Kerala's Trial-Labeled SMA Medicine Raises Questions About Inventory Controls
By Elizabeth Urbanek, Executive Editor
A government hospital in Kerala, India, supplied children receiving treatment for spinal muscular atrophy (SMA) with medicine labeled “Physician Sample” and “For Clinical Trials Only.” The labels raised questions about how the medicine was sourced, checked and cleared for routine patient use.
Sree Avittom Tirunal (SAT) Hospital in Thiruvananthapuram had begun switching eligible children from Roche’s Evrysdi to Natco Pharma’s lower-cost generic risdiplam, sold as Natsmart. The change is part of a state effort to lower the cost of SMA treatment and make medication more accessible.
According to The New Indian Express, SAT Hospital Superintendent Dr. I. Riaz said the sample-labeled medicine was supplied through the National Health Mission and Kerala Medical Services Corporation Ltd. during a temporary shortage of Natsmart. Government-supplied stock arrived the next day, and hospital officials contacted families after parents questioned the labels.
The Indian Medical Association’s Kerala branch called for clarification on the medicine’s source, quality checks and distribution.
What This Means For Clinical Supply
The issue goes beyond which medicine was prescribed. The labels on the bottles raised questions about whether the stock was intended and authorized for routine treatment.
The Central Drugs Standard Control Organisation (CDSCO) confirmed to The Times of India that Natco’s generic risdiplam formulation had received regulatory approval. Natco said the disputed labels appeared on bottles supplied free through its patient assistance program and maintained that the bottles were not intended for clinical trials.
Approval of the medicine does not, on its own, resolve questions about the status of the specific bottles supplied to patients. Public reporting has not established that the children were enrolled in a clinical trial or given an unapproved formulation.
For clinical supply teams, the case raises a practical question: when stock is moved to cover a shortage, how do teams confirm that its labeling, inventory status and distribution authorization match its intended use? Batch traceability and clear release records are essential to establishing where the product came from and whether it was suitable for that route of supply.
As of October 23, the Kerala Health Department was examining how the sample-labeled medicine reached patients. A final finding on whether any rules were violated had not been reported.
The Supply Question
What controls should prevent medicine labeled “For Clinical Trials Only” from being supplied to patients for routine treatment?
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About The Author:
Elizabeth Urbanek is the Executive Editor for Clinical Supply Leader, where she works with clinical trial supply and logistics professionals across pharma and biotech to bring real-world perspectives, operational challenges, trends, scientific insights and regulatory strategy to the field.
Before joining life sciences media, Elizabeth spent more than 15 years in broadcast, digital and live-event storytelling, helping highly technical teams communicate complex ideas with clarity and impact. She brings that same approach to clinical supply, creating editorial space for experts to share what is happening across clinical trial operations.
Elizabeth is passionate about connecting people and ideas, identifying emerging themes and showcasing work that can move the clinical supply field forward.