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The Drugs Control General of India (DCGI) has issued a significant advisory alert regarding Abbott's antacid, Digene gel.
The DCGI has urged patients to immediately discontinue the use of Digene Gel that has been manufactured at Abbott's Goa facility. The regulartory has also instructed the wholesalers to remove impacted product with all batch numbers produced at the facility that are still within their active shelf life.
Healthcare professionals have been advised to exercise caution when prescribing Digene Gel and educate their patients to discontinue its use. Furthermore, they are encouraged to report any adverse drug reactions (ADRs) that may arise from the consumption of the concerned product.
Lastly, the DCGI has directed state, union territory (UT), zonal, and sub-zonal officers to maintain strict oversight over the movement, sale, distribution, and stock of the Digene Gel product in the market. They are also instructed to draw samples if the product is still available in the market and to take necessary actions in accordance with the provisions outlined in the Drugs and Cosmetics Act and Rules.