Drug regulator suspends pharma firm from manufacturing eye drops

The pharma firm’s permission to manufacture the ophthalmic solution — under rule 84 of the New Drugs and Clinical Trial Rules, 2019 of the Drugs and Cosmetics Act 1940 — was suspended.

Dr Aditya Kelkar, director, the National Institute of Ophthalmology, said this was a welcome step as presbyopia, which is characterised by an age-related condition that affects near vision, commonly appears after the age of 40 and impacts millions worldwide.

“These drops do not represent a revolutionary treatment. Rather, it is a modification of an established medication accompanied by potential risks and needs careful evaluation,” Dr Kelkar told The Indian Express.

Dr Kelkar added that the drops may impair vision in low-light conditions, presenting risks for activities such as driving in low light conditions and that the prolonged use of these drops might accelerate cataract formation, particularly in predisposed individuals.

The efficiency of the drops may vary depending on the colour of a person’s iris, possibly requiring higher doses for certain individuals. There was also the risk that pupils might loose their function to dilate with regular use and might complicate cataract surgeries. “So considering all this, the best option at this time remains traditional reading glasses,” he added.