Regulator suspends Entod Pharma’s eye drop nod citing unapproved claims

New Delhi: India’s drug regulator suspended the permission granted to Entod Pharmaceutical Ltd. to manufacture a type of eye drops, citing the company’s unapproved claim to promote it as a drug that reduces dependency on reading glasses among people with presbyopia.
The said eye drops have not been approved for any such claim in India that they can reduce the need for reading glasses, and the “permission is suspended” until further orders, according to the Drugs Controller General of India’s 10 September order reviewed by Mint. The regulator said the promotion raised concerns about the safety of the eye drops and their over-the-counter use when they were approved as a “prescription drug”.
Nikkhil Masurkar, chief executive officer of Entod Pharmaceuticals, said in a statement that the company has not made any unethical or false presentation of facts about Presvu eye drops. The company will challenge the order in court.
On 20 August, the Drugs Controller General of India permitted the firm to manufacture and market PresVu—pilocarpine hydrochloride ophthalmic solutions USP 1.25% weight in volume—for treating presbyopia in adults. The company, in its promotion on 3 September, claimed that it is the “first eye drop in India specifically developed to reduce dependency on reading glasses” for individuals affected by presbyopia.
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A day later, the regulator issued notice to the firm on various claims and examined its response on 5 September.
Claim 1: The “first eye drops in India designed to reduce the need for reading glasses”.
Company response: There are currently no other eye drops approved for the treatment of presbyopia in India.
Claim 2: “This eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses”.
Company response: In the clinical trial, subjects did not wear glasses to participate. 
Claim 3: The drug can provide an advanced alternative that arguments near vision within 15 minutes.
Company response: One doctor evaluated the drug product compared to the reading glasses.
The regulator said the eye drops have approved for the treatment of presbyopia in adults and not for enhancing near vision without the need for reading glasses.
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“After a perusal of your reply, you had failed to respond to the queries as put to you,” the drug regulator said in its final order. “You tried to justify the claims for the product for which no approval was granted. You have not obtained any prior approval from the Central Licensing Authority to make such claims for the said product.”
The regulator said the company has “violated the condition of the permission” issued to you for manufacturing and marketing of the drug under the provisions of the New Drugs and Clinical Trials Rules, 2019. “There is a likelihood of the public being misled by the claims made by you for which no approval was granted,” the regulator said, also citing provisions of the Drugs and Cosmetic Act, 1940.
In his statement, Entod chief executive Masurkar said the DCGI has not cited any specific violation of the Drugs and Cosmetics Act for this action.
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“…we have decided to challenge this suspension in the court of law to get justice. Our fight will not only allow innovative medicines to be available in India but also encourage other pharmaceutical entrepreneurs and companies in the MSME sector to continue the research drive in India without facing similar obstacles,” he said.
“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 a yardstick of near vision improvement. Such eye drops with the same active ingredient and same concentration have been approved by the US FDA and marketed in the US for the last 3 years without any serious complications. FDA didn’t take any action on the company’s marketing the same in USA,” he said.
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