NEW DELHI, Sept 11: The Centre has for the time being suspended the permission it had granted to the Mumbai-based pharmaceutical company ENTOD Pharmaceuticals to manufacture and market its eye drop which it had claimed could lead to eliminating reading glasses needed for presbyopia.
The Central Drugs Standard Control Organization (CDSCO) issued the fresh order on Tuesday following controversy over the company’s claim on reading glasses. In its notification, the CDSCO said the company had made claims for the drug, for which it had not obtained prior approval from the Central Licensing Authority, thereby violating provisions under the New Drugs and Clinical Trial Rules, 2019. It also said in view of public interest, and due to the likelihood of the general public being misled by these claims, permission had been suspended.
In a statement issued on Wednesday, ENTOD Pharmaceuticals said it would challenge this suspension in a court of law. The statement, from CEO Nikkhil K. Masurkar, said the company had not made any unethical or false presentation of facts to the media or the public with regard to its product, PresVu Eye Drops.
It said media reports on the new product launch went viral and “public imagination led to an unusual escalation for which ENTOD Pharmaceuticals is not responsible.” It further said its Drug Controller General of India (DCGI) approval was based on a valid controlled clinical trial in 234 patients, which it said, was successful in showing efficacy and safety of the eye drops in patients with presbyopia.
The issue first hit the spotlight after the company recently issued a press release about its PresVu eye drops, developed to reduce dependency on reading glasses for individuals affected by presbyopia, a common age-related vision condition that typically impacts those over 40.
On September 4, ENTOD Pharmaceuticals tweeted, tagging Prime Minister Narendra Modi “PresVu was the first DCGI-approved proprietary prescription eye drops to eliminate the need for reading glasses.” It further said the drug was “a proud Indian innovation that could help millions of Indians see better and that too at an affordable price.”
Following widespread interest in this, several ophthalmologists began sounding a cautionary alarm and the company was asked for an explanation for its ‘unethical and false representation of facts.’ Ophthalmologists pointed out that the active ingredient used in the eye drops, pilocarpine, had been used for decades to treat another eye condition, glaucoma, but had since been replaced with the advent of newer, better drugs. They pointed out that the use of pilocarpine could cause several side effects.
“We do not use Pilocarpine anymore as it is known to cause some discomfort to the eye and also because we have better drugs available in the market for glaucoma. The miosis or constriction of the pupils induced by Pilocarpin helps people to see objects close to them better and is, at best, only a temporary solution for presbyopia,” said some eye surgeons.
“Pilocarpin-induced miosis is a phenomenon that lasts 4 to 6 hours. Thus, a person will need multiple doses of the drug throughout the day if he/she has to do away with the use of reading glasses. This has us worried because we do not know the safety profile of pilocarpine when it is used continuously and long-term— we are talking about the usage of 35 to 40 years because presbyopia begins usually in the 40s,” they said.
It was pointed out that the All India Ophthalmological Society has now constituted an experts’ group to discuss the possible adverse effects of the newly marketed drug and to frame guidelines for the public. “Most people hate wearing reading glasses because it gives away their age and we anticipated that there would be a lot of interest among the public regarding the drug. As an ophthalmologist, I do have reservations about advising this drug as the answer to presbyopia before we weigh in the pros and cons,” the doctors said.
Dr Babu K.V., an ophthalmologist and a public health activist, has now written to the Union Health Minister stating that the tweet by ENTOD Pharmaceuticals was a gross violation of Section 3 (d) of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, which specifically prohibits the advertisement of drugs for the treatment of diseases and disorders of the optical system.
“Section 3 (d) says that none shall publish any advertisement referring to the use of a drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule. There are 54 diseases/disorders/conditions, specified in the said Schedule and no. 11 in the list is ‘Diseases and disorders of the optical system’. Presbyopia is a disorder of the optical system and hence the tweet, publicising the drug, is a contravention of the DMR(OA) Act,” said Dr Babu.
In the permission given by the Central Drugs Standard Control Organisation on August 6 for ENTOD pharmaceuticals to manufacture the new drug for sale or distribution, the indication for the drug is “for the treatment of presbyopia in adults” and it was laid down that no claims except this may be made for the drug without prior approval of the Central licensing authority.
“The tweet by the pharma firm that the drug can “eliminate reading glasses” is thus an overreach of the claim. The fact that the drug company on its own has made this claim in the public domain (X platform) even before the data is presented before the medical fraternity or before conducting the Phase IV clinical trial studies post-marketing, to monitor its safety and efficacy, is certainly not acceptable,” Dr Babu added.
(Manas Dasgupta)