PANAJI: According to government records, Goa state in India has told the local Abbott Laboratories (ABT.N) branch that it intends to revoke the antacid medication’s manufacturing license after inspectors discovered potential contamination concerns and sanitization problems at the facility.
After voluntarily recalling numerous batches of its Digene Gel syrup manufactured there beginning in August in response to consumer complaints about taste and odor, the drugmaker with headquarters in the United States is embroiled in a battle with drug authorities in the vacation state of Goa in western India.
The health of the patient is unaffected, according to Abbott.
According to healthcare data portal Pharmarack, the Goa factory is one of Abbott’s two plants in India, where Digene has a 7% market share for so-called antiflatulent medications. Pharmarack estimated yearly Digene syrup sales at $11 million, with 8 million units supplied.
Inspectors identified problems such water stagnation in tanks and pipes, saying: “This may lead to the contamination and microbial growth,” during four inspections they carried out at Abbott’s Goa factory between August 24 and September 2.
After that, on September 11, Jyoti J. Sardesai, the state director of the Goa Food and Drugs department, sent Abbott a warning letter in which she stated: “I intend to cancel the product permission for all variants of Digene Gel/suspend the licenses held by you for a period of time deemed fit.”
Abbott has seven days to react to the notification and present its case to the state authorities.