Nisha Pandey

Health and Me

From ₹6.2 Lakh To ₹15,900: Kerala Health Minister Defends Generic SMA Drug But Parents Want Safety Assurance

From ₹6.2 Lakh To ₹15,900 Kerala Health Minister Defends Generic SMA Drug But Parents Want Safety Assurance

<span>Kerala</span>'s decision to switch from an expensive branded medicine for children with <span>spinal muscular atrophy</span> (<span>SMA</span>) with a much cheaper Indian-made alternative has sparked a dispute over the drug’s safety, regulatory procedures and parents' right to know what treatment their children receive.

Health Minister K Muraleedharan has defended the switch to <span>Natco Pharma</span>'s generic risdiplam, which is sold as Natsmart. However, some parents and opposition leaders have questioned why bottles supplied to children at the <span>Sree Avittom Thirunal</span> (SAT) Hospital in Thiruvananthapuram were labelled “Physician's Sample” and “For Clinical Trials Only”.

The controversy has since expanded beyond the medicine's price. It now concerns how the drug reached the hospital and what evidence backs its use in children already receiving treatment.

<h2>Why Did Kerala Switch To The Generic SMA Medicine?</h2>

Also read: <a href="https://www.healthandme.com/health-wellness/1-in-5-us-lung-cancer-patients-never-smoked-report-highlights-hidden-risk-factors-article-156400245" data-type="tilCustomLink">1 In 5 US Lung Cancer Patients Never Smoked: Report Highlights Hidden Risk Factors</a>

<a href="https://www.healthandme.com/health-news/christina-applegate-reveals-multiple-sclerosis-misdiagnosis-why-the-disease-is-hard-to-diagnose-article-156374433" data-type="tilCustomLink">SMA</a> is a rare inherited disorder that causes progressive muscle weakness and wasting because of the loss of motor neurons. It can affect movement, swallowing and breathing. Its treatment may need to continue over a long period.

The branded risdiplam, Evrysdi, is manufactured by Swiss pharmaceutical company <span>Roche</span>. Its reported market price is around ₹6.2 lakh per bottle. <span>Natco</span>'s generic alternative, Natsmart, is listed at ₹15,900 per bottle. The Kerala government has negotiated even a lower procurement price.

The difference could substantially reduce public expenditure. The state has been providing risdiplam free to eligible children through its <span>KARE</span> programme. Reports indicate that around 109 children are receiving treatment under the scheme.

The generic switch was intended to make treatment more affordable.. Public health expert B Ekbal has backed the decision, arguing that lower-cost medicines can expand access without compromising quality.

The debate is not over whether generic medicines should be used. Opposition leaders, including former chief minister Pinarayi Vijayan, say their objections concern the handling of the medicine that were labelled for clinical trials and the transparency of its distribution.

<h2>‘Clinical Trial’ Label Alarmed The Parents </h2>

Also read: <a href="https://www.healthandme.com/health-news/swiss-team-including-indian-scientists-develops-electric-implant-to-lower-blood-sugar-without-insulin-or-drugs-article-156391878" data-type="tilCustomLink">Swiss Team Including Indian Scientists Develops Electric Implant To Lower Blood Sugar Without Insulin Or Drugs</a>

The controversy surfaced after families received bottles bearing the clinical trial and physician sample labels. Parents questioned whether their children had been given medicine intended for testing and whether they had adequately informed before.

Former Kerala health minister and CPI(M) leader K K Shailaja raised concerns about quality and the need for transparency and evidence before changing treatment.

“Just because a new company offers a price reduction doesn’t mean we can purchase everything. Besides price reduction, quality is what matters most. Some companies might lower prices just to push unsold products or for other interests,” she said, according to The South First.

The government says the labels indicate that they belong to sample stock and do not mean that the children were enrolled in a clinical trial.

Dr R Shankar, who heads the technical committee that evaluated the medicine, said, “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.”

Hospital authorities said the disputed bottles were taken back after parents raised concerns. The minister has maintained that this was done to address their apprehensions, not because the government had concluded that the medicine was unsafe.

Muraleedharan has said the switch was based on an expert committee's recommendations and that the drug had received regulatory approval. 

On October 24, he said, “People had concerns, but the doctors have addressed them. The treating doctors themselves have cleared the doubts.” He also said he would provide further clarification in the state Assembly on October 26.

Also read: <a href="https://www.healthandme.com/health-news/keralam-senior-citizens-bill-what-it-means-for-indias-ageing-population-article-156337865" data-type="tilCustomLink">Keralam Senior Citizens Bill: What It Means For India’s Ageing Population</a> 

<h2>SMA Patient Says The Generic Medicine Worked For Her</h2>

Amid the concerns, SMA patient Seba P A has defended Natsmart, saying she has taken Natco's generic risdiplam since April through a patient assistance programme. “Taking Natsmart produces the same effect as when I was taking Evrysdi,” she said. “I have felt no issues due to the change in brand.”

Seba also said bottles supplied to her free of cost carried the same physician sample and clinical trial labels. She argued that the labels were intended to prevent the free medicine from being resold.

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Natsmart contains risdiplam, the same active pharmaceutical ingredient as Evrysdi. The Central Drugs Standard Control Organisation (CDSCO) has approved Natco's formulation for marketing in India. 

They maintain that the generic medicine is suitable for patients and that the labels do not indicate an ongoing clinical trial involving the children.

However, questions have been raised about bioequivalence evidence, quality checks and the process followed before procurement. Bioequivalence studies are used to establish whether a generic formulation delivers an active ingredient into the bloodstream at a rate and to an extent comparable with the reference medicine. 

The dispute therefore cannot be resolved by comparing prices or relying solely on individual patient experiences. Families need clear information about the product's approval, the evidence for its use in children, the significance of the labels and the safeguards in place to monitor adverse effects.

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Kerala's decision to switch from an expensive branded medicine for children with spinal muscular atrophy (SMA) with a much cheaper Indian-made alternative has sparked a dispute over the drug’s safety, regulatory procedures and parents' right to know what treatment their children receive.Health Minister K Muraleedharan has defended the switch to Natco Pharma's generic risdiplam, which is sold as Natsmart. However, some parents and opposition leaders have questioned why bottles supplied to children at the Sree Avittom Thirunal (SAT) Hospital in Thiruvananthapuram were labelled “Physician's Sample” and “For Clinical Trials Only”.The controversy has since expanded beyond the medicine's price. It now concerns how the drug reached the hospital and what evidence backs its use in children already receiving treatment.Why Did Kerala Switch To The Generic SMA Medicine?Also read: 1 In 5 US Lung Cancer Patients Never Smoked: Report Highlights Hidden Risk FactorsSMA is a rare inherited disorder that causes progressive muscle weakness and wasting because of the loss of motor neurons. It can affect movement, swallowing and breathing. Its treatment may need to continue over a long period.The branded risdiplam, Evrysdi, is manufactured by Swiss pharmaceutical company Roche. Its reported market price is around ₹6.2 lakh per bottle. Natco's generic alternative, Natsmart, is listed at ₹15,900 per bottle. The Kerala government has negotiated even a lower procurement price.The difference could substantially reduce public expenditure. The state has been providing risdiplam free to eligible children through its KARE programme. Reports indicate that around 109 children are receiving treatment under the scheme.The generic switch was intended to make treatment more affordable.. Public health expert B Ekbal has backed the decision, arguing that lower-cost medicines can expand access without compromising quality.The debate is not over whether generic medicines should be used. Opposition leaders, including former chief minister Pinarayi Vijayan, say their objections concern the handling of the medicine that were labelled for clinical trials and the transparency of its distribution.‘Clinical Trial’ Label Alarmed The Parents Also read: Swiss Team Including Indian Scientists Develops Electric Implant To Lower Blood Sugar Without Insulin Or DrugsThe controversy surfaced after families received bottles bearing the clinical trial and physician sample labels. Parents questioned whether their children had been given medicine intended for testing and whether they had adequately informed before.Former Kerala health minister and CPI(M) leader K K Shailaja raised concerns about quality and the need for transparency and evidence before changing treatment.“Just because a new company offers a price reduction doesn’t mean we can purchase everything. Besides price reduction, quality is what matters most. Some companies might lower prices just to push unsold products or for other interests,” she said, according to The South First.The government says the labels indicate that they belong to sample stock and do not mean that the children were enrolled in a clinical trial.Dr R Shankar, who heads the technical committee that evaluated the medicine, said, “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.”Hospital authorities said the disputed bottles were taken back after parents raised concerns. The minister has maintained that this was done to address their apprehensions, not because the government had concluded that the medicine was unsafe.Muraleedharan has said the switch was based on an expert committee's recommendations and that the drug had received regulatory approval. On October 24, he said, “People had concerns, but the doctors have addressed them. The treating doctors themselves have cleared the doubts.” He also said he would provide further clarification in the state Assembly on October 26.Also read: Keralam Senior Citizens Bill: What It Means For India’s Ageing Population SMA Patient Says The Generic Medicine Worked For HerAmid the concerns, SMA patient Seba P A has defended Natsmart, saying she has taken Natco's generic risdiplam since April through a patient assistance programme. “Taking Natsmart produces the same effect as when I was taking Evrysdi,” she said. “I have felt no issues due to the change in brand.”Seba also said bottles supplied to her free of cost carried the same physician sample and clinical trial labels. She argued that the labels were intended to prevent the free medicine from being resold.            Is the Generic SMA Drug Safe?Natsmart contains risdiplam, the same active pharmaceutical ingredient as Evrysdi. The Central Drugs Standard Control Organisation (CDSCO) has approved Natco's formulation for marketing in India. They maintain that the generic medicine is suitable for patients and that the labels do not indicate an ongoing clinical trial involving the children.However, questions have been raised about bioequivalence evidence, quality checks and the process followed before procurement. Bioequivalence studies are used to establish whether a generic formulation delivers an active ingredient into the bloodstream at a rate and to an extent comparable with the reference medicine. The dispute therefore cannot be resolved by comparing prices or relying solely on individual patient experiences. Families need clear information about the product's approval, the evidence for its use in children, the significance of the labels and the safeguards in place to monitor adverse effects.

from ₹6.2 lakh to ₹15,900: kerala health minister defends generic sma drug but parents want safety assurance

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From ₹6.2 Lakh To ₹15,900: Kerala Health Minister Defends Generic SMA Drug But Parents Want Safety Assurance

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