The Drug Controller General of India (DCGI) has suspended the manufacturing and marketing license of PresVu eye drops, produced by Entod Pharmaceuticals, citing misleading claims about its efficacy. The eye drops, which the company promoted as a groundbreaking solution to replace reading glasses and enhance near vision within 15 minutes, have now been barred from the market.
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| The Indian Express had reported that Pilocarpine Hydrochoride — the active ingredient used in the eye drop — is not a new drug. |
Entod Pharmaceuticals initially claimed that PresVu was the first non-invasive eye drop in India designed to improve near vision, particularly for individuals with presbyopia, an age-related condition where the eye’s lens loses flexibility, making it difficult to see objects up close. However, the DCGI determined that the company had misled the public with these assertions, stating that no such claims were approved when the eye drops were licensed.
The active ingredient in PresVu, Pilocarpine Hydrochloride, is a well-established drug that has long been used in treating eye conditions like cataracts and glaucoma. It works by contracting the iris muscles, which can improve the eye's ability to focus, thereby helping those with presbyopia. However, the DCGI emphasized that while PresVu was approved for treating presbyopia, it was never authorized for the broader claims made by Entod, including its potential to replace reading glasses.
“The company failed to respond to queries and tried to justify claims for the product for which no approval was granted,” the DCGI’s order stated. The regulator added that the company’s marketing materials exaggerated the product’s capabilities, potentially misleading the general public.
Entod Pharmaceuticals has announced that it plans to challenge the suspension. In a statement, CEO Nikkhil Masurkar defended the company's actions, saying, “Announcing new product launches to the media is a routine practice followed by all pharma companies. Unfortunately, media reports went viral and led to an unusual escalation in public expectations.”
Masurkar also argued that the company’s press release provided a more detailed explanation of the drug’s potential benefits than what was approved by regulators. He pointed out that similar press releases from other major pharmaceutical companies often go beyond the exact wording of regulatory approvals.
When asked why the company claimed PresVu was the first eye drop in India designed to reduce the need for reading glasses, Masurkar stated that there were no other eye drops approved for presbyopia in the country. However, the DCGI clarified, “You are informed that this drug has not been approved for any such claim that it is designed to reduce the need for reading glasses.”
Entod also defended its claim that the product could improve near vision without glasses, arguing that subjects in its trials did not use glasses during testing. As for the assertion that the eye drops could enhance near vision within 15 minutes, the company pointed to one doctor’s evaluation comparing the product to reading glasses.
In light of the widespread media coverage and potential for public confusion, the DCGI emphasized that the company’s claims could mislead consumers. “Considering the various media reports, there is a likelihood of the general public being misled by the claims made by you, for which no approval was granted,” the order stated.
For now, the license to manufacture and market PresVu has been suspended pending further review. Entod Pharmaceuticals faces an uphill battle as it prepares to challenge the suspension while navigating the regulatory concerns raised by the DCGI.
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