Keralam Health Minister Defends Switch To Indian-Made SMA Drug, Says Supply Will Continue

By: News18 India

Published: 24 October 2026

Keralam Health Minister Defends Switch To Indian-Made SMA Drug, Says Supply Will Continue

Photo / Illustration: Haldwani Times News Desk

Keralam Health Minister K Muraleedharan on Friday defended the government’s decision to continue providing Natsmart, a lower-cost generic version of risdiplam manufactured by Indian pharmaceutical company Natco Pharma, to children suffering from spinal muscular atrophy (SMA). Amid a controversy over medicine bottles carrying “Clinical Trial" and “Physician’s Sample" labels, the minister maintained that the drug was safe and that doctors had addressed parents’ concerns. He also suggested that a competing foreign pharmaceutical company could be behind the controversy. The issue has sparked criticism from the Opposition CPI(M), which has questioned the procurement process and quality checks conducted before the medicine was supplied to children. The controversy began after parents of children receiving treatment for SMA at SAT Hospital in Thiruvananthapuram noticed that some bottles of Natsmart carried labels indicating that they were physician samples or intended for clinical trials. SMA is a rare genetic disorder that causes progressive muscle weakness and wasting. Risdiplam is used to treat the condition. Under a free-medicine initiative introduced by the previous LDF government in 2022, children with SMA were receiving Evrysdi, the original branded version of risdiplam manufactured by Swiss pharmaceutical company Roche. Some families reported significant improvements in their children’s condition after receiving treatment, with some children reportedly beginning to walk without support. The switch to Natsmart raised questions among parents about whether the generic medicine would deliver comparable results. Health Minister Defends Decision To Continue Natsmart Muraleedharan maintained that Natsmart was safe, met regulatory requirements and offered a substantially more affordable treatment option. Rejecting allegations of negligence, he said, “There is no confusion. There are only 150 patients. Their parents asked some questions to the doctors, and the doctors explained everything." “This is not negligence. Not a lapse, because doctors explained things," he added. Responding to questions about meetings between Natco representatives and him, the minister said the discussions concerned a corporate social responsibility (CSR) initiative. He also questioned the CPI(M) over campaign donations allegedly made by the pharmaceutical company during previous ministerial tenures. Dr R Shankar, head of the expert committee tasked with evaluating the medicine, defended its safety and regulatory clearance. “If the concern is over the label, there was ‘physician’s sample’ written on it. It means it is a tested molecule. The container contains the same medicine," he said. CPI(M) Questions Procurement And Quality Checks Former Keralam health ministers P K Sreemathi, K K Shailaja and Veena George raised concerns at a joint press conference over the circumstances surrounding Natsmart’s procurement and distribution. The CPI(M) leaders questioned why bottles carrying clinical-trial-related labels had been supplied to children and sought clarification on the testing and quality-assurance procedures followed by the government. Shailaja said the government must reassure parents before replacing a medicine that children had already been receiving. “We have no issue with it, but the government must convince the parents that we are replacing the old medicine with a new one. The new one is being bought at a lower price, which is fine," she said. She maintained that procurement and price negotiations should be handled by the Kerala Medical Services Corporation Limited (KMSCL), the state agency responsible for purchasing medicines, rather than through direct interactions between pharmaceutical companies and ministers’ offices. Shailaja also expressed concern over reports that KMSCL’s quality-check cell had been shut down and that quality checks were now being handled by the Drug Controller. “In the new medicine’s case, the pharma company is coming and directly selling it. It’s not a usual process. There was a short tender called too, reportedly. There is no requirement for the same at this point," she said. She also questioned whether the medicine had undergone bioequivalence testing. “What we know is that the bioequivalence test of this medicine has not been conducted. If it’s generic medicine, you can avoid clinical trial, but bioequivalence testing has to be conducted. We are asking them to clarify whether that was conducted. If it was done, then submit its certificate," she added. However, drug regulatory officials have clarified that bioequivalence studies were not required for the formulation under the applicable draft guidance. How Much Does Natsmart Cost Compared With Evrysdi? Affordability has been a key factor behind the government’s decision to switch to Natsmart. Natsmart has a listed price of Rs 15,900 per bottle, which was reportedly negotiated down to approximately Rs 8,500 for government procurement. Evrysdi, meanwhile, has a listed price exceeding Rs 5 lakh per bottle, although the state was reportedly obtaining it at a substantially lower effective cost. The government has argued that the lower price would help sustain the state’s free-treatment programme for children with SMA. Pinarayi Vijayan Seeks Action Over Alleged Lapses Leader of the Opposition Pinarayi Vijayan also raised concerns over the distribution of medicines carrying clinical-trial-related labels. In a Facebook post, Vijayan said the matter could not be taken lightly and called for action against those responsible if any lapses were established. “Administering medicines labelled for experimental use to children with the disease without the fully informed consent of their parents is a matter that cannot be taken lightly," he said. The controversy has brought the state’s medicine procurement procedures under scrutiny, with Opposition leaders seeking accountability over the distribution of sample-labelled bottles. Muraleedharan, however, has ruled out reversing the decision, maintaining that Natsmart will continue to be supplied to children with SMA. The controversy erupted after parents at SAT Hospital discovered that some Natsmart medicine bottles carried labels indicating they were physician samples or intended for clinical trials. This raised parental concerns regarding the safety, quality checks, and regulatory compliance of the generic drug compared to the original branded version, Evrysdi. Health Minister K Muraleedharan defended the decision, maintaining that Natsmart is safe, meets regulatory requirements, and provides an affordable treatment option that will continue to be supplied. However, opposition leaders like Pinarayi Vijayan and former health ministers raised serious concerns over the lack of informed consent and procurement procedures, calling for strict action against lapses.

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