Chief Minister V D Satheesan told the Assembly that Natco Pharma’s generic version of risdiplam cost approximately ₹15,000 for a 12-day supply, against about ₹6.5 lakh for Roche’s branded treatment. The government hoped to bring that cost down to ₹9,000, including the necessary supplies, he said.
Health Minister K Muraleedharan said the administration’s eventual objective was to provide medicines free of cost to all SMA patients. An announcement on expanding support would follow, he indicated, without setting a timetable.
The statements came during a heated Assembly debate on an adjournment motion sought by the CPI(M)-led Left Democratic Front. Speaker Thiruvanchoor Radhakrishnan refused permission for the motion after the government’s response, prompting Opposition legislators to stage a walkout.
The dispute followed the distribution of bottles of Natco’s Natsmart formulation at Sree Avittom Thirunal Hospital in Thiruvananthapuram bearing labels referring to physician samples and clinical trials. Parents questioned whether the medicine had undergone adequate scrutiny and whether they had been properly informed about the substitution.
Opposition Leader Pinarayi Vijayan said his coalition was not against lower-cost generic medicines. Its objection, he argued, concerned the circumstances in which children received bottles marked for clinical trials and the government’s handling of the ensuing concerns.
Satheesan rejected suggestions that children were being enrolled in an experimental programme. He said the Central Drugs Standard Control Organisation had cleared Natco’s formulation and that the medicine was being administered under established protocols rather than as part of a clinical trial.
He also cited court proceedings involving Roche, the manufacturer of the branded drug Evrysdi, and said the generic formulation was already used at institutions including the Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow.
The legal and regulatory clearances, however, did not remove the need to explain the product’s labelling and treatment decisions to families. The Kerala branch of the Indian Medical Association has supported making SMA treatment more affordable while calling for transparent information about quality assurance, procurement and distribution.
Hospital superintendent I Riyas previously said six children received bottles carrying the disputed wording when regular supplies were temporarily unavailable. The hospital subsequently took back those bottles following objections from parents, he said.
The state’s Kerala United Against Rare Diseases programme provides subsidised access to exceptionally expensive treatments, with risdiplam supplied free to eligible children. The policy debate has therefore centred both on the safety of an alternative formulation and the number of patients whom the government can support within its budget.
Satheesan said the proposal to acquire the generic medicine predated the UDF administration. He referred to an April 6 communication from the National Health Mission director drawing attention to the price difference and seeking a decision, followed by technical committee discussions in May.
The Kerala High Court permitted the state to proceed with procurement in September despite objections seeking continued provision of Roche’s product. Natco has maintained that a separate bioequivalence study is unnecessary for its oral solution because it contains the same active ingredient at the same concentration as the reference medicine.
Some parents have nevertheless requested more evidence and direct discussions with treating specialists before changing a treatment that their children have been receiving. Patients outside the free-treatment programme have also argued that generic availability could make sustained therapy financially possible.
(The article ‘Govt backs generic SMA treatment, eyes price cut’ appeared first on Free Press Journal.)
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