DCGI Halts Entod Pharma's Eye Drops Amid Controversy

The Drugs Controller General of India (DCGI) has suspended Entod Pharmaceuticals' approval to manufacture and market eye drops designed to reduce dependency on reading glasses for presbyopia. The suspension follows claims by the company that were not approved by the Central Licensing Authority, violating clinical trial regulations.

The Drugs Controller General of India (DCGI) has taken a decisive step by suspending the manufacturing and marketing approval granted to Mumbai-based Entod Pharmaceuticals for its eye drops purported to reduce dependency on reading glasses.

The action came after Entod Pharmaceuticals made unapproved claims about the effectiveness of Pilocarpine Hydrochloride Ophthalmic Solution for treating presbyopia, a refractive error troubling middle-aged and older adults. The National Eye Institute describes presbyopia as a condition that impairs near vision.

This suspension highlights regulatory concerns, illustrating the necessity of adhering to approval standards set by the Central Licensing Authority, which found Entod's statements misleading and potentially deceptive to the general public.

(With inputs from agencies.)