Antacid Digene Gel - made at Goa plant- recalled after complaints; Drug regulator issues advisory

India’s drug regulator has issued an advisory announcing removal of a section of Digene Gel – one of the most popular antacids – from the market 12 days after the manufacturer announced “voluntary recall” of all the batches of the medicine produced in its Goa plant, after receiving complaints on some of the batches.

The Central Drug Standards Control Organisation (CDSCO) on August 31 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.

The central regulator asked the state-level agencies to keep a watch on the movement of Digene Gel made at the plant and asked consumers to be careful.

The company first informed the pharma regulator about a voluntary stoppage in the production of a few batches of Digene Gel manufactured at its Salcette unit, but a week later told the Drugs Controller General of India it was recalling of all batches of Digene Gel of all flavours (mint, orange and mix fruit flavour), which were within the shelf life and manufactured at the Goa facility.

“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,” the company said 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.”

The firm has a production unit in Himachal Pradesh too.

Officials in the Union Health Ministry and CDSCO did not respond to queries on why issuing such an advisory took 12 days after the company informed them about the voluntary recall decision.

According to the chronology of the event that Abbott India shared with the regulator, on August 9, one bottle of Digene Gel Mint flavour was reported of having wrong colour (white instead of pink) with bitter taste and pungent odour following which the company first withdrew one batch and later recalled Digene Gel (orange flavour) from four batches and stopped production at the Goa facility.

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.”

While the company did not provide any other clarification apart from a brief statement, industry veteran Chandra M Gulhati, editor, Monthly Index of Medical Specialities told DH, “The manufacturer withdrew it to save its reputation and this will affect its sale. But it is not a case of public safety.”