Here is why DCGI has suspended approval of PresVu eye drops that claimed usage would help get rid of reading glasses
It was projected as a wonder drug that could help millions of people say goodbye to their reading glasses for good. But you will not be able to buy the eye drops, PresVu, as the manufacturer has been suspended by the Drugs Controller General of India (DCGI).?The drug regulator took the step days after Entod Pharmaceuticals made headlines across India, with claims that PresVu can reduce dependency on reading glasses.
What DCGI said about PresVu
The DCGI on Wednesday suspended PresVu after Entod Pharmaceuticals failed to respond to the queries on the product, for which the DCGI says no approval was granted.
"Taking serious note of the unauthorised promotion of the product, PresVu (1.25% Pilocarpine w/v) by M/s Entod Pharmaceuticals Ltd, after getting permission from CDSCO to manufacture and market, the regulator has suspended their permission till further order. The unauthorised promotion in the press and over social media had raised doubts on its unsafe use by patients and safety concerns for the public. The promotion raised concern about its use like OTC drugs, whereas it is approved as a prescription-only drug," the Union Ministry of Health and Family Welfare said in a statement.
Entod Pharmaceuticals' claims about PresVu??
Earlier, Entod Pharmaceuticals had claimed that, "PresVu is the first eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40. PresVu has also been applied for a patent for this invention in terms of its formulation and the process. The proprietary formula not only gets rid of reading glasses but also helps the patient lubricate their eyes as a side benefit."
Medical experts question?Entod Pharmaceuticals' claims
The DCGI said the claims made by Entod Pharmaceuticals were unethical and a false presentation of facts. Medical experts also said the company's claims are misleading.
Clinical scientist Dr. Cyriac Abby Philips said that PresVu is not a proprietary product of Entod Pharmaceuticals or an Indian innovation as the manufacturer claimed. According to him, PresVu contains 1.25% of pilocarpine, a drug that helps improve near vision temporarily and is used in people suffering from presbyopia.
Dr. Philips pointed out that two companies in the US have been granted approval by the USFDA in 2021 and 2023 to use pilocarpine in adults.
For more news and current affairs?from around the world, please visit?Indiatimes News.
