The directorate general of Health Services (DGHS), under the Central Drugs Standard Control Organisation (CDSCO), recently suspended ENTOD Pharmaceuticals’ licence to manufacture and market Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25%, branded as PresVu.
The suspension follows allegations of misleading claims regarding the treatment of presbyopia, a condition affecting near vision due to ageing.
ENTOD Pharmaceuticals received regulatory approval on August 20 to manufacture and market PresVu. However, a notice issued on September 4 cited several unapproved claims made by the company. ENTOD has been accused of overstating the product’s capabilities, including claims that the eye drop could reduce reliance on reading glasses and offer a non-invasive solution to improve near vision within 15 minutes. The drug regulator found these claims to be unauthorised.
In response, ENTOD Pharmaceuticals maintained that the claims were based on clinical trials and aligned with industry practices. Nikhil K. Masurkar, CEO of ENTOD Pharmaceuticals, said that the product’s benefits were based on approvals by the Drugs Controller General of India and that similar formulations had been marketed in the US.
ENTOD Pharmaceuticals argued that the DGHS’s action stifles innovation in the Indian pharmaceutical sector. Masurkar also noted that the case could set a precedent affecting other small- and medium-sized pharmaceutical companies.
PresVu, marketed as a non-invasive alternative to reading glasses for treating presbyopia and as a lubricant for the eyes, has raised concerns among ophthalmologists.
Dr Sanjay Dhawan, CEO and Director of Medical Services at Indira Gandhi Eye Hospital in Gurugram, warns of more serious risks like retinal detachment and allergic reactions, stressing the importance of medical supervision.
Dr Jay Goyal, an eye specialist at Surya Eye Hospital in Mumbai, echoes these concerns, advising, PresVu should not be viewed as a long-term solution. “While it may offer temporary benefits, the lack of long-term data raises concerns about its safety and effectiveness,” he said.
Doctors, including Goyal, emphasise that PresVu should not be sold over-the-counter and should only be prescribed after a thorough examination by an eye specialist.
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