Parents, a former health minister, a public health expert and hospital authorities are giving different accounts of the Natco generic risdiplam now being introduced for children with spinal muscular atrophy (SMA) in Kerala. The dispute, reported on 21 October 2026, turns on approval status, labelling, price and whether families have seen enough evidence for the switch.
Key takeaways: who says what on the Natco generic risdiplam
- Hospital authorities said the Natco generic risdiplam has approval from the Central Drugs Standard Control Organisation (CDSCO), according to the report.
- Former Health Minister KK Shailaja alleged children were given clinical-trial medicines without parental consent; this is an allegation, not an established finding.
- Public health expert Dr B Ekbal backs the switch and says no medicine should be presumed inferior simply because it is cheaper.
- Parents and the Cure SMA Foundation of India want branded supply to continue until adequate evidence on the generic is available.
- The Health Minister said an inquiry would be held if a written complaint is submitted.
The regulatory position on 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 safety and efficacy studies were not needed for a generic. The regulator’s website is cdsco.gov.in. We have not seen the approval documents or dates.
The legal route is separate. The Delhi High Court ruled on 9 October 2025 that Natco could manufacture and market generic risdiplam after Roche sought to block its launch. Reports have referred to a state-level regulator in Telangana, but the sources we could open do not mention one, so we do not attribute the approval to any authority beyond what is quoted above.
Patient and family concerns about the Natco generic risdiplam
About 118 children receive risdiplam free of cost, according to parents. Parents question whether the switch was properly explained to families, and say completed bioequivalence or therapeutic equivalence studies have not been shown for the new formulation. Shailaja said that children who were bedridden improved significantly on the Roche drug. That is a claim we have not been able to verify.
On the other side, Dr Ekbal notes that generic approval under the Drugs and Cosmetics Act requires completed bioequivalence studies and that Natco must show its drug enters the bloodstream comparably to the original. His argument appeared as a signed opinion piece, which does not reflect the publisher’s views. Both sides therefore agree on the test; they disagree on whether it has been shown.
The Natco generic risdiplam labelling issue and the company’s silence
Reports said some bottles at Sree Avittom Thirunal Hospital in Thiruvananthapuram carried the labels Physician Sample and For Clinical Trials Only. Hospital authorities said the medicine had CDSCO approval, and the Health Minister said an inquiry would follow a written complaint. The report contains no statement from Natco Pharma, whose site is natcopharma.co.in, so the labelling remains unexplained.
Price: the numbers behind the Natco generic risdiplam decision
The open-market price is ₹15,900 per bottle for the generic against ₹6,20,835 for Evrysdi, according to the report. By our own arithmetic, that is about 39 times cheaper, or a saving of roughly 97%. With a bottle lasting about 12 days, a month needs roughly two and a half bottles, so by our arithmetic about ₹40,000 for the generic and ₹15.5 lakh for the branded drug. Dr Ekbal’s opinion piece gives a figure nearer ₹30,000 for the generic, so the monthly cost depends on dose and age.
The state government said the switch would let more patients access treatment, and that it would consider contrary expert opinions if they are presented. For further reading on SMA, see the US National Library of Medicine’s MedlinePlus entry.
General background: how a state decides to switch to a generic risdiplam
A state programme weighs price, regulatory status, expert committee advice and family consent. Where a generic is approved, procurement rules may favour it. Where families rely on a branded product that has worked for their child, the change can feel like a risk even if regulators judge the products equivalent. This tension is not unique to Kerala, and our pharmaceuticals coverage has followed similar debates.
Our analysis: trust depends on transparency
In our assessment, the Natco generic risdiplam dispute is as much about communication as about science. If the bioequivalence data exist, publishing a summary would answer a central question quickly. If the labelling was an administrative error, saying so plainly would help. If neither is done, the allegations will continue to fill the gap.
We do not conclude that the generic is unsafe or less effective, and we have seen no data that would let us. We also do not suggest that the families’ concerns are unreasonable. Treatment decisions belong with clinicians and families.
What is not disclosed about the Natco generic risdiplam
- Natco Pharma’s statement on the labelling.
- The bioequivalence data and reviewers.
- Approval dates and the issuing authority for each step.
- How consent was handled for children switched to the generic.
- Clinical outcomes after the switch.
Risks and caveats of the Natco generic risdiplam switch
The report is a single regional account supported by an opinion article. Statements by politicians, campaigners and officials are attributed, not verified. Prices are open-market figures and our ratios are approximate. This article is news reporting and not medical advice.
What to watch next on the Natco generic risdiplam
- Whether a written complaint prompts an inquiry.
- Any publication of the committee’s reasoning or bioequivalence data.
- A statement from Natco or the hospital on the labelling.
- Whether branded supply continues for families who ask for it.
FAQ
What is the controversy over the Natco generic risdiplam?
It concerns disputed labels, approval and equivalence evidence for a low-cost SMA drug that Kerala plans to use, with families asking for branded supply to continue meanwhile.
Who supports the switch?
The state government, an expert committee and Dr B Ekbal, according to the report.
Who is opposed?
Parents, the Cure SMA Foundation of India and opposition leaders, who want more evidence or an inquiry.
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.
