Thu Sep 12 05:36:59 UTC 2024: ## Entod Pharmaceuticals Fights Back Against DCGI Suspension of PresVu Eye Drops
**Mumbai, India:** Entod Pharmaceuticals, a Mumbai-based pharmaceutical company, has vehemently denied making unethical claims or misrepresenting facts about their new PresVu eye drops, following a suspension of the product’s manufacturing and sale by the Drugs Controller General of India (DCGI).
The DCGI revoked Entod’s permission after the company announced that PresVu could potentially eliminate the need for reading glasses in individuals with presbyopia. The drug regulator claimed that these claims were made without proper approval from the Central Licensing Authority, violating the New Drugs and Clinical Trial Rules of 2019.
Nikkhil K Masurkar, CEO of Entod Pharmaceuticals, stated that the company’s media announcements were solely based on the DCGI’s approval, especially after successful phase 3 clinical trials conducted in India. He argued that such announcements are standard practice within the Indian pharmaceutical industry. Masurkar blamed the media for sensationalizing the news, resulting in an exaggerated public reaction.
Entod maintains that the DCGI’s approval was based on a valid clinical trial involving 234 patients, demonstrating the efficacy and safety of PresVu in treating presbyopia. The company highlights that PresVu contains pilocarpine, a US FDA-approved drug for presbyopia, and that clinical trials have shown its ability to temporarily improve near vision.
The DCGI, however, insists that no such claims for reducing the need for reading glasses were ever approved for PresVu. The regulator also expressed concern over the potential for misleading the public with the company’s pronouncements.
Entod Pharmaceuticals has taken legal action to challenge the DCGI’s suspension. The company believes this fight will not only allow innovative medicines to be available in India but also serve as a precedent for other MSME pharmaceutical companies seeking to introduce new therapeutic options.
The situation raises concerns about the communication and approval processes for new pharmaceuticals in India and underscores the importance of transparent and accurate information for both patients and regulatory bodies. The legal battle between Entod and the DCGI is likely to be closely watched by the pharmaceutical industry and the general public.
First Piper 