Goa state warns Abbott India on antacid Digene license suspension (updated)

Abbott India

14/09/2023 12:32

(Adds details from government documents, context paragraphs
9-13)
    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 of 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.
    
    INSPECTION REPORTS 
    "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.
    Inspection reports said they found sanitization was not done
at the Goa factory as per standard operating procedures, and
records showed batches in question were kept for 21 days after
manufacturing in a holding tank without mixing, "which may be
the possible reason for contamination or growth of bacteria." 
    The warning notice was issued even as Abbott, in a letter to
Goa regulators on Aug. 28 seen by Reuters, stated it will take
"corrective and preventive measures" to address concerns,
including those related to cleaning processes.
    Digene syrups in mint, orange and mixed fruit flavours are 
popular across India. The medicine continues to be manufactured
by Abbott at its other Indian factory in Himachal Pradesh state,
though the drug's manufacturing in Goa has been halted by the
company.
    Inspection documents said the Digene recall affected 179
batches of 7.6 million bottles, many of which would have been
consumed. By the end of August, 486,439 bottles were yet to be
recalled.
    Goa authorities have also ordered Abbott to stop the
manufacturing or filling of liquid products which used "common
facilitites" as those for Digene, leading to a halt in making
laxative syrups Cremaffin and Duphalac at the plant.

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