Drug controller issues notice recalling antacid Digene gel

The Central Drugs Standard Control Organisation (CDSCO) has issued an advisory recalling Digene gel – one of the most popular antacids in the market–twelve days after the manufacturer Abbot India announced “voluntary recall” of all the batches of the medicine produced in its Goa plant, after having receiving complaints.

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 drug is commonly used to relieve acidity, gastroesophageal reflux disease (acid reflux) and heartburn. It uses basic compounds like magnesium hydroxide to neutralise the stomach acid.

The Central Drug Standards Control Organisation (CDSCO) on 31 August released the advisory asking the distributors and wholesalers to remove all the stock of Digene Gel manufactured at Abbott India’s Goa facility following complaints on the colour, taste and odour of the popular medicine. The advisory was made public on Tuesday (5 September). The firm has a production unit in Himachal Pradesh too.

The Drugs Controller General of India (DCGI), who heads the CDSCO, advised the doctors and healthcare professionals to educate the patient to discontinue the use of Digene Gel and to report any adverse reactions arising from its consumption.

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

CDSCO has asked all zonal and state drug controllers to keep a vigil on the movement, sale, distribution, and stock of the said Digene gel. “Draw samples if the said product is lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics acts and rules…” read the notice.

“Abbott in India has voluntarily recalled Digene Gel antacid medicine manufactured at our Goa site, due to isolated customer complaints on taste and odour. There have been no reports of patient health concerns,” said the company in a statement.

“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,” read the statement. The company did not provide any other clarification.

The Abbott spokesperson on Wednesday (6 September) underscored 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. The other production site is in Baddi,” said the spokesperson.

Abbott India, in its letter to the regulator on 31 August , had stated that one bottle of Digene gel mint flavor was reported of being white in colour instead of pink and had a bitter taste and pungent odour. Following this, the company withdrew one batch and later recalled four batches of orange-flavoured Digene gel and stopped production at its Goa unit.

A week later, it informed the CDSCO that production of all batches of Digene Gel of all flavour had been recalled because the “impugned product may be unsafe and its use may result in adverse reaction”.