DCGI cautions against Digene gel use over safety concerns
Following a complaint, DCGI Rajeev Singh Raghuvanshi has asked all drug controllers to keep a strict vigil on the movement, sale, distribution and stock of Abbott India’s Digene gel
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 9 August alleging that one bottle of Digene Gel mint flavour was of regular taste (sweet) and light pink in 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.
It further said that 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 of 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 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, as per the regulator.