Why has Digene gel, the acidity medicine, been recalled in India? Is it safe to consume?

Is Digene gel unsafe? Batches of the popular antacid used to soothe acidity have been recalled in India by drugmaker Abbott India after a complaint of a bitter taste and pungent odour. This comes after the Drug Controller General of India (DCGI) issued an advisory against using the product manufactured at a particular plant. Digene gel is used to provide relief from acidity. So, what happened? And is Digene unsafe? Let’s take a closer look: What happened? The DCGI has issued an advisory recommending that consumers and patients not consume Digene Gel manufactured at Abbott India’s Goa plant. The DCGI has issued the advisory on the basis of a complaint filed on 9 August. The plaint alleges that one bottle of Digene Gel mint flavour tasted normal and was pink in colour while another bottle from the same batch had a bitter taste and pungent odour and was white in colour. As per News18, the DGCI, in its letter, stated, “On 9th August 2023, one bottle of Digene Gel Mint flavour used by the customer is of regular taste (sweet) and light pink colour whereas another bottle of same batch observed it was of white colour with bitter taste and pungent odour as per complaint (sic)”. The Times of India reported that the DGCI cautioned that all flavours – mint, orange and mixed fruits – within shelf life and manufactured at this plant should not be consumed.

The DGCI in its letter warned that use of the product manufactured at this plant may ‘result in an adverse reaction’.

“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product,” the DGCI wrote in its letter. The DGCI has further directed retailers and wholesalers to remove the product manufactured at Abbot’s Goa plant from shelves and distribution. The DCGI also directed states/Union Territories Drugs Controllers to keep a strict vigil on the movement, sale, distribution, stock of the drug products in the market, draw samples of the product lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules. ‘Initiated recall voluntarily over isolated complaint’ Abbott India in its letter to DCGI dated 11 August said it had voluntarily recalled the impugned product and also stopped production of all variants of Digene Gel manufactured at their Goa facility.

Abbott India told News18 the voluntary recall has been given the go-ahead following “isolated customer complaint on taste and odour”.

“Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site due to isolated customer complaints on taste and odour,” an Abbott spokesperson told News18. “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.” As per Moneycontrol, Digene gel manufactured at other facilities has not been impacted. With inputs from agencies