Look for Drugs and Conditions

Representative Image

DCGI Suspends Licence of PresVu Eye Drop Amid Safety Concerns

In a decisive action, the Drug Controller General of India (DCGI) suspended the license of PresVu, an eye drop firm that claimed its medication might lessen the need for glasses in patients suffering from presbyopia, a common disorder that affects close vision. Concerns about the product's safety and promotional strategies prompted the ban.


Presbyopia is a disorder in which people struggle to focus on close objects, usually beginning around middle life. PresVu's solution promised to address this issue by improving users' ability to read small text without the need for glasses. However, official sources stated that the company's aggressive marketing and unauthorised promotion had come under inspection, raising additional worries about the product's safety for public usage.

Reports indicate that PresVu's unauthorised promotional methods prompted the DCGI's action, raising questions about the company's compliance with regulatory rules. These sources also stated that the eye drop may offer hazards to consumers, prompting the ban.

A source familiar with the matter said that DCGI probe found the company promoting the product in a manner that is not only misleading but potentially unsafe for the general public.

Entod Pharmaceuticals, PresVu's parent firm, replied promptly to the suspension, denying any wrongdoing and stating that the medicine was safe. The business issued a statement defending the eye drop, saying, "The DCGI approved the eye drop following a credible clinical trial on 234 patients that established both safety and efficacy. "After taking the medicine, patients with presbyopia were able to read more lines on the Snellen's Chart."

Entod also stated that the US Food and Drug Administration (FDA) had approved a similar eye drop with comparable chemicals, with no reports of major consequences in the US. They stated their intention to fight the DCGI's judgement in court.

"We will pursue legal action against this decision because the product has undergone rigorous clinical trials and the US FDA has deemed it safe," the statement added.

The suspension underscores wider concerns about regulatory oversight in India's pharmaceutical sector, specifically in relation to public drug sales. The DCGI's decision to suspend PresVu's license emphasises the need for balancing innovation and consumer protection. Analysts suggest that the case shows persistent difficulty in ensuring that corporations follow ethical promotion norms and provide transparency in clinical studies.

Moving forward, the court case will be critical in determining whether PresVu's product will return to the market. The outcome may also affect future regulatory proceedings against corporations that engage in problematic advertising activities, further changing India's pharmaceutical supervisory landscape.


0 Comments
Be first to post your comments

Post your comment

Related Articles

Ad 5