Is Digene banned in India?

Digene is Abbott's antacid brand, sold as chewable tablets and as a gel of magaldrate with simethicone. It is not banned, but it is one of the few consumer medicines in India to have gone through a publicised recall, which is why the question persists.

In early September 2023 a consumer complained that a bottle of Digene gel, mint flavour, tasted bitter and smelled unusual. Abbott investigated, identified the batches concerned, all made at its Goa facility, and initiated a voluntary recall. The Drugs Controller General of India followed with an advisory asking doctors to prescribe with caution and patients to stop using gel from the affected batches and to report any reactions. The recall covered specific gel batches only; Digene tablets and gel from other sites were not part of it. The date and reference of the DCGI advisory are flagged for verification against the CDSCO's own record.

A recall of this kind is a manufacturer's action on a quality defect, taken with the regulator's oversight. It is not a Section 26A notification, and no such notification has been issued against magaldrate, simethicone or the Digene brand. The product has continued to be sold since the recalled batches were withdrawn.

Anyone with a 2023-dated bottle of Digene gel should discard it. Otherwise the brand can be used as labelled, and, as with any antacid, heartburn that needs treatment most days is a reason to see a doctor.