A major move by DGCI was suspension of approval of eye drops due to claims on presbyopia; The company said- we will go to court against this decision

In a landmark decision, the Drug Controller General of India (DCGI) has suspended the approval of a new eye drop. Taking a dig at claims by Mumbai-based Endod Pharmaceuticals regarding eye drops, the DCGI has suspended the company's approval to manufacture and sell its new eye drops. However, the company said it will appeal the decision in court. A new eye drop from Endod Pharmaceuticals is said to help presbyopia sufferers reduce their dependence on glasses. However, according to the National Eye Institute, presbyopia makes it difficult for middle-aged and other adults to see things up close. However, Endod Pharmaceuticals CEO Nikhil K. Mazurkar said the company would challenge the suspension in court. Last month, the DGCI had granted approval to any drug product the company claimed had not obtained the necessary approval from the Central Licensing Authority, thereby violating the New Drugs and Clinical Trials Rules, 2019. violated. In an order issued by the TCGI on Tuesday (September 10), the directorate had approved the manufacture and marketing of pilocarpine hydrochloride ophthalmic solution for the treatment of presbyopia in adults on August 20 last month. However, after this, on September 4, the top drug regulator sought an explanation from the drug manufacturer regarding the claims made in the media, after which the drug manufacturer gave its reply. According to the company, this is the first eye drop manufactured in the country to reduce the need for reading glasses. The company also said that no other eye drops are currently approved for the treatment of presbyopia in India. The DGCI in its decision said that the order on behalf of the DGCI, in this regard, you are informed that such claim that Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v reading has been formulated has not been approved. Reduces the need for glass. Whereas the company claimed that this eye drop is a drug that improves vision to see near objects without the need for glasses. And the order reads, “You are informed that Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v is approved for the treatment of presbyopia in adults. Claims that these eye drops can improve vision without the need for glasses have not been accepted. The drug regulator also said the company failed to respond to other queries on the matter. He tried to justify claims for a product for which no endorsement had been made. The order further said that in view of several media reports, the public is likely to be misled by the claims made by the company, which is not warranted. Therefore, in the public interest, the manufacture and sale of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v is offered under the provisions of Rule 84 of the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019. permission Issued until further orders.