Key Points
New Delhi: Last week, the Central Drugs Standard Control Organisation (CDSCO), Indias apex drug regulator, revoked the authorisation issued to Mumbai-based Entod Pharmaceuticals to manufacture and market an eye drop, which was projected to replace the need for reading glasses in middle-aged people...
ThePrint explains the development, the controversy and safety concerns around pilocarpine, the active ingredient used in the eye drop...
In a press release issued 3 September, Entod Pharmaceuticals had said 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 blurry vision condition that typically impacts those over 40...
But in an order issued last week, the CDSCO revoked the marketing and sale authorisation to the eye drop, saying that Entod was violating conditions of marketing permission by falsely projecting it as a replacement for reading glasses...
In a scientific commentary published in The Indian Journal of Ophthalmology last year, Dr Tarannum Mansoori, a senior eye specialist with Anand Eye Institute in Hyderabad, had written that continuous and regular use of pilocarpine 1.25 percent for the treatment of presbyopia needs to address some of the questions on adverse effects, which may not become evident within 30 daysthe duration of the clinical trial...
