NEW DELHI: Days after India’s drug regulator suspended manufacturing and marketing permission of Mumbai-based ETOD Pharmaceuticals, which had claimed that their new eye drop reduced dependency on reading glasses for those suffering from presbyopia, an age-related vision condition, on Thursday clarified that it is a “therapeutic option, available only by prescription from the registered medical practitioner.”This paper was the first to report that the Drug Controller General of India (DCGI) has sought a detailed explanation from the company after they claimed that their PresVu eye drops offers an advanced alternative that augments near vision within 15 minutes.“PresVu eye drops are not intended to replace reading glasses or non-invasive options for presbyopia. It’s a therapeutic option, available ONLY by prescription from the registered medical practitioner, for patients diagnosed with presbyopia, as assessed by an eye doctor,” said its CEO Nikkhil K Masurkar in a statement.The company received approval from the Central Drugs Standard Control Organisation (CDSCO) on August 6. On September 3, they held a press conference and, in a statement, stated that PresVu is the first eye drop in India specifically developed to reduce dependency on reading glasses for individuals affected by presbyopia. This common age-related vision condition typically impacts those over 40.Taking serious note of the unauthorised promotion of the product, the CDSCO on September 10 said that the pharma company’s permission to manufacture and market the eye drop has been suspended till further notice. After the suspension order, Masurkar had said they have “decided to challenge this suspension in the court of law to get justice.”The pharma company said they have met with the Drug Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, earlier this week to address the concerns raised in the notice and appealed that the suspension be reconsidered.Masurkar said they understand the DCGI’s concerns and respects his decision to suspend the permission of PresVu eye drops following hyped claims in news reports.He added that seeing the DCGI take swift action in the public interest and demonstrating such good governance is praiseworthy.Once again blaming the media for creating hype, he said their press conference was done in good faith. “In the process of explaining the treatment of presbyopia, we stated the data from the Indian phase 3 clinical trial with respect to tthe 15-minute onset of action and the possibility of replacing reading glasses.”“It appears that some of these explanatory statements were quoted out of context in certain news reports and never intended to be claims of our company. Subsequent to the discussions with the DCGI, we understand how the implications of these would be perceived by lay people and how it could potentially be misleading to the public.”Kerala-based RTI activist K V Babu, who had shot a letter to both the DCGI and the Union Health Ministry after the company, in a now-deleted tweet, had claimed that the eye drop ‘eliminate the need for reading glasses,’ said, “Instead of accusing the media about creating hype, they could have withdrawn the tweet with a public apology.”“The present clarification will not absolve them of the drug law violation by tweeting about a drug which falls under the schedule of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. Ads under this Act are prohibited in our country,” Babu, an ophthalmologist, told this paper.Masurkar said it is a regulatory-compliant and responsible pharmaceutical company. He said as one of India’s eye care leaders with nearly half a century of ophthalmic expertise, ENTOD has built substantial goodwill and trust with doctors, patients, and trade partners over the years.He also said that they have assured the DCGI with a written undertaking that ENTOD will fully comply with the conditions outlined in the permission for PresVu eye drops and only make approved claims.Vice President-Marketing Mohammed Kamil Khan said, “Any future launch of PresVu eye drops would include nationwide academic sessions with eye doctors, thorough field staff training, and chemist counter awareness about the eye drop’s prescription-only status. We also welcome the decision of the apex body of ophthalmologists to consider forming clinical guidelines for this molecule to treat presbyopia.”The company has over 150 ophthalmic formulations in the domestic market for various eye ailments and supplies to 67 countries globally, the company said in its statement.“Its R&D is currently working on cutting-edge treatments for myopia in children, glaucoma, corneal diseases, and retinal eye diseases,” it added.
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