New Delhi:

Taking serious note of Mumbai-based Entod Pharmaceuticals’ claims that it can help reduce dependency on reading glasses for those suffering from presbyopia, the Drugs Controller General of India (DGCI) has suspended permission given to the company to manufacture and sell their new eye drop, PresVU.

According to the National Eye Institute, presbyopia is a refractive error that makes it hard for middle-aged and older adults to see things up close.

The DCGI said the company made claims for the product for which it had not obtained approval from the Central Licensing Authority, violating provisions under the New Drugs and Clinical Trial Rules, 2019.

The DCGI on Tuesday said it gave permission on August 20 for manufacture and marketing of Pilocarpine Hydrochloride Ophthalmic Solution for the treatment of presbyopia in adults. On September 4, the drug regulator had asked for an explanation from the company for the claims it made in the press following which the pharma firm gave its response.

The company had claimed it was the “first eye drop in India designed to reduce the need for reading glasses”.

“In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/v has not been approved for any such claim that it is designed to reduce the need for reading glasses,” the DCGI order said.

In response, the company said, “This eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses.”

The DCGI order said considering the media reports, there is a likelihood of the general public being misled by the claims made by the company for which no approval was granted.

While the eyedrop was approved for the treatment of presbyopia in adults, it was not approved for near vision within 15 minutes without the need for reading glasses.

The drug’s approval from the regulator was only as a prescription drug, and not as an over-the-counter drug, which it was being wrongly promoted.

Abbott India informed drug controller Central Drugs Standard Control Organisation of the voluntary recall of Digene Gell and stopped production of all variants of the product manufactured at their Goa facility. Photo: digeneindia.com

The Central Drugs Standard Control Organisation (CDSCO) has alerted healthcare professionals, consumers, patients, wholesalers, distributors, and regulatory authorities about the voluntary recall of Abbott India’s popular antacid syrup Digene Gel, manufactured at its Goa facility.

The public notice issued by the apex drug controller on its website said: “The impugned product may be unsafe and its use may result in adverse reaction.”

The Drugs Controller General of India (DCGI), who heads the CDSCO, also advised the doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the use and to report any adverse drug reactions arising due to consumption of Digene Gel.

“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product,” the DCGI stated in the letter.

The drug controller’s notice said the company initially withdrew one batch of its product available in mint flavour and four batches in orange flavour after receiving a complaint about a product that was white, had bitter taste and pungent smell early August. Within a week the company recalled all batches of its Digene syrup sold in mint, orange, and mixed-fruit flavours manufactured at its Goa facility.

CDSCO said it was reported on August 9 that one bottle of Digene Gel Mint Flavour used by customers was of regular taste (sweet) and light pink colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour as per the complaint.

Abbott India Limited informed the drug controller of the voluntary product recall and voluntarily stopped production of all variants of Digene Gel manufactured at their Goa facility.

CDSCO also urged distributors and users to discontinue the use of Digene Gel manufactured at the Goa facility while stating that there is no need to panic.

The drug is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas. It can be prescribed for gastritis (inflammation of the stomach lining) and acid reflux (a condition where stomach acid flows back to the food pipe). It uses basic compounds like magnesium hydroxide to neutralise the stomach acid.

Abbott spokesperson on Wednesday noted that the company had voluntarily recalled the antacid medicine manufactured at Goa site due to isolated customer complaints on taste and odour. 

“There have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs are not impacted and Digene Gel manufactured at our other production site is not affected and continues to be available in sufficient quantities to meet current demand. The other production site is in Baddi,” the spokesperson added.