MULAGO CLARIFIES ON HIV DRUG TEST
By Jennifer Bakyawa & David MuWanga
The Monitor (Kampala) 3 April 2002
The company that manufactures Nevirapine withdrew its application to
register the HIV/AIDS drug with the United States of America's Food and
Drug Administration (FDA) because Mulago Hospital wrote to them asking
for more time.
"We wrote telling them that we were not ready for a visit. There was
difficulty, in obtaining some documents," Prof. Francis Mmiro, who
headed the Nevirapine trials in 1997 said.
Nevirapine given to mothers on the onset of labour and babies soon
after birth reduces the rate of HIV transmission from parent to child
He was speaking at a press conference held yesterday at the Ministry
of Health headquarters.
Mmiro said there was difficulty in obtaining source documents because
they are stacked up in a container due to the ongoing rehabilitation at
The Director General of Health Services, Prof. Francis Omaswa said that
though they had entered all the data in computers, the FDA needed
original documents for their audit before, they could register the drug.
He said the documents would have been ready for the FDA visit but the
authority changed its requirements like source documents for registration
when they passed a new law in 1998.
Teams use source documents on the onset of a trial to record personal
data of people participating in a study. This information is later transferred
to a case record reform.
Boehringer Ingelheim (BI) applied to FDA for, registration of Nevirapine to
prevent transmission of HIV from mother to child in November 2001.
The pharmaceutical company continues to donate Nevirapine to programmes
in 23 countries where the drug is used to help prevent mother-to-child HIV
The FDA, group was slated to carry out the audit March this year in conjunction
with the National Institute of Health (NHI). The NHL which sponsored the study
in Uganda, went ahead and prepared the hospital for the FDA audit.
"BI will reapply to FDA and carry out the audit this year or early- next year,"
Mulago has so far obtained 100 source documents out of the 600 they
registered during the Nevirapine trials.