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Drugs watchdog issues alert against antacid Digene gel, Abbott initiates voluntary recall

The public notice issued on August 31 by Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, said: “The impugned product may be unsafe, and its use may result in an adverse reaction.” NEW DELHI: The Drug Controller General of India (DCGI) has issued an advisory alert against the popular Abbott’s antacid syrup, Digene gel, which is used against acidity and gas. The company announced that it had withdrawn all its batches that were being manufactured at its Goa facility following a complaint from a customer that the liquid in the bottle had turned white, tasted bitter, and had a pungent smell when they bought it in early August. Digene gel is a sugar-free syrup that effectively acts against acidity and gas, reduces stomach pain, and protects the stomach from making excess acid for long-lasting relief. The syrup, which is pink in colour, has a sweetish taste. It is available in mint, orange, and mixed fruit flavours. The public notice issued on August 31 by Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, said: “The impugned product may be unsafe, and its use may result in an adverse reaction.” It further issued advisory to doctors, healthcare professionals, consumers, wholesalers and distributors, and to regulatory authorities. DCGI has asked doctors and healthcare professionals to “carefully prescribe and educate their patients to discontinue the use and for reporting any ADRs (adverse drug reaction) arising due to consumption of the said product.” “Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product.” It asked the consumers to “discontinue” Digene Gel, manufactured at the Goa facility. ALSO READ | Late marriages and lifestyle lead to high infertility rates in south, says survey The regulator has also instructed all state/UTs Drug Controllers and all zonal and sub-zonal officers of CDSCO to keep a strict vigil on the movement, sale, distribution, and stock of the said drug products in the market, draw samples if the product is lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules. According to Dr Shuchin Bajaj, Consultant Internal Medicine, Ujala Cygnus Group of Hospitals, the recalling of Digene Gel and the advisory issued in this regard by DCGI is in the best interest of the public. “It is to be noted that unsupervised and long-term usage of antacids can lead to kidney issues and other complications. Therefore, people should always consult a registered healthcare practitioner before consuming any medicine,” he told this paper. One should take proper guidance on the dosage of such antacids and not consume any form of medicine out of habit, he added. "Besides, one should always watch out for the physical properties of the treatment they are consuming and immediately discontinue any medication that differs in appearance, smell, or taste as this could indicate subpar quality," he further said. Abbott India Limited initially withdrew one batch of its product available in mint flavour and four batches in orange flavour after receiving the complaint. Later, within a week, the company recalled all batches of Digene gel in all variants manufactured at its Goa facility. “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," it said. It also said that "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." The DGCI said that it was reported that the complaint was received on August 9 about the medicine. following which on August 11, the company informed the DCGI office of a voluntary recall of the product under question. Further, the company on August 18 had intimated to the DCGI office regarding the voluntary product recall of all batches of Digene Gel of all flavours (Mint, Orange, mix fruits flavour) which are within the self-life and manufactured at the Goa facility. (THE NEW INDIAN EXPRESS)