Centre Suspends PresVu Eye Drops Licence For Claiming To Replace Reading Glasses, Company To Move Court
DCGI has suspended the license of PresVu eyedrops, used for Presbyopia, due to unauthorized promotions by the manufacturer
The Drug Controller General of India (DCGI) has suspended the licence for the eye drops meant to reduce the need for reading glasses in people with Presbyopia. The licence of PresVu eye drops, manufactured by Entod Pharmaceuticals, was suspended due to the company’s unauthorized promotions, creating doubts about the product's safety and its misuse by patients.
"Taking serious note of the unauthorized promotion of the product, PresVu (1.25% Pilocarpine w/v) by M/s Etod Pharmaceuticals, after getting permission from CDSCO to manufacture and market, the regulator has suspended their permission till further order. The unauthorized promotion in the press and over social media had raised doubt about its unsafe use by patients and safety concerns for the public. The promotion had raised concerns about its use like OTC drugs whereas it is approved as a prescription-only drug," the Ministry Of Health and Family Welfare said in a notification.
Taking serious note of the unauthorized promotion of the product, PresVu (1.25% Pilocarpine w/v) by M/s Etod Pharmaceuticals, after getting permission from CDSCO to manufacture and market, the regulator has suspended their permission till further order. The unauthorized promotion… pic.twitter.com/ge29eZRTl5
— ANI (@ANI) September 11, 2024
Meanwhile, Entod Pharmaceuticals denied making any false presentation of facts regarding the PresVu eye drops and said it would challenge the suspension order in court. Nikkhil K Masurkar, CEO of Entod Pharmaceuticals, in a statement, said that all facts disclosed by the company about PresVu to the media were "strictly on the basis of the DCGI's approval", especially after the "results of the phase 3 clinical trial conducted by us in India."
Our response to the suspension of the permission of #presvu by the Indian Drug Controller. #911dayinindianpharma #indianresearch #innovateinindia pic.twitter.com/2GW7HnTJm6
— Entod Pharmaceuticals (@EntodPharma) September 11, 2024
"Announcing the new product launch to the media is a routine industry practice followed by all pharma companies in India and in the recent past, many such announcements have been made. In our case, media reports went viral and public imagination led to an unusual escalation for which Entod Pharmaceuticals is not responsible," he said.
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