Insight: Indian cough syrup: mystery middleman may be new clue

SKC

29/04/2023 07:00

By Krishna N. Das and Jennifer Rigby
       NEW DELHI/LONDON, April 29 (Reuters) - An unnamed
middleman in Mumbai provided a crucial raw material used in
Indian-made cough syrups that have been linked to the deaths of
more than 70 children in Gambia, a chemicals trader involved in
the supply chain told Reuters.
    The World Health Organization said last year the syrups,
made by Indian manufacturer Maiden Pharmaceuticals Ltd,
contained lethal toxins ethylene glycol (EG) and diethylene
glycol (DEG) – used in car brake fluid. These ingredients can be
used by unscrupulous actors as a substitute for propylene glycol
(PG), which is a key base of syrupy medicines – because they can
cost less than half the price, as Reuters reported in March.
    The children who died were mostly under age 5 and died of
acute kidney injury, some within days of taking the syrups.
    India's drugs regulator told the WHO in December that the
propylene glycol used in the syrups came from Goel Pharma Chem,
a Delhi-based pharma-supplies company, and was "recorded to have
been imported" from South Korean manufacturer SKC Co Ltd
 011790.KS .
    Sharad Goel, whose eponymously named company is based in
north Delhi, said he had bought the ingredient in sealed barrels
– but not directly from SKC.
    "We bought the propylene glycol from an importer in Mumbai
who bought it from SKC," Goel told Reuters in February, speaking
out for the first time.
    "I can't name the supplier - we have business links that we
need to keep," said Goel, adding his company had "not done
anything wrong." He said his business was "just a trader and we
pass on sealed barrels that we get. We can do nothing with
them."
    Reuters could not independently confirm Goel's assertion. He
said that after the Gambia poisonings, his company had stopped
selling PG but continued to supply other products such as
starch, and that he generally buys most of his products from
8-10 importers. 
    Goel subsequently stopped answering calls and when a
reporter called at his business twice in April, it was locked.
Workers at a neighbouring factory said they had not seen it 
opening in the past few months.
    SKC told Reuters it had never supplied any PG either to Goel
or to Maiden.
    If true, Goel's claim would point to a missing link in
investigations by Gambia, India and the WHO into the
contaminated products. The clue comes as the WHO and Gambia's
government say the search for a culprit has been stymied by a
lack of information from India.
    India's drugs regulator said in December its own tests found
no toxins in the syrups, but its factory inspectors did earlier
find that batches of medicine may have been incorrectly labeled,
according to a notice it sent to Maiden seen by Reuters. 
    It has not made clear how, in light of that, it can be sure
it tested the correct batch.
    India's health ministry did not respond to questions about
the alleged intermediary or about any of the other issues raised
in this story.
    Asked to comment on the claim there was a middleman in the
supply chain, the WHO's lead investigator said inquiries have
reached a "dead end" due to a lack of information from the
Indian authorities and the drugmaker.
    "If you ask and you don't get informed, it's a dead end,"
Rutendo Kuwana, the WHO's team lead for incidents with
substandard and falsified medicines, told Reuters in an
interview on March 31.
    A WHO spokesperson said this week that the information it
has received from Indian authorities so far is only that Goel
bought propylene glycol from SKC, but that no evidence of the
trades was provided. The WHO said it also has not been able to
confirm that transaction with the Korean regulator. The Korean
regulator did not respond to a request for comment. 
    India's regulator said its information on the raw materials
came from certificates of analysis (COAs) – standard paperwork
used to track each ingredient in a drug supply chain. Maiden
said last October that it had obtained raw materials from
"certified and reputed companies."
    As well as denying that Maiden's syrups are connected to the
deaths in Gambia, India's health ministry has told the WHO that
its allegations "adversely impacted the image" of the country's
$41 billion pharmaceutical industry. 
    Maiden's boss, Naresh Kumar Goyal, told Reuters in December
his company did nothing wrong, and did not respond to further
questions for this story. A Maiden representative in its New
Delhi headquarters also declined to comment. 
    Gambia's Medicines Control Agency also said it had not
received any information from Maiden or the Indian authorities
"despite our request for information after the discovery of the
tainted products." 
    The WHO'S Kuwana told Reuters his agency is still intent on
finding out what happened with Maiden's products. The WHO is
also trying to find out more about the supply chains of two
other Indian drugmakers who produced contaminated cough syrups
sold in Uzbekistan and the Marshall Islands and Micronesia,
according to alerts published by the agency. Both companies deny
wrongdoing; Indian police arrested three employees of one of
them in March.
    Authorities in Uzbekistan arrested four people in January in
relation to that case. Neither they nor the authorities in
Micronesia responded immediately to requests for comment.
    
    VIOLATIONS
    Maiden has a track record of production issues. In February,
an Indian court sentenced two of its executives, Managing
Director Goyal and Technical Director M.K. Sharma, to
two-and-half years in jail for exporting substandard drugs to
Vietnam nearly a decade ago. 
    The court gave them a month to appeal; Reuters could not
ascertain the status of the case. Goyal did not respond to
requests for comment; neither Sharma nor his lawyer could be
reached. The Maiden representative declined to comment.
    Drug inspectors found a dozen violations at Maiden last
October related to the production of the cough syrups sold to
Gambia, a government document showed. Among these, some of the
COAs of raw ingredients used in making the syrups, including
propylene glycol, were missing batch numbers. Others lacked
manufacturing and expiry dates.
    Four industry and regulatory experts told Reuters this means
that there could be no reliable record of where the ingredients
came from.
    The government inspectors also found Maiden had failed to
test the PG used in the syrups. They cited discrepancies in the
documentation of the finished products - the labels on the syrup
bottles said they were made in December 2021 but batch
manufacturing records pointed to later dates, between February
and March in 2022.
    This mismatch would make it difficult for government testers
to be certain the medicines they were analysing were the same as
those sent to Gambia, according to a former Indian health
ministry official. 
    "There is complete discordance in the data in the labels and
the batch records, which raises questions about the genuineness
of the product," said Kundan Lal Sharma, who was in charge of
drug and food regulation in the health ministry between 2014 and
2017.
    "This means something has been cooked up," he said. "Nobody
can guarantee anything unless proper documentation is there."
    India's health ministry has declined to say how it verified
that the syrups tested by its labs came from the same batches
and Maiden has not responded to questions about the labeling or
documentation. 
    Kuwana said the WHO was sure of its own cough syrup test
results from two separate independent laboratories, both of
which showed contamination.
    He said the agency has not seen the full results of the
tests conducted on the syrups by the Indian government, or the
COAs for the raw materials or finished products sampled, despite
repeated requests.
    The agency says it is now reviewing its guidelines on how
countries should police raw materials in medicines, based on the
recent events.
    Asked how it was possible that test results from the WHO and
India did not match, Kuwana said that in past incidents of
adulterated medicines, a manufacturer has substituted samples
for testing that did not represent what was on the market. The
WHO is not aware whether that happened in this case, he said.
    "Normally when that happens, it is because we haven't tested
the same sample," said Kuwana.

    <^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
As African children died, doctors fought to get toxic Indian
cough syrup banned     https://www.reuters.com/investigates/special-report/health-coughsyrup/
    ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
 (Additional reporting by Edward McAllister in Senegal, Joyce
Lee in Seoul, Devjyot Ghoshal in New Delhi, John Mair in Sydney;
Edited by Sara Ledwith and Michele Gershberg)
 ((krishna.das@thomsonreuters.com))