India's CDSCO Takes Action Against Entod Pharmaceuticals for Misleading Eye Drops Promotion
Regulatory Suspension of Eye Drops
The Central Drugs Standard Control Organization (CDSCO) has taken a significant step by suspending the manufacturing and marketing license of Entod Pharmaceuticals for its eye drops, PresVu, due to unauthorized promotion.
Misleading Claims and Regulatory Concerns
On September 10, the CDSCO issued an order stating, “PresVu by Entod Pharmaceuticals Ltd has not been approved to make any claims that it is designed to reduce the need for reading glasses.” The approval was strictly for treating presbyopia in adults, and Entod's claims regarding enhanced near vision were unauthorized.
- The CDSCO's order emphasized that false claims misleadingly portrayed PresVu as an over-the-counter drug rather than a prescription-only medication.
- Concerns were raised over the promotion including misleading statements in press and social media, reflecting misuse of granted permissions.
- Safety concerns prompted the regulator to challenge Entod's claims, leading to the suspension until satisfactory explanations were provided.
Clinical Trials and Prescription Only Status
Entod highlighted that their approval by DCGI was based on valid controlled clinical trials involving 234 patients, showing safety and efficacy in improving near vision.
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