keralam are trying to get political support for their opposition to the State government’s decision to replace the life-saving medication being administered to their kids with a generic drug.

A section of them recently met Opposition leader Pinarayi Vijayan and Industries Minister P.K. Kunhalikutty. Mr. Vijayan also wrote to Health Minister K. Muraleedharan, urging him to address the concerns related to the efficacy of the new medicine. Mr. Vijayan, in the letter, sought to reconsider the decision to cut the ₹30 crore sanctioned during the previous government’s tenure for the free drug distribution scheme for those aged up to 12 till they turn 25.

Risdiplam, a life-saving drug

Children with SMA are being given Risdiplam, a life-saving drug patented by the company Roche Pharma, since 2021. It costs ₹5.4 lakh a bottle. The then Left Democratic Front government procured it at a negotiated price of about ₹1-₹1.25 lakh, to be distributed for free among the children. However, the United Democratic Front-led State government recently issued an order to procure its generic version manufactured by Natco Pharma, whose price is 97% lesser than its patented version. Government officials claim that the attempt is to widen the drug access to more SMA patients.

However, Cure SMA Foundation of India, an advocacy organisation representing those affected by the condition, along with the parents of the affected children, claim that the efficacy and safety of this generic version have not yet been established.

They point out that the medication currently being administered has been proven 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 said. They are requesting the authorities to continue the same medication until scientific study results demonstrating the efficacy and safety of the generic drug are made available.

“SMA is a neurodegenerative disease, and timely and 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 once again,” one of the parents says. 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 impact their children’s health. The parents and patients claim that though multiple petitions were submitted highlighting their concerns, all of them were disregarded.