India
Eye drops license revoked over safety concerns – Times of India
NEW DELHI: The Drug Controller General of India (DCGI) on Wednesday granted the license for the production and market PresVuan eye drop that is claimed to reduce the need for reading glasses in people with Presbyopia – a common age-related problem making it difficult to focus on close objects.
According to government sources, the measure was taken because the makers of the eye drops, Entod Pharmaceuticalswere involved in the unauthorized promotion of the product, raising concerns about its unsafe use by patients and safety concerns for the public. “The promotion has raised concerns about its use as an over-the-counter medicine when it is only approved as a prescription drug,” government sources said.
Entod Pharmaceuticals, on the other hand, denies that the facts have been presented unethically or incorrectly regarding PresVu eye drops. Furthermore, the company will challenge the suspension order in court to get justice.
“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients, which was successful in demonstrating the efficacy and safety of these eye drops in patients with presbyopia, who used these drops without glasses and who could read extra lines on Speeding“The ‘s graph is a measure of short-term visibility limitations,” the company said in its statement.
“Such eye drops with the same active ingredient and concentration have been approved by the US FDA and marketed in the US for the past three years without any serious complications. The FDA has not taken any action against the companies marketing the same in the US,” the statement said.
According to government sources, the measure was taken because the makers of the eye drops, Entod Pharmaceuticalswere involved in the unauthorized promotion of the product, raising concerns about its unsafe use by patients and safety concerns for the public. “The promotion has raised concerns about its use as an over-the-counter medicine when it is only approved as a prescription drug,” government sources said.
Entod Pharmaceuticals, on the other hand, denies that the facts have been presented unethically or incorrectly regarding PresVu eye drops. Furthermore, the company will challenge the suspension order in court to get justice.
“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients, which was successful in demonstrating the efficacy and safety of these eye drops in patients with presbyopia, who used these drops without glasses and who could read extra lines on Speeding“The ‘s graph is a measure of short-term visibility limitations,” the company said in its statement.
“Such eye drops with the same active ingredient and concentration have been approved by the US FDA and marketed in the US for the past three years without any serious complications. The FDA has not taken any action against the companies marketing the same in the US,” the statement said.
