Pharmacists under the Pharmaceutical Society of Uganda want the
National Drug Authority-NDA to make changes in its drug-testing protocols.
Samuel Opio, the President of the Pharmaceutical Society of
Uganda says that while drug recalls are common, NDA is mandated to make sure
that all the products that end up on the market are safe. He says that
even without international recalls, NDA should have checks and balances to
ensure that all medicines on the market are safe.
"At the moment,
the only testing that is carried out is for mandatory drugs such antimalarial.
Other drugs are tested when they are already on the market. And this has shown
to be a problem,” Opio said.
According to Opio, the many recalls that have been issued during
2019 are a sign that more needs to be done. He suggests that NDA should carry
out more extensive testing.
“NDA needs to see how to minimize recalls. They need to see that
whatever enters the market needs to complete its shelf life without it being
pulled off. They have to strengthen premarket testing. They rely now on post-market
but premarket testing is needed. Mandatory testing should be carried out for
more products,” Opio explained.
At the moment, Uganda only carries out mandatory testing for ARVs, antimalarial
and condoms because they are categorized as important medicines.
Four big recalls have been issued this year. The first recall occurred in
September 2019 when Cipla recalled Hepatitis B drugs Texavir because their
quality was affected due to poor packaging.
In October, following warnings made by international drug agencies
like the US Food and Drug Administration, NDA recalled popular ulcer and
heartburn medicine Zentac because it was discovered to have cancer-causing
molecules. The authority also recalled 14 painkillers and antibiotics that were
manufactured by China-based company Zhejiang Ruixin Pharmaceutical Co Ltd and
imported by Astra Pharma (U) Limited.
Despite all these recalls, NDA says that instead of people questioning its
credibility, they should be applauding for a job well done. According to NDA,
the recalls are evidence that the authority is working.
Dr David Nahamya, the secretary to the authority says that recalls are normal
things that happen from time to time due to the ever-changing field of
medicine. He says that the body has carried out its mandate.
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While NDA says the drug recalls are not something to worry about,
the recalls brings question of how drugs end up on the market. Ideally, before
a drug can be allowed onto the market, there must be evidence that the drug is
safe. If a drug is being locally manufactured, NDA has to get samples of the
compounds and finished product and subject them to testing upon which a
certificate is issued.
Importers or distributors of drugs need to apply for an import
permit from NDA. Once NDA receives the application, it verifies the application
by checking to see a need of the drug and whether it is cleared and licensed by
international drug or health regulatory companies like World Health
Organisation or the Food and Drug Administration in the USA.
If the drug appears on the register, NDA then makes a site visit
to the country of origin of the drug to ascertain whether Good Manufacturing
Processes- GMP are met during the production of the drug. These take into
account the environment drugs are being manufactured in, the level of
sterilization and availability of personal protective equipment.
If GMP standards are met, NDA then clears the import license and the drug
can be imported into the country. It must be accompanied by a certificate of
analysis which shows that the drugs were tested and passed international
According to data from the ministry of health, 90 percent of the
drugs that are consumed in Ugandan are imported. Only 10 percent are
manufactured within the country.
Dr Nahamya says that they are working as an authority to be able
to carry out more testing of drugs.
“We have large volumes of drugs that enter the country but we
cannot test everything due to human resource challenges and also technical
ability. But we are working on this. We are building a new laboratory that will
increase our ability as a country to test what is on the market,” Dr Nahamya