A special kind of eye drawer was going to be launched in the market for presbyopia patients. Recently this news made a lot of headlines. In which a company claimed that it is going to make such an eye drop. Those who are patients of presbyopia, that is, those who cannot see even the nearby objects properly. And for this they use glasses. It will make them remove their glasses. But now such news is coming.
Know why DGCI suspended him
Antod Pharmaceuticals, which claimed to manufacture eye drops, has had its approval suspended by the Drugs Controller General of India (DCGI). However, Nikhil K. Masurkar, Chief Executive Officer (CEO) of Antod Pharmaceuticals, said that the company will challenge this decision in court.
Antod Pharmaceuticals had claimed that this eye drop will prove beneficial for the patients of presbyopia. It can end their dependence on glasses. According to the ‘National Eye Institute’, people of any age can suffer from presbyopia. In this, one cannot see near objects. While suspending the approval of the drug, the drug regulator said that the company has not taken approval from the Central Licensing Authority for the drug product it has claimed. Due to which the provisions of the New Drugs and Clinical Trials Rules, 2019 were violated.
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DGCI said in an order issued on December 10 that the Directorate had given permission on August 20 for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of presbyopia in adults. After this, on September 4, the drug regulator had sought clarification as evidence of the claim made in the press. But the company making the claim has not yet given any clarification in response to this.
Company’s claim
The company had claimed that it is the first Made in India eye drop to reduce the need for reading glasses. The company also said that there is no other eye drop in India for the treatment of presbyopia. It is informed in this regard that Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v has not been approved for any claim that it is formulated to reduce the need for reading glasses.’
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DGCI’s claim
At the same time, DGCI has said in its order that this decision has been taken keeping in mind the public interest. Under the provisions of Rule 84 of the New Drugs and Clinical Trial Rules, 2019 of the Drugs and Cosmetics Act, 1940, the permission granted for the manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% W/V has been suspended till further orders.
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