Shillong, Sept 7: The Drugs Controller General of India (DGCI) has advised patients and healthcare professionals to stop using Digene Gel, a popular antacid, due to safety concerns arising out of experienced by consumers that the liquid in the bottle had turned white, tasted bitter and had a pungent smell when they bought it early August.
The drug is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas.
Responding swiftly, the Meghalaya health department has issued a direction to expedite the ban on the sale of the same medicine while alerting the public of the concerns for their safety.
A communique signed by the Assistant Drug Controller of Meghalaya, I Toi has alerted all wholesalers and retailers of medicines through all inspectors of the state to immediately take stock of the commodity and cease immediately from further sale.
“We have taken immediate cognizance of the DGCI advisory and directive and alerted all our Drug Inspectors to respond accordingly, if thereafter, we find any Pharmacy selling the product then appropriate action shall be taken as per the law,” Toi said over phone, adding, “The public should not worry and panic, it is just four batches that seem to have generated this reaction and Abbot has already voluntarily withdrawn the same. But we are not taking any chances.”
Drug manufacturer Abbott India has recalled all batches of the antacid syrup, Digene gel, which were manufactured at its Goa facility. The Drugs Controller General of India (DCGI) has issued an advisory alert against Abbott’s antacid Digene gel.
The DCGI has asked patients and consumers to discontinue the use of the antacid gel with a public notice stating, “The impugned product may be unsafe and its use may result in adverse reaction,” while urging people to discontinue the use of Digene gel manufactured at the Goa facility.
The regulator added the wholesalers should remove impacted products with all batch numbers manufactured at the facility within active shelf life to from distribution.
DCGI has asked healthcare professionals to “carefully prescribe and educate their patients to discontinue the use and for reporting of any ADRs (adverse drug reaction) arising due to consumption of the said product”.
Digene, available in both liquid and pill form, is used for is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas.
Mumbai-based Abbott India on August 11 had informed the DCGI office for a voluntary recall of the product under question – Digene Mint flavor batch flagged by the customer and three other Digene Gel orange flavour and voluntarily stopped production of all variants of the product manufactured at the Goa facility, Moneycontrol reported.
Later on August 18, the company informed the DCGI office regarding voluntary product recall of all batches of Digene Gel of all flavours (Mint, Orange, mix fruits flavor) which are within the self-life and manufactured at the Goa facility.