The Natco generic risdiplam row in Kerala began when reports emerged that some bottles supplied at a Thiruvananthapuram hospital carried labels reading Physician Sample and For Clinical Trials Only. The medicine is a low-cost generic version of the spinal muscular atrophy (SMA) drug risdiplam, and the dispute, reported on 21 October 2026, now spans approval status, labelling, price and the concerns of families.
Key takeaways on the Natco generic risdiplam controversy
- Reports say some bottles at Sree Avittom Thirunal Hospital, Thiruvananthapuram, carried the labels Physician Sample and For Clinical Trials Only.
- Hospital authorities said the medicine has approval from the Central Drugs Standard Control Organisation (CDSCO), according to the report.
- The generic is priced at ₹15,900 per bottle in the open market, against ₹6,20,835 for the branded drug Evrysdi, according to the same report.
- Parents and the Cure SMA Foundation of India want branded supply to continue until adequate evidence on the generic is available.
- Health Minister K Muraleedharan said an inquiry would be held if a written complaint is submitted.
What happened with the Natco generic risdiplam labels
According to a regional news report, bottles from the hospital bore labels that did not look like those of a marketed medicine. Former Health Minister KK Shailaja and Leader of the Opposition Pinarayi Vijayan raised the issue, and Vijayan demanded an inquiry. Shailaja alleged that children were given clinical-trial medicines without parental consent. Those are allegations made by political figures, and we have not seen evidence that supports or refutes them.
Hospital authorities responded that the medicine has CDSCO approval. The report does not say who first reported the labels, does not explain why the wording appeared, and carries no statement from Natco Pharma. We therefore cannot say whether the labels reflect a packaging error, a batch intended for another purpose or something else. That question is open.
Approval status of the Natco generic risdiplam
The report says the Technical Committee on SMA noted that the generic was approved by CDSCO, and that the Drug Controller General of India approved the molecule for marketing. It adds that the committee said no separate safety and efficacy studies were needed for a generic. Separately, the Delhi High Court ruled on 9 October 2025 that Natco could manufacture and market generic risdiplam after Roche sought to block its launch. The regulator’s website is cdsco.gov.in.
Public health expert Dr B Ekbal, who backs the switch, points out that generic approval under the Drugs and Cosmetics Act requires completed bioequivalence studies. Bioequivalence tests whether a generic delivers the active ingredient into the bloodstream at a comparable rate and extent to the original. Parents say they have not been shown completed studies for the new formulation. We have not seen the underlying documents, so we cannot say who is right.
Price: how far apart are the two medicines?
The report gives the open-market price of Natco’s generic as ₹15,900 per bottle, and the price of Evrysdi as ₹6,20,835 per bottle. By our own arithmetic, that is a ratio of about 39 to 1, or a saving of roughly 97%, which matches the description of the generic as almost 40 times cheaper. A bottle lasts roughly 12 days, so by our arithmetic a month needs about two and a half bottles, or roughly ₹40,000 for the generic against ₹15.5 lakh for the branded drug.
Those monthly figures match the ones Dr Ekbal gave, though an opinion piece by the same author puts the generic monthly cost nearer ₹30,000. The difference may reflect dosing assumptions, and the author notes that real costs vary with age, dose and volume. Treat the monthly numbers as indicative.
Why the Natco generic risdiplam matters for families
SMA is a rare genetic disorder that progressively weakens muscles. Risdiplam cannot cure it but can slow progression, and timing matters, as the US National Library of Medicine explains on its MedlinePlus SMA page. For a state programme, a price this much lower could make it possible to treat more children from the same budget. For families, the question is whether the switch is safe to accept.
Around 118 children currently receive risdiplam free of cost, according to parents. The state government has said that the switch would let more patients access treatment, and that the change was recommended by an expert committee. It has also said it would consider contrary expert opinions if presented. Our pharmaceutical coverage will follow any inquiry.
General background: how generics reach the market in India
A generic medicine enters the market after the regulator is satisfied that it contains the same active ingredient and performs comparably to the original. Patents are a separate question, handled by courts, which is what the Delhi High Court addressed in October 2025. A company may be free to sell once a court allows it, but regulatory approval and supply labelling remain separate requirements. The company’s own website is natcopharma.co.in.
Our analysis: separating three different questions
In our assessment, the Natco generic risdiplam debate bundles three questions that should be kept apart. The first is approval: whether the product is lawfully approved. The second is labelling: why some bottles carried wording suggesting trial or sample use. The third is equivalence: whether families and clinicians have seen enough data to be comfortable. A satisfactory answer to one does not settle the others.
The labelling issue may prove to be an administrative matter, but it should be explained in writing, because unclear labels erode trust in a programme that depends on it. We make no claim about the safety or efficacy of the generic, and we have seen no data that would let us do so.
What is not disclosed about the Natco generic risdiplam
- Why the Physician Sample and For Clinical Trials Only wording appeared on some bottles.
- Any statement from Natco Pharma on the labels.
- The bioequivalence data submitted for the Natco generic risdiplam.
- Which state or central authority granted each approval, and the dates.
- The exact number of bottles affected.
Risks and caveats
This account rests on a single regional report and a signed opinion piece, and several statements are allegations or positions taken by officials, politicians and campaigners. We have not independently verified the labels. Nothing here is medical advice, and families should speak to their treating specialists before any change in treatment.
What to watch next
- Whether a written complaint is filed and an inquiry begins.
- A clarification of the labelling from the hospital, state or manufacturer.
- Publication of the bioequivalence data or committee findings.
- Whether branded supply continues for families who request it.
FAQ
What is the Natco generic risdiplam?
It is a low-cost generic version of risdiplam, a treatment for spinal muscular atrophy, sold by Natco Pharma.
Is the Natco generic risdiplam approved?
According to the report, hospital authorities and a technical committee said it has CDSCO approval, and the Delhi High Court allowed Natco to sell it in October 2025.
How much cheaper is it?
About 39 times cheaper per bottle by our arithmetic, at ₹15,900 versus ₹6,20,835, according to the report.
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.