Goa state warns Abbott India on antacid license suspension

Abbott India

14/09/2023 12:06

By Rishika  Sadam
       HYDERABAD, India, Sept 14 (Reuters) - India's Goa state
has warned the local unit of Abbott Laboratories  ABT.N  it
plans to suspend the manufacturing license of its popular
antacid medicine after inspectors flagged contamination risks
and sanitization issues at its factory, government documents
show.
    The U.S. based drugmaker is locked in a tussle with drug
regulators in the tourist state of Goa in western India after
the company, starting August, voluntarily recalled many batches
of its Digene Gel syrup produced there after it received
customer complaints on taste and odor. 
    Abbott says there is no impact on patient health.
    The Goa plant is one of Abbott's two factories in India,
where Digene has a 7% share in the market for so-called
antiflatulent medicines, according to Pharmarack, which
estimated annual Digene syrup sales at $11 million, with 8
million units sold.
    Following the recall, inspectors conducted four inspections
at Abbott's Goa factory between Aug. 24 and Sept. 2 and flagged
issues such as water stagnation in tanks and pipes, saying:
"This may lead to the contamination and microbial growth,"
confidential inspection reports reviewed by Reuters showed. 
    Following that, the state director of the Goa Food and Drugs
department, Jyoti J. Sardesai, wrote a warning notice to Abbott
on Sept. 11, saying: "I intend to cancel the product permission
for all variants of Digene Gel/suspend the licenses held by you
for a period deemed fit."
    The state authorities have given Abbott seven days to
respond to the notice to defend its position. Abbott India
 ABOT.NS  did not immediately respond to a request for comment.
    "Whatever protocol has been laid down for the state
government to follow when it comes to handling such issues, that
has been followed," Goa Health Minister Vishwajit Rane told
Reuters about the Abbott incident.

 (Reporting by Rishika Sadam; Editing by Aditya Kalra and David
Holmes)
 ((Rishika.S@thomsonreuters.com))