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<keyword id="15160768" type="General" weightage="20" keywordseo="presvu" source="Orion">PresVu</keyword> eye drops, developed by <keyword id="20007796" type="General" weightage="20" keywordseo="entod-pharmaceuticals" source="keywords">Entod Pharmaceuticals</keyword>, were launched with considerable media attention earlier this month as a novel solution for <keyword id="23035383" type="General" weightage="20" keywordseo="presbyopia" source="keywords">presbyopia</keyword>. Presbyopia is a condition where individuals aged 40 and above experience difficulty focusing on nearby objects, often requiring reading glasses. PresVu claimed to reduce or eliminate the need for these glasses, offering an alternative through its active ingredient, 1.25% Pilocarpine, which temporarily contracts the pupil, improving near vision.<br /><br />Entod Pharmaceuticals earlier announced that the product had approval from the <keyword id="20047866" type="General" weightage="20" keywordseo="drug-controller-general-of-india" source="keywords">Drug Controller General of India</keyword> (<keyword id="20046022" type="General" weightage="20" keywordseo="dcgi" source="keywords">DCGI</keyword>). These announcements created substantial buzz, as the treatment promised a non-invasive solution to a common problem affecting millions of people.<br /><h2>Regulatory backlash</h2>The situation escalated when the Drug Controller General of India suspended the marketing and distribution licence of PresVu eye drops. The suspension was issued due to unauthorised promotional campaigns by Entod, which made unverified claims about the drug's capabilities. The company had reportedly promoted PresVu not as a prescription drug, but as an over-the-counter (OTC) solution that could potentially replace reading glasses — a claim that regulators found highly misleading.<br /><br />The DCGI expressed concerns that such promotions could lead to misuse, with patients potentially self-administering the product without medical guidance, raising significant safety concerns. Furthermore, the regulatory body pointed out that while the product had been approved as a prescription drug, the marketing blitz implied it was a quick-fix solution available to anyone, which it was not.<br /><h2>Entod Pharmaceuticals responds</h2>Entod Pharmaceuticals quickly defended itself against these allegations, maintaining that their marketing campaign was based on the information cleared by the DCGI. According to Entod, the promotion highlighted only the approved uses of the <keyword id="4537914" type="General" weightage="20" keywordseo="eye-drop" source="Orion">eye drop</keyword>, and any misconceptions arose from how the media and public interpreted the information. The company asserted that it would challenge the suspension in court, emphasising that other pharmaceutical companies frequently follow similar marketing practices without facing such scrutiny.<br /><br />In a statement, Entod’s CEO, <keyword id="21011592" type="General" weightage="20" keywordseo="nikkhil-k-masurkar" source="keywords">Nikkhil K Masurkar</keyword>, clarified that the company had conducted phase 3 clinical trials in India to ensure the product’s safety and efficacy.<br /><div type="Article" hostid="261" msid="113251803" title="The next big market for weight-loss drugs: children" mstype="2" mssubtype="0"></div>“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia, who used these drops without eyeglasses and could read additional lines on Snellen's chart which is yardstick of near vision impairment,” Masurkar commented in a statement.<br /><br />He insisted that the product’s promotional activities had followed standard protocols and blamed the viral nature of media reports for blowing the issue out of proportion. Despite these defences, the product remained suspended pending further investigations.<br /><br />"Such eye drops with the same active ingredient and same concentration have been approved by the US <keyword id="19918726" type="General" weightage="20" keywordseo="fda" source="keywords">FDA</keyword> and marketed in the US for the last three years without any serious complications. FDA didn’t take any action on the companies marketing the same in the USA,” Masurkar further elaborated.<br /><h2>Public and expert reactions</h2>The controversy garnered widespread attention, particularly from medical professionals. The Liver Doc, a prominent liver specialist that takes to social media to debunk pseudoscientific claims, criticised the situation on X (former Twitter), warning about the dangers of exaggerated medical claims in advertising.<br /><br />The doctor’s tweet emphasised that blaming Indian media for blowing Entod’s claims out of proportion was “shameless”, noting that the media merely reported exactly what the company had themselves claimed earlier.<br /><div type="twitter" handle="theliverdr" handlename="theliverdr" favoritecount="0" retweetcount="0" id="1833828866210849170"></div>As of September 12, 2024, the suspension of PresVu's marketing approval remains in place. Entod Pharmaceuticals is preparing to contest the decision in court, hoping to reinstate its flagship product in the Indian market. The regulatory investigation continues, with the DCGI seeking clarification on the exact nature of the promotions and whether they indeed violated ethical standards.<br /><div type="Article" hostid="261" msid="113229771" title="China&amp;#39;s drug regulator clears mpox vaccine; to undergo clinical trial" mstype="2" mssubtype="0"></div>Despite Entod’s defence, the controversy has raised important questions about the marketing of prescription drugs in India, with regulators, the media, and the public closely watching how this case will evolve. The outcome could set a precedent for how pharmaceutical companies in India can market innovative treatments, particularly when dealing with sensitive areas like vision correction.<br />

PresVu eye drops: Why has a pharma company fallen in controversy for claiming to cure near-sightedness?

<ul><li>DCGI has approved market authorisation for the COVID-19 vaccine <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> as a heterologous booster dose for adults.</li><li>The DCGI's approval came following recommendations by the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> of the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="50" keywordseo="cdsco" source="Orion">CDSCO</keyword>).</li></ul>The <keyword id="6386816" type="General" weightage="50" keywordseo="drug-controller-general-of-india" source="Orion">Drug Controller General of India</keyword> (DCGI ) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of <keyword id="9617748" type="General" weightage="50" keywordseo="covishield" source="Orion">Covishield</keyword> or <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword>, official sources said on Monday. The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). <br /><br /> Prakash Kumar Singh, Director of Government and Regulatory Affairs at the <keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> (<keyword id="52604" type="General" weightage="80" keywordseo="sii" source="Orion">SII</keyword>), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said. <br /><br /> "The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said. <br /><br /> The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children aged 7- 11 years on June 28 last year subject to certain conditions. <br /><br /> Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the <keyword id="43588" type="General" weightage="50" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> (WHO) on December 17, 2021. <br /><br /> In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> and low-and-middle-income countries.<br /><br />SEE ALSO:<br /><a href="https://www.businessinsider.in/tech/news/amazon-great-republic-day-sale-2023-best-deals-and-offers-on-tvs/articleshow/96987966.cms">Amazon Great Republic Day Sale 2023 – Best deals and offers on TVs</a><br /><a href="https://www.businessinsider.in/tech/apps/news/these-audio-setting-tweaks-can-make-music-sound-better-on-spotify/articleshow/96876010.cms">These audio setting tweaks can make music sound better on Spotify</a><br />

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PresVu eye drops: Why has a pharma company fallen in controversy for claiming to cure near-sightedness?

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Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

PTI

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