Due to safety concerns and unauthorised claims, the Central Drugs Standard Control Organisation (CDSCO) of India has suspended the manufacturing and marketing license of Entod Pharmaceuticals’ PresVu eye drops, which contain 1.25% Pilocarpine w/v.
The CDSCO’s suspension order noted that PresVu was not approved to make claims about reducing the need for reading glasses.
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The product was only permitted for treating presbyopia in adults, and not for any other benefits such as enhancing near vision.
According to the CDSCO, Entod engaged in promotional activities that included “unauthorised claims” in the media and on social platforms.
These activities showcased that PresVu could be an advanced alternative for near vision improvement – a claim not sanctioned by the regulator.
The promotion of PresVu also led to concerns about its use as an over-the-counter drug, despite its approval only as a prescription medication.
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By GlobalDataThe CDSCO emphasised that eye drops should not be sold without a valid prescription, either in physical stores or online.
The CDSCO had previously requested explanations from Entod Pharmaceuticals concerning these claims. The suspension order was a consequence of the company’s inadequate response to the regulator’s concerns.
Entod Pharmaceuticals CEO Nikkhil Masurkar stated: “We will challenge this suspension in the court of law to get justice.”
In a media release, Masurkar went on: “Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing [the] efficacy and safety of these eye drops in patients [with] presbyopia, who used these drops without eyeglasses and could read additional lines on Snellen’s chart which is a yardstick of near vision improvement.”
“Such eye drops on the same active ingredient and same concentration have been approved by the US FDA and marketed in the USA for the last three years without any serious complications. The FDA did not take any action on the companies marketing the same in the USA.”
