Parents of SMA-affected children in Kerala seek political support for their concerns about generic drugs

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Parents of children suffering from spinal muscular atrophy (SMA), a serious genetic disorder, are seeking political support in Kerala for their opposition to the state government’s decision to replace life-saving drugs given to their children with a generic drug.

A section of them recently met Opposition Leader Pinarayi Vijayan and Industries Minister PK Kunhalikutty. Mr. Vijayan also wrote to Health Minister K. Muraleedharan, urging him to address concerns related to the efficacy of the new drug. In the letter, Mr. Vijayan sought a reconsideration of the decision to reduce the ₹30 crore sanctioned during the previous government’s tenure for the free drug distribution scheme for under-12s to 25-years-old.

Risdiplam, a life-saving drug

Children with SMA are being given Risdiplam, a life-saving drug patented by Roche Pharma, from 2021. It costs ₹5.4 lakh per bottle. The then Left Democratic Front government procured it at a negotiated price of about ₹ 1-1.25 lakh to be distributed among children for free. However, the Democratic Front-led United States government recently issued a purchase order for its generic version manufactured by Natco Pharma, which costs 97% less than its proprietary version. Government officials say the effort is to expand access to drugs for more SMA patients.

However, the Cure SMA Foundation of India, an advocacy organization representing people affected by the disease, along with parents of affected children, say the efficacy and safety of this generic version has not yet been established.

They point out that currently administered drugs have been shown by long-term scientific studies to have a high level of safety and efficacy. The 118 children currently receiving the free drug are showing significant health improvements, they say. They are asking the authorities to continue with the same medication until the results of scientific studies proving the effectiveness and safety of the generic drug are available.

“SMA is a neurodegenerative disease and early and effective treatment is key. If a new drug does not have the same level of efficacy or safety as the current one, there is a risk that the condition of children who have already recovered may deteriorate again,” says one parent. Parents also express concern that a sudden, unannounced switch to a generic drug — for which bioequivalence or therapeutic equivalence studies have not been completed — could seriously affect their children’s health. Parents and patients say that although several petitions have been submitted raising their concerns, they have all been ignored.

Published – 18 Oct 2026 19:08 IST