New Delhi: The Drugs Controller General of India (DCGI) has suspended the approval granted to Entod Pharmaceuticals for manufacturing and selling their eye drops, PresVu, which were promoted as a solution for presbyopia, an age-related vision condition.
The suspension follows concerns raised over the unauthorized promotion of PresVu (1.25% Pilocarpine w/v) in the media and on social platforms, leading to public safety worries.
The eye drops, approved only as a prescription drug, were being marketed in a manner suggesting over-the-counter use, according to a statement by the Union Ministry of Health and Family Welfare.
Entod Pharmaceuticals has been criticized for failing to adequately address regulatory queries. However, CEO Nikhil Masurkar defended the company, stating that their promotions were based on DCGI approval and clinical trials. The company plans to challenge the suspension in court.
