DCGI Regulations Impacting Entod Pharma's Eye Drop for Presbyopia
DCGI Action on Entod Pharma's Eye Drop
New Delhi: The Drugs Controller General of India (DCGI) has suspended the permission granted to Entod Pharmaceutical Ltd. to manufacture its eye drop, PresVu, due to unapproved claims that it can reduce dependency on reading glasses for individuals affected by presbyopia. The DCGI's order, issued on September 10, cited concerns over the safety of the product and its promotion as an over-the-counter option despite its approval as a prescription drug.
Corporate Response and Marketing Claims
Nikkhil Masurkar, CEO of Entod Pharmaceuticals, expressed that the company has acted ethically, stating the firm will legally contest the DCGI’s decision. Originally approved on August 20, the company claimed that PresVu was the “first eye drop in India specifically developed to reduce dependency on reading glasses.” However, the DCGI raised questions regarding this assertion after reviewing the claims made in promotional materials.
- Claim 1: The eye drops are the *first designed to reduce the need for reading glasses*.
Response: No other eye drops have been approved for treating presbyopia in India.
- Claim 2: Offers a *non-invasive option that enhances near vision without glasses*.
Response: Participants in clinical trials did not wear glasses.
- Claim 3: Provides an *advanced alternative that improves near vision within 15 minutes*.
Response: A doctor compared it against reading glasses.
The regulator emphasized that while the eye drops are approved for presbyopia treatment, they are not sanctioned for claims of enhancing near vision without reading glasses. The DCGI criticized Entod Pharma for failing to address regulatory concerns adequately and for justifying claims that lack prior approval.
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.