Following an investigation into Abbott's local operations, Goa State officials issued a warning letter to Abbott India regarding the suspension of their licence for an antacid composition known as Digene gel. At the factory, the inspection authorities detected potential environmental dangers as well as sanitization difficulties.
Diagene gel is widely used in India to treat conditions like peptic ulcers, oesophagitis, gastritis, and hyperacidity. It is also available in tablet and gel in multiple flavours like orange, mint, and mixed fruit.
It may be recalled that CDSCO (the Central Drug Standard Control Organisation) had already issued an alert to Abbott India for their Diagene antacid gel. In the statement, CDSCO said, "The impugned product may be unsafe, and its use may result in adverse reactions." The company voluntarily recalled the product after consumer complaints. According to media reports, the product recall affected 7.6 million bottles from 179 consignments.
U.S.-based Abbott has two manufacturing plants in India: in Baddi (Himachal Pradesh) and Verna (Goa). In the antacid drug market, Diagene has a 7% market share. Pharmarack, a health data platform, estimates that Digene syrup sales are about eleven million US dollars, with eight million units sold annually.
After the recall, four inspections were carried out at its plant in Verna Industrial Estate, Goa, from August 24 to September 2, 2023. During the inspection, the team found that stagnation in pipes and tanks was the source of contamination. In the report, they said, "This may lead to contamination and microbial growth."
|-CDSCO warns about spurious medications in India after WHO issues an alert|
|-Abbott recalls Digene Gel from the market after DCGI notification.|
As per the inspection report, the Goa plant did not follow standard sanitization procedures, and batches were stored in the holding tanks without mixing for 21 days after production. Despite the assurance provided by the company, the state regulatory agency issued a warning notice to address concerns associated with the cleaning procedures.
In the warning notice to Abbott, the State Director of the Goa Food and Drugs Department, Jyoti J. Sardesai, said, "I intend to cancel the product permission for all variants of Digene Gel or suspend the licences held by you for a period deemed fit."
In response to the warning letter, Abbott India said, "The letter issued by the Goa FDA and their recent visit to our site is part of the regulatory process."
Talking to the media, Goa Health Minister Vishwajit Rane said, "Whatever protocol has been laid down for the state government to follow when it comes to handling such issues, that has been followed."
The Goa State regulatory agency has granted Abbott seven days to submit its written response clearing its position.
They also instructed the Abbott plant to halt the manufacturing of their liquid formulations that used regular facilities such as those used in Diagene preparation, resulting in the termination of the laxative syrup production of Cremaffin and Duphalac at the local unit.