New Delhi: India’s apex drug regulator has suspended, till further orders, the regulatory approval issued to manufacture and market an eye drop that was slated as a replacement for reading glasses, citing “unauthorised promotion” and possible “unsafe use” by patients.
Last week, Mumbai-based Entod Pharmaceuticals had announced the launch of 1.25 percent pilocarpine hydrochloride, under the brand name PresVu, saying it was meant to address presbyopia after receiving the licence to manufacture and market the product by the Central Drugs Standard Control Organisation (CDSCO) on 20 August.
The company was set to make the eye drop—costing Rs 345 per 5ml vial—available across the country from October this year.
Presbyopia is a common age-related vision condition that causes the eyes to gradually lose their ability to focus on nearby objects. It typically impacts those over 40 years of age and the company had said that the product will be best suitable for those aged 40-55 years.
But following a show-cause notice issued to Entod on 4 September and receiving a reply, the Drugs Controller General of India (DCGI), who heads the CDSCO, has now said the drugmaker “failed” to reply satisfactorily to the queries raised and instead tried to “justify the claims” made earlier.
The order, undersigned by DCGI Rajeev Singh Raghuvanshi Tuesday, says the company violated the condition of marketing permission issued for the product and falsely projected it as a replacement for reading glasses. ThePrint has seen a copy of the order.
The unauthorised promotion in press and over social media had raised doubt on the eye drops’ unsafe use by patients and safety concern for the public, states the order.
It also adds that the promotion had raised concern about its use as an over-the-counter drug, whereas it is approved as a prescription-only drug.
Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, has announced that the company would challenge the DCGI’s decision.
“We at Entod Pharmaceuticals hereby declare that we have not made any unethical or false presentation of facts to the media or public when it comes to Presvu Eye Drops. All facts disclosed to the media were strictly on the basis of the recent DCGI approval for treatment of presbyopia in adults and the results of the phase 3 clinical trial conducted by us in India,” he said in a statement Wednesday.
Announcing a new product launch to the media is a routine industry practice followed by all pharma companies in India and in the recent past, many such announcements have been made, Masurkar said.
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‘Claim that product can reduce need for reading glasses not approved’
The drug contains pilocarpine, a plant-derived molecule which has been used to treat glaucoma, a serious eye condition that can lead to blindness, for decades.
A similar drug, sold under the brand name Vuity by Dublin-based pharmaceutical firm Allergan, an AbbVie company, was approved by the US Food and Drug Administration (FDA) in October 2021 but there have been concerns around its adverse effects in the US
ThePrint had earlier reported on a plan by the All India Ophthalmological Society (AIOS)—the top professional body of India’s ophthalmologists—to assess the eye drops’ safety, keeping in mind the drug’s “potential inappropriate marketing” and possible “indiscriminate use”.
Dr Sreeni Edakhlon, a member of the AIOS management committee, had told ThePrint that questions on the possible adverse effects of continuous and regular use of pilocarpine hydrochloride 1.25 percent for the treatment of presbyopia need to be addressed.
“Even though pilocarpine 1 and 2 percent have been indicated for glaucoma for decades, it is not a drug of choice to treat the disease in most patients now, as there are safer options available,” he had said.
He had pointed out that long-term use of pilocarpine can alter lens permeability, potentially leading to a shift in lens cations (positively-charged ions) and water accumulation which, in turn, can cause changes in the intraocular metabolism (metabolism in eye which involves enzymes that help prevent or eliminate foreign particles in the eye), apart from causing the lens to become more opaque.
The latest order issued by the DCGI says that the permission issued by it for the eye drops under New Drugs and Clinical Trials Rules, 2019, does not approve any claim that it is designed to reduce the need for reading glasses.
Also, while the product was approved for the treatment of presbyopia in adults, it had not received approval for the claim that it can enhance near vision without the need for reading glasses, it clarifies.
The show-cause notice by the DCGI had demanded to know why the company was claiming PresVu as an advanced alternative that augments near vision within 15 minutes.
In response, the company informed the drug regulator that one doctor had evaluated the drug product as compared to reading glasses.
‘We strongly resist this action’
Masurkar, in his statement, said that in the case of PresVu, media reports went viral and public imagination led to an unusual escalation for which the company is not responsible.
“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 eye glasses and could read additional lines on Snellen’s chart which is a yardstick of near vision improvement,” he stated.
Such eye drops with the same active ingredient and same concentration have been approved by the USFDA and marketed in the US for the past three years without any serious complications. FDA didn’t take any action on the companies marketing the same in the US, he pointed out.
“However, Entod Pharmaceuticals has received a suspension order from the DCGI who has made no reference to any specific violation of the Drugs and Cosmetics Act for this action. The logic applied here is the contents 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, which is treatment of presbyopia,” the CEO stated.
“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,” he stressed.
“We strongly resist this action against a proud Indian pharma company in the MSME (micro, small and medium enterprises) sector like Entod Pharmaceuticals which is purely research and innovation driven and attempts to bring new therapeutic options to the Indian market,” Masurkar added.
“As a result, 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,” the statement added.
(Edited by Nida Fatima Siddiqui)
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