India's Drug Regulator Suspends ENTOD's PresVu Eye Drops Following Misleading Claims

Mumbai-based ENTOD Pharmaceuticals met with the DCGI to address concerns about PresVu eye drops for presbyopia. The drug's approval was suspended due to potentially misleading media claims. ENTOD's CEO clarified the usage and expressed respect for DCGI's decision, assuring compliance and seeking reconsideration.

Mumbai-based ENTOD Pharmaceuticals has met with India's Drug Controller General to address issues surrounding their PresVu eye drops for presbyopia, following its suspension on September 10 over potentially misleading media claims. Originally approved on August 6, the drug's authorization was halted after reports suggested exaggerated benefits.

ENTOD's CEO, Nikkhil K Masurkar, clarified their intentions behind the media announcement and expressed respect for the DCGI's decision. 'We explained the PresVu situation and our sincere and honest intentions,' Masurkar stated. 'PresVu eye drops are not meant to replace traditional reading glasses, but serve as a prescription-only therapeutic option.'

Masurkar assured the DCGI of ENTOD's compliance with regulatory conditions and called for a reconsideration of the suspension. Vice President-Marketing, Mohammed Kamil Khan, highlighted plans for academic sessions and training to ensure proper usage. ENTOD continues its commitment to ophthalmic research and development, with over 150 formulations available in the domestic market and global supply chains.