The minutes of the SEC held on March 27 say, “After detailed deliberation, the committee recommended for grant of permission for manufacture and market of Pilocarpine Hydrochloride solution USP 1.25%w/v subject to the condition that the firm should conduct Phase IV clinical trial. In addition to the above, the firm should fulfil the requirements for CMC data. Accordingly, the firm should submit the Phase IV clinical trial protocol within three months from date of approval to CDSCO for further review by the committee.”According to Kerala-based K V Babu, “No other minutes of SEC regarding the approval are available on the CDSCO website, and there is nothing to suggest that the pharma company submitted any long-term studies.”“In this context, as an Ophthalmologist, I believe DCGI should put on hold its permission, if given to the company, to market the drug. The fraternity has also expressed concerns on this matter,” he told this paper.The pharma company officials told TNIE that they contacted the DCGI and provided an explanation. Further details were not shared. Experts also said there are short- and long-term side effects of using eye drops, which the company has not shared.In a written statement, its CEO, Nikkhil K Masurkar, told TNIE that they “hereby declare that they have not made any of the unethical or false presentation of facts to the media or public when it comes to Presvu Eye Drops.”“All facts disclosed to the media are strictly based on the approved indication for treatment of presbyopia in adults and the phase 3 clinical trial data generated by us. Some of the opinions and claims printed in news stories do not represent those of ENTOD Pharmaceuticals or any of its spokespeople. The widespread media interest in such a therapy has been unprecedented and has led to the sensationalisation of the story.
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