GG News Bureau
New Delhi, 11th Sept. The Drugs Controller General of India (DCGI) on Tuesday suspended the permission granted to Mumbai-based Entod Pharmaceuticals to manufacture and sell their new eye drops for presbyopia. The decision came after the drug regulator noted that the company had made unapproved claims about the product’s benefits.
Entod Pharmaceuticals had received permission on August 20 to manufacture and market Pilocarpine Hydrochloride Ophthalmic Solution for treating presbyopia, a common condition that affects middle-aged and older adults, making it difficult to see objects up close. However, the DCGI raised concerns over the company’s claims that the eye drops could reduce the need for reading glasses and provide near-instant vision enhancement.
The regulator’s order, issued on September 10, stated that Entod had not obtained approval from the Central Licensing Authority for the claims made about the eye drops. The DCGI’s review highlighted discrepancies between the company’s promotional statements and the approved uses of the product.
Entod Pharmaceuticals’ CEO, Nikkhil K Masurkar, announced that the company would challenge the suspension in court. In a statement, Masurkar defended the company’s practices, asserting that Entod Pharmaceuticals had not misrepresented the product to the media or public. He criticized the suspension as unfair, emphasizing that the company is committed to bringing innovative therapeutic options to the Indian market.
According to the DCGI, the company had failed to address queries regarding their claims and attempted to justify unapproved statements about the product’s effectiveness. The regulator also expressed concerns that the misleading claims could confuse the public.
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