The Directorate General of Health Services (DGHS), which is part of the Central Drugs Standard Control Organisation (CDSCO), has terminated ENTOD Pharmaceuticals Ltd.’s license to produce and commercialize Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v, known as PresVu. This case concerns charges of false claims about the treatment of presbyopia, an age-related visual problem.
According to the order, ENTOD Pharmaceuticals had received approval on 20 August 2024 to produce and market the eye drops for managing presbyopia in adults. However, a notice dated 4 September 2024 highlighted several unapproved claims made by the company in media releases.
The DGHS identified three specific instances where ENTOD allegedly overstated the product’s capabilities, including claims that the eye drops could reduce the need for reading glasses and provide a non-invasive option to improve near vision within 15 minutes. The regulator clarified that these claims were not authorised, potentially misleading the public.
In response, ENTOD Pharmaceuticals defended its actions, stating that the claims were based on clinical trials and aligned with routine industry practices. “All facts disclosed to the media are strictly on the basis of recent DCGI approval and clinical trials,” said Nikhil K Masurkar, CEO of ENTOD Pharmaceuticals. The company also noted that similar formulations have been marketed in the United States without regulatory issues.
Despite the company’s defence, the DGHS, citing concerns for public interest, suspended the product’s licence under the Drugs and Cosmetics Act, 1940. “The permission issued on 20.08.2024 is hereby suspended until further order,” stated Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
ENTOD Pharmaceuticals has announced plans to challenge the suspension in court, arguing that the decision hinders innovation in the Indian pharmaceutical sector. ENTOD plans to challenge the suspension in court, characterizing the DCGI’s action as “unjust.” Masurkar added, “This fight will not only allow innovative medicines in India but also encourage other MSME pharmaceutical companies to continue their research.”Get the Latest News Updates and Stay Informed with FELA NEWS!
Source: BT
