Abbott India warns of laxatives shortage in tussle with Goa regulator

Abbott India

22/09/2023 14:13

By Rishika  Sadam
       HYDERABAD, Sept 22 (Reuters) - Abbott Laboratories'
 ABT.N  Indian unit has warned of potential supply shortages of
two popular laxative syrups after production was prohibited in
India's Goa state, where drug inspectors have found lapses at a
company factory, a letter shows.
    Goa, where Abbott has one of its two India plants, asked the
company to halt production of Cremaffin and Duphalac syrups last
month. The request followed the recall of another Abbott drug
which triggered factory inspections by health officials who
found contamination risks and sanitisation issues.
    The two laxative brands together have estimated annual sales
of $70 million in India, healthcare data firm Pharmarack says.
    In a letter to Goa's Directorate of Food and Drugs
Administration dated Sept. 18, which is not public and has not
previously been reported on, Abbott  ABOT.NS  pushed state
regulators to allow it to restart manufacturing the two
medicines.
    "The two products have a high consumption rate and are
highly prescribed," Abbott said in the letter seen by Reuters.
"We are likely to face a supply shortage of these two products,"
it warned.
    Cremaffin, Abbott argued, is a "necessity to support
hospitalised patients" while Duphalac is prescribed in serious
disorders caused by liver failure.
    Abbott in India and the Goa FDA spokesperson did not
immediately respond to requests for comment. 
    India is a major market for Abbott. Its currently regulatory
challenges in the country began in August with the recall of
thousands of bottles of its popular Digene Gel antacid syrup
following complaints about its taste and odour. 
    Abbott has since halted production of Digene but says there
is no impact on patient health.
    Drug inspectors who visited the Goa facility following the
recall flagged issues such as water stagnation in tanks and
pipes, saying it could lead to contamination and microbial
growth. 
    They asked the company to fix the problems and the FDA
warned it could revoke the manufacturing licence for Digene
syrup, Reuters reported earlier this month. 
    In its latest letter, Abbott told Goa authorities it had
taken corrective steps, segregating the manufacturing lines of
different drugs and changing its cleaning protocols.
    "We are committed to invest and upgrade the manufacturing
site," it said, asking that no action on the licence be taken.

 (Reporting by Rishika Sadam in Hyderabad; Editing by Aditya
Kalra, Kirsten Donovan)
 ((Rishika.S@thomsonreuters.com;))