📷 Image: Wikimedia Commons / Ministry of Science and Technology
Health
Natco's SMA Generic Drug Approved, Kerala Labels Spark Controversy
✍️ The Times of India
🗓 23 Oct 2026, 03:17 PM
👁 13
India's regulatory body has cleared Natco Pharma's generic spinal muscular atrophy medication, but the inclusion of 'clinical trial' labels has sparked a dispute in Kerala.
India’s Drugs Controller General of India has approved Natco Pharma’s generic formulation of a drug used to treat spinal muscular atrophy (SMA), a rare neuromuscular disorder that leads to progressive muscle weakness.
The approval marks a significant step for patients in India, offering a more affordable alternative to the high‑cost branded therapies that are currently available.
However, the drug’s packaging bears a “clinical trial” label, a designation that has raised questions about its status and the regulatory process. The label has prompted criticism from health officials and patient groups in Kerala, who argue that the terminology could mislead consumers.
The Kerala health department has called for a review of the labeling and is demanding clearer communication about the drug’s approval status to ensure patients receive accurate information.
The approval marks a significant step for patients in India, offering a more affordable alternative to the high‑cost branded therapies that are currently available.
However, the drug’s packaging bears a “clinical trial” label, a designation that has raised questions about its status and the regulatory process. The label has prompted criticism from health officials and patient groups in Kerala, who argue that the terminology could mislead consumers.
The Kerala health department has called for a review of the labeling and is demanding clearer communication about the drug’s approval status to ensure patients receive accurate information.