The Drug Controller General of India (DCGI) has suspended the authorisation granted to Mumbai-based Entod Pharmaceuticals to manufacture and market its eye drops, citing unapproved claims made by the company regarding its effectiveness in reducing dependence on reading glasses for individuals with presbyopia.
According to National Eye Institite, Presbyopia is a common refractive error affecting middle-aged and older adults, impairing their ability to see up close. The condition is typically managed with reading glasses.
DCGI's Concerns and Suspension Order
The drug in question, Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25%, was originally approved for treating presbyopia in adults. However, the DCGI raised concerns over various marketing claims made by Entod Pharmaceuticals that were not covered under the approved indications.
One of the most prominent claims was that the eye drop was "the first in India designed to reduce the need for reading glasses." The company responded by stating that no other eye drops have been approved in India for the treatment of presbyopia. However, this explanation did not satisfy the regulatory body, which reiterated that the product was not approved for reducing the need for reading glasses.
In another claim made by the company suggested the eye drops "offer a non-invasive option that enhances near vision without the need for reading glasses." Entod Pharmaceuticals claimed that participants in clinical trials did not wear reading glasses. The DCGI, however, maintained that the product’s approval only covered the treatment of presbyopia and not any claims about reducing reliance on glasses.
In a third claim, the company advertised that PresVu, the marketed name for the eye drops, could "augment near vision within 15 minutes." Entod provided a response citing an evaluation by a doctor comparing the product to reading glasses, but the DCGI again clarified that such a claim was not part of the approved indication.
The suspension order concluded that Entod Pharmaceuticals had "failed to adequately respond to the queries raised." The agency reprimanded the company for making claims not approved by the central licensing authority, stating that no prior approval was sought for these assertions.
Response Of Entod Pharmaceuticals
In response to the suspension, Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, expressed the company's intention to contest the order in court. He said that announcing new product launches to the media is a routine practice in the pharmaceutical industry and noted that similar announcements by other companies often contain additional descriptions beyond the exact approved indications.
Masurkar said that the viral spread of media reports had escalated the situation and asserted that Entod Pharmaceuticals was not responsible for the resulting public perception. “Entod Pharmaceuticals has received a suspension order from the DCGI who has made no reference to any specific violation of Drugs and Cosmetics Act for this action.” he added.
"We strongly oppose this action against Entod Pharmaceuticals, an MSME that is research and innovation driven. Our aim is to bring new therapeutic options to the Indian market," Masurkar stated.
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