Entod Eye Drops’ License Suspended for Misleading Claims and Overselling
Entod Eye Drops’ License Suspended for Misleading Claims and Overselling
The Mumbai-based pharmaceutical company plans to challenge the suspension in court, claiming no ethical violations.
The Drugs Controller General of India (DCGI) has suspended the license of Entod Pharmaceuticals to manufacture and market its “PresVu” eye drops, citing misleading claims and overselling of the product’s benefits. The eye drops, intended to treat presbyopia (age-related farsightedness), were originally scheduled for an October launch.
PresVu, chemically known as Pilocarpine Hydrochloride Ophthalmic Solution, was approved by the DCGI on August 20 for the treatment of presbyopia in adults. However, the national drugs regulator has suspended its approval, stating that the company exaggerated the product’s benefits, including claims that it could reduce a patient’s dependency on reading glasses, which were not part of the approved indication.
The DCGI’s suspension order, issued on Tuesday, cited public interest as the reason for halting the product’s marketing and manufacturing. The regulator expressed concerns that Entod was promoting the eye drops as an over-the-counter solution and falsely claimed it as “the first eye drop in India designed to reduce the need for reading glasses.” Entod was issued a show-cause notice on September 4 to explain these misrepresentations.
Despite the suspension, Entod Pharmaceuticals’ CEO, Nikkhil K Masurkar, defended the company’s actions, stating that no unethical or misrepresentative claims were made. Masurkar clarified that the company had only used more elaborate language in its press release to communicate the product’s benefits to the public but maintained that the drug’s approved use—treating presbyopia—was never misrepresented.
Entod plans to contest the suspension in court, claiming the DCGI’s order lacked specific references to any violation of the Drugs and Cosmetics Act. Until further notice, the approval to manufacture and market PresVu remains suspended.
