The apex drug regulator of India has suspended eye drops PresVu, which claimed to eliminate the need for wearing reading glasses, before they could reach retail shelves. The medicine came under the scanner due to its bold assertions and now the drug regulatory agency, Central Drugs Standard Control Organisation (CDSCO), has revoked the marketing and manufacturing approvals granted to Mumbai-based Entod Pharmaceuticals until further notice.
Last week, Entod launched ‘PresVu’ eye drops made using pilocarpine – the medicine that treats ‘presbyopia’ by reducing the size of the pupils which helps see objects up close.
Presbyopia is the age-linked decline in the eyes’ ability to focus on nearby objects. The company had claimed in the press conference and interviews that a single drop of the medicine starts working in just 15 minutes and its effects remain for the next six hours. If the second drop is also poured within three to six hours of the first drop, the effect will stay even longer. The drops were to hit the shelves across pharmacies in October at a retail price of Rs 340.
However, on Tuesday, the chief of CDSCO, Drugs Controller General of India (DCGI), suspended the product approvals after the company failed to justify the overstated claims for the product. News18 has seen a copy of the order.
The permission issued for marketing and manufacture of the drug “is hereby suspended till further order under the provisions of Rule 84 of the New Drugs and Clinical Trials Rules, 2019 of the Drugs and Cosmetics Act, 1940", said the order issued by DCGI’s Rajeev Singh Raghuvanshi on September 10. The order has been sent to Entod Pharmaceuticals, along with food commissioners of Mumbai and Gujarat and other regulatory officers for compliance.
According to multiple official sources, the Union ministry of health and family welfare took this matter seriously due to concerns of misuse of the product. “The promotion had raised concern about its use like OTC drugs whereas it is approved as a prescription only drug," a source said, adding, “The unauthorised promotion in the press and over social media had raised doubts on its unsafe use by patients and safety concerns for the public."
WHY IS THE PRODUCT SUSPENDED?
According to the order for suspension, the drug regulatory agency had approved the medicine — pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% — for the treatment of presbyopia in adults. However, it found various claims made by the company for which approval was not given. The order copy shared the details of questions raised by the DCGI and replies submitted by the drug maker.
For instance, in response to the claim of “first eye drop in India designed to reduce the need for reading glasses", the company had stated that there are currently no other eye drops approved for the treatment of presbyopia in India. However, the response failed to satisfy DCGI. “…you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% wv has not been approved for any such claim that it is designed to reduce the need for reading glasses."
Similarly, in response to the claim that “this eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses", the company had submitted a response that in the clinical trial conducted, subjects did not wear glasses to participate, etc. “In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/ is approved for the treatment of Presbyopia in adults and is not approved for such claim that these eye drop can enhance near vision without the need for reading glasses."
In response to the third claim that “Presu can provide an advanced alternative that augments near vision within 15 minutes", the company submitted a response that one doctor has evaluated the drug product compared to reading glasses. The reply from drug regulator said, “You are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/ is approved for the treatment of Presbyopia in adults and is not approved for such claim that PresVu can provide an advanced alternative that augments near vision within 15 minutes."
The order — evaluating the responses from the firm — concluded that “after a perusal of your reply, it is clear that you had failed to respond to the queries as put to you. You had tried to justify the claims for the product for which no approval was granted". The regulatory agency reprimanded the drug maker saying that “it is clear that you have not obtained any prior approval from the central licensing authority to make such claims…"
It held the company responsible for violating the drug laws considering the “likelihood of the general public being misled by the claims made by you, for which no approval was granted".
Multiple eye experts told News18 that in the real-world scenario, replacing spectacles with reusable eye drops is not a good idea in the long run. Experts believe that any such drops can offer a stop-gap arrangement, but not a lifetime solution.
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