The Natco generic risdiplam, a low-cost version of the spinal muscular atrophy (SMA) drug, is priced at ₹15,900 per bottle in the open market against ₹6,20,835 for the branded Evrysdi, according to a 21 October 2026 report from Kerala. The price gap, roughly 39 to 1 by our own arithmetic, is why a state programme wants to switch and why some families are asking for evidence first.
Key takeaways: the Natco generic risdiplam and what it costs
- The generic is ₹15,900 per bottle in the open market; Evrysdi is ₹6,20,835 per bottle, according to the report.
- By our arithmetic the generic is about 39 times cheaper per bottle, a saving of roughly 97%.
- The Delhi High Court ruled on 9 October 2025 that Natco could make and sell generic risdiplam after Roche tried to block the launch.
- Generic approval in India requires bioequivalence data; parents say they have not been shown completed studies for the new formulation.
- Some bottles reportedly carried the labels Physician Sample and For Clinical Trials Only, which hospital authorities responded to by saying the drug has CDSCO approval.
How the Natco generic risdiplam price compares
Evrysdi cost about ₹5.4 lakh per bottle in 2021, according to the report. Negotiations under the previous Kerala government brought the price down to about ₹1 lakh to ₹1.25 lakh, and the current open-market price is ₹6,20,835. A bottle lasts roughly 12 days, so by our own arithmetic a month needs about two and a half bottles. That is roughly ₹40,000 a month for the generic and about ₹15.5 lakh for the branded drug, figures that match those given by public health expert Dr B Ekbal.
A separate opinion piece by the same author puts the monthly generic cost nearer ₹30,000 and describes the generic as about 97% cheaper. The author notes that actual costs vary with age, dose and volume. We treat the monthly figures as indicative, not precise.
Is the Natco generic risdiplam approved?
The report says the Technical Committee on SMA noted that the generic was approved by the Central Drugs Standard Control Organisation, and that the Drug Controller General of India approved the molecule for marketing. The patent question is separate: the Delhi High Court decision of 9 October 2025 allowed Natco to manufacture and market the product. Approval records are held by the regulator, whose site is cdsco.gov.in.
We have not seen the approval documents. Reports have referred to a state-level regulator in Telangana, but the sources we could open do not mention one, so we do not state which authority granted which approval.
What bioequivalence means for the Natco generic risdiplam
Bioequivalence studies compare how much of the active ingredient reaches the bloodstream, and how quickly, between a generic and the original. If the two are equivalent within accepted limits, regulators generally allow the generic to rely on the original’s safety and efficacy data. That is the logic behind the committee’s reported view that separate safety and efficacy studies were not needed.
Parents and the Cure SMA Foundation of India have asked for branded supply to continue until adequate evidence on the generic is available. They say completed bioequivalence or therapeutic equivalence studies have not been shown for the new formulation. The report carries no statement from Natco Pharma, whose site is natcopharma.co.in.
The label dispute around the Natco generic risdiplam
Reports said some bottles at a Thiruvananthapuram hospital carried the labels Physician Sample and For Clinical Trials Only. Former Health Minister KK Shailaja alleged children were given clinical-trial medicines without parental consent, and Opposition Leader Pinarayi Vijayan demanded an inquiry. These are allegations. Hospital authorities said the medicine has CDSCO approval, and the Health Minister said an inquiry would follow a written complaint.
General background: SMA and why the Natco generic risdiplam matters
SMA is a rare inherited disorder that progressively weakens muscles, and it can affect movement and breathing, according to the US National Library of Medicine. Risdiplam does not cure it but can slow progression, and starting earlier generally matters. Around 118 children in Kerala receive risdiplam free of cost, according to parents. More on drug pricing in our pharmaceutical news.
Our analysis: what the Natco generic risdiplam shows about rare disease pricing
In our assessment, the case shows how patent litigation, regulatory approval and procurement interact. A court decision opened the door; a regulator reportedly approved the product; and a state decided to buy it because the saving is large. Each step is legitimate, but families will judge the outcome by whether children do as well as before, and no data on that has been presented.
The price numbers also show how much rare disease budgets depend on a single supplier. When a second supplier appears, the price can fall by more than 90%, though that does not by itself answer questions about equivalence. We make no claims about the safety or efficacy of the generic.
What is not disclosed about the Natco generic risdiplam
- The bioequivalence data and who reviewed it.
- Natco Pharma’s own statement on the labels.
- The dates and issuing authorities for each approval.
- The number of bottles carrying the disputed labels.
- Clinical outcomes for children switched from the branded drug.
Risks and caveats of the Natco generic risdiplam switch
This account relies on one regional report and a signed opinion piece. Prices are open-market figures and may differ from state procurement prices. Our ratios and monthly estimates are our own arithmetic. This is news reporting and not medical advice; treatment decisions belong with a child’s specialist.
What to watch next on the Natco generic risdiplam
- Whether a formal complaint triggers an inquiry.
- Publication of bioequivalence or committee findings.
- Any statement from Natco or the regulator on the labelling.
- Whether other states consider procuring the generic.
FAQ
How much does the Natco generic risdiplam cost?
₹15,900 per bottle in the open market, according to the report, against ₹6,20,835 for Evrysdi.
Why are families concerned?
They say completed bioequivalence studies have not been shown, and they want branded supply to continue until evidence is available.
Was a patent ruling involved?
Yes. The Delhi High Court ruled on 9 October 2025 that Natco could make and market generic risdiplam.
How we reported this: we relied on a regional news report and an opinion article, attributed all claims to them and left out unverified statements. Calculations are labelled as ours. Last updated 23 October 2026. This is news reporting and not advice.
