CDSCO Suspends Manufacturing of Eye Drops: Concerns Over Presbyopia Claims
CDSCO Takes Action Against ENTOD Pharmaceuticals
In a significant move, the Central Drugs Standard Control Organisation (CDSCO) has suspended the manufacturing and marketing of PresVu, an eye drop developed by ENTOD Pharmaceuticals that claimed to assist those with presbyopia. This condition generally leads to a decreased ability to see close objects and is often managed using reading glasses. The company had initially received approval from the CDSCO to market this product as a revolutionary alternative to reading glasses.
Concerns Over Promotional Practices
The CDSCO raised serious concerns following unauthorized promotional claims that suggested PresVu has effects akin to those of over-the-counter drugs. These claims prompted an immediate suspension, highlighting the potential safety risks to consumers.
- CDSCO's suspension is pending further evaluation.
- Dr. Rajeev Singh Raghuvanshi, the Drug Controller General of India, has demanded clarifications regarding the promotional practices.
- The company’s CEO, Nikkhil K Masurkar, asserted that they did not provide misleading information.
Legal and Ethical Implications
A Kerala-based RTI activist, K V Babu, filed a complaint citing violations of the Drugs and Magic Act, 1954, regarding the advertisement of medications for certain conditions. Experts stress the importance of adhering to drug regulations to ensure public safety.
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