Gambia tightens rules for Indian drugs after cough syrup deaths - letter
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[June 21, 2023]
By Krishna N. Das and Edward McAllister
NEW DELHI (Reuters) -Gambia will make it mandatory for all
pharmaceutical products from India to be inspected and tested prior to
shipment from July 1, according to Gambian government documents reviewed
by Reuters, the first known restrictions on national exports following
the deaths of dozens of children linked to Indian-made cough syrups.
The new rule highlights how governments are reassessing their reliance
on India's $42 billion pharmaceutical industry since the contamination
came to light last year. India's industry supplies nearly half of the
pharmaceuticals used in Africa. In April, India’s government said its
officials had held meetings in Africa to ensure its drug exports did not
suffer after at least 70 children died in Gambia after ingesting the
cough syrup last year.
Gambia's latest move is to "address issues related to substandard and
falsified (counterfeit) medicines entering the country", the executive
director of its Medicines Control Agency (MCA), Markieu Janneh Kaira,
wrote in a letter to India's drug controller general, Rajeev Singh
Raghuvanshi, dated June 15. The letter said that the MCA had appointed
Quntrol Laboratories, an independent inspection and testing company for
pharmaceuticals based in Mumbai, to issue a so-called Clean Report of
Inspection and Analysis (CRIA) for all shipments from India.
"Quntrol shall conduct document verification, physical inspection of the
consignment and sampling, for laboratory testing for each shipment," the
letter said. "If conformity is established at all levels, Quntrol shall
issue the mandatory CRIA document. If conformity is not established with
regards to the quality of the product, the shipment will be quarantined
or seized by the MCA and the necessary regulatory actions shall be
taken."
Janneh Kaira told Reuters the rule "applies to India for now only".
Since June 1, India has made tests mandatory for all cough syrups before
they are exported.
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Grieving parents hold up signs during a
news conference, calling for justice for the deaths of children
linked to contaminated cough syrups, in Serekunda, Gambia, November
4, 2022. In October 2022, the deaths of more than 70 Gambian
children from Acute Kidney Injury were linked by global health
officials to cough syrups made in India and contaminated with
ethylene glycol (EG) and diethylene glycol (DEG). REUTERS/Edward
McAllister/File Photo
Raghuvanshi did not respond to a
Reuters request for comment. In a letter to Indian state regulators,
he asked them to take note of the new Gambia guidelines.
"This is for your information and immediate action," Raghuvanshi
said in the letter posted to the website of the country's Central
Drugs Standard Control Organisation on Wednesday.
With 2.5 million people, Gambia is one of Africa’s smallest and
poorest countries. The World Bank is funding a testing laboratory in
Gambia but it is not yet finished.
The letter said Quntrol would send samples for testing to "one of
the analytical laboratories approved by MCA". It did not say if the
laboratory would be based in India or elsewhere.
At least 70 children, most of them under the age of 5, died in
Gambia last year due to acute kidney injury that doctors have linked
to adulterated cough syrups from India.
The World Health Organization said last year that the India-made
cough syrups contained lethal toxins ethylene glycol and diethylene
glycol – commonly used in car brake fluid and other products not fit
for human consumption.
These ingredients can be used by unscrupulous actors as a substitute
for propylene glycol, which is a key base of syrupy medicines –
because they can cost less than half the price – manufacturing
experts say.
(Reporting by Krishna N. Das; Editing by Aurora Ellis and Jamie
Freed)
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