New Delhi (Agency): The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi, has issued a crucial advisory concerning the use of Digene Gel, an antacid produced by Abbott India at its Goa manufacturing unit. The advisory has been issued in response to a complaint received on August 9, which highlighted discrepancies in the product.
The complaint specifically pointed out that there were noticeable differences in the appearance and taste of Digene Gel from the same batch. One bottle of Digene Gel mint flavor had a regular, sweet taste and a light pink color, while another bottle from the same batch was white in color with a bitter taste and a pungent odor.
In light of these concerns, the DCGI has expressed that the product manufactured at the Goa facility could potentially be unsafe and may lead to adverse reactions in those who use it.
To address this issue, the DCGI’s advisory contains several key points:
Doctors and healthcare professionals have been advised to carefully prescribe this product and educate their patients about discontinuing its use. They are also encouraged to report any adverse drug reactions (ADRs) associated with the product.
The advisory recommends the removal of the product from distribution if it is within its active shelf life.
State and Union Territory Drugs Controllers have been instructed to closely monitor the product’s movement, sale, distribution, and stock in the market. They are also urged to draw samples from the market and take necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules.
In response to the advisory, Abbott India has voluntarily recalled the affected product and has halted the production of all variants of Digene Gel manufactured at their Goa facility. This advisory serves as a precautionary measure to ensure the safety of individuals using antacids, particularly Digene Gel, in India.