Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi has issued an advisory to discontinue the use of antacid Digene Gel manufactured by drugmaker Abbott India at its Goa unit.
The DCGI has issued the advisory following a compliant on August 9 alleging that one bottle of Digene Gel mint flavour is 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.
The DCGI said the impugned product manufactured at the Goa facility may be unsafe and its use may result in adverse reaction.
"The doctors and healthcare professionals should carefully prescribe and educate their patients to discontinue the use and for reporting of any ADRs (adverse drug reactions) arising due to consumption of the said product. Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product," read the advisory issued by Dr Raghuvanshi recently.
It further said the said product within active shelf life to be removed from the distribution.
The DCGI also asked states/union territories drugs controllers to keep strict vigil on the movement, sale, distribution, stock of the drug products in the market, draw samples if the product lying in market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules.
Abbott India in its letter to DCGI on August 11 said it had voluntarily recalled the impugned product and also stopped production of all variants of Digene Gel manufactured at their Goa facility, as per the regulator.
Meanwhile, Abbott in a statement said, “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."
"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," it said.