Drug regulator suspends licence for Pres Vu eye drop that claimed to replace reading glasses

General public being misled by Entod Pharmaceuticals, says Drug Controller General of India. Company to challenge order

Written by Anonna Dutt

New Delhi | Updated: September 12, 2024 11:59 AM IST

4 min read

The Indian Express had reported that Pilocarpine Hydrochoride — the active ingredient used in the eye drop — is not a new drug. (File photo)

Days after approving it, the country’s apex drug regulator, the Drug Controller General of India (DCGI), suspended the manufacturing and marketing licence for PresVu eye drop, saying its makers Entod Pharmaceuticals had made misleading claims about it being the first eye drop which would replace reading glasses, that it was a non-invasive option for enhancing near vision without glasses and that it augmented near vision within 15 minutes.

The Indian Express had reported that Pilocarpine Hydrochloride — the active ingredient used in the eye drop — is not a new drug. In fact, it is among commonly used drugs for which the government controls pricing. The drug has been used as a first-line treatment for cataract but is known to help with presbyopia (an eye condition that makes the lens less flexible and harder to see objects up close as people age). It does so by contracting the iris muscles, thereby helping the eye to focus better.

The order from the DCGI said that the company “failed to respond to queries… (and) tried to justify the claims for the product for which no approval was granted.” The DCGI clarified that while the drop was approved for presbyopia, it was not approved for any claims that it can enhance vision without the need for reading glasses.

On its part, Entod Pharmaceuticals will challenge the orders of the drug controller. “Announcing the new product launch to the media is a routine industry practice followed by all pharma companies in India…In our case, media reports went viral and public imagination led to an unusual escalation…Entod Pharmaceuticals has received a suspension order from the DCGI…The logic applied here is the content of our press release, which has described the application of this new drug for the benefit of the lay Press in more verbose terms than the exact wording of the approved indication…If you examine many such press announcements of other big pharma companies, which are present on their website, you will always find additional descriptions about the product and condition beyond the exact approved indication,” said the statement from CEO Nikkhil Masurkar. In response to why it claimed to be the first eye drop in India designed to reduce the need for reading glasses, the company said that currently there are no other eye drops approved for the treatment of presbyopia in the country. “You are informed that … (the drug) has not been approved for any such claim that it is designed to reduce the need for reading glasses,” the DGCI said.

In response to why it claimed that the eye drop offered a non-invasive option that could enhance near vision without the need for reading glasses, the company said that in the trial conducted, the subjects did not wear glasses. Countering the claim that PresVu was an enhanced alternative that could augment near vision within 15 minutes, the company said that one doctor had evaluated the product as compared to reading glasses.

“Considering the various media reports, there is a likelihood of the general public being misled by the claims made by you, for which no approval was granted. In view of the above and considering public interest, the permission …issued to manufacture and market Pilocarpine Hydrochloride Ophthalmic Solution is hereby suspended till further orders,” the DGCI order said.

Anonna Dutt

Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More

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Drug Controller General of India