The Drug Authority Retracts Approval for Eye Drops Due to ‘Misleading’ Claims

Following last week’s controversy over Mumbai-based ENTOD Pharmaceuticals’ claims that its eye drops could eliminate the need for reading glasses in cases of presbyopia, the Central Drugs Standard Control Organization (CDSCO) has suspended the company’s authorization to manufacture and market the product until further notice. In a notification dated September 10, the CDSCO stated that the company had made claims for the drug without obtaining prior approval from the Central Licensing Authority, thereby violating the provisions of the New Drugs and Clinical Trials Rules, 2019.

The CDSCO further noted that the suspension was imposed in the public interest, due to the potential for misleading the general public with such claims. ENTOD Pharmaceuticals, in a statement issued on Wednesday, September 11, announced plans to challenge the suspension in court. The company’s CEO, Nikkhil K. Masurkar, insisted that ENTOD had not made any unethical or false representations to the media or public regarding its product, Pres Vu Eye Drops. The statement also attributed the escalation of the controversy to viral media reports and “public imagination,” for which the company claimed no responsibility. ENTOD further stated that its approval from the Drug Controller General of India (DCGI) was based on a legitimate controlled clinical trial involving 234 patients, which demonstrated the product’s efficacy and safety for patients with presbyopia.

The issue first gained attention after ENTOD Pharmaceuticals issued a press release about its Pres Vu eye drops, which were designed to reduce dependence on reading glasses for those suffering from presbyopia, an age-related vision condition affecting individuals over 40. On September 4, the company tweeted, tagging Prime Minister Narendra Modi, and claimed that “Pres Vu was the first DCGI-approved proprietary prescription eye drops to eliminate the need for reading glasses.” The tweet also hailed the product as “a proud Indian innovation” that could benefit millions of Indians at an affordable price.

Following this widespread publicity, several ophthalmologists raised concerns, prompting a call for the company to explain its “unethical and false representation of facts.” Experts pointed out that the active ingredient in the eye drops, pilocarpine, had been used for decades to treat glaucoma but had since been replaced by newer, more effective drugs. They highlighted potential side effects associated with pilocarpine use. “We no longer use pilocarpine due to its known discomfort to the eyes, and because better alternatives are now available for treating glaucoma,” said Sreeni Edakhlon, an ophthalmic surgeon from Thalassery. “Pilocarpine-induced miosis, which helps people see close objects more clearly, is a temporary solution at best for presbyopia.” Dr. Edakhlon also expressed concerns about the long-term safety of pilocarpine, noting that its effects last only 4 to 6 hours, requiring multiple daily doses to replace reading glasses. “We are worried because the safety profile of continuous and long-term use of pilocarpine—potentially over 35 to 40 years since presbyopia typically begins in the 40s—remains uncertain,” he added.

The All India Ophthalmological Society has formed an expert group to discuss potential adverse effects and provide public guidelines. “Many people dislike wearing reading glasses as they reveal their age, so public interest in this drug was expected. However, as an ophthalmologist, I have reservations about recommending it for presbyopia before thoroughly weighing the pros and cons,” Dr. Edakhlon concluded. Additionally, Dr. Babu K.V., an ophthalmologist and public health activist, wrote to the Union Health Minister, alleging that the company’s tweet violated Section 3(d) of the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, which prohibits advertisements for drugs claiming to treat diseases or disorders of the optical system. “Section 3(d) specifies that no one shall publish any advertisement promoting a drug for the diagnosis, cure, mitigation, treatment, or prevention of any disease, disorder, or condition listed in the Schedule. This includes 54 diseases or disorders, with ‘Diseases and disorders of the optical system’ being number 11. Since presbyopia is a disorder of the optical system, the tweet publicizing the drug contravenes the DMR(OA) Act,” said Dr. Babu.

The permission granted by the CDSCO on August 6 for ENTOD Pharmaceuticals to manufacture and distribute the new drug stipulated that it could only be promoted as “for the treatment of presbyopia in adults,” and no other claims could be made without prior approval from the Central Licensing Authority. “The company’s claim that the drug can ‘eliminate reading glasses’ is an overreach of the approved claim. That the company made such a claim in the public domain, even before presenting data to the medical community or conducting Phase IV clinical trials post-marketing to monitor safety and efficacy, is certainly not acceptable,” Dr. Babu added.

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Aryan GulatiFreelance Journalist

Aryan Gulati is a dedicated media student based in Meerut with a wealth of experience in various newspapers and media houses. He has numerous published articles and specializes in political and crime news writing, demonstrating a strong commitment to impactful journalism.

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