India’s Goa state has issued a warning to Abbott Laboratories, stating its intention to suspend the manufacturing licence of the company’s antacid medicine. This comes after inspectors identified contamination risks and sanitization issues at Abbott’s factory in Goa. The US-based drugmaker had earlier initiated voluntary recalls of several batches of its Digene Gel syrup, after customer complaints regarding taste and odor. Abbott maintains that the medicine has no negative impact on patient health.
The Goa plant, which produces Digene, is one of Abbott’s two factories in India. Digene has a 7% market share of the antiflatulent medicines segment in the country, according to healthcare data platform Pharmarack. Sales of Digene syrup are estimated at $11 million annually, with 8 million units sold.
In response to the recall, inspectors conducted four inspections at Abbott’s Goa factory, uncovering issues such as water stagnation in tanks and pipes. These issues were identified as potential sources of contamination and microbial growth. The Goa Food and Drugs department subsequently issued a warning notice to Abbott, stating its intention to suspend the manufacturing licenses of all variants of Digene Gel.
Abbott has been given seven days to respond to the notice and defend its position. The company has stated that it is in the process of responding to the notice and has characterized the actions of the Goa FDA as part of the regulatory process.
Inspection reports highlighted several deficiencies at the Goa factory, including deviations from standard operating procedures for sanitization and improper handling of batches. Records indicated that batches in question were kept for 21 days in a holding tank without proper mixing, potentially leading to contamination and bacterial growth.
Abbott had previously pledged to take corrective and preventive measures to address concerns raised by Goa regulators. However, the warning notice was still issued. Production of Digene syrup has been halted at the Goa site, though manufacturing continues at Abbott’s other factory in Himachal Pradesh state.
In addition to suspending production of Digene, the Goa authorities have also ordered Abbott to stop manufacturing or filling other liquid products that utilized common facilities with Digene. As a result, the production of laxative syrups Cremaffin and Duphalac at the Goa plant has been halted.
Goa Health Minister Vishwajit Rane has stated that the state government has followed all protocols in dealing with the issue. Meanwhile, the recall of Digene has impacted 179 batches of 7.6 million bottles, a considerable portion of which had already been consumed. By the end of August, 486,439 bottles were yet to be recalled.
For Abbott, the suspension of its manufacturing license in Goa represents a significant setback. The company will need to respond effectively to the notice and implement measures to address the contamination and sanitization issues highlighted by the inspectors.
