The government has issued advisory against the use of Digene Gel manufactured by Abbott India (X Photo)
Why was Digene Gel recalled? What are the options?
The Centre issued an advisory for the discontinuation of Digene Gel manufactured by Abbott India at its Goa unit after the company recalled the drug from the market
The Directorate General of Health Services (DGHS) on August 31 issued an advisory to consumers, medical practitioners and various enforcement authorities to discontinue the use and sale of Digene Gel, an over-the-counter syrupy drug taken to remove acidity. The advisory came after Abbott India, manufacturer of Digene Gel, on August 18 informed the DGHS office about its voluntary recall of all batches of the drug.
So what is all the controversy about?
What is Digene?
Digene is a group of medicines called “antacids” used to treat abdominal ailments such as acidity, heartburn, indigestion, inflammation of the stomach (gastritis) and stomach upset. These symptoms appear when the mucous layer that protects the internal lining of the intestine gets eroded owing to excessive production of acid. Digene neutralises the impact of excessive production of acid and provides relief from these symptoms.
Who makes Digene?
Abbott India, a Mumbai-based pharmaceutical company, manufactures Digene Gel at its Goa facility. Abbott India is a subsidiary of Abbott Laboratories, a US medical devices and pharmaceutical company, working in the field since 1910.
Why is it being recalled?
Abbott India decided to recall the drug after the company received a complaint from a user that a bottle of Digene Gel Mint Flavor was of white colour, was bitter in taste and had a pungent odour. The company has also voluntarily stopped production of the drug at its Goa-based manufacturing unit.
What DGHS directive says?
The Central Drugs Standard Control Organization (CDSCO), the Enforcement Division of DGHS, has in its advisory asked doctors and healthcare professionals to observe precaution while prescribing the drug and educate their patients to discontinue its use. They should also report if they see any adverse impact on any patient.
All wholesalers and distributors have also been advised to take off the stock.
Besides this, CDSCO has also asked all drug controllers of all state and Union Territories to “keep a strict vigil on the movement, sale, distribution and sale of the drug products in the market”. They have also been asked to draw samples from the market and initiate necessary action.
What do experts say?
According to health professionals and medical practitioners, though Digene Gel is usually safe, its long use may lead to other complications. Its long-term use can lead to kidney and bone issues and it should taken only under the guidance of a doctor.Alternatives to Digene Gel
However, the advisory issued by the DGHS in the wake of product recall by Abbott India does not forbid the use of the tablet form of the drug. Then there are other alternatives to the recalled drug like Ulgel, Visco Syrup, Entagene, and Riflux Forte Syrup, among others which are cheaper and equally effective.
