ENTOD Pharmaceuticals Addresses Concerns Over PresVu Eye Drops with DCGI
ENTOD Pharmaceuticals, based in Mumbai, recently met with the Drug Controller General of India (DCGI) to discuss concerns about their PresVu eye drops. These eye drops were approved on August 6 for treating presbyopia in adults but had their approval suspended on September 10 due to potentially misleading claims in news reports.
Nikkhil K Masurkar, CEO of ENTOD, explained, “We clarified the situation to the DCGI and expressed our sincere intentions behind the media announcement. We respect the DCGI’s decision to suspend the approval following the hyped claims in news reports.”
Masurkar emphasized that PresVu eye drops are not meant to replace reading glasses and are available only by prescription from a registered medical practitioner. He noted that some statements made during a press conference were quoted out of context, leading to misunderstandings.
ENTOD has assured the DCGI that they will comply with all conditions and make only approved claims. They have also requested the DCGI to reconsider the suspension. Mohammed Kamil Khan, Vice President-Marketing, mentioned plans for nationwide academic sessions and thorough training for future launches of PresVu eye drops.
ENTOD Pharmaceuticals has a strong presence in the eye care market with over 150 ophthalmic formulations and supplies to 67 countries. Their R&D is focused on treatments for myopia in children, glaucoma, corneal diseases, and retinal eye diseases.
Doubts Revealed
ENTOD Pharmaceuticals -: ENTOD Pharmaceuticals is a company that makes medicines, especially for eye care.
DCGI -: DCGI stands for Drug Controller General of India. This is the person or office that makes sure medicines in India are safe and work well.
PresVu eye drops -: PresVu eye drops are a type of medicine used to help adults with presbyopia, which is when it’s hard to see things up close.
presbyopia -: Presbyopia is a common eye problem in adults where they can’t see things up close clearly, often needing reading glasses.
Nikkhil K Masurkar -: Nikkhil K Masurkar is the CEO, or boss, of ENTOD Pharmaceuticals.
prescription -: A prescription is a special note from a doctor that lets you buy certain medicines from the pharmacy.