The minister said the generic medicine, manufactured by Natco Pharma under the brand name Natsmart, had received regulatory approval and was being supplied following recommendations from an expert committee. He maintained that no evidence had been presented establishing that the medicine was inferior to the more expensive branded formulation.
The decision has triggered objections from parents, opposition leaders and former health ministers, particularly after bottles distributed through Sree Avittom Thirunal Hospital in Thiruvananthapuram reportedly carried labels referring to physician samples and clinical trials.
Muraleedharan said the government would examine objections supported by expert medical opinion but saw no justification for discontinuing the medicine. He also indicated that allegations concerning the distribution of improperly labelled bottles could be investigated upon receipt of a formal complaint.
The controversy concerns the government’s decision to replace Evrysdi, manufactured by Swiss pharmaceutical company Roche, with Natco’s substantially cheaper formulation under the Kerala United Against Rare Disease programme.
Risdiplam is an oral medicine used to treat SMA, a rare inherited disorder that progressively weakens muscles and can impair movement, swallowing and breathing. Continuous treatment is important for patients receiving the medicine.
The government decided in July to procure the generic formulation, citing recommendations from a technical committee and the need to maintain treatment for eligible children without imposing unsustainable expenditure on the public health system.
Natsmart carries a market price of approximately ₹15,900 per bottle, compared with more than ₹6 lakh for Roche’s branded product. The government previously obtained Evrysdi through negotiated pricing and arrangements involving free supplies.
Under the existing programme, 109 children were identified as beneficiaries, requiring an estimated 2,133 bottles annually. The substantially lower price of the generic medicine has become central to the government’s argument for expanding affordable access.
However, several parents have questioned whether sufficient evidence has been provided to establish therapeutic equivalence between the two formulations. They argue that children showing improvement while receiving Evrysdi should not be switched without adequate medical assurances.
The Cure SMA Foundation of India has sought greater transparency concerning the scientific evidence supporting the substitution. Its representatives have stressed that affordability should not displace considerations of patient safety and treatment continuity.
The Central Drugs Standard Control Organisation has approved Natco’s formulation for marketing. Nevertheless, the disputed labelling has generated questions about the circumstances under which particular bottles were supplied to patients.
Hospital authorities have rejected suggestions that children were being subjected to unauthorised clinical trials. They maintain that the medicine distributed was an approved generic formulation rather than an experimental treatment.
Former health ministers P K Sreemathi, K K Shailaja and Veena George have demanded a comprehensive investigation into the distribution of the disputed bottles and the circumstances surrounding procurement.
The three CPI(M) leaders also questioned a meeting involving Muraleedharan and representatives of Natco Pharma, alleging that the interaction warranted scrutiny.
Hospital superintendent R S Riyas rejected suggestions that the meeting established improper influence over procurement. He explained that company representatives had met the minister in connection with corporate social responsibility assistance for renovating a hospital isolation ward.
According to the hospital administration, Natco had contributed an initial ₹25 lakh towards the renovation following a request submitted by the previous superintendent in March.
(The article ‘Generic SMA treatment to continue despite objections’ appeared first on Free Press Journal.)
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