India’s drug regulator, the Drugs Controller General of India (DCGI), has taken a significant step by suspending the permission granted to Entod Pharmaceutical Ltd. to manufacture PresVu eye drops. The reason? The company’s unapproved claims that these eye drops can reduce the need for reading glasses among individuals with presbyopia, a common age-related vision condition.
This decision stems from the DCGI’s concerns about the safety of the eye drops and their over-the-counter use. While PresVu was approved as a prescription drug for treating presbyopia, the company’s promotional materials claimed it could reduce dependency on reading glasses – a claim that lacked the necessary regulatory approval.
The DCGI’s order, issued on September 10th, explicitly states that the “permission is suspended” until further notice. The regulator stated that the company’s promotional claims, particularly regarding the eye drops’ ability to enhance near vision without glasses, raised serious concerns about the safety of the product.
Entod Pharmaceuticals, however, has vehemently denied any wrongdoing. Nikkhil Masurkar, the company’s CEO, issued a statement asserting that they have not made any unethical or false claims about PresVu. The company is now planning to challenge the DCGI’s order in court.
The controversy surrounding PresVu began in August when the DCGI granted the company permission to manufacture and market the eye drops, containing pilocarpine hydrochloride, for treating presbyopia in adults. However, on September 3rd, the company released a promotional campaign claiming PresVu was the “first eye drop in India specifically developed to reduce dependency on reading glasses.” This claim triggered the DCGI’s investigation.
The regulator examined several claims made by Entod in its promotional materials and scrutinized the company’s responses. The DCGI found that the company had failed to provide adequate justification for these unapproved claims. The regulator concluded that Entod had violated the terms of its permission to manufacture and market the drug, citing potential misleading information presented to the public.
Entod, in its defense, has highlighted that the eye drops have the same active ingredient and concentration as similar products approved by the US Food and Drug Administration (FDA) and marketed in the United States for the past three years. The company argues that there have been no serious complications reported with the US FDA-approved version of the eye drops.
This case underscores the importance of regulatory oversight in ensuring the safety and efficacy of pharmaceutical products. The DCGI’s decision to suspend the approval of PresVu serves as a reminder of the need for manufacturers to adhere to rigorous standards and obtain necessary approvals before making claims about their products. The outcome of Entod’s legal challenge will determine the future of PresVu eye drops and shed further light on the complex regulatory landscape surrounding pharmaceutical products in India.
