Presbyopia Treatment: DCGI Suspends Entod Pharma’s Eye Drop Approval
Presbyopia Treatment Claims Controversy
Days after Entod Pharmaceuticals claimed their eye drop PresVu could reduce dependency on reading glasses, the Drug Controller General of India (DCGI) suspended its approval. This decision followed allegations that the company had not obtained the necessary permissions to market the product properly.
Violation of Regulations
In an order issued on September 10, the DCGI cited violations of the New Drugs and Clinical Trial Rules, 2019 for unauthorized promotion. Despite receiving CDSCO approval, Entod's promotional activities led to public safety concerns.
- Presbyopia impacts those over 40, complicating vision; hence, its treatment is vital.
- DCGI pointed out that the product was marketed as an OTC drug despite being a prescription-only treatment.
Company’s Stance
Entod Pharmaceuticals maintains that all media disclosures are based on appropriate approvals. Their CEO, Nikkhil K Masurkar, indicated a willingness to challenge the suspension in court, emphasizing a commitment to bringing innovative treatments to India.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.